COMMENT DUE DATE:  

February 14, 2020

DATE: 

January 15, 2020

Bill Bryant, Researcher, Innovative Services 405 521-4175

Dena Thayer, Programs Administrator, Legal Services - Policy 405-521-4326

Nancy Kelly, Policy Specialist, Legal Services - Policy 405-522-6703

RE:  

APA WF 20-2C

It is very important that you provide your comments regarding the DRAFT COPY of policy by the comment due date. Comments are directed to *STO.LegalServices.Policy@okdhs.org. 

The proposed policy is  Permanent .  This proposal is subject to Administrative Procedures Act

It is important that you provide your comments regarding the draft copy of policy by the comment due date.Comments are directed to *STO.LegalServices.Policy@okdhs.org.The proposed amendments are permanent.

A public hearing is scheduled for 10:00 a.m. on February 24, 2020, at DHS, Sequoyah Memorial Office Building, 2400 N. Lincoln Boulevard, Oklahoma City, Oklahoma 73105, Room C-48.Anyone who wants to speak must sign in at the door by 10:05 a.m.

SUBJECT:CHAPTER 2. ADMINISTRATIVE COMPONENTS

Subchapter 39. Office of Planning, Research, and Statistics Innovation Services

Part 1 - Office of Planning, Research, and Statistics Innovation Services

340:2-39-1 Office of Planning, Research, and Statistics Innovation Services

[AMENDED]

Part 3. Oklahoma Department of Human Services Institutional Review Board (DHSIRB) [AMENDED]

340:2-39-5 through 340:2-39-11[AMENDED]

340:2-39-11.1 [NEW]

340:2-39-12 [AMENDED]

340:2-39-12.1 [NEW]

340:2-39-12.2 [NEW]

340:2-39-13 [AMENDED]

(Reference WF 20-2C)

SUMMARY:

The proposed amendments to Chapter 2, Subchapter 39:  (1) change the Office of Planning, Research, and Statistics name to Innovation Services (IS); (2) expand Oklahoma Administrative Code (OAC) 340:2-39-1 to include a function presently defined in OAC 340:2-39-6; (3) provide that IS carries out Office of Planning, Research, and Statistics functions; (4) implement rules to conform to new federal regulations for the protection of human research subjects; and (5) improve Oklahoma Department of Human Services (DHS) Institutional Review Board (DHSIRB) operations.

The proposed amendments broadly support the DHS state fiscal year 2019-2020 Strategic Plan by continuing efforts to implement innovative solutions improving how DHS does business.In particular, the amendments will build and maintain effective partnerships with investigators wanting to conduct human subject research. Over time, the amendments will assist DHS promote greater programmatic knowledge for staff, with the potential to streamline processes and improve the accuracy of service delivery.

The proposed changes clearly identify DHS IS to describe the functions that are within the Subchapter 39 administrative components for which DHS is responsible. The changes also provide a consolidated listing of functions that are assigned to IS.

The federal regulations on the protection of human research subjects were recently revised and revisions are needed to align with the federal changes. The proposed changes result in clearer guidance to researchers, helping them to conduct valuable research while fully protecting human research subjects.

PERMANENT APPROVAL:Permanent rulemaking is requested.

LEGAL AUTHORITY:Director of Human Services; 56 O.S. § 162; C.F.R. § 46.108(a)(3); and 45 CFR § 46.116.

Rule Impact Statement

To:Programs administrator

Legal Services - Policy

From:Jami Ledoux, Chief of Innovation

Innovation Services

Date:December 13, 2019

Re:CHAPTER 2. ADMINISTRATIVE COMPONENTS

Subchapter 39. Office of Planning, Research, and Statistics Innovation Services

Part 1 - Office of Planning, Research, and Statistics Innovation Services

340:2-39-1 Office of Planning, Research, and Statistics Innovation Services [AMENDED]

Part 3. Oklahoma Department of Human Services Institutional Review Board (DHSIRB) [AMENDED]

340:2-39-5 through 340:2-39-11[AMENDED]

340:2-39-11.1 [NEW]

340:2-39-12 [AMENDED]

340:2-39-12.1 [NEW]

340:2-39-12.2 [NEW]

340:2-39-13 [AMENDED]

(Reference WF 20-2C)

Contact:Jami Ledoux, Chief of Innovation, (405) 522-3167

Bill Bryant, Researcher, (405) 521-4175

A.Brief description of the purpose of the proposed rule:

Purpose.

The proposed amendments to Chapter 2, Subchapter 39 are to:  (1) change the Office of Planning, Research, and Statistics name to Innovation Services; (2) expand Oklahoma Administrative Code (OAC) 340:2-39-1 to include a function presently defined in OAC 340:2-39-6; and (3) provide that Innovation Services (IS) carries out Office of Planning, Research, and Statistics functions.

The proposed amendments to Subchapter 39, Chapter 2: (1) implement policy changes that conform to new federal regulations for the protection of human research subjects; and (2) improve the Oklahoma Department of Human Services (DHS) Institutional Review Board (DHSIRB) operations.

Strategic Plan Impact.The proposed amendments broadly support the DHS state fiscal year 2019-2020 Strategic Plan by continuing efforts to implement innovative solutions improving how DHS does business.In particular, the amendments will build and maintain effective partnerships with investigators wanting to conduct human subject research. Over time, the amendments will assist DHS promote greater programmatic knowledge for staff, with the potential to streamline processes and improve the accuracy of service delivery.

Substantive changes.

Part 1 - Office of Planning, Research, and Statistics Innovation Services

OAC 340:2-39-1 is amended to change the name of the Office of Planning, Research, and Statistics to IS.The added item, "provides technical assistance in the design, development, implementation and evaluation of projects, programs, and grants…" is from OAC 340:2-39-6 and consolidates the list of IS functions.

Part 3.Oklahoma Department of Human Services Institutional Review Board (DHSIRB)

OAC 340:2-39-5 is amended to:(1) more accurately state the DHSIRB purpose; and (2) more narrowly describe the scope of research involving human subjects, in particular, the scope of such research is revised to include the observation of behavior "in which an investigator interacts with human subjects."

OAC 340:2-39-6 is amended to define or re-define several words and terms that are used in Part 3. For example, the definition of "human subject" is expanded to include individuals about whom a researcher may obtain a biospecimen, in addition to other identifiable private information, through intervention or interaction with the individual.

OAC 340:2-39-7 is amended to:(1) include a list of DHSIRB duties that are required in Section 46.108(a)(3) of Title 45 of the Code of Federal Regulations (45 C.F.R. § 46.108(a)(3)); (2) describe the DHSIRB responsibility to ensure prompt reporting by investigators; and (3) describe the DHS duty to provide staff and resources necessary for the DHSIRB support.

OAC 340:2-39-8 is amended to clearly describe the DHSIRB membership requirements including the DHSIRB officer and member duties.

OAC 340:2-39-9 is amended to:(1) provide general rules for DHSIRB meetings;

(2) clarify the meaning of "quorum"; and (3) carefully specify how the DHSIRB may approve motions by a majority vote of members.

OAC 340:2-39-10 is amended to: (1) clarify DHSIRB record requirements, including the manner in which DHSIRB members are identified; (2) expand the list of items documented in DHSIRB minutes; (3) describe the scope of documentation that is required for continuing review activities in greater detail; and (4) delete a paragraph on written procedures and guidelines because these requirements are more thoroughly described in OAC 340:2-39-12 and 340:2-39-12.2.

OAC 340:2-39-11 is revised to provide clearer guidance to investigators or researchers wishing to conduct research that is focused on DHS employees or DHS clients. A more detailed application process is described, including: (1) reference to a specific DHS form is deleted; (2) a statement of "general requirements"; (3) detailed requirements for "new research proposals" are described; (4) a statement about "previously approved research" is deleted as it is listed in OAC 340:2-39-12.2;

(5) subsection (c) provides guidance for researchers who want to request a determination that a proposed research project is not human subjects research; (6) a statement about research that "departs from the original proposal" as it is listed in OAC 340:2-39-12.1; (7) subsection (d) is provided for researchers who want to request a determination that a proposed research project is exempt from DHSIRB review and oversight; (8) a statement saying that "In general, action on all proposals is taken within two months after submission" is deleted – better guidance is given in OAC 340:2-39-12; (9) Subsection (e) is provided for researchers who wish to request an expedited review by the DHSIRB. A statement about "decisions to disapprove" an application is deleted as it is listed in OAC 340:2-39-12; (10) subsection (f) is provided for researchers who want to ask the DHSIRB to recognize proposed research projects as cooperative research projects; and (11) lengthy guidance about "Information provided to the DHSIRB by the investigator" is deleted as it is listed in in revised subsections (a) through (e).

OAC 340:2-39-11.1 is added to provide Standards for Informed Consent that must be satisfied by all research studies submitted for DHSIRB approval.The general requirements are codified at 45 CFR § 46.116.

OAC 340:2-39-12 is revised to modify the DHSIRB process used for review and approval of new research projects.

OAC 340:2-39-12.1 is added to provide guidance to researchers who want to make changes in their research project after DHSIRB approval.

OAC 340:2-39-12.2 is added to explain how the DHSIRB will conduct a continuing review of any research study it approved at intervals appropriate to the degree of risk, but not less than once per year, as needed.

OAC 340:2-39-13 is revised to specify that a request for reconsideration of a DHSIRB decision is accomplished in the same manner as the preliminary review and assessment.

Reasons.The proposed changes clearly identify DHS IS to describe the functions that are within the Subchapter 39 administrative components for which DHS is responsible. The changes also provide a consolidated listing of functions that are assigned to IS.

The federal regulations on the protection of human research subjects were recently revised and revisions are needed to align with the federal changes. The proposed changes result in clearer guidance to researchers, helping them to conduct valuable research while fully protecting human research subjects.

Repercussions.The proposed amendments result in greater clarity of communication and a better understanding of how Subchapter 39 functions will be managed.

Legal authority.Director of Human Services; 56 O.S. § 162; C.F.R. § 46.108(a)(3); and 45 CFR § 46.116.

Permanent rulemaking approval is requested.

B.A description of the classes of persons who most likely will be affected by the proposed rule, including classes that will bear the costs of the proposed rule, and any information on cost impacts received by the Agency from any private or public entities:The classes of persons most likely to be affected by the proposed amendments are DHS employees, program managers within the United States Department of Health and Human Services, research investigators seeking approval from DHSIRB, and members of the public who are interested in the administrative components described in OAC 340:2-39.

These administrative rules apply to any person paid by, under the control of, or affiliated with DHS, such as scientists, contractors, trainees, technicians and other staff members, students, fellows, guest researchers, or collaborators.Additionally, the rules describe protections for DHS employees and DHS clients and/or patients including individuals receiving DHS benefits or services provided at DHS-operated facilities, who participate in any research activity as a "research subject" or "human subject."

C.A description of the classes of persons who will benefit from the proposed rule:The classes of persons most likely to benefit from the proposed amendments will be DHS offices and divisions, DHS employees, program managers within the United States Department of Health and Human Services, research investigators seeking DHSIRB approval, and the public. The revisions are anticipated to better protect human subjects, including personal information or biospecimens, involved in research, while reducing burden, delay, and ambiguity for investigators.

D.A description of the probable economic impact of the proposed rule upon the affected classes of persons or political subdivisions, including a listing of all fee changes and, whenever possible, a separate justification for each fee change:No economic impact is likely as a result of the proposed amendments. DHS does not charge or collect any fees associated with these rules.

E.The probable costs and benefits to the Agency and to any other agency of the implementation and enforcement of the proposed rule, the source of revenue to be used for implementation and enforcement of the proposed rule and any anticipated effect on state revenues, including a projected net loss or gain in such revenues if it can be projected by the Agency:The proposed amendments will result in greater DHS efficiency.It is unlikely DHS will incur any additional costs as a result of these proposed amendments.

F.A determination whether implementation of the proposed rule will have an impact on any political subdivisions or require their cooperation in implementing or enforcing the rule:The proposed amendments do not have an economic impact on any political subdivision, nor will the cooperation of any political subdivisions be required in implementation or enforcement of the rules.

G.A determination whether implementation of the proposed rule will have an adverse economic effect on small business as provided by the Oklahoma Small Business Regulatory Flexibility Act: There are no anticipated adverse effects on small business as provided by the Oklahoma Small Business Regulatory Flexibility Act.

H.An explanation of the measures the Agency has taken to minimize compliance costs and a determination whether there are less costly or nonregulatory methods or less intrusive methods for achieving the purpose of the proposed rule: The proposed amendments are intended to minimize compliance costs and intrusive regulations, while fully complying with federal mandates. There are no less costly or non-regulatory methods or less intrusive methods for achieving the purpose of the proposed amendments.

I.A determination of the effect of the proposed rule on the public health, safety, and environment and, if the proposed rule is designed to reduce significant risks to the public health, safety, and environment, an explanation of the nature of the risk and to what extent the proposed rule will reduce the risk:These proposed amendments are required to adjust to the changing landscape of regulations and rules dealing with human subjects research and to align DHS rules with current federal regulations. The revisions are anticipated to better protect human subjects, information or biospecimens, involved in research, while reducing burden, delay, and ambiguity for investigators.

J.A determination of any detrimental effect on the public health, safety, and environment if the proposed rule is not implemented:Without the proposed amendments, the DHS administrative rules that set forth the ethical principles for safeguarding the rights and welfare of human beings recruited to participate in research activities will remain as it existed in 2015. The concept of identifiable biospecimens, in particular, and related protections will not be adequately addressed.

K.The date the rule impact statement was prepared and, if modified, the date modified:Prepared June 10, 2019; modified December 13, 2019.

SUBCHAPTER 39. OFFICE OF PLANNING, RESEARCH, AND STATISTICS INNOVATION SERVICES

Part 1 - OFFICE OF PLANNING, RESEARCH AND STATISTICS INNOVATION SERVICES

340:2-39-1. Office of Planning, Research, and Statistics Innovation Services (IS)

Revised 4-25-099-15-20

(a) Purpose.The Office of Planning, Research, and Statistics (OPRS) IS:

(1)conducts data-driven research and statistical analysis of Oklahoma Department of Human Services (OKDHS) (DHS) programs and services, including grant evaluation;

(2)collaborates with (OKDHS) (DHS) divisions to communicate and disseminate information regarding (OKDHS) (DHS) research, programs, and services;

(3)provides technical assistance in the design, development, implementation, and evaluation of projects, programs, and grants conducted or supported by DHS;

(3)(4) serves as the official DHS clearinghouse for language translation, forms, and appendices for (OKDHS);

(4)(5) provides technical assistance in designing, developing, and implementing DHS strategic planning for (OKDHS); and

(5)(6) maintains program statistics and prepares policy-related analysis and a variety of complex state reports.

(6) provides leadership for developing and implementing quality and performance improvement strategies and initiatives; and

(7) works to build a culture of continuous improvement.

(b) Reports.OPRS prepares and files IS assists with the preparation of the DHS:

(1)    OKDHS Annual Report, required by Section 162 of Title 56 of the Oklahoma Statutes (56 O.S. § 162), each year to the Governor on or before November 1; and

(2)    OKDHS Strategic Plan, required by 62 O.S. § 45.3, every two years, as described in OAC per Oklahoma Administrative Code 340:1-1-18.

Part 3. OKLAHOMA DEPARTMENT OF HUMAN SERVICES INSTITUTIONAL REVIEW BOARD (DHSIRB)

340:2-39-5. Purpose, scope, and authority

Issued 9-15-15Revised 9-15-20

(a) Purpose. The purpose of the Oklahoma Department of Human Services (DHS) Institutional Review Board (DHSIRB) is to protect the rights and welfare of human participants involved in research and assist the investigator and the institution in their mutual obligation to comply with all applicable federal, state, and local laws, rules and regulations, including internal policies of the Oklahoma Department of Human Services (DHS), with respect to the research participants and investigators.:

(1) protect the rights and welfare of DHS employees and DHS clients and/or patients, including individuals receiving DHS benefits or services provided at DHS- operated facilities, who participate in a research activity as a "research subject" or "human subject" as defined in this Part; and

(2) assist the investigator and DHS in their mutual obligation to comply with all applicable federal, state, and local laws, rules, and regulations, including DHS internal policies, with respect to the research participants and investigators.

(b) Scope. The DHSIRB operates, per Part 46 of Title 45 of the Code of Federal Regulations and applicable state laws. Unless the research meets the criteria for review exemption, per Oklahoma Administrative Code (OAC) 340:2-39-12(b) 340:2-39-11(d), DHSIRB reviews research and program evaluation projects involving including program evaluation projects with a human subjects research component that involve:

(1) direct interaction between the investigator and the research subject, including:

(A) experimentation, such as experimental medication or treatment, involving the research subject;

(B) surveys or interviews with research subjects;

(C) interaction with research subjects beyond normal service delivery; and

(D) performance of any procedures not performed for the sole benefit of the person involved, and any procedures in which either a primary or secondary purpose, or objective, is the collection of data for research analysis;

(2) any research or evaluation program intended to contribute to generalized knowledge; and

(3) the collection of protected information about research subjects from third parties for research analysis of program evaluation.

(A) Research involving human subjects is not limited to deliberate experimentation with human subjects. It also includes the performance of any procedures not performed for the sole benefit of the person involved and any procedures in which either a primary or secondary purpose or objective is the collection of data for research analysis.

(B) The scope of research involving human subjects covered by this Part not only involves physical, chemical, electrical, or psychological stimulation of responses within the human body, but also includes:

(i) interviews;

(ii) observation of behavior in which an investigator interacts with human subjects;

(iii) test administration of tests; or

(iv) other measurement techniques of measurement.

(C) Some research involving human subjects may be exempt from on-going DHSIRB review. Authority for the decision on whether a research or evaluation project is exempt resides with the DHSIRB. Research involving human subjects is not intended to cover data obtained as part of the teaching or training of individuals in which the performance of therapeutic procedures is for the direct and sole benefit of the person involved, or for any area of investigation of individuals as part of the performance of professional services.

(D) All activities related to human participant subject research, regardless of funding source, is guided by the ethical principles in The Belmont Report.

(c) Authority.

(1) The DHSIRB receives its authority from the DHS Director of Human Services. The DHSIRB is registered with the federal Department of Health and Human Services (DHHS) and has approved the Federalwide Assurance of Protection for Human Subjects submitted to United States Department of Health and Human Services DHHS.

(2) DHSIRB has the authority to review any research funded through DHS or that involves focuses on DHS staff or human participants individuals receiving DHS benefits or services provided at DHS operated facilities. In addition, DHSIRB has the authority to:

(A) approve, disapprove, or order research modification of research based upon consideration of the risks and benefits to the human participants subjects;

(B) oversee the conduct of the research and require periodic progress reports from research investigators;

(C) suspend or terminate prior approval of a research project;

(D) place restrictions on a research project;

(E) require research investigators to promptly report breaches of confidentiality, within five-business days; and

(F) require research investigators to promptly report if within five-calendar days of discovery when any researcher or research participant is endangered physically or psychologically during the data collection period of the study.

340:2-39-6. Definitions

Issued 9-15-15Revised 9-15-20

The following words and terms, when used in this Part, shall have the following meanings, unless the context clearly indicates otherwise:

"Children" means persons under 18 years of age.

"The Belmont Report" means a statement of basic ethical principles governing research involving human subjects issued by the National Commission for the Protection of Human Subjects in 1978.

"Child" means an individual, who has not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research is conducted.For research conducted in Oklahoma, where federal regulations and Oklahoma law both apply, an unmarried or unemancipated individual younger than 18 years of age meets the definition of "child." For research conducted outside of Oklahoma or in a jurisdiction where Oklahoma law does not apply, individuals who meet the definition of a child are those individuals described under the applicable jurisdiction law where the research is conducted.

"Clinical trial" means a research study in which one or more human subjects are prospectively assigned to one or more interventions, which may include placebo or other control, to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes, per Section 46.102(b) of Title 45 of the Code of Federal Regulations (45 C.F.R. § 46.102(b)).

"Cognitively impaired" means a person with:

(A) a psychiatric disorder, for example, psychosis, neurosis, personality or behavior disorders;

(B) dementia;

(C) a developmental disorder for example, mental retardation affecting cognitive or emotional functions to the extent that capacity for judgment and reasoning is significantly diminished; or

(D) a compromised ability to make decisions in his or her best interest, for example:

(i) persons under the influence of or dependent on drugs or alcohol;

(ii) those suffering from degenerative diseases affecting the brain;

(iii) terminally ill patients; and

(iv) persons with severely disabling physical handicaps.

"Confidentiality" means the treatment of information an individual discloses in a relationship of trust with the expectation that it is not divulged to others or in ways inconsistent with the understanding of the original disclosure without his or her permission.

"Demonstration project" means a project, deliberately small in scale and limited in scope project, usually with a short project cycle.

"Department of Human Services Institutional Review Board (DHSIRB)" means a specially constituted review body established or designated by the Oklahoma Department of Human Services (DHS) to protect the welfare of human subjects recruited to participate in biomedical or behavioral research, per Sections 46.102(g), 108, and 109 of Title 45 of the Code of Federal Regulations (45 C.F.R §§ 46.102(g), 46.108, and 46.109).

"The Belmont Report" means a statement of basic ethical principles governing research involving human subjects issued by the National Commission for the Protection of Human Subjects in 1978.

"Director" means the DHS Director, per Chapter 1 of this Title.

"Federalwide Assurance (FWA)" means a formal, written, binding commitment an institution submits to the United States (U.S.) Department of Health and Human Services (DHHS), U.S. Office for Human Research Protections (OHRP), in which it commits to DHHS compliance with the requirements set forth in the regulations for the protection of human subjects, per 45 C.F.R. § 46.

"Generalizable knowledge" is information where the intended use of the research findings can be applied to populations or situations beyond those being studied.In practice, generalizable knowledge refers to research results that are:

(A) published, including research papers published as a thesis or dissertation;

(B) presented to the public; or

(C) developed for others to build upon. Generalizable knowledge may include theses, dissertations, and some oral histories.

"Human Protections Administrator protections administrator (HPA)" means the person designated by the DHS Office of Planning, Research and Statistics Innovation Services director, who provides administrative support to the DHSIRB, serves as the Office of Human Research Protection's OHRP primary institutional contact, and has the administrative responsibility for the program. The HPA:

(A) has comprehensive knowledge of all aspects of the DHS system of protections for human subjects;

(B) is familiar with the institution's commitments under the Human Subject Assurance (HSA) FWA; and

(C) plays a key role in ensuring the institution fulfills its responsibilities under the HSA FWA.

"Human subject" means a living individual about whom an investigator, whether professional or student, conducting research obtains:

(A) data through intervention or interaction with the individual obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or

(B) identifiable private information per 45 C.F.R. § 46.102(f). DHSIRB extends the definition to include deceased individuals about whom an investigator conducting research obtains identifiable private information uses, studies, analyzes, or generates identifiable, private information or identifiable biospecimens.¢ 1

"Human Subject Assurance (HSA)" means a formal, written, binding commitment an institution submits to the United States Department of Health and Human Services (DHHS), Office for Human Research Protections (OHRP), in which it promises to comply with applicable regulations governing research with human subjects and stipulates the procedures through which compliance is achieved per 45 C.F.R. § 46.103.

"Identifiable biospecimen" means a biospecimen for which the identity of the subject is, or may readily be, ascertained by the investigator or associated with the biospecimen.

"Identifiable private information" means private information for which the identity of the subject is, or may readily be, ascertained by the investigator or associated with the information.

"Individual with impaired decision-making capacity" means an individual with a compromised ability to make decisions in his or her own best interest, such as individuals:

(A) under the influence of, or dependent on, drugs or alcohol;

(B) suffering from degenerative diseases affecting the brain;

(C) terminally ill patients;

(D) with severely disabling physical handicaps including, but not limited to:

(i) a psychiatric disorder, such as psychosis, neurosis, or personality or behavior disorders;

(ii) dementia; or

(iii) a developmental disorder, such as an intellectual disability affecting cognitive or emotional functions to the extent that capacity for judgment and reasoning is significantly diminished.

"Informed consent" means a person's voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic, therapeutic, or preventive procedure. In giving informed consent, subjects may not waive or appear to waive any of their legal rights, or release or appear to release the investigator, the sponsor, the institution, or agents thereof from liability for negligence, per 45 C.F.R. § 46.116, and 21 C.F.R. §§ 50.20 and 50.25, and Form 21AD084E, Application to the Oklahoma Department of Human Services Institutional Review Board (DHSIRB).

"Innovation Services (IS)" means the DHS office that provides technical assistance in the design, development, implementation, and evaluation of projects, programs, and grants conducted or supported by DHS.IS conducts data-driven research and statistical analysis of programs and services, and disseminates information and results.

"Institution" means DHS unless the context clearly indicates otherwise.

"Interaction" means communication or interpersonal contact between investigator and subject.

"Intervention" means physical procedures by which information or biospecimens are gathered, such as venipuncture because it is a physical procedure to gather a biospecimen, as well as manipulations of the subject or his or her environment that are performed for research purposes.

"Investigator" means a scientist or scholar, who may be a professional or a student,with primary responsibility for the design and conduct of research.

"Legally-authorized representative"means an individual, judicial entity, or other body authorized under applicable law to consent on behalf of a prospective subject to his or her participation in the procedure(s) involved in the research. When there is no applicable law addressing this issue, legally-authorized representative means an individual recognized by DHS policy as acceptable to provide consent in the non-research context on behalf of the prospective subject to his or her participation in the procedure(s) involved in the research.

"Minimal risk" means the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests, per 45 C.F.R. § 46.102(i)(j). For example, the risk of drawing a small amount of blood from a healthy individual for research purposes is no greater than the risk of doing so as part of routine physical examination.

"Office of Human Research Protection (OHRP)" means a federal agency that provides leadership in the protection of the rights, welfare, and well-being of subjects involved in research conducted or supported by DHHS. OHRP ensures this by:

(A) providing clarification and guidance;

(B) developing educational programs and materials;

(C) maintaining regulatory oversight; and

(D) providing advice on ethical and regulatory issues in biomedical and social-behavioral research.

"Office of Planning, Research and Statistics (OPRS)" means the DHS office that provides technical assistance in the design, development, implementation and evaluation of projects, programs, and grants conducted or supported by DHS.OPRS conducts data-driven research and statistical analysis of programs and services and disseminates information and results.

"Principal investigator (PI)" means the research investigator who is ultimately responsible for assuring ensuring compliance with applicable federal, state, and local laws, rules, and regulations, and the conduct of the research.

"Privacy" means having control over the extent, timing, and circumstances of sharing one's self physically, behaviorally, or intellectually with others.

"Private information" includes information, such as medical records, about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place. Information is provided for specific purposes, and he or she can reasonably expect the information is not made public.

"Research" means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge, per 45 C.F.R. § 46.102(l).

"Research subject" means a DHS employee, client, and/or patient:

(A) who is voluntarily participating as a human subject in a research project;

(B who is voluntarily participating in a survey or interview conducted as part of a research or program evaluation project; and/or

(C) whose protected information is disclosed to, and used by, an investigator during a research or program evaluation project. The words "subject" and "participant" are used interchangeably.

"Research" means a systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge per 45 C.F.R. § 46.102(d).

"Risk" means the probability of harm or injury whether physical, psychological, social, or economic occurring as a result of participation in research. Both the probability and magnitude of possible harm may vary from minimal to significant.

"Systematic investigation" means an activity that involves a prospective plan incorporating data collection, either quantitative or qualitative, and data analysis to answer a question, such as systematic investigations that include surveys and questionnaires, interviews and focus groups, analyses of existing data or biological specimens, epidemiological studies, evaluations of social or educational programs, cognitive and perceptual experiments, and medical chart review studies.

INSTRUCTIONS TO STAFF 340:2-39-6

Issued 9-15-20

1.While deceased individuals cannot be human subjects according to the United States Department of Health and Human Services, the deceased may be human subjects according to the Federal Drug Administration. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) or other state or local laws may still apply to activities involving deceased individuals.Applicants are encouraged to consult the entity from which they received or accessed the information for further guidance.

340:2-39-7. Principle Principles and Policies policies

Issued 9-15-15Revised 9-15-20

(a) Ethical principles. The Oklahoma Department of Human Services Institutional Review Board (DHSIRB) is guided by the ethical principles regarding research involving human subjects set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research entitled, "Ethical Principles and Guidelines for the Protection of Human Subjects of Research" or the "The Belmont Report." The DHSIRB recognizes the principles of respect for persons; beneficence, including minimization of harms and maximization of benefits; and justice as stated in The Belmont Report and strives to apply these principles in all research covered by this Part. In addition, DHSIRB makes all reasonable efforts are made to comply with the requirements in Part 46 of Title 45 of the Code of Federal Regulations (45 C.F.R. Part 46) for all research conducted or funded by DHSIRB subject to its review.

(b) Institutional policies.

(1) DHSIRB acknowledges and accepts its responsibility for protecting the rights and welfare of human research subjects.

(2) DHSIRB acknowledges that it, and its investigators, accept those responsibilities necessary for the performance of all research covered by this Part including compliance with applicable federal, state, and local laws, if any.

(3) DHSIRB works to assure ensure that, before subjects are involved in research, the requirements listed in (A) - (G) of this paragraph are met.

(A) Risks to participants are minimized by:

(i) using procedures consistent with sound research design that do not unnecessarily expose participants to risks; and

(ii) employing procedures already being performed on the participants for prevention, diagnostic, or treatment purposes, when appropriate.

(B) Risks to participants human subjects are reasonable relative to anticipated benefits, if any, to human subjects, and the importance of the knowledge that may reasonably be expected to result.

(C) Selection of participants human subjects is equitable.

(D) Participants Human subjects, or the participant's their legally authorized representative representatives, provide voluntary informed consent for participating in research, unless otherwise exempted by state or federal law, perOklahoma Administrative Code 340:2-39-11.1.

(E) There are adequate provisions for ensuring the human subjects' safety of participants.

(F) There are adequate provisions to protect the human subjects' privacy of participants and maintain the data confidentiality of data.

(G) When necessary, appropriate additional safeguards are included in research involving subjects who are likely to be vulnerable to coercion or undue influence, such as children, including those who are wards of the state or any other agency, prisoners, pregnant women, cognitively impaired persons, individuals with impaired decision-making capacities, or economically or educationally disadvantaged persons.

(4) DHSIRB encourages and promotes constructive communication among its administrators, research supervisors, research investigators, and all other relevant parties as a means of maintaining a high level of awareness to safeguard the rights and welfare of research subjects.

(5) DHSIRB exercises appropriate administrative oversight to assure ensure its practices and procedures designed for the protection of the rights and welfare of human subjects are effectively applied.

(6) DHSIRB serves in a collaborative relationship with research investigators to ensure that research with human subjects is conducted in accordance with legal requirements and ethical principles of respect for persons, beneficence, and justice.

(7) DHSIRB provides each individual conducting or reviewing human subject research, such as research investigators, research supervisors, research reviewers, and division directors with a copy of this section Section.

(8) Per 45 C.F.R. § 46.108(a)(3), DHSIRB is responsible for:

(A) conducting its initial and continuing review of research and for reporting its findings and actions to the investigator and to appropriate Oklahoma Department of Human Services (DHS) managers, supervisors, and directors;

(B) determining which projects require review more often than annually and which projects need verification from sources other than the investigators when no material changes occurred since the previous DHSIRB review; and

(C) ensuring prompt reporting by investigators to DHSIRB of proposed changes in a research activity; and ensuring investigators conduct the research activity in accordance with DHSIRB terms of approval until any proposed changes are reviewed and approved by DHSIRB, except when necessary to eliminate apparent immediate hazards to the subject.

(9) DHSIRB is responsible for ensuring prompt reporting by investigators to DHSIRB; appropriate DHS officials; the department or agency head; and the Office for Human Research Protections, the Department of Health and Human Services (DHHS), or any successor office, or the equivalent office within the appropriate federal department or agency of any:

(A) unanticipated problems involving risks to subjects or others or any serious or continuing noncompliance with this policy or the DHSIRB requirements or determinations; and

(B) DHSIRB suspension or termination of approval.

(c) Support for DHSIRB functions and operations.

(1) In order to ensure that DHSIRB has the necessary resources to carry out its duties, DHS provides sufficient:

(A) staff support, which includes at a minimum, the human protections administrator (HPA). The HPA provides administrative support to DHSIRB, serves as the Office of Human Research Protection's primary DHS contact, and has the administrative responsibility for DHSIRB functions and operations; and

(B) meeting space for the Board to convene.

(2) Additional necessary resources, such as filing space, reproduction equipment, and computers for DHSIRB are provided by DHS through the Innovation Services (IS) division.

340:2-39-8. Membership

Issued 9-15-15Revised 9-15-20

(a) Requirements for membership of the Oklahoma Department of Human Services Institutional Review Board (DHSIRB) membership requirements.

(1) The DHSIRB is comprised of at least seven members. Membership criteria includes, but is not limited to, consideration of earned degrees, representative capacity, and indications of experience, such as board certifications or licenses sufficient to describe each member's chief anticipated contributions to DHSIRB deliberations.

(2) Prior to serving on the DHSIRB, all members submit certificates of completed Human Subject Assurance Training offered by the federal Office for Human Research Protections (OHRP), and sign a statement that they have received and reviewed the DHSIRB rules.The federal OHRP training is available at http://ohrp-ed.od.nih.gov/CBTs/Assurance/login.asp.

(3) Prior to serving on the DHSIRB, all members must sign the an Acknowledgments of Receipt that states stating they have received and reviewed the DHSIRB rules.

(4) The To the greatest extent reasonably possible, the DHSIRB members of the DHSIRB have varying academic, professional, and personal backgrounds to promote complete and adequate review of research activities commonly conducted by the institution Oklahoma Department of Human Services (DHS) or at state-operated facilities. In addition to possessing the experience and expertise necessary to review specific research activities, the members are able expected to ascertain the acceptability of proposed research in terms of institutional DHS commitments and rules and regulations, applicable law, and standards of professional conduct and practice.

(5) DHSIRB includes members with consideration of race, gender, cultural, and professional backgrounds, and sensitivity to issues, such as community attitudes. The DHSIRB does not consist entirely of men or women. There is at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas. In addition, DHSIRB includes at least one member who is not otherwise affiliated with the Oklahoma Department of Human Services (DHS) and who is not part of the immediate family of a person who is affiliated with the institution. The DHSIRB similarly strives, through member experience, expertise, and diversity, including race, gender, cultural backgrounds, and sensitivity to issues, such as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects.

(A) Scientific background. The DHSIRB includes at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas.

(B) A member not affiliated with DHS. The DHSIRB includes at least one member who is not otherwise affiliated with DHS and who is not an immediate family of a person who is affiliated with DHS.

(C) Ad hoc members with special competence. The DHSIRB may, in its discretion, invite individuals with competence in special areas to assist in the review of issues that require expertise beyond, or in addition to, that normally available to DHSIRB members. These individuals may not vote on any DHSIRB matter.

(6) DHSIRB membership consists of at least a member of DHS:

(6)(A) A member of DHS Office of Client Advocacy (OCA) serves on the DHSIRB.;

(7)(B) A member of DHS Legal Services serves on the DHSIRB.;

(8)(C) A member of DHS Child Welfare Services serves on the DHSIRB.;

(9)(D) A member of DHS Community Living and Support Services serves on the DHSIRB.Children's Services;

(10)(E) A member of DHS Adult and Family Services serves on the DHSIRB.;

(G) Adult Services;

(H) Information Security; and

(11)(I) A member of DHS Office of Planning, Research and Statistics serves Innovation Services.The Innovation Services member serves on the DHSIRB representing scientific areas.

(12)(7) The DHS Director of Human Services (Director) approves the selection of DHSIRB members, including that of the Chair, Vice-Chair, and alternates, and is notified by the Chair of any studies that are disapproved by the DHSIRB.

(b) Alternate members.

(1) Alternate members are designated by the DHSIRB members and approved by the Director to serve as voting members in the event the primary member is not available to attend the regularly scheduled meeting. Primary DHSIRB members may designate an alternate member from his or her respective programs or divisions, who subject to Director approval, serves as a voting member in the event the primary member is not available to attend any regularly scheduled meeting. Alternate members complete the any primary DHSIRB member required training, and may then vote on any new submission, when needed. Alternate members receive meeting documents, such as agendas, minutes, and protocols for review and are encouraged to attend all meetings.

(2) An alternate member-at-large is designated and approved by the Director to serve if when both a voting member and his or her alternate are not available to attend a regularly scheduled meeting. The alternate member-at-large may not serve as an alternate for a representative of particularly vulnerable subjects is approved based on the same criteria per (a)(5), of this Section.

(c) Ad hoc members.

(1) If When the DHSIRB reviews research applications involving particularly vulnerable subjects including, but not limited to, children, including those who are wards of the state or any other agency, prisoners, pregnant women, or cognitively impaired persons, prospective research subjects who have impaired decision-making capacity or who otherwise are considered vulnerable to coercion or undue influence,consideration is given to the inclusion of including one or more individuals who are knowledgeable about, and experienced in, working with these participants prospective subjects.

(2) DHSIRB may, at its discretion, invite individuals with competence in specific areas to assist in the review of issues that require expertise beyond or in addition to that available on the DHSIRB.

(3) Ad hoc members are non-voting members.

(4) No person outside of the DHSIRB may override a not-approved vote.

(d) Roles and responsibilities.

(1) The DHSIRB Chair:

(A) is appointed by the DHS Director;

(B) serves for a minimum of one year, with the possibility of reappointment;

(C) does not resign when the majority of the DHSIRB membership consists of new members who have served for less than one year;

(D) serves as a member of the DHSIRB in addition to his or her authority as Chair;

(E) prepares for, and convenes meetings with, the assistance of the Human Protections Administrator human protections administrator (HPA);

(F) ensures meeting coverage by the vice-chair Vice-Chair when not able to serve as chair;

(G) ensures a quorum is present for all meetings;

(H) carries out an initial assessment of submissions with the Vice-Chair and the OCA member of OCA;

(I) carries out an expedited review of submissions that qualify under such condition, or designates one or more experienced reviewers from among members of the DHSIRB conditions by convening a DHSIRB subcommittee to complete the expedited review, per Oklahoma Administrative Code 340:2-39-12(d);

(J) delegates review responsibilities as necessary and applicable;

(K) distributes copies of the submissions to the appropriate DHSIRB members with the HPA assistance of the HPA;

(L)(K) ensures adequate expertise for review and determinations;

(M)(L) consults with investigators as necessary;

(N)(M) assists the reviewers and other members with any concerns in preparing for the meeting;

(O)(N) ensures assigned reviewers present a clear and concise review of research materials;

(P)(O) votes on each DHSIRB action;

(Q)(P) is temporarily removed in the event of a conflict of interest;

(R)(Q) is permanently removed in the event of termination of employment or at the Director's discretion of the Director; and

(S)(R) notifies the Director of any disapprovals disapproval.

(2) The DHSIRB Vice-Chair:

(A) is appointed by the Director;

(B) serves for a minimum of one year, with the possibility of reappointment;

(C) serves as a member of the DHSIRB in addition to his or her DHSIRB authority as Vice-Chair;

(D) assists or acts on behalf of the Chair in particular DHSIRB matters and at DHSIRB meetings;

(E) carries out an initial assessment of submissions with the Chair and the OCA member of OCA;

(F) carries out an expedited review of submissions that qualify under such conditions by participating on a DHSIRB subcommittee to complete the expedited review, per OAC 340:2-39-12(d);

(F)(G) is temporarily removed in the event of a conflict of interest;

(G)(H) is permanently removed in the event of termination of employment or at the Director's discretion of the Director.

(3) The DHSIRB members:

(A) are approved by the Director;

(B) serve at least one year with the option of rotating with designated alternate;

(C) do not resign from the DHSIRB, if without good cause, when the majority of the members are in their first year of serving;

(D) are responsible for reviewing research protocols submitted for full DHSIRB review;

(E) are responsible for reviewing research protocols submitted when designated for an expedited review;

(F) are responsible for attending all scheduled meetings;

(G)(F) are removed from the DHSIRB if when more than two consecutive meetings are missed without having the designated alternate attend;

(H)(G) are temporarily removed in the event of a conflict of interest; and

(I)(H) are permanently removed in the event of termination of employment or at the Director's discretion of the Director.

(4) DHSIRB Chair, Vice-Chair, and members:

(A) annually, July 1 – June 30, submit training certificates from the Assurance Training Modules on the OHRP website. Training certificates are not required for ad hoc members ensure any required IRB training is completed and sufficient IRB training certification is submitted as necessary;

(B) annually submit signed acknowledgements of reading the DHSIRB procedures and supporting documents. Supporting documents are not required for ad hoc members ensure DHSIRB primary members and designates submit signed acknowledgments affirming the DHSIRB procedures and that supporting documents were reviewed and submitted as necessary;

(C) have access to the reference materials available through the DHSIRB HPA-maintained library maintained by the HPA;

(D) receive no compensation for serving as members of the DHSIRB;

(E) conduct reviews of submitted research proposals as delegated, mandated, or requested;

(F) provide written responses to the research investigator and organization containing the DHSIRB findings of the DHSIRB;

(G) determine which research requires review more often than annually;

(H) determine which research needs verification that no material changes have not occurred since previous DHSIRB review, from sources other than the investigators;

(I) advise research investigators to promptly report changes to the approved research activities;

(J) advise research investigators that changes in approved research are not initiated without DHSIRB review and approval, except when necessary to eliminate apparent immediate hazards; and

(K) advise research investigators to promptly, within five-business days, report to DHSIRB and appropriate institutional DHS officials of:

(i) unanticipated problems involving risks to research participants, interviewers, or others;

(ii) serious or continuing noncompliance with the DHSIRB requirements of the DHSIRB;

(iii) suspension or termination of DHSIRB approval; or

(iv) disapproval of other DHSIRB submissions.

(5) Consultants are may be invited to review submissions and attend meetings when a submitted proposal contains information outside of the scope of the DHSIRB members' collective knowledge. No individual with an interest or involvement in the research study application under DHSIRB consideration is utilized in any consultative capacity.

(6) The Office of Planning, Research and Statistics Performance Outcomes and Accountability provides administrative support for the DHSIRB.

(7) Resources for the DHSIRB, for example filing space, reproduction equipment, and computers are provided by DHS.

(8) Meeting areas are provided by DHS.

(e) Conflict of Interest.No DHSIRB member votes on a submission if when there is an actual or potential conflict of interest with regard to the member's professional or personal interests, including financial interests of the member.Every DHSIRB member recuses himself or herself from consideration of any research study application in which that member or the member's immediate family has any involvement or interest in the study or its outcome.

(1) DHSIRB members are not selected by potential investigators. Based on a DHSIRB majority vote, any DHSIRB member may be excluded from participating in an initial or continuing review of any project in which the member has an actual, apparent, or potential conflicting interest.

(2) When a member is directly involved with a research, the member recuses himself or herself from the meeting while the submission is reviewed and abstains from voting on the submission.A conflict of interest exists when any DHSIRB member, including alternate members and ad hoc members, has an interest sufficient to influence, or appear to influence, the objective exercise of his or her official duties.A conflicting interest may:

(A) be personal in nature or may result from divergent professional responsibilities;

(B) arise when a DHSIRB member is involved with a research project as an investigator, a researcher, a director, an assistant, an advisor, or as another type of stakeholder;

(C) arise when any DHSIRB member or the member's immediate family has a financial interest in the outcome of the research. Immediate family includes spouses/domestic partners, siblings, parents, and dependent minors and adult children; and

(D) be recognized for any other reason that is considered to be an unacceptable conflict of interest by the member or by DHSIRB.

(3) When a DHSIRB member has a conflict of interest, the member:

(A) discloses his or her conflict of interest; and

(B) recuses himself or herself from participation in the meeting while the submission is reviewed or discussed, and

(C) abstains from voting on the submission.

(4) Recusal means the member with a conflict of interest:

(A) refrains from discussing any research project in which he or she has a conflict of interest;

(B) does not seek to influence other DHSIRB members prior to a vote; and

(C) removes himself/herself from the meeting room while the discussion and DHSIRB vote takes place, except to provide DHSIRB-requested information.

(5) It is each DHSIRB member's duty to ensure participant protection, DHSIRB review integrity, and that research projects conducted are not jeopardized by an undisclosed, unidentified, or unmanaged conflict of interest.

340:2-39-9. Meetings

Issued 9-15-15Revised 9-15-20

(a) The Oklahoma Department of Human Services Institutional Review Board (DHSIRB) meetings are held monthly. If there is insufficient business, the meeting is cancelled. Full actions of the DHSIRB require a quorum of the voting members.Oklahoma Department of Human Services Institutional Review Board (DHSIRB) meetings general rules.

(1) DHSIRB meetings are scheduled monthly.

(2) A DHSIB meeting can be held when there is a quorum of voting members and sufficient business to conduct a meeting. The decision to conduct a meeting is left to the discretion of a majority determination by the DHSIRB Chair, Vice-Chair, and an OCA member. A DHSIRB meeting may be cancelled when there is insufficient business, when a quorum is not available, or for other unforeseen reasons.

(3) DHSIRB meetings require a quorum of the voting members.

(b) Quorum. A quorum is defined as 50 percent plus one of all primary DHSIRB voting members, including the at least one member whose primary concerns are in nonscientific areas.

(1) DHSIRB member refers to the primary members and alternate members who are approved by the Director and are eligible to vote.

(2) If at any time during a meeting the members who are eligible to vote on a matter fail to constitute a quorum, then the matter is tabled for consideration until the next meeting.

(A) Ad hoc members do not count toward the quorum requirement because they are not eligible to vote.

(B) A member who is recused from discussion and voting on any item is not counted toward the quorum requirement while the item is under consideration.

(3) The determination of a quorum sufficient to convene and conduct a meeting of the DHSIRB is left to the sole discretion of the DHSIRB Chair.

(c) A majority vote is required of those present for approval of a motion. Majority vote required. For approval of a motion, a majority vote of those present and eligible to vote is required.

(1) A member who is eligible to vote has a right to abstain and cannot be compelled to vote. An abstention does not count toward the majority required to approve a motion.

(2) DHSIRB does not recognize voting by proxy. All voting occurs in person at the time of the meeting by the member or his or her designated alternate.

(d) Prior to the meeting. One week prior to the meeting, DHSIRB members and alternates receive:

(1) a reminder of the upcoming meeting, including the date, location, and time;

(2) minutes from the previous meeting;

(3) an agenda for the upcoming meeting; and

(4) all new submissions for review at the upcoming meeting including:

(A) survey instruments;

(B) consent, assent, and permission forms, when applicable;

(C) letters from other IRBs Institutional Review Boards and agency directors, if when applicable; and

(D) the assigned unique identifier DHSIRB number.

(e) Other requirements. At a minimum:

(1) the Chair convenes and conducts the meetings;

(2) the minutes of the prior meeting are approved by an open,recorded vote of the members;

(3) all actions taken require an open, recorded vote of the members following discussion and the making and seconding of a motion; and

(4) meeting minutes are recorded by the Human Protections Administrator or a designated individual.

340:2-39-10. Record requirements

Issued 9-15-15Revised 9-15-20

(a) The Oklahoma Department of Human Services Institutional Review Board (DHSIRB) prepares and maintains documentation of its activities, per Section 46.115 of Title 45 of the Code of Federal Regulations (45 C.F.R. § 46.115) and 21 C.F.R. § 56.115, including:

(1) a list of the DHSIRB members identified by:

(A) name;

(B) earned degrees;

(C) representative capacity, including a brief statement of competence, scientific concerns, and affiliation;

(D) indications of experience, such as board certifications and licenses, sufficient to describe each member's anticipated contributions to DHSIRB deliberations; and

(E) any employment or other relationship between each member and the institution Oklahoma Department of Human Services (DHS), including whether the member is a full-time or part-time employee, member of a governing panel or board, or a paid or unpaid consultant;

(2) copies of:

(A) all research proposals reviewed;

(B) scientific evaluations, if any, that accompany the proposals;

(C) approved sample consent documents;

(D) progress reports submitted by investigators; and

(E) reports of injuries to subjects;

(3) DHSIRB meeting minutes which shall to document:

(A) attendance;

(B) actions taken by the DHSIRB;

(C) the vote on actions including the number of members voting for, against, and abstaining;

(D) declarations of any DHSIRB member's conflict of interest with regard to any research projects;

(E) any recusal of a member with a brief explanation why recusal was necessary;

(D)(F) the basis for requiring changes in or disapproving research; and

(E)(G) a written summary of the discussion of controversial controverted issues and their resolution;

(4) records of continuing review activities, including the rationale for conducting continuing review of research that otherwise would not require continuing review, per 45 C.F.R. § 46.109(f)(1);

(5) copies of all correspondence between the DHSIRB and investigators; and

(6) written procedures and guidelines for: records documenting DHSIRB activities, per Oklahoma Administrative Code 340:2-39-7(b)(8).

(A) conducting initial and continuing review of research and reporting the findings and actions to the investigator and the institution;

(B) determining which research requires review more often than annually;

(C) determining which research needs verification that no material changes have occurred since the previous DHSIRB review from sources other than the investigators;

(D) prompt reporting to the DHSIRB of proposed changes in an approved research;

(E) initiating proposed changes in an approved research only after DHSIRB review and approval, except when necessary to eliminate apparent immediate hazards to the subject; and

(F) prompt reporting to the DHSIRBof any:

(i) unanticipated problems involving risks to subjects or others;

(ii) serious or continuing noncompliance with this Part or the requirements or determinations of the DHSIRB; and

(iii) suspension or termination of DHSIRB approval.

(b) Records are retained:

(1) for at least three years from the date of creation for general administrative record; and

(2) for at least three years after research completion.

(c) All records are accessible for inspection and copying by authorized representatives of the United States Department of Health and Human Services (DHHS) or the Office of Human Research Protection (OHRP) at reasonable times and in a reasonable manner, per 45 C.F.R. § 46.115(b).

(d) DHSIRB submits a list of current DHSIRB members, and any changes in membership, to OHRP, DHHS per 45 C.F.R. §§ 46.103(b)(3) and 115(a)(5). DHS or the DHSIRB may maintain the records in printed form or electronically.

340:2-39-11. Application procedures

Issued 9-15-15Revised 9-15-20

(a) A completed Oklahoma Department of Human Services Form 21AD084E, Application to the Oklahoma Department of Human Services Institutional Review Board (DHSIRB), is submitted with each new research proposal. General requirements.

(1) Investigators or researchers wanting to conduct research focused on OklahomaDepartment of Human Services (DHS) employees or DHS clients must first secure written approval from the Department of Human Services Institutional Review Board (DHRIRB).

(2) Investigators submit an application to the DHSIRB before initiating any part of a research project, including subject recruitment.

(3) Permission requests may be made through the application procedures described in this rule.

(b) Previously approved research must request to continue beyond any one-year period of time. Re-review and re-approval of research occurs on or before the one-year anniversary of the initial Oklahoma Department of Human Services Institutional Review Board (DHSIRB) approval date, unless the degree of risk, complaints about the research, or investigator non-compliance necessitate more frequent re-review. Research found exempt is reviewed annually. New research proposals.

(1) The DHSIRB provides DHS Form 20AD085E, Application and Instructions, for investigators who want to submit a research proposal to DHSIRB.

(2) The application and all required attachments must be submitted to DHSIRB. When received 14 or more calendar days prior to the next meeting, the application is reviewed at the next regularly scheduled DHSIRB meeting. When received 13 or fewer calendar days prior to the next meeting, the application is reviewed at the following regularly scheduled DHSIRB meeting. No application is considered for approval until it is fully completed and submitted along with any required attachments.

(3) Information provided to the DHSIRB in Form 20AD085E includes, at a minimum:

(A) the professional qualifications of the principal investigator as well as co-investigators;

(B) a description of necessary support services and facilities;

(C) a description of the research protocol, including and addressing the:

(i) research title;

(ii) research purpose, including identifying any expected benefits as a consequence of doing the research;

(iii) research sponsor;

(iv) results of previous, related research;

(v) research participant inclusion or exclusion criteria;

(vi) justification for the use of special or vulnerable participant populations;

(vii) research design including appropriateness of research methods discussion;

(viii) description of procedures to be performed;

(ix) potential risks and a discussion of their relationship to potential participant benefits;

(x) circumstances surrounding consent procedure, including the:

(I) setting;

(II) participant autonomy concerns;

(III) language difficulties;

(IV) reading level; and

(V) particularly vulnerable subjects;

(xi) procedures for documentation of informed consent, including any procedures for obtaining assent from minors, using witnesses, translators, and document storage;

(xii) compensation to participants for their involvement;

(xiii) compensation for injured research participants;

(xiv) provisions for protection of subjects' privacy;

(xv) extra costs to participants for their involvement in the research; and

(xvi) extra costs to third-party payers because of participant's involvement;

(D) investigator's brochure, when one exists;

(E) informed consent document; and

(F) each application must include a description of how the investigator obtains human subject consent, including a copy of the investigator's proposed consent document. For further guidance, refer to Oklahoma Administrative Code (OAC) 340:2-39-11.1.

(4) The DHSIRB makes a determination on the request using procedures, per OAC 340:2-39-12.

(c) If the research departs from the original proposal, the DHSIRB is advised and a new application is submitted for DHSIRB approval. Requesting a determination that a proposed research project is not human subject research.

(1) The principal investigator is responsible for obtaining the DHSIRB determination on whether a proposed project does or does not qualify as human subject research.A determination includes, whether human subjects, as defined in OAC 340:2-39-6, are involved.

(2) To receive a determination that a research project does not constitute human subject research, the investigator must submit a request in writing to DHSIRB. The request must include:

(A) a completed Form 20AD085E, as described in (b) of this Section; and

(B) the proposed justification for determining the research does not constitute human subjects research.

(3) The DHSIRB makes a determination on the request using procedures, per OAC 340:2-39-12(b).

(d) In general, action on all proposals is taken within two months after submission. Investigators are notified in writing of the DHSIRB decisions within two weeks of board action. Requesting a determination that a proposed research project is exempt from review.

(1) In some limited circumstances, per this Section and in federal regulations, per Title 45 of the Code of Federal Regulations, an investigator may request that DHSIRB recognizes his or her proposed research project as a project exempt from DHSIRB review and oversight.

(2) To receive a determination that a research project is exempt from review, the investigator must submit a request in writing to DHSIRB. The request must include a completed Form 20AD085E, per (b) of this Section, and written justification why the investigator is seeking an exemption determination.

(3) The DHSIRB makes a determination on the request using the procedures, per OAC 340:2-39-12(c).

(e) Decisions to disapprove are accompanied by reasons for the decision. Requesting an expedited review.

(1) An expedited review may be requested if the principal investigator submits to the DHSIRB that the proposed research project involves no more than minimal risk and:

(A) the proposed research falls within a category of research, as determined by the U.S. Secretary of Health and Human Services and is specifically identified in the DHSIRB application, that it is eligible for expedited review by the DHSIRB;

(B) minor changes in previously approved research during the period for which approval is authorized; or

(C) the proposed research for which limited DHSIRB review is sought qualifies as a condition of exemption, per Title 45 C.F.R. 46.104(d)(2)(iii), (d)(3)(i)(C), and (d)(7) and (8).

(2)The investigator must submit a request in writing to the DHSIRB to ask for an expedited review of his or her proposed research project. The request must include a completed Form 20AD085E, per (b) of this Section, and written justification why the investigator is seeking an expedited review.

(3) The DHSIRB makes a determination on the request, per OAC 340:2-39-12(d).

(f) Information provided to the DHSIRB by the investigator is the: Cooperative research projects.

(1) DHSIRB application Form 21AD084E; A cooperative research project is a research project that involves DHS and at least one other institutional review board, per 45 C.F.R. § 46.114.

(2) professional qualifications to do the research, including a description of necessary support Services and facilities; An investigator, in limited circumstances, may request the DHSIRB recognize his or her proposed research project as a cooperative research project, per 45 C.F.R. § 46.114.

(3) research protocol, including and addressing the: In the conduct of cooperative research projects, each institutional review board including the DHSIRB, is responsible for safeguarding the rights and welfare of human subjects.

(A) title of the research;

(B) purpose of the research, including the expected benefits obtained by doing the research;

(C) sponsor of the research;

(D) results of previous related research;

(E) research participant inclusion or exclusion criteria;

(F) justification for use of any special or vulnerable participant populations;

(G) research design, including, as needed, a discussion of the appropriateness of research methods;

(H) description of procedures to be performed;

(I) potential risks, and a discussion of their relationship to the potential benefits to the participants;

(J) circumstances surrounding consent procedure, including the:

(i) setting;

(ii) participant autonomy concerns;

(iii) language difficulties;

(iv) reading level; and

(v) particularly vulnerable subjects;

(K) procedures for documentation of informed consent, including any procedures for obtaining assent from minors, using witnesses, translators, and document storage;

(L) compensation to participants for their involvement;

(M) compensation for injured research participants;

(N) provisions for protection of subjects' privacy;

(O) extra costs to participants for their involvement in the research; and

(P) extra costs to third party payers because of participant's involvement;

(4) investigator's brochure, when one exists; To receive recognition that a research project is a cooperative research project, the investigator must submit a request in writing to the DHSIRB. The request must include:

(A) a completed Form 20AD085E, per OAC 340-2-39-11(b)(1);

(B) identifying information about the other institution, including a reliable point of contact; and

(C) a description of the other institution's proposed role in the cooperative research project.

(5) informed consent document. The DHSIRB makes a determination on the request, per OAC 340:2-39-12(f).

(A) Per Section 50.23 of Title 21 of the Code of Regulations (21 C.F.R. § 50.23) and 21 C.F.R. § 50.24, except in situations of medical emergency or active military, no investigator may involve human subjects as participants in research covered by this Part unless the investigator has obtained the legally effective informed consent of the participant or the participant's legally authorized representative. An investigator seeks such consent only under circumstances that provide the prospective participant or the representative sufficient opportunity to consider whether to participate and that minimize the possibility of coercion or undue influence. The information given to the participant or the representative is in language understandable to the participant or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the participant or representative is made to waive or appear to waive any of the participant's legal rights or releases or appears to release the investigator, sponsor, institution, or its agents from liability for negligence.

(B) The proposed informed consent document contains the elements listed in (A) of this paragraph.

(C) When necessary, a translated version of the informed consent is provided to the participant;

(6) requests for changes in research after initiation;

(7) reports of unexpected adverse events, including events involving research participants or interviewers;

(8) periodic progress reports if the research has continued past the approval period; and

(9) final report stating the closure of the research and findings.

340:2-39-11.1. Informed consent standards

Issued 9-15-20

(a) Informed consent general requirements.

(1) Research studies submitted for Oklahoma Department of Human Services Institutional Review Board (DHSIRB) consideration must adhere to those requirements necessary to obtain informed consent, per 45 C.F.R. § 46.116. Requirements include, but are not limited to:

(A) obtaining consent prior to involving a human subject in any research study;

(B) providing sufficient time that allows a human subject the opportunity to consider and discuss whether to participate;

(C) presenting sufficient information about the research study in an understandable and comprehensible format; and

(D) information that must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research.

(i) The manner in which the key information is described and presented is reasonably determined by the complexity of the research project. Key information elements may include:

(I) a statement that the project is research and participation is voluntary;

(II) a summary of the purpose of the research, procedures, and duration of participation;

(III) reasonable, foreseeable risks or discomforts;

(IV) reasonable, expected benefits; and

(V) alternative procedures or course of treatment, if any.

(ii) The key information elements of the informed consent must be organized and presented in a way that facilitates comprehension.

(iii) Informed consent must present information in sufficient detail relating to the research, and must be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the prospective subject's or legally authorized representative's understanding of the reasons why one might or might not want to participate.

(2) Informed consent may not include any exculpatory language through which the subject or the legally authorized representative is made to waive or appear to waive the subject's legal rights or releases or appears to release the investigator or other party associated with the research study from liability for negligence.

(3) Basic elements of informed consent include:

(A) a statement that the study involves research, an explanation of the research purposes and the expected duration of the subject's participation; a description of the procedures to be followed; and identification of any procedures that are experimental;

(B) a description of any reasonably foreseeable risks of discomforts to the subject;

(C) a description of any benefits to the subject or to others that may reasonably be expected from the research;

(D) a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;

(E) a statement describing the extent, if any, to which confidentiality of records identifying the subject are maintained;

(F) an explanation for research involving more than minimal risk, whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of or where further information may be obtained;

(G) an explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights and in the event of a research-related injury to the subject;

(H) a statement that participation is voluntary, refusal to participate involves no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled; and

(I) one of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens:

(i) a statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility; or

(ii) a statement that the subject's information or biospecimens collected as part of the research, even when identifiers are removed, is not used or distributed for future research studies.

(4) DHSIRB enforces the general requirements for informed consent, per 45 C.F.R. § 46.116.

(5) Except as described in (b) and (c) of this Section, before involving a human subject in research covered by this Part, an investigator obtains the subject's or the subject's legally authorized representative's legally effective informed consent. The minimum requirements of legally effective informed consent are given in the federal regulations at 45 C.F.R. § 46.116(a) through 45 C.F.R. § 46.116(d).

(A) Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension.

(B) Informed consent must present information in sufficient detail relating to the research, and must be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the prospective subject's or legally authorized representative's understanding of the reasons why one might or might not want to participate.

(C) An investigator seeks informed consent only under circumstances that provide the prospective subject or the legally authorized representative sufficient opportunity to discuss and consider whether to participate and that minimize the possibility of coercion or undue influence.

(D) The information that is given to the subject or the legally authorized representative is in language understandable to the subject or the legally authorized representative.

(E) The prospective subject or the legally authorized representative must be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information.

(6) On a case-by-case basis, the DHSIRB may determine that other information, in addition to that specifically mentioned in the federal regulation at 45 C.F.R. §46.116, is given to the subjects when in the DHSIRB's judgment the additional information would meaningfully add to the subjects' protection of the rights and welfare.

(A) The DHSIRB makes this determination based on the nature of the research as well as the local research context.

(B) If the DHSIRB determines that additional elements are appropriate, this additional information is considered as essential as the basic elements of informed consent described in the federal Department of Health and Human Services (HHS)regulations at 45 C.F.R. § 46.116(b).

(b) Broad consent in lieu of informed consent. The DHSIRB may permit broad consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens, collected for either research studies other than the proposed research or nonresearch purposes, when the:

(1) application specifically declares it is seeking broad consent and contains an adequate description of the broad consent process; and

(2) proposed research project satisfies the requirements of Title 45 C.F.R. § 46.116(d).

(c) Waiver or alteration of consent. When appropriate, an application for a proposed research study may seek a waiver from the requirements to obtain informed consent or it may seek permission to alter the informed consent requirements. Such a waiver or alteration may be permitted by the DHSIRB when the requirements of 45 C.F.R. § 46.116(e) & (f) are met.

(d) Informed consent documentation.

(1) Use of a written informed consent form. Except as provided in (3) of this subsection, informed consent is documented by the use of a written informed consent form, approved by the DHSIRB and signed, including in an electronic format, by the subject or the subject's legally authorized representative. A written copy is given to the person signing the informed consent form.

(2) Written consent form options. Except as provided in (3) of this subsection, the informed consent form may be either (A) or (B).

(A) A written informed consent form that meets the requirements of this Section. The investigator gives the subject or the subject's legally authorized representative adequate opportunity to read the informed consent form before it is signed; alternatively, this form may be read to the subject or the subject's legally authorized representative.

(B) A short written consent form stating the elements of informed consent required by this Section were presented orally to the subject or the subject's legally authorized representative, and that the key information required by 45 C.F.R. § 46.116(a)(5)(i) was presented first to the subject, before other information, if any, was provided.

(i) Informed consent must begin with a concise, organized, and focused presentation of the key information most likely to assist a prospective subject or legally authorized representative understand the reasons why one might, or might not, want to participate in the research. This portion of the informed consent process must be organized and presented in a way that facilitates comprehension.

(ii) The DHSIRB approves a written summary of what is said to the subject or the legally authorized representative.When the short form method is used, there must be a witness to the verbal presentation.Only the short form itself is signed by the subject or the subject's legally authorized representative.The witness signs the short form and a copy of the summary, and the person obtaining consent signs a summary copy.

(iii) Summary and short form copies are given to the subject or the subject's legally authorized representative.

(3) Documentation waiver requirement.

(A) In certain defined circumstances, the DHSIRB may waive the requirement for the investigator to obtain a signed informed consent form for some or all subjects.

(i) The requirement may be waived if the DHSIRB makes a determination that the only record linking the subject and the research would be the informed consent form, and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject or legally authorized representative is asked if the subject wants documentation linking the subject with the research. The subject makes the decision.

(ii) The requirement may be waived if the DHSIRB makes a determination that the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.

(iii) The requirement may be waived if the DHSIRB makes a determination that the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm. The DHSIRB must also determine that the research presents no more than minimal risk of harm to subjects, and there is an appropriate alternative mechanism for documenting that informed consent was obtained.

(B) In cases in which the documentation requirement is waived, the DHSIRB may require the investigator to provide subjects or legally authorized representatives with a written statement regarding the research.

340:2-39-12. Review and approval process

Issued 9-15-15Revised 9-15-20

(a) Submission requirements and initial assessment. Preliminary review and assessment.

(1) The proposed research is submitted to the Oklahoma Department of Human Services Institution Review Board (DHSIRB) no less than 14 calendar days prior to the next regularly scheduled meeting. Upon receipt of a completed application for a proposed research project, a preliminary assessment of the application is performed by the Oklahoma Department of Human Services Institution Review Board (DHSIRB).

(2) The Chair completes an initial assessment of submissions with the Vice-Chair and the assigned member of the Office of Client Advocacy. The initial assessment includes: The preliminary assessment is completed by the chair or the Chair's designee.The assessment determines if the applicant is seeking a full review, an expedited review, or an exemption from review and ensures the provided documentation complies with the pertinent application, per Oklahoma Administrative Code (OAC) 340:2-39-11.

(A) determining whether the research requires review and contains all supporting documents;

(B) assigning a unique identifier number;

(C) determining whether the submission:

(i) is exempt from review;

(ii) meets the requirements for an expedited review; or

(iii) requires a full review by the DHSIRB; and

(D) distributing copies of the submissions to the appropriate DHSIRB members for:

(i) an expedited review by a subcommittee of no less than two voting members of the DHSIRB. The subcommittee includes:

(I) a scientific member; and

(II) a non-scientific member; or

(ii) a full DHSIRB review by all voting members and their alternates.

(3) When the application is incomplete in any way, the Chair or the Chair's designee notifies the applicant and explains any deficiencies. The applicant is invited to re-submit the application with deficiencies corrected.

(4) When the application is determined to be complete, the Chair or the Chair's designee assigns a unique identifier number to the proposed research project. This number is used in all future correspondence with the applicant and/or investigator.

(5) When the chair determines the application satisfactorily seeks an expedited review or exemption review, the application and its materials are presented to the Vice-Chair and the DHSIRB Office of Client Advocacy member for review.

(6) When the chair determines the application requires a full review, the application and its materials are presented to all DHSIRB members for review and consideration at the next DHSIRB meeting.

(7) When it is determined that additional information and/or clarification is needed for an application's review, the Chair or the Chair's designee notifies the applicant. The applicant has 90-calendar days to respond.

A) When the applicant does not respond in a satisfactory manner to the request for additional information and/or clarification within 90-calendar days, the DHSIRB notifies the applicant that the application was administratively closed.

(B) An application that is administratively closed may not be re-opened;however, a new application may be submitted.

(b) Requirements for exempt submissions. DHSIRB does not review activities that do not involve the disclosure of protected information to non-DHS staff, and do not involve greater than minimal risk. Research involving human subjects in one or more of the categories listed in (1) - (5) of this subsection, are exempt from DHSIRB review per Section 46.101(b) of Title 45 of the Code of Federal Regulations (45 C.F.R. 46.101(b)). Determination that a proposed research project is not human subjects research.

(1) Research conducted in established or commonly accepted education settings, involving normal educational practices, such as research on: When an investigator or researcher submits an application with a request for a determination of not human subjects research, the DHSIRB chair follows the procedures described in (A) and (B) of this paragraph.

(A) regular and special education instructional strategies; or The Chair convenes a subcommittee consisting of the Chair, the Vice-Chair, and the Office of Client Advocacy member.

(B) the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. The subcommittee reviews completed Form 0AD085E and the principal investigator's justification why the proposed research does not qualify as human subjects research.

(i) Based on this review, if the subcommittee determines the proposed research project does not constitute human subjects research, the Chair or the Chair's designee informs the applicant, in writing, of the DHSIRB decision.

(ii) When the subcommittee determines that the proposed research project does constitute human subjects research, the Chair or the Chair's designee informs the applicant, in writing, of the DHSIRB subcommittee decision.The applicant is directed to re-submit the application with a request for an exempt, expedited, or full board review.

(2) Research involving the use of educational tests such as, cognitive, diagnostic, aptitude, and achievement, survey procedures, interview procedures, or observations of public behavior unless: DHSIRB members are notified each time a research proposal is determined to not constitute human subjects research.The information is presented electronically or in hard copy format at the earliest possible DHSIRB regular meeting.

(A) information obtained is recorded in such a manner that human participants can be identified, directly or through identifiers linked to the study participants; and

(B) any disclosure of the human participants' responses outside the research could reasonably place the participants at risk of criminal or civil liability or be damaging to the participants' financial standing, employability, or reputation.

(3) Research involving the use of educational tests such as, cognitive, diagnostic, aptitude and achievement, survey procedures, interview procedures, or observations of public behavior that is not exempt under (2) of this subsection, if: If the investigator or researcher disagrees with the DHSIRB decision, a request for reconsideration may be submitted, per OAC 340:2-39-13(c).

(A) the human participants are elected or appointed public official or candidates for public office; or

(B) federal statute requires without exception that the confidentiality of the personally identifiable information is maintained throughout the research and thereafter.

(4) Research involving the collection or research of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that participants cannot be identified, directly or through identifiers linked to the participants.

(5) Research and demonstration projects conducted by or subject to the approval of department or agency heads, and designed to research, evaluate, or otherwise examine:

(A) public benefit or services programs;

(B) procedures for obtaining benefits or services under those programs;

(C) possible changes in or alternatives to those programs or procedures; or

(D) possible changes in methods or levels of payment for benefits or services under those programs.

(6) Per 45 C.F.R. 46, Subparts C and D, sometimes exemptions do not apply to research involving vulnerable subjects, such as prisoners, pregnant women, fetuses, children, or cognitively impaired persons.

(c) Requirements and procedures for expedited review. DHSIRB may use an expedited procedure to review research that presents no more than minimal risk to participants per 45 C.F.R. 46.110. Additionally, an expedited review may be used when:Applications with an exemption request.

(1) minor changes have been made to previously approved research during the period of one year or less for which approval is authorized; When an investigator or researcher submits an application with a request for recognition that his or her project is exempt from review, the DHSIRB chair follows the procedures in (A) and (B) in this paragraph.

(A) The chair convenes a subcommittee consisting of the Chair, the Vice-Chair, and the Office of Client Advocacy member.

(B) The subcommittee reviews the completed application and materials supporting the justification why the research project is exempt from review.

(i) Based on this review, if the subcommittee determines that the proposed research project is properly exempt from any review, the Chair or the Chair's designee informs the applicant, in writing, of the DHSIRB decision.

(ii) If the subcommittee determines that the proposed research project is conditionally exempt from DHSIRB review, the subcommittee must also conduct a limited review, per (g) of this Section.

(I) The subcommittee conducts a limited review when the proposed research is of a type described in the federal regulations at Title 45 C.F.R. § 46.104(d)(2)(iii), (d)(3)(i)(C), (d)(7) or (8).

(II) The subcommittee may conduct a limited review when the subcommittee believes a limited review is necessary in order to protect the privacy of subjects or to maintain the confidentiality of data or to ensure broad consent was properly obtained and documented.

(iii) If the subcommittee determines that the proposed research project is not exempt from a review, the subcommittee proceeds with an expedited review of the project using the procedures in (e) of this Section.

(2) enrollment of new subjects is permanently closed and no additional risks have been identified; all subjects have completed all research-related interventions; and the research remains active only for long-term follow-up of subjects; Within 14-calendar days after the DHSIRB action on the exemption request, the Chair or Chair's designee sends a written notification informing the applicant of the determination.The written notification includes:

(A) the unique identifier DHSIRB number;

(B) research name; and

(C) reason(s) the exemption request was approved or denied.

(3) remaining research activities are limited to data analysis; If the investigator or researcher disagrees with the DHSIRB decision, a request for reconsideration may be submitted, per OAC 340:2-39-13(c).

(4) research appears in the list of categories published as a Notice in the Federal Register per 63 C.F.R. 60364 - 60367, that include: The DHSIRB members are notified each time a research proposal is approved through exemption.The information is presented electronically or in hard copy format at the earliest possible DHSIRB regular meeting.

(A) collection of data from voice, video, digital, or image recordings made for research purposes; and

(B) research on individual or group characteristics or behavior including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies;

(5) the review process ensures the research meets the requirements for an expedited review; and

(6) proposals reviewed under the expedited procedure may be approved, conditionally approved, or referred for full DHSIRB review if not approved as proposed. The reviewers may exercise all of the authority of the DHSIRB except the reviewers may not disapprove the research. Research may be disapproved only after a full DHSIRB review.

(d) Applications with a request for an expedited review.

(1) When an investigator or researcher submits an application with a request for an expedited review, the DHSIRB Chair follows the procedures described in this paragraph.

(A) The chair convenes a subcommittee consisting of the Chair, Vice-Chair, and Office of Client Advocacy member. The subcommittee reviews the completed application and assesses the proposed research project based upon the criteria for an expedited review, per OAC 340:2-39-11(e).

(i) Based on this review, if the subcommittee determines that the proposed research project satisfies the criteria for an expedited review, the subcommittee carries out the proposed project initial review.

(I) The subcommittee may exercise all DHSIRB authorities except disapproving research.

(II) When the subcommittee fails to accept the research project for an expedited review, then the proposed research project is reviewed in accordance with the non-expedited procedures described in (e) of this Section.

(III) A research project may be disapproved only after review in accordance with the non-expedited procedure.

(ii) If the subcommittee determines that the proposed research project does not meet the criteria for an expedited review, the Chair presents the application to the DHSIRB for a non-expedited review at the next scheduled meeting.

(B) The Director may restrict, suspend, terminate, or choose not to authorize the DHSIRB's use of this expedited review procedure.

(2) The DHSIRB members are notified each time a research proposal is approved through the use of this expedited process. Information about each expedited approval is given to the DHSIRB members in a written report of expedited actions. The report is presented in written or electronic form and disseminated to all board members or at the earliest possible DHSIRB regular meeting. DHSIRB members are given an opportunity to review the report of expedited actions. The review must include an opportunity for members to ask questions or raise concerns about any expedited action. A motion to accept or approve the report may be entertained.

(e) Full DHSIRB review. Full review of new research projects, non-exempt, non-expedited.

(1) Proposals are reviewed at regularly scheduled meetings of the DHSIRB and investigators are informed in writing of the results of the review. Each proposed research project includes: Review at a convened meeting. Except when an expedited review procedure is used, per (d), the DHSIRB performs an initial review of proposed new research projects at a convened meeting when a quorum is present.In order for the research to be approved, it must receive the approval of a majority of those members present at the meeting.

(A) a detailed description of the research design and procedures as they affect human subjects;

(B) a list of precautions necessary to safeguard the subjects' welfare;

(C) a precise description of the subject population involved in the research;

(D) a description of the informed consent process and all consent forms used; and

(E) methods used to protect data confidentiality and subject privacy.

(2) Proposals are assigned to one of the four categories listed in (A) - (D) of this paragraph. Reliance on the written application. To complete its review, the DHSIRB may choose to rely solely on the written application, including attachments submitted by the applicant.

(A) Approved. Research is approved as submitted. Investigators whose proposals are approved can begin work immediately.

(B) Conditionally approved. Research is conditionally approved until investigators comply with items identified by the DHSIRB for final approval. There are no structural problems with the study.

(C) Deferred. DHSIRB does not have enough information to make a determination. Investigators whose proposals receive a deferral must resubmit the entire application to address the required changes.

(D) Not approved. The magnitude and/or number of concerns is such that conditional approval is not appropriate. Investigators whose work is disapproved cannot conduct the research or resubmit their proposals.

(3) Optional review of other information. In addition to its review of the written application, including attachments, the DHSIRB may also choose to invite:

(A) the primary investigator to provide additional information;

(B) subject matter experts to assist in the review; or

(C) experts and guests to attend the meeting when the review takes place.

(4) Review criteria. In order to approve new research covered by this subsection, the DHSIRB determines, per 45 C.F.R. § 46.111 that the requirements in (A) through (G) are satisfied.

(A) Risks to subjects are minimized by using procedures:

(i) consistent with sound research design and that do not unnecessarily expose subjects to risk; and

(ii) already performed on the subjects for diagnostic or treatment purposes, whenever appropriate.

(B) Risks are reasonable in relation to anticipated benefits to subjects, if any, and the importance of the knowledge that may be expected to be gained. In evaluating risks and benefits, DHSIRB considers only those risks and benefits that may result from the research as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research. Per 45 C.F.R. § 46.111(a)(2), DHSIRB does not consider possible long-range effects of applying the knowledge gained in the research.

(C) Selection of subjects is equitable. In making this assessment the DHSIRB takes into account the research purposes and the setting in which the research is conducted. Additionally, the DHSIRB is particularly cognizant of the special problems of research involving subjects who are likely to be vulnerable to coercion or undue influence, such as children, prisoners, economically or educationally disadvantaged persons, or individuals with impaired decision-making capacities.

(D) The proposed research includes a plan to seek informed consent from each prospective participant or the subject's legally authorized representative, per OAC 340:2-39-11.1.

(E) Informed consent is appropriately documented or appropriately waived, per OAC 340:2-39-11.1.

(F) When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the subjects' safety.

(G) When appropriate, there are adequate provisions to protect the subjects' privacy and maintain the confidentiality of data.

(5) Additional requirements. In order to approve new research projects covered by this subsection the DHSIRB reviews the investigator's qualifications to conduct and supervise the proposed research. This process may include:

(A) reviewing the investigators', sub-investigators', and other necessary research staffs' resumes, verifying professional associations and licenses and may include a review of the investigators' previous specific experience as demonstrated by recent presentations or publications;

(B) using previous DHSIRB experience with the investigators; and

(C) requesting additional information confirming the investigators' qualifications from an administrator of the investigators' institutions.

(f) Review criteria. In order to approve research covered by this Part, DHSIRB reviews the investigator's qualifications to conduct and supervise the proposed research. This process may include: Review and approval of cooperative research projects.

(1) reviewing the curriculum vitae of the investigator, sub-investigators, and other necessary research staff, verifying professional associations and licenses. It may also include a review of the investigator's previous specific experience as demonstrated by recent presentations or publications; Cooperative research projects are those projects that involve the Oklahoma Department of Human Services (DHS) as well as one or more additional institutions.

(A) In the conduct of cooperative research projects, DHSIRB and the other institution(s) are responsible for safeguarding the rights and welfare of human subjects.

(B) DHSIRB makes arrangements with the other institution(s) to avoid duplication of efforts.

(C) When a cooperative research project is sponsored by a federal department or agency that is supporting or conducting the research, DHSIRB relies on the federal department or agency to identify the reviewing Institution Review Board(IRB).

(D) Consistent with the federal regulations, per Title 45 C.F.R. § 46.114(b), DHSIRB recognizes that any institution located in the United States (U.S.) engaged in cooperative research must generally rely upon approval by a single IRB for the portion of the research conducted in the U.S., unless:

(i) more than a single IRB review is required by law, including tribal law passed by the official governing body of an American Indian or Alaska Native tribe;

(ii) a federal department or agency supporting or conducting the research determines and documents that the use of a single IRB is not appropriate for the particular context; or

(iii) the cooperative research project does not have a federal sponsor.

(2) using previous DHSIRB experience with the investigator; and When DHSIRB participates with another institution in a cooperative research project that does not have a federal sponsor, DHSIRB seeks to avoid duplication of effort by:

(A) entering into a joint review agreement with the other institution;

(B) relying on the review of the other institution's IRB; or

(C) making similar arrangements for avoiding duplication of effort.

(3) requesting additional information confirming the investigator's qualifications from an administrator of the institution.

(g) Additional requirements. DHSIRB determines whether all of the additional requirements listed in (1) - (9) of this subsection are met. Limited reviews.

(1) Risks to participants are minimized by using procedures: If the DHSIRB affirms that a research proposal meets the criteria for a conditional exemption from review, per OAC 340:2-39-12(c), the DHSIRB performs a limited review of the proposal.

(A) consistent with sound research design; and

(B) already being performed on the participants for diagnostic or treatment purposes, whenever appropriate.

(2) Risks are reasonable in relation to anticipated benefits to participants, if any, and the importance of the knowledge that may be expected to be gained. In evaluating risks and benefits, DHSIRB considers only those risks and benefits that may result from the research as distinguished from risks and benefits of therapies that participants would receive even if not participating in the research. Per 45 CFR 46.111(a)(2), DHSIRB does not consider possible long-range effects of applying the knowledge gained in the research. The scope of the limited review depends on the type of research proposal.The four types of research are in (A) through (D).

(A) Mildly obtrusive interactions research, per 45 C.F.R. § 46.104(d)(2)(iii), is defined as research with features in (i) and (ii) of this subparagraph.

(i) Mildly obtrusive interactions research only includes interactions involving:

(I) educational tests, such as cognitive, diagnostic, aptitude, and achievement tests;

(II) survey procedures;

(III) interview procedures; or

(IV) observation of public behavior, including visual or auditory recording; and

(ii) the information obtained is recorded by the investigator so the human subjects' identity can readily be ascertained, directly or through identifiers linked to the subjects.

(B) Benign behavioral interventions, per 45 C.F.R. § 46.104(d)(3)(i)(C), is defined as research with features in (i) and (ii) of this subparagraph.

(i) Benign behavioral interventions involves interventions in conjunction with the collection of information from an adult subject through verbal or written responses, including data entry, or audiovisual recording if the subject prospectively agrees to the intervention and information collection.

(ii) The information obtained is recorded by the investigator so the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects.

(C) Storage or maintenance for secondary research for which broad consent is required, per 45 C.F.R. § 46.104(d)(7), is defined as research involving the storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use.

(D) Secondary research for which broad consent is required, per 45 C.F.R. § 46.104(d)(8), is defined as research involving the use of identifiable private information or identifiable biospecimens for secondary research use, when the conditions in (i) through (iii) are present.

(i) Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained.

(ii) Documentation of informed consent or waiver of documentation of consent was obtained, per OAC 340:2-39-11.1.

(iii) The investigator does not include returning individual research results to subjects as part of the study plan.

(3) Selection of participants is equitable. In making this assessment the DHSIRB takes into account the purposes of the research and the setting in which the research is conducted and is particularly cognizant of the special problems of research involving particularly vulnerable subjects, such as children, prisoners, pregnant women, or cognitively impaired persons. For mildly obtrusive interactions research and for benign behavioral interventions, the DHSIRB review is limited to determining that there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

(4) Informed consent is sought from each prospective participant or the participant's legally authorized representative and contains: For storage or maintenance for secondary research for which broad consent is required, and for secondary research for which broad consent is required, the DHSIRB review is limited to determining that:

(A) an explanation of the purposes of the research broad consent for storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens is obtained, per OAC 340:2-39-11.1(b);

(B) an expected duration of the participant's involvement in the research broad consent is appropriately documented or waiver of documentation is appropriate, per OAC 340:2-39-11.1(d); and

(C) a description of the procedures to be followed; if there is a change made for research purposes in the way the identifiable private information or identifiable biospecimens are stored or maintained, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

(D) identification of any experimental procedure;

(E) a description of any reasonably foreseeable risks or discomforts to the participant;

(F) a description of any benefits to the participant or to others that may reasonably be expected from the research;

(G) disclosure of appropriate alternative procedures or courses of treatment, if any, that may be advantageous to the participant;

(H) a statement describing the extent, if any, to which confidentiality of records identifying the participant is maintained;

(I) an explanation for research involving more than minimal risk:

(i) whether any compensation is available if injury occurs;

(ii) whether medical treatment is available if injury occurs, and if so, what it consists of; or

(iii) where further information can be obtained;

(J) an explanation of whom to contact:

(i) for answers to pertinent questions about the research;

(ii) to discuss research participant's rights; and

(iii) in the event of a research-related injury to the participant;

(K) a statement that:

(i) participation is voluntary;

(ii) refusal to participate involves no penalty or loss of benefits to which the participant is otherwise entitled; and

(iii) the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled; and

(L) when appropriate, one or more of the elements of information listed in (i) - (viii) of this subparagraph is provided to each participant.

(i) Statement that the particular treatment or procedure may involve unforeseeable risks to the participant or to the embryo or fetus, if the participant is or may become pregnant.

(ii) Anticipated circumstances under which the participant's involvement in the research may be terminated by the investigator without regard to the participant's consent.

(iii) Any additional costs to the participant that may result from involvement in the research.

(iv) Consequences of a participant's decision to withdraw from the research and procedures for orderly termination of involvement by the participant.

(v) Statement that significant new findings developed during the course of the research, that may relate to the participant's willingness to continue, are provided to the participant.

(vi) Approximate number of participants involved in the research.

(vii) Research treatment(s) and the probability of random assignment to a placebo or control group, or to each treatment.

(viii) Other information the DHSIRB determines that would meaningfully add to the protection of the rights and welfare of the participants.

(5) Informed consent is appropriately documented by the use of a written form approved by DHSIRB and signed and dated by the participant or the participant's legally authorized representative at the time of consent. Per 45 C.F.R. 46.117(a), a copy is given to the person signing the form. Except as provided by 45 C.F.R. 46.117(c), consent form may be either of the following:

(A) a written consent document that embodies the elements described above. The consent document may be read to the participant or the participant's legally authorized representative; however, the investigator provides either the participant or the representative opportunity to read the document before it is signed; or

(B) a short form written consent document stating the required elements of informed consent were presented orally to the participant or the participant's legally authorized representative. When this method is used, there is a witness to the oral presentation. The DHSIRB approves a written summary of what is to be said to the participant or the representative. Only the short form is signed by the participant or the representative. However, the witness signs both the short form and a copy of the summary, and the person actually obtaining the consent signs a copy of the written summary. A copy of the summary is given to the participant or the representative in addition to a copy of the short form.

(6) When appropriate, there are adequate provisions to obtain affirmative agreement from children to participate in research and the permission of their parents or guardians.

(7) When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of participants.

(8) When appropriate, an advocate for children participating as subjects in research is appointed by the DHSIRB, in addition to any other individual acting on behalf of the child as guardian or in loco parentis. The advocate acts in the best interests of the children for the duration of their participation in the research (45 C.F.R. 46.409 (b).

(9) When appropriate, there are adequate provisions to protect the privacy of participants and maintain the confidentiality of data.

(A) When some or all of the participants, such as children, prisoners, pregnant women, or cognitively impaired persons, are likely to be vulnerable to coercion or undue influence, additional safeguards are included in the research to protect the rights and welfare of these participants.

(B) To approve research in clinical settings in which some or all of the participants are children, DHSIRB shall take steps to ensure all research is in compliance with the federal Food and Drug Administration's regulations regarding children per 21 C.F.R. § 50(D).

(10) For some or all participants, DHSIRB may waive the requirement that the participant or the participant's legally authorized representative, sign a written consent form if it finds the research presents no more than minimal risk of harm to participants and involves no procedures for which written consent is normally required outside the research context.

(11) If the submission falls under the jurisdiction of an IRB other than DHSIRB, the approval letter from the other IRB is included in the original submission.

(h) Communication from DHSIRB for exempt submissions. For exempt research, the Chair: Review and approval notification.

(1) presents the submission finding to the DHSIRB members at the next scheduled meeting; Approval categories. As a result of the DHSIRB review, each research proposal is assigned to one of the categories in (A) through (E) of this paragraph.

(A) Not human subjects research. Proposal determined to not constitute human subjects research. Investigators whose proposals receive this determination may begin work immediately.

(B) Approved. Research is approved as submitted. Investigators whose proposals are approved may begin work immediately.

(C) Conditionally approved. Research is conditionally approved, but research may not begin until investigators comply with items identified by the DHSIRB for final approval.

(D) Deferred. DHSIRB does not have enough information to make a determination. Investigators whose proposals receive a deferral must resubmit the entire application to address the required changes.

(E) Not approved. The magnitude and/or number of concerns are such that conditional approval is not appropriate. Investigators whose work is disapproved may not conduct the research or resubmit their proposals.

(2) writes a letter to the investigator within 14 days of DHSIRB action. The letter contains: Notification required. The DHSIRB notifies investigators and appropriate managers, supervisors, and directors within DHS in writing of its decision regarding the proposed research activity, including any modifications or conditions required to secure DHSIRB approval of the research activity.

(A) the unique identifier DHSIRB number; Approved applications.

(i) At a minimum, the approval letter contains:

(I) the unique identifier DHSIRB number;

(II) the research name;

(III) the date of approval;

(IV) all reviewed and approved DHSIRB documents;

(V) the duration of the approval; and

(VI) circumstances, such as adverse events or closure of the research, for which DHSIRB must be contacted.

(ii) The approval date is the date when the application is approved.

(iii) Continuing review is not required except when there is a good reason for doing so, per OAC 340:2-39-12.2(c).

(B) name of the research; Conditionally approved applications.

(i) A letter describing the concerns of the DHSIRB is sent to the investigator.The letter makes it clear the research may not begin until DHSIRB issues a letter of approval.

(ii) Investigators have 90-calendar days from the day they are notified about the conditionally approved research to respond.If a response is not received during this period, investigators must resubmit the entire application.

(iii) To review the investigator's response, the chair convenes a subcommittee consisting of the Chair, the Vice-Chair, and the Office of Client Advocacy member.The subcommittee reviews the investigator's response for appropriateness.

(iv) The subcommittee makes a determination as to whether the response adequately addresses the DHSIRB concerns.

(v) A DHSIRB final approval letter is sent to the investigator when the response is approved.At that time, the research may begin.The approval date is the date the investigator's response is approved.Continuing review is not required except when there is a good reason for doing so, per OAC 340:2-39-12.2(c).

(C) reasons the research is exempt from DHSIRB review; and Deferred. A letter describing the determination is sent to the investigator.

(D) signature of the DHSIRB Chair or Vice-Chair; and Not approved. A designation of not approved indicates the magnitude and/or number of concerns is such that conditional approval is not appropriate, as determined by the DHSIRB.

(i) A letter describing the DHSIRB decision and concerns is sent to the investigator.The investigator is notified of the opportunity to respond to the DHSIRB, in writing or in person, regarding the determination, per OAC 340:2-39-13.

(ii) The DHSIRB accomplishes any reconsideration in the same manner as the preliminary review and assessment described in (a) of this Section.

(iii) The investigator is not advised to resubmit disapproved research without consulting the DHSIRB.

(iv) In the event of a resubmission, the DHSIRB submission is given a new number and addressed as a completely new submission.

(3) files a copy of the letter in the DHSIRB file with the submission. In general, action on all proposals is taken within two months after submission.Investigators are notified, in writing, of the DHSIRB decisions within two weeks of board action.

(i) Communication from DHSIRB for non-exempt but expedited review submissions. For expedited review submissions approved or conditionally approved, a letter is written to the investigator(s). At a minimum, the letter contains the: Further reviews by DHS. Research covered by this Part approved by the DHSIRB may be subject to further appropriate review and approval or disapproval by DHS officials.However, DHS officials may not approve the research if it was not approved by the DHSIRB.

(1) unique identifier DHSIRB number;

(2) name of the research;

(3) date of approval or conditional approval;

(4) duration of the approval;

(5) circumstances for which DHSIRB must be contacted, such as adverse events or closure of the research; and

(6) signature of the DHSIRB Chair or Vice-Chair.

(j) Communication from DHSIRB for non-exempt and non-expedited review submissions.

(1) The submission is forwarded to the Chair and all voting members. If a voting member is not available to attend the meeting to review the submission, he or she forwards the submission to his or her alternate member.

(2) The DHSIRB determines if the submission meets the criteria for approval.

(k) Quorum requirements.

(1) A quorum of the DHSIRB includes a majority of voting members, for example five members plus one if DHSIRB has 10 members.

(2) Any quorum must include one non-abstaining outside member.

(3) An investigator may be a member of the DHSIRB so long as the investigator-as-member does not participate in any review and approval process for any research in which he or she has an actual or potential conflict of interest.

(A) Any investigator-as-member with a conflict of interest is allowed to be present only to provide information requested by the DHSIRB.

(B) The investigator-member is absent from the meeting room during the discussion and voting phases of the review and approval process.

(C) DHSIRB minutes reflect whether these requirements are met.

(l) Voting requirements. After appropriate research discussion, the Chair calls for a vote and announces each vote option. Each member votes in only one category.

(1) Abstain. A DHSIRB member declares an abstain vote if the member:

(A) is helping to direct the research;

(B) is an investigator or co-investigator of the research;

(C) has any significant financial interest in the outcome of the research; or

(D) has what he, she, or the DHSIRB considers an unacceptable conflict of interest for other reasons. The minutes of the DHSIRB meeting reflect a vote of abstention. In addition to abstaining from voting on the research, a DHSIRB member with a conflict of interest related to a research does not attend the meeting scheduled to review the research unless requested by the DHSIRB to answer specific questions per (k)(3) of this Section. If the DHSIRB requests the investigator-as-member with a conflict of interest to attend the meeting to provide information, this is reflected in the DHSIRB minutes.

(2) Approved. The approval date is the date of the DHSIRB meeting. The approval is valid for one year unless the committee designates a shorter period based on the risk of the research. An approval letter is sent to the investigator. At a minimum, the approval letter contains:

(A) the unique identifier DHSIRB number;

(B) the name of the research;

(C) the date of approval;

(D) all documents reviewed and approved by the DHSIRB;

(E) the duration of the approval;

(F) circumstances for which the DHSIRB must be contacted, such as adverse events or closure of the research; and

(G) signature of the DHSIRB Chair or Vice-Chair.

(3) Conditionally Approved.

(A) A letter describing the concerns of the committee is sent to the investigator. The letter makes it clear the research may not begin until DHSIRB issues a letter of approval.

(B) Investigators have 90 calendar days from the day they are notified about the conditionally approved research to respond. If no response is received during this period of time, investigators must resubmit the entire application.

(C) The investigator's response is reviewed for appropriateness by the Chair or designated DHSIRB member(s).

(D) A final approval letter from the DHSIRB is sent to the investigator once the response is approved. At that time, the research may begin. The approval date is the date of the original DHSIRB meeting at which the conditional approval determination was made. DHSIRB approval is valid for one year unless the committee designates a shorter period based on the risk of the research.

(4) Deferred. A letter describing the determination is sent to the investigator.

(5) Not Approved. A designation of not approved indicates the magnitude and/or number of concerns is such that conditional approval is not appropriate.

(A) A letter describing the decision and concerns of the DHSIRB is sent to the investigator. The investigator is notified of the opportunity to respond to the DHSIRB in writing or in person regarding the determination.

(B) The DHSIRB accomplishes any reconsideration in the same manner as an intial review.

(C) The investigator is not advised to resubmit disapproved research without consulting the DHSIRB.

(D) In the event of a resubmission, the DHSIRB submission is given a new number and addressed as a completely new submission.

(6) DHSIRB does not recognize voting by proxy. All voting occurs in person at the time of the meeting by the member or his or her designated alternate.

(7) A deferral decision is reviewed as a new submission. The voting occurs independent of the prior voting.

(8) Research including particularly vulnerable subjects. For a research including particularly vulnerable subjects, such as children, prisoners, pregnant women, or cognitive impaired persons, a quorum includes an advocate representing those subjects.

(m) Approval. For a research to receive approval, it must obtain an approval vote from the members attending the meeting. A decision for each category is determined using the process listed in (1) - (2) of this subsection:

(1) Approved (A) and conditionally approved (CA) versus not approved (NA). The NA vote is compared with the sum of the A and CA vote. If the sum (A + CA) is greater than the NA votes, the conditions of approval are refined using the approach described. If the NA vote is greater than the sum (A + CA), the research is not approved. If the NA vote and the (A + CA) vote are tied, the research is not approved.

(2) Approved (A) versus conditionally approved (CA). If the CA vote is greater than (A + NA), the research is conditionally approved. If the CA vote is less than or equal to (A + NA), a second vote is taken with the choices limited to approved, conditionally approved, and abstain. If the A vote and CA votes are tied, the research is conditionally approved.

(n) Communication from the DHSIRB.

(1) Assigned DHSIRB member reviewers presenting the submission may contact the investigator with questions regarding the submission.

(2) The investigator is notified of the review decision within 14 business days following the meeting. This notification may be done electronically with a signed letter to follow.

(3) All parties, including funding agencies, facility directors, and other IRBs with jurisdiction to review the submission, are sent a copy of the signed response letter.

(4) Discussion and individual votes are confidential. Votes by individual members may not be discussed or divulged outside the DHSIRB meeting.

(o) Continuing review.

(1) All research is reviewed by DHSIRB until it is completed. This happens when the analysis of data has ended and reports have been written.

(2) Approval for a research project is valid for no more than one year.

(3) DHSIRB is required to conduct continuing reviews of research at intervals appropriate to the degree of risk, but not less than once a year per 45 C.F.R. § 46.109(e).

(4) The principal investigator is responsible for the timely submission of a continuation application to the DHSIRB that previously reviewed the protocol.

(5) Research protocols that initially required full DHSIRB review and that have not completed data collection generally require full DHSIRB review for continuation. The review takes place at a convened DHSIRB meeting, and action on the research must be approved by a majority of the members present. The DHSIRB's stipulations, if any, must be met before approval for continuation is granted.

(6) Research protocols initially approved as exempt need to submit a request for continuation if the research extends beyond the approval period.

(7) Research protocols that initially required full DHSIRB review, that have completed data collection, and are in the process of analyzing data, may be reviewed using the expedited process. Research protocols that were initially reviewed using the expedited process may be re-reviewed using the expedited process as long as the degree of risk associated with the research has not changed. A continuation request must include a:

(A) request to continue the research project;

(B) copy of all currently approved informed consent forms if subjects are still involved;

(C) brief report on the status of the research project including:

(i) the protocol's progress to date;

(ii) the reasons for continuing the research;

(iii) plans for the next approval period;

(iv) a description of any adverse events or unanticipated problems involving risks to participants or others;

(v) a discussion of the number of refusals, withdrawal of participants from the research or complaints about the research;

(vi) a summary of any recent literature;

(vii) findings obtained thus far; and

(viii) modifications to the research.

340:2-39-12.1. Research project changes after Oklahoma Department of Human Services Institution Review Board (DHSIRB) approval

Issued 9-15-20

(a) After initial approval of a research project by the DHSIRB, the investigator conducts the research activity in accordance within the terms of the DHSIRB approval.

(b) The investigator may not make changes in an approved research activity until the proposed changes are submitted to the DHSIRB for review and approval, except when necessary to eliminate apparent immediate hazards to the subject.

(c) When the investigator encounters any unanticipated problems involving risks to subjects or others or any serious or continuing noncompliance with this Part or with DHSIRB requirements or determinations, those problems and difficulties must be immediately reported to the human protections administrator.

(d) An investigator may ask the DHSIRB to review and approve a proposed change by submitting a completed DHS Form 20AD085E, Oklahoma Department of Human Services Institutional Review Board (DHSIRB) Application and Instructions, per OAC 340:2-39-11(b).

(1) Form 20AD085E and all required attachments must be received by the DHSIRB. When Form 20AD085E and all required attachments are received 14 or more calendar days prior to the next meeting, the application is reviewed at the next regularly scheduled DHSIRB meeting. When Form 20AD085E and attachments are received 13 or fewer calendar days prior to the next meeting, the application is reviewed at the following regularly scheduled DHSIRB meeting.

(2) The investigator may request an expedited review for minor changes in a research activity.

340:2-39-12.2. Continuing review requirements

Issued 9-15-20

(a) Except as provided for in (b) of this Section, the DHSIRB conducts continuing review of any research study it approved at intervals appropriate to the degree of risk, but not less than once per year.Principal Investigators are responsible for submitting a continuing review application at annual intervals unless directed by the DHSIRB to submit more frequently.

(b) Unless the DHSIRB determines otherwise, continuing review of research is not required in the circumstances in (1) through (3).The:

(1) research was eligible for expedited review, per Oklahoma Administrative Code (OAC) 340:2-39-12(c);

(2) proposed research was reviewed by the DHSIRB using one of the limited review procedures, per OAC 340:2-39-12(g); or

(3) research progressed to the point that it involves only:

(A) data analysis, including analysis of identifiable private information or identifiable biospecimens; or

(B) accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care.

(c) Notwithstanding the provisions of (b) of this Section, the DHSIRB may require a continuing review of any research when it determines there is a good reason for doing so. A determination to conduct a continuing review must be made in a DHSIRB-convened meeting, and a rationale for conducting continuing review of research must be stated.

(1) DHSIRB requires the investigator to submit a continuation request that must include a:

(A) specific request to continue the research project;

(B) copy of all currently approved informed consent forms when subjects are still involved; and

(C) brief status report on the research project including:

(i) the protocol's progress to date;

(ii) the reasons for continuing the research;

(iii) plans for the next approval period;

(iv) a description of any adverse events or unanticipated problems involving risks to participants or others;

(v) a discussion of the number of refusals, withdrawal of participants from the research, or complaints about the research;

(vi) a summary of any recent literature;

(vii) findings obtained thus far; and

(viii) modifications to the research.

(d) The continuing review by the convened DHSIRB may be supplemented by other review activities, as determined appropriate by the DHSIRB, such as:

(1) progress report(s) submitted by the principal investigator; or

(2) compliance report(s), if any, prepared by the human protections administrator or others, including:

(A) reports on observations of the consent process, per 45 C.F.R. § 46.109(g);

(B) reports on observations of the research, per 45 C.F.R. § 46.109(g);

(C) reports on any material changes that occurred in the research project since the previous DHSIRB review; per 45 C.F.R. § 46.108(a)(3)(ii);

(D) any complaints received from human subjects, legally authorized representatives, or others; and

(E) any findings of serious or continuing noncompliance with this Part or the DHSIRB requirements or determinations, per 45 C.F.R. § 46.108(a)(4)(i).

(e) As a result of its continuing review, the DHSIRB may suspend or terminate approval of research that is not conducted in accordance with the DHSIRB's requirements or that was associated with unexpected serious harm to subjects. Any suspension or termination of approval includes a statement of the reasons for the DHSIRB action and is reported promptly to the investigator, appropriate DHS officials, and others as appropriate, per 45 C.F.R. § 46.113.

(f) When the DHSIRB decides to suspend or terminate research activity approval, it includes, in its written notification, a statement of the reasons for its decision and gives the investigator an opportunity to respond in person or in writing, per 45 C.F.R. § 46.109(d).

340:2-39-13. Appeal process

Issued 9-15-15Revised 9-15-20

(a) Institutional Oklahoma Department of Human Services officials may not approve research disapproved by the Oklahoma Department of Human Services Institutional Review Board (DHSIRB), per Section 46.112 of Title 45 of the Code of Federal Regulations.

(b) There is no mechanism for an appeal of DHSIRB decisions to other departmental components. DHSIRB is an autonomous entity and its decisions are binding.

(c) Principal investigators may request reconsideration of a DHSIRB decision regarding a research protocol. The request is must be submitted in writing and includes must include any pertinent information relative relevant to the decision. The reconsideration is accomplished in the manner described for initial review preliminary review and assessment, per Oklahoma Administrative Code 340:2-39-12(a). Upon reexamination and reconsideration of its actions, the subsequent DHSIRB decision of the DHSIRB is final.