COMMENT DUE DATE:
March 19, 2015
DATE:
February 6, 2015
Naneida Lazarte Alcala, (405) 521-4174
Dena Thayer, OIRP Programs Administrator (405) 521-4326
RE:
APA WF 14-16
The proposed policy is Permanent . This proposal is subject to the Administrative Procedures Act
SUBJECT:CHAPTER 2. ADMINISTRATIVE COMPONENTS
Subchapter 39. Planning, Research and Statistics
Part 3. Institutional Review Board [NEW]
OAC 340:2-39-5 through 340:2-39-13 [NEW]
(Reference APA WF 14-16)
SUMMARY:The proposed issuance of Chapter 2, Subchapter 39, Part 2 is to establish an administrative body that protects 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.
Oklahoma Administrative Code (OAC) 340:2-39-5 is issued to explain the purpose, scope and authority of the DHS Institutional Review Board (DHSIRB).
OAC 340:2-39-6 is issued to list definitions for the most common terms used in the DHSIRB rules.
OAC 340:2-39-7 is issued to outline the primary principles governing the DHSIRB.
OAC 340:2-39-8 is issued to establish the requirements, roles, and responsibilities of the members of the DHSIRB.
OAC 340:2-39-9 is issued to describe the regulations under which DHSIRB meetings will be held.
OAC 340:2-39-10 is issued to explain record requirements in terms of DHSIRB members, research proposals reviewed, and its general administration.
OAC 340:2-39-11 is issued to provide a description of the research application procedures, including all the information the investigators are required to provide for review.
OAC 340:2-39-12 is issued to present the major focal points of the DHSIRB review and approval process.
OAC 340:2-39-13 is issued to explain the mechanisms in place for an appeal process for a DHSIRB decision.
PERMANENT APPROVAL:Permanent rulemaking is requested.
LEGAL AUTHORITY:Director of Human Services; Section 162 of Title 56 of the Oklahoma Statues (56 O.S. § 162); 56 O.S. § 168; Part 46 of Title 45 and Parts 50 and 56 of Title 21 of the Code of Federal Regulations.
Rule Impact Statement
To:Programs administrator
Office of Intergovernmental Relations and Policy
From:Connie Schlittler, Director
Office of Planning, Research and Evaluation
Date:January 16, 2015
Re:CHAPTER 2. ADMINISTRATIVE COMPONENTS
Subchapter 39. Planning, Research and Statistics
Part 3. Institutional Review Board [NEW]
OAC 340:2-39-5 through 340:2-39-13 [NEW]
(Reference APA WF 14-16)
Contact:Naneida Lazarte-Alcala, PhD.
405-521-4175
A.Brief description of the purpose of the proposed rule:
Purpose.The proposed issuance of Chapter 2, Subchapter 39, Part 2 is to establish an administrative body that protects 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.
Strategic Plan impact. The proposed rules contribute to DHS goals of having stronger Oklahomans and achieving stronger practices by strengthening the culture of accountability and improving well-being of our clients.
Substantive changes.
Oklahoma Administrative Code (OAC) 340:2-39-5 is issued to explain the purpose, scope and authority of the DHS Institutional Review Board (DHSIRB).
OAC 340:2-39-6 is issued to list definitions for the most common terms used in the DHSIRB rules.
OAC 340:2-39-7 is issued to outline the primary principles governing the DHSIRB.
OAC 340:2-39-8 is issued to establish the requirements, roles, and responsibilities of the members of the DHSIRB.
OAC 340:2-39-9 is issued to describe the regulations under which DHSIRB meetings will be held.
OAC 340:2-39-10 is issued to explain record requirements in terms of DHSIRB members, research proposals reviewed, and its general administration.
OAC 340:2-39-11 is issued to provide a description of the research application procedures, including all the information the investigators are required to provide for review.
OAC 340:2-39-12 is issued to present the major focal points of the DHSIRB review and approval process.
OAC 340:2-39-13 is issued to explain the mechanisms in place for an appeal process for a DHSIRB decision.
Reasons. The proposed rules establish an otherwise non-existent DHSIRB in the agency that reviews research involving human subjects.
Repercussions. If the proposed revisions are approved, DHS will be out of compliance with federal policy requirements.
Legal authority.Director of Human Services; Section 162 of Title 56 of the Oklahoma Statues (56 O.S. § 162); 56 O.S. § 168; Part 46 of Title 45 and Parts 50 and 56 of Title 21 of the Code of Federal Regulations.
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:Investigators undertaking research and program evaluation projects involving human subjects will be affected.
C.A description of the classes of persons who will benefit from the proposed rule: All DHS clients and staff involved in research and program evaluation will benefit.
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:The revised rules do not have an economic impact on the affected entities. There are no fee changes associated with the revised 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 probable cost to DHS includes the cost of printing and distributing the rules, estimated to be less than $20. The revised rules will result in enhanced delivery of services to individuals served by DHS.
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 rules 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:There are no less costly or non-regulatory methods or less intrusive methods for achieving the purpose of the proposed rules.DHSIRB members will not receive any compensation for serving on the Board.
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:
The proposed rules will have a positive impact on public safety, especially of DHS clients and staff involved in research, by protecting the rights and welfare of human research subjects.
J.A determination of any detrimental effect on the public health, safety, and environment if the proposed rule is not implemented:If the proposed rules are not implemented it may have a detrimental effect on the rights and welfare of human research subjects involving DHS clients or its staff.
K.The date the rule impact statement was prepared and, if modified, the date modified:Prepared May 5, 2014; modified January 16, 2015.
SUBCHAPTER 39. PLANNING, RESEARCH, AND STATISTICS
PART 3. INSTITUTIONAL REVIEW BOARD
340:2-39-5. Purpose, scope, and authority
Issued 8-1-15
(a) Purpose.The purpose of the Oklahoma Department of Human Services 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.
(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), DHSIRB reviews research and program evaluation projects involving:
(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;
(iii) administration of tests; or
(iv) other 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 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 Director of Human Services.The DHSIRB is registered with the federal Department of Health and Human Services and has approved Federalwide Assurance of Protection for Human Subjects submitted to United States Department of Health and Human Services.
(2) DHSIRB has the authority to review any research funded through DHS or that involves staff or human participants receiving services provided at DHS operated facilities.In addition, DHSIRB has the authority to:
(A) approve, disapprove, or order modification of research based upon consideration of the risks and benefits to the human participants;
(B) oversee the conduct of the research and require periodic progress reports from research investigators;
(C) suspend or terminate prior approval of a research;
(D) place restrictions on a research;
(E) require research investigators to promptly report breaches of confidentiality; and
(F) require research investigators to promptly report if any researcher or research participant is endangered physically or psychologically during the data collection period of the study.
340:2-39-6. Definitions
Issued 8-1-15
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.
"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 permission.
"Demonstration project" means a 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 §§ 102(g), 108 and 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.
"Human Protections Administrator (HPA)" means the person designated by the DHS Office of Planning, Research and Statistics director, who provides administrative support to the DHSIRB, serves as the Office of Human Research Protection’s 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); and
(C) plays a key role in ensuring the institution fulfills its responsibilities under the HSA.
"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; 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.
"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.
"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, 21 C.F.R. § 50.20 and 50.25 and Form 21AD084E, Application to the Oklahoma Department of Human Services Institutional Review Board (DHSIRB).
"Investigator" means a scientist or scholar with primary responsibility for the design and conduct of 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).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 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.
"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.
340:2-39-7. Principle and Policies
Issued 8-1-15
(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 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, all reasonable efforts are made to comply with the requirements in Part 46 of Title 45 of the Code of Federal Regulations for all research conducted or funded by DHSIRB.
(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 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 participants for prevention, diagnostic, or treatment purposes, when appropriate.
(B) Risks to participants are reasonable relative to anticipated benefits, if any, and the importance of the knowledge that may reasonably be expected to result.
(C) Selection of participants is equitable.
(D) Participants, or the participant’s legally authorized representative, provide voluntary informed consent for participating in research, unless otherwise exempted by state or federal law.
(E) There are adequate provisions for ensuring the safety of participants.
(F) There are adequate provisions to protect the privacy of participants and maintain the 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, 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 its practices and procedures designed for the protection of the rights and welfare of human subjects are effectively applied.
(7) DHSIRB serves in a collaborative relationship with research investigators.
(6) 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.
340:2-39-8. Membership
Issued 8-1-15
(a) Requirements for membership of the Oklahoma Department of Human Services Institutional Review Board (DHSIRB).
(1) The DHSIRB is comprised of at least seven members.
(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 sign the Acknowledgments of Receipt that states they have received and reviewed the DHSIRB rules.
(4) The members of the DHSIRB have varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution or at state-operated facilities.In addition to possessing the experience and expertise necessary to review specific research activities, the members are able to ascertain the acceptability of proposed research in terms of institutional commitments 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.
(6) A member of DHS Office of Client Advocacy (OCA) serves on the DHSIRB.
(7) A member of DHS Legal Services serves on the DHSIRB.
(8) A member of DHS Child Welfare Services serves on the DHSIRB.
(9) A member of DHS Community Living and Support Services serves on the DHSIRB.
(10) A member of DHS Adult and Family Services serves on the DHSIRB.
(11) A member of DHS Office of Planning, Research and Statistics serves on the DHSIRB representing scientific areas.
(12) The Director of Human Services (Director) approves the selection of DHSIRB members, including that of the chair, vice-chair, and alternates, and is notified 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.Alternate members complete the training and may vote on any new submission.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 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.
(c) Ad hoc members.
(1) If the DHSIRB reviews research 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, consideration is given to the inclusion of one or more individuals who are knowledgeable about, and experienced in, working with these participants.
(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 the DHSIRB may override a not approved vote.
(d) Roles and responsibilities.
(1) The DHSIRB chair:
(A) is appointed by the 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 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 (HPA);
(F) ensures meeting coverage by the 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 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 to complete the expedited review;
(J) delegates review responsibilities as necessary and applicable;
(K) distributes copies of the submissions to the appropriate DHSIRB memberswith the assistance of the HPA;
(L) ensures adequate expertise for review and determinations;
(M) consults with investigators as necessary;
(N) assists the reviewers and other members with any concerns in preparing for the meeting;
(O) ensures assigned reviewers present a clear and concise review of research materials;
(P) votes on each DHSIRB action;
(Q) is temporarily removed in the event of a conflict of interest;
(R) is permanently removed in the event of termination of employment, or at the discretion of the Director; and
(S) notifies the Director of any disapprovals.
(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 member of OCA;
(F) is temporarily removed in the event of a conflict of interest;
(G) is permanently removed in the event of termination of employment, or at the 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 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) are removed from the DHSIRB if more than two consecutive meetings are missed without having the designated alternate attend;
(H) are temporarily removed in the event of a conflict of interest; and
(I) are permanently removed in the event of termination of employment, or at the 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 OHRP website.Training certificates are not required for ad hoc members;
(B) annually submit signed acknowledgements of reading the DHSIRB procedures and supporting documents.Supporting documents are not required for ad hoc members;
(C) have access to the reference materials available through the DHSIRB 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 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 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 report to DHSIRB and appropriate institutional officials of:
(i) unanticipated problems involving risks to research participants, interviewers, or others;
(ii) serious or continuing noncompliance with the requirements of the DHSIRB;
(iii) suspension or termination of DHSIRB approval; or
(iv) disapproval of other DHSIRB submissions.
(5) Consultants are invited to review submissions and attend meetings when a submitted proposal contains information outside the scope of the DHSIRB members’ collective knowledge.
(6) The Office of Planning, Research and Statistics 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 there is an actual or potential conflict of interest with regard to the professional or personal interests, including financial interests, of the member.
(1) DHSIRB members are not selected by potential investigators.
(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.
340:2-39-9. Meetings
Issued 8-1-15
(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.
(b) A quorum is defined as 50 percent plus one of all primary members, including the member whose primary concerns are in nonscientific areas.
(c) A majority vote is required of those present for approval of a motion.
(d) 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 and agency directors, if applicable; and
(D) the assigned unique identifier DHSIRB number.
(e) At a minimum:
(1) the chair convenes and conducts the meetings;
(2) the minutes of the prior meeting are approved by an open vote of the members;
(3) all actions taken require an open 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 designated individual.
340:2-39-10. Record requirements
Issued 8-1-15
(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) 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;
(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 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) the basis for requiring changes in or disapproving research; and
(E) a written summary of the discussion of controversial issues and their resolution;
(4) records of continuing review activities;
(5) copies of all correspondence between the DHSIRB and investigators;
(6) written procedures and guidelines for:
(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 DHSIRB of 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).
340:2-39-11. Application procedures
Issued 8-1-15
(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.
(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.
(c) If the research departs from the original proposal, the DHSIRB is advised and a new application submitted for DHSIRB approval.
(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.
(e) Decisions to disapprove are accompanied by reasons for the decision.
(f) Information provided to the DHSIRB by the investigator is the:
(1) DHSIRB application Form 21AD084E, Application to the Oklahoma Department of Human Services Institutional Review Board (DHSIRB);
(2) professional qualifications to do the research, including a description of necessary support services and facilities;
(3) research protocol including and addressing the:
(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;
(5) informed consent document.
(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.
340:2-39-12. Review and Approval Process
Issued 8-1-15
(a) Submission requirements and initial 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.
(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:
(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.
(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)).
(1) Research conducted in established or commonly accepted education settings, involving normal educational practices, such as research on:
(A) regular and special education instructional strategies; or
(B) the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
(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:
(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:
(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:
(1) minor changes have been made to previously approved research during the period of one year or less for which approval is authorized;
(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;
(3) remaining research activities are limited to data analysis;
(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:
(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.
(e) Full DHSIRB review.
(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:
(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.
(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.
(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:
(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;
(2) using previous DHSIRB experience with the investigator; and
(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.
(1) Risks to participants are minimized by using procedures:
(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.
(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.
(4) Informed consent is sought from each prospective participant or the participant's legally authorized representative and contains:
(A) an explanation of the purposes of the research;
(B) an expected duration of the participant’s involvement in the research;
(C) a description of the procedures to be followed;
(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:
(1) presents the submission finding to the DHSIRB members at the next scheduled meeting;
(2) writes a letter to the investigator within 14 days of DHSIRB action.The letter contains:
(A) the unique identifier DHSIRB number;
(B) name of the research;
(C) reasons the research is exempt from DHSIRB review; and
(D) signature of the DHSIRB chair or vice-chair; and
(3) files a copy of the letter in the DHSIRB file with the submission.
(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:
(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.
340:2-39-13. Appeal process
Issued 8-1-15
(a) Institutional officials may not approve research disapproved by the 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 submitted in writing and includes any pertinent information relative to the decision.The reconsideration is accomplished in the manner described for initial review per Oklahoma Administrative Code 340:2-39-12(a).Upon reexamination and reconsideration of its actions, the decision of the DHSIRB is final.
