SOP 200 IRB Organization (OR)
201 Composition of the IRB
1. OBJECTIVE
The IRB shall ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. The IRB should also promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects.
Therefore, the IRB shall consist of at least five regular, voting members. Qualified persons from appropriate professions shall be considered for membership. IRB membership shall not consist entirely of men or of women.
The institution will make every effort to have a diverse membership appointed to the IRB, within the scope of available expertise needed to conduct its functions.
Specific Procedures
1.1 Membership Selection Criteria
The members of the IRB shall be sufficiently qualified through experience and expertise, for reviewing research proposals in terms of regulations, applicable law and standards of professional conduct and practice, and institutional commitments.
The membership shall be diverse, so selection shall include consideration of race, gender, cultural backgrounds, clinical experience, healthcare experience and sensitivity to such issues as community attitudes to assess the research submitted for review.
There shall be at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas. There shall be one member who has no affiliation with this institution beyond IRB membership, either personally or through a family member.
1.2 Composition of the Board
Regular members: The backgrounds of the regular members shall be varied in order to promote complete and adequate reviews of the types of research activities commonly reviewed by the IRB. Regular members must include:
A. Nonaffiliated member(s): The nonaffiliated member(s), who can be either scientific or nonscientific reviewers, should be knowledgeable about the local community and be willing to discuss issues and research from that perspective. Consideration should be given to recruiting individuals who speak for the communities from which Brigham Young University will draw its research subjects.
B. Scientific members: The IRB includes individuals with appropriate education and experience in social, physical biomedical, or biological sciences. Such members satisfy the requirement for at least one scientist. When an IRB encounters studies involving science beyond the expertise of the members, the IRB may use a consultant to assist in the review, as provided by 21 CFR 56.107(f).
C. Nonscientific member: The intent of the requirement for diversity of disciplines is to include members whose main concerns are not in scientific areas. Therefore, nonscientific members are individuals whose education, work, or interests are not solely in scientific areas.
D. Chairperson: The IRB Chairperson should be a highly respected individual, from within Brigham Young University, fully capable of managing the IRB and the matters brought before it with fairness and impartiality. The Chairperson must have continuing status at the University in order to serve. Brigham Young University may invite a graduate student to serve as a representative for the student body.
2. SCOPE
These policies and procedures apply to the membership of the IRB.
3. APPLICABLE REGULATIONS AND GUIDELINES
45 CFR 46.107
21 CFR 56.107
4. REFERENCES TO OTHER APPLICABLE SOPs
This SOP affects all other SOPs.
202 Management of the IRB
1. OBJECTIVE
The management of the membership of the IRB and oversight of member appointments, IRB related activities, communications, and other administrative details are the responsibility of the IRB Administrator.
Specific Procedures
1.1 Term
Members will be appointed to the IRB for a term of three years. The Chairperson will be appointed for a term of five years. Graduate Student member will serve on the IRB for a term of one year. Reappointment for additional terms may occur, by mutual agreement of the Institutional Official, the IRB Chairperson, the IRB Administrator, and the Member.
1.2 Appointments
The Institutional Official in consultation with the IRB Chairperson and IRB Administrator has the authority to appoint members to the IRB. Members will be solicited from Brigham Young University and greater Utah communities.
1.3 Resignations and Removals
A member may resign before the conclusion of his/her term. The vacancy will be filled as quickly as possible. A member may be removed by the Institutional Official. The Chair can be removed with a majority of the IRB members voting against him/her or removal by the Institutional Official.
1.4 Compensation
Participation by Brigham Young University faculty, staff, or students is considered a component of their job responsibilities as established by their supervisors. Regular members who are not affiliated with Brigham Young University may receive compensation for their service.
1.5 Liability Insurance
Regular and alternate members have liability insurance coverage as part of their IRB membership in their capacity as agents of Brigham Young University.
2. SCOPE
These procedures apply to the IRB membership.
3. APPLICABLE REGULATIONS AND GUIDELINES
None
4. REFERENCES TO OTHER APPLICABLE SOPs
This SOP affects all other SOPs.
203 Duties of IRB Members
1. OBJECTIVE
Each IRB member's primary duty is the protection of the rights and welfare of the individual human beings who are serving as the subjects of BYU research. In order to fulfill their duties, IRB members are expected to be versed in regulations governing human subjects protection, biomedical and behavioral research ethics, and the policies of BRIGHAM YOUNG UNIVERSITY germane to human subjects protection.
Specific Procedures
1.1 Duty to Brigham Young University
The IRB is appointed as the Institutional Committee. As such, the IRB members serve BRIGHAM YOUNG UNIVERSITY as a whole, rather than a particular department. Therefore, members must not allow their own interest or that of their department to supersede their duty to protect the rights and welfare of research subjects.
1.2 Specific Duties
1.2.1 Regular Members:
- Nonaffiliated member(s): Nonaffiliated members are expected to provide input regarding their knowledge about the local community and be willing to discuss issues and research from that perspective.
- Non-scientific members: Nonscientific members are expected to provide input on areas germane to their knowledge, expertise and experience, professional and otherwise. For example, members who are lawyers should present the legal views of specific areas that may be discussed, such as exculpatory language or state requirements regarding consent. Non-scientific members should advise the IRB if additional expertise in a non-scientific area is required to assess if the protocol adequately protects the rights and welfare of subjects.
- Scientific members: Scientific members are expected to contribute to the evaluation of a study on its scientific and statistical merits and standards of practice. These members should also be able to advise the IRB if additional expertise in a non-scientific area is required to assess if the protocol adequately protects the rights and welfare of subjects.
- Graduate Student member: Graduate Student member is expected to provide input and be willing to discuss issues and research
- Chairperson: In addition to the above responsibilities (germane to the member's capacity), the Chairperson chairs the meetings of the IRB. The Chairperson performs or delegates to an appropriate voting IRB member 27 expedited review when appropriate. He/she is empowered to suspend the conduct of an approved study deemed to place individuals at unacceptable risk, pending IRB review. The Chairperson is also empowered, pending IRB review, to suspend the conduct of a study if he/she determines that an investigator is not following the IRB’s requirements.
A. The Chairperson may appoint a Co-chairperson to assist or act on behalf of the Chairperson in particular IRB matters and at IRB meetings, either as a general procedure, or on a case-bycase basis. The Chairperson also may delegate any of his/her responsibilities as appropriate to other qualified individual(s). Such documentation must be in writing and maintained by the IRB Administrator.
B. The Chairperson represents the IRB in discussions of IRB decisions with other members of the University.
C. The Chairperson directs the proceedings and the discussion of the full-committee meeting. This includes keeping the discussion focused on important IRB issues and seeing that the full-committee meeting process is both effective and efficient.
D. The Chairperson has an in-depth understanding of the ethical issues, state law, institutional policy, and federal research regulations that are applicable to the studies being reviewed. The Chairperson is not expected to be the only authority on compliance issues. The IRB Administrator or other committee members also take responsibility for compliance verification.
E. The Chairperson assists the IRB administration in drafting letters from the full-committee meeting to investigators regarding IRB decisions. The Chairperson reviews and makes decisions about responses to conditions for IRB approval of research in a timely fashion.
The IRB must be perceived to be fair and impartial, immune from pressure either by the institution's administration, the Investigators whose protocols are brought before it, or other professional and nonprofessional sources.
1.2.2 Reviewers:
In addition to the duties described in section 1.3.1, each regular member may be expected to act as a Reviewer for studies at convened meetings. Each member presents his or her findings resulting from review of the application materials and participates in the IRB discussion of the study.
2. SCOPE
These policies and procedures apply to all IRB Members.
3. APPLICABLE REGULATIONS AND GUIDELINES
45 CFR 46.107, 46.108, 46.109
OHRP IRB Guidebook
4. REFERENCES TO OTHER APPLICABLE SOPs
This SOP affects all other SOPs.