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HRPP Policy - IRB Membership
About This Policy
- Effective date:
- Last updated:
- Policy Contact:
IU Human Subjects Office
Members are appointed to the IU IRBs to ensure the following requirements are met:
- Each IRB has at least five members with varying backgrounds to promote complete and adequate review of research activities commonly conducted by IU and its affiliates.
- Each IRB is sufficiently qualified, through the experience and expertise (professional competence), and diversity of its members, including race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects.
- Each IRB is able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations (including policies and resources), applicable local, state, and federal requirements, and standards of professional conduct and practice.
- If an IRB regularly reviews research that involves a category of subjects that is vulnerable to coercion or undue influence, such as children, prisoners, adult individuals lacking consent capacity, or economically or educationally disadvantaged persons, consideration is given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these categories of subjects. IRB's reviewing VA research should also consider including a veteran or veteran's representative.
- No IRB consists entirely of members of one profession.
- Each IRB includes at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are unambiguously in nonscientific areas (i.e., little or no scientific or medical training or experience).
- Each IRB includes at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution.
- Retired VA employees who are receiving VA retirement benefits are considered to be affiliated when they are members of a VA IRB, but veterans who receive their care at the facility, but have never been employed by VA, would not be considered affiliated.
- Each IRB includes at least one member who represents the perspective of research subjects.
- Each IRB that regularly reviews research involving prisoners:
- includes a majority of members that have no association with the prison(s) involved, apart from their membership on the IRB
- has at least one voting member who is a prisoner or prisoner representative with a close working knowledge, understanding, and appreciation of prison conditions from the perspective of a prisoner
The following may not serve as voting members of the IRB:
- Individuals responsible for business development for IU and its affiliates
- Individuals who own equity in the institution
- VA facility research staff including, but not limited to, the Associated Chief of Staff for Research & Development (R&D) and the Administrative Officer for R&D
- VA Research Compliance Officers; however, these individuals may act as consultants to the IRB
- VA Facility Directors, their administrative staff, Chief of Staff, other facility senior administrators such as Associate or Assistant Directors or Chief Nurse, and NPC Administrative Staff
The VA Privacy Officer and the Information Security Officer serve in an advisory capacity to the IRB as consultants.
IRB membership rosters are maintained which list IRB members identified by name, earned degrees, representative capacity, indications of experience such as board certifications, licenses, etc., sufficient to describe each member's primary anticipated contributions to each IRB deliberation, and any employment or other relationship between each member and the institution (e.g., full time employee, member of governing panel or board, paid or unpaid consultant).
For alternates, the roster identifies by name the primary member(s) for whom each alternate member may substitute. Alternates must have qualifications similar to the member they replace.
IRB membership information reported to the Office for Human Research Protections (OHRP) is updated within 90 days after changes to an IRB chairperson or the contact person who provided the IRB registration information.
The Vice President for Research or his/her designee appoints IRB members, including Chairs and Vice Chairs, based on recommendations from IU department chairs and following a careful review of candidate qualifications to ensure adequate representation. The Roudebush VAMC Director appoints VA representatives. IRB members may be appointed for terms of up to three years, and may be reappointed for an unlimited number of terms. At the time of appointment and at reappointment, as requested, IRB members are required to:
- read the Belmont Report
- complete the required IRB member modules of the Collaborative Institutional Training Initiative (CITI) course
- review the IRB Member Education website
- disclose potential conflicts of interest.
IRB members cannot serve as voting members until these requirements are met.
A reasonable number of alternates who may serve in place of absent members are also appointed. Alternates must also complete the appointment requirements listed above.
All IRB members and alternates are expected to fulfill the following responsibilities:
- Attend monthly IRB meetings (alternates attend only upon request)
- Serve as primary reviewer for IRB submissions assigned to them
- Conduct an in-depth review of all materials
- Be prepared for discussion at the meeting, including presenting the submission to the IRB and making a recommendation regarding IRB action
- Complete Reviewer Checklist(s)
- Be familiar with all other submissions included on the meeting agenda
- Be knowledgeable about the local research context in order to make appropriate determinations
- Be knowledgeable of the community from which the subjects are drawn to ensure the protection of subjects' rights and the appropriateness of the informed consent process
- As applicable, review the storage and control plans for investigational drugs and devices to ensure that they are used only in approved research and under the direction of approved investigators
- Review expedited submissions on an ad hoc basis
- Complete Reviewer Checklist(s)
- Complete annual membership evaluation
- Disclose potential conflicts of interest
In addition, IRB Chairs and Vice Chairs are responsible for the following:
- Attend IRB Executive Committee Meetings
- Conduct IRB meetings, including:
- Call meetings to order
- Facilitate discussions
- Provide counsel to IRB Members
- Call for motions and votes
- Adjourn meetings
- Work with Human Subjects Office (HSO) staff to coordinate resolution of compliance issues, including discussion and mediation with study teams
- Review and provide comments on requests for study suspensions
- Evaluate IRB Members annually, in conjunction with HSO staff
IRB members, including Chairs and Vice Chairs, are evaluated annually using the IRB Member Evaluation Form by the Assistant Vice President for Research Compliance, in collaboration with the Director of the Human Research Protection Program (HRPP) and selected IRB members. Feedback may be provided individually or in aggregate either electronically or in a meeting setting. Information from the evaluation is maintained by the HSO. The Evaluation Tool addresses attendance, quality of reviews, contributions at IRB meetings, timeliness of reviews, and evidence of understanding of applicable regulations, policies, and procedures.
Concerns with any IRB member's performance are resolved in consultation with the IRB Chair or Vice Chair (when appropriate), department Chair, Associate Vice President for Research Compliance, and/or the IRB member directly, as appropriate. Potential outcomes can range from further education for the IRB member to removal from the IRB.
When IRB members are considered for reappointment, evaluations that occurred during their service on the IRB are considered along with input from members of the HRPP staff, IRB Chairs and/or Vice Chairs, and department Chairs.
- AAHRPP Standards
- Element I.1.E
- Element II.1.A
- Element II.1.B
- Element II.1.C
- 21 CFR 56, especially 56.107
- 45 CFR 46, especially 46.107 and Subpart E
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH): Guideline for Good Clinical Practice E6(R2), especially section 3.2
- Memorandum of Understanding Between Richard L. Roudebush Veterans Affairs Medical Center and Indiana University Concerning Utilization of Indiana University's Institutional Review Boards
- VHA Directive 1200.05 - Requirements for the Protection of Human Subjects in Research, especially section 7
device (medical device) As regulated by the FDA, an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is: 1) recognized in the National Formulary, or the United States Pharmacopeia, or any supplement to them; 2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals; or 3) intended to affect the structure or any function of the body of man or other animals, and; which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. See FDA Guidance for Industry and FDA Staff on Classification of Products as Drugs or Devices and Additional Product Classification Issues.
drug As regulated by the FDA, A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and B) rticles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and D) articles intended for use as a component of any articles specified in clause (A), (B), or (C). See FDA Guidance for Industry and FDA Staff on Classification of Products as Drugs or Devices and Additional Product Classification Issues.
fetus The product of conception from implantation until delivery.
investigational biologic, drug, device, or test article A drug or device that is the object of a clinical investigation.
investigator (FDA, see also research personnel, IU-affiliated research personnel, key personnel, non-key personnel, non-affiliated research personnel, principal investigator (PI), student, fellow, resident PI, site-specific PI) In research subject to FDA regulations, an individual who actually conducts a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team.
neonate A newborn child less than four weeks old. A Bold-nonviable neonate-Bold is an expelled or delivered fetus who, although living, cannot sustain life independently, even with medical intervention.
prisoner Any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute; individuals detained in other facilities by virtue of statutes or commitment procedures that provide alternatives to criminal prosecution or incarceration in a penal institution; and individuals detained pending arraignment, trial, or sentencing. Examples of individuals considered prisoners are available in the Link-OHRP Prisoner Research FAQs.-Link
research A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge (Synonymous with clinical investigation For research subject to FDA regulations, any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the FDA under §505(i), §507(d), or §520(g) of the Food, Drug & Cosmetic Act, or need not meet the requirements for prior submission to the FDA under these sections of the act, but the results of which are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit. The term does not include experiments that must meet the provisions of part 58 regarding nonclinical laboratory studies (21 CFR 50.3(c)).) The following activities are deemed not to be research under this definition: Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information that focus directly on the individuals about whom the information is collected; Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters); Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for the activities authorized by law or court order solely for criminal justice or criminal investigative purposes; Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.
suspension Temporary cessation of some or all activities in a currently approved research study.Back to top