The University has established its IRB in accordance with the compositional requirements of 45 CFR 46.107. These regulations require that an IRB:
Must be comprised of at least 5 members from diverse backgrounds to promote complete and adequate review of research activities commonly conducted at the University;
Must be sufficiently qualified through the experience and expertise of its members, and the diversity of its members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes and issues related to vulnerable populations, to promote respect for its advice and counsel safeguarding the rights and welfare of human participants;
Must be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice and shall, therefore, include persons knowledgeable in these areas; and
Must include qualified persons of both genders so long as no selection is made on the basis of gender.
At least one member must be someone whose primary concerns are in a non-scientific area and at least one member whose primary concerns are in a scientific area;
At least one member must be not otherwise affiliated with the University and who is not part of the immediate family of a person who is affiliated with the University;
Members may not participate in the IRB’s initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB;
The IRB may, at 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 available on the IRB. These individuals may not vote; and
Studies that are more than minimal risk and propose to involve youth or adults confined or at risk for confinement in the correctional or involuntary mental health system may only be reviewed when a member designated as a “prisoner advocate” is present and eligible to vote.
Individuals who are appointed to the IRB as alternates may not contribute to the quorum or vote on applications under review at a given IRB meeting unless s/he is replacing a regular member. A nonscientist regular member can only be replaced by another nonscientist (because one must always be part of the quorum).
Appointments to the IRB
The Institutional Official (IO), in consultation with the IRB Chair and IRB Administrator, makes formal appointments of full-time UNI faculty, staff, and community members to the IRB for terms not more than 3 years in length. Terms are renewable.
The Institutional Official, with input from the IRB Administrator and IRB members, appoints the Chair of the IRB for a 3-year renewable term.
Special roles that may be established by the IRB, such as Continuing Reviewer, Survey Reviewer, and/or Advocate for Children with Special Needs, are assigned by the IRB Chair, in consultation with the IRB Administrator. The Continuing Reviewer role will be documented in writing, as required by regulation.
Member Files and Qualifications
The names and affiliations of all regular and alternate members of the IRB shall be on file with the U.S. Office for Human Research Protections (OHRP), in accordance with the requirements of the University/PHS Federal Wide Assurance, and in the IRB Office in East Bartlett Hall. All changes in IRB membership are reported to OHRP as appropriate.
Member files include: 1) a letter of appointment showing the specific term of appointment, 2) curriculum vitae, and 3) documentation of human protections training.
The following are some of the characteristics that are given consideration in identifying and recruiting new Board members and renewing appointments of existing members.
- Commitment to regular monthly meeting attendance
- Availability of at least 8-10 hours/month for monthly meetings, training in protocol review and regulations, and protocol reviews as appropriate
- Interest and willingness to learn regulations and guidelines
- Experience in research involving human participants and oversight of student research
- Recognition of the value in and need for institutional oversight and support of research
- Interest in ethics and ethical decision-making in research
- Cross-campus representation and membership diversity