Administrative Regulation Title:  IRB Membership, Size and Purpose

Regulation Number:  2.7.1

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The chairperson must hold a terminal degree (M.D., D.O., D.V.M., or Ph.D.) and be a member of the staff of Eastern Wyoming College. The chairperson must have previous service on the EWC IRB as a committee member.

Responsibilities:

  • Chair the meetings to which they are assigned
  • Substitute as chair on other IRB committees
  • Serve as an alternate IRB member as needed
  • Serve as Designated Expedited Reviewer
  • Participate in the on-call schedule for emergency consultation with investigators
  • Advise investigators on and acknowledging the appropriateness of emergency use of investigational drugs and devices in accordance with federal regulations
  • Participate on IRB Executive Committee meetings
  • Facilitate and participate in IRB educational activities
  • Keep abreast of regulations and policies governing IRB review of research and the conduct of human subjects’ research
  • Evaluate IRB member’s thoroughness of review, and level of engagement and attendance at convened IRB meetings
  • Adhere to and administer determinations by the IRB
  • All chairpersons must have the approval of their supervisor and the Vice President of Student and Academic Services.

Scientific Committee Member

The IRB Scientific Member must hold a scientific degree (e.g., M.D., D.O., D.V.M., Ph.D., Pharm.D. or Bachelor of Science in Nursing). Scientific members must have professional training and experience in an occupation that would incline them to view scientific activities from the standpoint of someone within a behavior or biomedical research discipline. Registered nurses, nurse practitioners, pharmacists, therapists, radiologists and other biomedical health professionals would be regarded to have primary concerns in the scientific area.

Responsibilities:

  1. Participate as a reviewer on applications to which the individual is assigned
  2. Review and participate in a discussion of all applications and agenda items for each convened IRB meeting
  3. When acting as primary IRB reviewer, attempt to resolve questions or concerns prior to the meeting, which may necessitate contacting researchers.
  4. Serve as an alternate IRB member as needed
  5. Provide a written review summary to the Committee Chair prior to the meeting, if assigned as a primary reviewer and unable to attend the meeting due to an emergency
  6. Keep abreast of regulations and policies governing IRB review and the conduct of human subjects’ research
  7. Participate in IRB educational activities

Scientific members employed by Eastern Wyoming College must have the approval of their supervisor and the Vice President of Student and Academic Services.

Non-Scientific Committee Member

The IRB Non-Scientific Member must have experience with complex information processing and interpersonal communication. In addition, the non-scientific member must be comfortable with the electronic environment and able to navigate in email and the internet. Examples of non-scientific or non-medical occupations may include, but not limited to, lawyers, clergy, ethicists, teachers, engineers, accountants, musicians, or business majors.

Responsibilities:

  1. Participate as a reviewer on applications to which the individual is assigned
  2. Review and participate in a discussion of all applications and agenda items for each meeting
  3. Serve as an alternate IRB member as needed
  4. Keep abreast of regulations and policies governing IRB review of research and the conduct of human subjects’ research
  5. Participate in IRB educational activities
  6. Contribute expertise with regulations, policies and the conduct of human subjects’ research
  7. Represent nonscientific interests such as: how well is the research explained in order to comprehend the risk, benefit, and distributable justice (Belmont Principles)

Non-Affiliated (Community) Committee Member

The Non-Affiliated Committee Member is experienced with complex information processing, interpersonal communication, and is sensitive to unique community populations and cultures. In addition, the non-affiliated member must be comfortable with the electronic environment, able to navigate in email, and have access to high-speed internet. The Non-Affiliated Member is not a current or former employee or student of Eastern Wyoming College and does not have an immediate family member who is a current or former employee or student of Eastern Wyoming College.

Responsibilities:

  1. Participate as a reviewer on applications to which the individual is assigned
  2. Review and participate in a discussion of all applications and agenda items for each meeting
  3. Serve as an alternate IRB member as needed
  4. Keep abreast of regulations and policies governing IRB review of research and the conduct of human subjects’ research
  5. Participate in IRB educational activities

Attendance Expectations and Length of Service for All Members

  1. The anticipated length of service for members is three years.
  2. The minimum attendance requirement is for at least 70% of the meetings scheduled for the member’s assigned IRB.
  3. IRB shall have no less than quarterly meetings per year if necessary

According to federal regulations, the minimum number of people required for an IRB is five and will be composed of members of varied backgrounds to facilitate diversity in its composition. Accordingly, if you are doing federally funded or other research, you will need to make sure that your IRB is composed of members who represent the following characteristics:

  1. Scientific area. At least one member must work in science (e.g., biology, psychology, chemistry).
  2. Nonscientific area. At least one member must work in a non-science area (e.g., history, English, philosophy).
  3. External to the institution. One member must come from outside the institution and not be affiliated with the institution.
  4. Diversity of representation. An effort must be made to achieve diversity of representation, particularly if members of a “vulnerable population,” such as children or people with intellectual disabilities, are frequently a subject of study (see definitions in Appendix A). If such populations will be used, someone who has knowledge of or experience with those populations should participate as a member of the IRB.
  5. Diversity of gender. The IRB should have both male and female representation.
  6. Diversity of profession. The IRB should not have representation from just from one profession, such as psychology.

An IRB may not allow any member to participate in the review of any project in which the member has a conflicting interest. That would include researchers involved in the project and administrators involved in the grant applications.

An IRB may invite individuals with expertise in specific areas to assist in the review of projects that require expertise that is not represented sufficiently on the IRB; however, they may not vote with the IRB.

By definition, the IRB is a board, not a committee. As such, it means that members of an IRB are tasked with rendering decisions about research they review. In contrast, members of standing committees may or may not be tasked with rendering decisions—often, their purpose is to offer recommendations or organize information used to help others make decisions. The appointment process to an IRB often differs from the appointment process to other standing committees, as federal regulations include specific requirements about the membership of an IRB.

Members of an IRB will determine the level of IRB review required for submitted research proposals (e.g., “exempt,” “expedited,” or “full” IRB review). Studies that meet the definition of “research” and that involve human participants may be considered exempt if they meet certain requirements.

A “full” IRB review is required when the research is defined as (a) a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge (38 CFR 16.102d); (b) that involves human subjects (i.e., a living person about whom a researcher collects either identifiable private information OR data through an intervention or interaction); and (c) involves greater than minimal risk to those human subjects. A full IRB review usually requires attendance from a quorum of IRB-appointed members.

An “expedited” IRB review is selected when the research is defined as meeting the first two classifications noted above but involves no more than minimal risk to subjects OR is being reviewed strictly for minor changes to previously approved protocols in the research project. An expedited review procedure can be conducted by a subset of reviewers designated by the IRB chairperson from members of the IRB.

An “exempt” IRB review is selected when the research falls into one of the six approved categories of exempt research (45 CFR 46.101 [b]) and is not applicable to research in a covered research category (e.g., FDA regulation – 21 CFR 50.20). Exempt research does not mean that a research project has no review. Rather, for studies that are determined to be exempt, it means that the exemption (and its corresponding category) is documented in the IRB records and that the decision is communicated in writing to the investigator.

 

Original Adoption Date:  3/8/16

Revision Date(s):  2/13/18

Date reviewed, no change: