COTTAGE HEALTH SYSTEM POLICY

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SUBJECT:

Institutional Review Board Membership

IRB Membership

 

DEPT: IRB POLICY #: 8012.09

 

 

GOAL:

To establish an institutional policy regarding the guidelines to be used in setting up and operating the IRB membership according to Federal regulations.

 

POLICY:

Institutional Review Board membership must meet the requirements set forth in Title 45, Part 46, Section107 of the Code of Federal Regulations (45 CFR 46.107).

 

 

PROCEDURE:

The CHS Institutional Review Board is a medical staff committee.  Members and alternate members of the Institutional Review Board are appointed by the Chief of Staff and approved by the Board of Directors of Cottage Health System on a biennial basis.

 

There are 11 primary members and usually 11 alternate members on the CHS IRB.  One alternate member may be assigned to more than one primary member; or, alternatively, more than one alternate may be assigned to one primary member.  The IRB membership is diversified among institutional, non-institutional, scientific, and non-scientific members as stipulated by Federal regulations.

 

When selecting IRB members, the potential for conflicts of interest are considered. When members frequently have conflicts and must absent themselves from deliberation and abstain from voting, their contributions to the group review process are diminished and can hinder the review procedure. Even greater disruptions may result if this person is chairperson of the IRB.

 

Membership commitment is two years, at which time members may renew their memberships indefinitely, as long as no material changes have occurred which may create conflicts with their IRB duties.  Appointments as IRB Chair coincide with the two year IRB membership term, however the Chair may only renew his/her Chair position twice (serving a total of no more than six years).  Once the Chair steps down from his/her position, s/he may continue as a primary member without term restrictions or limitations.

 

Member Description

IRB Chairpersons.  The Chief of Staff designates one member as the IRB Chair and one member as the Vice-Chair.  It is generally expected for the Vice-Chair to be promoted to IRB Chair and assume the Chair's responsibilities, when the IRB Chair steps down from the position.

 

Requirements for IRB Chair include:

  • Member of the Active Staff of a Cottage Health System facility
  • Experience in IRB activities.
  • Willingness to serve as Chair or Vice-Chair and be available for review of protocols on a continuous basis.

 

Primary Members:   The Chief of Staff appoints primary IRB members. The IRB roster identifies the alternate member(s) who may substitute for each primary member.

 

Alternate Members:  The Chief of Staff appoints alternate IRB members. The IRB roster identifies the primary member(s) for whom each alternate member may substitute. To ensure maintaining an appropriate quorum, the alternate's qualifications should be comparable to the primary member being represented. The IRB minutes document when an alternate member replaces a primary member. When an alternate substitutes for a primary member, the alternate member receives and is responsible for reviewing the same material that the primary member received or would have received.

 

Clinical Investigators as Members:  A Clinical Investigator may be an IRB member. However, IRB regulations prohibit any member from participating in the IRB's initial or continuing review of any study in which the member has a conflicting interest, except to provide information requested by the IRB.

 

Confidentiality Agreements

IRB members will sign confidentiality agreements, as provided by the institution, promising to maintain in strict confidence all information shared with the IRB from the sponsor, investigator, or other individuals regarding confidential research information. (see Attachment A).

 

HHS Regulations on IRB Membership Codified at 45CFR46

  • The IRB must have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB is sufficiently qualified through the experience and expertise of its members and the diversity of the members, including consideration of race, gender, 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. In addition to possessing the professional competence necessary to review the specific research activities, the IRB shall 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. The IRB shall therefore include persons knowledgeable in these areas. If an IRB regularly reviews research that involves a vulnerable category of subjects, such as children, prisoners, pregnant women, or handicapped or mentally disabled persons, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these subjects.
  • Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or entirely of women, including the institution's consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one profession.
  • Each IRB shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas.
  • Each IRB shall include 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.
  • No IRB may have a member 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.
  • An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of issues which require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB.

 

4/11

 


COTTAGE HEALTH SYSTEM POLICY

RECOMMENDED BY: Leilani Price DATE: 9/12/02

ORIGINAL POLICY EFFECTIVE DATE: 11/02

APPROVED BY: .. DATE: -

DATE REVISED: 4/11 DATE REVIEWED: 4/06, 1/08, 1/09