[Code of Federal Regulations]

[Title 45, Volume 1]

[Revised as of October 1, 2005]

From the U.S. Government Printing Office via GPO Access

[CITE: 45CFR46.107]



[Page 120-121]

 

                        TITLE 45--PUBLIC WELFARE

 

           SUBTITLE A--DEPARTMENT OF HEALTH AND HUMAN SERVICES

 

PART 46_PROTECTION OF HUMAN SUBJECTS--Table of Contents

 

  Subpart A_Basic HHS Policy for Protection of Human Research Subjects

 

Sec. 46.107  IRB membership.



    (a) Each IRB shall have at least five members, with varying 

backgrounds to promote complete and adequate review of research 

activities commonly conducted by the institution. The IRB shall be 

sufficiently qualified through the experience and expertise of its 

members, and the diversity of the members, including consideration of 

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. In addition to 

possessing the professional competence necessary to review 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.

    (b) 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.

    (c) 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.

    (d) 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.

    (e) No IRB may have a member participate in the IRB's initial or 

continuing review of any project in which



[[Page 121]]



the member has a conflicting interest, except to provide information 

requested by the IRB.

    (f) 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.