[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2006]

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

[CITE: 21CFR56.107]



[Page 296]

 

                        TITLE 21--FOOD AND DRUGS

 

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 

                                SERVICES

 

PART 56_INSTITUTIONAL REVIEW BOARDS--Table of Contents

 

                  Subpart B_Organization and Personnel

 

Sec.  56.107  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, 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 or 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 those subjects.

    (b) Every nondiscriminatory effort will be made to ensure that no 

IRB consists entirely of men or entirely of women, including the 

instituton'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 the scientific area 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 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 complex issues 

which require expertise beyond or in addition to that available on the 

IRB. These individuals may not vote with the IRB.



[46 FR 8975, Jan 27, 1981, as amended at 56 FR 28028, June 18, 1991; 56 

FR 29756, June 28, 1991]