Department:

UAMS Human Research Advisory Committee               

Policy Number:

4.5

Section:

Committee Operations

Effective Date:

July 31, 2002

Revision Date:

November 18, 2002

  SUBJECT: Functions of the HRAC Committee

  Each HRAC shall follow written procedures for the following (21CFR56.108):

  1. Conducting its initial and continuing review of research and for reporting its findings and actions to the investigator and the institution;
  2. Determining which projects require review more often than annually and which projects need verification from sources other than the investigator that no material changes have occurred since previous HRAC review;
  3. Ensuring prompt reporting to the HRAC of changes in research activity;

  4. Ensuring that changes in approved research, during the period for which HRAC approval has already been given may not be initiated without HRAC review and approval except where necessary to eliminate apparent immediate hazards to the human subjects.

  5. Ensuring prompt reporting to the HRAC, appropriate institutional officials, and the Food and Drug Administration of:

    1. Any unanticipated problems involving risks to human subjects or others;
    1. Any instance of serious or continuing noncompliance with these regulations or the requirements or determinations of the HRAC; or
    1. Any suspension or termination of HRAC approval.

Except when an expedited review procedure is used (21CFR56.110; 45CFR46.110), the HRAC reviews proposed research at convened meetings at which a majority of the members of the HRAC are present including at least one member whose primary concerns are in nonscientific areas. In order for the research to be approved, it shall receive the approval of a majority of those members present at the meeting.