NCJ Number
44807
Journal
Federal Register Volume: 43 Issue: 3 Dated: (JANUARY 5, 1978) Pages: 1050-1053
Date Published
1978
Length
4 pages
Annotation
REGULATIONS TO PROTECT PRISONERS INVOLVED IN RESEARCH ACTIVITIES CONDUCTED OR SUPPORTED BY THE U.S. DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE ARE PROPOSED.
Abstract
THE PROPOSED REGULATIONS ARE INTENDED TO IMPLEMENT THE RECOMMENDATIONS OF THE NATIONAL COMMISSION FOR THE PROTECTION OF HUMAN SUBJECTS OF BIOMEDICAL AND BEHAVIORAL RESEARCH. UNDER THE PROPOSED RULES, INSTITUTIONAL REVIEW BOARDS MAY APPROVE BIOMEDICAL AND BEHAVIORAL RESEARCH INVOLVING PRISONERS AS SUBJECTS ONLY UNDER THE FOLLOWING CONDITIONS: (1) ADVANTAGES THAT WILL ACCRUE TO THE PRISONER THROUGH PARTICIPATION ARE NOT OF SUCH A MAGNITUDE THAT THE PRISONER'S ABILITY TO WEIGH THE RISKS IS IMPAIRED; (2) THE RISKS INVOLVED ARE COMMENSURATE WITH THOSE THAT WOULD BE ACCEPTED BY NONPRISONER VOLUNTEERS; (3) PROCEDURES FOR SELECTING SUBJECTS ARE FAIR AND IMMUNE FROM ARBITRARY INTERVENTION BY PRISON OFFICIALS OR PRISONERS; (4) INFORMATION ON THE RESEARCH IS PRESENTED IN AN UNDERSTANDABLE FORM; (5) THERE IS ASSURANCE THAT PARTICIPATION IN RESEARCH PROJECTS DOES NOT AFFECT PAROLE BOARD DECISIONS; AND (6) PROVISIONS ARE MADE FOR ANY NECESSARY FOLLOWUP EXAMINATIONS. THE BOARDS MAY APPROVE RESEARCH INVOLVING PRISONERS AS SUBJECTS ONLY IF THE RESEARCH CONCERNS THE STUDY OF POSSIBLE CAUSES, EFFECTS, AND PROCESSES OF INCARCERATION; THE STUDY OF PRISONS AS INSTITUTIONS OR OF PRISONERS AS INCARCERATED PERSONS; OR PRACTICES THAT HAVE POTENTIAL FOR IMPROVING THE HEALTH AND WELL-BEING OF THE SUBJECT. COMMENTS PERTAINING TO THE COMMISSION'S RECOMMENDATIONS ARE SUMMARIZED. (LKM)