SACHRP recommendations for review of children's research requiring DHHS secretary's approval

IRB Ethics and Human Research

Volumn 27, Issue 3, 2005, Pages 8-10

  Fisher, Celia B ^a   Kornetsky, Susan Z ^b  

^a FORDHAM UNIVERSITY   (United States)

^b BOSTON CHILDREN S HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADVISORY COMMITTEE; ARTICLE; BIOMEDICAL AND BEHAVIORAL RESEARCH; CHILD; CHILD ADVOCACY; ETHICS; GOVERNMENT REGULATION; HUMAN; HUMAN EXPERIMENT; LEGAL APPROACH; LEGAL ASPECT; MULTICENTER STUDY; ORGANIZATION AND MANAGEMENT; PROFESSIONAL STANDARD; PUBLIC HEALTH SERVICE; SECRETARY'S ADVISORY COMMITTEE ON HUMAN RESEARCH PROTECTIONS; STANDARD; UNITED STATES;

BIOMEDICAL AND BEHAVIORAL RESEARCH; LEGAL APPROACH; SECRETARY'S ADVISORY COMMITTEE ON HUMAN RESEARCH PROTECTIONS;

ADVISORY COMMITTEES; CHILD; CHILD ADVOCACY; ETHICAL REVIEW; ETHICS COMMITTEES, RESEARCH; GOVERNMENT REGULATION; HUMAN EXPERIMENTATION; HUMANS; MULTICENTER STUDIES; UNITED STATES; UNITED STATES OFFICE OF RESEARCH INTEGRITY;

EID: 23244466521     PISSN: 01937758     EISSN: None     Source Type: Journal    
DOI: 10.2307/3564073     Document Type: Review

References (5)

1. 45 CFR 46 Subpart D. Additional DHHS Protections for Children Involved as Subjects in Research.
2. Nelson RM, Prentice ED, Hammerschmidt DE. The process of federal panel review of research protocols involving children. Medical Research Law & Policy Report 2002;1:613-615.
3. FDA regulations 21 CFR 50.51-54 for the protection of children parallel 46.404-407 classifications; see http://www.accessdata.fda.gov/scripts/cdrh/ cfdocs/cfcfr/CFRSearch.cfm.
4. Under federal statute, non-Federal Advisory Committees are not permitted to submit a consensus document. Protocols jointly reviewed by OHRP and FDA may issue a consensus report if reviewed by the FDA Federal Advisory Committee.
5. Available at http://www.hhs.gov/ohrp/sachrp/index.html.