Ordering Information for Human Subject IRB Guidebook and Videotapes

Description: The 1993 Guidebook is designed to assist institutional review board (IRB) members, research, and institutional administrators in fulfilling their responsibilities for protecting the rights and welfare of human subjects as defined in the HHS regulations (45 CFR 46) entitled, "Protection of Human Subjects," revised June 18, 1991. The Guidebook is not designed to tell IRBs whether or not specific protocols should be approved, however, it does point out issues to which IRBs should pay attention and presents, wherever possible, areas where ethicists and others concerned with these issues have arrived at a consensus on the ethical acceptability of a particular activity or method. Constructed in a looseleaf format, this book holds the regulations and policies, relevant institutional documents, text dealing with specific topics, a glossary of terms, and a bibliography.

Suggested Audience: The Guidebook is also intended to be a resource that will serve as the focal point of IRB administrators and IRB members involved in human subjects work.

Note: the Guidebook is available Online at this website.

Ordering Information: Specify that you would like to order the "PROTECTING HUMAN RESEARCH SUBJECTS: Institutional Review Board Guidebook," (S/N: 017-040-00525-3) and provide your name, title, organization, address, and telephone number to the Superintendent of Documents, P.O. Box 371954, Pittsburgh, PA 15250-7954 (202-512-1800 or FAX No. 202-512-2250).

Cost: $45.00 for domestic orders; $56.25 for international orders; cost includes shipping fees.

Superintendent of Documents Order Form

Description: The Office for Protection from Research Risks produced a videotape series entitled "PROTECTING HUMAN SUBJECTS," that consists of three instructional videotapes, as follows:

1. "EVOLVING CONCERN: Protection for Human Subjects" traces the development of today's comprehensive program to protect human subjects of research out of earlier ethical codes and societal concerns. This film selected historic events in behavioral and biomedical research to show why protection is needed and how it came about.

2. "BALANCING SOCIETY'S MANDATES: Criteria for Protocol Review" depicts an Institutional Review Board (IRB) in action. Dr. Edmund Pellegrino, Director of the Kennedy Institute of Ethics, explains the basis for the criteria that an IRB follows in reviewing research. In commenting on IRB deliberations he points out why the IRB seeks clarification and information from the researcher.

3. "THE BELMONT REPORT: Basic Ethical Principles and Their Application" describes the basic ethical principles that underlie research involving human subjects; respect for persons, beneficence, and justice. This film illustrates their application in case studies of biomedical and behavioral research and shows the principles at work in the resolution of ethical conflicts.

Suggested Audiences: Researchers, institutional officials, reviewers, students, investigators, IRB members, and staff may also find the material useful.

Ordering Information: Please provide requestor name, title, institution name, address, and telephone number via letter to Lannette Myers, Program Assistant, Office for Human Research Protections, The Tower Building, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852, or FAX your request to (301) 402-0527) - ATTN: Lannette Myers.

Cost: No charge

OHRP Home Page

If you have questions about human subject research, click   ohrp@osophs.dhhs.gov
If you have questions/suggestions about this web page, click  lniemoeller@osophs.dhhs.gov
Updated June 28, 2004