Preserving Public Trust: Accreditation and Human Research Participant Protection Programs (2001)
Chapter: PUBLICATIONS CITED IN ACCREDITATION STANDARDS
staffing, time allocated by the staff to the research, funding, space, record-keeping capability, and back-up for adverse events.
3.7 Principal Investigators should, when appropriate, communicate with potentially concerned sectors of the community or of the specific population to be recruited in their investigation.
COMMENTARY on Standard 3.7: Discussions about research with prospective research participants and/or the community in which the research will be conducted is a regulatory requirement in some circumstances (e.g., FDA and other DHHS requirements for research conducted in emergency circumstances, etc.). However, investigators should be aware that community involvement in the design and conduct of some research studies may benefit research participants, researchers, and the community. For example, the likelihood of improving informed consent may be enhanced if the community has the opportunity to be included more directly in the decisions made by the organization. Addressing the concerns and values of the community early in the process can help engender a positive attitude in the community for the research organization and/or for the researcher.
3.8 When appropriate, the investigator should explain to, and discuss with, the potential research participants their responsibilities to enhance their protection and to support the integrity of the investigation in ways which include:
(A) Ensuring that research participants understand the risks and benefits of the study, and alternatives thereto;
(B) Ensuring that research participants know whom to contact when they feel they have been dealt with inappropriately;
(C) Ensuring that research participants know whom to contact on the research team if they believe that an adverse event has occurred; and
(D) Recognizing that the safety of research participants and the integrity of the research study are enhanced by ongoing and candid communications between research participant and researcher(s).
U.S. Department of Health and Human Services, Office of Inspector General, “Institutional Review Boards: A Time for Reform,” OEI-01-97-00193 (June 1998). Copies are available through the Boston office: (617) 565-1050, or the OIG Web site: http://www.dhhs.gov/progorg/oei
U.S. Department of Health and Human Services, Office of the Secretary, The National Commission for the Protection of Human Research Subjects, The Belmont Report:
Ethical Principles and Guidelines for the Protection of Human Subjects of Research (April 18, 1979). Copies are available at the following Web site: http://ohrp.ospophs.|dhhs.gov/humansubjects/guidance/belmont.htm
