Recommendation 5.2: Institutional review boards should require appropriate community involvement in housing health hazards research involving children and require that investigators’ protocols are responsive to any community concerns.
Recommendation 6.3: Institutional review boards that review intervention studies or longitudinal cohort studies on housing health hazards involving children should require that the informed consent process reflects appropriate community input and includes plans that ensure that parents of child participants understand the essential elements of the research.
Recommendation 7.4: Institutional review boards that review housing health hazards research should examine the researchers’ plans for responding to risks observed in the home and require that they be appropriate in the context of the research and the affected community.
U.S. Department of Health and Human Services (DHHS) of its regulations has been the subject of critical reports in recent years (Institute of Medicine, 2004). In response to those criticisms, DHHS in 2000 reorganized its oversight structure to emphasize the importance of protections for human research subjects: the entity charged with principal responsibility for human research subject protections was moved from an office in the National Institutes of Health (NIH) to the Office of Public Health and Science, which is in the office of the DHHS secretary (Institute of Medicine, 2004). This principal entity, now named the Office for Human Research Protections (OHRP, formerly the Office for Protection from Research Risks), is charged with overseeing compliance with DHHS regulations for the protection of human subjects. OHRP establishes criteria for and approves assurances of compliance with institutions engaged in DHHS-conducted or DHHS-funded human subject research, provides guidance on involving humans in research, develops and implements educational programs and resource materials, and promotes the development of approaches to enhance human subject protections.
OHRP is guided by the 11-member Secretary’s Advisory Committee on Human Research Protections (SACHRP). The advisory committee members are selected on the basis of their expertise in any of the several disciplines and fields pertinent to human subjects protection or clinical research. Membership of SACHRP also includes non voting ex-officio members who