Ethical Considerations for Research on Housing-Related Health Hazards Involving Children (2005) / Chapter Skim
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8 Research Oversight
8 Research Oversight
Pages 145-162
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From page 145... ...
In response to specific ethical issues raised by the context of housing health hazards research, the committee recommends that researchers consult with the affected communities (Chapter 5) , ensure that parents' decisions to enroll children in research is truly informed and voluntary (Chapter 6)
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From page 146... ...
Recommendation 7.4: Institutional review boards that review housing health haz ards research should examine the researchers' plans for responding to risks ob served in the home and require that they be appropriate in the context of the research and the affected community.
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From page 147... ...
In addition, it discusses in detail issues related to research that involves a minor increase over minimal risk and no prospect of direct benefit given the particular concerns regarding this type of research in the context of housing health hazards research. RESEARCH PROTECTIONS As discussed in Chapter 3, Subpart A of the federal regulations (45 CFR 46, the "Common Rule")
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From page 148... ...
SACHRP is currently considering these terms and is expected to propose an updated list of interventions that may appropriately be considered minimal risk and minor increase over minimal risk, together with an explanation of the reasons for the decisions. The committee supports this ongoing work and believes it will provide the necessary foundation for OHRP to issue guidance that will help IRBs and researchers carefully consider what would justify labeling an intervention minimal risk or minor increase over minimal risk.
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From page 149... ...
Guidance Regarding Economically and Educationally Disadvantaged Populations Subpart A of the federal regulations reminds IRBs to "be particularly cognizant of the special problems of research involving vulnerable populations such as children, prisoners, pregnant women, mentally disabled persons, and economically and educationally disadvantaged populations" (45 CFR 46.111(a)
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From page 150... ...
As stressed throughout this report, housing health hazards research raises unique issues related to targeting residents of poor-quality housing who are typically economically and educationally disadvantaged. While community involvement and enhanced efforts to facilitate informed consent as we recommend will address some of the issues raised in this research, specific guidance on how to design and conduct research with economically and educationally disadvantaged populations would benefit IRBs and researchers.
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From page 151... ...
We appreciate that "disorder or condition" must be interpreted to include healthy children at risk for a serious condition in order to carry out studies of the pathophysiology of diseases and to create the foundation of knowledge that allows therapeutic and preventive interventions or diagnostic tests to be developed. However, for research on housing health hazards involving children, the ethical dilemmas are particularly pronounced given the context of the research -- research that is often conducted with economically and educationally disadvantaged populations with multiple vulnerabilities.
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From page 152... ...
The committee struggled with these ethical dilemmas. Although the committee could not identify any specific housing health hazards research project that is or was conducted under Section 406, we did not want to
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. Although Chapter 5 outlines a range of approaches to community involvement, the committee concludes that research involving more than minimal risk and no prospect of direct benefit
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From page 154... ...
Given the considerable public controversies surrounding some research protocols under Section 406, IRBs should be encouraged to state their reasoning explicitly and document it. An IRB should explain how it determined that all the criteria in Section 406 were met: that the research presents a minor increase over minimal risk, that the intervention presents experiences that are reasonably commensurate with the medical and psychosocial situations of the child subjects, that the knowledge gained from the research is of vital importance to understanding or ameliorating the participants' disorder or condition, and that provisions for parental permission and children's assent are adequate.
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. In the case of research involving minimal risk to participants, an IRB can provide an expedited review by less than the full committee (45 CFR 46.110)
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Several issues affect the ability of IRBs to provide effective oversight of housing health hazards research.
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From page 157... ...
members who are themselves researchers and who have a basic familiarity with the sorts of research that frequently come under scrutiny. In the case of housing health hazards research, IRBs should consider the possibility of including local community residents who are representative of the community: for example, if the community is primarily a low-income minority community, the IRB representative should be as well.
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From page 158... ...
If a center does a large amount of nonclinical research, it may be appropriate to have dedicated IRBs that specifically review projects involving housing health hazards research and develop the needed expertise. It will often be appropriate to include IRB members who have a good working knowledge of housing health hazards research.
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From page 159... ...
For example, if an institution and its IRB often review housing health hazards research, members of the target community or communities can be invited to serve as institutionally unaffiliated IRB members. If this unique role is taken seriously by the sponsoring institution and the IRB, it can enhance community representatives' ability to influence the manner in which research is conducted.
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From page 160... ...
. The particular expertise needed will vary depending on the specific research protocol, and the appropriate IRB response will vary based on the frequency with which it is asked to review housing health hazards research and the nature of the research; see Box 8-2 for a summary list of possible approaches.
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From page 161... ...
Recommendation 8.2: The Office of Human Research Protections should issue guidance to institutional review boards on how to inter pret the key regulatory terms -- "minimal risk," "minor increase over minimal risk," "disorder or condition," "reasonably commensurate with those inherent in their actual or expected medical, dental, psycho logical, social, or educational situations," and "vital importance" -- in the context of housing health hazard research.
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From page 162... ...
162 ETHICAL CONSIDERATIONS Recommendation 8.3: The Secretary's Advisory Committee on Human Research Protections should develop guidelines for research with eco nomically and educationally disadvantaged participants for use by the Office for Human Research Protections in issuing guidance for re searchers and institutional review boards. Recommendation 8.4: Institutional review boards that review housing health hazards research involving children should ensure that those boards have the necessary expertise to conduct a complete and ad equate review, including expertise on research involving children and community perspectives.
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