Elder Mistreatment Abuse, Neglect, and Exploitation in an Aging America (2003) / Chapter Skim
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8. Research Ethics
8. Research Ethics
Pages 140-149
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From page 140... ...
have embraced varying approaches to these problems, and that unduly restrictive IRB positions could impede important advances in the understanding of elder mistreatment. In reviewing proposed research protocols in the current regulatory context, IRBs exercise a great deal of discretion within the general parameters set by the federal research regulations (i.e., the so-called Common Rule)
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From page 141... ...
First, aging research suggests that most older adults are cognitively intact and should be regarded as presumptively able to make informed, voluntary decisions about research participation; merely being older than age 65 or 75 does not warrant special screening procedures or other protections. Heightened safeguards should be considered when the research involves greater than minimal risk and the study population is especially likely to include persons with decisional impairments or persons who are especially vulnerable to pressure or influence.
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From page 142... ...
Moreover, impairments that would preclude valid consent in studies with significant risk are ethically immaterial in studies involving less than minimal risk (National Bioethics Advisory Commission, 2001~. Similarly, additional safeguards that may be needed to ensure proper consent in studies involving significant risk are not necessary in studies involving lower risk.
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From page 143... ...
the research, the investigator may owe both of them a duty to avoid harm. If these puzzles were not enough to create ethical complexity, the possibility that state laws may require researchers to clisclose evidence of mistreatment to official agencies highlights a possible incongruity between state reporting policies (requiring breaches of conficlentiality)
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From page 144... ...
and should take this information into account in developing the protocol. It appears that the biggest impediment to sensible and consistent resolution of the ethical issues raised by elder mistreatment research is the concern that state law requires researchers to report possible cases of mistreatment to public agencies.
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From page 145... ...
In the panel's view, NIH should issue certificates of confidentiality designed to insulate elder mistreatment researchers from any legal obligation to disclose possible cases of mistreatment that otherwise may arise under state law, including tort "duty to protect" obligations as well as reporting statutes. Issuance of these certificates should be predicated on the assumption that IRBs will carefully scrutinize the protocols to ensure that participants' interests are being protected from harm and that, under appropriate circumstances, IRBs will permit investigators to take voluntary steps to protect subjects in danger.
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From page 146... ...
The supreme court of Minnesota subsequently ruled that the preemptive effect of the federal law authorizing Health and Human Services to issue confidentiality certificates for alcohol treatment research was itself superseded by a subsequently enacted federal statute requiring states to enact child abuse reporting statutes as a condition of receiving federal funds (State v. Andring, 342 N.W.
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From page 147... ...
The proper response probably varies across research contexts. The Common Rule provides that an investigator seeking IRB approval to omit information that ordinarily must be disclosed must establish that participants will be exposed to no more than minimal risk; that waiving or altering informed consent "will not adversely affect the rights and welfare of the subjects;" and that the study would be "impracticable" if the infor.
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From page 148... ...
In such instances, the residual possibility that the researcher might disclose evidence of mistreatment does not present a material risk that must be disclosed in order to obtain informed consent. As Dresser observes: In applying the Common Rule's minimal risk and consent waiver provisions, the focus should be on whether research participation exposes older persons and caregivers to risks greater than those present in ordinary life and routine medical and social service encounters.
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From page 149... ...
has sought to clarify some of the issues in these two areas and to provide some needed guidance. Eventually, the National Institute on Aging, in collaboration with the Office for Human Research Protections and other federal partners, should take the lead to promote further clarification, thereby helping investigators and IRBs to achieve the proper level of participant protection while enabling important research involving older and vulnerable adults to move forward.
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