Elder Mistreatment Abuse, Neglect, and Exploitation in an Aging America (2003) / Chapter Skim
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11. Ethical and Policy Issues in Research on Elder Abuse and Neglect
11. Ethical and Policy Issues in Research on Elder Abuse and Neglect
Pages 303-338
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From page 303... ...
Second, the research involves collecting information that could have negative legal, financial, and social consequences for the older persons and caregivers being studied. The ethical and policy analysis is further complicated by an absence of regulatory guidance and ethical consensus regarding the appropriate procedures to govern research involving persons who lack the ability to decide about research participation.
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From page 304... ...
The principle of justice addresses fairness in selection of research participants. Provisions in the Common Rule incorporate these Belmont Report principles and requirements.
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From page 305... ...
The Belmont Report and the Common Rule address, but do not fully resolve, these classification issues. Distinguishing Research from Other Information Gathering Activities Underlying the research oversight system is the judgment that research presents particular ethical concerns.
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From page 306... ...
Researchers, on the other hand, collect data and perform interventions "to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowIedge" (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979:3~. Like the Belmont Report, the Common Rule's definition of research looks primarily to the intended aim of the activity.
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From page 307... ...
The Common Rule explicitly applies only to research performed or funded by federal agencies that have adopted the Rule (U.S. Department of Health and Human Services, 1991:28,012~.
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When access to medical records or other private information would enable an investigator to readily determine the identity of a person, obtaining such information qualifies as research involving human subjects. The Common Rule's definition of research involving human subjects incorporates certain ethical judgments.
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From page 309... ...
Adequate protection may also require investigators to exclude decisionally incapable individuals from certain risky or burdensome studies that are permissible when conducted with capable, consenting individuals. Standards and Procedures for Evaluating Decisional Capacity Central to applying the principle of respect for persons is the determination of whether a prospective research participant can make autonomous decisions about study participation.
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From page 310... ...
The presence or absence of a dementia diagnosis fails to indicate whether someone has the necessary abilities to make choices about study participation. Similarly, although they may furnish preliminary guidance, simple mental status assessments are insufficient to determine whether someone is able to make autonomous research decisions.
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The Report describes the following risks, each of which is specifically relevant to elder abuse and neglect research: "psychological harm, physical harm, legal harm, social harm, and economic harm" (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979:7~.
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From page 312... ...
Voluntary Choices About Research According to the Belmont Report, decisions to enroll in research are voluntary if they occur in the absence of coercion or undue influence. Coercion exists "when an overt threat of harm is intentionally presented by one person to another in order to obtain compliance." Undue influence exists when there is "an offer of an excessive, unwarranted, inappropriate, or improper reward or other overture in order to obtain compliance" (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979:6~.
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From page 313... ...
Some groups say that IRBs should be authorized to decide when independent evaluations are needed in specific studies. The NBAC declared that when research proposals present greater than minimal risk, IRBs ordinarily "should require that an independent, qualified professional assess the potential subject's capacity to consent" (1998:58~.
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From page 314... ...
The most common protective safeguards are (1) to designate as a research decision maker someone "likely to understand the incompetent subject's situation and to act in that person's best interest" (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979)
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From page 315... ...
Investigators should make every effort to select research representatives genuinely concerned with the decisionally incapable individual's welfare. One way to do this is to conduct screening and education of potential representatives, with the aim of detecting inappropriate decision makers and increasing the odds that those chosen will adequately protect research participants' interests.
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From page 316... ...
Such surrogate parents would be expected to participate not only in the process of soliciting the children's cooperation but also in the conduct of the research, in order to provide reassurance for the subject and to intervene or support their desire to withdraw if participation becomes too stressful (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1975:19~. An analogous approach might be adopted in studies of elder abuse an]
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From page 317... ...
The Report suggests that incomplete information disclosure could be acceptable under certain circumstances. This view is incorporated in a Common Rule provision permitting exceptions to the general requirements for informed consent.
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According to the Belmont Report, withholding information is never justified simply to make it easier to enroll participants. Instead, withholding should be permitted only if full disclosure would "destroy or invalidate the research" (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979:6~.
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From page 319... ...
Instead, those evaluating the ethics of proposed studies must "decide when it is justifiable to seek certain benefits despite the risks involved, and when the benefits should be forgone because of the risks" (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979:4) Two Common Rule provisions incorporate the beneficence principle.
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From page 320... ...
Examples of research offering potential direct benefit are studies designed to enhance current biomedical or behavioral therapies or to create new training or educational materials (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1978:131. Direct benefits in research on elder abuse and neglect could be available in studies comparing different interventions to reduce the occurrence of elder abuse and neglect or studies to determine the best methods of assistance to provide once maltreatment has occurred.
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From page 321... ...
For example, studies proposing to test minor variations in existing health or social service interventions might hold little prospect of material benefit to others.5 , ~ Potential Harms in Research As noted above, the Belmont Report lists the following as risks to research participants: "psychological harm, physical harm, legal harm, social harm, and economic harm" (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.1979:7)
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From page 322... ...
In evaluating potential research harms, the emphasis should be on any additional risks that will arise due to the data gathering associated with a research project. If research participation will entail interviews, examinations, or other interventions that participants would not encounter in their usual contacts with health care and social services personnel, the risks accompanying these interventions are properly classified as research risks that should be minimized, justified, and, in many cases, disclosed to poten.
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From page 323... ...
Strict security measures can also be adopted, including identifying participants by code and severely restricting access to documents linking codes with individual participants (Office of Protection from Research Risks, 1993:3-33~. The Common Rule permits IRBs to waive the usual requirement for a signed consent form if such forms would be the sole record tying an individual participant to research and a breach of confidentiality constitutes the principal study risk (U.S.
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Finally, social services interventions may clo more harm than good for an oicler incliviclual. As this discussion reveals, the ethical and policy directive to minimize risks can present clifficult tracle-offs in elcler abuse and neglect research.
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From page 325... ...
As observed in the section on respect for persons in research, the Common Rule permits investigators to withhold certain information from prospective participants, or to forgo consent altogether, only if research interventions present no more than minimal risk. In addition, the NBAC proposed that research interventions presenting greater than minimal risk and no prospect of direct benefit should be allowed only with an incapable individual's prior competent consent or after review and approval by a special standing pane!
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From page 326... ...
Such an approach would thus disregard the ethical principle of justice, discussed below. 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 services encounters.
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From page 327... ...
Thus, investigators ought not exclude certain people from studies simply because it is more inconvenient or costly to recruit them (Institute of Medicine, 1994:82~. Another application of the justice principle involves ensuring that the improved interventions publicly funded research makes possible are reasonably available to research participants and to those in the general population who would benefit from them (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979:5~.
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From page 328... ...
Research ethics and policy also deem important the protection of research participants from unnecessary and unreasonable risks. These ethical and policy considerations support certain restrictions on the conduct of research.
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From page 329... ...
Investigators in a consortium of longitudinal studies of child abuse and neglect known as LONGSCAN, as well as those conducting the MacArthur Risk Assessment Study of community violence in former mental patients, recognized an ethical responsibility to prevent harm to both study participants and third parties, although their exact responses varied due to the specific study circumstances and different philosophies of study teams and their reviewing IRBs (Knight et al., 2000; Monahan et al., 1993~.6 The ethical and legal duties to report suspected abuse and neglect are strongest when researchers conclude that an older person is at risk of serious, imminent harm. If an older person appears to be in imminent danger, a report to protective services workers may be justified even if the older person refuses assistance (Garfield, 1991:870~.
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From page 330... ...
One option is to furnish research participants with information on available community resources for individuals and families with various living difficulties. Investigators can also express any concerns they may have about a participant's living situation and urge the at-risk individual to obtain help.
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From page 331... ...
At the same time, such approaches have been challenged on ethical grounds. For example, the NBAC criticized the Common Rule's failure to cover anonymous surveys that ask sensitive questions (2001:37~.
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As indicated above, disclosure in both situations will often be required. The Common Rule permits exceptions to disclosure only when research presents no more than minimal risk to participants and when disclosure would make research impracticable.
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In study consent forms, prospective participants were told that confidentiality would be preserved unless researchers believed the lives of participants or third parties were in danger or child abuse was discovered (Monahan et al., 1993~. Thus, individuals had the option to refuse participation or to modify their response to investigators based on their awareness that reporting was possible.
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From page 334... ...
Since the Belmont Report and Common Rule were written, community consultation and representation have emerged as methods for making research more ethical. Indeed, the NBAC specifically advised that representatives of prospective research participants, including those from vulnerable populations, "should be encouraged to participate in the study design and oversight processes" (2001:91~.
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REFERENCES Advisory Work (group on Human Subject Research Involving the Protected Classes 1998 Recommendations on the Oversight of Human Subject Research Involving the Protected Classes. New York: New York State Department of Health.
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1999 Research involving persons with mental disabilities: A review of policy issues and proposals. In Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity, vol.
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From page 337... ...
2001 EtI7ical and Policy Issues in Research Involving Human Participants: Report and Recommendations, Bethesda, MD: National Bioethics Advisory Commission. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research 1975 1978 1979 Research Involving Children: Report and Recommendations, DHEW Publication No.
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From page 338... ...
World Medical Association 2000 Declaration of Helsinki: Ethical principles for medical research involving human subjects. Journal of the American Medical Association 284:3043-3045.
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