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Lack of research ethics is horribly harmful. We now have safeguards in place wit

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Lack of research ethics is horribly harmful. We now have safeguards in place with the Belmont Report and IRB requirements. Try your hand at being an IRB member with the following exercise.. Choose ONE of the following case studies and answer the questions that follow. Please make sure to specify which case you have chosen at the top of your submission. Answers should be 2-4 sentences per question.
Case 1: A small Native American tribe has remained isolated from the rest of society. In recent years, the tribe has experienced an epidemic rate of diabetes. Researchers at the State University are interested in studying the connections between the genetic make-up of this tribe and the onset of diabetes, various other diseases, as well as the migration pattern of the people. The tribe consents to donating genetic samples to the researchers, but with the migration patterns of people. The tribe consents to donating genetic samples to the researchers, but with the understanding that the samples would be used only in diabetes research, but since identifiable data was not taken with the samples, formal IRB approval was not sought. The researchers used the samples in the extraneous studies about schizophrenia, inbreeding, and migration patterns, and the results, which specifically mentioned the tribe, were widely published and shared with other institutions. Upon learning of the use of their genetic material, the tribe claimed that not only did they not consent to participate in these studies, but they moreover suffered cultural harms as a result. The migration studies undermined certain spiritual beliefs of the tribe. The researchers claim that the tribe’s reaction is “hysterical,” and they have no valid reason to be so upset.
Did the researchers violate the principle of informed consent in using the tribe’s genetic material in extraneous studies?
Compared to individuals, are there analogous claims to privacy and informed consent in the case of a small, easily identifiable social group?
Should past stigma and prejudice affect how researchers view potential cultural harms? Are concepts like spiritual traditions, historical narratives and customs of a group appropriate concerns for researchers when making that decision?
Should the researchers have done anything differently prior to using the samples for secondary purposes?
Source: McGregor, J.L., (2007). Population genomics and research ethics with socially identifiable groups. Journal of Law, Medicine, and Ethics 35(3), 356-370.
Case 2: During a routine physical required for changing from contract worker to regular employee, Mr. M’s doctor diagnoses him with Hepatitis C. Though Mr. M. remains asymptomatic, the company denies him the change in employment status. Mr. M. believes he lost the promotion solely due to the diagnosis, and when he complains to the company, his contract is terminated. Mr. M. sues the company on the basis of disability discrimination. The company defends its actions, arguing that the illness was likely to cause the company future financial harm through expected excessive sick leave, absences and turn-over costs.
As a result of such cases, public health researchers are interested in exploring whether there is a relationship between employees’ medical records and their job status. Specifically, researchers want to investigate how a negative result or diagnosis from a routine physical required by a company will impact an employee’s chance for promotion or termination, even if the employee remains asymptomatic. Conducting this study would require access to private medical records held by companies as well as employment files. Researchers propose that informed consent from individuals be obtained. They are concerned however, that obtaining permission from companies to access the company-held medical records and employee files for the study will jeopardize the quality of the data received. Researchers thus propose that, in order to gain access to the companies’ records, the companies be asked voluntarily to participate in a public health survey of how medical diagnoses impact “work performance.” The companies will be notified of which employees allow their personal information to be used to transfer the company-held medical records and employee files.
Should deception of the companies be allowed? Why or why not?
What are other options for conducting this study? What are the pros and cons of those alternatives?
Source: Silvers, A. (2007). Predictive genetic testing: congruence of disability insurers’ interests with the public interest. Journal of Law, Medicine, and Ethics, 35(2), 52-58
Case 3: In an attempt to accurately predict the future prevalence of AIDS cases across different populations, the CDC conducted unlinked anonymous screening of HIV infection nationwide. The CDC did not obtain individual informed consent from donors because the donors’ blood was drawn for other purposes, and would have been discarded. Though identifying information was destroyed, demographic information was retained. The donors were not aware that their samples would be used by the CDC for HIV surveillance.
What ethical issues does this practice raise?
Is it permissible to use samples collected for other purposes in this type of research? Would your answer be different if this “proactive” surveillance was not based on previously stored samples, but rather just a tally of HIV+ results reported to individual state departments of health (which oftentimes do include identifiable data)?
Is surveillance associated with other diseases (like the elaborate system of cancer registries we have) fundamentally different from tracking HIV? Should the act of tracking cancer be different from tracking HIV?
Source: Brody, B. (1998). Ethics of Biomedical Research. New York: Oxford University Press.
Case 4: A geriatric psychiatrist, Dr. Brown, is interested in implementing certain technologies to aid patients who suffer from dementia and Alzheimer’s disease. Specifically, he has developed a protocol in which patients would be electronically “tagged” through the use of technology similar to pet-tracking microchips but would be worn outside the body and be difficult to remove. This would allow caregivers to monitor their locations and easily find them should they wander. The study would document the experiences of both the patients and the caregivers through interviews administered at the start of the study and then periodically every six weeks. Critics of this method argue that the sue of technology in such a manner is demeaning and infringes upon patient autonomy.
What concerns emerge since many patients would lack the capacity to give informed consent or might lose this capacity during the study? Is the infringement upon patients’ autonomy justified in this study?
What are the relevant interests of potential participants with AD?
Should such a study be permissible? Why or why not? If so, should there be any safeguards?
Case 5: Investigators propose a study to examine psychosocial stressors and the prevalence of anxiety disorders and depression in gay and lesbian adolescents. In order to obtain a large enough sample size, they plan to recruit participants through a gay and lesbian community center.
Center staff members are enthusiastic about the project. However, they inform the investigators that most of the students who come into the center have not told their parents about their sexual orientation. The researchers believe that getting parental consent to participate in the study is not in the best interest of these adolescents because notifying the parents of the purpose of the study might place the child at risk for psychological or physical harm. Center staff agree.
As an IRB member, would you grant a waiver of parental permission for this study?
Source: Kimberly Hoagwood, Peter S. Jensen, and Celia B. Fisher, Ethical Issues in Mental Health Research with Children and Adolescents, Lawrence Erlbaum, 1996
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