Pragmatic Tools for Sharing Genomic Research Results with the Relatives of Living and Deceased Research Participants
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The goal of this paper is to offer pragmatic guidance and implementation tools to facilitate the ethical return of genomic research results to family members. Because the issue of sharing research results with relatives arises in ethically and legally complex scenarios and in a wide variety of research studies, these tools provide a much-needed starting point and source of guidance for researchers, IRBs, biobanks, and research institutions. This toolkit will help them to anticipate family requests for research results and facilitate orderly return of results without overburdening the research institution.
Informed Consent in Translational Genomics: Insufficient Without Trustworthy Governance
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Should researchers prioritize the use of limited research resources to return only those results that require medical intervention in the near term to avert serious disease, or also those that could potentially inform medical action in the future? Should researchers consider offering results intended to motivate a healthier lifestyle — e.g., results indicating a higher risk of diabetes or coronary heart disease — given that the recommended lifestyle measures would be appropriate for everyone and data suggest such risk information is rarely motivating?Do results unrelated to the participant’s own health but potentially relevant to reproductive decision making, such as information about carrier status, merit return?.
Capacity, Vulnerability, and Informed Consent for Research
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This paper will discuss decisional capacity and vulnerabilities and how these characteristics must be recognized and addressed in the clinical research process. It reviews the concept of informed consent, especially in light of decisional capacity and vulnerability, and also describes the limitations of the current informed consent processes from the standpoint of the clinician researcher. Finally, it advances a theoretical model to stimulate further consideration of the effectiveness of the informed consent process under certain clinical circumstances.
The Ethics of Using Complementary Medicine in Pediatric Oncology Trials: Reconciling Challenges
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For childhood cancer patients, the process of medication reconciliation frequently reveals substances being administered by parents that are not approved by the FDA, including vitamins, herbal supplements, homeopathic agents, probiotics, and cannabis. Patients and parents choose to use complementary medicine not only for symptom and side-effect relief — including pain, nausea, pruritis, fatigue, and anxiety — but also with the hope that the patient’s overall health status will improve or the medications may even help cure the malignancy.
Avoiding Exploitation in Phase I Clinical Trials: More than (Un)Just Compensation
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Subjects in Phase I trials must often check into a clinical trial site for several weeks, where their diet, vital signs, and health status will be closely monitored as they are given an experimental drug. Sometimes they must undergo invasive procedures, such as endoscopies or lumbar punctures. Although most Phase I trials are relatively safe, some of them have resulted in disaster, such as the notorious TeGenero TGN1412 study at NorthWick Park Hospital in England, which sent six healthy, paid volunteers into multisystem organ failure in 2006. Since subjects in Phase I trials get no medical benefit from the studies, their primary motivation for enrolling is the payment. IRBs typically attempt to keep payment to subjects low, on the grounds that money might unduly influence the subjects, yet the subjects themselves naturally feel they deserve to be paid well.
Personal Experiences with Tribal IRBs, Hidden Hegemony of Researchers, and the Need for an Inter-cultural Approach: Views from an American Indian Researcher
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This brief article constitutes a reality-based, first-hand report on selected aspects of researcher-IRB dynamics. Much of the literature written in the scholarly model is silent on the items that the author bring forward here, and highlights those here precisely because they are little discussed. Moreover, the complexity of American Indian and Alaska Native culture, cultural dynamics, and cultural expressions across tribes (including the intra-group variations of a given population) make acknowledgement of the nearly infinite variations across and within tribes impossible to specify.
Seeing Beyond the Margins: Challenges to Informed Inclusion of Vulnerable Populations in Research
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The paper begins by providing the rationale for including racial/ethnic minorities and those of low socioeconomic status or educational attainment under the “vulnerable population” rubric. In the remainder of the paper, the authors describe the underrepresentation of these vulnerable populations in research, the harms that can result from exclusion, and finally describe recent strategies to improve informed consent. Throughout, they address two distinct but interrelated issues: underrepresentation and informed consent. Identifying and addressing the barriers to participation in research is related to the need to ensure informed consent, since informed consent is ethically necessary before participation can occur. As such, ensuring that vulnerable groups are given the opportunity to take part in research by eliminating structural barriers is a necessary first step to informed consent.
Where Did Informed Consent for Research Come From
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To understand the future of informed consent, we should pay attention to two ethical-legal sources in addition to the revised Common Rule. Physicians acting as investigators and patients serving as research subjects bring to that relationship a long history regarding consent to treatment, and everyone dealing with research ethics needs to be aware of the Nuremberg Code and other human-rights documents. These three streams make separate and distinctly different contributions to informed consent doctrine.
Health Research with Big Data: Time for Systemic Oversight
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In this paper, the authors propose a conceptual shift. First, they suggest that health research is set to take place within an evolving health data ecosystem; second, they situate the challenge of informed consent within this evolving ecosystem; and, third, argue for a systemic oversight approach to compensate for the ethical deficits caused by a weakened informed consent.
Design Issues in E-Consent
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John Wilbanks, B.A., is the Chief Commons Officer at Sage Bionetworks. Previously, Wilbanks worked as a legislative aide to Congressman Fortney “Pete” Stark, served as the first assistant director at Harvard’s Berkman Center for Internet & Society, founded and led to acquisition the bioinformatics company Incellico, Inc., and was Executive Director of the Science Commons project at Creative Commons. He talks electronic methods of informed consent and related issues.