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The Role of Biomedical Technology
Published in Kant Patel, Mark Rushefsky, Healthcare Politics and Policy in America, 2019
The President’s Council on Bioethics ceased to exist when, in November 2009, President Barack Obama created a new commission by an executive order, the Presidential Commission for the Study of Bioethical Issues (“History of Bioethics Commissions” n.d.). The commission acts as an advisory panel for the nation’s leaders in medicine, science, ethics, religion, law, and engineering. It advises the president on bioethical issues arising from advances in biomedicine and related areas of science and technology (“About the Commission” n.d.). The commission has not issued any new reports or studies on the subject of reproductive health since its creation.
The Renaissance and the Scientific Revolution
Published in Lois N. Magner, Oliver J. Kim, A History of Medicine, 2017
During the 1960s, many countries adopted the 1964 Helsinki Declaration's code of biomedical ethics. In the United States, laws governing research on human subjects were established in 1981 because of Senate hearings on the Tuskegee Study conducted by Senator Edward Kennedy. Reverby's research made it clear that widely accepted standards of biomedical ethics had been totally disregarded by researchers conducting the venereal disease experiments in Guatemala. U.S. President Barack Obama directed the Presidential Commission for the Study of Bioethical Issues to investigate both the Guatemala study and current rules for the protection of research participants. Dr. Francis S. Collins, director of the National Institutes of Health, condemned the Guatemala experiments and said that modern rules for federally financed research “absolutely prohibit” infecting people without their informed consent.
What is bioethics?
Published in Alastair V. Campbell, Bioethics, 2017
A second area of practical application has been the setting up of national bioethics advisory bodies in many countries, some sponsored by government agencies and others funded independently of government. (Examples of the former are the Presidential Commission for the Study of Bioethical Issues in the USA, and of the latter, the Nuffield Council on Bioethics in the UK.) These bodies are usually multidisciplinary and multi-professional, and they can have a major influence on government policies and on legislation, especially in newly emerging areas, like stem cell research and therapy.
NeuroEthics and the BRAIN Initiative: Where Are We? Where Are We Going?
Published in AJOB Neuroscience, 2020
Walter J. Koroshetz, Jackie Ward, Christine Grady
The NIH Brain Research through Advancing Innovative Neurotechnologies® (BRAIN) Initiative is the largest coordinated neuroscience project in history (Koroshetz et al. 2018; Mott et al. 2018). Since its launch in 2013, the trajectory of advances to date make it highly likely that the BRAIN Initiative and its related science will completely transform our understanding of how information is processed in the brain. With foresight, the Presidential Commission for the Study of Bioethical Issues (PCSBI) took up its charge to scope the ethical ramifications that might result from BRAIN technologies that probe the neural activity underlying human thought, emotion and action. The Commission was specifically instructed to address “potential implications of the discoveries that we expect will flow from studies of the brain…relating to privacy, personal agency, and moral responsibility for one’s actions; questions about stigmatization and discrimination based on neurologic measures of intelligence or other traits; and questions about the appropriate use of neuroscience in the criminal justice system, among others.”
Ethics and Collateral Findings in Pragmatic Clinical Trials
Published in The American Journal of Bioethics, 2020
Stephanie R. Morain, Kevin Weinfurt, Juli Bollinger, Gail Geller, Debra JH Mathews, Jeremy Sugarman
How should researchers and health systems manage such findings? Prior scholarship of the return of results that may have clinical implications for individuals in explanatory trials and clinical care has examined various ethical issues. In explanatory research, an incidental finding (IF) has been defined as a finding that has potential importance for health, reproductive decision-making, or personal utility that is “discovered in the course of conducting research but is beyond the aims of the study” (Wolf 2013). A secondary finding (SF) is a finding that is “actively sought by a practitioner that is not the primary target” (Presidential Commission for the Study of Bioethical Issues 2013). The chief difference between an IF and a SF hinges on whether generation of the result was intended. Extensive deliberation has supported the development of ethical guidance for the management of IFs/SFs arising in explanatory research and of IFs arising in clinical care (Christenhusz et al. 2013; Presidential Commission for the Study of Bioethical Issues 2013; Wolf et al. 2008). To date, however, such issues have not been addressed in the context of PCTs, which often differ structurally from both explanatory trials and from clinical care—differences that, as described below, are ethically salient, thereby limiting the applicability of existing guidance for PCTs.
How Payment for Research Participation Can Be Coercive
Published in The American Journal of Bioethics, 2019
Joseph Millum, Michael Garnett
It might be objected that the payments to participants should not be regarded as reducing the harmfulness of coercion on the grounds that monetary benefits are not supposed to be taken into account by RECs when they conduct their risk/benefit assessments.20 There is room for debate over whether this widespread view about monetary benefits is justified (Wertheimer 2013). In any case, we think such an objection would miss the mark. The claim that monetary benefits should not be taken into account is intended to rule out weighing payment against the risks of study procedures, such as the side effects of a drug. We do not take a view on that question here. We contend only that increased payment can compensate for the setback to interests that the payment itself may cause (through the way that the inducement may lead participants to be subject to the foreign will of the researchers). It would be perverse not to assess the benefits of an inducement when evaluating the harms of that very inducement. Analogously, consider that RECs are encouraged to consider the potential economic harms arising from research participation (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research 1979). These might include, for example, additional treatment costs resulting from research interventions. It is widely accepted that these financial risks can be mitigated or compensated for by providing care, or by paying for insurance or the cost of care (Presidential Commission for the Study of Bioethical Issues 2011, 56–62).