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  1. Identifying and addressing nonrational processes in REB ethical decision-making.Simon Nuttgens - 2021 - Research Ethics 17 (3):328-345.
    Ethical decision-making is inherent to the research ethics committee deliberation process. While ethical codes, regulations, and research standards are indispensable in guiding this process,...
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  • The truth about the truth: What matters when privacy and anonymity can no longer be promised to those who participate in clinical trial research?Ann Freeman Cook & Helena Hoas - 2013 - Research Ethics 9 (3):97-108.
    The ramifications of including genetic components in the clinical studies conducted in non-academic settings create unique ethical challenges. We used a qualitative research design consisting of semi-structured interviews that took place between October 2010 and September 2012. The sample consisted of 80 participants − 38 physicians and 42 coordinators − who worked across a number of different settings, including clinics, private practices, small hospitals, free standing research centers, and blended hospital-institutes in both rural and urban communities in 13 states across (...)
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  • The Reasonable Person Standard for Research Disclosure: A Reasonable Addition to the Common Rule.Rebecca Dresser - 2019 - Journal of Law, Medicine and Ethics 47 (2):194-202.
    The revised Common Rule adopts the reasonable person standard to guide research disclosure. Some members of the research community contend that the standard is confusing and ill-suited to the research oversight system. Yet the revised rule is not as radical as it might seem. During the 1970s, judges started using the standard to evaluate negligence claims brought by injured patients who said doctors had failed to obtain informed consent to the harmful procedures. In its influential Belmont Report, the National Commission (...)
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  • Research Information for Reasonable People.Rebecca Dresser - 2018 - Hastings Center Report 48 (6):3-4.
    In 2017, federal officials issued a revised version of the Common Rule, the federal regulations that govern much of the human subject research conducted in the United States. Two provisions on information disclosure have reportedly provoked confusion among researchers and people responsible for research oversight. These provisions incorporate the familiar and foundational legal concept known as the reasonable person standard, applying this to research disclosure. Although other, long‐standing Common Rule provisions require reasonableness judgments, the new provisions differ in that they (...)
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  • Exploring the Potential for Moral Hazard When Clinical Trial Research is Conducted in Rural Communities: Do Traditional Ethics Concepts Apply?Ann Freeman Cook & Helena Hoas - 2015 - HEC Forum 27 (2):171-187.
    Over the past 20 years, clinical research has migrated from academic medical centers to community-based settings, including rural settings. This evolving research environment may present some moral hazards or challenges that could undermine traditionally accepted standards for the protection of human subjects. The study described in this article was designed to explore the influence of motives driving the decisions to conduct clinical trial research in rural community settings. The researchers conducted semi-structured interviews with 80 participants who conducted clinical trials with (...)
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