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Research Ethics and Intellectual Disability
Published in Joel Michael Reynolds, Christine Wieseler, The Disability Bioethics Reader, 2022
Contemporary research ethics in the USA evolved in parallel with the disability rights movement. In the 1970s, disability activists prioritized the deinstitutionalization of people with intellectual disabilities (PWIDs). We here define PWIDs as people with congenital or early onset intellectual disabilities expected to be lifelong (Carlson 2013, 303–304). Segregated residential facilities for PWIDs often served as the sites for gross medical research misconduct. For example, at the Willowbrook State School, children with intellectual disabilities were purposely injected with hepatitis in an effort to investigate the treatment and progression of the disease (Iacono and Carling-Jenkins 2012, 1124). Public outrage over this misconduct played a major role in the enactment of the first human subject protection laws and regulations in the USA. The Federal Policy for the Protection of Human Subjects, known as the “Common Rule,” establishes standards, procedures, and institutions for protecting research participants.1
The imperative to publish healthcare improvement
Published in David P. Stevens, Writing to Improve Healthcare, 2018
The first decade of the twenty-first century was marked by bureaucratic turmoil in IRB policy. In the United States, the standard for human subjects ethical decision-making had been guided historically by a policy known as the Common Rule. Consequently, healthcare improvement professionals faced a challenging period as they tried to fit healthcare improvement studies into the framework defined by the Common Rule [18].
Sex-specific correlates of metabolic syndrome risk in college-aged young adults
Published in Journal of American College Health, 2022
Simon Higgins, Alexandra N. Smith, Ewan R. Williams, Bhibha M. Das, Michael V. Fedewa, Ellen M. Evans
This cross-sectional study included a convenience sample of 425 full-time, first-year students, who lived on-campus at a large southeastern U.S. university. The reported sample includes 379 students (67.3% female; 70.2% white, 18.3 ± 0.5 y/o) with complete data for all outcomes of interest. Recruitment took place via printed and digital advertisements and emails to university accounts. Individuals were excluded if they were pregnant, planning on becoming pregnant, or had given birth in the past 12 months. Athletes, as well as those who had been previously diagnosed with a cardiovascular, metabolic, or renal disease, were also excluded from the sample. The University’s Institutional Review Board (IRB) approved all aspects of the protocol and the study complies with the Office for Human Research Protections Common Rule. All participants provided written informed consent prior to participation.
Human Subjects Research Without Consent: Duties to Return Individual Findings When Participation was Non-Consensual
Published in The American Journal of Bioethics, 2020
First of all, PCTs represent particularly strong candidates for waiver of the regulatory informed consent requirement. The regulations governing human subjects research in the U.S., together known as the “Common Rule,” permit researchers to obtain an IRB waiver of informed consent in the event that a few conditions are met, including (1) “the research involves no more than minimal risk to the subjects”; (2) “the research could not practicably be carried out without the requested waiver”; and (3) “the waiver … will not adversely affect the rights and welfare of the subjects” (45 CFR 46.116). Since PCTs generally compare interventions that fall within the standard of care, where evidence is lacking to indicate that one intervention is superior to another, the trial—which would randomly assign patients to interventions—arguably does not impose additional risk on participants and does not adversely affect them (Dal-Ré et al. 2019, 2; Kim 2018, 2). And, if only because informing prospective participants of the research would compromise the “real world” setting and so the integrity of the study, requiring researchers to obtain participants’ informed consent may make the PCT impracticable (Wendler 2015, 679).
“Sorry I Didn’t Hear You.” The Ethics of Voice Computing and AI in High Risk Mental Health Populations
Published in AJOB Neuroscience, 2020
Christopher Villongco, Fazal Khan
The federal “Common Rule” is a collection of federal regulations that regulate human subjects research. Universities that receive federal funding for human research have to comply with these rules, which includes setting up institutional review boards (IRBs) to ensure compliance with the Common Rule. In addition, private companies that conduct human clinical trials for the purpose of developing pharmaceuticals, medical devices, or biologics, are also subject to oversight by the Food and Drug Administration (FDA). Yet, if a private company conducts research on human populations using digital, rather than biological samples, and they are not developing a product subject to FDA regulations, they are exempt from following the Common Rule and federal regulations. This presents a regulatory challenge, as more and more human research leverages AI to analyze social media and other online content (e.g., personal pictures and videos). Even among scholars in the research ethics community, there is a “consensus in favor of the status quo… [as] extending the Common Rule to all human subjects research would be cumbersome and impractical to enforce” (Relias Media 2014). However, this stance is based on the view that “most of the studies in question would be of low risk and more akin to surveys and quality improvement than clinical trials” (Relias Media 2014). This characterization of most of these studies being “low risk” makes sense if one is applying the clinical trials paradigm of minimizing physical or mental harm to subjects, but what if the risk of harm from a study comes in the form of damage to one’s political or economic rights? The problem is that the traditional Common Rule framework is ill-suited to consider these other types of harms.