Browsing by Subject "Research ethics"

Now showing 1 - 10 of 17
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    An ethics framework for consolidating and prioritizing COVID-19 clinical trials
    (Sage, 2021) Meyer, Michelle N.; Gelinas, Luke; Bierer, Barbara E.; Chandros Hull, Sara; Joffe, Steven; Magnus, David; Mohapatra, Seema; Sharp, Richard R.; Spector-Bagdady, Kayte; Sugarman, Jeremy; Wilfond, Benjamin S.; Fernandez Lynch, Holly; Robert H. McKinney School of Law
    Given the dearth of established safe and effective interventions to respond to COVID-19, there is an urgent ethical imperative to conduct meaningful clinical research. The good news is that interventions to be tested are not in short supply. Unfortunately, the human and material resources needed to conduct these trials are finite. It is essential that trials be robust and meet enrollment targets and that lower-quality studies not be permitted to displace higher-quality studies, delaying answers to critical questions. Yet, with few exceptions, existing research review bodies and processes are not designed to ensure these conditions are satisfied. To meet this challenge, we offer guidance for research institutions about how to ethically consolidate and prioritize COVID-19 clinical trials, while recognizing that consolidation and prioritization should also take place upstream (among manufacturers and funders) and at a higher level (e.g., nationally). In our proposed three-stage process, trials must first meet threshold criteria. Those that do are evaluated in a second stage to determine whether the institution has sufficient capacity to support all proposed trials. If it does not, the third stage entails evaluating studies against two additional sets of comparative prioritization criteria: those specific to the study and those that aim to advance diversification of an institution’s research portfolio. To implement these criteria fairly, we propose that research institutions form COVID-19 research prioritization committees. We briefly discuss some important attributes of these committees, drawing on the authors’ experiences at our respective institutions. Although we focus on clinical trials of COVID-19 therapeutics, our guidance should prove useful for other kinds of COVID-19 research, as well as non-pandemic research, which can raise similar challenges due to the scarcity of research resources.
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    Building the case for actionable ethics in digital health research supported by artificial intelligence
    (Springer Nature, 2019-07-17) Nebeker, Camille; Torous, John; Bartlett Ellis, Rebecca J.; School of Nursing
    The digital revolution is disrupting the ways in which health research is conducted, and subsequently, changing healthcare. Direct-to-consumer wellness products and mobile apps, pervasive sensor technologies and access to social network data offer exciting opportunities for researchers to passively observe and/or track patients ‘in the wild’ and 24/7. The volume of granular personal health data gathered using these technologies is unprecedented, and is increasingly leveraged to inform personalized health promotion and disease treatment interventions. The use of artificial intelligence in the health sector is also increasing. Although rich with potential, the digital health ecosystem presents new ethical challenges for those making decisions about the selection, testing, implementation and evaluation of technologies for use in healthcare. As the ‘Wild West’ of digital health research unfolds, it is important to recognize who is involved, and identify how each party can and should take responsibility to advance the ethical practices of this work. While not a comprehensive review, we describe the landscape, identify gaps to be addressed, and offer recommendations as to how stakeholders can and should take responsibility to advance socially responsible digital health research.
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    Data for a civil society: how we can harmonise privacy and use population data for public good
    (2007-06-15) Stanley, Fiona
    1. Modernity’s paradox - an uncivil society 2. Population data and record linkage 3. Understanding bias 4. Harmonising individual privacy and public good
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    Development and evaluation of a web-based assent for adolescents considering an HIV vaccine trial
    (Taylor & Francis, 2015-08) Blake, Diane R.; Lemay, Celeste A.; Maranda, Louise S.; Fortenberry, J. Dennis; Kearney, Margaret H.; Mazor, Kathleen M.; Department of Pediatrics, IU School of Medicine
    HIV vaccine trials with minors will likely require parental permission and informed assent from adolescents. For this to be a valid process, the information needs to be presented in a manner that promotes adolescent comprehension. Previous studies suggest that adolescent comprehension of assent is often insufficient. We developed an interactive web-based assent that included interspersed quiz questions for a hypothetical HIV vaccine trial. Efficacy of the web-based assent was compared to a standard paper assent with and without interspersed questions. One hundred twenty teen participants, ages 15-17 years, from five community organizations were randomized to self-administered web-based assent (n=60) or investigator-administered paper assent with (n=29) or without (n=31) interspersed quiz questions. After reviewing the assent, participants completed a 27-item comprehension test. Comprehension scores were compared between groups. The mean number of correctly answered questions were 21.2 for the full paper group and 21.1 for the web-based group (t118=-0.08, p=0.94). Scores were 20.2 for the paper without interspersed questions sub-group and 22.1 for the paper with interspersed questions sub-group (t58=1.96, p=0.055). Participants in the web-based group performed as well on the comprehension test as those in the paper group, and those in the paper with questions sub-group performed better than those in the paper without questions sub-group, suggesting that interspersed quiz questions may improve understanding of a traditional paper assent. The minimal investigator time and standardized administration of the web-based assent as well as ability to tailor the assent discussion to topics identified by incorrect comprehension test responses are advantages worthy of further investigation.
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    Development of a decision-making checklist tool to support technology selection in digital health research
    (Oxford University Press, 2020) Nebeker, Camille; Bartlett Ellis, Rebecca J.; Torous, John; School of Nursing
    Digital technologies offer researchers new approaches to test personalized and adaptive health interventions tailored to an individual. Yet, research leveraging technologies to capture personal health data involve technical and ethical consideration during the study design phase. No guidance exists to facilitate responsible digital technology selection for research purposes. A stakeholder-engaged and iterative approach was used to develop, test, and refine a checklist designed to aid researchers in selecting technologies for their research. First, stakeholders (n = 7) discussed and informed key decision-making domains to guide app/device selection derived from the American Psychiatric Association's framework that included safety, evidence, usability, and interoperability. We added "ethical principles" to the APA's hierarchical model and created a checklist that was used by a small group of behavioral scientists (n = 7). Findings revealed the "ethical principles" domains of respect, beneficence, and justice cut across each decision-making domains and the checklist questions/prompts were revised accordingly and can be found at thecore.ucsd.edu. The refined checklist contains four decision-making domains with prompts/questions and ethical principles embedded within the domains of privacy, risk/benefit, data management, and access/evidence. This checklist is the first step in leading the narrative of decision-making when selecting digital health technologies for research. Given the dynamic and rapidly evolving nature of digital health technology use in research, this tool will need to be further evaluated for usefulness in technology selection.
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    Disclosure of individual research results at federally funded Alzheimer's Disease Research Centers
    (Wiley, 2021-10-14) Roberts, J. Scott; Ferber, Rebecca; Blacker, Deborah; Rumbaugh, Malia; Grill, Joshua D.; Medical and Molecular Genetics, School of Medicine
    Introduction: This study describes practices for disclosing individual research results to participants in Alzheimer's disease research. Methods: An online survey of clinical core leaders at National Institutes of Health-funded Alzheimer's Disease Research Centers in the United States (response rate: 30/31, 97%) examined return of results practices across nine different types of research results. Results: Most centers had returned consensus research diagnoses (83%) and neuropsychological test results (73%), with fewer having shared amyloid positron emission tomography (43%), tau imaging (10%), or apolipoprotein E (APOE) genotype (7%) results. Centers reported having disclosed a mean of 3.1 types of results (standard deviation = 2.1; range 0-8). The most commonly cited reason for disclosure was to inform participants' medical decision-making (88%). Disclosure involved multiple professionals and modalities, with neurologists (87%) and in-person visits (85%) most commonplace. Discussion: Centers varied widely as to whether and how they disclosed research results. Diagnostic and cognitive test results were more commonly returned than genetic or biomarker results.
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    Experiences in Bioethics from Kenya: Equity, Informed Consent, and Community Participation in Research
    (2006-03-24T16:42:31Z) Sidle, JE;
    Second lecture in a series: International Research Ethics. February 23, 2006. Lecture I.
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    Family Health Needs Study: Bi-National Community Participatory Research
    (2006-04-07T18:56:57Z) Riner, ME
    Third lecture in a series: International Research Ethics. March 29, 2006. Lecture I.
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    Inclusion of Adolescents in STI/HIV Biomedical Prevention Trials: Autonomy, Decision Making, and Parental Involvement
    (American Psychological Association, 2018-09) Rosenthal, Susan L.; Morris, Marilyn C.; Hoffman, Lily F.; Zimet, Gregory D.; Pediatrics, School of Medicine
    In order to develop new methods for prevention and treatment of sexually transmitted infection (STI) and human immunodeficiency virus (HIV), clinical trials must be conducted in relevant populations. In the U.S., half of all STI incident infections are among 15-24 year olds (Satterwhite et al., 2013), making healthy adolescents a highly relevant population. The inclusion of adolescents in STD/HIV prevention research is critical for developing appropriate strategies to promote adolescent sexual health. Results from adult studies may not generalize to adolescents, given their biological and psychosocial developmental status (Hwang et al., 2009). In order to understand the extent to which these differences are applicable to safety, efficacy, and acceptability, the products must be tested in minors. Enrolling adolescents who have not reached the legal age of majority in sexual health research, though, poses legal and ethical challenges. Investigators have been described as facing moral conflict between their responsibility to protect the scientific rigor of the study and the well-being of the participants (Merritt, 2005). Institutional Review Boards (IRBs) must balance the interests of minors, their parents, and the institution (Knopf et al., 2016). Data suggest that adolescents are under-represented in biomedical trials of HIV and STD prevention (Tolley et al., 2014; Hoffman et al., 2016). We propose that the inclusion of these adolescents in sexual health research is not only ethically permissible but is ethically required.
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    Lessons Learned: Beta-Testing the Digital Health Checklist for Researchers Prompts a Call to Action by Behavioral Scientists
    (JMIR, 2021-12-22) Bartlett Ellis, Rebecca; Wright, Julie; Soederberg Miller, Lisa; Jake-Schoffman, Danielle; Hekler, Eric B.; Goldstein, Carly M.; Arigo, Danielle; Nebeker, Camille; School of Nursing
    Digital technologies offer unique opportunities for health research. For example, Twitter posts can support public health surveillance to identify outbreaks (eg, influenza and COVID-19), and a wearable fitness tracker can provide real-time data collection to assess the effectiveness of a behavior change intervention. With these opportunities, it is necessary to consider the potential risks and benefits to research participants when using digital tools or strategies. Researchers need to be involved in the risk assessment process, as many tools in the marketplace (eg, wellness apps, fitness sensors) are underregulated. However, there is little guidance to assist researchers and institutional review boards in their evaluation of digital tools for research purposes. To address this gap, the Digital Health Checklist for Researchers (DHC-R) was developed as a decision support tool. A participatory research approach involving a group of behavioral scientists was used to inform DHC-R development. Scientists beta-tested the checklist by retrospectively evaluating the technologies they had chosen for use in their research. This paper describes the lessons learned because of their involvement in the beta-testing process and concludes with recommendations for how the DHC-R could be useful for a variety of digital health stakeholders. Recommendations focus on future research and policy development to support research ethics, including the development of best practices to advance safe and responsible digital health research.