Protection Of Research Participants Research Articles

Genomic research and privacy: A response to Staunton et al.

The Protection of Personal Information Act No. 4 of 2013 (POPIA) promises a new dispensation of privacy protection for research participants in South Africa. In a recent article, Staunton et al. proposed that a purposive interpretation of POPIA would allow for the retention of the status quo of broad consent in the context of genomic research. In this response article, we analyse the argument presented by Staunton et al., and conclude that it fails to convince: firstly, because Staunton et al. do not present empirical data for their factual assumption that moving up the consent benchmark is likely to stymie research; secondly, because genomic research does not have a monopoly on the public interest, but shares it with the privacy rights of research participants; and thirdly, because POPIA was designed to promote the protection of privacy, not simply to preserve the status quo as found in existing policy instruments. In contrast to the position advocated by Staunton et al., we suggest that a purposive interpretation of POPIA is aligned with the plain meaning of the statute - namely that specific (not broad) consent is a prerequisite for research on genomic information.This article, which comments on an article by Staunton et al. (Staunton C, Adams R, Botes M, et al.Safeguarding the future of genomic research in South Africa: Broad consent and the Protection of Personal Information Act No. 4 of 2013. S Afr Med J 2019;109(7):468-470. https://doi.org/10.7196/SAMJ.2019.v109i7.14148), is followed by a letter by Thaldar and Townsend (Privacy rights of human research participants in South Africa must be taken seriously. S Afr Med J 2020;110(3):175-176. https://doi.org/10.7196/SAMJ.2020.v110i3.14450); and a response to the article and letter by Staunton et al. (S Afr Med J 2020;110(3):175-176. https://doi.org/10.7196/SAMJ.2020.v110i3.14450).

Open Data Sharing in the 21st Century: Sage Bionetworks’ Qualified Research Program and Its Application in mHealth Data Release

Sage Bionetworks (Sage) has developed a framework for qualifying solvers from around the world for accessing health and biomedical data within Synapse, Sage’s data sharing and collaboration platform. We identified three conceptual mechanisms – transactional cost, exposure, and openness – to enable the broadest researcher pool access to health and biomedical research data for discovery while still encoding basic contractual protections for research participants. Our qualified researcher framework was first piloted in 2015 with data gathered from mPower, an observational smartphone-based study of Parkinson disease symptoms. Here we describe the rationale and features of the framework and its application in the exemplar mPower study.

Privacy and Security Issues with Mobile Health Research Applications

This article examines the privacy and security issues associated with mobile application-mediated health research, concentrating in particular on research conducted or participated in by independent scientists, citizen scientists, and patient researchers. Building on other articles in this issue that examine state research laws and state data protection laws as possible sources of privacy and security protections for mobile research participants, this article focuses on the lack of application of federal standards to mobile application-mediated health research. As discussed in more detail below, the voluminous and diverse data collected by some independent scientists who use mobile applications to conduct health research may be at risk for unregulated privacy and security breaches, leading to dignitary, psychological, and economic harms for which participants have few legally enforceable rights or remedies under current federal law. Federal lawmakers may wish to consider enacting new legislation that would require otherwise unregulated health data holders to implement reasonable data privacy, security, and breach notification measures.

Minimizing Risks Is Not Enough: The Relevance of Benefits to Protecting Research Participants.

Forty years ago, the Belmont Report counseled that a "systematic, nonarbitrary analysis of risks and benefits" is vital to ensuring the ethical appropriateness of research with human subjects. Since then, research ethics has devoted considerable attention to the first half of this advice, emphasizing the ethical importance of assessing and minimizing the risks of research with human subjects. Significantly less attention has been devoted to a systematic assessment of the potential benefits of research participation. To the extent that benefits for individual participants are considered at all, commentators tend to focus on their potential to undermine the goal of minimizing risks. A chance for clinical benefit may obscure the fact that research poses risks not present in clinical care, while an offer of financial compensation or ancillary care may induce individuals to accept risks that conflict with their long-term interests. This article argues that, while undoubtedly important, minimizing risks fails to offer sufficient protection for research participants, especially those who cannot consent, because it neither ensures that the risks of research are justified nor protects participants from exploitation. Belmont's advice to develop systematic and nonarbitrary ways to ensure that research participants receive appropriate benefits needs to be heeded as well.

Randomised evaluation of government health programmes does present a challenge to standard research ethics frameworks

In a recent issue of Journal of Medical Ethics (JME), we discussed the ethical review of evaluations of interventions that would occur whether or not the evaluation was taking place....

A aprovação da Resolução CNS nº 510/2016 é um avanço para a ciência brasileira

Resumo A Resolução nº 510/2016 do Conselho Nacional de Saúde determina diretrizes éticas específicas para as ciências humanas e sociais (CHS) e é resultado de anos de trabalho de pessoas e instituições que há muito apontavam a inadequação de uma única orientação de cunho biomédico para pesquisas em diferentes áreas. Discutem-se aqui as principais diferenças entre a pesquisa em CHS e a pesquisa biomédica. A disputa pelo poder de definir o que é ciência caracteriza o campo científico, no qual não cabe a interferência do sistema de Comitês de Ética em Pesquisa/Comissão Nacional de Ética em Pesquisa, cuja missão é a proteção do participante de pesquisa. Comentam-se seis mudanças que a Resolução nº 510/2016 traz. Observa-se que as normas brasileiras sobre ética em pesquisa ainda são restritas. No âmbito internacional, vários códigos de ética são mais abrangentes. A Noruega dispõe de diretrizes específicas para as ciências sociais, humanas, jurídicas e teológicas, que contemplam o valor e a função social da pesquisa; os interesses da sociedade; a necessidade da liberdade para investigar; o papel e os interesses dos gestores acadêmicos; os princípios e os interesses dentro das comunidades científicas, inclusive em suas relações com os estudantes; a responsabilidade das agências de financiamento; as consequências dos resultados das pesquisas; e a popularização da ciência.

Ottawa Statement does not impede randomised evaluation of government health programmes

In this issue of JME, Watson et al call for research evaluation of government health programmes and identify ethical guidance, including the Ottawa Statement on the ethical design and conduct...

Research Data Disclosure in the Digital Age.

New advances in digital technologies and data-collection methods support expansion of the traditional research model in the current Digital Age. As researchers continue to explore ways to collect, manage, and share individual-level research study data, investigators must also acknowledge new ethical considerations that arise. To ensure protection of research participants, participants must remain a priority across the research continuum by researchers, institutional review boards, funding agencies, and consumers. Big data and data sharing also require additional investments and oversight to ensure proper management and, and even more important, protection of human subjects.

Recognizing the Role of Research Assistants in the Protection of Participants in Vulnerable Circumstances.

Little is known about how research assistants (RAs) protect participants in vulnerable circumstances. Using a critical qualitative method informed by feminist ethics, we ran five focus groups with experienced RAs. We identified two themes: (a) expressing moral competencies (subthemes: recognizing power, privilege, and vulnerability; adapting processes and providing support; understanding the sources of moral competencies) and (b) negotiating and making transparent roles and responsibilities (subthemes: separating responsibilities as a clinician from those of an RA; critically reflecting on the shared responsibilities of principal investigators and RAs; and identifying the role of the Research Ethics Committee). Although RAs possess a variety of moral competencies and have an important role in protecting research participants in vulnerable circumstances, that role is largely unrecognized.

Genetic testing, insurance discrimination and medical research: what the United States can learn from peer countries.

While genetic testing may be the gateway to the future of medicine, it also poses challenges for individuals, especially in terms of differentiated treatments on the basis of their genetic characteristics. The fear of unwanted disclosure to insurers and the possibility of genetic discrimination can hamper the recruitment of individuals for clinical research that involves genetic testing. Precision medicine initiatives, such as All of Us, are proliferating in the United States. In order to succeed, however, they must ensure that the millions of Americans recruited to share their genetic data are not penalized with regard to life, disability and long-term insurance coverage. In this Perspective, we discuss several initiatives adopted by countries around the world, such as the United Kingdom and France, that better balance the interests of insurers and research subjects, and explain how the United States might learn from them. We call for regulatory and industry leadership to come together to establish a voluntary moratorium on insurance pricing with the aim of protecting research participants.

Conservation publications and their provisions to protect research participants.

Social science methods are increasingly applied in conservation research. However, the conservation sector has received criticism for inadequate ethical rigor when research involves people, particularly when investigating socially sensitive or illegal behaviors. We conducted a systematic review to investigate conservation journals’ ethical policies when research involves human participants, and to assess the types of ethical safeguards documented in conservation articles. We restricted our review to articles that used social science methods to gather data from local people about a potentially sensitive behavior: hunting. Searches were conducted in the Web of Science, Scopus, and Google Scholar for research articles in English published from January 2000 to May 2018. Only studies conducted in countries in south and Southeast Asia, Africa, and Central and South America were considered. In total, 4456 titles and 626 abstracts were scanned, with 185 studies published in 57 journals accepted for full review. For each article, any information regarding ethical safeguards implemented to protect human participants was extracted. We identified an upward trend in the documentation of provisions to protect human participants. Overall, 55% of articles documented at least one ethical safeguard. However, often safeguards were poorly described. In total, 37% of journals provided ethics guidelines and required authors to report ethical safeguards in manuscripts, but a significant mismatch between journal policies and publication practice was identified. Nearly, half the articles published in journals that should have included ethics information did not. We encourage authors to rigorously report ethical safeguards in publications and urge journal editors to make ethics statements mandatory, to provide explicit guidelines to authors that outline journal ethical reporting standards, and to ensure compliance throughout the peer‐review process.

Ethnography and Participant Observation

Ethnographers routinely engage in important practices of research openness. For instance, ethnographers often describe how they accessed field sites or research interlocutors and what roadblocks prevented other potential research paths. Ethnographers consider the ways in which their subject position – for example, one’s gender, racial, or ethnic background, class position, or nationality – and enmeshment in webs of power may shape the kinds of insights they produce. They may discuss their prior theoretical assumptions and discuss how the experience of field work changed these assumptions. They may describe the emotional strains, challenges, or dangers they or their interlocutors experienced during research. They will typically discuss why and how they went about protecting research participants, potentially including choices for anonymization, data protection practices, data destruction after a certain period, and reasons why data may not be available for sharing. Yet even as ethnographers do engage in certain practices of research openness, as we discuss in greater depth below, such practices are rarely framed in terms of transparency. This is because the concept of transparency, as it is typically elaborated in positivist research traditions, often sits awkwardly against the practice of ethnography, which tends to require heavy amounts of improvisation in the field and usually privileges ethics protections for human subjects. Emblematic of this mismatch in our efforts to elicit a broad discussion among ethnographers about questions relating to transparency as a general concept, we were met with much resistance as to whether such a conversation should even take place. Some expressed that they were unwilling to participate in this process because “transparency” is not a meaningful concept for ethnography, at least not in the sense it is used in much positivist and quantitative research. Many also felt that participating in this conversation, and particularly engaging the terms of the DA-RT debate, would legitimize a set of critiques that are not only irrelevant to ethnographers, but also potentially destructive to the kind of work ethnographers do. Thus this statement aims to capture the full range of views on the issue, building from the open online discussions but including concerns and reservations expressed to us privately.

Final Rule Updates Protections for Research Participants: What You Need to Know

Continuing Professional Education (CPE) Information The Continuing Professional Education (CPE) quiz for this article is available for free to Academy members through the MyCDRGo app (available for iOS and Android devices) and through www.jandonline.org (click on “CPE” in the menu and then “Academy Journal CPE Articles”). Log in with your Academy of Nutrition and Dietetics or Commission on Dietetic Registration username and password, click “Journal Article Quiz” on the next page, then click the “Additional Journal CPE quizzes” button to view a list of available quizzes. Non-members may take CPE quizzes by sending a request to [email protected] There is a fee of $45 per quiz (includes quiz and copy of article) for non-member Journal CPE. CPE quizzes are valid for 1 year after the issue date in which the articles are published. In January 2017, the US Department of Health and Human Services finalized several changes to the Federal Policy for the Protection of Human Subjects—also known as the “Common Rule” because it has been adopted by sixteen federal departments and agencies—with the goal of modernizing the system that governs research participants. 1 Angelica N. HHS Federal Policy for the Protection of Human Subjects (Common Rule) (2017 Final Rule). Duke University. https://scipol.duke.edu/track/hhs-federal-policy-protection-human-subjects-common-rule-2017-final-ruleDate accessed: October 1, 2018 Google Scholar The Common Rule was originally promulgated in 1991, at a time when research was “conducted predominantly at universities and medical institutions, and each study generally took place at a single site,” according to the US Department of Health and Human Services. The final rule takes into account that research with human participants has “grown in scale and become more diverse and data has become more digital.” 2 Department of Health & Human Services. Office for Human Research ProtectionsPress release. January 18, 2017. Final rule enhances protections for research participants, modernizes oversight system. https://www.hhs.gov/about/news/2017/01/18/final-rule-enhances-protections-research-participants-modernizes-oversight-system.htmlDate accessed: October 1, 2018 Google Scholar The Continuing Professional Education (CPE) quiz for this article is available for free to Academy members through the MyCDRGo app (available for iOS and Android devices) and through www.jandonline.org (click on “CPE” in the menu and then “Academy Journal CPE Articles”). Log in with your Academy of Nutrition and Dietetics or Commission on Dietetic Registration username and password, click “Journal Article Quiz” on the next page, then click the “Additional Journal CPE quizzes” button to view a list of available quizzes. Non-members may take CPE quizzes by sending a request to [email protected] There is a fee of $45 per quiz (includes quiz and copy of article) for non-member Journal CPE. CPE quizzes are valid for 1 year after the issue date in which the articles are published.

Biomedical research ethics in Cameroon: a survey to assess training needs of medical residents and students

BackgroundTraining curricula in research ethics for potential and future researchers should be implemented and constantly updated. This requires data regarding training needs.MethodsWe conducted a cross-sectional survey on residents, fifth and sixth-year medical students registered in the 2006–2007 academic year at the Faculty of Medicine and Biomedical Sciences (FMBS) of the University of Yaounde 1, Cameroon.ResultsTwo-fifths (40.4%) of respondents (response rate 70.9%) reported training in research ethics. Less than half were aware of specific regulatory texts relevant to research ethics. Among those who reported conducting a research project 66.7% declared having obtained informed consent from participants and 32.9% having submitted their protocol to an Ethics Review Committee. Participants identified training priorities in research ethics and responsibilities of key actors in the protection of research participants.ConclusionThere is a need to improve the training and attitude of medical students and residents in order to prepare them to respect and protect research participants.

Requiring a Single IRB for Cooperative Research in the Revised Common Rule: What Lessons Can Be Learned from the UK and Elsewhere?

One of the most significant revisions to the Federal Policy for the Protection of Human Subjects (known as the “Common Rule”), from an organizational ethics and governance perspective, is the mandated transition towards a single institutional review board (sIRB) system that eschews IRB review at multiple research sites. The sIRB rule is controversial for several reasons. Nevertheless, in this article, I argue in support of the mandated transition towards an sIRB system. I argue that this reform that this is part of a wider principles-based regulatory objective of the revised Common Rule, which itself is part of an emerging international movement in health research regulation. This movement advocates both research participant protection and ethical research promotion. Notwithstanding my general support for the sIRB rule, I draw on my own recent empirical research to highlight several residual weaknesses in the US regulatory structure for research ethics review, and suggest ways in which these weaknesses might be addressed in future regulatory reforms to improve upon the sIRB rule.

Collaborative storage and research use of human biospecimens between MSKCC and AUB

Background: As biospecimens are ultimately institutional resources, biologic specimens-tissue, blood or other body fluids- with benign or malignant disease that are left over after all intended diagnostic tests for clinical care are stored at our facilities. This project aims to procure and maintain a repository of human biological specimens for distribution to investigators, while maintaining confidentiality of patients. Methods: Left over biospecimens are procured and stored in the pathology department by the Tissue procurement service in a manner consistent with high standards for the protection of human participants in research. Patients are approached by consenting professionals to obtain the consent as part of the informed consent process. The objective and nature of the study is explained, as well as the voluntariness of the process. Results: In the course of 3 years, over 500 samples were collected from the patients to perform research studies. The sample types vary, the organ from which samples were procured include among others: thyroid samples, breast, brain, stomach, pancreas, liver, intestine, colon, and rectum. They include a vast variety of pathologies. Conclusion: The stored biospecimens will play a vital role in the development of anticancer interventions benefitting from the size, diversity, and richness of demographic and clinical information linked to the specimens. Our repository of human biospecimens has grown and will continue to grow as more samples are being stored daily.

Bank on We the People: Why and How Public Engagement is Relevant to Biobanking

Biobanks emerged in the early 2000s and now facilitate scientific research through the provision of resources for research that requires a large scale of biospecimens and data. Biobank projects have also become intertwined with complicated socio-economic initiatives to boost economic development or to shape community identity. While legislators continue to debate the ethical and regulatory challenges associated with biobanks, the federal regulation over research involving human subjects, the Common Rule, is based on a traditional research model that fails to address the complex challenges unique to biobanking. Through an examination of the proposed revisions to the Common Rule concerning research using biospecimens and ethical controversies regarding informed consent, privacy, ownership, and benefit-sharing, this article highlights a participatory aspect of biobanking that calls for public engagement with respect to both ethics and norms. Many biobank projects try to appeal to a sense of civic engagement whereby citizens have rights as well as responsibilities with respect to participation in collaborative scientific projects. Domestic and international guidelines describe incorporating public engagement with biobanking as an essential means of protecting research participants and achieving good governance. International experiences with various approaches to public engagement have also proven that involving the general public is feasible. Moreover, the principle of democratic deliberation, which was proposed by the Presidential Commission for the Studies of Bioethical Issues to be a guiding principle for bioethics policy decisions further underscores the criticality of public engagement in biobanking.

Of Parachutes and Participant Protection: Moving Beyond Quality to Advance Effective Research Ethics Oversight.

There are several reasons to believe that Institutional Review Boards (IRBs) and Human Research Protection Programs (HRPPs) contribute to ethical research and the protection of research participants, but there are also important reasons to interrogate this belief. Determining whether IRBs and HRPPs "work" requires empirical evaluation of whether and how well they actually achieve what they were designed to do. In other words, it is critical to examine their outcomes and not only their procedures and structures. In this response to Tsan, we argue that the concept of IRB and HRPP quality entails three dimensions: (1) effectiveness, (2) procedures and structures likely to promote effectiveness, and (3) features unrelated to effectiveness but nonetheless essential, such as efficiency, fairness, and proportionality. Because not all types of quality necessarily guarantee or entail effectiveness, we suggest that broad quality assessments, including such features as regulatory compliance and other procedural measures suggested by Tsan, are unhelpful as the first step in evaluating IRBs and HRPPs. Instead, we must start with outcomes relevant to effectiveness. To do this, we launched the Consortium to Advance Effective Research Ethics Oversight (AEREO), with a mission to define and specify ways to measure relevant outcomes for research ethics oversight, empirically evaluate whether those outcomes are achieved, test new approaches to achieving them, and ultimately, develop and implement empirically-based policy and practice to advance IRB and HRPP effectiveness. We describe several anticipated AEREO projects and call for collaboration between various stakeholders to more meaningfully evaluate IRB and HRPPs.

What Does It Mean to Be an Author of an Article in a Scholarly Journal?

What Does It Mean to Be an Author of an Article in a Scholarly Journal?

Toward a Posthumanist Ethics of Qualitative Research in a Big Data Era

The Big Data phenomenon, and its uptake in qualitative research, raises ethical issues around data aggregation, data linkages, and data anonymization as well as concerns around changing meanings and possibilities of informed consent and privacy protection. In this article, I address the ethical issues that arise from Big Data through a posthumanist philosophical framework. The humanist ethics that underpins normative ethical concerns—as outlined above—focuses on the unequal power relationship between researchers and research subjects and the potential harm that research can cause to research participants. Ethical practice consists in following guidelines and codes of ethical conduct designed, not so much to avoid these power differentials, but to protect research participants from potential exploitation and infringements of their human rights. Unethical research is understood as research that breaches these principles and/or harms its research subjects. A posthumanist ethics treats knowledge-making itself as a matter of ethical concern. It shifts the focus away from the power of researchers over research participants toward the “world-making” powers of practices of inquiry: their ability to constitute (and not simply discover) the very nature of their objects/subjects of study. Its focus of ethical concern—what it regards as unethical—is research that claims to represent the world “as it really is.” On this approach, ethical practice consists in accounting for the ways in which research ontologically constitutes its objects and subjects of study. The critical intervention made possible by bringing a posthumanist perspective to bear on the ethics of qualitative research in a Big Data era is to foreground Big Data’s treatment of data as self-evident, and its positivist claim to represent the world innocently, accurately, and objectively, as matters of ethical concern.