Since 2013 the Petrie-Flom Center has collaborated with the Regulatory Foundations, Ethics, and Law Program of Harvard Catalyst | The Harvard Clinical and Translational Science Center at Harvard Medical School to promote the ethical conduct of research with human beings. Harvard Catalyst was established in 2008 to improve human health by enabling collaboration and providing tools, training, and technologies to clinical and translational investigators. It is funded by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program (grant 1UL1 TR001102-01), and by contributions from Harvard University, Harvard Medical School, Harvard School of Public Health, Harvard Law School, Beth Israel Deaconess Medical Center, Boston Children's Hospital, Brigham and Women's Hospital, Dana-Farber Cancer Institute, and Massachusetts General Hospital.
The Center's initial focus has been on developing practical solutions to key legal and ethical barriers affecting participant recruitment to and retention in clinical research studies. Clinical research cannot succeed without human research participants, but recruitment to research is often a serious challenge, involving complex ethical and legal issues. Key projects addressing these challenges are described below.
Using Social Media as a Research Recruitment Tool
Social media is emerging as a promising research recruitment tool. Despite this, there is no specific regulatory guidance and very little in the bioethics literature to help investigators and IRBs navigate this potentially unfamiliar terrain. This project develops a methodology for assessing social media recruitment techniques, analyzes and applies key norms of privacy and investigator transparency, and uses detailed case studies to shed light on relevant aspects of social media recruitment. A guidance document, completed in 2016, outlines numerous concrete recommendations for investigators and IRBs. We have disseminated the guidance document at various venues, and this year published two related academic articles, Using Social Media as a Research Recruitment Tool: Ethical Issues and Recommendations and Nonexceptionalism, Research Risks, and Social Media in the American Journal of Bioethics, alongside replies from scholars across the research community.
Evaluating Offers of Payment to Research Participants
Institutional Review Boards (IRBs) responsible for overseeing research with human subjects and investigators conducting such research express confusion and uncertainty over key regulatory concepts applicable to offers of payment to research participants, as well as the ethical boundaries that should be used in evaluating such offers. The result is substantial conservativism, spurred by fear that offers of payment are too high. This project aims to clarify the definitions of key terms such as “undue influence,” “coercion,” and “exploitation,” and to draw attention to the overlooked problems associated with paying research participants too little. We published a comprehensive law review article on these topics, Paying Research Participants: Regulatory Uncertainty, Conceptual Confusion, and a Path Forward, in the Yale Journal of Health Policy, Law, and Ethics in early 2017, and a second article directed at helping IRBs and investigators promote “fair” payment, The Outsized Influence of Undue Influence, has been accepted for publication at IRB: Ethics & Human Research (forthcoming 2017). In December 2016, we hosted a public symposium bringing together thought leaders on this topic, and convened a subsequent expert working group to collaborate on practical guidance materials for investigators and IRBs, scheduled for completion in Summer 2017.
When Clinical Trials Compete: Prioritizing Study Recruitment
It is not uncommon for multiple trials at the same institution to recruit concurrently from the same population. When the relevant pool of participants is limited, as it often is, trials essentially compete for them. There is evidence that such competition is a predictor of low study accrual, but there is no consensus on what steps, if any, institutions should take to manage this issue. One approach is for institutions to minimize competition between trials by prioritizing between them, allowing some studies to recruit eligible participants ahead of others. In this project we examine prioritization as a means of addressing the challenges of competing studies and address the ethical and practical issues involved with implementing institutional prioritization models. We published a feature article examining the ethical and practical grounds for prioritizing trials in the Journal of Medical Ethics, When Clinical Trials Compete: Prioritising Study Recruitment, as well as a response to expert commentaries, Institutions as an Ethical Locus of Research Prioritisation.
Motivations for Participating in Biobanking for Research
At present, a substantial portion of research with biospecimens – e.g., blood and tissue samples collected from patients and research participants – falls outside the scope of federal law and does not require informed consent from specimen sources. However, there are circumstances where prospective consent is needed or sought as a way of building trust with and empowering patient populations. In that context, it is essential to better understand why individuals agree or do not agree to have their biospecimens used for research purposes. This project undertakes an empirical research project, in collaboration with colleagues at other research institutions, aimed at answering this question. The data will be used to target educational efforts and refine biobank recruitment processes. To date, we have completed the survey instrument and are preparing a pilot study, in order to launch the survey in mid-to-late 2017.
There is growing interest in the research community in documenting informed consent for research using digital platforms and electronic means. While the federal government has issued guidance stating that e-consent is acceptable under certain circumstances, there remains uncertainty about how to implement e-consent in ways that comply with state laws and minimize ethical concerns. This project aims to provide practical recommendations to IRBs and investigators faced with navigating the legal and ethical challenges of using electronic means to document informed consent for research. It hopes to issue a practical guidance document aimed at facilitating the adoption of legally compliant and ethically sound e-consent processes by institutions.
Despite significant attention to consent as a cornerstone of ethical research, there remain significant challenges to modernizing and optimizing consent processes. There is, for example, growing interest in the research community in documenting informed consent for research using digital platforms and electronic means, but there remains uncertainty about how to implement e-consent in ways that comply with state laws and minimize ethical concerns. In addition, there is a widely recognized need to simplify consent forms in the service of enhancing participant understanding and to develop standardized consent form language and templates. This project, launched in 2017 and operationalized in part through the Consent Committee of the Regulatory Foundations, Ethics, and Law Program, will advance these goals.
The Center’s affiliates working on this project have also been involved in various educational initiatives, including lectures for Harvard Catalyst’s Introduction to Translational Medicine (ITTM) course, the Catalyst Clinical Trial Design Course, and Catalyst’s Program in Clinical and Translational Investigation (PCaTS).
Program Director of the Regulatory Foundations, Law and Ethics Program, Harvard Catalyst | the Harvard Clinical and Translational Science Center
Faculty Co-Director, the Multi-Regional Clinical Trials (MRCT) Center at Harvard and Brigham and Women's Hospital
Faculty Director, Petrie-Flom Center
Professor, Harvard Law School
Executive Director, Petrie-Flom Center
Lecturer on Law, Harvard Law School
Petrie-Flom Center/Harvard Catalyst Fellow in Clinical Research Ethics
Director, Regulatory Affairs Operations, Harvard Catalyst | the Harvard Clinical and Translational Science Center