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, the Harvard T. H. Chan 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 ethical and legal norms, and uses detailed case studies to shed light on relevant aspects of social media recruitment. This work has issued in a guidance document outlining numerous concrete recommendations for investigators and IRBs (The Use of Social Media in Recruitment to Research: A Guide for Investigators and IRBs) and a related publication forthcoming in the American Journal of Bioethics.

Evaluating Offers of Payment to Research Participants

There is currently a lack of consensus among Institutional Review Boards (IRBs) responsible for overseeing research with human subjects, as well as researchers conducting such research, concerning key regulatory concepts applicable to paying research participants, as well as the ethical boundaries that should be used in evaluating offers of payment. 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. To date it has issued in a law review article on these topics (Paying Research Participants: Regulatory Uncertainty, Conceptual Confusion, and a Path Forward) forthcoming in 2017 in the Yale Journal of Health Policy, Law, and Ethics, and a second article directed at helping IRBs and investigators promote “fair” payment. In December of 2016 the Center will host a symposium and working group on issues related to fair payment, bringing together leading voices on these topics toward the end of issuing practical recommendations and building consensus on best practices.

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 participants. There is evidence that such competition is a predictor of low recruitment rates, but there is no consensus on what steps, if any, institutions should take to manage this issue. One neglected but promising approach is for institutions to minimize competition between trials by prioritizing among them, allowing some studies to recruit eligible participants ahead of others. In this project we examine prioritization as way to manage competing studies and we address the ethical and practical issues involved with implementing institutional prioritization models. A second aspect of the project, currently underway, consists of qualitative interviews and focus groups with individuals involved with prioritization procedures at their research institutions, toward the end of building consensus around best practices.

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, and this will become increasingly true if proposed revisions to the federal regulations are finalized. 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 Partners Healthcare, Emory University, and the Medical University of South Carolina, administering surveys about why people agree or decline to participate in biobanking protocols. This data will be used to target educational efforts and refine the biobank recruitment process.

e-Consent

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.

Simplifying Consent

This project aims to create a simplified consent form separating the explanation of study-specific research information from common elements of consent (e.g., subject injury, HIPAA) by harmonizing language between different institutional consent forms and convening focus groups to reach consensus on what should be in a standardized section.

Educational Initiatives

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). 

Staff

I. Glenn Cohen

Project Lead

Professor, Harvard Law School

Faculty Director, Petrie-Flom Center

 

Holly Fernandez Lynch

Project Co-Lead

Executive Director, Petrie-Flom Center

Faculty, Center for Bioethics, Harvard Medical School

 

Luke Gelinas

Petrie-Flom Center/Harvard Catalyst Fellow in Clinical Research Ethics