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 tool for recruiting people into clinical trials and other important types of research. 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 freely available 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), as well as numerous presentations on the practical aspects of social media recruitment to investigators and research staff, IRB members, research participant advocacy boards, and other CTSA institutions. A related publication is forthcoming in the American Journal of Bioethics.

An overview of the guidance document The Use of Social Media in Recruitment to Research is available here.

Evaluating Offers of Payment to Research Participants

There is currently a lack of consensus among IRBs and researchers 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. In December of 2016 the Center will host a symposium and working group, bringing together leading voices on payments to identify the challenging ethical issues surrounding payment, work toward consensus on how to identify ‘fair’ payment under different circumstances, and identify best practices for the proposal and review of offers of payment to research participants. The conceptual and ethical foundations for this project have been laid in a law review article on these topics (Paying Research Participants: Regulatory Uncertainty, Conceptual Confusion, and a Path Forward) forthcoming in 2017 at the Yale Journal of Health Policy, Law, and Ethics.

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 how institutions approach competing clinical trials, conducting qualitative interviews with individuals responsible for managing competing trials at their home institutions to benchmark current practices. The second phase will involve convening subject matter experts into working groups to identify the practical and ethical challenges of managing competing trials and to explore institutional prioritization approaches as a feasible means of addressing them. This work will issue in a practical ‘points to consider’ guidance document for managing competing trials, which will be made freely available to the research community and disseminated across other CTSA institutions.

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, issuing in a ‘points to consider’ guidance document for institutions and research staff involved in biobank recruitment that will be made available to the research community and disseminated across CTSA institutions.

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. It hopes to issue a practical guidance document aimed at facilitating the adoption of legally compliant and ethically sound e-consent processes by institutions.

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. It is positioned to deliver a template consent form and standardized language that can be adopted and used across institutions and institutional contexts, and that can be presented to the research community and other CTSA institutions as a way of simplifying their consent forms and processes.  

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). 

Project Staff

Barbara E. Bierer

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

I. Glenn Cohen

Faculty Director, Petrie-Flom Center

Professor, Harvard Law School

 

Holly Fernandez Lynch

Executive Director, Petrie-Flom Center

Faculty, Center for Bioethics, Harvard Medical School

 

Luke Gelinas

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

 

 

Sabune Winkler

Director, Regulatory Affairs Operations, Harvard Catalyst | the Harvard Clinical and Translational Science Center