In late 2013, the Petrie-Flom Center joined the Regulatory Foundations, Ethics, and Law Program of Harvard Catalyst | The Harvard Clinical and Translational Science Center at Harvard Medical School. 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 participant recruitment to and enrollment in research studies. Clinical research cannot succeed without human research participants, but recruitment can be a serious challenge in some contexts, both ethically and legally. Accordingly, our work aims to develop practical solutions to key barriers and novel concerns, focusing on such issues as the use of financial incentives, social media, demographic targeting, diversity, and engagement with vulnerable populations. We were awarded a grant from the Brocher Foundation to host an international conference in Geneva in January 2015 focused on clinical trial recruitment, and we are also conducting an empirical survey to evaluate the key concerns of IRB members, institutional officials, investigators, research participants, and others related to offers of payment for research participation. Through exploration of international and comparative dimensions, engagement with critical stakeholders, and benchmarking current practices and concerns, this project will produce educational modules and guidance documents for IRBs, investigators, and recruitment managers, model policies and other toolkits, consensus statements, and the like.
Additional projects include:
Defining the clinical trials recruitment problem, including cataloguing various barriers to recruitment, outstanding data needs, and possible solutions, and developing a research agenda
Evaluating whether there are ways to prioritize trials and allocate research participants as a scarce resource
Considering innovative trial designs as a potential mechanism to address the recruitment problem
Developing a recruitment/retention toolkit to help investigators develop successful recruitment/retention plans
Addressing the proper parameters of remuneration to subjects
Developing surveys to learn more about participant motivations, expectations, and concerns
Conducting additional empirical research to develop knowledge that can improve clinical trial recruitment/retention
The Center’s project team is also involved in various educational initiatives, including several recorded lectures for the Catalyst online course Fundamentals of Clinical and Translational Research (FaCToR), as well as lectures for Introduction to Translational Medicine (ITTM).
Professor, Harvard Law School
Faculty Director, Petrie-Flom Center
Executive Director, Petrie-Flom Center
Petrie-Flom Center/Harvard Catalyst Fellow in Clinical Research Ethics