Dr. Barbara E. Bierer and MRCT Center Program Manager, Laura G. Meloney, co-authored “Strategies to optimize inclusion of women in multi-national clinical trials,” published in Contemporary Clinical Trials. The authors note the persistent complexities in the representation of women in clinical trials, particularly in some therapeutic areas and in certain countries. The article includes approaches and suggestions to consider to address the problem.
MRCT Center Senior Advisors, Luke Gelinas and David Strauss, MRCT Center Faculty Director, Barbara E. Bierer, and others co-authored, “IRBs and the Protection-Inclusion Dilemma: Finding a Balance,” published in The American Journal of Bioethics. The authors address the tension that Institutional Review Boards (IRBs) face “in aiming to both protect potential research participants from harm and include under-represented populations in research” and offer recommendations to support IRB decision-making.
Published in: Journal of Empirical Research on Human Research Ethics
Published recently in the Journal of Empirical Research on Human Research Ethics, Luke Gelinas, David Strauss, Hayat Ahmed, Barbara Bierer, and others co-authored an article entitled, “Protecting the Vulnerable and Including the Under-Represented: IRB Practices and Attitudes.” A pilot national survey of IRB Chairs was conducted to assess attitudes and practices with regard to protecting the vulnerable and including under-represented groups in research.
Ensuring that clinical trials, once launched, successfully complete and generate useful knowledge is an important and indeed ethically imperative goal, given the risks and burdens borne by research participants. Since there are insufficient willing research participants to power all the trials that are currently undertaken,1 addressing underenrolment will require prioritisation decisions that reduce the number of trials competing for participants. While there are multiple levels at which research priority-setting can and does take place, competition between trials often plays out in real time at the institutional or site level, where complex decisions must be made about how to manage overlapping trials in ways that balance different considerations, including the risk of non-completion. We sought to explore what research institutions in particular might ethically do to mitigate the risk that competition between trials will contribute to recruitment shortfalls.
