Partners in Research: The Study Team & Regulatory Team

Study teams and regulatory teams have different perspectives when it comes to executing research protocols, due simply to the different day-to-day responsibilities of a study team member versus a regulatory team member. While the ultimate goal of any research protocol is to generate new knowledge while protecting the rights and welfare of research subjects, sometimes study and regulatory teams differ on how to best achieve this goal. I have been fortunate enough to have worked as both a study and regulatory team member and have gained insight into how these teams differ and how they can best work together to ensure that research protocols run smoothly and achieve the highest standards of ethical research conduct. 

One area where study teams and regulatory teams may differ in perspective is in the day-to-day execution of research protocols versus their overall execution. It is important for study and regulatory teams to work together and acknowledge differing perspectives and responsibilities. For example, a study consent may offer participants the option to select which procedures they want to take part in, which may be viewed favorably because it enables participants to decide how they wish to participate. While it is important that participants have a choice in how they participate in research, offering too much choice can present challenges for study teams in tracking participants’ choices and ensuring that those choices are honored. In this scenario, a better approach to consider might be to have the study team and regulatory team work together, rather than in isolation, to develop a tracking sheet to track participants’ choices. While this may involve more work up front, it can save both teams time in the future and reduce the likelihood of non-compliance.

Another area where there may be differing perspectives when it comes to executing research protocols is the role of the IRB or regulatory office. The IRB or regulatory office can sometimes be perceived by some researchers as the “regulatory police”. When this view is present, researchers may be less likely to come forward with questions, concerns, or problems, which may result in noncompliance. However, when study teams and regulatory offices see each other as partners in research, it has been my experience that studies move forward more smoothly and study teams are better prepared to handle study-related problems that occur. This partnership approach makes it easier and more comfortable for researchers to approach a regulatory office to develop solutions to problems as they arise. This approach may ultimately result in the development of better solutions to problems than the previous one.

In summary, having experience working as a study team and regulatory team member I have learned that the differing perspectives of these groups can sometimes lead to issues in the review and execution of research protocols. It is important that both teams try to look at research protocols and related issues from both perspectives in order to find the best ways conduct research that effectively protects the rights and welfare of research subjects. It is also important that study teams and regulatory offices work together as partners instead of in opposition. When the study teams and regulatory teams are open to new perspectives and work together in partnership, the research process runs more smoothly and the highest standards of the ethical conduct of research are easier to achieve.

Molly Schleicher, MNSP is a Review Specialist in the Office of Research Subject Protection at the Broad Institute in Cambridge, MA and a member of the PRIM&R Emerging Professionals Working Group.