Poster Spotlight: Ethical Challenges and Solutions Involved in Reviewing a Protocol with Sex Offenders as Participants

by Meryn Robinson, Educational Program Intern

When reviewing a study that sought to investigate how sex offenders used networked technologies and communications for human trafficking, Hila Berger, MPH, CIP, and her colleagues on the IRB at Montclair State University faced a unique challenge: balancing protections for the study’s subjects—sex offenders—against protections for potential victims. The potential for subjects to incriminate themselves and potential legal obligations related to information disclosed during the research further complicated the protocol review. To overcome these challenges, the IRB and legal counsel worked together to implement additional protections for the group.

At the 2013 Advancing Ethical Research (AER) Conference, as a poster presenter and panelist, Hila discussed her experience and the systems put in place to manage such a challenging protocol at her institution. Recently, I connected with Hila to see how her work has progressed since last year’s conference.

Meryn Robinson (MR): It’s been nine months since you presented your poster at PRIM&R’s 2013 AER Conference. How has your research changed or evolved in the past nine months?
Hila Berger (HB): The work presented at the conference revolved around identifying and developing solutions for research involving sex offenders. The research in question is still ongoing, and the IRB and compliance team continue to informally assess whether the solutions we chose have been implemented successfully. Discussions with the principal investigator (PI) during additional submissions and at the time of continuing review have brought to light any concerns. Initially, during the review process, the PI had concerns about whether certain limitations would impact recruitment. However, according to the PI, while the project has struggled with recruitment, it is not as a result of the additional protections set forth by the IRB.

MR: What challenges have you faced in implementing these solutions?
HB: As a predominantly social-behavioral research-based institution, some assume that we do not have to regularly deal with greater than minimal risk research. This is far from the truth, but the nature of our greater than minimal risk studies do look different than those found in biomedical institutions. For example, since this initial protocol we have actually had another researcher request to conduct a study that would study involve assessing the effect of sexual offender legislation on registered sex offenders. Fortunately, the IRB was able to use some of the same protections put into place with the previous study. One of the most important lessons we’ve learned is that while a Certificate of Confidentiality may be appealing, as it offers additional protections for greater than minimal risk behavioral research, it may not always be attainable. Weighing the risk of subpoena against the benefits of the research may be something that can only be done with input from counsel, law enforcement, and other experts.

MR: What is one principle that guided you in your research?
HB: When reviewing this type of research, the key ethical principle that guides us is beneficence, as described in the Belmont Report. The moral dilemma of protecting sexual offenders did not escape the IRB’s discussions, but the group worked diligently to separate personal biases from the need to protect the subject population, in this case sex offenders, and to focus on the potential benefits that could emerge from such research.    

MR: What is one thing that you learned or took away from your experience?
HB: When it comes to human subject protections, there are always going to be unique research designs or populations that require the IRB to think critically and create a new recipe for protecting participants. There is no cookie-cutter solution that can be applied to every research study. Bringing in experts and taking the time necessary to fully understand the risks associated with a particular protocol will ultimately better serve the research and the participants.

Thank you for connecting with us and providing an update on your work, Hila. We hope that you are planning to join us for the 2014 AER Conference, which will take place December 5-7 in Baltimore, MD. This year’s program will feature more than 100 posters highlighting best practices and research related to human subjects protections, including nine exemplary posters, which will be presented during a special panel series.