Like some feverish character of in a Dostoyevsky novel, as a culture, we are obsessed with all things crime and punishment. Going to prison, being in prison, and life after prison are the topics dozens of television shows and movies. Illegal activity as entertainment? We’re in. Prisoners and prisoner biomedical issues for thoughtful, systematic research? Maybe not so much.
The need for scientific inquiry seems obvious: millions of people flow through the prison system each year, and based on health impact and health disparities for that group alone, you would think the research and medical communities would be paying close attention. There are some educational activities extolled for medical trainees, but there is a general reluctance to approach incarceration health in the biomedical world. Complex relationships with criminal justice partners, funding, and the daunting prospects of adhering to special prisoner research protections in 45 CFR 46, Subpart C are known barriers.
Two workshop sessions at the 2015 Advancing Ethical Research (AER) Conference aimed to demystify some of the IRB-associated barriers to research activity. Both helped clarify a number of complex issues such as mandatory reporting of illegal behavior by investigators and the impact of having a former prisoner as the required prisoner representative on the IRB review. Both sessions had interested, engaged audience members with plenty of their own stories to tell. And both raised more questions than time allowed to address—the ultimate hallmark of a great workshop session.
In Is That Illegal? Developing Best Practices for IRB Review of Research Investigating Illegal Behaviors, Drs. Fisher and Glantz showed their obvious expertise and reviewed a number of topics related to mandatory reporting and confidentiality. Eschewing a formal presentation, they instead invited an open dialogue with the audience which allowed presentation and discussion of a variety of examples. Take home pearls? Certificates of confidentiality can allow the researcher to refuse to turn over research records, but it doesn’t keep the researcher from giving up the data electively. Also, researchers and their staff are often not mandatory reporters of child endangerment or domestic violence. An example presented by Dr. Fisher was from a qualitative observational study of one behavior not related to children, where researchers observed children of sex workers helping their mothers by standing guard when mom was “working.” The investigator struggled with whether to report the children as “endangered.” The discussion focused on legal definitions in the mandatory reporting law. While reporting is always option (“see something, say something”), you may not be obligated to do so unless you are the designated medical care provider caring for a harmed person. States have different guidelines around the specifics and you can always choose to inquire about reporting as a person of conscience.
In the second workshop session, Representing Prisoners: Insights from an IRB Member Who has Been Incarcerated, three members of the Harvard IRB presented, including their community member who had spent many years in prison. The details of how they found David and his contributions to the IRB deliberations were thought provoking. And his contributions to their work were clear: he was able to spot participant safety considerations in recruitment and data collection activities that would not have been obvious to investigators who were unaware of prison culture.
Despite the excellent information provided, I still left with unanswered questions: Why are students so often the people who want to do prisoner related research? What do adverse events and unanticipated problems look like in some of the mobile technology studies involving illegal activity? As Dr. Glantz noted, life happens. Adverse events may occur to persons conducting illegal activities such as drug use or drug transport, but these are not unanticipated problems. That said, what if the participant has a mobile device, supplied by the researcher, that contains information subpoenaed by prosecutors or desired by a defendant? The adverse event reports just got a little more complex and writing up the risk section of the informed consent documents just a bit more challenging.
Thanks to all presenters for their after-session clarifications! Let’s continue with more sessions like this next year.
Jacqueline Tulsky, professor of medicine, emeritus at the University of California, San Francisco, is a member of the PRIM&R Blog Squad for the 2015 AER Conference. The PRIM&R Blog Squad is composed of PRIM&R members who blogged here, on Ampersand, to give our readers an inside peek of what happened at the conference in Boston, MA.