We need more education about psychiatric IRB processes: An interview with David H. Strauss

by Avery Avrakotos, education and policy manager

In January, PRIM&R welcomed three new members to its Board of Directors, including David H. Strauss, MD. Dr. Strauss is director of research at the New York State Psychiatric Institute and is vice chair for research administration, ethics, and policy at the Columbia University Department of Psychiatry. Dr. Strauss has been actively involved with PRIM&R for 10 years, and was Co-chair of the Core Conference Planning Committee (CCPC) for the 2012 and 2013 AER Conference. He is also be Co-chair of the CCPC for the 2014 AER Conference. 

I recently connected with Dr. Strauss to discuss why he chose to become involved with PRIM&R, as well as his perspective on some issues facing human subjects research.

Avery Avrakotos (AA): When and how did you first become involved with human subjects research?
David Strauss (DS): I started doing research with human subjects in medical school. Recently, I was looking back and realized I wrote a paper in medical school on patient rights and the right to refuse treatment—ideas about consent were part of what I was interested in even as early as medical school. Following residency, I was asked to be the attending psychiatrist for a dedicated research service. My daily life and administrative responsibilities were to construct a service that promoted patient and family involvement in decision-making while accomplishing research goals. It was at that point that I really began working with the institutional review board (IRB) as an investigator, and I became more familiar with the whole concept of human subjects protections.

AA: What challenges do you see ahead for medical research in general? Any ethical challenges in particular?
DS: There is a swinging back and forth of the pendulum in terms of the tension between the protection of subjects and the needs of research. In the late 1990s and early 2000s, we witnessed a clamp down by many institutions as a result of compliance actions by the Office for Human Research Protections. For the first time, institutions started investing in appropriate resources for human subjects protections, which laid the groundwork for the professionalization of IRB administrators. Subsequently, the world of research has grown in sophistication, and there has been an educated pushback by the academic and research community. For example, we hear complaints that an overly conservative approach to research protection hampers research and therefore progress. The pendulum is swinging back in the other direction in such a way that it seems we may be liberalizing our approach to certain aspects of research protections.

AA: What is one thing you wish the general public knew about human subjects research?
DS: My work is primarily in psychiatry and neuroscience, and I think there is a longstanding stigma associated with the conditions involved in those disciplines, but also with research in those areas. Historically, some of the most egregious examples of exploitation involved individuals in psychiatric facilities. I think what people need to understand about human research protections and human subjects research is that we can’t move the field forward without research, and that there is a sophisticated and careful institutional process involved in ensuring that people’s rights and welfare are supported when they choose to take part in research.

I recently had an opportunity to speak with a New York state based family advocacy group for individuals with mental illnesses. At their annual meeting, they are used to hearing from scientists; they are very interested in finding answers to the problems that impact their family members. However, while they want change, they are quite nervous about research. It was a great opportunity for me to talk about the changes that have occurred in human subjects protections and to tell them the stories that we’ve all learned from. I think that more public education about IRB processes would be a very good thing. Of course, as with everything else, we only hear about the occasional screw up—when there has been a deficiency in the process—but there is relatively little education about human subjects protections when it works well. There are many stories about when something goes wrong in research, but we haven’t done a really good job of promoting human subjects protections being done well.

AA: Why did you agree to serve on PRIM&R’s Board of Directors?
DS: Over the years, and throughout my involvement with the planning for PRIM&R’s annual Advancing Ethical Research Conference, I have been very impressed with the organization and its leadership. I feel honored to have been asked, and I feel honored to be among the luminaries that sit on the board. I don’t consider myself a luminary, but the individuals that sit on PRIM&R’s Board of Directors are all well known in the field. Of course, I also believe in the cause, and I am happy to contribute to serving the mission of the organization.

AA: Can you tell me about one or more articles, books, or documents that have influenced your professional life?
DS: I often recommend  easy and compelling reads to students. One book that is very interesting and that tells great stories is Strangers at the Bedside: A History of How Law and Bioethics Transformed Medical Decision Making by David J. Rothman. More recently, for people outside of psychiatry and for patients, I refer them to Elyn R. Saks’ memoir, The Center Cannot Hold: My Journey Through Madness.

AA: What advice do you have for young professionals interested in pursuing a career in research ethics?
DS: My advice is, like anything else career wise, don’t pursue it unless you feel that you love it. Of course, the only way to know if you love it is to go and do it in any way that you can. At my institution, we open our doors to let people sit in on our meetings. It is a way to encourage people to get involved. I was talking with a young nurse practitioner recently, and it was obvious to me that people who are involved in clinical practice care about patient’s rights, but they still need to learn about the differences between patient care and research. I invited this individual to come to our meetings. She was excited, and she is now serving as a member of our IRB.

It is really a fantastic field—it is a field for people that want to do good, and that want intellectual opportunities and challenges. There are lots of opportunities for individuals from all different backgrounds, but the first step is to learn more about it, quite frankly, through becoming a PRIM&R member, visiting their website, and attending the annual meetings.