Clinical Researcher—August 2019 (Volume 33, Issue 7)
ETHICS IN ACTION
This interview with Subhashini Gopal, MSc, MPhil, a psychologist and coordinator of psychological services at the Schizophrenia Research Foundation (SCARF) in Chennai, India, focuses on her experiences as a participant in the WIRB-Copernicus Group (WCG) Spring 2019 International Fellows Program. Founded in 2002, the program helps train global healthcare professionals who want to establish the infrastructure of ethical oversight of research in their countries. It features ethics and regulatory training at WIRB in Puyallup, Wash., and at the Division of Medical Ethics within the Department of Population Health at the Medical School for NYU Langone Health. Gopal is currently pursuing a PhD in psychology.
Q: How would you describe SCARF and your role there?
A: SCARF provides critical care for patients with mental illness and serves as a research foundation. When the organization was founded, it focused on patients with schizophrenia, but it has since expanded to include patients with all kinds of mental illness. SCARF has 150 to 170 staff members across a main center for outpatient care and three residential centers. I am involved in both clinical care and research at SCARF.
Q: Why did you join the WCG International Fellows Program?
A: In April 2018, I took over the role of Member Secretary for the SCARF Independent Ethics Committee (IEC). Bioethics was a new area for me, even though I am a researcher and get involved in a lot of research projects at my organization, so I wanted to learn a lot more about it.
Research ethics are especially complex in our field because we deal with the most vulnerable patient populations—those who have compromised autonomy and who are not able to decide what is in their best interest. I wanted to know how these vulnerable patient populations should be approached from an ethics perspective, and to learn from the experiences of healthcare professionals working in other developing countries.
Prior to joining the program, I thought that every country would have basic guidance or ethical principles that researchers had to follow, but I learned that India is advanced in that regard. Some countries have no guidelines laid out for them at all, and that shocked me.
Q: Which organizations provide ethical guidance in India?
A: The Indian Council of Medical Research has developed some guidelines. Researchers also have to apply to the Drug Council General India to obtain approval to conduct clinical trials. However, there is no central regulatory body overseeing the trials.
Q: What part of your work are you most proud of?
A: I am really proud of the patient care that I am able to provide, and the interventions I deliver that bring significant improvements to an individual’s quality of life.
My work is rewarding, but it is also very challenging. There are a lot of crises involved with mental illness. We can see patients doing really well one day, but the next day they can come with a full-blown relapse of their illness. If I’m able to bring a change in one person’s life, if I can make an effort that is reaching them, then I feel satisfied and proud about it.
Q: Is an IEC in India set up differently from an institutional review board (IRB) in the U.S.?
A: The composition of both groups is similar and they both review research protocols, but our IEC is focused on SCARF, so it only reviews mental health research. Furthermore, we need to have someone serving on our IEC who has a family member with a mental illness; they can represent the patient’s perspective because they see what challenges a patient with mental illness faces on a daily basis.
Our IEC meets every three months to review research protocols developed by our researchers and graduate medical students on site. In contrast to what we do, the review process at U.S. IRBs is very structured—they have very strict standards and checklists. That’s not the case in India.
Q: What are the most valuable skills or ideas that you’ve learned from the Fellows program?
A: Starting from the basic elements, we learned the history of ethics and how ethical principles have evolved. Then we heard about the U.S. Food and Drug Administration regulations and the categories of research, and how transferring them to a different culture is a big process. They cannot just be repeated in a local population or culture. What I learned will help us to shape our own evolution.
Q: What cultural differences will impact how you put these concepts into effect?
A: In India, we will do an intervention; we will go into the community and into the villages to recruit participants for a research program. It’s not easy. Their education and their level of comprehension are completely different. Making them informed, so that they can consent to the research, is a bigger challenge for the researchers in India than it is for those in the U.S.
We work with community leaders and explain to them the consent process, but the problem lies in getting participants to sign an informed consent. There are people in the villages who may have been cheated because someone got them to sign a paper and their property was taken. To get them to sign an informed consent is not that easy.
Others view researchers as doctors, and they equate doctors with god, because they are saving their life. So, when a doctor goes into the community to do research and get an informed consent, even though the doctor sits down and takes time to explain the intent of the research, they blindly love or hate it.
Even in defining risk, there is a contextual difference. To someone who has a city life, risk might be different.
If someone in a city got a fever, they might not go to work the next day. Someone with different living conditions and socioeconomic status might still have to go to work. They won’t take any kind of physical health or emotional problem as seriously as the person in the city.
Q: What experiences from the Fellows program would you like to implement in India?
A: I would like to propose some changes to our standard operating procedures. WIRB has a large checklist, which makes the work easier. I also plan to hold a workshop on how to write an informed consent form, so that we can create a more uniform process in our organization. It is something that I can bring to the researchers in my region.
It is a researcher’s responsibility to behave responsibly with his or her research subjects. The researcher has to make a point to be ethical, to be disciplined, and to follow the standards to protect those who volunteer to participate in studies.
This Q&A was developed for WCG by Rana Healthcare Solutions.