Spotlight on India

Clinical research is booming in India. Recent reports indicate the Indian clinical research industry could garner as much as $1.5 billion in funding from the US and Europe this year. While it is difficult to determine the exact number of clinical trials and institutional ethics committees (IECs)—also referred to as institutional review boards (IRBs) or research ethics committees (RECs)—tracking and monitoring of clinical research involving human subjects is on the rise.

PRIM&R is pleased to introduce S. Swarnalakshmi, Ph.D., IRB manager at the Y.R. Gaitonde Center for AIDS Research and Education (YRG CARE) in Chennai, India. Swarna may be a familiar face in our community; she attended the 2009 Advancing Ethical Research (AER) Conference as an international scholar.

PRIM&R Staff (PS): Please share with our readers your story: How did you come to the field of research ethics?

S. Swarnalakshmi, PhD (SS): Prior to joining YRG CARE as a research associate in 2001, I had no previous training in research ethics. After assuming the role of IRB coordinator in 2003, I became fascinated with the discussion of ethical issues during the IRB meetings. With institutional support, I started attending national and international workshops, conferences, and seminars in research ethics, and learned more about the latest trends and issues in the field. I then became even more involved after completing an intensive training program in bioethics organized by the Indian Council of Medical Research (ICMR) and sponsored by the National Institutes of Health (NIH) in 2007. I now organize the annual bioethics symposium at YRG CARE, and speak in research ethics workshops at other institutions.

(PS): Please tell us a little bit about the history of human subject protections and RECs in India.

(SS): Historically, physicians have referenced the texts from traditional systems of medicine in India, Ayurveda and Siddha, which offer guidelines for how physicians should conduct themselves, keeping in mind the welfare of patients. In 1980, the ICMR developed the first version of the Ethical Guidelines for Biomedical Research in Human Participants (ICMR Code).

The ICMR Code was then revised in 2000, and the current and latest version came out in 2006. However, these ethical guidelines do not have legal sanctity as in the US. Many institutions now feel the need to protect the interests and welfare of human subjects, and have started establishing IECs. However, as discussed in this editorial, there have been no systematic assessments of the number of IECs in India. According to the Office for Human Research Protections (OHRP) website, India has as many as 278 IRBs registered as of July 2010, of which 57 have been deactivated. The actual number of IRBs is likely higher, as this list only includes projects that are US government-funded.

Efforts are also underway to track and monitor clinical trials with a national registry. The Clinical Trials Registry-India (CTRI) began tracking clinical trials in 2007, and as of June 2009 it became mandatory to register trials before enrollment of the first participant. A recent article in The National Medical Journal of India states that the CTRI had registered 298 trials in 23 months before June 15, 2009, while 551 trials were registered in the following nine months.

(PS): Please share one unique challenge and one unique asset you and your colleagues face in protecting human subjects in India.

(SS): In international collaborative research projects, it is a challenge to balance the national good clinical practice (GCP) and ethical guidelines with the international regulatory requirements. For example, the informed consent forms administered to the study participants are translated in the local language, but great care has to be taken to ensure the study participants understand the complex and detailed technical information in these forms.

One unique asset at YRG CARE has been the commitment and dedication that IRB members exhibit. They vigilantly ensure that the rights and welfare of the study participants are well protected before, during, and after a research project ends. The institution has also been supportive of the IRB work and at present, we have two full-time staff members devoted to IRB work. This is not very common in India, as IRB members generally serve on the IRB in addition to their routine responsibilities.

(PS): How do you see the field of research ethics changing in India?

(SS): There is growing awareness of bioethics in India, and many research institutions like YRG CARE are organizing workshops and symposia to foster awareness of research ethics among investigators and students. The Indian Journal of Medical Ethics organizes the National Bioethics Conferences, and ICMR conducts several research ethics workshops. Though not on the level of PRIM&R’s Advancing Ethical Research Conference, there is increasing interaction and active participation in bioethics conferences and symposia in India, and I am confident that India will reach that level in the years to come!

Furthermore, more institutions in India are starting IRBs and streamlining the operations of these committees. I am hopeful that there will be further positive developments when an ICMR bill, the Biomedical Research Human Subjects Promotion and Regulation Bill, reaches legislative sanction. This bill will establish a Biomedical Research Authority, through which all ethics committees will be required to register.

(PS): Thank you for taking the time to share your perspective with the PRIM&R community, Swarna.

Interested in sharing your story about research ethics in your country? Please e-mail us for more information.