Globalization has opened up new avenues for promising business models and business process outsourcing is one among them. It has become a key business strategy for organizations of all domains ranging from a start up to multi-national companies. Major pharmaceutical companies are also likely to follow this trend and outsource a substantial amount of work to many developing countries like India. Over the past few years, India has become the biggest beneficiary of this boom owing to its technological development, world class infrastructure, growing economy and large talent pool.
While we swear by the pros of outsourcing, there is a lot of debate over India’s preparedness to sustain in long run. In this perspective, an aspect that has been mostly overlooked is the cultural diversity and the impact it has on clinical trials. Geographical differences give rise to a lot of questions, majority of them being ethical in nature. Social values of people belonging to different geographical regions vary greatly which would in turn influence the decision making process.
Culture is never a constant factor. It is highly influenced by exposure to other cultures and socio-economic and political factors. It may also differ between the urban and rural population; men and women; young and elder within a geographical region. So it is of utmost importance for the sponsor and the site countries to understand the cultural differences between the two regions and attain cultural competence before making decisions related to clinical trials.
In clinical trial point of view, it is up to the participant to make a conscious decision either individually or collectively weather to take part in the study or not. Researchers are obligated to safeguard the participants’ identity, dignity and safety and to serve this purpose, two major protections are offered to the participants – Written Informed Consent and Ethics Committee (EC) review.
The first official guidelines for the formation of EC were issued by Indian Council for Medical Research (ICMR) in 1980 followed by the release of ICMR guidelines in bioethics in the year 2000. However, in spite of enactment of guidelines since then, the ethics committee in India is still confronting some issues in implementing them due to inadequate or lack of manpower, standard operating procedures and administrative support. Heavy workload and insufficient manpower also culminate into partial implementation of those guidelines.
The need of the hour is to focus on capacity building and train the members of ethics committee on bioethics, standard operational procedures and good clinical practices keeping geographical, cultural and social differences in mind. Government agencies should take the initiative of conducting training programs and workshops to the members of ethics committee as they belong to different academic and research fields. Another important step to be taken is to centralize the autonomy and maintain a track of the details consisting of a list of institutes affiliated to ethics committee, EC members along with their details such as qualifications, training records, PAN details and related approvals to ensure transparency and reliability in the regulations.
At the James Lind Institute we offer various clinical trial courses via e-learning. To know more about these programs and how they can help your clinical research career please see this link: Online Clinical Trial Courses