Additional training topics suggested were: Legal aspects of trials Compensation Structure/design of study documents General understanding of the patient population visiting the site in terms of literacy/culture/socio-economic thoroughly status Appropriate methods for consent process. Contribution of lay person in ethics committee About two thirds of the responders (23) opined that the lay person is unable to contribute adequately in the EC meetings. Some of the perceived challenges for the lay person were: a) lack of medical/technical knowledge to keep pace with and decipher the discussions; b) diffidence to speak and too many power centers in the meeting to overturn his/her voice; c) the lay person is unaware about the importance of his/her role; d) role of the lay person is considered more so for the sake of meeting quorum; and e) inadequate exposure or training on clinical research, human rights, and compensation.

Informed consent process The responders shared their thoughts [Table 3] on the current informed consent process on a set of given parameters. Majority felt that the subject is offered the opportunity to ask questions and is able to refuse participation in clinical research, and also favored the need to record the consent process. Table 3 Informed consent process in India (n=34) Steps suggested to improve the consent process were: a) improved awareness to be created among the patients, society and medical fraternity on the need for clinical trials and patient’s rights; b) the EC or an independent committee or a patient research advocate should interview the subjects randomly or monitor the consent process; c) the audio-visual recording of the consent administration process may bring transparency, however this method should be considered more so to sensitize the researcher than to do policing; and d) the consent form to be simplified and include pictorial images for better patient understanding.

Adequacy of regulations to safeguard the clinical trial participants Of 34 responders, 18 expressed satisfaction with the current regulations, 15 opined that regulations are inadequate, and one did not opine.

The respondents, satisfied w ith the current regulations, felt that the following can be further improved: a) Brefeldin_A regular site inspections by authorities and publishing critical findings for public access; b) more transparency in publishing trial outcomes; c) clarity of guidelines for reimbursement and alternative treatment; d) accountability of the investigators to hospital administration; e) appointment of a supervisory body for trials; f) education on implementation Seliciclib of regulations; g) intermittent regulatory oversight (e.g. meeting the subjects); and h) inspections of all stakeholders with appropriate warnings/sanctions/penalties for non-compliances.