Rules make AV consent mandatory for phase III clinical trial

We have phase III clinical trial for new molecule entity involved participates with the age greater than 60 years who can read and understand. There is no condition regarding AV consent, as per clinical trial NOC for this study. Kindly guide us if we need the AV consenting for this population?
Vijay Behere
AV consent is required as per NDCTR 19. The rules make AV consent mandatory.

Please check the approval letter, which usually stipulates (vi) clinical trial shall be conducted in accordance with the approved clinical trial protocol and other related documents and as per requirements of Good Clinical Practices guidelines and the provisions of these rules.

Vulnerability is not just linked literacy. It includes many categories as per ICH Good Clinical Practices and Indian Council of Medical Research 2017 ethical guidelines. ICH Good Clinical Practices and Indian Council of Medical Research include many different categories in vulnerable group.

ICH Good Clinical Practices definition includes other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.

Indian Council of Medical Research 2017 guidance: Individuals may be considered to be vulnerable if they are:
• socially, economically, or politically disadvantaged and therefore susceptible to being exploited.
• incapable of making a voluntary informed decision for themselves or whose autonomy is compromised temporarily or permanently, for example people who are unconscious and differently abled.
• able to give consent, but whose voluntariness or understanding is compromised due to their situational conditions; or
• unduly influenced either by the expectation of benefits or fear of retaliation in case of refusal to participate which may lead them to give consent.
All patients coming to public hospital would fall in category of vulnerable as they are economically and socially disadvantaged. Many patients coming to private hospital would be vulnerable if they fall into one of the above categories.

Is it obligatory for ethics committee to share the study rejection reasons/rationale to the clinical research organization/sponsor?  
Vishal Barge
As per NDCTR 19 Ethics committee should give reasons for rejection to the investigator. The sponsor/clinical research organization can get copy of this letter. See the relevant excerpt from NDCTR 19.
Ethics committee
(v) In case an ethics committee revokes its approval accorded to a trial protocol, it must record the reasons for doing so and at once communicate such a decision to the Investigator as well as to the Central Licencing Authority (CLA).