When a foreign institution wants access to India's biodiversity for undertaking research it is necessary to get NBA approval

What are the regulatory requirements for compensation for injury to clinical research participants? Is insurance mandatory? Do we have to give a copy of insurance to trial participant?

Indian GCP and Schedule Y cover the issue of compensation.
It is mandatory for the sponsor to pay compensation. However, the requirement for insurance does not seem mandatory.

Indian GCP requirements :
2.4.7. Compensation for accidental injury
Research subjects who suffer physical injury as a result of their participation in the clinical trial are entitled to financial or other assistance to compensate them equitably for any temporary or permanent impairment or disability subject to confirmation from IEC in case of death, their dependents are entitled to material compensation.

2.4.7.1. Obligation of the sponsor to pay
The sponsor whether a pharmaceutical company, a government, or an institution, should agree, before the research begins, to provide compensation for any  serious physical or mental injury for which subjects are entitled to compensation or agree to provide insurance coverage for an unforeseen injury whenever possible.

As per Schedule Y EC approval letter, the documents for EC review require

• Insurance policy / compensation for participation and for serious adverse events occurring during the study participation.
• Schedule Y Appendix V Informed consent essential elements require the following statement on compensation. There is no mention of insurance.
• Compensation and/or treatment(s) available to the subject in the event of a trial-related injury

There is no mention of any requirement of giving a copy of insurance to trial participant in Indian GCP, ICMR guidelines or Schedule Y. However, each subject receives a copy of informed consent documents, which covers statement regarding compensation.

One of the hospitals has two centres situated at different places in Bangalore. Ethical Committee is same for these two centres. The hospital wants to carry out same study with same study design at these two centres with two different principal investigators (PIs). List of all the investigators name including PIs are same in both the centres. This has been provided to DCGI office. The sponsor has applied for DCGI approval and with single approval, hospital wants to carry out same study in these two centres. Is it permitted?

For clinical trial approval, DCGI office requires names and addresses of the investigators, in the undertaking .

Appendix VII Undertaking by the investigator

• Full name, address and title of the principal investigator (or investigator(s) when there is no principal investigator)
• Name and address of the medical college, hospital or other facility where the clinical trial will be conducted: Education, training and experience that qualify the investigator for the clinical trial (attach details including Medical Council registration number, and / or any other statement(s) of qualification(s))
• Name and address of the Ethics Committee that is responsible for approval and continuing review of the study.

If there are two locations, the undertaking should give address of both these locations.

If the sponsor's application covers the addresses of both the centres, than the hospital can carry out the study at two centres.

To conduct a clinical research on Ayurveda medicine which is sponsored by an MNC, is it necessary to get NBA approvals, other than regular regulatory approvals like DCG(I), EC, CTRI?

Please see an excerpt from National Biodiversity Authority website:

There is no requirement under the legislation for seeking permission of the National Biodiversity Authority (NBA) for carrying out research, if it is carried out in India by Indians, as well as under collaborative research projects that have been drawn within the overall policy guidelines formulated by the Central government.

The only situations that would require permission of the NBA are:

1. when the results of any research which has made use of the country's biodiversity is sought to be commercialised,
2. when the results of research are shared with a foreigner or foreign institution, and
3. when a foreign institution/individual wants access to the country's biodiversity for undertaking research

So if an MNC is sponsoring clinical research in Ayurvedic medicine, it would be desirable to check whether the purpose of such research falls into NBA jurisdiction. If so, permission from NBA would be required before initiating clinical trials in India.