6. Biological Specimen

6.1 Provide a list of documents needed for export permit relevant to biological specimen shipment.

Please refer to Section 2.7 of this guidebook.

6.2 Does local regulation require any separate consent for biological specimen collection, storage, and future research? If yes, please explain if there are any templates and/or links to be followed.

If biological specimens are collected during the trial, this should be included in the Informed Consent form. Separate consent is not required.

6.3 Does the local authority require any specific documents for customs clearance?

Yes. An application form to request a no objection certificate (NOC) to export biological samples is required.

Any research involving the exchange of biological materials with collaborative institutions outside India must sign an MTA. The MTA must justify the purpose and quantity of the sample being collected; the type of investigation(s) to be conducted using the material; and the names/addresses of the institution(s)/scientist(s) to whom the material is to be sent. The MTA must also address confidentiality issues, data sharing, post-analysis handling of remaining biological materials, safety norms, etc.

https://clinregs.niaid.nih.gov/country/india#specimen_import_&_export