India Draft Clinical Trial Guidelines Stress Consent, Privacy

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By Madhur Singh

Aug. 4 — Ethics committees for clinical trials on human subjects may have to comply with stricter norms for privacy of subjects' data if guidelines proposed by the Indian Council for Medical Research (ICMR), the apex biomedical research body in the country, come into force.

The Draft National Ethical Guidelines for Biomedical and Health Research involving Human Participants 2016 lay down procedures for a transparent and fair informed-consent process, and provide for better reporting and archiving of—and compensation for—adverse reactions.

The earlier 2006 guidelines were groundbreaking for addressing then-emerging issues such as organ transplant, stem cell research and DNA banking, and resulted in revision of legislation while providing a model for medical institutes in framing internal codes. The new draft proposes to take forward the principles already laid down, while expanding the scope of the checks and balances already provided.

The ICMR's guidelines derive legal backing from Schedule Y of the Drugs and Cosmetics Act, which requires all research ethics committees to formally declare that “notifications as per Good Clinical Practice Guidelines issued by Central Drugs Standard Control Organization and Ethical Guidelines for Biomedical Research on Human Subjects, issued by Indian Council of Medical Research” have been followed.

Privacy Provisions

Mansi Airi Gambhir, senior associate at PSA Legal Counsellors, told Bloomberg BNA in an e-mail Aug. 4 that the draft aims to build on the 2006 guidelines on five main issues: composition and role of the ethics committee (EC), informed consent process, international collaboration, norms for synthetic biology-related trials and research during humanitarian emergencies and disasters.

The draft suggests some basic qualifications for every member of the EC, and recommends that an EC must have a pharmacologist on board to look into adverse reactions of drugs over a period of time. “While enactment of a detailed pharmacovigilance code is still at a nascent stage in our country, this a welcome step towards that,” Gambhir said.

The new guidelines prescribe much broader roles and responsibilities for ECs. For instance, in addition to archiving all records for three years (and for five years when the documents relate to regulatory clinical trials), ECs would have to develop an internal archival and retrieval mechanism for every record. They also would have to develop a procedure to give regulatory bodies access to these records, while maintaining a high level of confidentiality.

Also, an investigator would have to comply with the Information Technology (Reasonable Security Practices and Procedures and Sensitive Personal Data or Information) Rules, 2011, which stipulate that any company (or person on a company's behalf) that collects, receives, possesses, stores or handles “sensitive personal information or data” of any person cannot share that information with any third party without prior permission from the person concerned.

“Further, with respect to ongoing review of projects approved by ECs, the 2016 [draft] guidelines provide that ECs must have a system of annual monitoring for each project and also ensure that at no stage do the participants have to bear the costs for the management of study-related injury,” Gambhir said. “There weren't any clear guidelines for these issues under the 2006 guidelines,” he added.

Informed Consent

With regard to informed consent—a highly contentious issue in India, where millions are illiterate or semi-literate—the 2016 draft guidelines recommend that ECs may conduct a “test of understanding” on the human subjects to ensure that they really have understood the procedures and extent of their involvement in a proposed study.

If a participant is unconscious or has lost insight (for example, due to psychosis) before the start of a study, efforts must be made to get their consent when they regain consciousness. In case of an illiterate participant, an impartial and unrelated literate person must witness the process, the consent form must be read to them in their language and the after-effects must be explained, as well as provisions for free medical management of serious reactions, Gambhir said.

Currently, sponsors and investigators have to comply with the Drugs Controller General of India's stipulation to obtain audio-visual recording of the informed consent process. The 2016 draft, like the 2006 guidelines, also recommends audio-visual recording for “certain regulatory clinical trials” and in some other cases, for instance, where the subject is illiterate.

Additional Provisions

As for foreign collaboration, the draft would impose an extra condition on research that receives funding from international agencies: it must comply with the Foreign Contribution Regulation Act. India's Home Ministry has recently used this law to crack down on international nongovernmental organizations that were critical of the government.

Also, material transfer agreements would have to be signed before any collaboration involving exchange of biological material or specimens and include clauses addressing issues such as confidentiality and intellectual property rights, under the draft.

On the controversial subject of synthetic biology—which includes genetically modified organisms, stem cells, cloning and artificial life forms that generate biofuels—the draft proposes that EC review, pre-market approval and registration should be “aimed at protection of human beings and environment.” Gambhir said, “Thus far, there is no regulatory framework on the subject.” The guidelines don't go beyond this general forewarning towards creating such a framework.

Finally, the draft specifies that for research during humanitarian emergencies and disasters, prior approval by the EC should be taken, as participants may not be in a position to give consent. At the same time, an attempt should be made to obtain participants' consent as soon as possible.

The draft is open for stakeholder comment until Sept. 15, after which the guidelines will be finalized.

To contact the reporter on this story: Madhur Singh in Chandrigarh, India, at

To contact the responsible editor for this story: Randy Kubetin at

For More Information

The 2016 draft guidelines are at

The 2006 guidelines are at

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