9.Standard operating procedures to be followed by the committee for vulnerable population:
The selection of vulnerable and special groups needs careful consideration, with provisions for additional safeguards and close monitoring.
Individuals/ groups/ populations are considered vulnerable if they are relatively or absolutely incapable of protecting their own interests because of personal disability; environmental burdens; social injustice; lack of power, understanding or ability to communicate or other reasons. Individuals are considered to be vulnerable if they are:
Socially, economically or politically disadvantaged and susceptible to exploitation
Incapable of making a voluntary informed decision for themselves or if their autonomy is compromised temporarily or permanently (e.g., people who are unconscious, differently abled)
Able to give consent, but their voluntariness or understanding is compromised due to their situational conditions
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.
Researchers must justify the inclusion/exclusion of a vulnerable population.
Additional precautions should be taken by all stakeholders such as researchers, the Ethics Committee and sponsors to avoid exploitation of vulnerable participants.
Informed consent process should be well documented and additional measures adopted if required, such as audio-visual/audio recording of assent/consent/reconsent.
Research proposals should undergo review in a full committee meeting.
Protection of privacy and dignity as well as provision of quality health care is required in dealing with vulnerable people, especially minorities.
Research involving children, in addition, should follow the National Ethical Guidelines for Biomedical Research Involving Children, ICMR, 2017.
Due approvals are needed from competent authorities before entering tribal areas.
Research involving cognitively impaired individuals or those with mental illness must be done carefully, especially if there is a risk to themselves, to others or suicidal ideation.
The EC should carry out the benefit–risk analysis and examine risk minimization strategies.
