To describe the policies and procedures for reviewing research involving vulnerable population such as pregnant women, children below 18 years, geriatric population, prisoners, foetuses, and individuals with consent capacity impairment.
This SOP will apply to all research proposals or study in which involves the vulnerable population.
Individuals may be considered to be vulnerable if they are 6.
- 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, differently abled.
- Able to give consent, but whose voluntariness or understanding is compromised due to their situational conditions, or
- Unduly influenced either by the expectations of benefits or fear of retaliation in case of refusal to participate which may lead to give consent.
Vulnerable populations may fall into the following categories6:
- Children below the age of 18 years i.e. below the age of maturity, including neonates.
- Pregnant women or lactating mothers and geriatric population.
- Refugees, migrants and homeless population.
- Individuals with mental illness and differently abled- mentally or physically disabled.
- Economically or socially disadvantaged individuals (orphans, those below poverty line, unemployed individuals)
- Those with diminished autonomy due to dependency or being under a herierachical system (students, defence personnel, prisoners and institutionalized individuals)
- Terminally ill.
- Tribals and marginalized communities.
The key principle to be followed when research is planned on vulnerable population is that others will be responsible for protecting their interests because they cannot do so or are in a compromised position to protect their interest on their own.
17.4 Principles of research among vulnerable populations:
- Vulnerable populations have an equal right to be included in research so that benefits accruing from the research apply to them as
- If any vulnerable group is to be solely recruited, then the research should answer the health needs of the
- Participants must be empowered, to the maximum extent possible, to enable them to decide by themselves whether or not to give assent and/or consent for participation.
- In vulnerable populations, when potential participants lack the ability to consent, a LAR (Legal Advisor Representative) should be involved in decision
- Special care must be taken to ensure participant’s privacy and confidentiality, especially because breach of confidentiality may lead to enhancement of
- If vulnerable populations are to be included in research, all stakeholders must ensure that additional protections are in place to safeguard the dignity, rights, safety and well-being of these individuals.
17.5 Additional safeguards/protection mechanisms
- When vulnerable individuals are to be recruited as research participant’s, additional precaution should be taken to avoid exploitation/ retaliation/ reward/ credits, , as they may either feel intimidated and incapable of disagreeing with their caregivers, or feel a desire to please them.
- Researchers must justify the inclusion of a vulnerable population in the
- IRBs will ensure that the justification provided is satisfactory and record the same in the proceedings of the IRB meeting.
- The informed consent process should be well documented. Additional measures such as recording of assent and reconsent, when applicable, should be
- IRBs should also carefully determine the benefits and risks of the study and examine the risk minimization
- As potential participants are dependent on others, there should be no coercion, force, duress, undue influence, threat or misrepresentation or incentives for participation during the entire research
- Vulnerable persons may require repeated education/information about the research, benefits, risks and alternatives, if any.
17.6 Roles and responsibilities
- Recognize the vulnerability of the participant and ensure additional safeguards are in place for their protection.
- Justify inclusion/exclusion of vulnerable populations in the study.
- COI issues must be addressed.
- Have well defined procedures (SOPs) to ensure a balanced benefit-risk ratio.
- Ensure that prospective participants are competent to give informed consent.
- Take consent of the LAR when a prospective participant lacks the capacity to consent.
- Respect dissent from the participant.
- Seek permission of the appropriate authorities where relevant, such as for institutionalized individuals, tribal communities, etc.
- Research should be conducted within the purview of existing relevant guidelines/regulations.
17.6.1 Ethics committee
- During review, determine whether the prospective participants for a particular research are vulnerable.
- Examine whether inclusion/exclusion of the vulnerable population is justified.
- Ensure that COI do not increase harm or lessen benefits to the participants.
- Carefully determine the benefits and risks to the participants and advise risk minimization strategies wherever possible.
- For studies with vulnerable participants frequent review and monitoring or ongoing study and site visits.
- Only the full committee should do initial and continuing review of such proposals. It is desirable to have empowered representatives from the specific populations during deliberations.
- ECs have special responsibilities when research is conducted on participants who are suffering from mental illness and/or cognitive impairment. They should exercise caution and require researchers to justify cases for exceptions to the usual requirements of participation or essentiality of departure from the guidelines governing research. ECs should ensure that these exceptions are as minimal as possible and are clearly spelt out in the ICD.
- The sponsor, whether a government, an institution or a pharmaceutical company, should justify the inclusion of vulnerable groups in the protocol and make provisions for protecting their safety.
- The sponsor must enable monitoring and ensure that procedures are in place for quality assurance (QA) and quality control (QC).
- The sponsor should ensure protection of the participants and research team if the research is on sensitive topics.
17.7 Protocol review process
17.7.1 For research involving Pregnant Women and lactating mothers:
- Researchers must provide the IRB with proper justification for inclusion of pregnant and nursing women in biomedical research designed to address the health needs of such women or their foetuses or nursing infants.
- A woman who becomes pregnant must not automatically be removed from the study when there is no evidence showing potential harm to the The matter should be carefully reviewed and she must be offered the option to withdraw or continue. In case the woman opts for continued participation, researchers and sponsors must adequately monitor and offer support to the woman for as long as necessary
- Prenatal diagnostic studies – research related to prenatal diagnostic techniques in pregnant women should be limited to detecting foetal abnormalities or genetic disorders as per the Pre-Conception and Pre-Natal Diagnostic Techniques (Regulation and Prevention of Misuse) Act, 1994, amended in 2003 and not for sex determination of the
- Research on sensitive topics – when research is planned on sensitive topics, for instance, domestic violence, genetic disorders, rape, , confidentiality should be strictly maintained and privacy protected. In risk mitigation strategies, appropriate support systems such as counselling centres, police protection, etc. should be established. At no time should information acquired from a woman participant be unnecessary, hurtful or appear voyeuristic. The IRB will be especially vigilant regarding these sensitive issues.
17.7.2 Research involving children:
Children are individuals who have not attained the legal age of consent (up to 18 years). At younger ages, children are considered vulnerable because their autonomy is compromised as they do not have the cognitive ability to fully understand the minute details of the study and make decisions.
At older ages, although they may attain the cognitive ability to understand the research, they still lack legal capacity to consent. Therefore, the decision regarding participation and withdrawal of a child in research must be taken by the parents/ LAR in the best interests of their child/ward.
The IRB will assess the benefit–risk assessment to determine whether there is a need to put into place additional safeguards/protections for the conduct of research in children.
17.7.2a Children can be included in research if the situation, condition, disorder or disease fulfils one of the following conditions
- It is exclusively seen in
- Both adults as well as children are involved, but the issues involved are likely to be significantly different in both these
- Both adults as well as children are involved in a similar manner and are of similar nature in terms of morbidity, severity and/or mortality, wherever relevant, and studies in adults have demonstrated the required degree of safety and
- Test interventions are likely to be at least as advantageous to the individual child participant as any available alternative
- Risk of test interventions that is not intended to benefit the individual child participant is low as compared to the importance of the knowledge expected to be gained (minor increase over minimal risk).
Research is generally permitted in children if safety has been established in the adult population or if the information likely to be generated cannot be obtained by other means.
17.7.2b Consent of the parent/LAR is required when research involves children
- The IRB will determine if consent of one or both parents would be required before a child could be enrolled
- Generally, consent from one parent/LAR may be considered sufficient for research involving no more than minimal risk and/or that offers direct benefit to the Consent from both parents may have to be obtained when the research involves more than minimal risk and/or offers no benefit to the child
- When the research involves sensitive issues related to neglect and abuse of a child, the IRB may waive the requirement of obtaining parental/LAR consent and prescribe an appropriate mechanism to safeguard the interests of the child
- Research involving institutionalized children would require assent of the child, consent of parents/LAR, permission of the relevant institutional authorities (for example, for research in a school setting: the child, parents, teacher, principal or management may be involved).
17.7.2c Assent of the Child:
In addition to consent from parents/LARs, a verbal or written assent, as approved by the IRB, should be obtained from children of 7–18 years of age. A child’s agreement to participate in research is called assent.
If the child objects, this wish has to be respected.
Guidelines for Assent:
- There is no need to document assent for children below 7 years of
- For children between 7 and 12 years, verbal assent must be obtained in the presence of the parents/LAR and should be recorded.
- For children between 12 and 18 years, written assent must be This assent form also has to be signed by the parents/LAR. Adolescents may have the capacity to give consent like adults. However, as they have not attained the legal age to provide consent, it is termed as assent and the consent of the parents/LAR should be obtained
Content of the Assent form:
- It has to be in accordance with the developmental level and maturity of the children to be enrolled and explained while considering the differences in individual understanding. The language of the assent form must be consistent with the cognitive, social and emotional status of the child. It must be simple and appropriate to the age of the child.
- Points to be included in the assent form are as given below:
- An explanation about the study and how it will help the child;
- An explanation of what will be done in the study, including a description of any discomfort that the child is likely to feel.
- The contact information of the person whom the child can approach if she/he needs an explanation; and a paragraph emphasizing that the child can refuse to participate in the study and if she/he chooses to do so, the treatment at the centre will not be compromised.
17.7.3 Research among tribal population
- Research on tribal populations should be conducted only if it is of a specific therapeutic, diagnostic and preventive nature with appropriate benefits to the tribal population.
- Due approval from competent administrative authorities, like the tribal welfare commissioner or district collector, should be taken before entering tribal areas.
- Whenever possible, it is desirable to seek help of government functionaries/local bodies or registered NGOs who work closely with the tribal groups and have their confidence.
- Where a panchayat system does not exist, the tribal leader, other culturally appropriate authority or the person socially acceptable to the community may serve as the gatekeeper from whom permission to enter and interact should be sought.
- Informed consent should be taken in consultation with community elders and persons who know the local language/dialect of the tribal population and in the presence of appropriate witnesses.
17.7.3 Research involving individuals with cognitive impairment:
Cognitively impaired Individuals or groups include people who are without full intellectual potential (intellectually disabled, previously called mentally retarded), unconscious, suffering from a number of neuropsychological disorders such as dementia or delirium, and those who cannot fully comprehend or participate in the informed consent process, either temporarily or permanently.
- IRB will consider selection issues, privacy and confidentiality, coercion and undue influence, and risk-benefit
- Additional safeguards will be considered by the IRB to protect these subjects wherever required.
Research among individuals who have diminished autonomy due to dependency or being under a hierarchical system:
While reviewing protocols that include students, employees, subordinates, defence services personnel, healthcare workers, institutionalized individuals, under trials, prisoners, and others the IRB will ensure the following:
- Individuals in a hierarchical position may not be in a position to disagree to participate for fear of authority and therefore extra efforts are required to respect their
- It is possible for the participant to deny consent and/or later withdraw from the study without any negative repercussions on her/his
Mechanisms to avoid coercion due to being part of an institution or hierarchy should be described in the protocol.