(adapted from 2017 National Ethical guidelines for Biomedical and Health research involving human participants, ICMR)
The context of health research using social and behavioral sciences methods is often different from typical clinical, biomedical and public health research. Many of these research initiatives are relevant in the mid to long term for knowledge production, science and society besides relevance for refinement of policies, projects and programmes development. Such research efforts will also have scholarship value, providing a deeper understanding of explanatory factors. Moreover, social science research informs policy-making activities about the various facets that can be considered to ensure that social equity and intersectionality of populations are accounted for. Social and behavioral sciences include, but are not limited to, anthropology, sociology, psychology, philosophy, political science, economics, history, communications and education etc.
Community behavioural studies on cultural and geographical contexts are conducted before introduction of new interventions and refinement of existing regimes and policies. To be judicious and ethical in understanding and assessing human behaviour, the details of symbolic communication of culture, which includes a group’s skills, knowledge, attitudes, values and motives, have to be first understood as they influence a participant’s response to research. In the Indian context, ethical relativism is evident due to multi-varied – religious, caste, class, endogamic, gender and geo-ethnic variations which are important characteristics of society that need to be considered in socio-behavioural research proposals. In view of the above, Ethical Committee (EC) should be aware of the challenges that may be encountered in the process of conducting such studies.
Emerging social science research on health care emphasizes the importance of bringing contemporary contexts to bourgeoning biomedical and health research. It has now emerged as a cross-cutting area of enquiry relevant to different type of medical, biomedical, clinical and health research such as clinical trials, epidemiological research, programme evaluations, implementation research, genetics, and research on disaster and conflict contexts. The principles of social science research ethics, with rights and responsibilities of the different stakeholders including participants, researchers, reviewers, publishers, etc., are similar to those for biomedical and public health research. There are, however, specific ethical issues involved in social and behavioural sciences studies as given in the box below
- Risks are non-measurable and dynamic in nature and therefore might be misconstrued as no/minimum risk research.
- PI’s obligations related to data sharing, incidental findings and post-research benefits to the study population would need to be reviewed by the EC on a case-by-case basis, and prior approval from the EC should be obtained for any exemptions.
- What would constitute ancillary care during such research needs to be carefully considered on a case-by-case basis by the EC.
- As part of the research protocols, socially, legally, medically and technically unacceptable practices and behaviour may be discovered, documented, or observed. While researchers are not required to interrupt such behaviours to determine the truth, they must document these in the research findings and appropriately disseminate the findings for the larger social good.
- While maintaining the privacy and confidentiality of the respondent’s identity, researchers have an obligation to report the extent or the patterns of behaviour, such as suicidal tendency or infanticide, to the concerned authorities.
Risks are often non-measurable and dynamic in nature and therefore might be misconstrued as no or minimum risk research. Principle Investigator’s (PI’s) obligations related to data sharing, incidental findings and post-research benefits to the study population would need to be reviewed by the EC on a case-by-case basis, and prior approval from the EC should be obtained for any exemptions. What would constitute ancillary care during such research needs to be carefully considered on a case-by-case basis by the EC. As part of the research protocols, socially, legally, medically and technically unacceptable practices and behavior may be discovered, documented, or observed. While researchers are not required to interrupt such behaviours to determine the truth, they must document these in the research findings and appropriately disseminate the findings for the larger social good. While maintaining the privacy and confidentiality of the respondent’s identity, researchers have an obligation to report the extent or the patterns of behaviour, such as suicidal tendency or infanticide etc., to the concerned authorities.
Ethical challenges are more pronounced in collaborative research (national or international) due to possible inequity of expertise and knowledge access between partnering institutions and researchers, and funding relationships. Appropriate experts/expertise of EC members in the social and behavioural sciences domain is an essential aspect to address the above challenges.
FIELD ETHICAL CHALLENGES
In addition to adopting sensible and effective methods, design and conduct of the study is important for a meaningful outcome in social and behavioural research.
- Rapport establishment
Social and behavioural researcher should ensure that the proposed site is feasible for scientifically sound study. The study should be built on an adequate prior knowledge base, and with scope to generate valuable information leading to more sensitive policies and programmes. In socially stratified groups and communities, researchers must be sensitive to establish rapport and become conversant with cultural norms and practices in order to develop strategies to build trust and negotiate power in ways that do not put research participants and the study at risk.
In some types of research within communities, appropriate interpreters would be required. They need to be carefully selected, keeping in mind the social dynamics and the hierarchies existing in the context. A local person from the same village in which the research is to be conducted should not be used as an interpreter. Instead, an interpreter should be chosen from some other nearby village so that her/his vulnerability and perceived threat from other participants is mitigated. Institutions should develop or have SOPs for handling deteriorating situations, including a pre-tested communication plan.
- Data Collection
The information about norms and practices should be collected from unbiased, authentic, reliable and multiple sources including multiple persons/ groups, which should be mentioned in detail. This knowledge should be considered while deciding the group of participants and style of interview/ investigation. However, the final decision about recruiting the participant should be based on the participant’s and her/his family’s opinion about norms/practices. These issues become particularly pertinent in cases of research that involve patriarchal or restrictive communities.
- Fieldwork challenges
Training should be given to the researcher(s) to meet unforeseen challenges. Situations such as trauma, humiliation and threats of violence are often reported from research fields.
ETHICAL COMMITTEE REVIEWS
Social and behavioural sciences research often unintentionally attracts unique ethical dilemmas which need to be considered by the EC on a case-by-case basis.
Social and behavioural sciences research approaches are not always positivist and, therefore, articulation of a hypothesis may not be possible at the beginning of the research. Instruments/ documents are developed during the course of the research; are reflective; and may keep changing as the research progresses. The EC must be kept informed about these changes and appropriate re-consent taken from participants. There searcher must take prior permission from the EC with justifiable reasons for audio/video recording of participants’ interviews.
PARTICIPANT’S RISK ASSESSMENT
Participants of behavioral and social science research face the potential of being exposed to significant and unique harm which may not be limited to physical harm. The researcher(s) and EC must recognize the cultural context and associated harm related to dignity as well as social and informational harm. This will avoid hurting or transgressing rights of the participants/community. Harm to dignity is likely to occur when individuals are not treated as persons with their own values, preferences, and commitments, but rather as mere means not deserving of respect. This is also sometimes classified as another form of negligence. It may result in individuals feeling hurt, humiliated, excluded, dismissed or unfairly treated.
Psychological and emotional harm may result from participating in a study where memories of traumatic experiences such as disasters (natural or otherwise), violence, conflict, abuse, assault and other such conditions need to be revisited by the participants. This may also affect and compound the vulnerabilities of participants already experiencing post-traumatic stress disorder (PTSD). Social harm is a non-medical adverse consequence of study participation, including difficulties in personal relationships and stigma or discrimination from family or community. Social harm can be related to personal relationships, travel, employment, education, health, housing, institutions (government/non- government) and others.
It is the potential for harm from disclosure of information about an identified research participant to others. For much of social and behavioural research, informational risk is one of the primary risks.
- Risk Mitigation
Measures should be employed to minimize potential risks and their negative impact, such as short- and long-term adverse impacts on participants of studies on abortion, sexual abuse and other sensitive subjects. These measures should be incorporated into research methods, with special reference to hierarchies that exist in the social context where the research is undertaken.
- Community Engagement
While devising methods and interpreting observations, researchers should engage potential participants and communities in a meaningful participatory process that involves them in an early and sustained manner in the design, development, implementation and monitoring of research, and in the dissemination of its results.
- Informed Consent
Human participants in a proposed research study must be informed about the nature of the research project, and researcher(s) must obtain their voluntary informed consent prior to their participation in the study. Legal guidance/ guardians involvement for special categories needs to be followed and informed consent obtained from the same.
- Community consent/ gate-keeper consent/ individual consent
Individual informed consent has to be taken after obtaining permission of gatekeepers, such as community/ religious heads or leaders/ culturally appropriate local authorities/ healthcare providers/ institutions or organizations responsible for community welfare or their appointed advocates. Consent procedures must respect local cultural customs; however, community traditions do not substitute for individual consent unless a waiver has been granted.
- Participant consent
Researchers must develop culturally appropriate ways to communicate information necessary for adherence to the standard required in the informed consent process.
SELECTIVE WITHHOLDING OF STUDY INFORMATION:
ECs may permit selective withholding of information/ hypothesis of the study in the consent form for achieving overall social and public good, without influencing the outcome of the study. On completion of the research, the participants should be de-briefed, if applicable.
- Safe Exit (Participant Refusal)
Researchers should be alert to cultural symbols of refusal, such as body language, silence, mono syllabic replies, or restlessness that communicate discomfort. Often the power differences between participants and researchers in India make it difficult for people to explicitly refuse to participate. They must not persist with the research under these circumstances but rather give opportunity for a safe exit.
- Relational Autonomy
Right to autonomy must be understood in relation to substantive equality of opportunity, sufficient social support and conditions for self-respect. Individuals are socially embedded where in the person identity is is shaped by social determinants, such as caste, class, ethnicity and gender. Therefore, the participant may not be autonomous in decision making. Accordingly, concerns about social justice must be central to any adequate conception of individual autonomy. The EC may take into account this context with due diligence regarding the vulnerable status of prospective participants during review, for example, a woman asking her husband or family before giving consent.
- Waiver of Informed Consent:
If the research has important social and public health value and poses no more than minimal risks to participants, the EC may waive the requirement for individual informed consent. Additionally, waiver may be granted if the EC is convinced that the research would not be feasible or practicable to carry out without a waiver, for example, research on harmful practices.
- Privacy and Confidentiality
Privacy and confidentiality of research participants should be considered while selecting sites for data collection, choosing sensitive research areas, specific contexts and settings. In some circumstances participants become more vulnerable in research because of heightened psychological, social, physical or legal risks. Breach of confidentiality in these types of research may cause serious harm to vulnerable participants. It is important to protect study participants from potential future risks and harm by establishing culturally sensitive and context specific safeguards.
- Duty to Disclose Sensitive Information
Researcher(s) may at times come across certain facts detrimental to a participant’s self or others, such as suicidal tendency/ ideation, notifiable diseases. In such a situation, researchers have a responsibility to disclose this information to relevant persons/ authorities to save life or prevent damage contemplated by the participant. Measures to be taken in such instances are given below: If there is a high likelihood of getting sensitive incidental findings during the research process, then the ways to handle these at individual, family and community levels should be discussed and mentioned in the protocol.
Researchers and the EC should have a basic understanding of the legal provisions in the related area. Persons with the necessary domain knowledge and experience can be special invitees to EC meetings.
- Studies Using Deception
Deception occurs when researchers provide false or incomplete information to participants for the purpose of misleading them so as to achieve the study objectives and for larger public good. Research employing any type of deception should undergo full committee review.
Research involving any kind of deception should:
- Pose no more than minimal risk;
- Not adversely affect the welfare and safety of the participants;
- Be conducted only when the research cannot be carried out without deception;
- Have an adequate plan for debriefing the participants after completion of the study, if appropriate;
- Disseminate results of research to the participants, if applicable; and be carefully reviewed by the EC.
- Active Deception
Selective withholding of the information/hypothesis of the study in the consent form along with giving incorrect information for achieving public good without influencing the outcome of the study, for example, psychology, neuro- behavioural, behaviour intervention study.
- Incomplete Disclosure
It is a phenomenon where research involves incomplete disclosure but no deception.
- Authorized deception
Unlike inactive deception, participants are informed that they would be deceived prior to the research but the nature of the deception will not be disclosed or research will not be described accurately or some procedures will be deceptive. Such revelation provides the participants an opportunity to decide whether or not to participate on these terms.
- Safety of Participants
Support systems, such as access to counselling centres, rehabilitation centres, police protection, etc., should be in place when research is on a sensitive issue, such as mental health, gender based violence and social exclusion and discrimination.
- Safety of Researcher(s) in the Field
The safety of the researcher(s) is the responsibility of the institution, sponsors and local authorities, particularly in research on sensitive topics or in sensitive research settings since disturbing instances while conducting the research. Besides providing safety, including insurance coverage, and giving training to the researcher(s) to meet such challenges, setting up community advisory boards could be helpful to ease the situation.
Unlike quantitative interpretation, the knowledge gathered through qualitative research is interpretative based on the observation and its analysis by the researcher(s) which is socially constructed at individual and socio-cultural levels. Informed consent is very often dynamic in nature and negotiable. When written consent may not be possible, other means could be used and documented.
The EC may look at issues that pertain to the design involving researcher–participant relationships, informed consent process and conduct of the research. Preliminary activity of observation for preparing notes, before actually initiating research based on the observation, need not be submitted for EC’s review. However, any ethical issues arising even during that preliminary phase, before actual collection of data, should be included in the research proposal for review by the EC.
In some observational research the EC may approve waiver of consent, provided mechanisms for maintaining privacy and confidentiality are justified. In collaborative research, it is desirable to establish a rapport with the community to be engaged in research through the gatekeepers or community advisory boards. Sharing raw data and notes with repositories, researchers, peer community, institutions, and funders is increasingly becoming a requirement for transparency in research. Sharing raw data including audio-visual material should protect confidentiality of the individual and research setting by sufficiently processing data to mask identifiers before sharing.
Researchers have a duty of disclosure to share research findings in aggregated form and relevant information in a user-friendly format with community leaders, gatekeepers and communities without disclosing individual identities. They must also share these findings and relevant information with the participants.