ETHICAL GUIDELINES FOR
SOCIAL SCIENCE RESEARCH IN HEALTH
Rights of Participants
IV.1. Relationship with the participants
IV.1.1. Participants should be seen as indispensable and worthy partners in research. Researchers should recognise and ensure that respect, protection and promotion of the rights of participants are made intrinsic to every stage and level of research undertaken by them.
IV.1.2. Research undertaken should not adversely affect the physical, social and/or psychological well being of the participants. The risks and benefits of the research to the prospective participants must be fully considered; research that could lead to unnecessary physical harm or mental distress should not be undertaken. Researchers should make adequate provision for the comfort of the participants as well as for protection against all possible and potential risks.
IV.1.3. The criteria for selecting research participants should be fair. The easy accessibility of the participants alone does not constitute a fair criterion for their inclusion in research as that will make them bear an unfair share of the direct burden of participation. At the same time, it should be borne in mind that no particular group or groups should be unfairly excluded from research, as that could well exclude them from the social understanding of their situation, and can also unfairly exclude them from direct, indirect or potential benefits of research.
IV.1.4. Unless consent on mutually beneficial arrangement is obtained, institution and student should not use community or research setting as a constant and long-term resource for data collection for curricular research or training in an institution.
IV.1.5. The relevant social, cultural and historical background of the participants should be taken into consideration and given appropriate importance in the planning and conduct of research.
IV.1.6. Researchers should not impede the autonomy of participants by resorting to coercion, promise of unrealistic benefits or inducement. Participants and communities should not be exploited and the time taken for data collection from these sources should not be inordinately long.
IV.1.7. Participants are autonomous agents and must have the right to choose whether or not to be part of the research. They also have the right to change their decision or withdraw the informed consent given earlier, at any stage of the research without assigning any reason.
IV.2. Informed consent
IV.2.1. Voluntary and informed participation of individuals or communities is necessary for research. Their participation should be based on informed consent; the greater the risk to participants, the greater is the need for it. Informed consent is essential to protect the participants, not the researchers and institutions.
IV.2.2. Consent for participation in research is voluntary and informed only if it is given without any direct/indirect coercion and inducement, and is based on adequate briefing given to the participants about the details of the project. The briefing should be given both verbally and in writing in a manner and language that the participants know and understand. In the prevailing circumstances in India, often, it may not be possible to obtain signed informed consent of the participants in social science research in health. It is however essential that the participants are furnished with written information giving adequate details of the research. Researchers have a duty to ensure that the participants comprehend the information given.
IV.2.3. The verbal and written briefing of the participants, in the manner and language they understand, should include the following details:
(i) Purpose of research: The goal and objective of research should be presented in simple local language.
(ii) Identity of the researchers: Name and address of researcher(s), the institution(s) and the main person of the ethics committee/ethical review board or any such ethics group of the institution.
(iii) Identity of others associated with the research: Name(s) and address of chief consultant(s), funder(s) or sponsor(s), etc., if any.
(iv) Why selected: Reasons or method for selecting the particular locality, community and/or any other setting; and individual(s) or group(s) within that, for participation in the study.
(v) Harms and benefits: The possible, anticipated and potential benefits and/or harms (direct/indirect, immediate/long term) of research and their participation.
(vi) Privacy, anonymity and confidentiality: Information on the extent of privacy, anonymity and confidentiality that will be provided to participant(s). This must include, at least, the firm commitment that privacy, anonymity and confidentiality of data identifying participants will be strictly maintained. In case the data identifying participants is to be shared with or made available to individuals/organisations not in the research team, information about them (their names, addresses etc.) should be provided.
(vii) Future use of information: The future possible use of the information and data obtained, including use as a database, archival research or recordings for educational purposes, as well as possible use in unanticipated circumstances, like its use as secondary data should be made known to participants. Such use should be only of anonymous or abstracted information and data, and should in no way conflict with or violate the maintenance of privacy, anonymity and confidentiality of information identifying participants.
(viii) Right not to participate and withdraw: Participants should also be informed about their right to decline participation outright, or to withdraw consent given at any stage of the research, without undesirable consequences, penalty and so on. The participants should be informed that they are free to object to and refuse to allow the use of data gathering devices, such as camera, tape recorder, etc.
(ix) Right to get help: The researcher should try and get all the possible help that the participants might require. The researcher also has a responsibility to help the participant(s) in cases of adverse consequence or retaliation against the participant(s) by any agency due to their participation in the research. Information, which may contribute to the improvement of quality of life of the participants, should be passed on to concerned person(s), official(s) or the agencies.
IV.2.4. If the data collection from the participant(s) is done in more than one sitting or contact and there is a long time period between the sittings/contacts, informed consent should be sought each time.
IV.2.5. In some cases, revealing the identity of the group of participants, groups, village(s), neighbourhood(s), etc, in the report could have an adverse effect on members/residents there. Sometimes the researchers are not able to anticipate the possibility of adverse effect at the time of conducting research and publishing reports. Researchers should take care that the study communities and/or localities are not identified or made identifiable in the report unless there are strong reasons for doing so. If the researcher(s) and institution intend to identify them in the report, participants' informed consent allowing such disclosure should be obtained.
IV.2.6. Non-disclosure of all information: In some specific situations and research issues, it is not practically possible to carry out research if all the details of the study are revealed to participants. This may be due to genuine difficulties in accessing participants, possibility of affecting change in behaviour or responses, etc., when the details are revealed. Thus, it is not possible to obtain the informed consent in the same way as described above. In such cases, the following should be done:
(i) A detailed justification for not revealing all necessary information must be provided in the research proposal and methodology and should be subject to peer and ethical reviews. Only on approval in peer review, should such research be undertaken.
(ii) The participants' right to privacy, anonymity and confidentiality gains additional importance in such cases as they do not know fully the real purpose or objective for which they provide information.
(iii) Even if through a peer review process it is accepted that some of the information about the study need not be revealed, participants must be provided the rest of the information. Under no circumstance should the researchers withhold the information regarding physical risks, discomfort, unpleasant emotional experiences, or any such aspect that would be a major factor in taking the decision to participate.
(iv) As far as possible, debriefing should be done with the participants after completion of the research, giving reasons for not providing full information. As a part of the debriefing process, it might often be necessary to provide services such as counselling and referral.
IV.2.7. Consent where gatekeepers are involved: In some situations there may be a need to obtain permission of the 'gatekeeper' to access the participants for research. The following care must be taken in such situation:
(i) Permission obtained from the gatekeeper must not be substituted for the need to take separate and full informed consent of the participants. The rights of participants in such situation are the same as in all other cases and need determined protection.
(ii) For obtaining permission of the gatekeeper, no pre-condition demanding sharing of information or data obtained should be accepted.
(iii) In the process of research or data collection, adequate care should be taken to ensure that the relationship between the gatekeeper and the participants is not jeopardised.
(iv) Greater care should also be exercised in protecting participants and their interest while publishing and disseminating results of research.
IV.2.8. Informed consent in the case of research with children (below the age of fourteen years) should be sought from the parents/guardians as well as the children themselves. Where the parents/guardians consent to participate, and the children have declined, the rights of the children should be respected. The consent from parents/guardians should be waived only in special cases such as child abuse. Peer review is indispensable and the protection of children especially from the immediate consequences of research gains prime importance.
IV.3. Privacy, anonymity and confidentiality
IV.3.1. Anonymity and confidentiality are the inherent of all participants. The right whether to remain anonymous or to be identified lies with the participant. It becomes all the more important in research projects dealing with stigmatised, sensitive or personal issues and information.
IV.3.2. Possibility of the breach of confidentiality and anonymity should be anticipated, addressed and explained to the participants.
IV.3.3. Appropriate methods should be devised to ensure privacy at the time of data collection. These methods are also essential to ensure the validity of data.
IV.3.4. The obligation to maintain privacy, anonymity and confidentiality extends to the entire research team, other researchers in the institution, the administrative staff, and all those (from or outside the institution) not directly associated with the research who may possibly have access to the information.
IV.3.5. While deciding on what information should be regarded as private or confidential, the perspective of the participant(s) on the matter should also be given adequate importance.
IV.3.6. Researchers should maintain appropriate anonymity and confidentiality of information in creating, storing, accessing, transferring and disposing of records under their control, whether these are written, automated or in any other medium.
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