Research Ethics in the context of Participatory Action Research on Vaccine Hesitancy

COVID PAR Discussion Note 2 Dated September 23, 2021

Ethics of Participatory Action Research on Covid Appropriate Behaviour and Vaccine Hesitancy

Praxis has been organising a Participatory Action Research on Covid appropriate behaviour and vaccination hesitancy since August 2021. As part of the research, a community fellow is provided training on key issues concerning Covid and vaccination; encourage her to form a four-members group in her hamlet, which collects information on vaccine uptake and reasons for uptake and non-uptake. An indicative participatory toolkit was prepared; and community fellows were trained on facilitating the toolkit (Annexure 1). Post piloting in one district, a round of discussion was organized with PAR researchers. (Details in Discussion Note 1)

Interestingly, community participants had a number of questions that largely belonged to the domain of ethics. A community member, actively into action research, asked, “What if an unconvinced person vaccinates herself based on our action research process; and she suffers medical problems?” When we explained, “The success of vaccination efforts lies in everyone vaccinating. Even if a few people remain vaccinated, the chances of pandemic to survive is high”. Another field researcher asked, “Is vaccination important for the individual’s well being or is it to protect a society as a whole or is it both?” In other words, is universal vaccination needed for greater common good? Does it mean certain individuals have to get vaccinated even if they are not convinced? Is this ethical? Similarly, one another community volunteer remarked, “As part of vaccination campaign, can we tell a community member that if you do not vaccinate you would not be able to access certain entitlements?” As a research team, are we subscribing to this practice of the government and businesses? Are we saying that compromising on human rights in the name of safety for the society is fine? What are the ethics that should govern these research actions? Are we not on the wrong side of ethics?

COVID, the disease; how it spreads; Vaccination and its way of functioning, significance of that to human health; potential risks of the vaccination; and overall benefit of the vaccination: these are the topics that we covered in our dialogue with community fellows. An experienced doctor with understanding of social inequalities anchored the discussion. Often, when doctor speaks, there is pin drop silence. It often seemed that everyone is convinced. However, many ethical questions, stated above, were not bio medical, but social and political. The silence when doctor speaks does help us understand that in a health research, the knowledge pertaining to bio-medical aspects of the health is very specialised for any ordinary person to fully comprehend, good enough to engage in a longer conversation. Often these conversations reduce to Q and A framework, wherein Doctors reply to all questions that are related to science of the issue. In other words, the narratives of problems belong to communities, whereas the narratives of solutions often rest with Doctors. Hence, in a health research, it is often expected from respondents to become merely ‘subjects’ of study. Respondents from poorer communities are often seen as passive information providers of their problems; but their very presence in the study is ‘claimed’ as their participation.

On the other hand, a participatory research seeks consented as well as active participation of communities in the study. A participant would know the objective of the study and how their information would be used. Often the participant is expected to engage with other participants in conversation and together plan for some action on the issue. Moreover, when Participatory research pertains to health, the communities are ‘participating’ in a venture, which could even make them vulnerable to health-related harms, which are often irreparable. Therefore, the ethics of participatory research on vaccination related issues need to be defined to prevent a scenario where a research team feels that (a) participants have consented to the process; and (b) participants even have engaged in action during the research, therefore there is complete consent of the participants. What is important from the lens of ethics is whether consenting to a study by participants reduces the responsibility of the research team in anyway? What would be the ethics in this regard? An active participant in a PHR makes herself the face of research among other participants in the hamlet; and therefore has a greater vulnerability of accusation by participants, if the latter gets affected by any research outcomes?

Discussion Note 3 Dated September 26, 2021

Institutional Review Boards and Participatory Action Research on Health related issues

Has our ethical review processes geared to these principles of PHR? In many organisations, the Institutional Review Boards (IRB) over the years has surely evolved into an institution by themselves. Their approval process is well systematised. The significance of an IRB is that it has an ocean of experience on looking at the ethics of research over many years. This gives IRBs a comparative advantage over the research team in terms of knowledge of dos and don’ts related to ethics. However, in the context of paradigmatic shift that PHR is trying to attempt over the otherwise mainstreamed conventional research, one needs to keep in mind that the standard ethical procedures would not have evolved to understand the ethics intrinsic to PHR. Further, a research team believing in Participatory Research would often condescendingly dismiss these IRBs as sub-evolved. The danger is that non-understanding of ethics of participatory research by IRB would cost the important oversight role that IRBs play in challenging the research team from the lens of ethics. There is no reason to assume that PHR team would be more conscious of ethics than the conventional health researcher. In fact, there is need to assume the other way round, for ethics is often an inadvertent casualty in the passion of research team to foster participation of communities in the research.

No doubt, Institutional Review Boards continue to have a very significant role. They have made a number of decisions in the past that influence research designs, being developed by the research team, from the conceptualisation stage itself. For example, some researchers would dismiss a research method prematurely thinking that IRB would not approve it. “Let us not make children facing mental health issues owing to sexual abuse part of the study; there would be unnecessarily a number of questions from the IRB.” The IRB thus already resides in the minds of researchers. On the other hand, some ‘powerful’ researcher would say in a whispered way, “let us go ahead. We will manage the IRB.” The irony of IRB is that at one time it appears as all-powerful no-nonsense guardian of ethics, which is even not open to new approaches; and at other times it appears as very vulnerable body of people.

An Institutional Ethics Review Board, therefore, has three faces: firstly, the face of the Institution, it belongs to, that is, its primary aim is to protect the reputation of the institution it is affiliated with; secondly, the face of ethics, that is, it guards ‘ethics’; it constantly defines ‘ethics’; over the period of time through precedents it would have set certain benchmarks, standards and norms related to ethics, especially around the need to protect research participants and researchers; and thirdly, the face of human-ness, that is, it is dialogic; it evolves; it negotiates; it is often overcautious; and that it does make mistakes, and is also vulnerable to power politics among researchers and departments.

In this context, the role of Participatory Health Research team is: (a) To be conscious of ‘ethics’ from the conceptualisation stage itself, knowing very well that potential oversight role played by IRB is still evolving; and (b) To be advocate of participatory approaches, even in evolving ethics of a research. Some of the suggested good practices that a participatory health research team should follow are: –

(a) Challenging the Stereotyping of IRBs: The research team may document its imagination of IRBs on what ethics IRB stands for. The document need to clearly state how the research team feels the way IRB generally defines ethics, which is often based on own past experience of engaging with IRBs or based on others experiences. Many a times, this imagination could be based on a false premise; hence there is a need to consciously write and articulate the same based on evidence. This document would be very useful for IRBs during the review process because often IRBs engage with what is present in the research design; it would never be able to see what could not become part of Research design because of IRBs past decisions or imagined stereotype. As a step 2, the research team may map its own agreements and disagreements with IRB’s (imagined) opinions, with reasons. This would help research team challenge its own understanding as well. This dialogic document would be useful for IRBs in the later stage to frame its arguments.

(b) Making Voice of Communities Count in defining Ethics: The research team may create and engage with Community-led ethical review board to understand the opinions of communities who are going to be part of the study; to understand the way communities define ethics and the kind of recommendations they make for overcoming ethical challenges. Often IRBs and research team engage in two-way power relationships. The community led ethical review board brings the third dimension in the power relationships. Of course, it is not to say that voice of CLERB would matter more than others. It is primarily a platform to ensure that their voices count.

(c) Mapping Power Relationships among stakeholders in terms of their individual identity and collective identity: The research team maps the stakeholders that the research would benefit or would harm, with clear rationale. While mapping the same, it should keep in mind that the research does not mean merely the data collection process. The ‘research’ includes steps taken during the very process of development of research design; and the way different stakeholders go on to use the end research product. Similarly, the harm need not be just seen as harm to individuals alone (for example, women named Lakshmi, Mary or Asiya) but also to the community as a whole (Residents of ABC) and to the community’s political identity (for example of being Dalits, Black or indigenous tribes).

(d) Reflecting on Local cultural Practices: A number of activities of researchers appear as ‘not scope of the study’ or ‘non-negotiable local cultural practices’. There are certain activities by researchers, which do not even have the luxury to be called as research activity. The research team would need to map even those actions of researchers, which are not conventionally part of the research design or activity but part of the so-called local practice; as often certain deeds could actually perpetuate certain discriminatory practices. (For example, as a practice, sometimes research team provides dolls and car-toys to girls and boys respectively as gifts after a group discussion with them.) The domain of health that is being studied need not be independent of these social practices. Further, it may be important to understand that a Participatory research is research for researchers but for participants it is a living space and looking for opportunities to confront discriminations they face. These discriminations often reside in these local practices. By denying our participants the space to challenge local practices may put our research in the wrong side of ethics.

(e) Solutions to ethical dilemmas also need to be subjected to ethics: The research team needs to put certain conventional recommendations that often come from IRBs into microscope. Many a times, these solutions would have become so routinized that often they lose the purpose for which the solutions were framed. For example, the purpose of consent letter that research teams seek from participants is to ensure that the researchers provide complete details of potential harms to the participants and their consent is obtained in an informed way. However, often consent letter has become the means to pass the responsibility of harm to participants, stating that the latter have consented to the study! Similarly, the research participants having taken the participation fee are seen as having been paid for their participation and that they have voluntarily consented to the process. The fee is for their opportunity cost and not any solution to address any ethical dilemma. The Ethics is about whether transaction has been organised in an ethical way; ethics itself cannot be reduced to a transaction. The research team needs to comprehensively articulate how the solution offered would not further disempower the participants.

These practices would help the research team in engaging with Institutional Review Board with multiple objectives: (a) to ensure IRB plays a significant oversight role from the lens of ethics, and thus learn from its experience; (b) to educate IRB on the contemporary shifts in participatory research and how that needs revisiting certain standard procedures of IRBs; and (c) to make voices of communities count in the Institutional Review Board processes.