Should health research be undertaken solely by researchers who understand the intricacies of its methodology and ethics or can it also involve non-researchers who represent key constituencies, to enrich its design and enhance its utility? Will non-academic partners who lack familiarity with research principles create conflicts that damage the research enterprise?

Demand responsive participatory research engages researchers and key actors in clinical or public health domains as equal partners to co-produce knowledge that can transform systems and improve services. Such co-production adopts the principles of active engagement with the end users, equality of partners, reciprocal receptivity to views and mutually beneficial relationships between stakeholders. This facilitated co-production of knowledge can be transformative in nature, but the accompanying challenges should not be underestimated. [1] Even well-intended co-produced research may create unique challenges that are not only logistical but ethical, largely linked to asymmetries in power and information between research partners, or potentially divergent objectives. For instance, the research may focus on policy change that has the potential to alter service delivery and thus have impact on patients. Ethical challenges include deciding who should be considered as a researcher and who is being researched and identifying their different interests, assessing risks to patients relative to risks to health care providers or policy-makers, maintaining confidentiality while actively engaging with multiple stakeholders, and understanding who sets the research agenda and priorities. [2]

It is a challenge to reflect the priorities of health system policy makers, while appropriately accommodating the perspectives of other government agencies, civil society and the public, which may not be convergent or vary considerably in emphasis. When undertaking Health Impact Assessments of policies outside healthcare what weights will be assigned to different priorities? Will a societal perspective on health protection be given equal or higher weightage over economic gains? Whether it is the economic analyses of tobacco control measures or assessment of the impact of lockdowns and social distancing as elements of the covid-19 pandemic response on employment and wages, the divergence of perspectives among the stakeholder groups may be difficult to bridge. “Lives versus livelihoods” is a contentious debate that may disrupt multi-stakeholder engagement.  Which population groups should have priority to get the covid-19 vaccine is one such contentious issue.

Equity should also be given due weight when defining research priorities and framing the research questions. A broad engagement of community representatives can help to prioritize public interest above narrow sectoral agendas. The role of funding agencies often raises ethical concerns, both in how research questions are prioritized and framed as well as how results are packaged for policy. Engagement of diverse stakeholder groups throughout the research process, coupled with transparency, could protect against undue influence of funders.

How will a co-production process between groups with different levels of technical knowledge work to assure both scientific rigor and ethical integrity? Individuals and communities receiving health care often voice the view “nothing about us, without us.” However, engaging with them as non-technical partners can have specific ethical challenges. Conflicting interests between technical and non-technical stakeholders or a lack of mutual understanding and respect for differences could undermine productive collaboration. For example, community health workers (CHWs) may identify with and prioritise the community’s social and cultural norms over the technical elements of  protocol based maternal and child health interventions. Will that perspective be appropriately reflected while designing and conducting research, without creating bias which undermines the validity of the results? Being accountable for the health system performance, CHWs may be inhibited from  transparent reporting of implementation challenges faced. They may find it difficult to avoid projecting their cultural norms onto the analysis and conclusions. On the other hand, academic researchers may have a tendency to  project their pre-conceptions onto community practices.

Often, conventional ethical codes for research are concerned with the individual rights of human subjects, whereas a participatory research model raises the challenge of extending such rights to groups or communities. Partnering with community members may add complexity when considering ownership of data, results and knowledge sharing, especially when researching traditional knowledge and practices in health care. There are also risks of academic exploitation of community data, stigmatization of communities and violation of anonymity, privacy and confidentiality. A lack of clear distinction between the technical team leading the research and other partners engaged in co-production may pose additional challenges e.g non-technical partners may breach privacy and confidentiality without understanding their essentiality. Therefore, community researchers or health practitioners conducting focus groups in their own communities and adopting a research role need high degrees of self-awareness to maintain confidentiality. [3] Addressing these challenges requires consciously adopting an intellectually open approach which values the knowledge and aspirations of the community.  Early exercises to analyse and define the different positions of different stakeholders are vital, alongside clear policies and procedures to identify and manage conflicting interests, supported by appropriate disclosures to the ethics review board. [4] Local ethical committees, who are familiar with the context of the study, should review the study protocol rather than leaving it only to international committees who may be unfamiliar with the cultural complexities of community engagement in other settings.

Co-produced research work should respect the dignity, traditional knowledge, culture and autonomy of communities and enable non-conventional research voices in the team to contribute to research design and interpretation of results.  Transparent and deliberate reflections on the community’s socio-cultural identity should be an integral part of inquiry to co-produce such knowledge out of this research model. [5] While working with communities, especially with indigenous communities, a practice of co-developing research protocols is important. This must ensure shared ownership, control, access and possession (OCAP) of data collected from the community. [6] Ethical review boards must carefully examine whether research protocols are respecting these obligations.

As a priority, research results should be disseminated to the communities involved as well as the wider public beyond professional peer groups. Results of benefit incidence analysis of policy recommendations from the study, especially with implications for the community, must be widely disseminated. There may also be conflicts related to the extent and timing of dissemination of research findings and linked recommendations for policy and practice. Policymakers may be reluctant to publicize some negative findings even if they are willing to respond and initiate action. Community members may want to share the findings quickly among their peers and in the public domain, without waiting for a peer reviewed publication. This places the researchers in an ethical dilemma on when and how much to disclose as part of the dissemination process. Researchers can mitigate such conflicts by being aware of the potential for ethical conflicts, making the issues explicit to stakeholders and arriving at prior agreement.

Conventionally applied principles of research ethics need to be contextualised and adapted to meet the distinctive challenges of engaging multiple stakeholders in participatory research, while making such research ethically sound.  An intellectually open, predefined approach that enables broader engagement of diverse partners in the co-production and co-ownership of knowledge are key actions desirable to address ethical challenges in Health Policy and Systems Research.

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K. Srinath Reddy is the president, Public Health Foundation of India (PHFI) and formerly headed the Department of Cardiology at All India Institute of Medical Sciences, New Delhi.

Suparna Ghosh-Jerath is professor and head, Community Nutrition at Public Health Foundation of India.

Rajeev Sadanandan is the CEO of Health System Transformation Platform, New Delhi, India.

Twitter: @hstpindia @rsadanandan @thePHFI

Competing Interests: The authors declare no competing interests.

Contributions: KSR, SGJ and RS conceptualized the opinion piece. KSR and SGJ prepared the first draft. RS reviewed and edited the manuscript. All authors contributed to critique the manuscript, read and approved the final version.

This article is part of a series produced in conjunction with the WHO and the Alliance for Health Policy Systems and Research with funding from the Doris Duke Charitable Foundation. The BMJ peer reviewed, edited, and made the decision to publish.

References: 

1. Heaton J, Day J, Britten N. Collaborative research and the co-production of knowledge for practice: an illustrative case study. Implementation Science. 2016 Feb 20;11(1):20. 
2. World Health Organization. Ethical considerations for health policy and systems research. Geneva: CIOMS; 2019. 
3. Gilroy R, Holland T, Hudson K, McNulty A, Owen J, Kindon S, et al. Community-based Participatory Research: Ethical Challenges. UK: Centre for Social Justice and Community Action, Durham University; 2011 p. 13. 
4. World Health Organization, Council for International Organizations of Medical Sciences. International ethical guidelines for health-related research involving humans. Geneva: CIOMS; 2017. 
5. Gillard S, Simons L, Turner K, Lucock M, Edwards C. Patient and Public Involvement in the Coproduction of Knowledge: Reflection on the Analysis of Qualitative Data in a Mental Health Study. Qualitative Health Research [Internet]. 2012 Jun 6 [cited 2020 Jul 28]; Available from: https://journals.sagepub.com/doi/10.1177/1049732312448541
6. Moodie S. Power, rights, respect and data ownership in academic research with indigenous peoples. Environmental Research. 2010 Nov;110(8):818–20.