Introduction and context

Health policy and systems research (HPSR), a critical area of public health research, aims to enhance our understanding about how health systems function and how health policies are generated and implemented. HPSR predominantly operates in “real life contexts” of communities or institutions (1). Such contexts significantly reduce the ability of researchers to exert the same level of control over their environment that is possible in biomedical/clinical research. A recent expert consultation led by the World Health Organisation, to explore the knowledge gap relevant to ethical review and practice of HPSR, recommends capacity building for local research ethics committees to deal with its complexities (2). This case presents the ethical dilemma faced by a public health researcher exploring the development of key policies governing the regulation of a specific branch of the health professions.

The case

The research aimed to analyse the policies which governed the education sector of a particular branch of health professional education in the country. This required interviewing civil servants and other officials from central regulatory agencies. The Institutional Ethics Committee (IEC) of the central institute where this research was conceived follows the Indian Council for Medical Research guidelines for ethical review of research proposals. These guidelines are predominantly governed by a biomedical/clinical research paradigm. The guidelines mandate that researchers obtain written informed consent from all prospective participants or their legally acceptable/authorised representatives, with few specific circumstances where a waiver could be sought. The researcher anticipated that most of the policy actors would not be comfortable signing a written informed consent document. However, the IEC directed that all participants had to give written informed consent prior to participation.

After the research proposal was cleared by the IEC, a key actor in the policy process was introduced to the researcher. This was a central government officer who had served for a long period in one of the central regulatory agencies responsible for major policy decisions relevant to the research. He told the researcher that he disagreed with many of these policy decisions but did not oppose them because he was just a cog in the wheel and had limited ability to initiate pressures or resist change.

The officer expressed willingness to participate in the study and share his own notes and personal research. He also consented to audio recording of the interviews on condition that he would operate the recorder himself, so that he could pause the recording in the midst of a conversation when he did not want to place the divulging of a specific piece of information on record, and continue when he wished to be on record. However, when the researcher sought his written informed consent to participate, the officer categorically stated that although he was willing to cooperate with the research, there was no question of signing any document.

The dilemma

The retired official could be a key informant to the research, since he was an important policy actor. He had expressed his interest in participating, offered to share his research and given his consent (conditional) to audio recording. His refusal was only to signing a document which, if revealed, could affect his reputation in government circles and lead to hostility from his former colleagues.

The proposed HPSR ethics framework requires researchers to consider the potential institutional reputational risks to participants and warn potential participants of this risk (2). Many retired officials get work assignments and deputations from the government. In this case, if the official’s participation in the research project became known, he could face hostility and stigma in official circles, and lose job opportunities.

In this case, the researcher’s dilemma was twofold:
• If she decided to engage with the participant without insisting on written consent, the research would be violating regulations.
• If she decided to forego his participation, she would miss gathering important insights on policy issues in her research subject.

Questions raised by the case

1. Could the researcher have conducted ethical research without doing the project injustice?
2. What alternative measures could have been suggested by the IEC in this case?
3. Does the requirement of signed informed consent uphold participants’ autonomy?
4. Should the concept of “risk” be redefined in the context of public health research