Applications for research involving human participants in lower- and middle-income countries (LMICs) may have additional ethical implications that should be considered in developing the research protocol.
Any partnership between the UK and research organisations in LMICs is expected to be fair and ethical. See our UKRI equitable partnerships guidance for more information.
Research involving human participants requires approval from an independent ethics committee in the UK. Ethical review should also be sought from an independent ethics committee in any developing country in which there are study participants. If you are struggling to obtain a UK Research Ethics Committee review, please email email@example.com.
In the ‘ethical implications’ section of the grant application form, applicants should describe any ethical implications relevant to their proposal and confirm that these are being addressed. The following is a list of ethical considerations that might arise when designing and conducting research in LMICs.
If any of these are relevant to your research and not discussed elsewhere, then you should confirm how these issues will be addressed. It is not necessary to make a statement about issues that are not relevant to the proposal.
The list of ethical considerations includes:
- research approvals: applicants should confirm that they will seek appropriate ethics review, and any other relevant approvals, in the UK and in any other countries involved. No research should start until these approvals are in place. They don’t need to be in place at the time of applying for a grant
- vulnerable groups: applicants should state whether any participants will be from vulnerable groups, justify their involvement and briefly clarify how the study design takes account of their needs. Examples of vulnerable groups might include children, prisoners, victims of violence, military conscripts, individuals lacking capacity, or disadvantaged by poverty or gender
- informed consent: applicants should indicate if there are specific considerations in relation to consent influencing their proposal, for example providing information to participants whose language has no written form, or seeking consent from community leaders as well as participants when this is expected
- managing participant care: applicants should state whether, in the design of the research, they have considered the risks of any intervention, the standard of care to be offered to participants (including controls) during the research, continuing care after the research ends and ancillary care
- information management: describe how participant confidentiality and data security will be managed, including transfer outside the developing country or sharing data in a registry. All relevant information formats should be considered, including conversations, medical consultations, written data, images, sample analyses, and research outputs. Research data management should be described in the data management plan, however specific issues can also be highlighted in the ‘ethical implications’ section of the application form
- management of biosamples or biobanks: if a proposal involves the collection or use of biosamples, then applicants should confirm that they will comply with relevant local and UK codes of practice or legal requirements. For example, this may influence arrangements for transfer of biosamples outside the developing country for analysis
- adverse impacts of the research: applicants should consider the wider impact of the research, negative as well as positive, on participants and communities and state how this will be managed. For example, this may include engagement with local stakeholders to ensure that the outputs of the research are used to benefit the local population and reduce inequity or discrimination
- public or community engagement (in the developing countries): applicants are encouraged to involve community and patient advocate groups in designing and conducting the research to increase the acceptability of the study and its findings. If preliminary engagement work has been undertaken or there are plans for future engagement, this should be stated. If all public engagement activities have taken (or will take) place only in the UK, then applicants should demonstrate that these are relevant to the developing country participant population and that consideration has been given to capacity-building in developing countries.