This section provides guidance on the regulations and approvals that may be required for specific types of research.
If your research will involve human participants, their biosamples (tissues) or data, then you should consider and address any relevant ethical issues in your application.
The following lists some common considerations for research involving people as participants, their biosamples or data. If any of these are relevant to your research, and you have not already covered these in your application, then please confirm how you intend to address them:
- benefits and risks: you should describe the nature and extent of any benefits likely to come from your research and outline how you will mitigate any risks (such as risks to the safety, dignity, rights or wellbeing of participants, potential participants, and staff working on the study)
- consent for research: appropriately informed, voluntary consent is the most common way to recruit human participants into research. You should indicate whether there are specific considerations in relation to consent in your proposal. Learn more on consent for research
- information management: your data management plan (please see paragraph 2.2.7) should describe how participant confidentiality, data security and any data sharing will be managed
- management of biosamples or biobanks: if you will access biosamples for your research from a biobank, then the biobank should review and confirm the feasibility of your sample access request, prior to the submission of your application for funding. You should also work with local contacts to ensure appropriate transfer and storage arrangements will be provided. Learn more in using human samples
- patient and public involvement: you are encouraged to consider how to involve patients or the public, or both, in developing your research. If preliminary engagement work has been undertaken or there are plans for future engagement, these should be stated in your application. Learn more about patient and public involvement
- ensure research outputs reflect diversity in society: to ensure that research brings fair benefits to all in society, it is important that the participants, proposed analysis and outputs from your research reflect the diversity of the population that you are studying. Learn about MRC’s expectations on the inclusion of both sexes in experimental design.
MRC has the following expectations when your research involves people as participants, their biosamples or data:
- you must comply with all relevant regulatory, policy and ethical requirements. Whilst your research organisation is responsible for ensuring compliance, you have a role to play (for example, in securing the relevant approvals or sponsorship, or both). For further guidance, please visit your local research office
- you should comply with relevant MRC policies and guidance. This includes open research policies that promote sharing of data, samples, materials, reagents, code and more
- your research should not start before the necessary approvals are in place. Approvals do not need to be in place at the time of applying for a grant.
You can find further guidance on requirements that may be relevant to your research below. You can also seek guidance and advice, to help you understand specific requirements for your research, from the MRC Regulatory Support Centre.