We value and support research involving human participants. It’s essential for understanding the factors underpinning health and disease and assessing the safety and effectiveness of biomedical and social interventions.
All researchers and organisations we fund must comply with the guidelines outlined on this page.
Wellcome will fund research involving human participants that:
Where there is no immediate sustainable health benefit, researchers must take extra care to make sure that participants understand the purpose of the research.
Researchers based in high-income countries, who are carrying out research in a low- or middle-income country, must explain why they have chosen this location.
This policy should be read alongside our policies on:
We use the World Health Organization(opens in a new tab) (WHO) definition of ‘research with human beings’:
'any social science, biomedical, behavioural, or epidemiological activity that entails systematic collection or analysis of data with the intent to generate new knowledge, in which human beings:
i) are exposed to manipulation, intervention, observation, or other interaction with investigators either directly or through alteration of their environment
ii) become individually identifiable through investigator's collection, preparation, or use of biological material or medical or other records'.
These requirements are set out in more detail below.
Wellcome is governed by UK law. The legislation supporting this policy relates to work carried out in the UK. We expect researchers to use similar standards and principles for any research outside the UK.
The rights, safety and standards for research design and conduct are governed by the:
Researchers must follow these guidelines.
Researchers and organisations must ensure that they take all reasonable means to prevent harm, exploitation, abuse and harassment occurring because of their work. They must protect people, especially children and vulnerable adults, from that harm and respond appropriately when harm does occur. They must have policies and processes in place for this and should tell participants about them, so they know how to report any concerns.
Researchers and organisations must ensure they take all reasonable means to prevent harm, exploitation, abuse and harassment occurring because of their work.
Researchers must comply with all relevant legislation relating to data, biological samples and ethics.
The Data Protection Act (DPA) 2018 is the UK law that reflects the General Data Protection Regulation (GDPR). Together they:
The DPA and GDPR only apply to personal data – they don’t apply to:
Data that has been pseudonymised is still personal data under GDPR. For more guidance, see the UK anonymisation network decision-making framework(opens in a new tab).
For more information about what GDPR means for research, read the:
Researchers must comply with the duty of confidentiality. An example is the clinician-patient relationship – patients expect information collected as part of their healthcare to be kept confidential.
To uphold the duty of confidentiality (regardless of whether consent is the legal basis for processing data under GDPR), researchers must:
or (if based in England and Wales)
Researchers must have appropriate safeguards in place to make sure that data from research participants is kept confidential and secure. Safeguards can include anonymisation techniques.
Read the MRC guide on using information about people in health research(opens in a new tab) for more information about the duty of confidentiality.
All researchers must tell us in their grant application how the tissue or data will be collected, stored and made available for access, subject to suitable safeguards.
In England, Wales and Northern Ireland, researchers using human biological samples must comply with the Human Tissue Act 2004(opens in a new tab).
In Scotland, researchers must comply with the Human Tissue (Scotland) Act 2006(opens in a new tab).
Details of UK legislation that researchers must comply with are on the MRC human tissue legislation summaries website(opens in a new tab). This includes help to identify:
Researchers based outside the UK must tell us in their grant application what the law and guidelines are in the area/jurisdiction in which they will be collecting samples, and how they will comply with these.
Before research begins, researchers must have in place:
Researchers must tell us in their grant application:
Ethical approval is not required when the grant application is submitted, but researchers must have:
Wellcome doesn’t need to see approval documents, but we reserve the right to see them at any point during the grant and after it has ended.
We won’t fund research where there are unresolved disagreements between ethics committees. Researchers must tell us about any disagreements.
Researchers can ask for the costs of the ethical review process in their grant application if the:
We will only pay the actual costs of the ethical review. We will not pay a percentage of the total cost of the grant.
Where research is expected to run for a number of years (for example in cohort studies), researchers must make sure that measures are in place to maintain continuing ethical oversight for the lifetime of the grant. For example, using an oversight committee with members who are independent of the research.
Researchers can ask for the costs of using an ongoing oversight committee in their grant application.
If we have any ethical concerns about a grant application, we reserve the right to send it to independent experts for review. They may be experts in ethics, research or any other relevant field.
We will do this before we make a funding decision.
Researchers must get ethical approval from an alternative source. This could be an inter-governmental organisation, for example the Science and Ethical Review Group at the WHO.
The host organisation must be satisfied with the procedures and quality of the ethical review.
Researchers must comply with any obligations that their host organisation might place on them. This could include dual (or even multiple) ethical reviews of the research.
Researchers must get consent from:
Researchers don’t need to get consent if they will be using data that is routinely collected (see Confidential patient data section).
We will consider funding emergency research where a person’s ability to give consent is compromised or not possible. This is provided that the research protocol:
Where appropriate, researchers should tell the public that these studies are planned or in progress. This information should be:
Researchers must consider possible appropriate future uses for the data when they set up the study and design their consent processes to accommodate this. If the opportunity to use data in a way that wasn't anticipated arises while the study is still in progress, researchers must:
Consent processes for completed studies may not have considered how the data generated could be used in the future.
Where this is the case, samples and/or medical data may be used for other purposes without going back to the participant for specific consent. This is provided that the proposed research:
Researchers must understand the ethics of research involving people.
Any Wellcome-funded researchers using samples or participants must have research ethics training that is appropriate for:
We reserve the right to see evidence of appropriate training at any point during the grant and after it has finished.
Where it's planned that samples will be removed from the country in which the research is taking place, researchers must:
For more information on import and export under the Human Tissue Act 2004, see the Medical Research Council (MRC) Regulatory Support Centre website(opens in a new tab). We expect researchers based outside the UK to use this guidance, where possible.
Researchers should tell participants about any health-related findings that affect them if:
Researchers can ask for costs incurred in telling participants about any health-related findings.
Wellcome will not pay healthcare costs incurred if a participant acts on that information.
Our Framework on the feedback of health-related findings in research [PDF 422KB] helps researchers identify and consider the relevant issues when designing and implementing a policy on the feedback of health-related findings.
Community consultation is a key benchmark of ethically conducted research. Researchers must consider how to maximise community involvement in their research.
This can include working with the community as co-creators to form the research question and design the programme.
It can also help to:
Community consultation be carried out in various ways, such as focus groups and public meetings.
Researchers in England and Wales should also refer to the HRA guidance on information for participants at the end of the study(opens in a new tab) if they’re carrying out clinical trials and other interventional or diagnostic studies that involve patients.
We want the research we fund to be open and accessible, so that it can have the greatest possible impact. We expect our researchers to publish their outputs as high-quality, peer-reviewed research articles, monographs and book chapters, or on open access platforms such as Wellcome Open Research(opens in a new tab). This requirement is part of our grant conditions.
We also expect researchers to:
Annex A of the guidelines for attributing the costs of health and social care research and development (AcoRD(opens in a new tab)) sets out the costs:
This is in line with our overheads policy.
Researchers must complete a Schedule of Events Cost Attribution Tool (SoECAT) form(opens in a new tab) if they’re applying for a clinical research study that:
This should be sent to us with the grant application form.
The SoECAT makes sure that the different activities and costs associated with clinical research are attributed in a standardised way.
It is the host organisation’s responsibility to make sure that compensation arrangements are in place to cover research participants and/or their dependants against injuries or damage caused by taking part in the research.
Wellcome will not:
This policy was updated in June 2020.