Policy on research involving human participants
We recognise that research involving human participants is an essential part of developing an understanding of the factors underpinning health and diseases, and of assessing the safety and effectiveness of biomedical and social interventions.
We support such research as a key part of our vision to achieve improvements in health. The first priority for researchers should always be the protection of the rights, interests and safety of research participants and we expect that research involving human participants should be undertaken in accordance with the appropriate standards.
Wellcome-funded researchers are responsible for ensuring they are aware of the issues, comply with relevant legislation, and follow best practice guidance surrounding the use of human subjects in research.
- For studies conducted in low- and middle-income countries, please also refer to our guidance notes on research involving people living in low- and middle-income countries.
- For studies that involve clinical trials, this policy should be read alongside our policy position on clinical trials.
When establishing a study involving human participants or re-consenting participants for follow-on research to an existing study, researchers should also refer to our policy position and framework on health-related findings in research.
Definitions and scope
Research involving human participants is governed by principles outlined in the Declaration of Helsinki, the Nuremberg Code, and the Council for International Organizations of Medical Sciences (CIOMS), all of which set out requirements with regard to the rights and safety of research participants and standards for research design and conduct.
The World Health Organization defines research with human subjects as "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, or ii) become individually identifiable through investigator's collection, preparation, or use of biological material or medical or other records".
This policy covers research involving human participants as defined above, including research involving human tissue and patient information.
Implementation and our requirements of grantholders
Healthcare benefits of research
We consider that all research we fund involving human participants should:
- be responsive to the healthcare priorities or needs within the research setting and be relevant to the short- or long-term needs or priorities of the region(s) or population(s) where the research is to be carried out;
- have outcomes that are likely to lead to sustainable health benefits and have local applicability; or
- be research that could have a 'global public benefit' and have potential relevance to the health of humans anywhere in the world.
We require researchers to have the relevant regulatory and ethical approvals, and appropriate governance mechanisms, in place before the relevant research begins, although researchers may apply for funding before this. In the event of an award being made, commencement of any research involving human participants will be subject to these approvals and governance mechanisms being in place – including, in the case of ethical review, from an appropriately constituted ethics review committee.
We do not require sight of approval documents when they are obtained, but we reserve the right to see relevant approval documents at any point during the lifetime of the grant.
Where research is anticipated to run over a number of years, for example in cohort studies, researchers must ensure measures are in place to maintain continuing appropriate ethical oversight and to monitor and, where necessary, obtain advice on ethical, legal and social issues on an ongoing basis.
An example of this would be use of an oversight committee with members who are independent of the research in question. These measures would be additional to ethics review and would provide an additional layer of ethical oversight throughout the lifetime of the research.
Funding for ethics review
We are prepared to meet the actual direct costs of the ethics review process in resource-poor settings, as part of a grant application. However, this must be done in a way that does not compromise the independence of the ethical review process. Such decisions will be made by us on a case-by-case basis, where an applicant may request a one-off fee for ethical review.
We will not consider calculating such payments in terms of a percentage of the total cost of the grant.
All Wellcome-funded researchers must have an understanding appropriate to their role of the ethics of research involving human participants. We recommend that all Wellcome-funded researchers involved in such research undergo training in the ethics of research where appropriate, and we require this where there is a need to build capacity in this respect.
Procedure in case of special ethical concerns
Where an application for funding raises ethical concerns for Wellcome committee members, referees or staff, we reserve the right to review the research protocol. If deemed appropriate, the research protocol will be referred for review by independent experts in ethics, research and other relevant fields for advice before making a funding decision.
Individual valid consent
All competent adults have the right to give or withhold consent to participate in research. Prospective research participants must therefore be provided with accurate, relevant and sufficient information on the nature and purpose of the study, the procedures involved, and any foreseeable risks associated with participation in the research. They must also be given an appropriate length of time to consider the implications of the information they have been provided with.
Written consent may not always be the most appropriate form of recording consent; for example, some participants might be visually impaired or illiterate. In such cases, it is recommended that alternative forms of recording consent be used. These could include making a note of verbal consent in a participant's personalised record or making an audio or video tape, with an independent witness to observe the consent process, where appropriate.
Participants must also be provided with information about any proposed arrangements for post-research access, including options for secondary use of tissue samples and data, where applicable (see also our policy on the use of personal information in research).
The consent-seeking process must be appropriate to the cultural context and to individual needs. When reviewing grant applications, independent referees and Wellcome funding committees may request clarification or information from grant applicants about the proposed consent procedures. In some cases, this could include asking grant applicants to supply them with the proposed consent forms.
The right to withdraw from ongoing participation in a research study is also a right of any participant, which participants should be made aware of. Researchers need to give careful consideration to the implications of individuals withdrawing their participation from the research. The feasibility and implications of withdrawing from research, and the extent to which that applies to the withdrawal of data and samples from a study, need to be clearly explained as part of the consent process.
Research involving vulnerable individuals and children
Subject to relevant ethics committee approval, we will consider funding research involving individuals incapable of providing consent, including children and people with mental disabilities, as long as their participation is deemed necessary to answering the research question and all measures have been taken to safeguard and promote their interests.
Researchers are expected to carry out all necessary discussions with a parent or other legal guardian and/or an appropriate legal authority responsible for the care of a mentally incapacitated person (where such a body exists) and to ensure that the research complies with relevant laws and best practice guidance.
We will consider funding emergency research (eg accident and emergency research) where the ability of an individual to give consent is compromised or impracticable, provided that the research protocol receives ethics review committee approval and complies with all relevant national legislation and any best practice guidance. Where appropriate, measures to inform the general public that these studies are planned or are in progress should be implemented.
Use of tissue samples and data
Where research will involve the collection of human tissue and/or data, researchers must outline as part of their application how the tissue or data will be collected, stored and accessed by any third parties and ensure that appropriate ethical approvals are sought. The confidentiality of research participants must be safeguarded, unless appropriate consent has been obtained to disclose information to a third party.
The consent process must, wherever practicable, include seeking consent for approved secondary use of the tissue or data in subsequent research studies. The Trust recognises, however, that in some situations, this may not be possible. In such cases, we consider that it is acceptable to use samples and/or medical data for secondary purposes without returning to the participant for specific consent, if the proposed research:
- has clear healthcare benefits in accordance with this policy (see section on 'Healthcare benefits of research', above)
- complies with relevant national laws
- complies with any binding codes of practice or ethical guidance (such as professional guidelines or licensing regulations)
- is not inconsistent with the consent as approved by an ethics committee for the original study
- uses samples or data that have been anonymised (either fully or, at a minimum, from the researcher's point of view)
- meets policy requirements regarding secondary use as required by the principal investigator's employing institution
- includes appropriate mechanisms to monitor consent for the original study and any cases where it is withdrawn, where practicable.
Transparency and publication
We believe that making the outputs of Wellcome-funded research available to the widest possible audience is a fundamental part of our mission. We therefore expect the outputs of research funded by us to be published in an appropriate form (usually in peer-reviewed journals), as detailed in our grant conditions.
We also support unrestricted access to the published outputs of research and expect researchers to maximise opportunities to make their research outputs available for free, including negative results, and to work towards full disclosure of research data. Researchers should also consider whether a data management and sharing plan is needed, and refer to our policy and associated guidance on data management and sharing.
Feedback to participants
Researchers must consider the circumstances and mechanisms by which aggregated research findings might be made available to research participants, where this is deemed appropriate, and the manner in which such information is presented.
Researchers should also refer to the Health Research Authority's guidance on information for participants at the end of the study, which is aimed at chief investigators and sponsors for studies in England undertaking clinical trials and other interventional or diagnostic studies involving patients.
Compensation for injury
It is the responsibility of the research sponsor1 to ensure that appropriate compensation arrangements (including insurance or indemnity cover where available) are in place to cover research participants and/or their dependants against injuries or damage caused as a result of their participation in research, in accordance with local law and best practice. The Trust will not fund the costs of such insurance or indemnity cover and would not be liable for any such compensation.
Clinical research costs for research in the NHS
Research conducted within the NHS is subject to the guidelines for attributing the costs of health and social care research and development (AcoRD), published by the Department of Health.
As a charity, we expect that the indirect costs of research carried out within the NHS will be paid by the Department of Health through the National Institute of Health Research or local NHS trusts. This is in accordance with our position on full economic costs. Further information on how research costs are attributed between funders is available in the AcoRD guidelines (Annex A, Part B).
- The Council for International Organizations of Medical Sciences: 'International Ethical Guidelines for Biomedical Research Involving Human Subjects', September 2002
- World Medical Association: Helsinki Declaration
- Wellcome Trust guidelines on good research practice
- Human Tissue Act (2004)
1As defined in the Department of Health Research Governance Framework for Health and Social Care (see sections 3.8 and 4.3).