Research involving human participants policy

Wellcome will fund research involving human participants that:

• could lead to sustainable health benefits that can be applied where the research takes place

or

• could have a global public benefit and potential relevance to the health of people anywhere in the world

or

• aims to generate new knowledge where there may be no immediate sustainable health benefit.

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:

• Research involving people living in low- and middle-income countries
• Clinical trials.

We use the World Health Organization (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

or

ii) become individually identifiable through investigator's collection, preparation, or use of biological material or medical or other records'.

Researchers must:

• protect the rights, interests and safety of participants
• comply with all relevant legislation, including data protection and the duty of confidentiality
• have all necessary approval and consent in place during the research
• contact us if they have any doubts about their research meeting the appropriate regulatory and/or ethical requirements
• follow best practice guidance on using human participants.

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:

• Declaration of Helsinki
• Nuremberg Code
• Council for International Organizations of Medical Sciences (CIOMS).

Researchers must follow these guidelines.

Researchers must comply with all relevant legislation relating to data, biological samples and ethics.

UK and EU data protection legislation

The Data Protection Act (DPA) 2018 is the UK law that reflects the General Data Protection Regulation (GDPR). Together they:

• are based on the principles of fairness, transparency and accountability
• set out what the valid grounds (appropriate lawful bases) are for collecting and using personal data
• apply to all people located in the UK and EU, wherever the data is processed
• apply to all data processed in the UK and EU, regardless of the nationality of the people it relates to.

The DPA and GDPR only apply to personal data – they don’t apply to:

• anonymous data
• data about people who are dead.

Data that has been pseudonymised is still personal data under GDPR. For more guidance, see the UK anonymisation network decision-making framework.

For more information about what GDPR means for research, read the:

• UK Research and Innovation GDPR FAQs
• Health Research Authority (HRA) DPR guidance – for researchers working within the UK Policy Framework for Health and Social Care
• MRC Regulatory Support Centre website – more information about the:
  • key principles to follow when collecting and using data about people in health research
  • legal framework in the UK.

Confidential patient data

Confidential patient data:

• identifies the patient
• has information about their healthcare or treatment.

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:

• get consent from participants or an appropriate other (see Consent from research participants section) and relevant ethical approval to use the data

or (if based in England and Wales)

• apply for a Section 251 approval from the HRA Confidentiality Advisory Group.

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 for more information about the duty of confidentiality.

Research using human biological samples

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.

In Scotland, researchers must comply with the Human Tissue (Scotland) Act 2006.

Details of UK legislation that researchers must comply with are on the MRC human tissue legislation summaries website. This includes help to identify:

• if consent is required for the research
• if a licence is required to store samples
• legislation and ethical standards for transport, import and export.

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.

Read our best practice guidelines for importing and exporting samples.

Ethical approval

Before research begins, researchers must have in place:

• ethical approval in every country where any part of the research will be carried out
• the relevant regulatory and ethical approvals for every site where research will be carried out
• appropriate governance mechanisms.

Researchers must tell us in their grant application:

• who will review the ethics of the project
• when it will be reviewed.

Ethical approval is not required when the grant application is submitted, but researchers must have:

• a clear pathway to ethical approval
• all approvals in place before the first participant is recruited.

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.

Read our best practice guidance on ethics training.

Disagreements between ethics committees

We won’t fund research where there are unresolved disagreements between ethics committees. Researchers must tell us about any disagreements.

Funding costs for ethical review process

Researchers can ask for the costs of the ethical review process in their grant application if the:

• organisation administering the grant is based in a low- or middle-income country

and

• ethical review process remains independent.

We will only pay the actual costs of the ethical review. We will not pay a percentage of the total cost of the grant.

Long-running research

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.

How Wellcome deals with special ethical concerns

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.

Where the research will take place in a country with no research ethics committee

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.

Responsibility of the host organisation

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.

Consent from research participants

Researchers must get consent from:

• research participants
• parents or other legal guardian where a child is legally unable to give consent
• an appropriate legal authority responsible for the care of an adult who lacks mental capacity (where such an authority exists).

Researchers don’t need to get consent if they will be using data that is routinely collected (see Confidential patient data section).

Research in acute/emergency settings

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:

• receives appropriate ethical review committee approval
• complies with all relevant national legislation and any best practice guidance.

Where appropriate, researchers should tell the public that these studies are planned or in progress. This information should be:

• accessible
• in the relevant location(s) so that people affected by the research can see it.

Use of data beyond the initial purpose of collection

New and continuing studies

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:

• consider reconsenting participants
• update the transparency information available to them.

Completed studies

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:

• is consistent with the consent approved by the ethics committee for the original study
• uses samples or data that have been anonymised (either fully or, at a minimum, from the researcher)
• meets policy requirements on additional use, as required by the researcher's employing organisation
• complies with relevant national laws
• complies with any binding codes of practice or ethical guidance (such as professional guidelines or licensing regulations)
• has clear health benefits in line with this policy
• includes appropriate mechanisms, where possible, to monitor the status of consent for the original study and cases where it’s withdrawn.

Grantholders must tell us immediately if they have any doubts about their research meeting the appropriate regulatory and/or ethical requirements.

This is a requirement of our grant conditions.

Ethics training

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:

• their role
• the specific tasks they may undertake.

We reserve the right to see evidence of appropriate training at any point during the grant and after it has finished.

Import and export of human tissue samples from the source country

Where it's planned that samples will be removed from the country in which the research is taking place, researchers must:

• comply with the ethical and legal framework that applies in the source country
• have permission from the source country government to export samples
• have clear systems in place for maintaining the quality, safety and governance of samples that are appropriate for the relevant jurisdiction
• get approval from a research ethics committee or equivalent in the source country – if researchers can’t make sure that ethical standards are in place, they must assess the risks of accepting the material
• take immediate corrective action where any non-compliance is identified.

For more information on import and export under the Human Tissue Act 2004, see the Medical Research Council (MRC) Regulatory Support Centre website. We expect researchers based outside the UK to use this guidance, where possible.

Health-related findings in research

Researchers should tell participants about any health-related findings that affect them if:

• the potential benefits of doing so clearly outweigh any potential harm to both the participant and the public

and

• it’s feasible to do so – unless participants have been informed that this will not happen.

Researchers must:

• have a policy that tells participants if any health-related findings, including incidental findings, will be fed back to them
• be able to demonstrate the reasoning behind their policy to participants, funders and the research ethics committee
• give participants clear information about their policy during the consent process
• develop a feedback method (and have the resources to maintain it) in studies where feedback is given.

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 (including patient and public involvement)

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:

• decide if it’s appropriate to approach members of a community to take part in research
• design procedures for getting consent
• identify areas of concern to the community
• advise how and when aggregated research findings can be made available to research participants, and if this is appropriate.

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 if they’re carrying out clinical trials and other interventional or diagnostic studies that involve patients.

Transparency and publication

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. This requirement is part of our grant conditions.

We also expect researchers to:

• Maximise opportunities to make their research outputs available for free. This includes negative results.
• Work towards full disclosure of research data (for example use CSDR if carrying out a clinical trial).
• Acknowledge the use of any data from participants that has been collected as part of routine clinical care, such as GP records. This data should be cited in any relevant academic papers, press releases and study web pages.
• Consider whether a data management and sharing plan is needed. Read our policy and associated guidance on data management and sharing.

Clinical research costs for research using NHS patients or facilities

Annex A of the guidelines for attributing the costs of health and social care research and development (AcoRD) sets out the costs:

• funded through the Department of Health and Social Care in England (or its equivalent in Northern Ireland, Scotland and Wales)
• Wellcome provides for research using NHS patients or facilities.

This is in line with our overheads policy.

Researchers must complete a Schedule of Events Cost Attribution Tool (SoECAT) form if they’re applying for a clinical research study that:

• will take place in the UK
• requires HRA or equivalent approval.

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.

Compensation for injury

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.

This must:

• include insurance or indemnity cover, where available
• comply with local law and best practice.

Wellcome will not:

• fund the costs of insurance or indemnity cover
• be liable for any compensation.

• Read our grant conditions.
• Read our guidelines on research involving people in low- and middle-income countries.
• Nuffield Council on Bioethics: The ethics of research related to healthcare in developing countries.
• Understanding patient data, an online resource to support conversations with the public, patients and healthcare professionals about health and care data.
• National Institute for Health Research: Supporting and applying research in the NHS, guidance on new processes to simplify research arrangements to improve patient care.
• NIHR Schedule of Events Cost Attribution Tool (SoECAT) form.
• NIHR guidance on how to complete a SoECAT form.

This policy was updated in June 2020.