Research Involving Human Participants Policy

1. Purpose

We value and support research involving human participants. It is essential for understanding the factors underpinning health and disease and assessing the safety and effectiveness of biomedical and social interventions. 

This policy is developed to protect participants’ rights, interests and safety when SEA DREAM-funded researchers carry out the research that involves human participants. All researchers and organisations we fund must comply with the guidelines outlined in this policy.

2. Our policy

SEA DREAM will fund research involving human participants that:

• could lead to sustainable health benefits that can be applied where the research takes place
• could have a global public benefit and potential relevance to the health of people anywhere in the world
• 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.

3. Definition of research involving human participants

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'.

4. What we expect from the researchers and organisations

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 in the following sections of this policy.

5. Participants' rights, interests and safety

The rights, safety and standards for research design and conduct in this policy are governed by the:

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

Researchers and their administering organisations must follow these guidelines.

5.1. Protect participants

Researchers and organisations must ensure they take all reasonable means to prevent harm, exploitation, abuse and harassment happening to research participants because of their work.

They must:

• protect people, especially children and vulnerable adults, from that harm and respond appropriately when harm does occur
• have policies and processes in place for this and should tell participants about them, so they know how to report any concerns. If these policies and process are still not in place or already outdated, organizations are expected to develop or revise them before the commencement of the intended research with human participants
• carry out a risk assessment to ensure participants and communities are not exploited or disadvantaged by their inclusion in the research

5.2. Avoid exploitation and undue inducement

Researchers must avoid exploitation and undue inducement, especially when carrying out research in low- and middle-income countries. Undue inducement could come with participant expenses, collateral benefits and any other forms.

5.2.1. Avoid exploitation and undue inducement

Researchers can ask for reasonable participant expenses in their grant application. Examples include:

• compensation for any inconvenience or time lost
• travel costs
• refreshments

Participant payments, in any form, should not be used to induce people to take part. Examples include book tokens for schools, or stickers and certificates for children.

5.2.2. Collateral benefits

Collateral benefits are gains that have arisen only because the research took place. They are not targeted at those taking part in the research – although they may benefit – as could their families and the wider community. Examples include providing healthcare benefits to communities during a research study or providing research-related technical or clinical equipment.

Researchers can include the cost of the collateral benefits of their research programme in their grant application, as long as the benefits will not:

• have an adverse effect on the research environment
• create undue influence to participate in the research

The collateral benefits resulting from the research must be included in ethics committee submissions.

5.3. Compensation for injury

It is the administering organisation’s responsibility to make sure that compensation arrangements are in place to cover research participants and/or their dependents 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

SEA DREAM will not:

• fund the costs of insurance or indemnity cover unless it is for a clinical trial and it is a direct cost of the research
• be liable for any compensation

5.4. Sharing research results and outcomes with research participants

Researchers should consider how they will share research results with participants and their communities. We will consider funding the costs to pay for these activities.

Any successful interventions that arise from SEA DREAM-funded research must be capable of being:

• made available to patients in the areas where the research was carried out (patients should not be asked to take part if it is clear at the outset that there would be no opportunity, or the potential for opportunity, to benefit)
• delivered through structures that already exist or are easy to change or develop

This is particularly relevant to research carried out in low- and middle-income countries.

We will consider funding for activities related to research access and uptake. This could include:

• meetings with relevant health authorities, government bodies, civil society organisations, pharmaceutical companies or bilateral organisations
• research management staff to support research uptake
• training in techniques that can help to explain the benefit of your research if these are not available from your administering organisation (for example, theory of change or audience engagement)
• workshops to help with wider dissemination

6. Legislation, including data protection and the duty of confidentiality

Researchers and organizations must comply with all relevant legislation of the countries where they are based relating to data, biological samples and ethics. If such laws and policies are still not in place, SEA DREAM suggests that researchers and organizations adhere to the Data Protection Act (DPA) and the General Data Protection Regulation (GDPR) of UK and EU.

6.1 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

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

6.2. Confidential patient data

Confidential patient data is the data that can identify the patient and has information about their healthcare or treatment.

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.

6.3. 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 addition, researchers 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.

7. Approval and consent

7.1. 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 (this includes approval from their administering organisation if it's based in a different country and the organisation requires it)
• 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, which need to be shared with SEA DREAM as soon as available

7.2. Disagreements between ethics committees

SEA DREAM will not fund research where there are unresolved disagreements between ethics committees. Researchers must tell us about any disagreements.

7.3. Funding costs for ethical review process

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

• it is a direct cost of the research
• the 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.

7.4. 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.

7.5. How SEA DREAM 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.

7.6. 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.

7.7. Responsibility of the administering organisation

The administering organisation must be satisfied with the procedures and quality of the ethical review. Researchers must comply with any obligations that their administering organisation might place on them. This could include dual (or even multiple) ethical reviews of the research.

7.8. 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 (e.g., Hospital administration data).

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

7.10. Use of data beyond the initial purpose of collection

7.10.1. 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

7.10.2. 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

8. When researchers must contact SEA DREAM

Grantees 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.

9. Best practice guidance

9.1. Ethics training

Researchers must understand the ethics of research involving people.

Any SEA DREAM-funded researchers using samples or participants must have research ethics training that is appropriate for their role and 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.

9.2. 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

9.3. 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 is feasible to do so – unless participants have been informed that this will not happen.

In addition, 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. However, SEA DREAM will not pay healthcare costs incurred if a participant acts on that information.

9.4. 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 can be carried out in various ways, such as focused groups and public meetings.

9.5. Transparency and publication

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 publishing trial results for guidance if carrying out a clinical trial
  • Read: Clinical Trials Policy
• 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:
    • Data, Software and Materials Management and Sharing Policy
    • Outputs Management Plan