Consent and Participant Information Guidance

The Participant Information Sheet (PIS) should describe how any complaints will be handled and what compensation may be available in the event of anyone being harmed. This information must be applicable to the setting in which the research will be conducted e.g. university, NHS, commercial or other public research facility etc.

Complaints – Contact details of where a complaint can be made should be given to potential participants.

• First point of contact might be your contact details, or that of someone else within the research team.
• You should also provide a contact independent of the research team for more formal complaints.

An example of possible wording that could be used is as follows:

If you have a concern about any aspect of this study, you should ask to speak to the researchers who will do their best to answer your questions [contact number]. If you remain unhappy and wish to complain formally, you can do this by contacting [insert details e.g. NHS Complaints Procedure or Private Institutional arrangements]. Details can be obtained from [insert details]

Harm – You should provide potential participants with details of what redress and/or compensation should be available to them in the event that they are harmed as a consequence of taking part in your research.

Details of insurance/indemnity schemes should be given, including whether compensation is dependent on demonstrating negligence or otherwise.

If you are unsure what indemnity or insurance is available to you, you should speak to your R&D/ research / research governance office.

NHS based research – NHS bodies are liable for clinical negligence and other negligent harm to individuals covered by their duty of care.

NHS Institutions employing researchers are also liable for negligent harm caused by the design of studies they initiate.

NHS Indemnity does not offer no-fault compensation i.e. for non-negligent harm, but they may offer an ex gracia payment.

If NHS indemnity is in place for your study, you could include the following possible wording:

In the event that something does go wrong and you are harmed during the research and this is due to someone's negligence then you may have grounds for a legal action for compensation against [name of Sponsor Organisation, NHS Trust, Private Clinic] but you may have to pay your legal costs. The normal National Health Service complaints mechanisms will still be available to you (if appropriate).

Universities – Universities employing researchers are liable for their employees' actions (undertaken as part of their job) and are expected to insure against the risk of claims relating to research studies that their staff design and undertake.

They may have insurance that covers both negligence and no-fault compensation; this would normally exclude clinical negligence for which NHS bodies are liable.

Appropriate statements should be included in the Participant Information Sheet (PIS), which describe what insurance cover is being provided, in terms that a lay person would understand.

Commercial research – For a Pharmaceutical industry sponsored study, where there are Association of the British Pharmaceutical Industry (ABPI) or other no-fault compensation arrangements, you should include the following form of words in your PIS:

We will provide compensation for any injury caused by taking part in this study in accordance with the guidelines of the Association of the British Pharmaceutical Industry (ABPI).

We will pay compensation where the injury probably resulted from:

• A drug being tested or administered as part of the trial protocol;
• Any test or procedure you received as part of the trial.

Any payment would be without legal commitment. (Please ask if you wish more information on this). We would not be bound by these guidelines to pay compensation where the injury resulted from a drug or procedure outside the trial protocol or where the protocol wasn't followed.

Potential participants must be told that the decision to take part in your research is entirely voluntary, and that they can change their minds at a later stage.

Potential participants will need to be assured that any such decision they may make to withdraw (or to decline the invitation to be involved in the first place) will not affect the care they receive from any relevant service (e.g. for patients, from the NHS).

You should make it clear at the outset what they should expect if they were to withdraw their consent. Some of the issues that may need to be addressed include:

• Does withdrawal simply mean that participants will no longer be attending further research clinics or taking any further active part in the research?
• What rights they are able to exercise in relation to their data, and what rights (e.g. deletion of data) may be restricted in order to ensure the integrity of the research (in accordance with data protection legislation). You should ensure that what you are promising potential participants does not conflict with the transparency information provided by your Data Controller(s). Data Controllers will provide information on what data subject rights they will guarantee to provide e.g. how they will respond to requests for erasure, restriction of processing, objection to processing etc. You should contact your Data Protection Officer (DPO) or Research Governance Office for more information on local decisions taken around the issue of withdrawal.
• Could participants withdraw their samples from further analysis?
• If your study includes medium to long term follow up, how can participants withdraw from this element? For example, if you intend to access registry data over time, how could participants withdraw from this?
• Could withdrawal post intervention pose a safety issue? If so, how would you manage this (e.g. with an exit check-up)? Participants should be able to ask that any information collected at an exit check-up be included or excluded from the study.
• Can participants withdraw both data and tissue samples from subsequent tissue or data banking?

It is important to make your intentions clear to the participant, and not to make promises that you cannot fulfil. For example:

If you withdraw from the study, we will destroy all your identifiable samples, but we will need to use the data collected up to your withdrawal.

Or

If you withdraw from the study, we will keep and continue to use all your previously collected data. We will, however not collect any further data about you.

Or

You can withdraw from treatment but keep in contact with us to let us know your progress. Information collected may still be used. Any stored blood or tissue samples that can still be identified as yours will be destroyed if you wish.

You should tell potential participants how their confidentiality will be safeguarded during and after the study. You may wish to tell potential participants how your procedures for handling, processing, storing and destroying their data match the Caldicott principles and/or appropriate legislation.

The potential participant should be told:

• If you intend to keep the data you collect for use beyond a specific research study/trial.
• Is it possible that you might share anonymous information with others in the future? Potential participants should be informed of the importance of data sharing with other researchers; to ensure that research is open to peer scrutiny, to optimise the use of good quality research data and to support policy and other decision-making.
• What arrangements are you going to make to ensure the information is kept secure? For example, will you keep direct identifiers, and separate them from health information? Will you destroy all direct identifiers and store only fully anonymised data in the longer term?
• Who will have responsibility of acting as the Data Controller? The Data Controller has legal accountabilities to ensure that you are compliant with the General Data Protection Regulation (GDPR) and new Data Protection Act.
• Do you intend to ask for further ethics committee approval for each re-use of the data, or not?
• Do you envisage sharing any of the information with others in the future, including those abroad (especially outside the European Economic Area (EEA)or commercial companies? If so, how are you going to ensure participants' confidentiality is maintained?
• If identifiable data will be shared with others outside the EEA, you should make potential participants aware that such countries might not offer the same level of protection of peoples' privacy as that demanded by law in the UK.  However, you can inform potential participants of the steps you will take to ensure that any such transfer of information abroad will not compromise their confidentiality.  If you plan to share data with the US, the EU-US Privacy Shield may be of interest (for further information please see the ‘Resources’ page)

You should avoid repeating information you provided earlier in your Participant Information Sheet. How much information and the nature of the information appearing in 'Supporting information' will very much depend on the type of study you are planning and the potential risks involved.

You should inform potential participants of your intentions with respect to publishing research findings, as well as how you intend to feedback findings to participants themselves. (This might include how you are going to handle individual health related findings, as well as overall outcomes of the study). Further guidance on health related findings is available from 'Content > PIS > Discovering health related findings'.

You should also provide relevant assurance that individual participants will not be identifiable from any report or publication placed in the public domain. If you think there is a risk that identifiable information may be published, you must ask potential participants for their explicit consent for this, having ensured that they understand the potential implications of agreeing to this.

You should tell potential participants which organisation(s) is/are sponsoring and which is/are funding your research (e.g. medical research charity, pharmaceutical company, academic institution, NHS organisation etc).

Potential participants should be told whether their doctor is being paid for their role in the study and if any conflicts of interest exist. The following is an example:

The sponsors of this study will pay (name of hospital department or research fund) for including you in this study.

Or

Your doctor will be paid for including you in this study.

You should explain how you have involved patients and the public in the design of your study and how they will be involved in the conduct of the research. The following are examples of how you might have involved patients / the public:

Service users helped develop the research topic and what research questions should be asked and one of them is a co-applicant who will continue to be involved in the study.

Potential participants were involved in reviewing the Participant Information Sheet.

In designing this study we have taken into account patient opinions on the frequency of participant visits and the tests that we will carry out.

Potential participants were involved in describing the inclusion and exclusion criteria for people taking part in this study.

Knowing how patients or the public have been involved in planning your study can give potential participants greater confidence in taking part, as it provides them with the assurance that what they are being asked to do is acceptable.

More information on how to involve patients or the public in your study can be found on the HRA website and from INVOLVE (further guidance is available from our 'Resources' page).

You should include some form of assurance to potential participants that your study has been reviewed and approved by a research ethics committee.

The following is suggested wording:

All research in the NHS is looked at by an independent group of people, called a Research Ethics Committee, to protect your interests. This study has been reviewed and given favourable opinion by _______________Research Ethics Committee.

You should provide potential participants with places where they can access more information, for example:

• General information about research: there are a number of web resources and booklets available, produced by research organisations, which explain why research is conducted, define some technical terms, and provide ideas as to the sorts of questions potential participants might like to ask before deciding if they will take part in research or not. Further guidance is available from our 'Resources' page.
• Data Protection transparency information: you should ensure that potential participants know where to access further information, including more detailed study-specific information and information published by the Data Controller. This information is likely to include corporate and other over-arching protections offered to each individual. Other information provided may include what data rights participants will have access to, and how they can access these. Data Controllers may inform all members of the public what their lawful bases are for all the different types of data processing they oversee, including that to support research. It is important that all the information provided to potential research participants about data protection is presented in a joined up manner, ensuring that all information sources are complementary and not ambiguous.
• Specific information about this research study: usually this would be provided by someone who is part of the research team; this could be you or some other member of your team. Potential participants should be given a name and contact details. If you also have a study website, details of where to find this should be included.
• Advice as to whether they should participate: this is usually a person who is independent of your study. It could be the potential participant's health care professional or a person you nominate who can provide support and who is independent of your study.
• Who they should approach if they are unhappy with the study: this would be a contact if participants have any concerns about your study and their involvement in it. For some studies, you may need to provide an emergency contact number that is manned 'out-of-hours'.

If you are conducting a study over a number of different sites, you should make sure that all of the contacts you provide are appropriate for each of the sites involved.

Your Participant Information Sheet should be dated, given a version number (referring to a protocol number if necessary) and state the IRAS ID. This can be done in a header, footer or within the body of the document(or equivalent if using electronic formats).

Date, version numbers and IRAS ID will not only help you and your research team to manage consent materials during the on-going study (including handling any subsequent amendment), but it will also be used by the research ethics committee, regulators or research governance offices when referring to 'approved' documents.

You should explain how potential participants should expect the consent process to proceed. You should inform them if you are intending to obtain a record of their consent in writing, by means of a consent form, and that they will be given a copy of the consent and participant information materials to take away with them. You will need to consider how to do this if you are not using paper materials.

Recruiting adults lacking capacity in England and Wales to non-CTIMPs.

Consultees should be informed that the advice they provide (i.e. advice on whether an adult lacking capacity should be included or excluded from your study) will be recorded on a Consultee Declaration form. A template is available to download from 'Examples & Templates'. This is because they are not being asked to give consent on behalf of the adult.

You must fully explain early in your Participant Information Sheet what you are asking them to do, why you are asking them to act as a consultee, what they need to consider when providing you with their advice and that they do not have to act as a consultee if they do not wish to do so. (Further guidance is available from 'Content> PIS> Adults not able to consent for themselves' and 'Principles> Adults Lacking Capacity').

During a participant's involvement in your study, significant findings might emerge that impact upon the risk / benefit balance that was originally explained to them. Potential participants need to be assured at the outset that if this happens you will let them know.

• You must give them further assurance that they can change their mind about their involvement and that this will not affect their care (in the case of patients). The following is an example:
  Sometimes we get new information about the treatment being studied. If this happens, your research doctor will tell you and discuss whether you should continue in the study. If you decide not to carry on, your research doctor will make arrangements for your care to continue. If you decide to continue in the study he may ask you to sign an agreement outlining the discussion.
• Potential participants should also be told at the outset if it is possible that they might be withdrawn from the study because of information that comes to light that relates specifically to them and their health. For example:
  If this happens, your research doctor might consider that you should withdraw from the study. He/she will explain the reasons and arrange for your care to continue.
• Similarly potential participants to some studies (in particular trials) should be made aware that the study may be stopped for safety reasons or if it becomes clear that one of the study treatments is much better than the other(s).
  If the study is stopped for any other reason, we will tell you and arrange for your continuing care.
• In all cases it is also important that potential participants are told of any further implications of their withdrawal, for example any safety, exit check-ups that might be necessary, post-study arrangements etc.

The Participant Information Sheet should make it clear if your study necessitates contact with a participant's General Practitioner (GP) or other health care professional. In such cases, you should explain to potential participants that if they agree to take part in your study you would need to contact their GP (or other health care practitioner). You should provide potential participants with an explanation of why this contact is necessary and what information would be exchanged.

You should give potential participants more information on your medium to long-term plans for any samples remaining after your specific piece of research has ended. This should include consideration of the following:

• Will participants' samples be destroyed at the end of this study, or do you intend to keep them for future use?
• How will you ensure confidentiality is maintained during medium to long-term storage?
• Do you intend to share samples with others, including transferring samples elsewhere, maybe even outside the UK?
• Could this future use include genetic testing, the use of animals, commercial involvement?
• How will you manage access to samples in the future? Will all future use require additional ethical approval?
• Is it possible that you might share anonymous information with others? Potential participants should be informed of the importance of data sharing; to ensure your research is open to peer scrutiny, to optimise the use of good quality research data and to support policy and other decision-making.
• Could any future use produce health related findings that might be significant to individual participants? If so, how will this be handled, what should potential participants expect? (For further guidance visit 'Content> PIS> Discovering health related findings').
• Are you making any specific provision for destruction of any remaining samples?

There are a number of options to consider when asking potential participants for consent to collect samples. These include obtaining:

• Generic consent – is non-specific consent, where potential participants are informed of the possible breadth of potential uses any donated samples might be put to in the future. This might include some studies that are already planned, but also some future research that cannot yet be described in detail.
• Tiered consent – is where you describe a number of discrete research activities that the donated tissue could be used for, and enable potential donors to agree to some but not necessarily all. Some of these elements may be well defined, whilst others could be relatively undefined as yet. You should only offer tiered consent if you are confident that you can deliver all aspects of consent in any combination the donor specifies.
• Specific consent – is when donors are asked only to give consent to specific use(s) of their samples, and when no future, as yet unspecified research is likely. You should think about offering this option only if you are sure that you have no intention of any further storage or use of the donated samples.

Further guidance is available on our 'Resources' page.

If your research or collection of samples/data is likely to directly feed into a discovery of commercial value, you need to make it explicit to potential participants that:

1. Your study may have commercial benefit.
2. Participants will not benefit financially in any way, if commercialisation of any research findings are successful.