Consent and Participant Information Guidance

This should cover:

• What is the nature and purpose of your research?
• What is already known (or not known) and how will this study help you learn more? (Be clear and succinct in your explanation).
• What interventions are additional to standard care (i.e. research elements), making it clear what potential participants are being asked to consider giving their consent to.
• Is your research study primarily educational? It is entirely reasonable for research studies to be primarily educational, but this should be made clear to potential participants at the outset.
• Is your research a therapeutic study? Therapeutic studies may require an explanation of the condition and other possible treatment alternatives.
• How many others will be in the study?
• Re-iterate the invitation to take part and explain why they specifically are being approached.

Before anyone decides if they wish to take part in your research study, they need to be made aware of what would be involved.

You should make clear which interventions are additional to standard care (i.e. the research elements) and ensure potential participants know what they are being asked to give their consent to. You can describe these elements in the context of what patients should expect in terms of standard care. Make it clear that their research consent only covers proposed research elements.

You should try to describe involvement from the potential participants' perspective – what should they expect to happen if they agree to take part?

This may include describing:

• How long the participant will be involved in the research?
• How long the research will last? (If this is different);
• If and how often they will need to meet a researcher, attend a research session, visit a clinic or their GP?
• How long will these visits last?
• What exactly will happen and what information is to be collected e.g. access to personal information samples / questionnaire, interview, discussion group, measurement, sample collection, blood tests, x-rays (carried out in addition to standard care or treatment), etc?
• Will participants be asked for information on particularly sensitive issues? Knowing whether an issue may be considered sensitive demands an understanding of your research population and what they might consider to be sensitive.
• For patients, how will participation in the research study affect or blend with their standard, clinical care?
• Any plans for long-term monitoring/follow-up?
• Whether your study will involve video/audio-taping or photography? Specific consent will be needed if published material would identify participants etc.

Potential participants must be made aware that if they agree to take part in your research you will be collecting data / information about them, their health and/or treatment. You must make it clear to them:

• The types of information you will be collecting;
• Who will have access to this information and how you will protect their confidentiality;
• The name of the Data Controller(s)
• Your future plans for ensuring that the data you collect will be used optimally; for example, data storage and re-use after the completion of this specific study, together with possibility of sharing anonymous or identifiable information with others in order to support science more generally. Potential participants should be informed of the importance of data sharing.
• What rights they are able to exercise in relation to their data, and what rights may be restricted in order to ensure the integrity of the research (in accordance with data protection legislation).

You should avoid creating the impression that participants are giving explicit consent to the processing of their personal data, and that they therefore have related rights flowing from the use of consent as a legal basis, since these rights will not usually be compatible with maintaining the integrity of the research. It should be clear that participants are consenting to take part in the study.

The use of tables or flow diagrams can help provide clarity when describing a complex series of interventions. It can often help to describe each stage of your proposed study, with its inherent risk, in chronological order in the 'What's involved' section of your Participant Information Sheet.

If appropriate, you should explain that participants should take study medication regularly as directed and whether they can continue to take their regular medication or other prescribed or over-the-counter medicines.

It should also be explained that they will need to consider whether they should participate if they are in other Clinical Trials of Investigational Medicinal Products (CTIMPs), or have been in the recent past (specify how long).

It is usually not possible to promise any direct benefits of taking part to potential participants, even though sometimes participants can end up benefiting directly.

You need to ensure that potential participants are aware that you do not know what the outcome will be, and this is why you are conducting the research.

Consultation with the community, service users or patient groups may help you identify indirect benefits that could come from taking part in the research, such as:

• Empowering participants to learn more about their condition,
• Supporting or adding to existing diagnoses where more may be learnt about their condition,
• Being seen more often and/or feeling more supported as a consequence of their involvement in the research etc.

The most likely benefits will be experienced by others with a similar condition, in the future, rather than the participants themselves, as a consequence of discovery through research.

A fair and honest evaluation of the consequences of research, including possible significant benefits and harms and their relative likelihoods, must be described to potential participants.

You should consider that:

• Explaining risk to potential participants in a meaningful way is not easy. However potential participants must be given an honest assessment of the likelihood that something might go wrong, and the consequent level of harm that might be caused.
• Assessing risk is a subjective judgment based on what you already know about this intervention.
• Consultation with the community, service users or patient groups can help you to determine what is likely to be a significant risk, and to design effective ways of presenting risk to potential participants (including careful use of graphic presentation).
• We often don't know the precise level of risk that research carries. You may only be able to present uncertainty or qualified estimates of risk to potential participants. These can often be placed in context e.g. how often has this drug been given to people, or what experience is there of using a certain technique etc.
• Each research study will have its own inherent risks, specific to the interventions involved, the types of participant recruited, the methods of assessment used etc.

Further guidance is provided on our 'Resources' page.

Distinguishing risks
You should ensure that potential participants understand the separation, between the risks:

• Of having a specific condition;
• Associated with standard clinical care;
• Inherent in the research itself.

A fair assessment of research risk needs to be placed in an appropriate context for potential participants to consider. Some risks are set out below.

Risk of physical harm
Give potential participants an assessment of likelihood of harm and the likely impact.

• For example:
• 1 in 10 people are likely to suffer from a minor stomach upset or
• 1 in 10 people are likely to suffer from severe diarrhoea or
• 1 in 1000 people are likely to suffer from severe diarrhoea or
• 1 in 1000 people are likely to suffer from a mild stomach upset.

Risk to confidentiality
You should also inform potential participants of any potential risk to their confidentiality:

• What is the realistic risk of identifiable information being accidentally disclosed and what measures are you going to take to keep their information safe?
• Who is going to have access to this identifiable information (e.g. within the research team)?
• Are auditors, inspectors or monitors likely to need to have access to identifiable information?
• Will you be passing identifiable information on to participants' GP, for example to check inclusion criteria during screening etc?
• Are you intending to access information from other sources (e.g. the Office for National Statistics (ONS) / National Records of Scotland (NRS) or NHS central register etc)?
• Are you working with collaborators elsewhere who will access information about participants? How will you ensure participant confidentiality is maintained despite wider information sharing?
• What are your long term plans with respect to the data you collect? Will you be keeping research data beyond the life of this project: reusing it and/or sharing it with others; ensuring that it is optimally used? How will you manage the risks to participant confidentiality? Potential participants should be told about the importance of data sharing in research.
• What are your plans in terms of publication of research findings? How will you ensure that the confidentiality of participants is maintained?
• In some circumstances you may consider there to be significant risk of uncovering abuse, neglect or potential harm to others during the course of your research. It is a matter of judgment whether you wish to explicitly inform potential participants of this possibility, and any action you may have to consider making with respect to information given to you in confidence.

Psychological risk
Some research may also pose specific psychological risk to participants, in particular where research directly addresses difficult experiences and challenging issues in peoples' lives.

Potential participants should be informed of the issues to be discussed, the types of questions that might be asked and the sort of information you wish to collect, to ensure that they appreciate what is involved and what this might mean for them.

Potential participants should be made aware of any support that will be made available to them during or after their involvement in your study.

If you intend to recruit adults not able to consent for themselves into your study, you will be:

• Seeking consent from legal representatives, or
• Gaining advice from consultees, or
• Seeking assent from close relatives or friends.

Further details on which of these is applicable can be found in 'Principles> Adults Lacking Capacity'.

In all circumstances, you should include the following in your Participant Information Sheet (PIS):

• Why you are approaching them (e.g. as legal representative or consultee etc)?
• What you are asking them to do (e.g. to give consent on behalf of another adult, to provide advice on what another adult may wish or feel or to give assent)?
• Their role in your study is voluntary; they do not have to provide consent, advice or assent if they do not wish to do so.
• They are asked to consider the potential participants views and feelings and to set aside their own.
• Details of your study, including any risks or benefits, as outlined in the remaining 'Content' guidance and as appropriate to your study.
• What they should do if they change their mind.
• If there is a significant chance that participants might regain capacity during the course of your study, how are you going to involve them in the on-going consent process?
• If you intend to collect on-going consent from any participant who regains capacity, you will need to provide a PIS suitable for this. Bear in mind what decision you will be asking the participant to make and the stage of research they might already be at.

If there could be harm to an unborn child and/or risk to an infant when breastfeeding then the Participant Information Sheet (PIS) should provide specific advice to potential participants about the risks of becoming pregnant, of fathering a child, or of breast-feeding whilst taking part in your research. Clear information should be provided for men and women.

For women:
You must give a clear warning to potential participants when there is a risk of harm to an unborn child or risk when breast-feeding. The information should include the need for pregnancy testing, contraceptive requirements, and how to report a pregnancy during the study.

The PIS should also provide information about what will happen if a participant becomes pregnant, including whether and how you will monitor the pregnancy. This would include access to mother's and/or child's notes, and any possible follow up of the child including post-natal examinations.

For men:
You must provide clear warnings and advice if the research treatment could damage sperm and consequently pose a risk to possible pregnancies. Information concerning the importance of careful contraception and what to do if their partner becomes pregnant is essential. Specific advice for pregnant partners may be needed, including information on any compensation arrangements.

For more guidance visit 'Young people and pregnancy' below.

The risk of harm caused during pregnancy is most likely if you are recruiting young people to a Clinical Trial of an Investigational Medicinal Product (CTIMP).

In this case, the law requires consent from someone over the age of 16, therefore:

You must discuss the risk of pregnancy, pregnancy testing and the use of appropriate contraception with their parents (or others with parental responsibility) as part of the consent process.

You must discuss the risk of pregnancy, pregnancy testing and the use of appropriate contraception with young potential participants as part of the assent process (in the case of a CTIMP).

It is particularly important that you consider the following being sensitive to local social beliefs:

• What are the likely religious beliefs and cultural expectations of your potential research population?
• What are the perceived consequences of under-age sex? How are you going to handle confidentiality if you discover under-age sex?
• What is the risk of young people (men and women) not telling the truth?
• How can you minimise embarrassment and engender honesty: e.g. by talking with young people privately, away from their parents, or by asking them to complete a written questionnaire?
• How are you going to handle the results of any pregnancy test? How are you going to ensure a young woman's privacy?
• Will young people have access to sexual heath advice, in private?
• At what age is it appropriate to be asking questions about sexual activity etc?

You should:

• Involve paediatricians and NHS Research Ethics Committees (RECs) in preliminary discussions if this is a concern,
• Consult young people when designing consent / writing information,
• Respect the young person's autonomy but encourage involvement of the parents,
• Be aware that in CTIMPs it is the parents of children under 16 who legally provide consent, and this will include consent to pregnancy testing and discussion of contraception, and
• Information needs to go beyond "We will do a pregnancy test…" to include, what in broad terms, will happen.

If you are asking patients to consider taking part in your study, you should make them aware of other clinical alternatives available to them. It is important that potential participants understand the context in which you are asking them to make their decision.

You must make clear to potential participants what they are being asked to consider giving their consent to. It is important that you highlight the additional or research elements of your study. You should avoid presenting standard care and additional research elements as optional, both to be considered during the research consent process. Potential participants should be aware that either they will receive standard care with additional research elements (which are clearly described), or that they will receive standard care minus specific research elements (again, with omitted elements clearly described).

When you are randomising participants to two or more treatment arms in order to directly compare treatment alternatives, you should explain to potential participants that there is no evidence of greater benefit or greater harm being associated with any of the alternatives being offered (For more guidance visit 'Randomisation and blinding' below).

Pragmatic trials are a simple and cost effective way to address uncertainties about the relative merits of different treatments in common use. They usually have the following characteristics:

• The study involves little or no deviation from usual care (including monitoring for adverse effects, extra research-specific laboratory tests, questionnaires etc.)
• All treatment interventions (including “watch and wait” approaches to care) and medicines in the trial are used within the terms of their licence and/or are in routine use
• All other interventions/diagnostic tests are in routine use within the NHS and will be undertaken by those qualified to do so
• Research risks are no greater than those involved in standard care/not greater than minimal (e.g. extra blood tests/tissue samples taken during a ‘clinically directed’ procedure)
• Healthcare Professionals have the option of using an intervention other than the one assigned if they believe doing so is important for a particular patient
• The patient has not expressed a strong preference for any particular treatment.

Point of Care trials are a sub-group of pragmatic trials and usually embedded in routine practice.  Patients are allocated to existing treatments and the data required for the research can often be collected through their electronic health records, as such studies often take place in primary care.

Information provided for potential participants must be appropriate to support specific decision making for each study.  In pragmatic trials a short Participant Information Sheet may well be adequate to accompany verbal information (provided by a healthcare professional) in supporting potential participants in making a decision.  Potential participants must be made aware of potential adverse reactions and interactions related to the intervention (which, in the case of licensed drugs, would also be detailed in the Patient Information Leaflet (PIL) supplied with the medicine pack).  Potential participants should also be made aware of what data will be collected about them, how this will be used and by whom, and any significant risks posed to their privacy etc.

Please visit Examples and Templates for an example Participant Information Sheet for use in pragmatic trials.

For trials of treatments/therapies you should include a short description of the drug, device or procedure being tested, and describe the stage of its development.

You should explain all reasonably foreseeable side effects. Rare side effects are relevant if they are likely to result in serious or permanent harm.

For new treatments, you should explain the possibility of unknown side effects. You should place the estimated risk in the context of how many people have taken the drug or describing the experience of using a certain technique etc.

Side effects should be described in terms the participant will clearly understand (e.g. 'damage to the heart' rather than 'cardiotoxicity'; 'abnormalities of liver tests' rather than 'raised liver enzymes').

The risk of side effects should be described in terms of likelihood and severity, again using language that an average participant can understand (For more guidance visit 'What are the possible disadvantages and risks of taking part' above). Any adverse events that have been noted in previous studies and that are thought most likely to be due to the underlying condition should not usually be listed as likely side effects.

Potential participants need to be given clear guidance on how to report any side effects they might suffer. You should provide contact numbers/details for the reporting of any side effects. If you intend to ask a participant’s GP to feedback suspected side effects or to monitor participants for side effects, you should provide potential participants with details of these plans.

If your study involves randomising participants to different treatment groups, interventions or assessment methods you need to explain this to potential participants.

Randomisation is not a concept that many people find easy to understand. So it is important to explain that:

• You do not know which treatment/ assessment method is best and this is why you are conducting your research study, i.e. explain why you are randomising.
• If potential participants take part in your research then they will not be allocated to treatment/assessment in line with usual clinical decision-making.
• Neither the participant nor their doctor will decide which treatment/assessment will be given.
• They will be randomly allocated to a treatment/assessment, akin to drawing lots, tossing a coin or rolling a die.
• Sometimes specific details about the participant (e.g. age or gender) are used to make sure each group in the trial are as similar as possible.
• They may or may not receive the treatment/assessment and what the relative likelihood is of being in a particular group. For example, they are just as likely to receive treatment/assessment 1 as treatment/assessment 2.

Blinding
If your trial is blinded (double or single blind) you should explain that participants and/or their doctor/research team will not know which treatment they are receiving. Where appropriate, it may help to explain to potential participants that all treatments, including any placebo, will look the same as each other.

You should also explain that in an emergency you will be able to find out what treatment a participant has been receiving.

Participants should be told if they will not be informed which treatment they have received at the end of their participation (e.g. as the study as a whole may still be on-going).

If you are asking potential participants to consider taking part in a study, where screening procedures determine eligibility, you must make this clear in the Participant Information Sheet.

Potential participants need to know what they should expect during the screening procedure:

• What tests will be involved?
• When will these tests be carried out?
• Are there any risks associated with the screening procedures themselves? How likely are these, and how severe? (Further guidance is available in 'What are the possible disadvantages and risks of taking part' above).
• What is the likelihood of you discovering significant health related findings during screening and how will these be handled? (Further detail is available in 'Discovering health related findings' below).

You should also explain to potential participants what will happen if the screening procedure either includes or excludes them, so that the path from either scenario is clear.

If you intend to involve participants’ GPs in screening, including verifying medical details, you should inform potential participants of these plans.

If you intend to involve participants’ GPs in, for example:

• Screening participants to verify that they meet inclusion criteria,
• Monitoring for, or notifying you of any adverse reactions to research treatments,
• Providing you with any additional information about the participant, or
• If you intend to communicate any discovered health related findings direct to a participant’s GP

You should inform potential participants of your plans, including the types of data that you are expecting to be transferred between the research team and participants’ GPs.

The Participant Information Sheet (PIS) should describe the arrangements for care after research, particularly if this differs from standard care.

You must be clear whether participants will have continued access to any benefits or intervention that they may have obtained during their participation in your research, once the research study stops.

Unless specific arrangements have been put in place for the supply of a treatment after research, the clinical decision about what happens after the study will come under the normal limitations of the NHS commissioning arrangements so this element of the PIS should explain:

• Whether participants will, or may be, offered continued access;
• Any waiting time between the end of participation in the research and any start of continued access (where this is possible);
• Any uncertainty in what may happen after research;
• When any remaining decisions are likely to be made.

If you are running a blinded trial, you should inform potential participants whether or not they will be told which treatment they have been receiving when their participation in your trial ends.

If your study involves taking tissue samples your Participant Information Sheet should cover the following:

• Are you asking potential participants if you could access excess samples left over after a routine clinical procedure?
• Are you asking potential participants to donate new samples (perhaps in addition to routine clinical samples)?
• What types of samples would you like to collect (blood, urine, surgical samples etc)?
• How often do you intend to collect such samples from them?
• What is/are the likely size(s) of these samples?
• When and where will the samples be collected? For example will they be collected during routine visits to a clinic or will you be inviting participants to attend research clinics?
• How are you going to collect the samples (needle biopsy, blood draw etc)?
• Are there any risks associated with the collection of your research samples? You should give potential participants some idea of what they can expect in terms of the likelihood of something going wrong and how severe such an event might be.
• Is there any likelihood of discovering significant health related findings during analysis of these samples? If so, how will this be handled? (Further guidance is available in 'Discovering health related findings' below).
• What are you intending to do with the tissue samples?
• What type of consent are you asking potential participants for:
• Specific consent to use their samples in a specific, described study;
• Generic consent, which covers many possible uses. (More detail is available in 'Generic consent' below); or
• Tiered consent where you are asking for their agreement to a variety of discrete activities; (further guidance can be found in 'Generic consent' below).
• Do you intend to transfer any of these samples out of the UK for analysis? If so, you should provide potential participants with some details of what would be involved.

When establishing a research tissue bank or research database, it is likely that you will be seeking generic consent from potential participants / donors. 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. (Further guidance is available in 'Generic consent' below).

You may choose to seek tiered consent where you describe a number of discrete research activities that the 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 are relatively undefined as yet. You should only offer tiered consent if you are confident that you will be able to deliver on all aspects of consent in any combination the donor specifies.

There are many further issues explored in this guidance that you should consider including in your Participant Information Sheet, for a research database or research tissue bank, in particular on this page: Tissue samples, Generic consent, Discovering health related findings, Genetic research.

Further guidance can also be found in Supporting Information: Will my data be kept confidential?, What will happen to the samples I give? etc.

If you are providing expenses (e.g. travel, meals, child-care, compensation for loss of earnings, etc) to participants and/or others who might accompany them, you should explain this to potential participants.

It is important that potential participants understand how these payments might be influenced by their duration of involvement in your study or by factors such as the completeness of diaries they provide etc.

Further guidance is available from our 'Resources' page.

Research studies may reveal health related or incidental findings of which participants were unaware (clinically significant or otherwise). For help in considering the issues involved, and in assessing the risks and benefits of acting upon health related findings, please refer to further guidance on our 'Resources' page.

If you determine that there is a significant likelihood of uncovering health related findings during the course of your research, you should ensure that potential participants are made aware:

• That you might discover something about their health of which they are currently unaware (perhaps with some indication about how likely you think this is, and how significant such a finding might be for participants).
• Whether you intend to feedback any such health related findings to participants (you may choose not to).
• If you do intend to feedback, how will you do this and who will feedback. For example, are you asking for consent to contact the participant's GP directly with the new health information, or will you provide participants themselves with feedback and encourage them to seek further advice?
• Will you be advising participants to seek confirmation of any findings through NHS diagnostic services?
• Will you be providing any additional support or contact with other services (e.g. Patient Support Groups etc)?

This information may well not appear as a separate section within the Participant Information Sheet (PIS), but you might include details in the sections covering benefits and risks in the first part of your PIS.

You need to inform potential participants of the risks and benefits of taking part in your study, in a manner that is both sensitive to commonly expressed public concerns about genetic research, yet is still commensurate with the risks involved. You should clearly explain:

• What is the background and purpose of your genetic study?
• What samples are you going to collect and what analyses are planned?
• Could any of your results be clinically significant to participants?
• Are you planning to feedback these findings to participants? (For more guidance visit 'Discovering health related findings' above)
• If appropriate, explain that you are not planning on feeding back any genetic information to them.
• If you are planning to conduct genome-wide analyses, you should inform potential participants that due to the nature of the analyses, you might look at or analyse genes related to the specific condition under investigation as well as unrelated genes.
• If you are planning a genetic sub-study to a main study, potential participants should be able to refuse participation in the sub-study whilst still being able to take part in the main study. This should be made clear to potential participants.
• How are you going to safeguard confidentiality? (For more guidance visit 'Content > PIS > Supporting Information').

Potential participants should be told if their participation in your study might affect any insurance cover that they may have (e.g. travel insurance, protection insurance (life insurance, income protection, critical illness cover) and private medical insurance) and advise that they seek expert advice on these issues, where necessary.

If ionising radiation is going to be used as part of your research study or to support your research study, information must be provided to all potential participants about the radiation exposure(s) involved and dosage to be administered.

You should include information on all exposures, both those delivered as part of standard care as well as any additional, research specific exposures. You should make it clear which are additional to standard care.

You should describe the level of risk associated with the planned exposures, in terms of likelihood and impact, in a form of words that will be understood by most of your potential participants.

More information about ionising radiation is provided in our 'Resources' page. The 'Examples and Templates' page includes generic ionising radiation risk statements that are designed for inclusion in the Participation Information Sheet.

You should include details of the information resources that you intend to access e.g. Office for National Statistics (ONS), National Records for Scotland (NRS) / General Register Office for Scotland (GROS), NHS Central Registers or other registries including those managed by NHS Digital (formerly Health and Social Care Information Centre (HSCIC), or Information Services Division (ISD), in Scotland. For further information, please visit our 'Resources' page.

You should describe what types of information you would like access to, and how this information is going to be used.

You will also need to inform potential participants about issues around their confidentiality and how these will be managed (For more guidance visit 'Supporting Information').

Potential participants should be asked specifically to consider the use of their data that are held centrally, in the consent process. Both NHS Digital and ISD have provided a form of words that they like to see in consent forms. The suggested wording is as follows:

I understand that the information held and maintained by The Health and Social Care Information Centre (or amend as appropriate) and other central UK NHS bodies may be used to help contact me or provide information about my health status.

If there is any intention to use data or samples from your study for future research and/or if you intend to collect data or samples in order to establish a data or tissue bank/collection, you should seek generic consent. In this scenario the Participant Information Sheet (PIS) needs to inform potential participants in very general terms of your future intentions which may still be ill defined. This may include describing:

• What are the potential types of research questions the donated tissue / data might be used to address; what areas of research might they be put to?
• Are you intending to share your data and/or tissue with others (here or overseas)?
• Are you establishing a local resource that will only be used by your direct research team?
• How will you decide who has access to your collection? How are you going to decide what research priorities your collection is going to support?
• How will you ensure confidentiality is maintained?
• Is there any likelihood that you, or others with whom you might collaborate in the future, might discover health related findings relevant to individual donors? If there is, how will you handle these? (For more guidance visit 'Discovering health related findings' above).
• There are certain uses of tissue that some people feel particularly strongly about, for example genetic testing, animal testing, commercial exploitation. You should inform potential participants of any such uses that you think are likely.
• Will any tissue or data be disposed of at any time? If so, when and by what means?

You should be careful if you offer potential participants options in specifying what they can agree to and what they might decline (i.e. tiered consent). You should only offer options if you are sure you will be able to deliver on all potential participants' wishes, in any combination.

In true generic consent, potential participants are asked only to give their consent if they agree to be involved in all of the activities described in your PIS and during consent (i.e. consent for all activities or none at all).

Further guidance is available from our 'Resources' page. < >