Consent to research
About this guidance
In Good medical practice,1 we advise doctors who are involved in research that:
Arfer meddygol da (2024).
You must be satisfied that you have consent or other valid authority before examining or treating patients, or involving patients or volunteers in teaching or research. More detail about this is given in our guidance on Decision making and consent which you must follow.
Our guidance Decision making and consent2 sets out the principles of good practice in making decisions in partnership with patients. That guidance focuses on decision making in the context of investigations and treatment, but the principles apply more widely, including to decisions on taking part in research. It gives advice on sharing information, discussing side effects, complications and other risks, and making and recording decisions. When relevant, you must follow the principles it sets out when seeking people’s consent to take part in research.
This guidance is intended to explain how good practice principles in making decisions and seeking consent apply to research. It also provides advice on involving in research children or young people, vulnerable people, and people who lack capacity to consent.
Annex B explains the key elements of the legislation for seeking people’s consent to take part in clinical trials of investigational medicinal products.3
You should read this guidance, which forms part of the professional standards, in conjunction with our other guidance, in particular:
- Good practice in research, which sets out the principles on which good practice in research is founded,
- Confidentiality: good practice in handling patient information,4 which gives guidance on research and other secondary uses of data, and
- 0–18 years: guidance for all doctors, which gives additional advice on research involving children or young people.
Together, these guidance documents set out the GMC’s advice to doctors involved in research. The professional standards describe good practice, and not every departure from them will be considered serious. You must use your professional judgement to apply the standards to your day-to-day practice. If you do this, act in good faith and in the interests of patients, you will be able to explain and justify your decisions and actions. We say more about professional judgement, and how the professional standards relate to our fitness to practise processes, appraisal and revalidation , at the beginning of Good medical practice.
O dan y Rheoliadau Meddyginiaethau i’w Defnyddio gan Bobl (Treialon Clinigol) 2004, mae treial clinigol yn golygu ‘unrhyw ymchwiliad mewn pynciau dynol, ar wahân i dreial heb fod yn ymyriadol a’i nod yw –
- darganfod neu wirio effeithiau clinigol, ffarmacolegol neu ffarmacodeinamig un neu’n fwy o gynhyrchion meddyginiaethol,
- nodi unrhyw adweithiau andwyol i un neu’n fwy o’r cynhyrchion hynny, neu
- astudio amsugnad, dosbarthiad, metaboliaeth ac ysgarthiad un neu’n fwy o’r cynhyrchion hynny, gyda’r amcan o gadarnhau diogelwch neu effeithlonrwydd y cynhyrchion hynny.
Mae cynnyrch meddyginiaethol ymchwiliol ‘yn golygu ffurf fferyllol o sylwedd weithgar neu blasebo yn cael ei brof, neu a fydd yn cael ei brof, neu a ddefnyddiwyd neu a fydd yn cael ei ddefnyddio, fel cyfeiriad mewn treial clinigol, ac mae’n cynnwys cynnyrch meddyginiaethol a chanddo awdurdodiad marchnata ond sydd, at ddibenion y treial –
- wedi’i ddefnyddio neu ei roi at ai gilydd (wedi’i ffurfo neu becynnu) mewn ffordd wahanol i ffurf y cynnyrch a awdurdodwyd o dan yr awdurdodiad
- wedi’i ddefnyddio am arwydd heb ei gynnwys yn y crynodeb o nodweddion cynhyrchion o dan yr awdurdodiad am y cynnyrch hwnnw, neu
- wedi’i ddefnyddio i gael mwy o wybodaeth am ffurf y cynnyrch hwnnw fel a awdurdodwyd o dan yr awdurdodiad’.
Seeking consent
Valid consent
Seeking consent is fundamental in research involving people. Participants’ consent is legally valid and professionally acceptable only if they have the capacity to decide whether to take part in the research, have been properly informed, and have agreed to participate without pressure or coercion.
When conducting research involving people who cannot consent for themselves, you must follow the guidance that applies, such as the advice on research involving children or young people in paragraphs 14 - 20 and on adults who lack capacity in paragraphs 23 - 25.
When considering involving children or young people in research, you must follow the advice in 0–18 years: guidance for all doctors.8 It gives advice on the circumstances in which children or young people can be involved in research, effective communication with children and young people, and assessing capacity to consent. It also explains the different legal requirements across the UK for 16 and 17-year olds who lack capacity to consent.
There are particular considerations in relation to seeking and acting on consent for children or young people to participate in research. As part of seeking approval for the project from a research ethics committee, you must clearly explain the arrangements for getting consent and seek advice if necessary.
Before involving a child or young person in research you must get consent from a parent,9 but you should get consent from both parents, if possible, particularly if the research involves more than low or minimal risk of harm. If a parent is under 16 years of age, you must get consent from them if they have the capacity to make a decision about whether their child should take part in the research project. If a child or young person is able to consent for themselves, you should still consider involving their parents, depending on the nature of the research.
You should aim to reach a consensus with parents about a child or young person’s participation in research. If disagreements arise it is usually possible to resolve them informally, and you should follow the advice in paragraphs 92-93 Decision making and consent. If disagreements cannot be resolved informally, you should not involve the child or young person in research, unless the treatment can be accessed only as part of a research project and you assess that it is in their best interests. In these circumstances, if the decision about entering the child or young person in research has significant consequences for the child or young person, you should seek legal advice about whether you should apply to the appropriate court for an independent ruling.
You should be familiar with the guidance on involving children or young people in research published by other relevant organisations,10 for example, the Medical Research Council, the Royal College of Paediatrics and Child Health, the Royal College of Physicians of London, and the British Medical Association.
Annex B contains specific advice on some of the legal requirements for involving children or young people under 16 in clinical trials of investigational medicinal products.
Circumstances may arise where involvement in research has the potential to benefit a child or young person who lacks capacity, but an urgent decision about the child’s involvement needs to be made before it is possible to get consent from a parent. This may arise because a parent cannot reasonably be contacted, or they do not have capacity to consent because of their own condition or distress. In such cases you can involve a child or young person in research if you have the approval of a research ethics committee for such recruitment. You must seek the consent of a parent as soon as possible to continue involving them in the project.
There are specific legal requirements that relate to involving children or young people under 16 in emergency clinical trials of investigational medicinal products. Annex B contains further guidance on the legal requirements in these circumstances.
This section gives guidance about specific issues in research involving adults who lack capacity. It sets out the key elements of the law that governs the involvement of people over 16 who lack capacity to consent. Annex A contains a summary of the law in this area, and annex B explains the key elements of the legislation that governs clinical trials of investigational medicinal products in the UK.
You must assess an adult’s capacity to make a particular decision at the time it needs to be made. You must follow the guidance in paragraphs 76, 78-79 and 84-86 of Decision making and consent,14 which gives advice on maximising a person’s ability to make decisions, and on assessing capacity.
You must only undertake research involving an adult who lacks capacity if it is related to their incapacity or its treatment. You must not involve in research adults who lack capacity if the same or similar research could be undertaken by involving only people with capacity.
Right to withdraw from research
You must make sure that people are informed of, and that you respect, their right to decline to take part in research and to withdraw from the research project at any time, with an assurance that this will not adversely affect their relationship with those providing care or the care they receive. You should tell people if the treatment options available to them might be affected by a decision to withdraw from a research project.
Giving information in a way that people can understand
You must make sure that people are given information in a way that they can understand. You should check that people understand the terms that you use and any explanation given about the proposed research method. If necessary, you should support your discussions with simple and accurate written material or visual or other aids.
You must make sure, whenever practical, that arrangements are made to meet people’s language, communication and other support needs. It is important to make sure that people who require additional assistance are not excluded from research and from the benefits that research can offer them and the wider groups to which they belong.
Responsibility for seeking consent
If you are responsible for seeking consent, you must understand the research project, including what the project will involve and any anticipated benefits and foreseeable risks.
If you delegate the responsibility to someone else, you must make sure they have sufficient understanding of the research project, and the appropriate skills and competence to seek consent.
Recording consent
You should record the key elements of your discussion with people about their decision to take part in research. If practical, you should ask them, or someone with valid authority, to give written consent. It is a legal requirement to get written consent from participants in clinical trials of investigational medicinal products.6
Mewn treialon clinigol o gynhyrchion meddyginiaethol ymchwiliol, mae’r caniatâd ond yn ddilys os caiff ei gofnodi ar bapur. Os na all y person roi caniatâd ysgrifenedig, er enghraifft os oes ganddynt anabledd sy’n golygu na allant ysgrifennu, gallant roi caniatâd ar lafar ym mhresenoldeb o leiaf un tyst a rhaid cofnodi hyn ar bapur.
Areas requiring special consideration
Research involving children or young people
When considering involving children or young people in research, you must follow the advice in 0–18 years: guidance for all doctors.8 It gives advice on the circumstances in which children or young people can be involved in research, effective communication with children and young people, and assessing capacity to consent. It also explains the different legal requirements across the UK for 16 and 17-year olds who lack capacity to consent.
There are particular considerations in relation to seeking and acting on consent for children or young people to participate in research. As part of seeking approval for the project from a research ethics committee, you must clearly explain the arrangements for getting consent and seek advice if necessary.
Before involving a child or young person in research you must get consent from a parent,9 but you should get consent from both parents, if possible, particularly if the research involves more than low or minimal risk of harm. If a parent is under 16 years of age, you must get consent from them if they have the capacity to make a decision about whether their child should take part in the research project. If a child or young person is able to consent for themselves, you should still consider involving their parents, depending on the nature of the research.
Mae cyfeiriadau at riant neu rieni yn yr arweiniad hwn yn golygu’r rhai a chanddynt gyfrifoldeb rhiant am y plentyn. Gweler atodiad 2 o 0-18 oed: arweiniad i bob meddyg am esboniad o’r term hwn. Dylech hefyd ystyried safbwyntiau pobl eraill sy’n agos i’r plentyn neu’r person ifanc ond nad oes ganddynt gyfrifoldeb rhiant.
You should aim to reach a consensus with parents about a child or young person’s participation in research. If disagreements arise it is usually possible to resolve them informally, and you should follow the advice in paragraphs 92-93 Decision making and consent. If disagreements cannot be resolved informally, you should not involve the child or young person in research, unless the treatment can be accessed only as part of a research project and you assess that it is in their best interests. In these circumstances, if the decision about entering the child or young person in research has significant consequences for the child or young person, you should seek legal advice about whether you should apply to the appropriate court for an independent ruling.
You should be familiar with the guidance on involving children or young people in research published by other relevant organisations,10 for example, the Medical Research Council, the Royal College of Paediatrics and Child Health, the Royal College of Physicians of London, and the British Medical Association.
Annex B contains specific advice on some of the legal requirements for involving children or young people under 16 in clinical trials of investigational medicinal products.
Medical research involving children (pdf) (Cyngor Ymchwil Feddygol, 2004), Guidelines for the ethical conduct of medical research involving children (Coleg Brenhinol Paediatreg ac Iechyd Plant: Pwyllgor Ymgynghorol Moeseg, 2000). Guidelines on the practice of ethics committees in medical research with human participants (Coleg Brenhinol y Meddygon, 2007).
Emergency research
Circumstances may arise where involvement in research has the potential to benefit a child or young person who lacks capacity, but an urgent decision about the child’s involvement needs to be made before it is possible to get consent from a parent. This may arise because a parent cannot reasonably be contacted, or they do not have capacity to consent because of their own condition or distress. In such cases you can involve a child or young person in research if you have the approval of a research ethics committee for such recruitment. You must seek the consent of a parent as soon as possible to continue involving them in the project.
There are specific legal requirements that relate to involving children or young people under 16 in emergency clinical trials of investigational medicinal products. Annex B contains further guidance on the legal requirements in these circumstances.
Research involving vulnerable adults
Some adults with capacity may be vulnerable to pressure to take part in research. You should be aware that their health or social circumstances might make them vulnerable to pressure from others. Vulnerable adults may be, for example, living in care homes or other institutions, or have learning difficulties or mental illness. In these circumstances, it is particularly important that you check whether they need any additional support to understand information or to make a decision.11 You must make sure that they know they have the right to decline to participate in research, and that they are able to decline if they want to. The Royal College of Physicians of London provides further guidance on involving vulnerable groups in research.12
Mae paragraffau 11, 13b, 21, 27-29 Gwneud penderfyniadau a chaniatâd yn rhoi arweiniad am rannu gwybodaeth.
Guidelines on the practice of ethics committees in medical research with human participants (Coleg Brenhinol y Meddygon, 2007).
You should raise concerns with a senior colleague, or your employing or contracting organisation, if systems are not in place to provide the additional support that vulnerable adults may need to make a decision about taking part in research. If you are not sure when or how to raise concerns, you should follow the guidance in Raising concerns about patient safety.13
Research involving adults without capacity
This section gives guidance about specific issues in research involving adults who lack capacity. It sets out the key elements of the law that governs the involvement of people over 16 who lack capacity to consent. Annex A contains a summary of the law in this area, and annex B explains the key elements of the legislation that governs clinical trials of investigational medicinal products in the UK.
You must assess an adult’s capacity to make a particular decision at the time it needs to be made. You must follow the guidance in paragraphs 76, 78-79 and 84-86 of Decision making and consent,14 which gives advice on maximising a person’s ability to make decisions, and on assessing capacity.
When adults without capacity might be involved in research
You must only undertake research involving an adult who lacks capacity if it is related to their incapacity or its treatment. You must not involve in research adults who lack capacity if the same or similar research could be undertaken by involving only people with capacity.
You should only involve in research adults who lack capacity, including clinical trials of investigational medicinal products, if the research is expected to provide a benefit to them that outweighs the risks. Research, not including clinical trials of investigational medicinal products, may also involve adults who lack capacity if the research is not expected to provide a direct benefit to them but is expected to contribute to the understanding of their incapacity, leading to an indirect benefit to them or others with the same incapacity, and if the risks are minimal. This means that the person should not suffer harm or distress by taking part. In all research involving adults who lack capacity, you must make sure that the foreseeable risks are kept as low as possible.15
Children Act 1989, Children Act (Northern Ireland) Order 1995 and Children Act (Scotland) 1995 give competent young people statutory rights to refuse medical or psychiatric assessments or examinations directed by the court or a children’s hearing for purposes of an interim care, supervision, child protection or emergency protection order or, in Scotland, a supervision requirement, assessment, protection or place of safety order. A young person’s refusal can be overridden in England, Wales and Northern Ireland by the inherent jurisdiction of the High Court (see South Glamorgan County Council v W & B [1993] 1 FLR 574). The position is less clear in Scotland; see Age of Legal Capacity (Scotland) Act 1991.
Seeking to involve adults without capacity in research
You should consider the views of people close to the adult who lacks capacity to consent before involving that person in a research project. They are often best placed to know the person’s wishes about taking part in research. In clinical trials of investigational medicinal products, you must get consent from a legal representative.16
Mae cynrychiolydd cyfreithiol o dan Reoliadau Meddyginiaethau i’w Defnyddio gan Bobl (Treialon Clinigol) 2004 yn golygu person sy’n addas i weithredu fel cynrychiolydd cyfreithiol plentyn dan oed (o dan 16 oed) neu oedolyn a chanddo ddiffyg gallu at ddiben y treial ac mae ar gael ac yn fodlon gwneud hynny. Rhaid iddynt beidio â bod ynghlwm yng nghyfawniad y treial. O ran treialon sy’n cynnwys oedolion a chanddynt ddiffyg gallu yn yr Alban, mae cynrychiolydd cyfreithiol yn golygu unrhyw warcheidwad neu dwrnai lles a chanddo’r grym i roi caniatâd, neu berthynas agosaf yr oedolyn. Ym mhob achos, os nad oes person felly, gellir troi at feddyg nad yw’n gysylltiedig â gwaith cynnal y treial ond sy’n gyfrifol am driniaeth feddygol plentyn dan oed neu oedolyn, neu berson a enwir gan y darparwr gofal iechyd perthnasol. Dylech gyfeirio at y rheoliadau am ddisgrifad llawn.
Under the Mental Capacity Act 2005 (in England and Wales) you must consult a consultee17 about whether the adult who lacks capacity should take part in the research, and what they think that person’s wishes would be if they had capacity to decide for themselves. If the consultee considers that they probably would not wish to take part, you must not include them in the research. Under the Adults with Incapacity (Scotland) Act 2000, you must get consent from any guardian or welfare attorney who has power to consent to the adult’s participation in research or, if there is no such guardian or welfare attorney, from the person’s nearest relative.18
Guidance on nominating a consultee for research involving adults who lack capacity to consent (Yr Adran Iechyd, 2008).
Mae Adults with Incapacity (Scotland) Act 2000 Part 5 Code of Practice: A short guidance to the Act yn rhoi gwybodaeth am warcheidwaid a thwrneiod lles.
If you are seeking to involve an adult who has lost capacity to consent, for example, through onset or progress of a condition that has impaired their capacity, such as dementia, you should take all reasonable steps to find out whether they have previously indicated their wishes about participating in future research, including any refusal to participate. You must consider any evidence of the person’s previously expressed preferences, such as an advance statement or decision.19
Gweler Cod Ymarfer y Ddeddf Galluedd Meddyliol (pennod 11, paragraff 11.30); Adults with Incapacity (Scotland) Act 2000 Part 5 Code of Practice (y rhan egwyddorion cyffredinol); Rheoliadau Meddyginiaethau i’w Defnyddio gan Bobl 2004 (atodlen 1, rhan 1, adran 1(5)).
Right to withdraw from research
You must make sure that a participant’s right to withdraw from research is respected. You should consider any sign of objection, distress or indication of refusal, whether or not it is spoken, as implied refusal. Under the Mental Capacity Act 2005 (in England and Wales) you should usually withdraw the participant from the research if the consultee considers that they would wish to be withdrawn. In clinical trials of investigational medicinal products, the legal representative can withdraw the participant from the trial at any time.
Loss of capacity during a research project
Some people with capacity will consent to take part in research, but then may lose capacity before the end of the project. If you become aware that a participant has lost capacity, you should consider carefully the benefits and harm that could occur from their continued participation in the research, and you must follow the law that applies where you work.20
Ceir rheoliadau penodol o dan Ddeddf Galluedd Meddyliol 2005 i gyfranogwyr a roddodd ganiatâd cyn 31 Mawrth 2008 i gymryd rhan mewn ymchwil a ddechreuodd cyn Hydref 2007 ond a gollodd allu i ganiatáu i barhau i gymryd rhan yn y prosiect yn dilyn hynny.
Mental Capacity Act 2005 (Loss of Capacity during Research Project) (England) Regulations 2007.
Rheoliadau Deddf Galluedd Meddyliol 2005 (Colli Galluedd yn ystod Prosiect Ymchwil (Cymru) 2007.
Nid oes unrhyw ddarpariaethau cyfreithiol penodol o dan yr Adults with Incapacity (Scotland) Act 2000 sy’n ymwneud â cholli gallu yn ystod ymchwil yn yr Alban.
Mewn treialon clinigol o gynhyrchion meddyginiaethol ymchwiliol, mae caniatâd oedolyn i gymryd rhan mewn treial yn parhau’n ddilys ar ôl colli gallu os na newidir y treial yn sylweddol (Medical Research Council ethics guide: medical research involving adults who cannot consent, 2007).
If you are seeking to involve a person in research who you believe may lose capacity during the course of the project, you should consider seeking their views about the circumstances in which they would wish to continue to participate. You should explain to them the steps that would be taken to decide whether they should continue to take part and how their wishes, if known, would be taken into account.
Research into treatment in emergencies
You may want to undertake urgent research into procedures or treatments used in emergencies when a person is unconscious or otherwise unable to make a decision. In an emergency situation it is not always possible to get consent to involve a person in research using the standard consent procedures.
The Mental Capacity Act 2005 permits urgent research in emergencies to start when it is not practical to consult someone about involving a person who lacks capacity in research. In this situation you must either get agreement from a doctor not involved in the research, or follow a procedure approved by a research ethics committee. Similarly, you can start a clinical trial of investigational medicinal products when it needs to be undertaken urgently if you cannot get the consent of a legal representative, as long as a research ethics committee has given approval for such action. The Adults with Incapacity (Scotland) Act 2000 provides for emergency clinical trials of investigational medicinal products but not for other types of emergency research. If this situation arises you should seek legal advice on how to proceed.
You must follow the law on continuing to involve in emergency research an adult who lacks capacity. You must get consent from the adult as soon as possible if they recover capacity.
Research involving human tissue
You must keep up to date with, and comply with, the laws and codes of practice that apply to the use in research of human organs, tissue and cells. The Human Tissue Authority (HTA) publishes a number of codes of practice,21 including those on consent and research, which advise on the issues you should consider when seeking consent for the purpose of research.
Yr Awdurdod Meinwe Ddynol – Codau Ymarfer.
In England, Wales and Northern Ireland, the Human Tissue Act 2004 requires consent22 to be obtained before the storage and use of a living person’s organs, tissue or cells for the purpose of research in connection with disorders in, or the functioning of, the human body. In a number of specific circumstances, there are exceptions to the consent requirements; for example, a living person’s organs, tissue or cells may be stored and used without consent if the researcher is unable to identify the person it has come from, and if it is used for a specific research project that has been approved by a research ethics committee. The Human Tissue Act 2004 also requires consent to be obtained for the removal, storage and use of a deceased person’s organs, tissue and cells for the purpose of research in connection with disorders in, or the functioning of, the human body. Regulations23 made under the Human Tissue Act 2004 permit the use and storage of organs, tissue or cells from adults who lack capacity for research under certain circumstances.
Mae Code of Practice 9 – Research yr Awdurdod Meinwe Ddynol yn cynghori y gallwch ddibynnu ar ganiatâd generig ond rhaid i chi wneud yn siŵr bod y caniatâd yn ddilys. Os mai’r bwriad yw storio’r feinwe at ddiben ymchwil nad yw’n hysbys eto neu fel rhan o gronfa feinwe ar gyfer ymchwil, dylid esbonio hyn gan nodi’r mathau o ymchwil a allai gael eu cynnwys, unrhyw oblygiadau ehangach a’r amgylchiadau y bydd y feinwe’n cael eu gwaredu oddi tanynt.
Deddf Meinwe Ddynol 2004 Rheoliadau (Pobl a Chanddynt Ddiffyg Galluedd i Ganiatáu a Thrawsblaniadau) 2006.
The Human Tissue (Scotland) Act 2006 requires authorisation to be obtained before the storage and use of a deceased person’s organs, tissue or cells for the purposes of research.24 The Act does not cover the storage and use of tissue from living people for the purposes of research.
Summary of legal requirements for research with human tissue in Scotland (pdf) (Cyngor Ymchwil Feddygol, 2007).
The Medicines for Human Use (Clinical Trials) Regulations 2004 apply to the use of tissue in clinical trials of investigational medicinal products.
