Consent to research

Consent to research

About this guidance

In Medical practice,1 we advise doctors who are involved in research that:

17. You must be satisfied that you have consent or other valid authority before you carry out any examination or investigation, provide treatment or involve patients or volunteers in teaching or research.

Our guidance Consent: patients and doctors making decisions together2  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 supplementary 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 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 Communitybaptistpa’s advice to doctors involved in research. You must use your judgement in applying the principles in the guidance to the types of research you undertake, and to the situations you face in practice as a doctor, whether or not you hold a licence to practise. Serious or persistent failure to follow the guidance will put your registration at risk.

3

Under the Medicines for Human Use (Clinical Trials) Regulations 2004 a clinical trial means ‘any investigation in human subjects, other than a non-interventional trial, intended–

  1. to discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more medicinal products,
  2. to identify any adverse reactions to one or more such products, or
  3. to study absorption, distribution, metabolism and excretion of one or more such products, with the object of ascertaining the safety or efficacy of those products’.

An investigational medicinal product ‘means a pharmaceutical form of an active substance or placebo being tested, or to be tested, or used, or to be used, as a reference in a clinical trial, and includes a medicinal product which has a marketing authorization but is, for the purposes of the trial–

  1. used or assembled (formulated or packaged) in a way different from the form of the product authorised under the authorization,
  2. used for an indication not included in the summary of product characteristics under the authorization for that product, or
  3. used to gain further information about the form of that product as authorised under the authorization’.

Areas requiring special consideration

Research involving children or young people

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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.

15

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.

16

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.

9

References to parent or parents in this guidance mean those with parental responsibility for the child. See appendix 2 of 0-18 years: guidance for all doctors for an explanation of this term. You should also consider the views of others who are close to the child or young person but who do not have parental responsibility.

17

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 77 - 78 in Consent: patients and doctors making decisions together. 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.

77

You should aim to reach a consensus about a patient’s treatment and care, allowing enough time for discussions with those who have an interest in the patient’s welfare. Sometimes disagreements arise between members of the healthcare team, or between the healthcare team and those close to the patient. It is usually possible to resolve them, for example by involving an independent advocate, consulting a more experienced colleague, holding a case conference, or using local mediation services. You should take into account the different decision-making roles and authority of those you consult, and the legal framework for resolving disagreements.20 

78

If, having taken these steps, there is still significant disagreement, you should seek legal advice on applying to the appropriate court or statutory body for review or for an independent ruling. Patients, those authorised to act for them, and those close to them, should be informed as early as possible of any decision to start such proceedings so that they have the opportunity to participate or be represented.

18

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.

10

Medical research involving children (pdf) (Medical Research Council, 2004), Guidelines for the ethical conduct of medical research involving children (Royal College of Paediatrics and Child Health: Ethics Advisory Committee, 2000), Guidelines on the practice of ethics committees in medical research with human participants (Royal College of Physicians, 2007).

Emergency research

19

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.

20

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

21

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 

11

Paragraphs 18–21 of Consent: patients and doctors making decisions together provide guidance on sharing information.

12

Guidelines on the practice of ethics committees in medical research with human participants (Royal College of Physicians, 2007).

22

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

23

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.

24

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 part 3 of Consent: patients and doctors making decisions together,14  which gives advice on maximising a person’s ability to make decisions, and on assessing capacity.

14