Consent to research A draft for consultation 1
Consent to research About the guidance Our guidance Consent: patients and doctors making decisions together (2008) 1 sets out the principles of good practice in making decisions in partnership with patients. The guidance focuses on decision-making in the context of investigations and treatment but the principles apply more widely, including decisions on taking part in research. It gives advice on sharing information and discussing treatment options, discussing side effects, complications and other risks, and making and recording decisions. You must also follow the principles in Consent: patients and doctors making decisions together (2008) where relevant 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 neonates, vulnerable people and people who lack capacity in research. Key elements in the law for seeking participant consent in clinical trials on medicinal products 2 are included in Annex B. 1 Consent: patients and doctors making decisions together (2008) www.gmc-uk.org/guidance/ethical_guidance/consent_guidance/index.asp 2 A clinical trial is defined by the Medicines and Healthcare Products Regulatory Agency (MHRA) as an investigation in human subjects which is intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more medicinal products, identify any adverse reactions or study the absorption, distribution, metabolism and excretion, with the object of ascertaining the safety and/or efficacy of those products. This definition includes pharmacokinetic studies. Medicinal products are defined by the MHRA as substances or combinations of substances which either prevent or treat disease in human beings or are administered to human beings with a view to making a medical diagnosis or to restore, correct or modify physiological functions in humans. 2
Guidance on involving children or young people in research is set out in 0-18 years: guidance for all doctors (2007) 3 Serious or persistent failure to follow the guidance will put your registration at risk. Seeking consent Valid consent 1. Seeking appropriate consent or other legal authority is fundamental to research involving people. Participants consent is legally valid and professionally acceptable only where the participants 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. Sharing information 2. You must give people the information they want or need before deciding whether to take part in research. How much information you share with people will depend on their individual circumstances. You must not make assumptions about the information a person might want or need or their knowledge and understanding of the proposed research. 3. In most cases, the information people will need to decide whether to take part in research will be included in the participant information sheet. The National Research Ethics Service gives advice on the design of information sheets and the key points they should give to people. You should follow the National Research 3 0-18 years: guidance for all doctors (2007) www.gmc-uk.org/guidance/ethical_guidance/children_guidance/index.asp 3
Ethics Service guidance if you are developing information sheets and consent forms 4. 4. You must give people any further information they ask for, including a copy of the protocol approved by the appropriate research ethics committee. You should give people a contact point where they can discuss the research project and get further information.. Give information in a way that people can understand 5. 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. You should support your discussions with simple and accurate written material or visual or other aids, where necessary. 6. You must make sure, wherever practical, that arrangements are made to meet people s language, communication and support needs. It is important to ensure that people who required additional assistance are not excluded from research and the benefits that research can offer them and the wider groups to which they belong. Responsibility for seeking consent 7. The person seeking consent must understand the research project, be familiar with the protocol, and be able to answer questions about the research project. They must be able to explain what the project will involve and any potential benefits and foreseeable risks. 4 Information & consent forms. Guidance for researchers and reviewers (National Research Ethics Service, 2007) www.nres.npsa.nhs.uk/applications/guidance/ Explaining research (National Research Ethics Service, 2008) www.nres.npsa.nhs.uk/news-and-publications/publications/nres-research-leaflets/ 4
Recording consent 8. You should ask participants to give written consent to participate in research wherever practicable. It is a legal requirement to get written consent for participation in clinical trials. Sharing information with others involved in care 9. You should seek consent to keep general practitioners and other clinicians responsible for the care of participants informed of their involvement in research. With the consent of the participant, you should provide general practitioners with any information necessary for their continuing care. Areas requiring special consideration Research involving children and young people 10. When considering involving children or young people in research, you must follow the advice in 0-18 years: guidance for all doctors (2007) 5. 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. 11. You should be familiar with the guidance about involving children and young people in research published by other relevant organisations 6, for example, the 5 0-18 years: guidance for all doctors (2007) www.gmc-uk.org/guidance/ethical_guidance/children_guidance/index.asp 6 Medical research involving children (Medical Research Council, 2004) www.mrc.ac.uk/utilities/documentrecord/index.htm?d=mrc002430 Guidelines for the ethical conduct of medical research involving children (Royal College of Paediatrics and Child Health: Ethics Advisory Committee, 2000) 5
Medical Research Council, Royal College of Paediatrics and Child Health and the Royal College of Physicians of London. 12. Specific advice on some of the legal requirements for involving children and young people under 16 in clinical trials is set out in Annex B. Research involving neonates 13. Neonates might be involved in research where, for example, treatment is available only as part of research. You must get consent from a parent 7 to involve a neonate in research. You should usually seek consent from both parents if possible. You should get research ethics committee approval for the arrangements to seek and act on consent. You should be aware that parents may feel considerable stress when a child is seriously ill and a decision about treatment is required quickly. 14. In an emergency you can involve neonates in research where it is not possible to get consent from a parent only if the research is expected to benefit the child. You must seek the consent of a parent as soon as possible to continue involving their child in the project. There are specific legal requirements for involving neonates in emergency clinical trials 8. http://adc.bmj.com/cgi/content/full/82/2/177?ijkey=4c02338a134372bb98433e55aee27951cd3f67a5& keytype2=tf_ipsecsha Guidelines on the practice of ethics committees in medical research with human participants (Royal College of Physicians, 2007) 7 References to parent or parents in this guidance means those with parental responsibility for the child. See Appendix 2 of 0-18 years: guidance for all doctors (2007) for an explanation of these terms. www.gmc-uk.org/guidance/ethical_guidance/children_guidance/appendix_2.asp 8 The Medicines for Human Use (Clinical Trials) and Blood Safety and Quality Amendment) Regulations 2008 www.opsi.gov.uk/si/si2008/uksi_20080941_en_1 6
Research involving vulnerable adults 15. Some people with capacity may be put under pressure to take part in research. You should be aware of people s health or social circumstances which might make them vulnerable to pressure from others. Vulnerable people 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 people understand the information they have been given and that they make their own decisions to take part in research. You must make sure that they know they have the right to refuse to participate in research and that they are entitled to refuse if they want to. The Royal College of Physicians of London provide further guidance on involving vulnerable groups in research 9. 16. You should raise concerns with your research team or employing or contract organisation if systems are not in place to provide the additional necessary support that vulnerable people 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 patients safety (2006) 10. Research involving adults without capacity 17. This section gives guidance about specific issues in research involving people who lack capacity. You must also follow the guidance in Consent: patients and doctors making decisions together (2008) 11, which gives advice on maximising a person s ability to make decisions and assessing capacity. The legal annexes give a summary of the law (see Annex A) and key elements of the clinical trials regulations 9 Guidelines on the practice of ethics committees in medical research with human participants (Royal College of Physicians, 2007) 10 Raising concerns about patients safety (2006) www.gmc-uk.org/guidance/current/library/raising_concerns.asp 11 Consent: patients and doctors making decisions together (2008) www.gmc-uk.org/guidance/ethical_guidance/consent_guidance/index.asp 7
(see Annex B) that govern the involvement of people over 16 who lack capacity in research. When adults without capacity might be involved in research 18. You should undertake research involving people who lack capacity only if it is related to the person s incapacity or to conditions that are linked to their incapacity. You must not involve people who lack capacity in research if the same or similar research could be undertaken by involving only people with capacity. 19. You must make sure that research has the potential to either benefit the participant and the expected benefit must outweigh the risk; or contribute to the knowledge or understanding of the person s incapacity leading to a benefit to them or others with the same incapacity and the risks must be minimal. This means that a person should not suffer harm or distress by taking part. In clinical trials, the trial must give a benefit to participants that outweighs the risks of the trial. In all cases, you must make sure that risks are kept as low as possible. Seeking to involve adults without capacity in research 20. If you are seeking to involve people who have lost capacity to consent, for example through onset or progress of a condition that has impaired their capacity (such as dementia), you should try and find out whether they have previously indicated their wishes about participating in future research, including any refusal to participate in research. You must consider any evidence of the person s previously expressed preferences, such as an advance statement or decision 12. 21. You should consider the views of people close to the person who lacks capacity before involving them in research. They are often best placed to know the 12 See the Mental Capacity Act Code of Practice (chapter 11, paragraph 11.30); Adults with Incapacity (Scotland) Act 2000 Part 5 Code of Practice (the general principles section); Medicines for Human Use (Clinical Trials) Regulations 2004 (schedule 1, part 1, section 1(5)). 8
person s wishes about taking part in research. Under the Mental Capacity Act 2005 (in England and Wales) you must consult a carer 13 about whether the person who lacks capacity should take part in the research, and what they think the person s wishes would be, if they had capacity to decide whether to take part. If the carer considers that they probably would not wish to take part you must not include the person 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 person s participation in research, or where there is no such guardian or welfare attorney, from the person s nearest relative. In clinical trials, you must get consent from the legal representative 14. Right to withdraw from research 22. You must ensure that the person 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 person from the research if the carer considers that they would wish to be withdrawn. In clinical trials, the legal representative may withdraw the person from the trial at any time. 13 A carer is involved in the person s care, interested in their welfare and is willing to help. They must not be a professional or paid care worker. Where there is no-one who meets these conditions the researcher must nominate a person to be consulted who has no connection with the research project. See the Mental Capacity Act Code of Practice (chapter 11, paragraph 11.22-11.28). 14 A legal representative under the Medicines and Human Use (Clinical Trials) Regulations 2004 means a person who is suitable to act as a legal representative for a minor (under 16) or an adult who lacks capacity for the purpose of the trial and is available and willing to do so. They must not be involved in the conduct of the trial. For clinical trials involving adults who lack capacity in Scotland, a legal representative means any guardian or welfare attorney who has power to consent or the adults nearest relative. In all cases, if there is no such person, a person not connected with the conduct of the trial who is a doctor responsible for the medical treatment of the minor or adult, or a person nominated by the relevant health care provider can be approached. You should refer to the clinical trials regulations for a full description. 9
Loss of capacity during a research project 23. Some people with capacity will agree to take part in research but 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 continued participation in the research project and follow the law 15. Research into treatment in emergencies 24. You may want to undertake urgent research into procedures or treatments used in emergencies where a person is unconscious or otherwise would be 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. In these circumstances, there are no specific legal provisions under the Adults with Incapacity (Scotland) Act 2000 which allow non-clinical trial emergency research. Under the Mental Capacity Act 2005 (in England and Wales) and the clinical trials regulations, exemptions may apply. 25. The Mental Capacity Act 2005 permits urgent research to be undertaken 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 an appropriate research ethics committee. Similarly, you can conduct a clinical trial when it needs to 15 There are specific regulations under the Mental Capacity Act 2005 for participants who gave consent before 31 March 2008 to take part in research that began before October 2007 but subsequently lost capacity to consent to continue to take part in the project. Mental Capacity Act 2005 (Loss of Capacity during Research Project) (England) Regulations 2007: www.opsi.gov.uk/si/si2007/draft/20075590.htm Mental Capacity Act 2005 (Loss of Capacity during Research Project) (Wales) Regulations 2007: www.opsi.gov.uk/legislation/wales/wsi2007/20070837e.htm There are no specific legal provisions under the Adults with Incapacity (Scotland) Act 2000 relating to the loss of capacity during research in Scotland. In clinical trials, consent from an adult to participate in a trial remains valid after loss of capacity providing the trial is not significantly altered (Medical Research Council ethics guide: medical research involving adults who cannot consent, 2007). 10
be undertaken urgently and you cannot get the consent of a legal representative if an appropriate research ethics committee has given approval for such recruitment. Research involving human tissue 26. You must keep up to date with, and comply with, the laws 16 and codes of practice that apply to the use of human organs, tissues and cells in research. The Human Tissue Authority (HTA) publishes a number of codes of practice 17, including those on consent and research, which advise on the issues you should consider when seeking consent for the purpose of research. 27. In England, Wales and Northern Ireland, the Human Tissue Act 2004 requires appropriate consent to be obtained before the storage and use of a living person s organs, tissues or cells for the purpose of research in connection with disorders, 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 appropriate consent if the researcher is unable to identify the person from whom it has come and if it is used for a specific research project which has been approved by an appropriate research ethics committee. The Human Tissue Act 2004 also requires appropriate 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, or the functioning of, the human body. 28. 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 16 Human Tissue Act 2004 www.opsi.gov.uk/acts/acts2004/ukpga_20040030_en_1 Human Tissue (Scotland) Act 2006 www.opsi.gov.uk/legislation/scotland/acts2006/asp_20060004_en_1 17 Human Tissue Authority - Codes of Practice www.hta.gov.uk/guidance/codes_of_practice 11
research. The Act does not cover the storage and use of tissue from living people for the purposes of research. 29. The Medicines for Human Use (Clinical Trials) Regulations 2004 apply to the use of tissue in clinical trials of investigational medicinal products. 12