Medical practice (2013).
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–
- to discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more medicinal products,
- to identify any adverse reactions to one or more such products, or
- 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–
- used or assembled (formulated or packaged) in a way different from the form of the product authorised under the authorization,
- used for an indication not included in the summary of product characteristics under the authorization for that product, or
- used to gain further information about the form of that product as authorised under the authorization’.
Information & consent forms. Guidance for researchers and reviewers (pdf) (National Research Ethics Service, 2011).
In clinical trials of investigational medicinal products, consent is only valid if it is recorded in writing. If the person is unable to give written consent, for example, if they have a disability which means that they cannot write, they can give consent orally in the presence of at least one witness and this must be recorded in writing
Paragraphs 26 - 33 of Confidentiality: good practice in handling patient information provide further advice on sharing information with others involved in care.
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.
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).
Paragraphs 18–21 of Consent: patients and doctors making decisions together provide guidance on sharing information.
Guidelines on the practice of ethics committees in medical research with human participants (Royal College of Physicians, 2007).
For the legal requirements to involve an adult without capacity in research see the Mental Capacity Act 2005 (section 31) and the Mental Capacity Act 2005 Code of Practice (chapter 11, paragraphs 11.9-11.19); Adults with Incapacity (Scotland) Act 2000 (section 51); Medicines for Human Use (Clinical Trials) Regulations 2004 (schedule 1, part 5).
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 trials involving adults who lack capacity in Scotland, a legal representative means any guardian or welfare attorney who has power to consent, or the adult’s nearest relative. In all cases, if there is no such person, a doctor not connected with the conduct of the trial but who is responsible for the medical treatment of the minor or adult, or a person nominated by the relevant healthcare provider can be approached. You should refer to the regulations for a full description.
Guidance on nominating a consultee for research involving adults who lack capacity to consent (Department of Health, 2008).
The Adults with Incapacity (Scotland) Act 2000 Part 5 Code of Practice: A short guidance to the Act provides information about guardian and welfare attorneys.
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)).
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.
Mental Capacity Act 2005 (Loss of Capacity during Research Project) (Wales) Regulations 2007.
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 of investigational medicinal products, 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).
Human Tissue Authority - Codes of Practice
The Human Tissue Authority’s Code of Practice 9 – Research advises that you can rely on generic consent but you must make sure consent is valid. If the intention is to store the tissue for an as yet unknown research purpose or as part of a tissue bank for research then this should be explained, setting out the types of research that may be involved, any wider implications and the circumstances under which the tissue will be disposed of.
Human Tissue Act 2004 (Persons who Lack Capacity to Consent and Transplants) Regulations 2006.
Summary of legal requirements for research with human tissue in Scotland (pdf) (Medical Research Council, 2007)