Subjects must give their informed consent before being entered into a trial*. Consent should be obtained before the first trial-specific activity is undertaken. For Clinical Trials of Investigational Medicinal Products (CTIMPs), Schedule 1 of The Medicines for Human Use (Clinical Trials) Regulations 2004 describes the requirements for consent.
*With the exception of certain emergency trials involving vulnerable subjects (minors or incapacitated adults – please see below).
For each trial, specific consent documentation consisting of a participant information sheet and consent form must be developed and approved by the ethics committee. The HRA consent web pages contain a range of documents including guidance and templates for preparing the consent documentation. It should be noted that involvement of patient groups when developing the consent process/documentation is looked upon favourably by ethics committees (see HRA Consent and Participant Information Sheet Preparation Guidance).
Throughout the trial, the subject’s willingness to continue participation should be reaffirmed periodically. However, if significant new information becomes available, subjects are provided with revised (and re-approved) consent documentation so that written consent can be formally documented if the subject is willing to continue.
For CTIMPs in Scotland, the legal provisions for incapacitated adults are slightly different. The legal representative will be the person who is able to consent to treatment under Section 51 of the Adults with Incapacity (Scotland) Act 2000 and as detailed in Part 1, 2(b) of Schedule 1. In Northern Ireland, it is currently governed by common law.
**A legal representative would only give consent on behalf of a minor in the rare circumstance that a person with parental responsibility is not available prior to their proposed inclusion by reason of the emergency nature of the treatment.
Informed Consent in Clinical Trials published by the HRA, outlines the hierarchy for consent using personal or professionallegal representatives. This document also describes the changes brought about by SI 2008 941 and SI 2006 2984 which amended provisions for consent in the emergency setting for minors (see section 16) and for incapacitated adults (see section 21).
For CTIMPs in Scotland, the legal provisions for incapacitated adults are slightly different. The legal representative will be the person who is able to consent to treatment under the Adults with Incapacity (Scotland) Act 2000 and as detailed in Part 1, 2(b) of Schedule 1.
Research other than CTIMPs:
Access of Patient Information for Research Without Consent
In certain research studies, there may be sufficient justification to access confidential patient information without consent. Section 251 of the NHS Act 2006 allows the Secretary of State for Health to make regulations to set aside the common law duty of confidentiality for defined medical purposes. The HRA took on responsibility for Section 251 and has established the Confidentiality Advisory Group (CAG).
The MRC Data and Tissue Toolkit provide further guidance on aspects of consent for the use of data and tissue in research.
General Data Protection Regulations (GDPR)
The GDPR requires organisations to publish transparency information when processing personal data for health and care research. Suitable transparency wording for public sector sponsors to use in participant information sheets can be accessed from the HRA website, along with comprehensive guidance.
Consent methods in paediatric emergency and urgent care trials
The CONNECT guidance was developed for all those who have a direct or indirect role in the funding, design, conduct and ethical review of paediatric or neonatal trials that involve critically ill children.
Clinical research involving children is essential to improve healthcare for children, yet there is evidence that health professions often feel uneasy about asking children and their families to take part in clinical trials. This brief guidance and further resources from the Nuffield Council on Bioethics can help researchers when seeking consent for children’s participation in clinical research
The MRC Hubs for Trial Methodology Research
The MRC HTMR have a number of other resources relevant to consent:
The Quintet Recruitment Intervention (QRI) aims to facilitate informed decision making by patients about RCT participation
This review provides an introduction to qualitative research techniques and explains how this approach can be used to understand, and subsequently improve, recruitment and informed consent within a range of clinical trials.
This paper describes three key techniques that recruiters can use to address patients’ treatment preferences to facilitate recruitment and informed consent.
Clinicians’ personal views about trial treatments can encroach on their ability to convey equipoise to patients. This article identifies broad practices that support or hinder equipoise communication.
The DevPICv2 provides a measure of informed consent that can be applied directly to recruitment appointments where trial participation is discussed in order to evaluate the quality of recruiter information provision and evidence of patient understanding.
The Q-QAT (Quanti-Qualitative Appointment Timing) is a simple technique to systematically identify key challenges to recruitment that stem from how the RCT and treatments are portrayed to patients in recruitment appointments. It can be used as a stand-alone intervention to assist in understanding RCT recruitment or as part of the development of strategies to improvement recruitment and informed consent.
- ICH GCP (E6) R2: (Section 4.8) Informed Consent of Trial Subject.
- The Clinical Trials Transformation Initiative (CTTI), a US public-private partnership, has produced guidance and tools relating to informed consent.
- MRC: Guidance on patient consent (including research involving children and adults who lack capacity).
- GMC: Consent to Research.
- INVOLVE: Public Involvement in Research: Impact on Ethical Aspects of Research (PDF, 528 KB).
- WMA: Declaration of Helsinki.