They should be given the opportunity to ask questions about the study to help them decide if they want to take part. Consent to take part in the study must be recorded in writing – signed and dated by all parties - with a copy given to the participant with the information sheet, copy stored in the medical notes, and a copy kept securely with the research data. This should also clearly state the participants right to withdraw from the study.
Capacity/competence to decide
• GMC Guidelines on seeking patient’s consent http://www.gmc-uk.org/standards • GAfREC – Governance Arrangements for NHS Research Ethics Committees http://www.dh.gov.uk/assetRoot/04/05/ 86/09/0458609.pdf • COREC – Central Office for Research Ethics Committees http://www.corec.org.uk/wordDocs/pis.doc
Valid informed consent for participation in research must be given voluntarily, without coercion, in light of sufficient information by legally competent individuals.
• Research Governance Framework Leaflet Series #1-12 Available from R&D below.
You must work on the presumption that every adult has the capacity to decide to consent or refuse to participate in a study, unless it is shown that they cannot understand the information presented to them.
For further information contact:
Special requirements apply to research involving children and vulnerable groups. Please contact the Research Ethics Committee for advice. Please note: In English Law no adult can give proxy consent for another adult to be enrolled in research in the event of incapacity.
Recommended reading • Research Governance Framework in Health and Social Care (2005) http://www.dh.gov.uk/PolicyAndGuidance/ ResearchAndDevelopment/fs/en • Department of Health consent pages http://www.dh.gov.uk/PolicyAndGuidance/ HealthAndSocialCareTopics/Consent/fs/en • Medical research Council – Ethics Series http://www.mrc.ac.uk
Research governance framework leaflet series
Informed consent in research
PCT Research Governance Facilitators R&D Department, Room 310, Learning Centre, Huddersfield Royal Infirmary, Lindley, Huddersfield, HD3 3EA. Tel: 01484 347007 Or Airedale, Calderdale and Huddersfield Research Ethics Committee, Fleming House, Airedale General Hospital Keighley, BD20 6TD. Tel: 01535 294657 Or for North Kirklees PCT:
PCT Leaflet No. 9
Wakefield District REC, Wakefield West PCT, White Rose House, West Parade, Wakefield WF1 1LT. Tel: 01924 213110
This leaflet was created by Calderdale and Huddersfield NHS Trust on behalf of the 4 PCTs © Calderdale & Huddersfield NHS Trust 2005
Calderdale Primary Care Trust, Huddersfield Central Primary Care Trust, North Kirklees Primary Care Trust and South Huddersfield Primary Care Trust
Research governance framework leaflet series Informed consent in research The Research Governance Framework (RGF) (2005) aims to improve research quality and safeguards the public by: • Enhancing ethical and scientific quality • Promoting good practice • Reducing adverse incidents and ensuring lessons are learned • Preventing poor performance and misconduct. This leaflet aims to explain the requirements and implications of the RGF with particular reference to Informed Consent.
What is Informed Consent? The RGF states that all research within the NHS should have arrangements in place for obtaining consent from participants. Potential participants should be given sufficient information about a study, in a format they understand, so they can make an informed decision as to whether or not to take part in a research study. In general the same principles apply to consent in research and clinical practice. Consent should always be: • Voluntary – without any direct or indirect coercion or inducement. • Informed – sufficient information about the study should be provided so participation can be determined.
• In writing – should involve participants giving written consent.
Why is informed consent in research so important? The dignity, rights, safety and well-being of participants must be the primary consideration in any research project. All studies must have the necessary arrangements in place for obtaining consent and the ethical review process will pay particular attention to those arrangements you have outlined.
When is it necessary to obtain informed consent? Informed consent should be obtained for research which involves interventions, observations or interviews with patients or health volunteers (including NHS employees) and/or their tissue or data relating to them. Consent for the user of existing anonymised datasets or tissue which was not collected for research purposes, must be gained from the Caldicott Guardian via the R&D approvals process.
Seeking informed consent The Principal Investigator (PI) has the overall responsibility for the consent process. However it can be delegated to another appropriately qualified person to obtain consent from prospective participants. However, that person should have sufficient knowledge of the study in order to adequately brief participants.
data must be reviewed by an NHS ethics committee before the study commences. The REC will ask for detailed information about how participants will be recruited and how consent will be obtained.
Providing information to participants Before recruited to a study, potential participants should be given information about the study and implications for their participation. It is appropriate to have a leaflet or information sheet summarising key points about the study. It should also address the likely concerns of participants. The text should be presented in a clear and easy to understand format. The wording should be accessible to participants in both language and style. Information should be translated into likely language(s) of participants or an interpreter should be provided. The information should include: • The identity of the researchers • The purpose of the research • Explanation of complex procedures • Others associated with the research identified • Explanation of why the participant has been selected • Harms and benefits • Privacy, anonymity and confidentiality • Future use of information • Right not to participate and withdraw • Time to decide
NHS Research Ethics Committee Approval All research involving patients, service users, care professionals, volunteers, their tissue or
• Other information. The information should be given to the person when they are approached about the study.