Since the inception of the Research Governance Framework for Health & Social Care  there has been an emphasis on reducing research related risks and adverse events, and enhancing the quality and safety of health research in the UK (1).  Informed consent procedures play a key role in addressing quality and safety in research.  All too often informed consent is not treated as a process but it is wrongly viewed as a signature on a form.  There are risks for researchers and patients alike in this regard.   

Valid informed consent for participation in research must be given voluntarily, in light of sufficient information by legally competent individuals.  This essentially involves four elements: information giving, understanding by participants, a participant's sense of voluntariness, and a decision-making capacity (2).       

Where to get advice and guidance: many professional bodies offer guidance on research involving the consent process, and particular attention is given to research involving children or adults who lack the capacity to consent (3, 4, 5).  Psychiatry is one example of where obstacles exist in establishing an ethical framework for informed consent that inspires confidence in patients who participate in research (6).  The British Psychological Society for example, offers guidance on issues which may affect the person's ability to give free informed consent, as in the case of prison based research (7).  The National Research Ethics Service, formerly COREC, frequently updates it's guidance on designing information sheets and consent forms for health and social care research (8).  

Common breaches in the informed consent process include simple and avoidable errors, such as failing to document consent processes appropriately.  Where NHS service users are concerned, proper documentation of the consent process would entail recording the process in the person's medical care notes, enclosing the original signed consent form.  It is considered good practice to give the person a copy of the information and signed consent and to retain a further copy for the study file.  Without documentary evidence of consent having been obtained there are serious implications for the researcher, leading to possible disciplinary procedures relating to research misconduct.      

A further example of common poor practice in the informed consent process concerns the timing of consent.  Potential research participants are often approached in a hurried fashion.  Although it is good practice but not a legal requirement to give participants a minimum of 24 hours to consider their involvement in research, any less time could be perceived as insensitive and coercive.        

Some researchers, defensively, monitor their own consent procedures by requesting anonymous feedback from participants.  Auditing or monitoring research procedures was once the tool of commercial research sponsors but this has been widely adopted in the public sector.  There are potential rewards and difficulties associated with monitoring the informed consent process. The rewards include helpful and reassuring feedback from participants and also an opportunity to change practice and culture within an organisation.  The difficulty with monitoring relates to participant recall, for example, in research involving vulnerable elderly participants their recall of the consent process may not be relied upon.  Furthermore, inviting negative feedback may also lead to legal action from research participants.                   

There are instances in which obtaining informed consent may be impracticable, for example, epidemiological or surveillance research.  In such cases PIAG approval must be sought.  The Patient Information Advisory Group was established in response to section 60 of the Health & Social Care Act (9).  The purpose of section 60 is to allow organisations to obtain personally identifiable information, for medical purposes, in circumstances where it is impracticable to obtain informed consent from the persons concerned.  Studies normally supported by the British Paediatric Surveilance Unit for example, have no patient contact and consent is not sought.  However, PIAG approval must be sought (10), and assurance of compliance with the Data Protection Act 1998 (11) and Caldicott Report 1997 (12) must be provided, as well as detailed information about steps taken to safeguard confidentiality. 

The message is simple: obtain consent whenever possible, ensuring that it is given voluntarily by fully informed, competent individuals.  If consent is not practicable do seek an opinion from appropriate authorities such as PIAG or the National Research Ethics Service.    

1. Department of Health.  Research Governance Framework for Health and Social Care 2^nd Edition, 2005.

2. Pedroni J., & Pimple K. (2001).  A brief introduction to informed consent in research with human subjects.    http://poynter.indiana.edu/sas/res/ic.pdf  

3. Medical Research Council: www.mrc.ac.uk/policyguidance/EthicsAnd Governance/InformedConsent/index.htm. 

4. Office for protection from research risks www.hhs.gov/ohrp/humansubjects/guidance/ictips.htm

5. General Medical Council www.gmc-uk.org/guidance/current/library/consent.asp

6. Davies, T. (2001) Editorial, British Journal of Psychiatry 178:397-398.

7. British Psychological Society.  Ethical Principles for conducting research with human participants www.bps.org.uk

8. National Research Ethics Service http://www.nres.npsa.nhs.uk   

9. Patient Information Advisory Group. http://www.advisorybodies.doh.gov.uk/piag/

10. British Paediatric Surveillance Unit.  http://bpsu.inopsu.com/apply/piag.html

11. Data Protection Act 1998.  The Stationery Office Limited. 

12. Department of Health: the Caldicott Committee. (1997). Report on the review of patient identifiable information.  http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4068403