Book contents
- Frontmatter
- Contents
- Editorial board
- Acknowledgements
- List of contributors
- Introduction
- Part I
- 1 The ethics of clinical research
- 2 Research ethics committees and the law
- 3 The regulation of medical research: a historical overview
- 4 The regulation of medical research in the UK
- 5 Observational and epidemiological research
- 6 Social survey research
- 7 Approaching qualitative research
- 8 Complementary and alternative medicine: challenges for research ethics committees
- 9 The ethical review of student research in the context of the governance arrangements for research ethics committees
- 10 The ethics of genetic research
- 11 Research or audit?
- 12 Randomised controlled trials
- 13 Determining the study size
- 14 Risk assessment for research participants
- 15 Absorbed radiation in patient and volunteer studies submitted to the ethical committee: a memorandum
- 16 A guide to the use of radioactive materials and radiological procedures for research purposes
- 17 Indemnity in medical research
- 18 The prevention and management of fraud and misconduct: the role of the LREC
- 19 Understanding clinical trials: a model for providing information to potential participants
- 20 The law relating to consent
- 21 Writing information for potential research participants
- 22 The law relating to confidentiality
- 23 Research involving vulnerable participants: some ethical issues
- 24 The ethics of research related to healthcare in developing countries
- Part II
- Index
21 - Writing information for potential research participants
Published online by Cambridge University Press: 08 January 2010
- Frontmatter
- Contents
- Editorial board
- Acknowledgements
- List of contributors
- Introduction
- Part I
- 1 The ethics of clinical research
- 2 Research ethics committees and the law
- 3 The regulation of medical research: a historical overview
- 4 The regulation of medical research in the UK
- 5 Observational and epidemiological research
- 6 Social survey research
- 7 Approaching qualitative research
- 8 Complementary and alternative medicine: challenges for research ethics committees
- 9 The ethical review of student research in the context of the governance arrangements for research ethics committees
- 10 The ethics of genetic research
- 11 Research or audit?
- 12 Randomised controlled trials
- 13 Determining the study size
- 14 Risk assessment for research participants
- 15 Absorbed radiation in patient and volunteer studies submitted to the ethical committee: a memorandum
- 16 A guide to the use of radioactive materials and radiological procedures for research purposes
- 17 Indemnity in medical research
- 18 The prevention and management of fraud and misconduct: the role of the LREC
- 19 Understanding clinical trials: a model for providing information to potential participants
- 20 The law relating to consent
- 21 Writing information for potential research participants
- 22 The law relating to confidentiality
- 23 Research involving vulnerable participants: some ethical issues
- 24 The ethics of research related to healthcare in developing countries
- Part II
- Index
Summary
Introduction
Good researchers show respect for participants' needs, rights, well-being and safety. In part, they do this by giving (potential) research participants clear and accurate written information. In this chapter we provide guidance on producing consent forms and information leaflets that are easy to read and understand. This will help researchers who prepare written information and research ethics committee (REC) members who review it. Researchers will need other sources of practical advice and we provide some references. For information on broader issues, you could contact Consumers for Ethics in Research (http://www.ceres.org.uk) or Consumers in NHS Research (http://www.hfht.org/ConsumersinNHSResearch/).
Information for potential participants should inform, educate and explain (Scotland, 1985). It must not coerce or unreasonably induce participation in research. Potential participants (patients, carers, users or volunteers) will usually have little medical knowledge and will possess a range of reading ages, education and intelligence. Participants with good reading and comprehension skills will not be insulted by simple and direct language.
Concern for participant welfare will guide study design and should be apparent in your writing. This chapter contains specific guidance on:
content that is accurate, unambiguous and comprehensible
style that is clear and direct (Anon, 2000)
layout and presentation that indicates competence (Secker & Pollard, 1995).
Content of written information
Detailed guidance on what to write in consent forms and information leaflets can be obtained elsewhere, for example:
your local REC
the Central Office for Research Ethics Committees (COREC) (http://www.corec.org.uk)
the US National Library of Medicine (http://www.clinicaltrials.gov)
the International Conference on Harmonisation (http://www.ich.org)
- Type
- Chapter
- Information
- Manual for Research Ethics CommitteesCentre of Medical Law and Ethics, King's College London, pp. 96 - 99Publisher: Cambridge University PressPrint publication year: 2003