Ethical issues and participant consent

This section contains the following:

• Introduction
• Things to consider when writing a protocol  
• Illustrated example - WHO pre-eclampsia trial
• Illustrated example - Perinatal care trial
• Illustrated example - CRASH trial
  
• Additional resources
• Further reading
  

Introduction

The process of obtaining informed consent to take part in a trial including a choice not to take part requires steps to be taken to protect an individual’s right to make choices.  These steps include:

• Ensuring that the individual receives full disclosure of relevant information
• Ensuring that the individual is competent to decide
• Ensuring that the individual acts voluntarily in the consent process.

Researchers must also attend to the quality of a patient’s understanding as part of this process.  This includes an understanding of:

• The purpose & nature of the trial
• What they have to do
• Possible benefits
• Possible risks

In obtaining informed consent, the investigator is required to comply with the applicable regulatory requirements, and should adhere to International Conference on Harmonization Guideline for Good Clinical Practice (ICH GCP - on the web) and the ethical principles that have their origin in the Declaration of Helsinki, and any local ethical guidelines.  

The process for obtaining informed consent usually involves providing information for participants.  Once a person has agreed to participate in a trial they are usually asked to sign a consent form.  Before the trial starts, the investigator should receive written approval of the consent form from an independent ethics committee.

Scenarios where special considerations apply:

Trials involving children

If the person eligible for the trial is under 16 years of age, approval of a parent or legal guardian is usually required.  People under 16 should also be asked to give consent where they are thought to have sufficient understanding and intelligence to make that decision; it does not depend upon a fixed age limit.

Trials with no consent

In emergency situations it is usually impossible to obtain informed consent (see Illustrated example - CRASH trial).  As research is necessary in these situations, recruitment without consent is provided for in the revised Declaration of Helsinki 1990 (Paragraph 1.13).

Cluster trials

Whilst ethical issues have been well elucidated in individual patient randomized trials of health care interventions, less attention has been paid to ethical issues arising in cluster randomized trials (Hutton 2002).  In our experience, it is helpful to distinguish between consent for trial participation (intervention allocation) and consent for data collection.  Edwards and colleagues (1999) distinguish between cluster – patient trials where the unit of allocation is the cluster but the level of intervention is the individual patient and cluster- cluster trials where the unit of allocation and intervention is the cluster.  Whilst individual patient consent for the intervention can be sought in cluster – patient trials, this is not the case for cluster-cluster trials.  In cluster - cluster trials, the health care organisation or professional acts as the ‘guardian’ for their patients choosing to participate in the trial if they think it is in the best interests of their patients.  This would raise concerns if the intervention promoted care that was not necessarily in the best interests of all patients (for example, failing to order a lumbar spine x-ray if a physician considered that a patient may have a malignancy but the patient did not fulfill the criteria suggested in the guidelines).  Under such circumstances professionals’ usual ethical responsibilities to do the best for their patients should over-ride the effects of any interventions promoting care that the professional may consider harmful for an individual patient.  It is important for researchers to make this explicit within the information sheet accompanying any trial (see Information for participants ).

Things to consider when writing a protocol

• Provide a description of how information will be given to participants.
• Provide a description of how patient understanding will be determined before consent to participate in the trial.
• Outline how specific issues related to different patient groups will be handled e.g. non-literate populations and children.
• Include a copy of the consent form in an appendix.
  

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Additional resources

The Declaration of Helsinki

The general ethical requirements of clinical research worldwide are outlined in the Declaration of Helsinki issued by the World Medical Association in 1960 and revised in 1975.  This brief document has been accepted internationally as the basis for ethical research.

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ICH guidelines for informed consent of trial subjects

These guidelines were developed for ICH Harmonised Tripartite Guideline: Guideline for Good Clinical Practice

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Consent Checklist

This checklist has been contributed by the Health Services Research Unit, University of Aberdeen.

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Sample consent forms

These are a selection of consent forms that have been previously used to record informed consent.

• Record trial consent form
  
• Magpie trial consent form  
• Prism trial consent form
• KAT trial consent form
  

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Special ethical issues in randomized trials text from 3rd edition of Clinical Epidemiology

This text has been contributed by Dave Sackett, who prepared it for the forthcoming 3rd edition of Clinical Epidemiology; A Basic Science for Answering Questions about Health Care, to be published by Lippincott, Williams & Wilkins in 2005.

Ethics in international health research

This article discusses the ethics of not using 'best treatment' in poorly resourced settings.

Ethical Issues in Research Involving Human Participants (Need link)

• Overview of the ethics of research involving human participants
• Historical perspectives on research involving human participants
• Informed consent
• Community consent
• Privacy and confidentiality
• Clinical trials
• Special or vulnerable populations
• Women
• Minorities and cross-cultural issues
• Children and adolescents
• Cognitively impaired
• Elderly
• Prisoners
• Military personnel
• Teaching and research using newly deceased patients

Further reading

World Medical Association. Declaration of Helsinki. Recommendations guiding physicians in biomedical research involving human subjects. JAMA. 1997;277:925-6.

Alderson P. Consent to health treatment and research: differing perspectives. London: University of London, Institute of Education, Social Science Research Unit, 1992. 56 p.

Brazier M. Protecting the vulnerable: autonomy and consent in health care. New York: Routledge; 1991. 183 p. (Social ethics and policy series).

Buchanan AE, Brock DW. Deciding for others: the ethics of surrogate decision making. New York: Cambridge University Press; 1989. 422 p. (Studies in philosophy and health policy).

Faden RR, Beauchamp TL, King NMP. A history and theory of informed consent. New York: Oxford University Press; 1986. 392 p.

Hirsch SR, Harris J, editors. Consent and the incompetent patient: ethics, law, and medicine. Proceedings of a meeting held at the Royal Society of Medicine; 1986 Dec 9. London: Gaskell; 1988. 101 p. (Gaskell psychiatry series).

Palmer RN. Consent and confidentiality. London: Medical Protection Society; 1991. 26 p.

Tomes JP. Informed consent: a guide for the healthcare professional. Chicago: Probus Pub. Co.; c1993. 164 p.

Hutton JL. Are distinctive ethical principles required for cluster randomised controlled trials.  Statistics in Medicine 2001;20:473-88.

Edwards SJL, Lilford RJ, Braunholtz DA et al. Ethical issues in the design and conduct of cluster randomised controlled trials. BMJ 1999;318:1407-9.

This page was last updated 21st September 2005.