Pharmacogenetics
Consent
3.28 The principle of consent in regard to participation in research was first established in the Nuremberg Code.24 As the interests of researchers and interests of participants may conflict, the Code and other guidelines on the conduct of clinical research require that participants should be informed about the risks of the study, have the right to withdraw from studies at any point, and must give their explicit consent to participation.25 It is common practice to require consent for the collection and banking of tissue and DNA samples of participants in research, especially if it is intended to combine genetic information with other information from the patient’s medical record. Most researchers obtain written consent from participants and are required to provide written information in advance of obtaining consent.
3.29 In the context of pharmacogenetic research, as in other forms of research, the nature of the information likely to be revealed and its implications for the patient should be set out for prospective participants as part of the standard process of obtaining consent. While the provision of information in obtaining consent is important, it should be noted that the ethically significant requirement of consent is not that it be complete, but rather that it be genuine. As we have discussed in a previous Report, since description can never be fully exhaustive, consent will always be to action that is incompletely described; moreover the descriptions offered are often incompletely understood.26 This incompleteness cannot be remedied by devising more elaborate consent forms. Fully informed consent is therefore an unobtainable ideal. Obtaining genuine consent requires medical practitioners to do their best to communicate accurately as much as patients, volunteers or relatives can understand about procedures and risks, and to react to the limits of their understanding, and of their capacities to deal with difficult information. If all reasonable care is exercised, adequate and genuine consent may be established, although it will necessarily fall short of fully informed consent.
3.30 Two further important areas of concern are the voluntary nature of the consent and the privacy of the information which is obtained and stored. There is a serious question regarding whether voluntary consent to pharmacogenetic testing can truly be obtained in the context of clinical trials or in clinical practice. If researchers require a pharmacogenetic test as a condition of enrolment in a study (paragraph 3.5), patients might not feel able to refuse, especially if they think it is possible that some personal benefit may accrue. Indeed, in some cases, taking part in a clinical trial may be the only way for a patient to have a chance of obtaining a particular medicine. Testing may become an integral part of the methodology of clinical trials, so that taking part in a trial requires consent to pharmacogenetic testing. This may well be to the benefit of patients in general, but might cause concern to individuals if other issues about the storage of and access to data are not resolved. While this perceived lack of choice on the part of patients may arise to a similar extent in any trial of a new medicine, it may be of particular concern when that research involves taking samples of DNA because of public perception.
Footnotes24 The Nuremberg Code (1947) arose from a trial at the end of the Second World War by the US Military Tribunal of 23 Germans accused of war crimes and crimes against humanity for their role in conducting unethical medical experiments on concentration camp inmates. The trial led to the production of a code which defined ‘permissible medical experiments’.
25 World Medical Association (2000) Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects (Adopted by the 52nd WMA General Assembly, Edinburgh, Scotland; Medical Research Council (1998) Guidelines for Good Clinical Practice in Clinical Trials (London: MRC); The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1979) The Belmont Report. Ethical Principles and Guidelines for the Protection of Human Subjects of Research. For further information, see Eckstein S (editor) (2003) Manual for Research Ethics Committees. 6th edition. (London: Centre of Medical Law and Ethics, King’s College).
26 Nuffield Council on Bioethics (1995) Human tissue: ethical and legal issues (London: Nuffield Council on Bioethics).