BACKGROUND: Informed consent has been proposed as the optimal method for ensuring the ethical entry of patients into clinical trials. However, it is known that problems with informed consent exist from the perspective of both patients and physicians. This has led to the suggestion that a third party, such as a research nurse or data manager, should be responsible for obtaining informed consent. The objective of this study was to explore the views of data managers concerning the nature, challenges, and rewards of their role and the similarities and differences between their role and that of physicians in obtaining informed consent. METHODS: Four focus groups in three large teaching hospitals were conducted. Twenty-one data managers who were involved in cancer or pain clinical trials participated. The focus groups were audiotaped, transcribed, and subjected to content analysis to identify themes. RESULTS: Data managers identified three primary roles complementary to that of physicians: information provision, quality assurance of the informed consent process, and ongoing support during the trial. Despite expressed concern that medical and drug company interests may lead to subtle coercion of the patient, participants did not support the notion that they may be solely responsible for the consent process. Participants described a range of ethical dilemmas they confronted, including patients asking them for medical details they could not provide and situations in which they felt that informed consent was compromised in some way, for example, dealing with situations in which the patient appeared to be entering the trial for the wrong reasons due to misunderstanding, need, or passivity. Effective functioning of the multidisciplinary team assisted data managers in performing their role. A range of training needs were identified, particularly communication skills training and trial start-up briefing. CONCLUSIONS: The issues raised by these data managers have important implications for the successful conduct of clinical trials, particularly the need for an integrated, multidisciplinary approach at all levels of the informed-consent process. Copyright 2002 American Cancer Society.DOI 10.1002/cncr.2002;10994
BACKGROUND: Informed consent has been proposed as the optimal method for ensuring the ethical entry of patients into clinical trials. However, it is known that problems with informed consent exist from the perspective of both patients and physicians. This has led to the suggestion that a third party, such as a research nurse or data manager, should be responsible for obtaining informed consent. The objective of this study was to explore the views of data managers concerning the nature, challenges, and rewards of their role and the similarities and differences between their role and that of physicians in obtaining informed consent. METHODS: Four focus groups in three large teaching hospitals were conducted. Twenty-one data managers who were involved in cancer or pain clinical trials participated. The focus groups were audiotaped, transcribed, and subjected to content analysis to identify themes. RESULTS: Data managers identified three primary roles complementary to that of physicians: information provision, quality assurance of the informed consent process, and ongoing support during the trial. Despite expressed concern that medical and drug company interests may lead to subtle coercion of the patient, participants did not support the notion that they may be solely responsible for the consent process. Participants described a range of ethical dilemmas they confronted, including patients asking them for medical details they could not provide and situations in which they felt that informed consent was compromised in some way, for example, dealing with situations in which the patient appeared to be entering the trial for the wrong reasons due to misunderstanding, need, or passivity. Effective functioning of the multidisciplinary team assisted data managers in performing their role. A range of training needs were identified, particularly communication skills training and trial start-up briefing. CONCLUSIONS: The issues raised by these data managers have important implications for the successful conduct of clinical trials, particularly the need for an integrated, multidisciplinary approach at all levels of the informed-consent process. Copyright 2002 American Cancer Society.DOI 10.1002/cncr.2002;10994
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Keywords:
Biomedical and Behavioral Research; Empirical Approach
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