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Ethical communication in clinical trials. Issues faced by data managers in obtaining informed consent
Winnie Y Loh1, Phyllis N Butow, Richard F Brown
1Medical Psychology Unit 1, University of Sydney, Camperdown, New South Wales, Australia. wloh@gmp.usyd.edu.au
Cancer
|November 19, 2002
Summary
Data managers play a vital role in clinical trials by providing information and ensuring informed consent quality. They identified challenges and training needs, emphasizing a multidisciplinary approach for ethical patient participation.
Area of Science:
- Clinical trials ethics
- Informed consent process
- Healthcare data management
Background:
- Informed consent is crucial for ethical clinical trial participation.
- Challenges exist for both patients and physicians in the informed consent process.
- Third-party involvement, like data managers, has been suggested for obtaining informed consent.
Purpose of the Study:
- To explore data managers' views on their role in informed consent.
- To identify challenges and rewards associated with data managers' involvement.
- To compare data managers' and physicians' roles in obtaining informed consent.
Main Methods:
- Conducted four focus groups across three teaching hospitals.
- Included twenty-one data managers from cancer and pain clinical trials.
- Utilized audiotaping, transcription, and content analysis for theme identification.
Main Results:
- Data managers identified complementary roles: information provision, quality assurance, and ongoing support.
- Expressed concerns about potential subtle coercion from medical and drug company interests.
- Did not support sole responsibility for the informed consent process.
- Encountered ethical dilemmas, including patients seeking unavailable medical details and consent compromise due to misunderstanding or passivity.
- Highlighted the importance of a multidisciplinary team and identified training needs, especially in communication skills.
Conclusions:
- Data managers' perspectives are crucial for successful clinical trials.
- An integrated, multidisciplinary approach is essential for the informed consent process at all levels.