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What should be disclosed to research participants?
1a Department of Bioethics , NIH Clinical Center.
The American Journal of Bioethics : AJOB
|November 22, 2013
Summary
The SUPPORT study reveals disagreement on disclosing information to research participants. Ethical concerns in clinical research require a clear consent process to ensure participant understanding and protection.
Area of Science:
- Clinical Research Ethics
- Informed Consent Process
Background:
- The SUPPORT study has sparked debate regarding disclosure standards in clinical research.
- Disagreement exists on whether trials testing standard-of-care interventions require higher disclosure than clinical settings.
Purpose of the Study:
- To address the lack of consensus on information disclosure for research participants.
- To identify ethical concerns inherent in clinical research.
- To determine the appropriate consent process for clinical research.
Main Methods:
- Analysis of the debate surrounding the SUPPORT study.
- Identification of ethical considerations in clinical research.
- Evaluation of consent processes for research participants.
Main Results:
- Absence of consensus on disclosure standards for clinical research participants.
- Divergent views on disclosure requirements for standard-of-care intervention trials.
- Need for a defined ethical framework for research consent.
Conclusions:
- Resolving the debate requires understanding ethical concerns in clinical research.
- Establishing an appropriate consent process is crucial for ethical research conduct.
- High disclosure standards may be necessary even for standard-of-care trials.
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