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Is informed consent necessary for randomized Phase IV 'observational' drug studies?
Rosemarie D C Bernabe1, Ghislaine J M W van Thiel, Jan A M Raaijmakers
1Julius Center for Health Sciences and Primary Care, Utrecht University Medical Center, Huispost Str. 6.131, PO Box 85500, 3508 GA Utrecht, The Netherlands. r.bernabe@umcutrecht.nl
Drug Discovery Today
|July 12, 2011
Summary
Informed consent (IC) cannot be waived in Phase IV randomized interventional drug studies (P4RIDS). While an opt-out procedure may be acceptable for minimal risk studies, universal waiver of IC is ethically unjustifiable.
Area of Science:
- Clinical Trials
- Bioethics
- Pharmaceutical Research
Background:
- Phase IV drug studies often involve observational designs.
- Randomization inherently classifies a study as interventional, not observational.
- The ethical implications of waiving informed consent require careful consideration.
Purpose of the Study:
- To determine if informed consent can be waived in Phase IV randomized observational drug studies (P4RODSs).
- To clarify the ethical permissibility of waiving informed consent in randomized interventional studies.
- To explore justifications for waiving informed consent based on public health and drug equivalence.
Main Methods:
- Conceptual analysis of study design terminology (P4RODS vs. P4RIDS).
- Ethical argumentation based on the right and harm principles.
- Review of public health considerations and drug characteristics (equipotency, bioequivalence).
Main Results:
- The term P4RODS is a contradiction; randomization mandates an interventional classification (P4RIDS).
- Universally waiving informed consent in P4RIDS is ethically unjustifiable.
- Public health benefits or drug equivalence do not justify waiving informed consent.
Conclusions:
- Informed consent can never be waived in Phase IV randomized interventional drug studies (P4RIDS).
- An opt-out procedure may be ethically acceptable for minimal risk studies.
- Ethical guidelines must uphold the principle of informed consent in clinical research.
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