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The ethics of withdrawal from study participation
Elisa J Gordon1, Thomas R Prohaska
1Alden March Bioethics Institute, Albany Medical Center, 47 New Scodand Avenue, MC 153, Albany, New York 12208-3478, USA. gordone1@mail.amc.edu
Accountability in Research
|September 14, 2007
Summary
Most research consent forms comply with federal regulations regarding participant withdrawal. However, some forms require additional steps, potentially creating barriers for participants wanting to leave a study.
Area of Science:
- Medical Ethics
- Clinical Research Compliance
- Informed Consent
Background:
- Federal Common Rule regulations mandate specific information within research consent forms.
- Understanding participant withdrawal is crucial for ethical research conduct and regulatory adherence.
Purpose of the Study:
- To evaluate consent form compliance with Federal Common Rule regulations on research withdrawal.
- To analyze the language used in withdrawal provisions and identify study-specific differences.
Main Methods:
- A random sample of 114 consent forms from a midwestern academic medical center was analyzed.
- Forms were examined for descriptive content regarding withdrawal parameters and adherence to specific CFR regulations.
Main Results:
- All consent forms included the required withdrawal statement (45 CFR 46.116(a)(8)).
- All forms adhered to regulations stating withdrawal does not affect patient care (45 CFR 46.116(b)(4)).
- 26% of studies required additional participant actions for withdrawal, with safety cited infrequently (13%) as justification.
Conclusions:
- Consent forms generally meet current Federal Common Rule requirements for withdrawal.
- Further research is needed to understand participant experiences and identify potential barriers to withdrawal indicated in consent forms.
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