A federal regulation has improved the availability of consent forms for clinical trials, impacting informed decision-making for participants.
- Federal mandate has improved the availability of consent forms for clinical trials listed on clinicaltrials.gov.
- The revised Common Rule now requires the posting of participant consent forms within 60 days of a trial’s completion, resulting in gradual improvements.
- Researchers found that while the rate of posting consent forms has increased, it still falls short of the 60-day timeline.
- Trial consent forms are crucial for informed decision making by participants, but can be difficult to access buried in lengthy protocol documentation.
- The study suggests that making consent forms publicly available earlier in the trial process could benefit prospective participants and enhance enrollment.
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Public Health & Prevention, Nursing