The U.S. Department of Health and Human Services (HHS) has released new regulations and guidance that delineate reporting requirements for clinical trials. The penalties for noncompliance could include the potential loss of grant money, according to an analysis from the American College of Radiology (ACR).
The new rules are aimed at encouraging greater participation in clinical trials and promoting the communication of trial results to help patients more quickly receive the benefits, the ACR said. The rules expand and clarify which trials are required to submit data to the ClinicalTrials.gov website, where researchers will have 90 days to post the information beginning January 18, 2017.
The ACR said that new requirements for clinical trials include the following:
- Registration within 21 days after the first human subject is enrolled
- Submission of summary results within one year of the study's completion
- Posting of protocols
- Disclosure of adverse events
- Inclusion of race and ethnicity information in results
Entities with trials that do not comply with the reporting requirements may be subject to penalties of up to $10,000 per day and loss of federal funding, as well as possible criminal penalties for making false statements to the government. The regulations and guidelines can be found in the Federal Register here and here.
