The Office for Human Research Protections (OHRP) has released a number of resources to help practices ensure compliance with the revised Common Rule, which went into effect on Monday, January 21, 2019.
Changes to the Common Rule, which protects human participants in biomedical research, include:
- New and revised definitions for “human subject,” “identifiable biospecimen,” and “clinical trial,” among others
- New categories of secondary research that are exempt from the Common Rule
- Elimination of continuing review for minimal risk studies (non-clinical research, benign behavioral interventions, consumer preference surveys and research)
- Revised informed consent requirements
OHRP resources include:
- Revised Common Rule Compliance Dates and Transition Provision: Information on how transitioning might affect regulated research at your institution.
- Revised Common Rule Q&As: Frequently asked questions about transitioning to and staying in compliance with the revised Common Rule.
ASCO has also developed a summary of the changes to the Common Rule.
For additional updates on cancer research policy changes, bookmark ASCO in Action.