THIS PAST January, the Department of Health and Human Services (HHS), along with more than a dozen other federal agencies, finalized updates to the Common Rule, which protects human participants in biomedical research. This marked the first time that the Common Rule has been updated in nearly 3 decades, and the changes make major strides in modernizing protections for human participants.
To help institutions and cancer researchers prepare for the changes, ASCO has developed a summary of the key provisions and changes. Changes include:
- New and revised definitions for “human subject,” “identifiable biospecimen,” “intervention,” “minimal risk,” and “clinical trial,” among others
- New categories of secondary research that are exempt from the Common Rule (if certain conditions are met), such as educational research, benign behavioral interventions, and surveys/interviews
- Elimination of continuing review for minimal risk studies such as nonclinical research, benign behavioral interventions, and consumer preference surveys/research
- Revised informed consent requirements that must be organized and presented in a way that facilitates comprehension and states information such as the purpose, procedure, and foreseeable risks/discomforts of the research.
New agency guidance can only be issued after consultation with the other 16 federal departments and agencies that adopted the Common Rule, unless the consultation is not feasible.
Details on the changes to the Common Rule can be found in the new summary document.
As of now, the revised Common Rule will go into effect on July 19, 2018, and will not apply to research approved before that date. However, on April 19, the Department of Health and Human Services proposed a delay to the new rules until January 21, 2019, with an exception to burden-reducing provisions in the 2018 requirements. ASCO will continue to keep the oncology community updated on potential changes to the implementation date.
Researchers should work directly with their local institutions and institutional review boards to prepare for compliance with the updated Common Rule provisions.
Read ASCO’s summary of the revised Common Rule and stay up to date on the latest in cancer policy and practice news at asco.org/ascoaction.
© 2018. American Society of Clinical Oncology. All rights reserved.
