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 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.
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