March of Dimes Hails Proposed Common Rule Revisions

Proposed Changes Would Strengthen Protections for Human Subjects Research

District of Columbia | Wednesday, September 2, 2015

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The March of Dimes, the nation’s leading nonprofit organization advocating for maternal and child health, today commended the U.S. Department of Health and Human Services (HHS) for issuing proposed regulations to update the Federal Policy for the Protection of Human Subjects, often referred to as the Common Rule.

“As science and medicine evolve, so must the rules that protect privacy and ensure the appropriate use of personal medical information in research,” stated March of Dimes President Dr. Jennifer L. Howse. “Strong federal rules must guarantee that individuals have all the information they need to decide whether to participate in research, including about the studies themselves and the privacy of their data. Only then will Americans be willing to participate in important medical research.”

The proposed rules issued today seek to make the most extensive updates in decades to the Common Rule. Among the key proposed changes is one that would require researchers to obtain informed consent to use biological samples, such as blood samples and tumor biopsies, that had originally been collected for a different purpose. The proposed rules would make consent forms shorter and easier to understand and would also streamline many procedures around having medical research reviewed and approved.

“These rules have important implications for research into maternal and child health,” Dr. Howse added. “While research involving pregnant women and children has always involved additional layers of protection, it’s critically important to ensure that we balance those vital protections with the ability to conduct lifesaving studies. We should protect pregnant women and children through research, not from it.”

The proposed rules will now be open for public comment, after which a final rule will be developed. The March of Dimes will submit detailed comments to HHS about the proposed rule and its implications for maternal and child health research. The Newborn Screening Saves Lives Act of 2015 (Public Law 114-240) requires HHS to publish final revisions to the Common Rule by the end of 2016.

About March of Dimes

March of Dimes leads the fight for the health of all moms and babies. We support research, lead programs and provide education and advocacy so that every baby can have the best possible start. Building on a successful 80-year legacy of impact and innovation, we empower every mom and every family.

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