HHS Considering Changes to Protections for Human Research Participants
The U.S. Government has policies in place designed to protect individuals who participate in federally funded human research (clinical trials). In July, the U.S. Department of Health and Human Services (HHS) announced it is evaluating these rules and considering major changes to them. Among the many things being considered are ways to improve the informed consent process. Click here to read the Advanced Notice of Proposed Rulemaking (ANPRM).
HHS has, over the years, received feedback that the packet of forms and documents given to patients at the “informed consent” stage can be lengthy and confusing. It is seeking feedback on ways to improve and streamline the materials study participants receive to ensure that the best information for making such an important decision is included.
PAN has been evaluating the proposed changes and communicating with Parkinson’s advocates and other community members so that we can provide comments and recommendations to HHS by the October 26 deadline.
While PAN will submit comments on the ANPRM, we also strongly encourage those of you who have participated in clinical trials to take advantage of this opportunity to share your valuable insights. This is your chance to share ideas about how to make the informed-consent process work better for you and the entire Parkinson’s community. For more information about how to submit your comments, please contact PAN’s Director of Government Relations, Becca O’Connor.
This is just the first of several windows of opportunity to provide feedback on the proposed changes. We will keep you informed of developments and opportunities to share input as this process moves forward.
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