TAG ARCHIVES FOR policy comments

14
Feb2019

PRIM&R’s Comments on HHS “Request for Information on Modifying HIPAA Rules to Improve Coordinated Care”

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14 Feb
No comments

The Office for Civil Rights (OCR) within the Department of Health and Human Services (HHS) recently put out a "Request for Information on Modifying HIPAA Rules to Improve Coordinated Care." PRIM&R submitted comments encouraging HHS to take this opportunity to harmonize the HIPAA Rules with the Common Rule to improve it's use in the research context. The research community has long argued that HIPAA is confusing, awkward, inconsistent, and unnecessarily burdensome as applied to human subjects research. Read more

5
Feb2019

PRIM&R’s Comments on the FDA’s Proposed Rule, “Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations”

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5 Feb
Comments: 1

PRIM&R recently submitted comments in response to the Food and Drug Administration (FDA)’s proposed rule "Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations," which was published in the Federal Register on November 15, 2018. Comments are due February 13. Read more

4
Dec2018

PRIM&R comments on NIH’s proposed provisions for data management and sharing policies

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4 Dec
Comments: 1

On October 10, the National Institutes of Health (NIH) published a Request for Information (RFI) from the public on Proposed Provisions for a Draft Data Management and Sharing Policy for NIH Funded or Supported Research. According to the NIH, it will take into account the feedback received as it develops a draft of a new NIH policy for data management and sharing. That draft will also be open for public comment, at a future date. Comments on this first stage of policymaking, the proposed provisions, are due December 10, 2018. Read more