Additional Clinical Trial Communication Resources

As you continue to reach out to your grantees and contractors about the clinical trial changes, remember to refer back to the Clinical Trial Communications Toolkit for the latest versions of resources. Corrections have recently been made to fix typos on presentations and the flier, and we continue to update the resources regularly.
Newly added:     Presentation on NIH Clinical Trial Reforms. Why the Changes?

Notice of Changes to NIH Policy for Issuing Certificates of Confidentiality (CoC)

To increase the protection of privacy of research participants, as of October 1, 2017, NIH funded researchers who are who are collecting identifiable, sensitive information as part of their NIH funded research will automatically be issued a CoC as part of the term and condition of their award. There is no need for them to apply for a CoC. Compliance with the privacy protections afforded by the CoC is also a term and condition of award. All research that was commenced or ongoing on or after December 13, 2016 and is within the scope of this policy is issued a Certificate through this policy.

Notice to Extend the Response Date for NOT-OD-17-090 “Request for Information (RFI): Inviting Comments on the Environmental Influences on Child Health Outcomes (ECHO)-wide Cohort Data Collection Protocol

Policy Supporting the Next Generation Researchers Initiative

This notice announces a new policy implementing special funding consideration for early and mid-career (early established) investigators. See policy summary below. This policy supersedes previous notices on new and early stage investigators. We anticipate that ICs will seek to fund other more senior investigators who are new to the NIH system through specific programs as well as select pay. Read more in the Open Mike blog on the policy and Open Mike blog on Data on Trends According to Career Stage.

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