Important National Institute of Health Changes

New Biosketch Form

The National Institute of Health  has issued a new biosketch form.  The sections remain the same, but a change has been made to the header.  Faculty should revise their existing bios, so that it reflects the correct form with the revision dates of  Rev. 9/17 Approved through 3/31/2020.   The new form is linked above and can also be found in the Proposal Development Resources in the CNR Hub.   Please contact your CNR Pre-Award Specialist with any questions.   

Changes to the Common Rule and new IRB forms

Changes to the Common Rule, the primary rule regulating human subjects research, are scheduled to go into effect on January 19, 2018. Beginning November 1, 2017, the Duke Health IRB will require that new protocol submissions use updated consent and waiver templates that contain new required elements. All new studies initially submitted in eIRB on November 1, 2017 or later must use the new templates.  These documents are available on the IRB website and are simply updates to the previous forms.

More details and documents are available at:  https://irb.duhs.duke.edu/about-us/irb-news/faqs-common-rule-changes

The IRB will host Research Wednesday presentations on changes to the Common Rule at 1:10 PM Duke North Room 2002 on the following dates :

• November 15, 2017
• December 13, 2017
• February 14, 2018

Certificates of Confidentiality

NIH announced that as of October 1 2017, Certificates of Confidentiality (CoC) are now automatically issued with awards for NIH- funded human subjects research. NIH awardees no longer need to apply for a separate CoC. These certificates protect participant privacy by limiting the disclosure of identifiable information in legal proceedings and to individuals not connected with the research. This policy change is retroactive to studies that were ongoing as of 12/13/16.

NIH expects that Certificate of Confidentiality standard language be included in the consent form – updated language is available under the Standard Language section of the IRB website and in the template consent forms.

• New Studies: All new NIH-funded human subjects research must include Certificate of Confidentiality Language in the consent form
• Existing Studies: Consent forms for existing NIH-funded research that is open to enrollment should be updated with the CoC language at the next renewal or amendment that alters the consent. Re-consent will not be required and the IRB will not require Certificate of Confidentiality language that already appears in consent forms to be updated.  

Studies funded by sources other than NIH may still apply to DHHS to obtain a CoC if needed.

More information is available here: https://humansubjects.nih.gov/coc/index