Changes to Question 2.8, Genomic Data Sharing, DoD Policy

OSIRIS Question 2.8 (questionnaires, interview or survey instruments)

The IRB has changed item 2.8 in OSIRIS. Investigators are now required (as of 9/1/15) to upload measures (e.g. questionnaires, surveys, interview questions) into item 2.8, regardless of whether they are commercially available/published with the exception of the SCID and KSADS. However, the use of the SCID and KSADS should be addressed in item 2.6. 

Genomic Data  Sharing    

The NIH issued the Genomic Data Sharing Policy this year which applies to all NIH-fund research that generates large-scale human genomic data, regardless of the funding level, as well as the future use of the data.  This also replaces the GWAS forms previously required. Detailed information on the process is available in a document listed in the A-Z Guidance section of the IRB website ( Genomic Data Sharing document which contains a link to the NIH-designated Genomic Data Repository form to be submitted to the IRB. 

Department of Defense Policy

The IRB Executive Committee approved a revision to Chapter 14 of the Policy and Procedure manual related to studies funded by the DoD on July 17, 2015. Revisions include:

  • Adding the DoD's definitions of minimal risk, non-compliance, and continuing non-compliance;
  • Replacing the term "medical monitor" with "research monitor." The responsibilities remain largely the same;
  • Updating information about inclusion of vulnerable populations;
  • Adding information about conducting DoD funded studies outside of the United States.