Policy Update - 2020 Q2

The revision of the human research protection program (HRPP) policies is ongoing. To date 22 HRPP policies have been approved, of which three (3) have been released and are implemented. The implemented policies are located on the Policy page on the newly updated OHSRP website. All other HRPP Standard Operating Procedures (SOPs) continue to apply until they are superseded by new policies. The active SOPs are also accessible on the Policy page. We will be implementing some of the approved policies in the very near future. Keep an eye out for announcements on these policy releases. To aid investigators and research teams in in understanding what has changed, these implemented policies will be accompanied by policy change documents. Investigators will be responsible for reviewing and complying with the newly implemented policies. The SOPs that have been superseded will continue to be available for historical purposes only, on the Policy Archive which is also located on the Policy page.

Accreditation Activities

In April 2020, the NIH Annual Report was submitted to the accrediting body, the Association for Accreditation of Human Research Protection Programs (AAHRPP). The report was accepted by AAHRPP with no changes. This year it took the NIH “Village” to prepare the report.  Thank you to the IC AAHRPP Liaisons and to ORSC for helping us with this year’s report.  This year, ORSC established a new QAQI database to help us collect information about IC QAQI activities. So, we want to give a special thank you to ORSC and the IC QAQI teams for piloting this new system. We got a little bit of a surprise in February, when AAHRPP asked us to pilot their new online submission system. On the upside, AAHRPP gave us till mid-April to submit the report, since we were willing to pilot their new system. However, they asked us for all the data we normally collect in preparation for re-accreditation, which is quite a bit more than what is normally requested in the annual report. With the help of our stellar IT team, we got the job done. It was a good dry run for our actual accreditation renewal which will be submitted in March 2021. That means we will have a site visit in early 2022!  Lastly, in May, we submitted a status report to AAHRPP to update the accrediting body on the status of the consolidation of the IC IRBs into the NIH Intramural IRB, and to provide an update regarding the streamlining of IRB operations. We were able to inform AAHRPP that we fully consolidated the IC IRBs into the NIH Intramural IRB in December 2019. We provided metrics which highlighted the increase in submission volume due to IRB consolidation, and the impact of COVID-19 on IRB operations. We also highlighted the changes to iRIS and the streamlining of forms. This report will be reviewed at the next AAHRPP Council.