Letter from the Director - 2019 Q4

Dear NIH Community,

The end of the year is frequently a time for pause and reflection, so I wanted to share with you some of what we have accomplished in the past year and where we are headed. 2019 was a busy year for OHSRP with lot of change across the clinical research landscape of the NIH Intramural Research Program. Some of the accomplishments of the past year are highlighted below.

Staff

25 new FTE and 5 contractors hired and onboarded

Space

Moved to new space at 6700B Rockledge and consolidating our on-campus footprint into renovated space in building 31 that was previously occupied by the CNS IRB.

IRBs

Rolled in all legacy IRBs into the new NIH Intramural IRB
Implemented the revised Common Rule
Implemented the flexible IRB model with the new NIH IM IRB meeting 3 times per week in 2019
Standardizing IRB and regulatory determinations across the IRP
Processes and Policies
Undertaking a complete rewrite of NIH HRPP policies. On track to complete by early 2020
Developed new protocol and consent templates
Revised short form consents
Removed the “witness to the signature” requirement
Updated exempt determination process, and put into IRIS
No more mandatory NHSR determinations (NHSR forms now in iRIS)

Electronic IRB system

Completed migration onto single platform
Consolidated IT team under IRBO leadership
Redesigning the forms, workflow and processes for enhanced efficiency
Federated login to support external users
Reliance/sIRB processes
Master agreement to WIRB and Advarra put into place
Manage exceptions to sIRB policy
Working with all parties to sign on to SMART IRB

Compliance

Completely new office of Compliance and Training formed within OHSRP
Revised and implemented new policies on the reporting and review of non-compliance, non-compliance and other reportable events.
Established the Research Compliance Review Committee

Education

New monthly NIH wide OHSRP education series
Implemented regular education and training for IRB operations staff, IRB members and Chairs training

What’s in store for 2020?

The upcoming year will focus heavily on process improvement. Now that the new IRB and IRB office are overseeing all research, we can direct our efforts to streamlining the review process and assuring that all protocols have the required regulatory determinations made and documented. Our goal is to minimize unnecessary burden on investigators and the IRB to allow for our energy to be focused on what matters, performing high quality reviews to make sure the best research moves forward ethically, efficiently and in a way that is compliant with all the regulatory requirements.

We will be concentrating our efforts in four major areas:

Streamlining our internal IRB processes as well as our interaction with other clinical center offices to allow for the most efficient review process.
Optimizing our electronic IRB submission system, iRIS, to facilitate an efficient submission and review.
Assuring that all protocols being conducted under NIH IM IRB oversight have the required regulatory determinations made and documented in the electronic system.
Providing educational opportunities on human subjects protections that are responsive to the needs of the NIH IRP community

I am enormously proud of all the work that the staff of the OHSRP has done to get to where we are today. There have been bumps in the road and I have no doubt new challenges will arise over the course of the next year, but also am confident that we can meet and overcome those challenges.

I am also extremely grateful for the support the leadership of the NIH has provided, and the support and patience of the entire NIH intramural research community. We could not do this without you. In the end, together we will have built the best HRPP in the country. Our patients, participants and researchers deserve nothing less.

Jonathan