OHSRP Newsletter - 2022 Q1 As we head into the middle of 2022, much of OHSRP’s efforts are focused on the design and implementation of our new eIRB submission system. As you can imagine, this is a complex project with lots of moving parts. The Huron team and OHSRP have been meeting multiple times each week to go over all aspects of the system design. In addition, the teams are working closely with representatives of the Scientific Review Groups, Office of Protocol Services,…

We enter 2022 having come off a successful site visit from our accrediting body (AAHRPP). A big thank you to the entire intramural community for supporting our site visit. The success of the visit reflects the high priority that the entire research community places on protecting the rights and welfare of our subjects. Your commitment shows and was recognized by the site visitors...

We Are Listening Over 130 individuals responded to our IRB investigator survey. While I wish I could say we got “straight A’s” in our evaluation, we did not. The good news is that we were provided with feedback on which we can act. One of the major themes that came out of the responses is that investigators feel a lack of transparency. We recognize that the experience of interacting with OHSRP is different than the legacy IRBs.…

eIRB System Selection and Transition Communication #1 NIH Research Community, As you have already been informed, the Office of Human Subjects Research Protections with the guidance of the NIH eIRB Steering Committee is beginning the process of considering alternative eIRB systems to our current system, iRIS by iMedris. We have formed a steering committee that meets monthly to bring key NIH stakeholders together. The members of the steering committee include: Bradley Alvarez Bibi Bielekova, M.D.…

We continue to move forward with evaluating new electronic IRB submission systems. An RFP was issued in March 2021 soliciting proposals, to which 7 vendors responded. Based upon a review by the steering committee, 3 vendors were selected to present their products to the NIH community. We are in the process of evaluating all of the stakeholder feedback and soliciting additional information as needed, and hope to make a final selection no later than the end of August.

OHSRP_Q2_2021_Newsletter_508C.pdf

One of our first initiatives in reorganizing OHSRP was to develop a new set of policies that reflected the new organizational structure and incorporated the requirements of the revised Common Rule. At times, it was a grueling undertaking, I am pleased to say that the process was completed this past quarter. The new policies are really something of which we can all be proud. They will serve the NIH community well for the foreseeable future and are outstanding examples for the rest of the regulated community. A huge shout out to Heather Bridge who led this effort, and extra special thanks to Carrie Kennedy in OGC for the enormous effort she put into helping us get this right. Thank you to the many, many individuals we tapped over the past 2 years to review, critique, edit and often re-review specific chapters. The new policies are now posted in the NIH Manual.

Download OHSRP_Q1_2021_Newsletter.pdf (PDF/3MB)

In our last newsletter, I shared with you the OHSRP Vision Statement that reflects the priorities and values of the Office of Human Research Protections. As we enter 2021, I would like to outline how we plan to work towards making this vision a reality.

Download OHSRP Q4 Newsletter.pdf (PDF/5MB)

eIRB System Selection and Transition Communication #2 NIH Research Community, As you know, the Office of Human Subjects Research Protections with the guidance of the NIH eIRB Steering Committee is beginning the process of considering alternative eIRB systems to our current system, iRIS by iMedris. We wanted to provide a brief recap around what has happened since our last communication in July.…

eIRB System Selection and Transition Communication #1 NIH Research Community, As you have already been informed, the Office of Human Subjects Research Protections with the guidance of the NIH eIRB Steering Committee is beginning the process of considering alternative eIRB systems to our current system, iRIS by iMedris. We have formed a steering committee that meets monthly to bring key NIH stakeholders together. The members of the steering committee include: Bradley Alvarez Bibi Bielekova, M.D.…

The iRIS team continues to streamline and make more efficient the iRIS workflow. Here are some of the improvements made for you in the late spring and summer...

September 16th was my 2-year anniversary of coming to the NIH. When I reflect on what we have accomplished together during these past 2 years, it is no wonder that sometimes I feel tired….as I am sure you do also. The road has been and still is bumpy, although I think the potholes are less deep and not as frequent. There is no doubt the pandemic has adversely impacted the ability of our office to consolidate and streamline its operations and develop the critical team structures that are needed to function optimally. Despite this, we continue to...

During this past quarter, the IRBO sent out a number of notifications to the research community through the NIH iRIS Notification System which included important information for investigators and research support staff. We have summarized this information here for your convenience.

During this past quarter of 2020, the OHSRP Education Series included a 2-part presentation by the IRB Office Reliance and Single IRB team (July and August 2020) that is now available in the archived presentations section on the OHSRP website. This link provides access to the slides and videocasts for all past sessions of the OHSRP Education Series. The Reliance and Single IRB team is also hard at work updating their presence on the IRBO website including revisions of existing resources and preparing new tools to assist investigators/study teams to conduct multisite research. These will be available later in 2020 and will include...

Human Research Protection Program (HRPP) policy development is wrapping up. OHSRP began rolling out the policies late this Summer, the remaining policies will be rolled out through the end of 2020. To aid in understanding key information about each policy, OHSRP has also developed supporting tools for the community, an overview/change table and a narrated presentation...