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Please carefully review our COVID-19 information hub for updates on IRB processes during the COVID-19 outbreak.

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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.…

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.

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 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...

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...

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...

Home    /    News    /    New Policy Implementation Guidance September 15, 2020 Dear Research Community Over the past 18 months, we have rewritten the HRPP policies to be compliant with the revised common rule and consistent with the reorganization of OHSRP and the NIH IRBs.  As these policies are all inter-related, with few exceptions we were not able to implement them as they were developed and cleared.  Now that they are complete, we are rolling them out in groups between now and years end.…

We are approaching the 6-month mark for the consolidation of all the legacy IRBs into the new NIH Intramural IRB (NIH IRB).  I know that this has not been the easiest transition for the NIH community, and I thank you for your support and patience as we continue to build our new organization.  Our goal is to serve the intramural research community by providing optimal protections for our research subjects and facilitating the ethical conduct of the life-saving research conducted here at NIH...

The iRIS team continues to streamline and make more efficient the iRIS workflow.  We thank all of the research community for their feedback in the development and testing of these improvements.  Below are some of the improvements made for you in the first half of this year...

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After the news of the spread of COVID-19 in the United States, the majority of IRBO staff immediately began teleworking.  Thank goodness for technology like Skype, MS Teams and WebEx which has allowed IRB Chairs, members, and staff to communicate and work diligently to continue to review vital NIH research projects. On March 17, we began holding all IRB meetings via teleconference and have held approximately 40 meetings in this manner since then. While meeting remotely is not ideal, we are proud to see the strong show of commitment on everyone’s part in stepping up to meet these new challenges...

We are approaching the 6-month mark for the consolidation of all the legacy IRBs into the new NIH Intramural IRB (NIH IRB).  I know that this has not been the easiest transition for the NIH community, and I thank you for your support and patience as we continue to build our new organization.  Our goal is to serve the intramural research community by providing optimal protections for our research subjects and facilitating the ethical conduct of the life-saving research conducted here at NIH...

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...