HSPP/IRB Bulletin
February 28, 2022
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Newly Revised Templates
Pre-Review Process for Full Board Studies
The Pre-Review Process is being expanded to include a new process for studies reviewed by the Full Board when the study is either tabled or revisions are requested with subcommittee re-review.
The new process will include the following:
- A mandatory pre-review/consultation by the Pre-Review Team for studies the full board determines are tabled and require full board re-review.
- An optional pre-review/consultation by the Pre-Review Team for studies the full board determines can be re-reviewed by an IRB subcommittee.
Please stay tuned for the New Standard Operating Procedures for Tabled Studies.
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Interested in Being a Featured Board Member in a Future Issue of this Bulletin?
Share your background, interests, and area(s) of expertise by being a featured board member in an upcoming issue of the HSPP/IRB Bulletin
Do you (or someone you know) have an interest in biomedical or social science research? Or do you know someone from the community that might be interested in serving as a community member on the Rutgers IRB? Would you (or they) like to be involved with protecting the rights, safety, and welfare of individuals who volunteer to participate in research?
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Website Revisions
HRP-307
HRP-308a
HRP-308b
HRP-310
HRP-311
HRP-312
HRP-313
HRP-314
HRP-315
HRP-316
HRP-317
HRP-318
Under HSPP Toolkit items under Section “D. External IRBs” including 1812A & 1812B forms.
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AAHRPP Accreditation Updates |
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Rutgers was notified that the AAHRPP Step 1 application was accepted. Congratulations to everyone, it was a major team effort.
Step 2 in the application process was submitted on February14th and is currently under review.
For more information, please contact Swapnali Chaudhari and Malica Dock.
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When is a ClinicalTrials.gov Record Considered
"Complete" or "Closeprocess was submitted d"?
1) Under the Study Status module:
- The Overall Study Status is "Completed", "Terminated" or "Withdrawn"
- The Primary and Study Completion Dates are "Actual" (rather than "Anticipated")
2) Under the Study Design module, the final Enrollment has been entered and changed to "Actual" (rather than "Anticipated").
3) Any required documents have been uploaded to the Documents section:
- If results are required, the Protocol and Statistical Analysis Plan must be uploaded (usually the SAP is included in the protocol).
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If the study is a Common Rule agency-supported clinical trial, the Consent Form must be uploaded per 45CFR46.116(h)).
4) If results are required, results data has been submitted, passed Quality Control review, and been made public with no outstanding Major Comments.
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Quality Assurance/Quality Improvement |
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The Quality Assurance Audit Team will be implementing a post-audit survey for Principal Investigators to complete at the end of each Post Approval Monitoring Review. The Survey will ask the Investigator about their experience with the QA/ QI Audit Team. The survey will inquire if the investigator and their study team learned anything from the onsite post-approval monitoring visit. It will also reflect on performance, on what was done well or if the audit process needs improvement. This survey will become the Quality Assurance Team’s standard procedure and be included as part of the exit interview for each audit conducted across all campuses.
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Education and Training Opportunities |
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eIRB Virtual Training Workshops Sessions will include a step-by-step tutorial on the electronic submission system, eIRB and Q&A.
These workshops are open to Rutgers faculty, staff, and/or students regardless of campus location or specific Rutgers IRB of Record.
- Thursday, March 3, 2022, at 11:30 am
- Wednesday, March 9, 2022, at 11:30 am
- Wednesday, March 16, 2022, at 2:30 pm
- Thursday, March 24, 2022, at 2:30 pm
- Wednesday, March 30, 2022, at 11:30 am
- Wednesday, April 4, 2022, at 11:30 am
- Wednesday, April 13, 2022, at 2:30 pm
Human Subjects Research Articles
COGR News Digest: Massive open index of scholarly papers launches (Nature)
An ambitious free index of more than 200 million scientific documents that catalogs publication sources, author information, and research topics, has been launched. The index, called OpenAlex after the ancient Library of Alexandria in Egypt, also aims to chart connections between these data points to create a comprehensive, interlinked database of the global research system, say its founders. The database, which launched on 3 January, is a replacement for Microsoft Academic Graph (MAG), a free alternative to subscription-based platforms such as Scopus, Dimensions and Web of Science that was discontinued at the end of 2021. https://www.nature.com/articles/d41586-022-00138-y
NIH issues a seismic mandate: share data publicly (Nature)
Under the new policy, which will go into effect on 25 January, all NIH grant applications for projects that collect scientific data must include a ‘data management and sharing’ (DMS) plan that contains details about the software or tools needed to analyze the data, when and where the raw data will be published and any special considerations for accessing or distributing that data. Such a seismic shift in practice has left some researchers worried about the amount of work that the mandate will require when it becomes effective…Irreproducible studies not only waste taxpayers’ money, says Lyric Jorgenson, the acting associate director for science policy at the NIH, but also undermine public trust in science. …..Jorgenson responds that the agency is evaluating the costs of compliance and hopes to prepare more guidance and information. https://www.nature.com/articles/d41586-022-00402-1
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In the works:
- The 2022 Fee Schedules for Commercial IRBs
- “How to Write an IRB Review” Guidance for IRB Members.
- Customer Service Satisfaction Surveys for Website & Email Interactions.
- Pre-Review SOP's for Full Board Studies
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Implementation of a Human Subjects Training Program known as CIRTification.
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