Protocol Builder Updates
Major updates have been made to Protocol Builder and will go live on Monday, April 17th.
Please note: if you have a protocol built in Protocol Builder that has not yet completed pre-review by the IRB you may have to re-answer the questions in Protocol Builder. You are encouraged to do one of the following things to make this transition easier:
- Complete submission and pre-review prior to April 17th
- Hold off on beginning a new protocol in Protocol Builder until after April 17th
- If neither of the above options will work for you, save the Protocol Cover Sheet as a reminder of how you answered the questions so they may be re-answered if needed.
Some of the updates include:
- additional questions for studies to be reviewed by a non-UVA IRB
- provision to list more than 2 study coordinators per study
- separation of information for all expedited and full board protocols into an IRB Application and a Protocol
- changes required by Human Research Protection Program (HRPP) accreditation process including revisions in terminology:
o Approved with Minor Mods changed to Approvable with Conditions
o Withheld Approval with Major Mods changed to Deferred
o Rejected changed to Disapproved
- addition of IRB-HSR Submission Type Table – may also be found on IRB-HSR website at http://www.virginia.edu/vpr/irb/HSR_docs/IRB-HSR_Submission_Types.docx
NIH Single IRB Review Policy
The NIH Policy requiring a single IRB to serve as the IRB of Record for all sites on an NIH funded multi-site trial will go into effect on September 25, 2017 (postponed from May 25, 2017).
This policy will go into effect for any Grant/Proposal submission to the NIH for a new grant/proposal or a competitive renewal of a grant/proposal submitted AFTER September 25, 2017. Multi-site studies within ongoing, non-competing awards will be expected to comply with the policy when a competing renewal application is submitted. This means that if additional subjects will be enrolled in the federally funded multi-site trial under the new funding, the IRB oversight of the study for all sites will need to be transferred to a single IRB of Record.
In person education will be provided this summer on this topic. Links to several resources are found below:
Learning Shot: : Single IRB Review for Multi-Site Studies
NIH Policy on the Use of a Single IRB for Multi-Site Research
NIH Single IRB Policy FAQs for Extramural Community
Scenarios to Illustrate the Use of Direct and Indirect Costs for Single IRB Review under the NIH Policy on the Use of a Single IRB for Multi-site Research
UVA IRB Reliance Agreements- Frequently Asked Questions
New UVA Human Research Protection Program (HRPP) Website
A new UVA HRPP website will go live in the next few months. The new website will combine some of the information currently found on the IRB-HSR and the IRB-SBS websites along with addition information for other HRPP compliance offices at UVA. Remaining information from the IRB-HSR website will be gradually converted to the new format. The new format will also allow all information to be viewable on different types of devices (smart phones, I pad etc.)
Final Common Rule
The long awaited final Common Rule will go into effect January 19, 2018.
Major changes include:
- Elimination of review of Grants/ Proposals by the IRB
- Elimination of continuation reviews for all expedited studies and for full board studies that have moved to analysis of data or accessing follow-up clinical data as part of clinical care. An annual update from study team regarding active /closed status will be required to enable the IRB to continue to provide Human Subject Research Protection Training Certificates.
- Review of medical records and collection of identifiable information will be transitioned from the requirement of expedited review to that of “limited” exempt review. A Data Security Plan will be required.
- Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. IRB-HSR consent form templates will be updated to include this requirement.
- A copy of an IRB approved consent form for clinical trials conducted or supported by a Common Rule department or agency will be posted by the awardee or agency in a publicly available federal repository.
Additional changes will occur January 19, 2020
- A single IRB of Record will be required for any U.S. multi-site study.
IRB Application Document required with Full Board Continuation Submissions
Submission of the IRB Application document is now required along with the protocol and consents for each continuation review requiring full board review.
Save the Date: Virginia IRB Consortium Conference
The Virginia IRB Consortium Conference will be hosted by Inova this year and held on Friday, October 6, 2017 in northern Virginia. Registration information will be shared when available.
(Last update 03/21/2017)
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