E-IRB News and Updates 2018
November 12, 2018
ORI Efforts to Minimize Impact of Freeze
The transition to the Revised Federal Policy for the Protection of Human Subjects (Common Rule) has forced the Office of Research Integrity (ORI) and Institutional Review Boards (IRB) to issue a Temporary Freeze on New Initial IRB Applications. Any protocol approved prior to January 20, 2019, must comply with the Current Rule and any protocol approved on or after January 21, 2019, must comply with the Revised Rule.
ORI and Research Information Services (RIS) have worked to lessen the impact of the temporary freeze for researchers wishing to create and begin work on new IRB applications during that time.
- New Initial Applications can be created during the freeze. However, if submitted, they will be returned to the researcher; but they will NOT be cancelled. The draft application can be found in the researcher’s Inbox. The researcher may continue to work on the draft application. On January 22, 2019, when the freeze is lifted, new questions based on the Revised Rule will appear in the E-IRB application. The researcher will need to answer the new questions prior to submitting.
- ORI and the IRB will strive to complete reviews on protocols submitted prior to the freeze. Those that are approved prior to January 21, 2019, will be grandfathered in under the Current Common Rule.
- During the freeze, ORI will work individually with researchers on a case-by-case basis to manage submissions with special circumstances (e.g., funding award deadlines).
E-IRB System Shutdown Dates
E-IRB will be offline from noon Friday, January 18, 2019, through 8:00 am Tuesday, January 22, 2019. The shutdown is required for RIS to implement programming changes based on the Revised Rule.
November 2, 2018
Revving Up for the Revised Common Rule
The revised Common Rule regulations for the protection of human subjects is scheduled to go into effect January 21, 2019. The UK IRB and Office of Research Integrity (ORI) have been implementing tools to facilitate compliance and take advantage of streamlined provisions provided under the revised rule; this will affect the new E-IRB system and how applications are managed starting in December 2018.
TEMPORARY FREEZE ON NEW INITIAL IRB APPLICATIONS:
To manage the transition given the volume of initial submissions, the ORI, IRB, and Research Information Service are implementing a freeze on new Full IRB applications effective December 5, 2018, and a freeze on new Expedited/Exempt applications effective December 14, 2018. The freeze will remain in effect until the January 21, 2019, implementation date of the Revised Common Rule.
For more details, see the November 2, 2018, listserv announcement.
August 15, 2018
E-IRB Featured Highlights: “Add Related Grant” option and “Approval Letter Details” option
Based on feedback acquired from investigators and the Office of Research Integrity (ORI) staff during the design phase of the E-IRB system, features were built in to enable researchers to customize their E-IRB application. The following highlights two examples. For future reference, details about these features are available on the E-IRB page under the “E-IRB Features/Known Issues" menu in the sidebar.
- The “Add Related Grants” feature, located in the Funding/Support section of the E-IRB application, enables the researcher to associate a specific research grant with the proposed (or approved) research activities. Please click here for more details.
- The “Approval Letter Details” feature, located in the Additional Information/Materials section of the E-IRB application, allows the researcher to write specific verbiage that they would like added to the IRB approval letter. When the approval letter is issued, the system will automatically add the verbiage to the letter. Please click here for more details.
June 6, 2018
Adding Tracking Text to Your Approved Consent Forms
Upon approval, the E-IRB system stamps Informed Consent documents with an Approved Stamp indicating the Approval Date. The system does not add an Expiration Date to the stamp. Generally, researchers are not permitted to make changes in consent/assent form(s) without prior IRB review and approval. However, the IRB reviewed its policy in light of the stamp function of E-IRB, and determined it is permissible for researchers to add text that serves as an internal tracking mechanism as long as it does not affect the information in the consent document, or confuse potential research participants. For example, researchers may add version numbers or consent form expiration dates in the footer of the document for tracking purposes or to facilitate compliance.
May 17, 2018
Improvements for Researchers Continue
On May 17, 2018, a "PI Contact Information" feature in high demand by researchers was installed in the E-IRB system. When the Principal Investigator (PI) contact information is being completed, the "Department" name and "Dept Code" are automatically populated in the department and department code field based on the individual’s primary department name in the employee/student records stored in SAP (the UK employee/student data warehouse). The default department name was unable to be edited in E-IRB prior to May 17th, but now, the researcher has a drop-down box in order to change the department name and code if necessary. This field will be editable per protocol and will not affect the individual's department information on other applications. Note: Selecting a different department name from the drop down box will automatically update the department code in the separate "Dept Code" field.
May 2, 2018
The streamlining feature promised in the April 17, 2018 announcement has been put into production sooner than anticipated! As of May 2, 2018, study personnel who have been delegated edit authorization (“DP”) of the E-IRB application can perform ‘submission’ tasks on behalf of the PI as needed.
In summary, on behalf of the Principal Investigator, “DP’s” have the capability to:
“Send for Signatures” (send the E-IRB application to other assurance statement signees like the Department Authorization, Faculty Advisor, “Review by Other”);
Submit Initial Review (IR), Modification Request (MR), or Continuation Review (CR);
Submit responses to requested revisions/additional information; and
Submit “Other Reviews”.
The PI is still required to:
Log-in to E-IRB and verify his/her identity with Link Blue ID and password in order to complete the PI Assurance Statement task, which now includes an additional statement for attestation to his/her awareness and responsibility for accuracy of all materials submitted to the IRB for review;
Submit study closure requests.
NOTE: At this time there is no automated email to notify the PI when his/her Assurance Statement is ready to be signed. This is an additional service that is being taken into consideration for building in E-IRB. In the meantime, ORI requests your patience until a determination can be made about what point(s) in the work flow such email notification should be triggered, and subsequent configuration of the system to generate the automated email notification.
April 17, 2018
ORI/IRB Listened: Streamlining E-IRB Application Process [Details: PDF]
Anticipated by mid-May, 2018:
Study personnel who have been delegated edit authorization of the E-IRB application will be permitted to:
send the E-IRB application to other assurance statement signees like the Department Authorization (e.g., Dept. Chair or equivalent), Faculty Advisor, “Review by Other”, and,
send the E-IRB IR, MR, or CR application to ORI for processing.
An addition to the PI’s Assurance Statement indicating the PI attests to his/her awareness of and full responsibility for the accuracy of all materials submitted to the IRB for review. The PI will still be required to log-in to E-IRB and verify his/her identity with Link Blue ID and password in order to complete the PI Assurance Statement task.
January 22, 2018
E-IRB went into full production! This means that all new Exempt, Expedited and Full Review Applications (Medical and Nonmedical IRB) must be submitted via the new E-IRB web-based application system.
All full and expedited IRB studies previously approved external to E-IRB will need to be imported and completed in E-IRB at Continuation Review time. For details, see the pertinent FAQ. [NOTE: If the researcher starts a new E-IRB application for a protocol that should have been imported, the new application may be returned as "withdrawn" along with a request to import the protocol.]
January 19, 2018
On January 17, 2018, the Office for Human Research Protections (OHRP) announced a postponement of six months for the requirement to comply with the revised common rule regulations. While this did affect which system update to install on January 19, 2018, it does not delay the launch of E-IRB into full production. Effective January 22, 2018, ALL new Exempt, Expedited and Full Review Applications (Medical and Nonmedical IRB) must be submitted via the new E-IRB web-based application system. All full and expedited IRB studies previously approved external to E-IRB will need to be imported and completed in E-IRB at Continuation Review time. For details, see the pertinent FAQ.
January 5, 2018
We are just two weeks away from the proposed effective date of January 19, 2018, for the revised common rule regulations! The Office of Research Integrity (ORI) and the Institutional Review Boards (IRB) are still waiting to learn whether the requested delay for implementation of the final rule is granted and therefore which regulations will apply as of January 19, 2018. However, regardless of the federal agency’s decision on implementation of the revised common rule, effective January 22, 2018, new Expedited and Full Review Applications must be submitted via the new web-based application system, "E-IRB". In addition, all full and expedited IRB studies previously approved external to E-IRB will need to be imported and completed in E-IRB at Continuation Review time. For details, see the pertinent FAQ. Submission of new Exemption applications in E-IRB has been mandatory since June 21, 2017.
Note that the E-IRB application available on January 19th may reflect the changes required by the common rule. All E-IRB applications in draft and not submitted to ORI/IRB by January 19th will automatically be converted to the updated E-IRB application. No previously saved data will be lost; however, the research investigator will need to verify the information in certain sections of the draft application, and if applicable, provide supplemental information before submission. E-IRB applications submitted to ORI/IRB before January 19th will not contain the updates; subsequent modification request or continuation review will trigger the application update.