What's New in 2018?
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December 12, 2018
Important Message for Investigators Who Are Conducting Research Initially Approved Prior to E-IRB Implementation:
All studies approved external to E-IRB, and subsequently converted into an E-IRB application, must have the old protocol number in the upper right-hand corner of the blue E-IRB application banner. The old protocol number is the trigger for the system to recognize that the protocol was IRB-approved prior to implementation of the revised common rule regulations.
If you have an active study initially approved outside of E-IRB and it is missing the old protocol number, e-mail Judi Kuhl, E-IRB System Administrator, at email@example.com and provide your old protocol number and your new E-IRB number; Judi will ensure your old number is inserted into the blue banner of your E-IRB application so the system and the IRB appropriately applies the old common rule or the revised common rule to future reviews of your study.
Existing Studies Not Yet Established in E-IRB
If you have not imported an approved protocol not yet established in the E-IRB system, you may import anytime, but must complete the import at Continuation Review. See video tutorial on how to “Import a Full or Expedited Application”).
November 29, 2018
ORI Guidance on the Revised Federal Policy for the Protection of Human Subjects
The UK Office of Research Integrity (ORI) has developed a guidance document outlining plans for transitioning to the revised human subject regulations (a.k.a., “the Common Rule”). The document also provides an overview of the key changes that will be effective after January 21, 2019. ORI will update the document with additional information as the federal Office for Human Research Protection (OHRP) releases guidance on interpretation and practical application of the new rule. Read more… [PDF]
November 12, 2018
General IRB Announcement: Follow up regarding Temporary Freeze on Initial IRB Applications
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
IMPORTANT DATES REGARDING IRB PROTOCOL SUBMISSION TO PREPARE FOR IMPLEMENTATION OF the Revised Policy for the Protection of Human Subjects (aka Revised Common Rule).
For simplicity, we will refer to the current regulations as the “Current Common Rule” and the January 21, 2019 regulations as the “Revised Common Rule.”
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.
If your submitted protocol cannot be approved by January 21, the submission will be canceled and ORI will provide you with a PDF version for use in resubmitting after January 21 when the Revised Common Rule is implemented in E-IRB.
Ongoing Approved Research:
BEGINNING November 14, 2018 Investigators are strongly encouraged to delay the creation of New Initial Review submissions until on or after January 21, 2019. If your submitted protocol cannot be approved by January 21, the submission will be canceled and ORI will provide you with a PDF version for use in resubmitting after January 21 when the Revised Common Rule is implemented in E-IRB.
REASON FOR TEMPORARY FREEZE - NO FEDERAL GRACE PERIOD
January 21, 2019 is both the effective date and the compliance date for the Revised Common Rule. This means that the institution cannot implement the revised rule before the effective date. It also means the regulation provides no grace period for which to transition to become compliant with the revised rule.
Due to the federal delay, the effective and general compliance date of the Revised Common Rule is January 21, 2019.
September 26, 2018
General Announcement: IRB Review Newsletter
Click here to read the IRB Review Newsletter:
In this issue:
- Importing Protocols into E-IRB at Continuation Review Time: what to include and how to incorporate changes
- Updated UK IRB Informed Consent Templates
- Replaced human subject training options for Non-UK study personnel
- October 4th Annual Human Subject Protection Conference; Advance registration ends Thursday, September 27, 2018.
September 17, 2018
General Announcement: Updated Informed Consent Templates
Based on feedback from researchers, IRB members, and participants from the Informed Consent Workshops, we have made revisions to both the Medical and Nonmedical Informed Consent Template. The changes involve:
- Clarifications in instructions and simplification of the section describing storage and sharing for future secondary use.
- Addition of collapsed sections the user can click to open and include if applicable. If not related to the research, the user simply deletes the section.
- Reducing appendix examples in the nonmedical template to one, as most nonmedical consents are sufficiently concise and not enhanced by appendices that merely duplicate information.
Available now for new submissions:
The updated medical and nonmedical informed consent templates are available for use immediately. Archive any saved versions of past templates, and use the current templates available in the “All Templates” menu option of your E-IRB application, or the UK Template website for new submissions. The template updates have not prompted ORI to ask investigators to edit consents that already have IRB approval or are submitted for IRB review.
Guides not carved in stone:
Templates are provided as guides to be customized to best meet the needs of the potential population and the context of the research. We encourage researchers to use conversational style, lay terminology resources and “plain language” techniques to create a consent document that facilitates understanding. After drafting, use the Consent Checklists to assess for regulatory compliance.
For more information on using consent templates, see the updated UK consent Form Template FAQ.
The UK ORI and IRB implemented a revised informed consent template December 2017, along with newsletter announcements, FAQs, and Informed Consent Workshop offerings. This transition occurred a year in advance of the January 2019 effective date of the new “Common Rule” regulations for protecting human subjects. The revision has provided an opportunity for researchers and IRB members to become familiar with select requirements from the new rule. In addition, the revised template included design and organization options for presenting information in a format intended to aid in understanding and help prospective subjects decide whether to participate in the research.
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.
July 11, 2018
General Announcement: IRB Review Newsletter [PDF]
In this issue:
- Updated Office of Research Integrity (ORI) Website
- CITI “Revised Common Rule” Course meets 3-year Human Subject Refresher Training requirement
- New Guidance for Researchers and IRB Members on Research Banks, Registries, & Digital Data
- Consent Contact for Greater than Minimal Risk Research
- Registration now open for the Annual Regional Conference, Human Subject Protection: Roll With It
October 4, 2018 Northern Kentucky Convention Center Early-Registration Discount
June 20, 2018
General Announcement: Nonmedical IRB Meeting Schedule Change [PDF]
Starting September 2018, the Nonmedical Institutional Review Board (IRB) will be convening on a monthly basis rather than a triweekly schedule. The new schedule will provide researchers with more time between submission deadlines to prepare their applications for Full Review. This change will also allow researchers to be more proactive and to contact Office of Research Integrity (ORI) staff for questions or feedback on applications prior to IRB review. ORI monitors the volume of reviews conducted by each IRB and adjusts the schedule accordingly. To view meeting dates and submission deadlines, please see below.
June 14, 2018
General Announcement: National Institutes of Health (NIH) Certificate of Confidentiality (CoC) and Participant Payment [PDF]
NIH funded studies that were ongoing or started after December 13, 2016 that collect “identifiable, sensitive information” from subjects, are deemed to have a Certificate of Confidentiality. The following information is provided to clarify the implications of an NIH issued CoC.
- If research subjects are paid $100 or less per occasion for study participation and cumulative payments do not exceed $600 in a calendar year, subjects ID or name is the only required data for payment via Business Procedures Manual E 9-1 Compensation to Research Subjects. Most research investigators with a CoC fall into this category.
- If research subjects with a reportable condition are paid $100 or less per occasion for study participation, subjects can still be paid under provision 1) listed above. The condition, however, is reportable per state law by a health professional if a reportable disease, or by the researcher for other reportable events. For reference, see the ORI summary of Kentucky reporting requirements (PDF).
- If payment(s) to a subject total $600 or more/year, the income has to be reported for tax purposes. The following verbiage, which can be found in the UK ORI/IRB informed consent template, shall be included to inform subjects of this fact: “With a few exceptions, study payments are considered taxable income and reportable to the IRS. A Form 1099 will be sent to you if your total payments are $600 or more in a calendar year”.
- At the request of a PI, ORI also consulted with an NIH CoC coordinator regarding entering research information protected by CoC into the medical records. NIH stated the following in response:Per the new CoC statute, identifiable research information can only be disclosed to those not involved in the research if it is required by other federal, state or local laws (except for legal proceedings), or for other research in compliance with federal human subjects regulations, or with the consent of the subjects. Generally, placing research information protected by a CoC in a subject’s medical record would require the subject’s consent.
- UK ORI will only provide a CoC certificate of acknowledgement for NIH CoC issued studies where subjects need additional protection for payment purposes.
- The UK ORI/IRB informed consent template contains NIH issued CoC language to be included in the consent form to inform subjects of the protections of the CoC.
- If a PI is using a non UK IRB, the PI is required to abide by the UK policies and procedures in regards to CoC and payment to research subjects (as well as local IRB requirements).
Additional information about NIH CoC is available at the NIH CoC Frequently Asked Questions website.
June 6, 2018
General Announcement: Adding Tracking Text to Your Approved Consent Forms [PDF]
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 does allow 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 21, 2018
E-IRB Improvements for Researchers Continue [PDF]
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 Info is being completed, the Department name and 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 could not 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 Dept. info on other applications. Note: Selecting a different department name from the drop-down box will automatically update the department code in the separate department code field.
May 4, 2018
General Announcement: UPDATE: Streamlining E-IRB Application Process [PDF]
ORI is pleased to announce that 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
General Announcement: 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.
April 3, 2018
IRB Review Newsletter [PDF]
- NIH Certificate of Confidentiality (CoC) Policy Change
- E-IRB: Tips for Choosing the Correct Study Personnel
March 5, 2018
IRB Review Newsletter [PDF]
- Delayed Effective Date for Revised "Common Rule" Regulation
- Informed Consent Changes based on New Common Rule
- Human Research Update at the 2/27/18 Clinical Research Update Series
- E-IRB Update & Details on Mandatory Use
- Informed Consent Workshop Announcement
January 5, 2018
General Announcement: E-IRB Transition [Details: PDF]
We are just two weeks away from the proposed effective date of January 19, 2018, for the revised common rule [PDF] regulations!
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 on the E‐IRB Frequently Asked Questions web page.
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.
January 2, 2018
General Announcement: Frequently Asked Questions on New UK Informed Consent Form Template [PDF]