BSD/UCMC IRB News

7/2/24

An updated Policies and Procedures Manual has been posted. Revisions include:

1. Add subsections for “Emergency use of drugs” and “Emergency use of devices” to emergency use section with information specific to drugs versus devices [Section IV.D]

Please see the Policies & Procedures page for the updated manual.

On April 8th AURA-IRB (the platform utilized for IRB protocol submission, approval, and tracking) will be upgraded. This upgrade has been in process for some time in response to the update of our HIPAA covered entity.  Questions have been added to the IRB submission forms to collect data to be utilized by the University and Medical Center Privacy Offices for appropriate tracking of studies. In addition, clarifications have been added regarding the use of electronic medical record data for research. Finally, the system was updated in light of a new version of the software.

The AURA IRB system went live in 2012. Since the system went live there have been additional questions added to the form due to changes in IRB policies, significant changes in 2018 to the federal regulations and other changes necessitated by changes in procedures. As a result of the current changes to the IRB form and the revisions in the current upgrade, all active protocols, regardless of age, will be prompted to transition to the current version of the AURA submission form at the time of submission of an amendment. When the first amendment to each protocol is submitted (after the upgrade), users will be prompted to answer additional questions on the protocol form. These are both the few new questions relative to HIPAA and, in most cases, questions added to the form since the implementation of the AURA system in 2012.  Most submissions will require only a few additional questions to be answered. However, older submissions, those that were submitted to the IRB 6 years ago or later and remain active, may require more substantial additions.

We have provided documents below to highlight the additional questions that will be asked at the time of submission of the first amendment (dependent upon the form version). If you are unsure of the Smart form Version for a given study, it is on the front page (face page) of the AURA_IRB submission – in the top half of the screen on the right side. Here is an example of where to find the version.

• Version 1 (Labeled in AURA-IRB as Smart Form Version (blank)) – Protocols created 2012 – 11/2016
• Version 2  - Protocols created 11/2016 – 4/2018
• Version 3 – Protocols created 2018 - present

When the amendment is submitted, you will receive an error message to inform you of any required questions that are missing. You may utilize this view to go back and answer any required questions as opposed to hunting through the smart form searching for these questions. For example, here is a view of the error message if none of the required changes are addressed prior to an attempt to submit the amendment. You can link directly to the question by clicking on the form section in the “Jump To” menu.

Please reach out to Millie Maleckar, IRB Director at mmalecka@bsd.uchicago.edu if you have further questions.

4/11/24

An updated Policies and Procedures Manual has been posted. Revisions include:

1. Removed text that member from the same section as the PI cannot serve as primary reviewer for a submission. [Section VIII.A]
2. Added policy that PC responses cannot include substantial changes to study design; such changes should be submitted as an amendment or the submission should be withdrawn and resubmitted. [Section VIII.B]
3. Renamed CTRC to PRMC and removed SAM [Section XI.D and throughout] as per information received from UCCCC.

Please see the Policies & Procedures page for the updated manual.

A revised BSD/UCMC IRB consent/authorization form template is now available for use. The new version is dated November 2023. An edit has been made to the template text in the “What happens if I have an injury” section. This change was made to help integrate research conducted at affiliated sites and clarify that subjects are always encouraged to seek emergency care at the nearest location in the event of an emergency.

The following statement was added to the end of the “What happens if I have an injury” section:

“In the event of an emergency, you should seek care at the nearest emergency room or call 911.”

BSD/UCMC consent/authorization form template (November 2023 version)

 

For new submissions to the IRB, please incorporate this statement into applicable consent forms beginning January 2024. For existing approved studies with active consent form(s), the IRB requests that this statement be added at time of the next continuing review, if not done with an amendment prior to continuing review.

Please contact the IRB office if you have questions about this revision to the consent/authorization form template. 

A revised consent/authorization form template is now available for use. The new version is dated September 2023. Edits have been made to the template text regarding an NIH Certificate of Confidentiality. Please contact the IRB office if you have questions about the minor revisions.

 

BSD/UCMC consent/authorization form template (September 2023 version)

6/29/23

An updated Policies and Procedures Manual has been posted. Revisions include:

1. Added OHRP expedite category 1 as an allowable expedite category. Researchers are advised that this category applies to minimal risk research involving collection of data on use of drugs and devices as part of clinical care. This category will not apply to studies where drug would be administered as part of the study. 
2. Incorporated existing BSD policy on research related injury.
3. Minor editorial changes.

Please see the Policies & Procedures page for the updated manual.

A revised consent/authorization form template is now available for use. The new version is dated March 2023. Edits have been made to the template text in the "Key Information" and "What are the Benefits" sections. Please contact the IRB office if you have questions about the minor revisions.

 

BSD/UCMC consent/authorization form template (March 2023 version)

4/29/22

An updated Policies and Procedures Manual has been posted. Revisions include:

1. HIPAA related changes, including revised text regarding when HIPAA applies to the research, tracking disclosure of PHI in the medical record, and record retention.
2. Alteration of consent requirements clarified to confirm that researchers cannot alter elements at 45CFR116.a.
3. DOD requirements updated: Per Army website, independent monitor is no longer required.
4. Added CRI feasibility memo in the list of documents to be included with a new submission.
5. “CTRC approved with documentation” status added as an option for CTRC review.
6. Minor editorial changes.

Please see the Policies & Procedures page for the updated manual.

A revised consent/authorization form template is now available for use. The new version is dated March 2021. An edit has been made to the template text in the "What Are the Costs" section for clinical trials. Please contact the IRB office if you have questions about the new language.

 

BSD/UCMC consent/authorization form template (March 2021 version)

2/24/21

An updated Policies and Procedures Manual has been posted. Revisions include:

1. Added text to define “individually identifiable information” as containing one or more elements of PHI as defined by HIPAA.
2. Added text to state that re-opening a permanently closed study to enrollment would require a new protocol submission rather than an amendment.
3. Revised section I.D. to state that IRB determination letters do not require a signature (IRB Chair or otherwise).
4. Removed gender binary language throughout, e.g. “he or she.”
5. Minor editorial changes.

Please see the Policies & Procedures page for the updated manual.

As of February 1, 2021, submitting budget/contract documents at the same time as the IRB submission is no longer required. A copy of the memo detailing this change can be found here.

The IRB new submission acceptance requirements were updated to reflect this change.  

If a project requires clinical/research billing, both the IRB submission and ROC submission processes continue to require Medicare Coverage Analysis (MCA), which is commonly referred to as the schema and schema review memo. This is essential documentation that is used by both ROC and IRB during their review processes. An ARTEMIS record cannot be routed to OCR prior to an associated AURA IRB. For projects with clinical/ research billing an IRB AURA record cannot be submitted without an ARTEMIS record being created. If you have questions please direct them to the Office of Clinical Research [OCR] clinicresearch@bsd.uchicago.edu

The Office of Clinical Research is open both virtually and in person, and we are fully operational. All staff are working remotely and most meetings are being held virtually, with some in person scheduling available as needed. Staff are happy to arrange Zoom meetings or conference calls with researchers and staff.

Please send an email to bsdirb@bsd.uchicago.edu if you have a question about COVID-19 related research or an amendment to an existing study that is needed due to the current circumstances.

Please see the attached FAQs for IRB-specific questions related to COVID-19 and its impact on new and existing research: COVID19 FAQs

12/26/19

An updated Policies and Procedures Manual has been posted. Revisions include:

1. Added text indicating that grant congruency review is no longer required of the IRB by the federal regulations at 45CFR46.
2. Added policy on emergency waiver of informed consent.
3. Added text to the “Amendments” section: if study is open to enrollment and/or has active subjects, revised consent form is required when submitting risk changes (i.e. new IBs) to studies where consent is required – or – study team must provide confirmation as to how risks will be communicated to subjects.  
4. Clarified that requirements for approval of research with prisoners apply to “federally-regulated” research.
5. Revised language regarding IRB’s role under HIPAA to clarify that IRB performs HIPAA review functions.

Please see the Policies & Procedures page for the updated manual.

A revised consent/authorization form template is now available for use. The new version is dated November 2019. Suggested text as well as sample text has been added to the "What about confidentiality" section. Please contact the IRB office if you have questions about when to include the new language.

 

BSD/UCMC consent/authorization form template (November 2019 version)

Over the past few months, the IRB offices have been considering changes to streamline their processes and to decrease the turnaround times for new protocols. Currently, the IRB processes for new protocols involve submission of studies for a stated deadline with subsequent review by the fully convened Committee three weeks later. Currently, there are two deadlines per month. In reviewing data from the past six months, approximately 60% of submissions that were submitted by the deadline are not able to be reviewed by the IRB Committee. Reasons for the delay include lack of a response to the IRB administrative review, lack of submission of budget and contract documents to the Office of Clinical Research, as well as other issues, including incomplete submissions.

In light of these findings, the IRB office (effective July 1) will no longer post new submission deadlines. The IRB staff will process protocol submissions for full review on a weekly basis. The IRB administrators will complete the preliminary review process and upon receipt of a “complete” IRB submission, the protocol will be placed on the next available meeting agenda. 

The IRB staff has prepared guidance for what constitutes an acceptable submission to be considered for preliminary processing as well as what constitutes a “complete” submission in order to be assigned to a meeting agenda. The IRB staff will follow these standardized, published checklists when determining what studies are ready for IRB review.

Our goals are to increase standardization of IRB admin comments and decrease the protocol turnaround times between acceptance for submission and final approval. We will be tracking this data over the next several months to determine whether or not this change in process has resulted in a decrease in turnaround times.

 

5/14/19

An updated Policies and Procedures Manual has been posted. Revisions include:

1. Clarified text regarding continuing reviews to state that policy applies only if continuing review is a requirement for that study
2. Added section “Deception and Withholding Information”
3. Re-ordered sections due to addition of section on deception and withholding of information
4. Revised new protocol submission policy to state that submissions must be complete to be reviewed by the IRB
5. Clarified emergency use procedure for timeline to report to FDA (5 days) and
6. Clarified timeline for reporting unanticipated device effects to FDA (10 days).

Please see the Policies & Procedures page for the updated manual.

1/18/19

An updated Policies and Procedures Manual has been posted. Revisions include:

1. Implemented requirements of revised Common Rule throughout
2. Revised unanticipated problem reporting policy to reflect that internal events should be reported “in a timely manner” (this language matches FDA guidance on reporting timelines)
3. Revised policy on consenting individuals who cannot read or write to reflect two separate populations: low literacy subjects and physically disabled subjects and
4. Minor editorial changes. 

IMPLEMENTATION DATE: JANUARY 21, 2019

Major Changes of the Revised Common Rule Regulations
The 2018 Requirements focus on reducing administrative burden and aligning protection of human subjects with level of research risk. Several of the changes reduce or remove requirements for low-risk research, while other changes offer additional flexibility within the current framework.

• New Exempt Categories:
  • Research with benign behavioral interventions (will likely result in the majority of currently-expedited social-behavioral-educational research being exempt)
  • Secondary research use of information/biospecimens protected by HIPAA
• Removal of renewal requirements for expedited research and full Board research which is now in long-term follow-up only or data analysis only. U of C will consider the flexibility of this approach on an individual protocol basis at the time of continuing review for all previously approved research, as the FDA regulations have NOT been revised to remove the continuing review requirement.
• Informed Consent Impacts:
  • Consent must begin with a concise and focused presentation of key information which participants want in order to make a decision (e.g. statement that the project is research and that participation is voluntary and a summary of the purpose, duration, procedures, risks, discomforts, benefits, appropriate alternatives, costs and payment).
  • New elements of informed consent must be included (when applicable):
    • Potential for future use of deidentified information
    • Potential for commercial profit and sharing of profits with subjects
    • Whether clinically relevant research results will be disclosed to subjects and, if so, under what conditions
    • For research involving biospecimens, whether the research will involve whole genome sequencing

What to Expect
The 2018 Requirements will result in a large number of changes to Institutional Review Board policies and procedures.
 

• Implementing the Informed Consent Changes

1. Concise Presentation: The new regulations require that consent begin with a concise and focused presentation of key information which participants need to make a decision, and which explains why a potential subject might or might not want to participate. The goal of this concise presentation is to provide a summary of the research up front so potential participants can more easily understand the research and the consequences of participation, both positive and negative. The consent form template includes suggested language for this section. In addition, sample text has been provided based upon study type.
2. New Elements of Informed Consent: The revised regulations also add four new elements of informed consent. These elements represent additional information which must be included in the informed consent form and presented to potential subjects, when applicable. Suggested language for each of these new elements is included in the revised informed consent template.
3. Using the Informed Consent Templates: Revised informed consent templates have been published to the IRB website. The revised informed consent template should be utilized for all new studies submitted for IRB review. Research which is approved on or after January 21, 2019, must meet the new requirements; as such, informed consent forms for those studies must include the concise presentation/summary and additional elements of informed consent. The IRB will consider, at the time of continuing review, whether or not existing studies will need to be amended to comply with the new requirements.
4. Revisions to Waiver of Consent Criteria: Research which meets certain criteria may be eligible for a waiver (or modification) of the informed consent process. The revised Common Rule adds one new criterion to this list. Specifically, if the research involves utilization of identifiable information or biospecimens, the investigator must justify that the research could not practicably be carried out without the use of identifiers.
5. Posting of Consent Forms: The new regulations also require posting of the consent form document for all federally funded clinical trials on a publicly accessible website. One IRB approved consent form that was used to enroll subjects must be posted on a federal website once the study has been closed to recruitment and within 60 days of the last study visit by any subject. At this time, two publicly available federal websites that will satisfy the consent form posting requirement: ClinicalTrials.gov and a docket folder on Regulations.gov (Docket ID: HHS-OPHS-2018-0021).  We have been told that HHS and other Common Rule departments and agencies are developing instructions and other materials providing more information to the regulated community about this posting requirement. However, this guidance has not been published. It should be noted that this requirement will only be relevant for studies approved under the new  Common Rule. At this time, there is no expectation to post clinical trial consent forms for studies approved prior to this date.

• AURA-IRB Changes: The AURA-IRB form was revised to reflect requirements in the revised Common Rule. The new version of the AURA-IRB form went live January 2019.