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Commercial IRB Utilization and IRBIS Update

 

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To: UNC-Chapel Hill Research Community

On September 10, 2019 the UNC-Chapel Hill Office of Human Research Ethics (OHRE) will have several revisions go into effect to the OHRE/IRB Standard Operating Procedures (attached) and IRBIS updates that were identified through listening sessions and feedback from our research community;

Commercial IRB Utilization

  1. For all multi-site, industry sponsored clinical trials a commercial IRB should be utilized.

a. This change is in order to facilitate faster study start-up, focus internal resources on investigator initiated and/or NIH funded work, and facilitate effective review for the research community.

b. An abbreviated application will be available to users starting Wednesday, September 11, 2019, see additional details below.  The UNC-CH IRB is required to complete review of “local context” for all studies where UNC-CH is engaged in research regardless of the requirements of the reviewing external IRB.

i. Following the IRBIS update on 9/10/2019, a follow-up session with OHRE representatives will be available on 9/25/2019 to review the updated system and address user questions. In addition, UNC’s representative from WIRB will be available to answer submission questions.

ii. IRBIS Review Update, 9/25/2019 3:00-4:00 PM, https://unc.zoom.us/j/387692833 (Dial-in: 1-929-436-2866/ID:387-692-833)

iii. The OHRE has also been updating its Requesting Reliance on a Commercial IRB webpage and will continue to update with guidance documents (flowcharts, templates and instructions).

Frequently Asked Questions – Commercial IRB Utilization: 

    1. What if I already have an application in IRBIS for a multi-site, industry sponsored clinical trial to be reviewed by UNC-Chapel Hill started?
      • If an application for a multi-site, industry sponsored clinical trial is already in progress, the submission can still be reviewed by the UNC-CH IRB.  However, you may also choose to have the submission changed to be reviewed by a commercial IRB.
      • If other exceptions are needed and you believe your study should be reviewed by the UNC-CH IRB, please consult with the Reliance Manager.

     2. What if my multi-site, industry sponsored clinical trial is already approved by the UNC-Chapel Hill IRB? 

      • This does not affect studies already approved by the UNC-CH IRB. UNC-CH IRB review may continue throughout the study lifecycle.  However, if you would like for this study to be reviewed by the commercial IRB, please contact the Reliance Manager, John Roberts at jtr@unc.edu.

3. What about other study types? 

      • This does not affect non-industry sponsored multi-site clinical trials (e.g., investigator initiated/sponsored, federally funded, or non-funded research).

IRBIS Updates

  1. The UNC-Chapel Hill IRB will now offer submission types for initial applications. 

a. In feedback from our research community, it was shared that although some of our community may not know the type of submission (e.g. exempt, rely-on, 118/JIT) they need, many of our experienced researchers and study teams know the type of submission they need and having to answer questions that were not specific to their application made it cumbersome and time-consuming.

b. As a first step, we are separating the application types. This will allow us to facilitate submission type by submission type weeding of questions to help improve effectiveness for all.

c. An IRBIS update document will be sent out on 9/10/2019.

Frequently Asked Questions-IRBIS Update:  

    1. What if I have a submission in progress? 
      • Please continue with the submission. If any issues occur, please consult Laura Cowan, Mike Matamoros, or Cassie Myers. Contact information is available below.
    1. When willother application types be reviewed and revised? 
      • The “Rely-On: Commercial IRB” application was reviewed for this release and a 40-50% reduction was identified in questions.  We will be reviewing other application types over the next 12-18 months.

Board Restructuring

  1. The UNC-Chapel Hill IRB no longer has a biomedical, non-biomedical or safety designation. 

a. We have observed over recent years that the lines between biomedical and non-biomedical are no longer as easily defined, and previous methods of utilizing the PI’s department were not effective without creating delays and frustrations.

b. Reviewing New Safety Information at one board meeting per month is not serving our participants or research community the best.  New Safety Information (NSI) needs prompt review and our previous structure made this difficult to facilitate.

Frequently Asked Questions-Board Restructuring:  

    1. What will the new board structure look like? 
      • UNC will have 6 board meetings a month and, provided appropriate expertise is available, will negate the need for many of our non-biomedical groups to “wait for a specific committee.” This will also allow New Safety Information (NSI) to be reviewed with the resulting modification.
    1. What does this mean for my study? 
      • As we are our transitioning the boards over the next several months, the new calendar with “submission” deadlines will be updated starting January 2020.  Some submissions may be moved as part of the transition, however during this transition we can’t ensure that a study will be reviewed sooner than the published timeframes.

These updates require several changes to UNC’s electronic IRB Information System, IRBIS.  The system will be unavailable from 5:00 pm until approximately 9:00 pm on Tuesday, September 10, 2019.

In preparation for these revisions, the Office of Human Research Ethics (OHRE) presented informational sessions hosted by NC TraCS in August and September.  The presentation will be available at: Requesting Reliance on a Commercial IRB.

If your department/division/group would like a brief overview of the above and how these revisions may impact your research or if you have additional questions, please reach out to one of the individuals below.

Commercial and Externally Reviewed/Reliance Agreements: 
John Roberts, Reliance Manager
919-966-2748 | jtr@unc.edu

Sarah Washam, IRB Analyst-Commercial IRB
919-966-0105 | swasham@unc.edu

UNC IRB Reviewed Studies/IRBIS Questions:  

Mike Matamoros, Quality Assurance/Improvement Manager
919-966-2738 | matamoros@unc.edu

Laura Cowan, Data & Information Manager
 919-966-3685| lbcowan@unc.edu 

Cassandra (Cassie) Myers, OHRE Director
 919-966-6893 | cassandra.myers@unc.edu

OHRE General Questions: IRB_Questions@unc.edu
IRBIS System Technical Helpdesk: IRBIS@unc.edu

Safety/Compliance: 

Jeanne Lovmo, Compliance Manager
919-843-8806 | lovmo@unc.edu

Thank you,

Cassie Myers

Cassandra Myers, CIP
Director, Office of Human Research Ethics
University of North Carolina at Chapel Hill
720 Martin Luther King Jr. Boulevard
Chapel Hill, NC 27599-7097
919.966.6893 (Office Line)| 919.966.3113 (Main Line)
cassandra.myers@unc.edu

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