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IRB Operations Update - 2019 Q4


By: Tiffany Gommel

What’s New

As of December 2019, the protocols and committee members of all twelve of the legacy IRB committees have been centralized under NIH IRB Panel 1 Committee.  The NIH IRBO and the NIH IRB now have approximately 2000 active studies under their purview. These protocols span the entire NIH IRP. In January, we transitioned to holding all IRB meetings in Building 31, Room B2B32. This space has been freshly painted and has new carpet.  Additional planned updates to the space will include new furniture and technology for use by both IRB staff and IRB members. This will be the OHSRP footprint space on the NIH campus for staff to work on site on the day of IRB meetings, and hold in person consults and meetings, etc.

Since our last update, the following new staff have joined the office as IRB Analysts: Annika Shuali, Jason Wilson and Jaime O'Brien. We are excited to share that we have also hired two additional trainers to join the iRIS training team, Anthony Marchi and Jacqueline Claiborne. We are currently in the process of recruiting one more IRB analyst position and beginning to interview and hire two IRB Coordinators.

In addition, we are piloting a new initiative whereby staff in each IC will be responsible for the formatting of their own consent forms.  Specifically, research staff in the ICs will be responsible for formatting (font type, color, size, spacing, etc.) and making any other necessary changes (e.g. headers and footers), prior to submitting their consent forms in iRIS. We have created formatting guidelines for the research staff to follow in conducting this task.  As of January 27, we began piloting this new process in NCI and NHLBI.  We are hoping that this will improve efficiencies by allowing the IRBO to focus on key aspects of the IRB review process, including editing the consent form for readability and accuracy instead of focusing on formatting. The pilot is expected to last at least through the end of February.

Coming Soon

OHSRP Website: We have been working hard on a newly design OHSRP website.  We think you will love its new "look and feel".  In the meantime, please continue to go to https://irbo.nih.gov/ to access protocol and consent templates, forms, submission guidelines, SOPs, and information about iRIS, education & training, etc.

Did You Know?

  • IRB Approved Consent Forms: As of the end of the December, you can now access your IRB-approved and watermarked consent forms in iRIS as soon as you receive your IRB approval letter for Initial Reviews and Amendments. Of note - OPS will continue to post the consent forms that the IRBO provides to them on the “search your studies” website.
  • Closing Protocols: If you have completed all analyses associated with the original aims of your IRB-approved protocol and all planned publications have been accepted (i.e. you don't need to re-access your identifiable specimens or data to validate any analyses), you can close your protocol with the IRB. You do not need to maintain an open protocol with the IRB simply because you are holding on to identifiable specimens or data.  If you wish to pursue new secondary research with identifiable data or materials, you should submit a new protocol to the IRB for review and approval.
  • No Continuing Review for Some New Studies: If your study was approved by the IRB under expedited review on or after January 21, 2019, your study has no expiration date and does not need to go through a formal Continuing Review process with the IRB. Instead, we will ask you to submit a “Progress Report” in iRIS at the time you would normally submit your continuing review. This information will be reviewed in an administrative fashion and won't hold up any study activities.  In addition, after 2/7/2020, there will be 1 form in iRIS to complete either a continuing review, progress report or study closure. This form will be call the Progress Report Form.
  • Sharing Specimens and Data: No matter how old your protocol is or whether it is open or closed with the IRB, the original consent form language should be respected. If you wish to share materials collected under a research protocol, you need to review all the versions of the consent forms previously used to ensure that your planned sharing or research is not inconsistent with the original consent form language. De-identifying specimens or data in order to avoid having to comply with the original consent form language, while allowable under the regulations, is still considered unethical from the perspective of human subjects protections.

Reminders

  • Problem Submissions: Submissions that don’t meet minimum standards may be immediately returned to the study staff before pre-review. All the following factors can significantly delay the IRB review and approval process:
    • Use of old consent templates or not updating protocols or consent forms per the required changes, i.e. documents which are missing required content (e.g. don't follow approved templates).
    • Lack of careful review prior to submission, e.g. inconsistencies between and within the study application, protocol, consent forms and/or associated documentation
    • Failing to include both MS Word versions of documents (tracked changes and clean versions with changes accepted)
    • Using long, confusing naming conventions for documents
    • Submitting amendments without clearly delineating all the changes and the rationale for those changes.
    • Uploading multiple versions of the same clean or tracked documents separately rather than "versioning and stacking"
  • Amendments:
    • Protocols: Remove the face page with the list of study personnel and then create and submit the Key Study Personnel
    • Consent Forms:
      • Make sure you have transitioned to the most up to date version of the consent template (pre-2018 or post-2018) and that you are including all the required NIH language (blue text) and sections, as applicable
      • For covered protocols, add the new COI language found on page 10 of the new post-2018 NIH consent template (not the pre-2018 consent template)
      • Even if the approved consent form language has only been moved to the new consent form template, and there are no other changes, this is still considered a change to the submission. Please be sure to name this as one of the changes in the Amendment form.
      • Also see "Revising Documents" below
    • Revising Documents: If you are submitting a revised protocol, consent form, recruitment document, study instrument, etc., you must always upload both a tracked version and a clean version of the document in MS Word. The version date (including the header and/or footer) within the document should also be updated with every revision.

Reminder – the above changes should be made when you submit your NEXT amendment. Please do not submit an amendment just to make these changes.

Tips

Versioning and Stacking: Knowing how to properly 'check out' current documents and 'checking in' new versions of tracked and clean documents is an expectation of research teams who are using iRIS under the NIH IRB.  This activity also involves updating titles and version dates in iRIS itself.  Performing this activity correctly is the only way to ensure that the IRB is reviewing the most current versions of your documents. If you don't know how to version and stack, please refer to the Instruction Sheet #10 here: https://irbo.nih.gov/confluence/display/IRBO/NIH+iRIS or reach out to the iRIS trainers at iris_training@od.nih.gov.