The OHSRP Education Series Presentation 2019: When IRB Approval is Necessary and How to Complete the New Investigator Attestation for Tech Transfer Agreements

March 18, 2019 / Julie Eiserman

Videocast

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Changes to the NIH IRBs and Common Rule

2019 / Jonathan Green & Tiffany Gommel

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The OHSRP Education Series 2020: Research vs Practice: Separating church from state in NIH protocols

February 4, 2020 / Jonathan Green

Videocast (NIH only)

The OHSRP Education Series 2020: What information should be included in protocols submitted to the NIH IRP IRB? AKA: How to write a protocol 101

March 3, 2020 / Tiffany Gommel, Nicole Grant

Videocast (NIH only)

iRIS Update - 2019 Q4

By: Sue Tindall

What’s new in iRIS?

Lots to be proud of over this last year!  As you know, IRBO is working continuously all year to improve the iRIS system to be more streamlined and user friendly.  Some of the changes being made for you in last few months are outlined below:

• 02 Upgrade – A new “look & feel” of the system will be implemented at the end of December. While all study activities and workflow behave the same, most of the changes lie in the appearance of the Dashboard Layout. Improvements include:
  • cleaner look & feel
  • shortcut activities that take you to relevant sections of your workspace
  • customizable filters on workspace, that remain in place (‘sticky filters’)
  • ability to view study data, status, and history on the dashboard level.
  • revisions to KSP sections that later in 2020 will allow us to transition the community into moving all KSP into one section 3
  • ability to create ‘study pools’ of KSPs, which you can later add to a study with one click
  • ‘drag & drop’ document functionality
• Consent Form Stamping – finalizing consent documents in iRIS has been slightly revised, and the IRB analysts will now be stamping all Initial Reviews (IRs) and Amendment (AMs) automatically via iRIS. Consents are no longer sent to OPS post-IRB approval, to process and “stamp.”  Study teams now receive approved consent documents in real time (at the time of receiving their IRB approval outcome letter). 
• Scientific Review Pilot – The NCI, NHLBI, and NINDS continue to pilot the revised Scientific Review Form and gather their feedback for IRBO to implement into the SRC project. Once this is completed, IRBO will engage all ICs in the implementation/roll out of using iRIS to complete their Scientific Review form required by Dr. Gallin in iRIS as well.  This way, all ICs are conducting this important review in the same way, in one system, allowing for consistency and critical reporting data.
• IRB Outcome Letters Improvements – You may notice a difference in appearance of your IRB Outcome letters. Due to the final acquisition of all IC’s IRBs under IRBO and Panel 1, we took this time to optimize our letters.
• Continuing Review Reminder Notices – You may notice a difference in appearance of your Continuing Review Reminder Notices. This was done because some minor inconsistencies needed to be corrected.
• Revision to Routing Signatures Language - Based on the MEC’s recent revisions to signature requirements, iRIS  has been revised to reflect this in the routing signatures language.  Please review carefully all signature language in your submissions for any revised requirements, which are summarized here:
  • Initial reviews: PI and Branch Chief or CD must sign.  If the PI is the CD, then the SD must sign.
  • Amendments and CRs: PI signoff only.  No Branch chief/CD signature required.

• New Progress Report Form - A new single submission form will take the place of the former separate Continuing Review and Study Closure forms. There will now be one single form for the following three types of submissions:
  • Continuing Review
  • Study Closure
  • Progress Report*
    (*This is a new, brief, institutional “check-in” required for minimal risk studies that the IRB has approved on or after Jan 21, 2019 under the revised Common Rule and has determined to not require continuing review.)

New Progress Form update:

The IRB is now requesting at the time of continuing review, that for protocols which have enrolled any subjects since the last review, a redacted copy of the last signed consent for each of the approved forms be attached. 

The responsibility to ensure that research is conducted as approved by the IRB and in accordance with the regulations and institutional policies is a responsibility that is shared by the institution, the investigator and the IRB.  This can and should be accomplished in a number of ways, including monitoring by the research team, by external bodies (including regulatory agencies), as well as by the IRB.  It is a responsibility of the IRB to assure at the time of continuing review that the protocol is in fact being conducted as approved.  An explicit goal of monitoring is to detect problems at their earliest stage. Problems with informed consent documents are among the most frequent compliance findings, which can lead to adverse findings in sponsor and/or regulatory audits. By reviewing the submitted consents, the IRB will be doing a “spot check” for compliance with the consent requirements as outlined in the protocol.  We hope this will allow for us to identify any issues that can then be brought to the research teams attention for corrective measures. 

Compliance & Training Update - 2019 Q4

By: Peg Sanders

In the months since Policies 801 and 802 as well as use of the new Reportable Event Form (REF) have been implemented, we hope you have become more familiar with the process for reporting such events to the OHSRP Division of Compliance and Training via iRIS.  We continue to see a reduction in number of REF submissions compared to prior to the new reporting policy.  As a reminder, when you are reviewing events that occur during the conduct of non-exempt human subjects research, deviations that do not meet the criteria for a major deviation do not require expedited reporting in iRIS but can, instead, be included as part of a high-level summary of deviations provided at the time of Continuing Review (CR). Major deviations that require expedited reporting in iRIS are those that have EITHER the potential to negatively impact the rights, safety or welfare of subjects or others OR have the potential to negatively impact the scientific integrity or validity of the study. Also, regarding reporting of deaths in iRIS, if the death of a research subject is possibly, probably or definitely related to the research, it must be reported within 24 hours of the investigator becoming aware of the death.  Deaths that are unrelated to the research, however, do not require expedited reporting and are considered SAEs that are not unanticipated problems, and these deaths may be reported as part of a high-level summary of SAEs and AEs at the time of CR.

The Research Compliance Review Committee (RCRC) has been meeting monthly to review events that rise to the level of possible serious and/or continuing noncompliance.  The RCRC, a duly convened NIH IRB, is a group of 9 specific members who provide thoughtful review and insightful discussion regarding the events that have been brought to that Committee for its deliberation. The stable membership of this committee provides consistency in determinations across protocols and ensures that there is robust corrective action in place to address concerns related to the noncompliance.

The OHSRP Compliance and Training group is gearing up for the 2020 OHSRP Education Series, and our next session will occur on Tuesday, January 14, 2020 from 3-4 PM in Lipsett.  We plan to cover updates related to informed consent based on questions we have received from the IRP community.  After that, these monthly sessions will occur the first Tuesday of the month from 3-4 PM.  The location will vary based on conference room availability, and I urge you to check the OHSRP calendar to confirm the location for specific sessions.

How are you notified when FDA makes labeling changes or adds a Black Box Warning to approved drugs being administered as part of your protocol? Click here and you will find instructions describing how you can register to receive these updates from the FDA.  Email updates are provided roughly once per week and an example is included below.  If there is a drug of interest, simply click on the drug, and this will take you to a page where you can click on the link to the updates.”

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).
    • For information about the requirements: https://irbo.nih.gov/confluence/display/IRBO/Newly+Transitioned+IRBs
  • 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.

NIH IM IRB Metrics - 2019 Q4

Mean days to approval for studies reviewed by the NIH IM IRB full board committee from July 2019 through the end of January 2020

Total number of forms approved by the NIH IM IRB at the full board through the end of January 2020

Mean time to approval of forms approved by the Full Board in January 2020 for each IC

Mean time to approval for forms approved by expedited means July 2019 through January 2020

Total number of forms approved each month by expedited procedures

Total number of each form type submitted to the IRB each month

Grand total of forms submitted to the IRB from July 2019 – January 2020

Letter from the Director - 2019 Q4

Dear NIH Community,

The end of the year is frequently a time for pause and reflection, so I wanted to share with you some of what we have accomplished in the past year and where we are headed.  2019 was a busy year for OHSRP with lot of change across the clinical research landscape of the NIH Intramural Research Program.  Some of the accomplishments of the past year are highlighted below.

Staff

• 25 new FTE and 5 contractors hired and onboarded

Space

• Moved to new space at 6700B Rockledge and consolidating our on-campus footprint into renovated space in building 31 that was previously occupied by the CNS IRB.

IRBs

• Rolled in all legacy IRBs into the new NIH Intramural IRB
• Implemented the revised Common Rule
• Implemented the flexible IRB model with the new NIH IM IRB meeting 3 times per week in 2019
• Standardizing IRB and regulatory determinations across the IRP
• Processes and Policies
• Undertaking a complete rewrite of NIH HRPP policies. On track to complete by early 2020
• Developed new protocol and consent templates
• Revised short form consents
• Removed the “witness to the signature” requirement
• Updated exempt determination process, and put into IRIS
• No more mandatory NHSR determinations (NHSR forms now in iRIS)

Electronic IRB system

• Completed migration onto single platform
• Consolidated IT team under IRBO leadership
• Redesigning the forms, workflow and processes for enhanced efficiency
• Federated login to support external users
• Reliance/sIRB processes
• Master agreement to WIRB and Advarra put into place
• Manage exceptions to sIRB policy
• Working with all parties to sign on to SMART IRB

Compliance

• Completely new office of Compliance and Training formed within OHSRP
• Revised and implemented new policies on the reporting and review of non-compliance, non-compliance and other reportable events.
• Established the Research Compliance Review Committee

Education

• New monthly NIH wide OHSRP education series
• Implemented regular education and training for IRB operations staff, IRB members and Chairs training

What’s in store for 2020?

The upcoming year will focus heavily on process improvement.  Now that the new IRB and IRB office are overseeing all research, we can direct our efforts to streamlining the review process and assuring that all protocols have the required regulatory determinations made and documented.  Our goal is to minimize unnecessary burden on investigators and the IRB to allow for our energy to be focused on what matters, performing high quality reviews to make sure the best research moves forward ethically, efficiently and in a way that is compliant with all the regulatory requirements.

We will be concentrating our efforts in four major areas:

1. Streamlining our internal IRB processes as well as our interaction with other clinical center offices to allow for the most efficient review process.
2. Optimizing our electronic IRB submission system, iRIS, to facilitate an efficient submission and review.
3. Assuring that all protocols being conducted under NIH IM IRB oversight have the required regulatory determinations made and documented in the electronic system.
4. Providing educational opportunities on human subjects protections that are responsive to the needs of the NIH IRP community

I am enormously proud of all the work that the staff of the OHSRP has done to get to where we are today.  There have been bumps in the road and I have no doubt new challenges will arise over the course of the next year, but also am confident that we can meet and overcome those challenges.

I am also extremely grateful for the support the leadership of the NIH has provided, and the support and patience of the entire NIH intramural research community.  We could not do this without you.  In the end, together we will have built the best HRPP in the country.  Our patients, participants and researchers deserve nothing less.

Jonathan