NEWSLETTER

SPRING 2016

Change in IRB Chair

Melanie Plaut retires; KPNW Physician Ryan Radecki appointed as new chair.

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Melanie Plaut, MD, chair of the Kaiser Permanente Northwest Institutional Review Board (KPNW IRB), is retiring effective May 31. Melanie joined the KPNW IRB as chair in June 2003. During her tenure she has been instrumental in creating a collaborative board whose members have a high level of expertise. She also has done an excellent job managing board meetings and providing guidance for researchers and IRB staff in the ethical protection of human subjects in research.

Many positive changes have occurred under Melanie’s leadership, such as significant progress in consent forms being written in plain language and the use of the expedited review procedures for new studies that meet the criteria. We are grateful for Melanie’s many years of dedication to the work of the IRB. She will be greatly missed.

Ryan Radecki, MD, MS, FACEP, will succeed Melanie as KPNW IRB chair. Ryan is a physician in the KPNW Department of Emergency Medicine and works at both Kaiser Sunnyside and Westside hospitals. He started his professional life as a faculty member in a medical school in Texas, where he completed a training fellowship in Patient Safety and Quality. He attended medical school at The Ohio State University College of Medicine and did his residency at East Carolina University. Ryan is very interested in research and is currently the KPNW PI on two Resuscitation Outcomes Consortium studies being done in collaboration with OHSU. We are very fortunate to have him join us and look forward to working with him.


Change in Process for 'Approval in Concept'

Change in Process for IRB ‘Approval in Concept’ for Just-In-Time Requests by Funders.  

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The Research Compliance Office published an article in its Spring 2014 newsletter outlining a process for obtaining a letter for IRB “approval in concept” for Just-In-Time (JIT) requests. One requirement of a JIT request is IRB approval within 10 business days of the date of the request. In discussions with CHR’s Sponsored Projects Administration (SPA) staff, we learned that the “approval in concept” letter cannot replace IRB approval at the JIT stage.

The SPA staff will work with the Investigator and the funding agency to explain the IRB approval status and anticipated IRB approval date. The funding agency will often make the award with restrictions to spending on human subjects research. With this restriction, you will have the funding available to develop materials for IRB approval. For more information and guidance, please contact Erika Murchison, Manager of SPA, at (503) 528-3965 (tie-line 60-3965).

 


Non-KP Collaborators and Access to KP PHI

 Documentation is required in the IRQ when outside collaborators view KP PHI. 

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When an individual collaborates with KPNW, the appropriate documentation must be provided to address disclosure of PHI. Most of us know that when we share PHI outside of KP with a non-KP collaborator, the IRQ must either include a notation that the study will utilize a Limited Data Set (LDS) or a Risk Assessment Tool (RAT) must be uploaded with the study materials.

However, did you know that “disclosure” includes a non-KP employee viewing PHI by coming on site and/or being given remote electronic access, even if no PHI is removed from KP’s premises? So, for example, if an outside collaborator will be assisting with a screening process that entails either coming to a KP campus to look at records or being given remote electronic log-in permission to do so, these activities are considered a disclosure even though the data are not leaving KP.

If a non-KP collaborator will access but not remove KP PHI, the study protocol should include a very brief description about this. Also, as a reminder, in all cases when KP PHI will be disclosed to a non-KP collaborator, the IRQ must include a completed Risk Assessment Tool on the Supporting Documents page at the end of the application.  

 

 


eIRB Upgrade Update

The upgraded eIRB system is on track to launch early June! 

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You have likely heard that the eIRB system is getting a much-needed upgrade.  We have nearly completed testing and configuring the new system and are preparing it for launch.  Studies that have a continuing review due by June 1 will be moved from the old system to the new system in early May and will submit their continuing review in the new system. If everything works as expected for those studies, the estimated launch date for all other studies, including new submissions, is June 2!

A few things to keep in mind for the transition:

  • Close studies that are completed.  Closed studies will not be moved to the new system, but you will still be able to access the records through the old system.
  • Communicate with the RSPO office if you plan on submitting a new study or a significant modification in May or June.  The office will advise you on whether you should try to get it submitted in the old system, or if it would be best to wait for the new system.
  • Watch for training opportunities!  Around the time of the launch, the RSPO will host an open house as well as hold interactive training sessions for those who would like assistance navigating the new system.

 


Naming Study Documents in the Upgraded System

Guidance on Requirements for Naming Study Documents: Use these helpful tips when working with the upgraded eIRB.

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Draft and final versions of study documents can be accessed under the study’s Documents tab in the upgraded eIRB. Documents will not be divided into separate buckets by category (protocol, recruitment, consent, etc.) as they are in the current version of the eIRB. The category will be identified in the upgraded version, but the list of documents cannot be sorted. Thus, it is important to use names that make documents readily identifiable and easy to track if they are revised during the course of the study. IRB staff may return a submission with changes requested if document names do not conform to the following guidance.

As used in this article, the term “document name” refers to the name given to a study document when it is attached to an IRQ in the eIRB system. The term “file name” refers to the name given to a document when it is saved to a computer or network drive. “You” refers to a project manager or other member of the study team.

This pop-up appears when you attach a document to the IRQ:

 

 

Please use the Name field (#2 above) to name the document as you want it to appear in the IRB approval letter. You may enter a descriptive name for the document, or you may use the file name. The system will default to the file name if the field is left blank. The file name* must conform to the following guidance if you want to use it as the document name in the eIRB.

The beginning of the name should identify the type of document, e.g., protocol, consent, recruitment.

Add specific information to distinguish this document from other documents of the same type, for instance, when a study has multiple consent or recruitment documents. This part of the name should not be changed when the document is revised. Version numbers and dates are not required for IRB purposes. They should be entered at the end of the document name if you want them included in the approval letter.

Field #3 (Version number) in the pop-up shown above is optional. The eIRB will automatically assign an internal version number the first time a document is uploaded. The eIRB version number will be updated each time the document is revised to track version history within the system. You may use this field if needed for your reference. Please remember that version number and date must be entered at the end of the document name in field #2 if you want this information to be included in the approval letter.

Use abbreviations and acronyms with discretion. Remember that IRB members and staff are not as familiar as your study team with terminology specific to a particular study. Common abbreviations such as ”ppt” for participant, “QOL” for quality of life, and “IB” for Investigator Brochure are OK. As always, if in doubt, ask an IRB coordinator. Your submission may be returned with changes requested if IRB coordinators do not recognize an acronym or abbreviation used in a document name.

Examples

Study title: Coffee and Productivity (CAPS)

Study sponsor: Maxwell House

  • Protocol – Main Study
  • Protocol – Maxwell House MH12345 Amend3 4/1/2016. “Maxwell House MH12345” would be entered as part of the name if you want it to appear in the approval letter because the sponsor requires it or for other reasons. “Protocol Maxwell House MH12345” should not be changed when the document is revised. “Amend3” and “4/1/2016” are optional. It is fine to include this information if the sponsor wants it in the approval letter. Amendment/version numbers and dates can be updated as appropriate when the document is revised.
  • Consent – Main
  • Consent – CAPS MH12345 main v.3 4/1/2016. “Consent – CAPS MH12345 main” would be used if the study has more than one consent document and you want “CAPS MH12345” to appear in the approval letter. It should not be changed when the document is revised. “v3 4/1/2016” can be updated as appropriate when the document is revised.
  • Consent – Pharmacogentic genetic sub-study v.1 12/25/2015
  • Consent script – clinician interview
  • Recruitment – brochure
  • Recruitment script – clinician
  • Survey – CAPS QOL 666
  • Investigator Brochure MHS12345 Ed 2, 11/11/2015

The upgraded eIRB will produce a final version of all approved documents. All tracked changes will be accepted and comments removed in the final version. Beware! Document names must have more than three characters for the final version to be named properly. For instance, a Privacy Rule Authorization draft named “PRA” will be named “.pdf” in the final version listed under the Documents tab. This is an unfortunate quirk of the eIRB system. Your documents list in the eIRB will look something like this:

*A reminder about file names. It is best to keep file names short. File names should never contain spaces or special characters. This will ensure consistency and enable accurate backup and retrieval of data.

You can save a document to a descriptive file name using hyphens and underscores to avoid spaces in the file name:

  • Consent_Sponsor_main_MH12345_v.1.docx
  • Consent_PGx_MH12345_3-18-13.docx
  • Privacy_Rule_Auth_4_1_2016.docx or Privacy_Rule_Auth_4-1-2016.docx or PrivacyRuleAuth.docx

IRB Tips and New Information

Reporting Participant Withdrawals at Continuing Review

The IRB requires a report at continuing review on the number of KP participants who withdrew from the research during the report period and the reasons for their withdrawal, if known (per SOP KP-002 Continuing Review of IRB-Approved Research). If you do not know the reason for a participant’s withdrawal, please state that the reason for withdrawal is not known.

Should a co-author on a paper be listed as a co-investigator?

An individual whose only involvement with a study is as a co-author on a paper, journal article, or presentation may not need to be listed as a co-investigator in the IRQ if that person is not obtaining data about the subjects of research through intervention or interaction, viewing individually identifiable private information about the subjects of research, or obtaining the informed consent of human subjects for the research. Please contact the Research Compliance Office if you are unsure about whether a co-author on a paper should be considered a co-investigator.

Graphics versions of documents – When submitting a modification to add the final graphics version of an already approved document, be sure to confirm in the modification form that you have compared the two versions and no additional changes were made.

Acronyms and referencing other studies in IRQs – When using acronyms in an Institutional Review Board (IRB) submission, protocol, consent form, or other research document, please make sure to spell out the components of the phrase upon first reference, with the acronym listed in parenthesis after. It is also helpful if you refer to another IRB submission that you include that study’s IRB number.

 

Migration to the new eIRB system is right around the corner. Please consider closing your study in the current eIRB system if all of the following are true:

  • Enrollment is closed
  • Participants/have completed all research-related interventions
  • Data collection is complete
  • Data analysis of identifiable private information described in the IRB-approved research plan has been completed

Please see the Winter 2016 issue of the Compliance Newsletter for information on closing studies.