NEWSLETTER

WINTER 2016

New Cede Request Flowcharts

The process for review of collaborative research by a single IRB—a ceding request—is complicated and can be confusing. The Research Compliance Office is developing guidance...

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The Research Compliance Office is developing guidance to help PIs and project managers navigate the administrative process and understand their responsibilities under a ceding arrangement.

Our first initiative is the creation of flowcharts to show project managers the steps they need to take to initiate a ceding request and what steps the IRB staff manages. The new cede request flowcharts can be found on the Research Compliance website For Researchers IRB Process and Submissions Collaborating with Other Institutions and Investigators.

The flowcharts cover the following types of ceding arrangements:

  • An IRB authorization agreement between KP and another institution
  • The memorandum of understanding between OHSU and Kaiser Foundation Research Institute on behalf of KPNW for IRB review of designated cooperative research (OHSU MOU)
  • The HCSRN (formerly HMORN) IRB Reciprocal Reliance Arrangement
  • KP interregional research conducted in accordance with SOP KP-004: IRB Review of Interregional Research

KPNW also has IRB authorization agreements with the National Cancer Institute Central IRB for certain oncology studies and with the National Dental PBRN Central IRB for National PBRN studies. Those arrangements are not included in the flowcharts because administrative procedures specific to them have been developed with Clinical Research Support Services and National Dental PBRN staff.

In the coming months the Research Compliance Office will provide additional guidance about ceding arrangements, including:

  • PI responsibilities when another institution cedes review to KPNW
  • PI responsibilities when KPNW cedes review
  • Institutional requirements that do not go away when a review is ceded to another IRB

Please contact the RSPO if you have questions about a ceding request.

 

When Can I Submit a Final Report to Close My Study?

Information about when to submit a final report.  

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A final report may be submitted when ALL of the following criteria have been met:

 

  1. Enrollment is closed,
  2. Participants/subjects have completed all research-related interventions,
  3. Data collection is complete, and
  4. Data analysis of identifiable private information described in the IRB-approved research plan has been completed.

 Sometimes people worry they will get questions after a publication that will make them want to go back to look at the data again and therefore they are hesitant to close the study. It is acceptable to look at the raw data after the study has closed IF you just want to answer a question, but you can’t do any additional analysis on that data. However, if you de-identify the data first you can do additional analysis on that de-identified data. De-identified means that the identity of the subject is or may not readily be ascertained by the investigator or associated with the information.

For multi-site studies: If you have completed data collection and analysis at this site and have no other responsibility in the trial, the study may be closed at this site even if it is continuing elsewhere. Please note that if you are the prime awardee for the study you must keep it open until all four criteria above are met at all sites.

Now is an excellent time for you to consider closing any of your studies that you can. As reported in this newsletter in the article on “eIRB upgrade update” we will be moving to a new eIRB system this summer. All ongoing studies will need to be converted into the new system at that time.

Note that federal regulations require research records be maintained for 3 years after completion of the research. HIPAA requires written documentation, including signed authorization forms and documentation of waivers, be retained at least 6 years after their creation or the date they were last in effect, whichever is later. Therefore, if you have a signed authorization that never expires, you cannot destroy it. To minimize confusion with the two requirements, the Research Compliance Department recommends that all research records be kept for at least 6 years.


Why do I need to complete non-required sections of my IRQ?

Susie Project Manager was confident the human subjects submission she’d created for a new project would sail through the review process. Not only did they not receive immediate approval, but Susie and her PI were instructed to complete non-required sections of the IRQ. What happened?

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Susie Project Manager’s PI directed her to create a human subjects submission for a killer research project. Susie was well-versed on the topic, having been instrumental in providing feedback on the initial phases of the grant submission. Writing the Initial Review Questionnaire (IRQ) and study materials was a breeze and, with the submission under her belt, she knew she and her PI would get the study through review and approval in a snap.

Imagine her dismay when the study was kicked back, with the IRB coordinator requesting changes to descriptions and completion of what were noted as non-required sections in the IRQ! Susie was frustrated. She felt like the IRB coordinator was asking her to provide unnecessary information that the office had already indicated was not required and at the study team’s discretion to complete.

When IRB coordinators undergo training, they are told to look for certain language and descriptions that provide a holistic picture of a proposed research project, in light of the federal regulations related to human subjects. Sometimes the information provided in an IRQ doesn’t give the whole picture, which is why we ask for non-required questions to be answered or descriptions to be edited. Remember, we are coming to your project with a fresh set of eyes, so we can’t fill in gaps in the submission like a study team member who is an expert in the project.

IRB coordinators are charged with making sure the IRB has all of the information it needs to proceed with review and approval, and if we feel an IRQ needs more information, we will ask for it, not to further burden you, but in anticipation of what the Board will want to see. Our goal is to avoid deferral.

The required questions in an online IRB system also function as “work flows” for moving a study to submission; in other words, there are basic questions everyone has to answer. We include some non-required questions because, while they are not applicable to all studies, there are instances where we need to collect that information as part of the review process. Non-required questions then do not affect the eIRB system workflow but we do include them in case the IRB coordinator, IRB member, IRB chair, etc. need additional information.  

Back to our friend Susie. She stopped in to talk with her IRB coordinator about the additional information that had been required. The coordinator explained that answering the non-required questions filled in gaps in the information needed to provide a holistic picture of the research project. Susie realized she had more working knowledge of the protocol so had filled in the gaps in her mind without writing down the information. Answering the questions helped the IRB team see the big picture regarding study activities and move the project forward to approval.

At RSPO we are committed to open, collaborative communication. If you are confused by a question posed to you as part of the IRB review process, we are always willing to talk it through and explain the rationale for the information being requested. Even when a question is not required in the IRQ, if your IRB coordinator asks for it to be completed, that request is not arbitrary but couched in the criteria for approval and KP IRB review requirements and processes.

Ultimately, we are here to help you provide the information required to meet federal regulations and guidelines to receive approval for your research projects. Think of us as an extension of your study team: a resource that is trained to know the IRB requirements so you don’t have to!

 


eIRB Upgrade Update

You may have heard that the eIRB is getting an upgrade this year! Expect some big changes.

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We are planning to launch the new and improved system sometime this summer.  It is an updated version of the same system we are using now, from the same vendor, so you will notice a lot of similarities in how the submission process works.  However, a few things are changing in a big way. Some examples:

  • Shorter IRQ + Protocol Document: The Initial Review Questionnaire (IRQ) will be reduced to a few pages. Instead of asking for detailed study information in the IRQ as we do now, you will be asked to upload a protocol document. If you already have a protocol, you will no longer need to cut and paste information from it into the IRQ. If you don’t have a protocol, we have developed a new template you can follow to ensure that you include all the information the IRB needs. Doing a super-simple data-only study? We will have a super-short protocol template just for you.
  • Combined Modification/Continuing Review Option: Prepping for your annual Continuing Review and realize you want to update a few things? The new system has an option for you to include modifications to your study materials along with your Continuing Review progress report, eliminating the need for an extra review.
  • Flexible Submission Form: Whether you are preparing a full study, requesting an exemption, submitting an IRB Inquiry, or asking us to cede review to another IRB, you’ll fill out the same IRQ form, so you won’t need to worry about picking the wrong one and having to start over! As with the forms we use currently, the format is “smart,” so your answers to certain questions will automatically direct you to the relevant follow-up questions.

We need your help! To make sure the new eIRB meets your needs (and wants), we will be asking for volunteers to help us evaluate and test the system. Watch for opportunities to get involved over the next few months. Remember those new protocol templates? Right now, we are making them available by request in exchange for your feedback. If you have a project in the works and would like to give them a try, please contact us!


Modification Descriptions and the IRQ

What is the IRB looking for with modification submissions? Here’s guidance for submitting a modification and revising your IRQ.

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When modifications are created a clear and accurate description of the changes, additions, and/or deletions must be included in the modification form. As you revise the IRQ, be sure to reflect what is currently happening in the study. We have seen study teams entering the date and/or modification number and then describing what is being revised in the IRQ with the modification.

That means as time goes on and more mods are submitted, the IRQ answers get longer and longer, and often include incorrect or outdated information. This does not mean that you should remove references to parts of the study that have been completed, like a data-only portion, or recruitment. However, if you change the amount of money being provided to subjects for completing a questionnaire, please include only the current reimbursement plan.

It sometimes makes sense to add the date and to state exactly what is being changed within the IRQ. One example: when you are adding a new site or new arm to the study. It can be helpful to know when the change was made and what was being added. While we encourage you to use your discretion when revising the IRQ, please keep in mind that as we transition to the new eIRB upgrade, we will be asking for the updated IRQ to reflect only study activities that are occurring at that time without tracking prior modifications in the IRQ text.

We realize that what study staff/researchers see when revising the IRQ is very different from what the IRB staff sees when we review the changes. We use the “view differences” option from the “modified study” page. This shows us exactly what was revised in an easy-to-view format (see below). When you are making the revisions, you do not have that view and may not even know it exists, so are just ensuring that the IRB staff can easily tell what has been revised.

View Differences: This clearly shows what has been revised in the IRQ: 

Upload consent material(s).

2.0

Optional - Provide clarification or details on consent materials:
We will be collecting signed consents from patients, health plan clinicians and administrators taking part in a qualitative interview. The consent forms are uploaded above. For patients participating in the intervention, we will obtain signed consent to audio-record the intervention sessions. Participants will be informed that recordings will be shared with members of the study team for staff training and fidelity purposes. A consent to audio record is uploaded above.MP 01-08-2015: Updating revised patient interview to remove 2nd signature; no changes made to content in consent form.

Upload consent material(s).

2.0

Optional - Provide clarification or details on consent materials:
We will be collecting signed consents from patients, health plan clinicians and administrators taking part in a qualitative interview. The consent forms are uploaded above. For patients participating in the intervention, we will obtain signed consent to audio-record the intervention sessions. Participants will be informed that recordings will be shared with members of the study team for staff training and fidelity purposes. A consent to audio record is uploaded above. Potential subjects will be given a written copy of the consent form as a handout at the Orientation Session. We are not making changes to the consent process; verbal consent will still be obtained over the phone using the consent script. However, we want to provide a written document that they can review in advance of the phone consent in case they want to discuss with a provider, family, or keep for their records.

 


IRB Tips and New Information

New information

Change in PI and Attestation

 

When you submit a modification for a change in PI, you must revise the IRQ by removing the old PI and adding the new one. The new PI’s CV must be uploaded, and include the Change in PI Attestation. Please contact the RSPO Office for a copy of the Change in PI  Attestation. If the previous PI is staying on the study as a co-investigator be sure to add her/his name to the co-I list and re-upload their CV.

 

Requirement to Report When Ceded Study Is Completed

 

PIs are required to report to the KPNW IRB when ceded studies are completed at the reviewing institution. Completion of ceded studies should be reported in a timely manner.

 

Study staff should log into the eIRB system and notify the IRB of study completion by using the “Send Email to IRB Staff” activity in the study workspace. IRB staff will then change the study status to completed.

 

The eIRB sends PIs and study contacts annual reminders to confirm that studies are still active. No response to the eIRB’s annual reminder is required if the study remains open.

 

Data Destruction Description in the IRQ

 

The IRQ has an instruction that says: “Describe the plan to destroy the identifiable information at the earliest opportunity. If there is a health, research, or legal justification for retaining the identifiers, describe.”

 

Many people answer this “per policy.” The policy titled “Electronic Data Destruction Definition and Documentation for Research” defines “destruction” of electronic data. It states that when you are following this policy you may respond to this question in the IRQ in this way: “electronic data will be destroyed according to CHRNW policy.”

 

If you are doing something other than following this policy, please be sure to describe your plan for destroying identifiable information in the IRQ.