NEWSLETTER

SUMMER 2018

Timeline for the Revised Common Rule

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On January 19, 2017, the Department of Health and Human Services (HHS) published revisions to the Common Rule—the regulations that govern human subjects—with the intent of strengthening subject protections, reducing administrative burdens, and adapting to current culture and technology. The revisions were to go into effect in January 2018; however, the effective date was extended to July 19, 2018. Then in June 2018, HHS and 15 other federal agencies announced another six-month delay.

As a result of this second delay, institutions must continue to comply with pre-2018 Common Rule requirements until January 21, 2019—with one exception.  The exception gives institutions the option of implementing three of the new burden-reducing provisions during the delay period, while still complying with the pre-2018 requirements. However, adopting the three burden-reducing provisions early comes with consequences. It requires that the studies be re-reviewed in January 2019 under the new 2018 requirements (unless those studies were determined to be exempt).

Kaiser Foundation Research Institute (KFRI) has chosen not to take on parts of the new Common Rule until its official effective date of January 21, 2019, when all studies will be reviewed with the new 2018 provisions. KFRI has adopted a toolkit to facilitate implementation of the new provisions, and educational documents will be made available to researchers prior to January 2019. For more information on the revisions, click on the Revised Common Rule link.


Writing a Protocol

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Advising about writing protocols is not technically a function of the IRB. However, in reviewing reasons for deferral or disapproval of research applications, the KPNW IRB has identified poorly written protocols as a major factor. A badly written protocol can contribute to delayed approval times especially for investigator-initiated studies.

The protocol provides the scientific basis for the proposed research; it defines the study objectives, the population to be studied, the procedures to be followed, the evaluations to be performed, and the plan for analysis; and it discusses the administrative aspects of the study such as safety management and regulatory issues.

Some submitted protocols contain cut-and-pasted information from the investigator's grant. This information provides much more scientific background information than is appropriate for a protocol and does not provide enough information regarding conduct and execution of the study. A protocol functions like a recipe and should act as a guide anyone who knows how to conduct the study; it is specific and detailed enough to ensure that the study will have fruitful results.

At the other extreme, some protocols contain virtually no information: They may be shorter than a single page and not contain language required to address important scientific, and ethical, issues.

To help researchers write protocols that contain all of the information needed for an efficient IRB review, the KPNW Research Subject Protection Office has developed a protocol template and a data-only studies template (i.e., no human interactions). These templates not only are informational guides for researchers, but also include many helpful instructions and links to various policies and procedures. The templates are located in on the Research Compliance website, as well as in the Library in eIRB, located on the left-hand side of your screen.  


Policy Updates


NWRC.RIM.03 – Quality Improvement Monitoring. This policy was revised to incorporate our region’s use of the KFRI shared service model for clinical trials monitoring in addition to our local monitoring program.

NWRC.HRPP.102 – Collaborative IRB Reliance Arrangements. This is a new policy to address how Research Compliance will evaluate requests from investigators to rely on an external IRB, or to serve as the IRB of record for another site. This new P&P will be the foundation for a collection of procedures and guidance materials, currently being developed by the RSPO team, that will help Research Compliance facilitate single IRB review arrangements. These arrangements are becoming more common and will eventually be required for certain federally funded studies.

NWRC.HRPP.02 – Continuing Review of IRB Approved Research. This policy was extremely outdated and was revised to reflect our current review process.

NWRC.PRIV.04 – Privacy Rule Documentation for Research. This policy was revised as part of a routine review to include several clarifications and corrections. The table in Appendix A is a particularly useful summary of agreement and other requirements for different types of data sharing.


IRB Announcements

eIRB Tip - Whom to notify when you comment in the eIRB

When you add a comment in the eIRB, you have the option of notifying the PI/proxy/primary contact, study team, or IRB coordinator. If you select a PI/proxy/primary contact, emails will go to your PI and whomever is assigned as the primary contact on the project. The study team option will result in emails to the study team in its entirety. And if you select IRB coordinator, a notification will go to the IRB team member assigned to the study. If an IRB coordinator is not yet assigned, all RSPO staff are notified of comments.

Please keep in mind that IRB coordinators do not need to be included on certain notifications. Specifically, when a submission is ready for PI notification, the IRB coordinator should NOT be included in that email. IRB coordinators should only be cc’d on and notified of comments when you have a direct question or are documenting information such as responding to a question from the IRB coordinator or making a comment that the PI has accepted requested changes, etc. For internal notifications of the PI, however, the IRB coordinator should be left out of this correspondence.

eIRB Reminder – Naming documents in eIRB

When uploading a document in the eIRB system, please use the Name field to name the document in accordance with IRB requirements. This is the easiest way to name your document. The system will default to the file name if the Name field is left blank. You do not need to change the file name to conform with IRB naming requirements unless you wish to have it serve as the default name in the eIRB system.

For additional guidance, see the eIRB Help Center document, Naming Study Documents in the eIRB. Document titles will appear in the approval letter as they are named here. Document titles must be at least FOUR characters long.

IRB Humor — It’s all in the phrasing (pulled from an actual consent submitted to the IRB)

“Bleeding: Cases of fatal bleeding have been reported in participants treated with study drug. Most of these occurred during the first cycle. Subjects did not receive a second cycle.”