Providing Guidance and Support for all KPNW Research Compliance Activities

New Researcher Training Policy

The Research Compliance Committee, in consultation with other stakeholder groups, has recently finalized a Researcher Training policy that delineates who is required to complete what training (human subjects, FCOI, etc.) based on their roles in research.

The policy includes a quick-reference table (Research-Specific Training Requirements Matrix) that lists which training modules are required for which job titles and roles.

The final document can be found on the Research Compliance Policies page under Research Integrity & Misconduct.  Links are also available on the Training and Education page.

A note about eIRB:  As a rule of thumb, all researchers who are required to complete human subjects training should be listed on the eIRB submission for the project(s) on which they are working.*  This means they must be registered for an eIRB account.  Updating your study following migration to the new system is a great time to ensure that your list of study team members is up to date.

*Exception:  Projects involving BAC staff at CHR do not need to list each BAC staff person separately.  There is a “person” in the eIRB named “BAC Staff” that can be added to the study instead.

eIRB UPGRADE

The upgraded eIRB system went live on June 2. All IRB submissions made after the deadline for June submissions (end of work June 1) should be made in the new eIRB system.

Existing studies in the approved, ceded, or exempt status were migrated to the new system on June 1 unless they had an open modification or continuing review. Studies with open submissions (new study, modification, continuing review, reportable event) in the old system will be migrated to the new system after IRB approval. Study staff will be able to access the study in the new system the following day.

On the first submission after migration:

• Read the blue text at the top of the mod/CR form!
• Update study personnel
• Move documents from the old system
• Check that migrated information is correct
• Fill in missing information

If the first submission for a migrated study is a final report, you will not need to make any other updates to study information.

For more guidance: eIRB Upgrade Info Sheet

If you have any questions, please contact us.

Next IRB meeting: October 19, 2016

Submissions for review at the October 2016 IRB meeting should be submitted through the electronic IRB system (eIRB) by the end of work on 10/3/2016.

RE: Continuing Review Submissions: It is the Principal Investigator's responsibility to submit a report for continuing review by the submission deadline.

The eIRB sends courtesy reminders to the study team when a continuing review submission is due. Reminders are sent at 90, 60, and 30 days prior to the approval expiration date. These are the only reminders the study team will receive.

Reminders are discontinued after a continuing form has been opened. If you create a continuing review in the eIRB when you receive the 90-day reminder, you will not receive additional reminders at 60 and 30 days.

Compliance Committee Meeting Schedule

• CHR Research Compliance Committee (local/NW) meets the second Wed of the month
• CHR Compliance Group meets the fourth Wed of the month.

View 2016 RCC Charter & Membership

View 2016 CHR Charter & Membership

Proposed Changes to the "Common Rule": Federal Regulations for Research Involving Human Subjects

The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have announced proposed revisions to the regulations for protection of human subjects in research. A Notice of Proposed Rulemaking (NPRM) was published in the Federal Register on September 8, 2015. The NPRM seeks comment on proposals to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.

If the proposed changes become final, there will be significant changes for the oversight of human research and the IRB review process. Kaiser Permanente has submitted comments to the regulators on the proposed rule.