Effective Oct. 1, the Center for Infectious Disease Research (CIDR) joined Seattle Children’s Research Institute (SCRI). Below is a look into the transition plan for the IRB.

Effective Oct. 1

  • All IRB inquiries should be sent to the research institute’s IRB office; email IRB@seattlechildrens.org.
  • All existing non-exempt CIDR IRB protocols reviewed and approved at external IRBs (e.g., Western Institutional Review Board (WIRB), Quorum, etc.) will continue to be reviewed at those IRBs.
  • All "other status" determinations previously made by CIDR (e.g., exempt, non-human subjects research) will be subsumed by the research institute. The research institute IRB will not re-review these determinations unless and until changes are made to the project(s).
  • All new IRB protocols (non-exempt, exempt, not-human subjects research, etc.) must be submitted in Click IRB, the research institute's electronic protocol management system.
  • All research institute IRB policies and SOPs will apply.

Protocol Transfer into Click IRB

  • Basic "shell" information for existing CIDR IRB protocols (non-exempt, exempt, non-human subjects research, etc.) will be transferred by IRB staff into Click IRB on behalf of CIDR principal investigators.
  • For existing external IRB studies (e.g., those relying on WIRB or Quorum), CIDR principal investigators will be asked in the near future to update their studies in Click so they reflect accurate and complete information. More information will follow.

Need-to-Know Changes

  • Since the research institute is considered a covered entity, the HIPAA Privacy Rule (HIPAA) may apply to your project effective Oct. 1 if it involves protected health information (PHI) of participants. Please see the Investigator Manual (HRP-103) in the Click IRB Library for more detailed information on HIPAA requirements/obligations. Questions? Contact the IRB office.
  • The research institute IRB office does not provide administrative support for principal investigators and study teams (e.g., drafting protocols, preparing IRB submissions, etc.). For the time being, please continue with business as usual and route IRB administrative support requests through Tracie VonGoedert. During this time, the research institute will be assessing investigators' needs in this regard. Questions or concerns? Email Jenny Barrett.

Training/Resources

  • The IRB office will offer training (both in-person and on the IRB website) to CIDR researchers and staff on IRB business processes and applications, starting Sept. 2018.
  • The IRB office holds regular monthly office hours on the second Tuesday of every month from 1 to 2 p.m. See the IRB website for more details. You are also welcome to contact the IRB office at any time to request an in-person or phone consultation, if preferred.
  • NOTE: Two of the best tools for principal investigators and study teams are the Investigator Manual and the IRB website.
    • Investigator Manual: Researchers can find the Investigator Manual (HRP-103) in the Click IRB Library, under the General tab. The Investigator Manual offers a wealth of information for researchers from how to create a consent document to how to close out a study.
      • Tip: always use the Investigator Manual in the Click IRB Library. Printing a hard copy, or saving an electronic version to your computer, may result in you using an old version with outdated information.
    • IRB Website: The IRB website includes information on Click IRB, including training information and Quick Guides, Consultation Process, Emergency Use Process, External IRB Process, FAQ’s, Guidance, and Human Subjects Protection Training.