OHSU

Single IRB Review for Joint OHSU-KPCHR Studies

Introduction

Some qualifying research protocols meeting specific criteria may undergo a single IRB review by an IRB at either OHSU or KPNW, eliminating the requirement for review by both institutions.  The IRB performing the review depends on factors such as:

  • Investigator location
  • Location of subjects
  • Location of research activities
  • Research risks
  • Study design

In many circumstances, it will be clear which IRB could serve as the IRB of record.  In other cases, consultation with with either IRB or OCTRI staff should be sought. The final determination of whether single IRB review is appropriate, and which IRB will be the reviewing IRB  is made by the IRBs of both institutions.  Once it is determined the study is eligible for single review and which IRB will perform the review, the IRB performing the initial review will perform all subsequent continuing reviews, adverse event, unanticipated problem and protocol deviation reports and review of any requested amendments.

Procedure

Requesting OHSU Perform Single Review: Requests for the OHSU IRB to perform a single review for an OHSU-KPNW research protocol will likely be approved for studies meeting the following criteria:

  • The research protocol involves only nonhuman subjects research (does not involve interaction with a living person or individually identifiable data),  is exempt from IRB oversight  or involves only minimal risk research.  
  • The performance of any medical procedures (e.g., blood draws, tissue collection) by KPNW employees or agents is not beyond what is conducted as part of normal, standard clinical care, i.e., KPNW employees or agents do not perform medical procedures specifically for research purposes.  Examples of activities KPNW employees’ which fall within this definition include:
  • Intellectual collaboration (e.g., co-investigator responsibilities)
  • Recruitment
  • Data analysis
  • Release of non-sensitive PHI, including specimens, pursuant to a HIPAA authorization or waiver
  • Chart review
  • Provision of clinical standard care of research subject
  • OHSU is the major site evidenced by investigator location, most of subjects, most of the research activity.

The procedure for requesting that OHSU perform the review is as follows and is outlined in Figure 1:

  • The investigator completes the initial review questionnaire (IRQ) in the OHSU eIRB system.
  • If the study has NOT already been approved by the KPNW IRB, the investigator should submit a short IRQ within the KPNW eIRB system. One of the first pages in the KPNW IRQ asks for the type of submission. Please select “A request that the KPNW IRB rely on another institution’s IRB to conduct review (i.e., a “ceding request”)”. The eIRB system will lead you through a request that OHSU perform the review of the research.
  • If the study has already been approved by the KPNW IRB, the investigator must submit a modification request within the KPNW eIRB system. The investigator should indicate that the type of modification is a “Ceding request: KPNW IRB rely on the review of another IRB”. The eIRB system will lead you through a request that OHSU perform the review of the research.
  • The investigator will be notified by the KPNW and OHSU IRBs whether  the request is approved.
  • If the request is approved, the investigator finishes the OHSU IRB application process in the eIRB.
  • If the request is not approved, the investigator completes the OHSU application process in the eIRB and also submits a full KPNW IRB application to the KPNW IRB.

Requesting KPNW Perform Single Review: Requests for the KPNW IRB to perform a single review for an OHSU-KPNW research protocol will likely be approved for studies meeting the following criteria:

  • The research protocol involves only nonhuman subjects research (does not involve interaction with a living person or individually identifiable data), is exempt from IRB oversight  or involves only minimal risk research.

The request will likely be approved for activities such as:

  • Chart review
  • Noninvasive evaluation
  • Surveys
  • Questionnaires
  • Focus groups not involving sensitive information
  • Blood collection by capillary stick or venipuncture
  • Noninvasive sample collection or data procurement such as EKG, Echo, or ultrasound
  • Dietary therapies and nutritional counseling
  • Administration of FDA approved drugs
  • Administration of nutritional supplements
  • Kaiser is the major site (evidenced by, e.g., investigator location, most of subjects, most of the research activity).

The procedure for requesting that KPNW perform the review is as follows and is outlined in Figure 2:

  • The investigator completes the KPNW initial review questionnaire (IRQ)
  • The investigator creates a study in the OHSU eIRB, completes a “Request for Waiver”, uploads the KPNW IRQ and all required supporting documents into eIRB, and submits the request for waiver.
  • Investigator will be notified by the OHSU and KPNW IRBs whether the request is approved.
  • If the request is approved, the investigator finishes the application process at the KPNW IRB.
  • If the request is not approved, the investigator  completes and submits a full IRQ with all required supporting documentation to the OHSU IRB for regular review and completes the KPNW IRB application process.