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103.10(b) Organization Policy on Assignment of IRB Review

June 2021

It is the policy of the Organization that applications for the conduct of human subjects research shall be reviewed by an IRB. One of the JHM IRBs may review the study, or it may be reviewed by an outside IRB pursuant to the terms of a reliance agreement. Procedures for review are governed by written review agreements, contractual terms, or internal guidelines issued by the Institutional Official (IO).

For studies reviewed by the JHM IRB, the study will be assigned to one of the seven JHM IRBs. Scholarly and scientific expertise of the IRB members will be considered when making assignments. Assignment information will be made available to researchers on the IRB website.

When a newly submitted study is identified as being identical to one that has been previously approved or is being concurrently reviewed by one JHM IRB, the new study shall be assigned to the same IRB for review.

If the Principal Investigator (PI) is the Chair or Member of an IRB, the newly submitted study shall not be assigned to the IRB(s) on which that individual serves as a primary member. There are two exceptions to this provision:

  1. The Institutional Official or the Director of the Human Research Protections Program may grant an exception for the purposes of ensuring that a study is reviewed by an IRB with appropriate scholarly or scientific expertise; and,
  2. For the Chair or Members of the Johns Hopkins All Children’s Hospital (JHACH) IRB, studies for which they serve as PI may be assigned to the JHACH IRB for review.

In the case of either exception, the PI must recuse him or herself from all of the IRB’s deliberations concerning the study, including its presentation, discussion, and the vote.

Once assigned to an IRB, that IRB will continue to review the study until expiration or termination unless the study is transferred (see Organization Policy 103.14 “Transfer of Studies Between JHM IRBs”). Further Study Actions (Changes in Research, Continuing Reviews/Progress Reports, and Protocol Event Reports) may be reviewed other IRBs as deemed appropriate by OHSR Management for reasons of urgency or expertise.

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