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The Organization requires compliance with DHHS 45 CFR 46.111(a)(1) and FDA 21 CFR 56.111(a)(1) regarding determinations that must be made by an IRB. The IRBs are required to consider whether risks to participants are minimized, in part, by using procedures consistent with sound research design. The JHM IRB review process will include an assessment of whether the research question asked in a proposed human participants research project is valid and whether the research design is sound and could yield the expected knowledge. Documentation of the determinations will be recorded for the record on the JHM IRB review sheet. The review requirement does not mean that the IRBs will perform a level of review comparable to the NIH peer review process.
Many applications sent to the JHM IRBs have had prior scientific review by one of the following entities:
Department of Defense funded research: The IRB will require confirmation by the PI that scientific review of substantive amendments occurred prior to submission of the amendments for IRB review. The JHM IRBs may consider such prior reviews to affirm in the review process that the research design is sound.
The IRB will note in the review process whether outside scientific review has or has not been done. When the PI has a copy of the outside scientific review outcome, it is to be uploaded into the eIRB application. The meeting minutes shall state the entity that conducted an outside scientific review; and the minutes will document when the reviewing IRB members have the expertise required to perform the required review.
If an outside scientific review has not been done and the reviewing IRB believes it does not have the expertise required to make the required determinations, the IRB will request outside scientific review by a consultant prior to taking action on a project. The consultant shall be outside that IRB but may be within the Institution or a member of another JHM IRB. Prospective consultants may not have any conflicts of interest, personal or financial, with the study, investigator, or sponsor (See JHM IRB Policy 107.2). The consultant will be provided with a review form to address, at a minimum, the following:
1) Does the research use procedures consistent with sound research design? and
2) Is the research design sound enough to yield the expected knowledge?
The consultant’s response will be available to the IRB during final deliberations on the study. The IRB’s determination of scientific review based on a consultant’s input will be documented on the review sheet and in the minutes.