Scientific Review

Scientific Review Policy

• Proposed new human research studies must undergo departmental/college scientific review by a research committee, chairperson, designee within the primary scientific discipline relevant to the research, or other institutionally recognized subcommittee or review group. Such review is to encompass scientific merit, available resources, and feasibility.
• Each department, subcommittee, or review group may develop its own mechanism to conduct the scientific review and must designate an appropriate individual to be responsible for overseeing the review process. This individual could be a Department Chair or Associate Chair for Research or Chair of the respective subcommittee or review group.
• Scientific reviewers must not have a conflict of interest (financial or nonfinancial).
• Scientific reviewers must be independent of the proposed study (i.e., not a member of the study team).
• A scientific review form, created by the review committee, will be used to summarize and document the scientific review for IRB applications. The form must identify (by name) the individual scientific reviewer(s).
• The scientific review documentation will be attached, where designated, to the IRB electronic application (iRIS) and submitted to the IRB.
• An external IRB of record may waive the requirement to submit documentation of scientific review as part of the IRB review process. However, for all research conducted at BYU and requiring scientific review per this policy, documentation of scientific review must be included in “Request to Rely on External IRB” applications registered via the BYU IRB iRIS system.

Exceptions

There are exceptions to the policy that will streamline IRB reviews. The scientific merit reviews should be commensurate with the complexity of the study.

• Protocols that have been peer reviewed by a federal-funding agency (e.g., NIH, NSF, DOD).
• Protocols that have been peer reviewed by a national foundation.
• Research that does not require direct involvement of human subjects (e.g., archival research). Please note that online surveys are considered direct data collection.
• Research categorized as exempt.
• On-going studies previously approved before September 3, 2019 and converted to iRIS.
• Student Thesis/Dissertations approved by their academic committees prior to IRB submission (evidence of the approval must be attached in the iRIS system).

Scientific Review Committees

The scientific review process is designed to focus on selected sections of the IRB application: Section 7.3 methods, study aims, and literature review. The scientific review checklist is designed to be general enough for each unit to adjust for their discipline and needs. Scientific review committees will be overseen by the Associate Deans of Research and/or unit directors, independent of the IRB. Typical reviews should take about 15 minutes, perhaps more time for more complex, invasive, greater risk studies. The committee can be standing or ad-hoc, and department/college policies and procedures to streamline the reviews is encouraged.