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Additional Committee Review and Approval

Some human Subjects research studies may require review by and approval from regulatory offices or committees other than the IRB. Depending on the type of review, IRB approval may be withheld until approval has been obtained.

Scientific Merit Review

Scientific Merit Reviews are conducted at the department or college level. Each subcommittee review group uses its own mechanism to conduct the scientific review and designates an individual to be responsible for overseeing the review process—at BYU, this process is independent of the IRB. The scientific merit approval serves as the verification that the research is appropriate in design (i.e., the research uses procedures consistent with sound research design, the study design can be reasonably expected to answer the proposed question, and the importance of the knowledge expected to result from the research is known). There are exceptions to this policy .

The process

  1. Complete an IRB application in the iRIS system, but do not submit it to the IRB at this point.
  2. Download the application as a PDF file.
  3. Email the PDF file to the Scientific Review Committee (SRC).
  4. The SRC will review the application.
  5. The SRC will work through the study design according to the Scientific Review Checklist.
  6. When the SRC approves the study, they will give the researcher a complete, signed checklist.
  7. The researcher uploads the approved scientific review checklist to the IRB Study Documents (Section 5.0, Initial Submission Packet).
    1. If a honors thesis, graduate thesis or dissertation, the committee chair will check and sign the scientific review checklist.
      1. For the studies from the McKay School of Education, the scientific review is reviewed by the SRC for final sign off.
  8. When IRB application is complete and all the appropriate documents uploaded to iRIS, the researcher can submit the application.

Studies Using Magnetic Resonance Imaging

BYU IRB must approve MRI research involving human subjects. The BYU MRI Research Facility houses a research-dedicated MRI scanner and does not provide clinical diagnostic scanning.

The BYU MRI Research Facility has detailed information on their website regarding requirements and procedures for the protection of human subjects and researchers ( see MRI Safety ).

The process

Researchers who plan to conduct human subjects research at the BYU MRI Research Facility must follow these steps:

  • Complete an IRB application in the iRIS system, but do not submit it to the IRB at this point.
  • Next the researcher must save a PDF copy of the application and email the file to the MRI Research Facility Director at mri_director@byu.edu .
  • The MRI Research Facility Director will review the proposal and provide you with an approval letter that should be uploaded to the researcher’s iRIS profile as part of the researcher’s certifications.
    • MRI studies only need to seek approval from the MRI Facility Director with the initial submission of the study.
    • Faculty PIs are responsible for ensuring their research teams have completed the required safety trainings with the MRI Research Facility.
    • Faculty PIs are also responsible for maintaining MRI data integrity and confidentiality once the data leave the MRI Facility.
  • When the approval is uploaded to iRIS and the researcher has completed all sections of the application and submission packet; the application is submitted to the IRB for review.

Research in the Partnership Public Schools

Research in the Utah public school districts require planning, careful preparation, and ample time for review and to obtain permission to conduct studies.

  • Researchers should familiarize themselves with each school district’s demographics, policies, and procedures before they submit an application. There are certain times of the year that the districts do not allow research in the classrooms.

The process

  • Contact relevant stakeholders about the feasibility of the study (e.g., teacher, principal, special education director, curriculum director). The school district contact person is never the superintendent and we ask that you do not contact them.
  • Complete an IRB application in the iRIS system, but do not submit it to the IRB at this point.
  • Download the application as a PDF file.
  • Submit the PDF file of the application to your college/department Scientific Review Committee, including evidence of conversations with the Partnership schools/districts (for McKay School of Education researchers, mse_src@byu.edu ).
  • The researcher uploads the approved scientific review checklist to the IRB Study Documents (Section 5.0, Initial Submission Packet).
  • When IRB application is complete and all the appropriate documents are uploaded to iRIS, the researcher can submit the application.
  • BYU IRB will approve the study contingent upon the approval of the school district. IRB approval does not guarantee that the school districts will approve the research.
  • After IRB approval, the researcher submits the approved IRB to the school district via the “ Consent to Conduct Research Form ”.
    • To access this page, contact Gary Seastrand , Director, CITES Brigham Young University Executive Director.
    • MSE Web team will grant access to the form on a case by case basis.
  • School districts will review and make a determination about the research based on the study topic, benefit to their schools, scheduling, etc.
  • Researchers must submit written documentation on letterhead from each school district to BYU IRB before initiating any research procedures by submitting a modification through iRIS (Section 1.3, step 3).
  • Research conducted in charter schools will require the approval of the school principal.
  • Research conducted outside the Partnership School Districts will follow policies and procedures set forth by each institution.

External IRB’s or Ethics Committees

  • When an external IRB is providing review, documentation of IRB approval is required at time of Reliance Request submission
  • If required for transnational research, review may be conducted concurrently with the IRB process but it is strongly recommended that documentation of approval be provided at time of IRB submission. Documentation must be provided prior to IRB approval. The approval must cover the same protocol and consent versions reviewed by BYU IRB, including any IRB provisions.