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Scientific and Scholarly Validity

Scientific and Scholarly Validity. Angela Bain, IRB Administrator abain@uga.edu 706-542-3821. Why Scientific Review?. Study design review considers The least risky procedures Achievability of study aims Sufficient importance to justify the risks Adequate resources. Criteria for Approval.

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Scientific and Scholarly Validity

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  1. Scientific and Scholarly Validity Angela Bain, IRB Administrator abain@uga.edu 706-542-3821

  2. Why Scientific Review? • Study design review considers • The least risky procedures • Achievability of study aims • Sufficient importance to justify the risks • Adequate resources

  3. Criteria for Approval • “Risks to subjects are minimized by using procedures which are consistent with sound research design”

  4. Student Research • Must work under the supervision of a PI • PI should provide review for scholarly validity • Thesis or dissertation projects are reviewed by advisory faculty/committee

  5. Funded Research • Examples of Federal Sponsors: • National Institute of Health • National Science Foundation • Examples of Non-Federal Sponsors: • American Cancer Society • American Heart Association • March of Dimes

  6. Expedited Review • Designated Reviewer • Subject Matter Expert • Consultant

  7. Examples of Expedited Studies that require scientific or scholarly review • Studies where biological samples are collected • MRI/EEG/NIRS/Ultrasound procedures • Studies that involve genetic analyses • Studies with physical interventions (e.g., cold stressor or pressure tasks, electrical shock, exercise or nutritional intervention)

  8. Continued: • Studies with psychological manipulation (interaction or deception) used to obtain sensitive information • Studies with the potential for group harm • Studies that involve vulnerable or special populations such as prisoners, individuals with cognitive impairment, children with disabilities, pregnant women, neonates or infants, and undocumented aliens

  9. Committee Review • Primary Reviewer • Secondary Reviewer • Consultant

  10. IRB Composition • Each IRB must be appropriately constituted for the types of human research to be reviewed in accordance with federal regulations. • Included are members with diverse experience and expertise to assure the professional competence necessary to review the university’s research, as well as knowledge of community attitudes.

  11. Roles and Qualifications of IRB Members • Scientific Members • Nonscientific Members • Non-Affiliated (Community) Members

  12. Use the Scholarly Review Checklist This will ensure that • The research conducted at UGA is up to standard for research publication • UGA’s research program is on par with our peer and aspirational institutions

  13. Thank you

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