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 Scientific review is done to evaluate the scientific and scholarly validity of the study. The review ensures that proper consideration is given to the study design. Those considerations include: Are the procedures outlined in the study the least risky while ensuring sound research design. Are the study aims achievable? Is there sufficient scientific importance to justify the risks of the study? Are there adequate resources to complete the study.

Criteria for Approval “Risks to subjects are minimized by using procedures which are consistent with sound research design” The first approval criteria requires that the IRB ensure that risks to subjects are minimized by using procedures which are consistent with sound research design. If the design of the study is poor, the risks incurred in the study are not justifiable. Review by individuals with the knowledge to evaluate the rationale, aims, experimental design and methods of the research may occur at several steps in the review process depending on the research area and level of review.

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 Students conducting research must work under the oversight and supervision of a Principal Investigator, who will be a faculty member, and will provide review for scientific and scholarly validity. Student projects for thesis or dissertation will also be reviewed by the student’s advisory faculty/committee.

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 The scientific or scholarly review requirement may be satisfied when a research project has been subjected to full peer review such as a review by a study section or grant committee of federal funding organizations or non-federal organizations employing peer review mechanisms for awarding of funding. These reviews are considered by the IRB in its scientific evaluation and in making the determination of whether the regulatory criteria for approval are met.

Expedited Review Designated Reviewer Subject Matter Expert Consultant Research eligible for expedited review may be reviewed for scientific and scholarly validity by the designated reviewer, or at the discretion of the designated reviewer, by a subject matter expert or consultant.

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)

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

Committee Review Primary Reviewer Secondary Reviewer Consultant Research requiring committee review will be evaluated for scientific and scholarly validity by the primary and secondary reviewers assigned to the study. Additional expertise and review of benefits and risks may be provided during the discussion by any attending committee member. A consultant may also be called upon to attend the meeting or provide a report to the committee.

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.

Roles and Qualifications of IRB Members Scientific Members Nonscientific Members Non-Affiliated (Community) Members Scientific Members: Scientific members are expected to review assigned studies, as well as contribute to the evaluation of a research project on its scientific merits and standards of practice. These members are able to advise the IRB if additional expertise in a scientific area is required to assess if a research project adequately protects the rights and welfare of subjects. Nonscientific Members: Nonscientific members are expected to provide input on matters germane to their individual knowledge, expertise and experience, professional and otherwise. Nonscientific members advise the IRB if additional expertise in a nonscientific area is required to assess if research project adequately protects the rights and welfare of subjects. Non-Affiliated (Community) Members: Non-affiliated members are expected to provide input regarding their individual knowledge about the local community and be willing to discuss issues and research from that perspective. A non-affiliated member is also a scientific or nonscientific member and would be expected to provide input on areas germane to his/her knowledge, expertise and experience, professional and otherwise.

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 Susan Sanchez, Department of Infectious Diseases, College of Veterinary Medicine: professor, assistant director Biomedical & Health Sciences Institute

Thank you