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V. Relationship of UT Arlington IRB to Other Agencies, Institutions and Committees

1. Compliance with Federal Regulations -- UT Arlington has filed a Federalwide Assurance (FWA) with the Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP) affirming that the University is in compliance with 45 CFR 46. This assurance applies to all research involving human participants as defined and regulated by the “Common Rule” – (DHHS regulations incorporate the Common Rule as Subpart A of 45 CFR 46).

In studies involving products regulated by the Food and Drug Administration regulations, the UT Arlington IRB complies with the requirements set forth in 21 CFR 5021 CFR 5621 CFR 312, and 21 CFR 812.

2. Review of Research Activities by Other University Committees -- UT Arlington IRB coordinates the review with other institutional committees as described below. None of these committees are a formal part of UT Arlington IRB structure, but there is communication between the committees regarding status of review and/or conditions of approval if there are human participants involved.

  1. Institutional Animal Care and Use Committee (IACUC) - The IACUC is responsible for insuring that research involving animal participants complies with the Animal Welfare Act and Animal Welfare Regulations, the Public Health Service Policy, and Office of Laboratory Animal Welfare (OLAW) guidelines. Investigators are required to submit a protocol to the IACUC for all research involving live vertebrate animals. The protocol must be reviewed and approved by the IACUC prior to the initiation of the research.

    IACUC deliberations are normally not shared with the IRB unless there are specific issues involving human participants. In instances where both animal and human participant research issues are involved, investigators should: i) notify the IRB and IACUC chairs; and ii) submit separate protocols to the IRB and IACUC, respectively. In certain instances, the IRB may deem it appropriate to receive notification of the related IACUC approval before approving the IRB protocol.

  2. Institutional Biosafety Committee (IBC) - The IBC is responsible for ensuring that recombinant DNA activities comply with the National Institutes of Health (NIH) Guidelines for Research Involving Recombinant DNA Molecules. Investigators are required to submit an exemption form and/or an application form to the IBC for all recombinant DNA experiments. The investigator must receive approval from the IBC prior to the initiation of the research.

    IBC deliberations are generally not shared with the IRB unless there are specific issues related to human participants. In instances where both biosafety and human participant research issues are involved, investigators should: i) notify the IRB and IBC chairs; and ii) submit separate protocols to the IRB and IBC, respectively. In certain instances, the IRB may deem it appropriate to receive notification of the related IBC approval before approving the IRB protocol.

3. External Requests for Recruitment/Involvement of UTA Students as Human Subjects -- The University of Texas at Arlington prohibits the involvement or recruitment of its students as human subjects unless the project will contribute to research or academic value for the University. To qualify, the project must involve a University employee or student engaged in the research project as a collaborator. Recruitment requests received from external parties will be evaluated by the IRB Staff to determine if the intent of this policy is met. Exceptions will be submitted to the Vice President for Research for evaluation and final determination. 


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