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Dear ATSU-AZ Students, Faculty and Staff,
The ATSU-AZ Institutional Review Board (IRB) has revised the forms for study protocols. Highlights of the new forms include:
IRB committee meetings are usually held on the first Monday of the month. The IRB Chair calls for a full committee meeting only if a study requires full IRB review. The IRB does not conduct full committee meetings to review studies that could qualify for an Expedited Review (always minimal risk) or an Exemption (always minimal risk).
Federal explanation for whether you're doing "Human Research":
This website will be updated periodically, so Investigators should check the forms in the different review tabs before submitting documents.
CITI TRAINING
The ATSU-AZ IRB are committed to serving our Arizona campus research community with relevant guidelines and information, accessible forms and simple to use document templates. The guidelines and regulations for research conduct and oversight can be complex, confusing, and seemingly contradictory. We are here to demystify the regulatory processes, ensure that complete and understandable information is always provided to your research participants/partners, evaluate and oversee studies to ensure risks to participants are minimized and acceptable in consideration of the benefits and advise and consult on research ethical conduct issues.
The review-type tabs contain the basic IRB initial, continuing review and final report applications. Supplemental forms for evaluating protocols, reporting research changes, serious adverse events and unexpected events are also under this tab.
The Getting Research Consent tab has general information on obtaining informed consent and templates for consents. Every consent document (adult, teen, child or parent permission) has both an annotated and non-annotated version. The IRB recommends that Investigators print the applicable annotated version as an instructions guide for consent writing. The corresponding non-annotated version can be downloaded and utilized for completing the pertinent required elements of consent. The Elements of Consent document is a checklist the IRB will use to evaluate consent forms for compliance and completeness. Investigators can use this document to evaluate their consents prior to submission.
The IRB Training tab has links to the web-sites for key historical documents on the ethics of human subjects (participants) research. Links to government regulatory sites can also be found under this tab. These web sites are for Investigator interest and edification. Investigators may find this library of documents helpful when studying for human subjects protection certifications. The links to two human research participants training sites are presented here.
The Investigators tab contains a summation of federal government "Best Practices" for Investigators leading research teams. This tab presents both expectations and practical suggestions for delegation, training and documentation of research staff members' responsibilities for protection of study participants, protocol adherence, team leadership and reporting to the Institutional Review Board.
Contact the IRB Administration Office for questions or concerns.
mesaIRB@atsu.edu
Brigit Ciccarello, M.A.
IRB Administrator
