U9D1-60 S1 - Ethics: Protection of Human Participants - See Detail Questions.

IRB PROCESS

Within the end-to-end research process, review by the Institutional Review Board, or IRB, often represents one of the most formal, complex, and in some cases daunting aspects of the research process.

The process of submitting an IRB application and obtaining approval requires the involvement of many individuals, each playing a different role. Researchers work with their mentors or research supervisors to develop and complete the IRB application. IRB Office Staff screen the initial submission to assess whether it is complete and ready for review and determine the appropriate level of review. IRB Reviewers determine if the proposed research study meets the institutional standards and federal regulations for ethical research with human participants or their records.

The first step toward obtaining IRB approval begins in the design phase, as the researcher assesses the risk and benefits of the study, develops study procedures to minimize risks for participants, and carefully develops a plan for the protection of human participants. Doctoral learners should consult their mentors as they develop their research design.

Next, the researcher should begin completing the IRB application. The IRB application is a webbased form started within IRBManager. Researchers will have to upload supporting documents to the application. Supporting documents include but are not limited to, drafts of informed consent documents, recruitment materials, and permissions to use existing instruments in the research. Any communication that will be shared with participants must be included as part of the application. Researchers should prepare drafts of emails or letters, fliers, and scripts. These materials should be written at the 8th grade reading level or as appropriate for the intended population. Researchers should also begin collecting letters of permission from the organization or site where the research will take place.

Once the researcher has completed the application, it is submitted to the mentor through IRBManager. The mentor should already be very familiar with the study documents, but should carefully review the materials once more to ensure their completeness and coherence. Upon review, the mentor will either return the application to the researcher for revisions or submit to the IRB.

Upon submission by the mentor to the IRB, the IRB Office will screen the application for completeness and coherence, ensuring that the researcher has completed the application correctly, and that he or she has uploaded the necessary supporting documents. If the application isn't correct or is missing any of the supporting documents, the IRB Office will return the application to the researcher through IRBManager. Submitting an incomplete application will delay the review process.

Once the submission is complete, it's ready for review. There are three levels of IRB review: exempt, expedited, and full review. The level of review is determined by the IRB, not by the researcher or mentor. Studies that are determined not to involve human participants will be approved, and no further review by the IRB will be needed. Research studies that involve greater than minimal risk require review by the full IRB Committee. Such studies may involve especially sensitive topics such as intimate partner violence, mental illness, racism, bullying, or PTSD or vulnerable populations such as veterans, medically

underserved groups, cognitively impaired persons, or children. Research involving deception or prisoners always requires review by the full IRB Committee. Other research studies may be referred to the Full IRB Committee for review.

Regardless of the level of review, the study will be evaluated to ensure that it meets the institutional standards and federal regulations regarding the ethical conduct of research. In the review of the research, the IRB may make the decision to approve, defer, approve with conditions, or disapprove the study; Only the full IRB Committee may disapprove a study.

Once the IRB has approved the IRB application, the researcher is authorized to begin conducting the study by recruiting participants, administering informed consent, and collecting data. Doctoral researchers may be required to obtain additional approvals or take additional steps prior to conducting their research and should consult school and program guidelines.

Depending on the level of review of the study, some IRB approvals expire within a year or less. The IRB approval letter will detail if the IRB approval has an expiration date on it. If the researcher is still interacting with participants, the researcher will have to apply for continuing review.

Researchers must follow their study procedures as approved by the IRB. Any changes to study procedures or study related documents must be approved, however minor, by the IRB before implementation. Researchers must report any unexpected problems or adverse events that occur in the course of the research study. The IRB must be contacted within 24 hours if participants become ill, injured, or emotionally disturbed while participating in the research, if there is a higher-than-expected dropout or withdrawal rate, or if any participant concerns or complaints are made. Non-compliance such as failure to adhere to the approved study procedures, conducting research following the expiration of IRB approval, enrolling a participant who does not meet inclusion criteria or breaching participant confidentiality should also be reported promptly to the IRB. Prompt reporting ensures the protection of participants and the ultimate success of the researcher in conducting a study that meets ethical requirements.

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Voice Talent:

Crystalanya Khokhlov

Tara Schiller, Kate Bendzick

Tyssa Erickson

Julie Greunke

Karen Weber

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