Policies & Procedures

Below is a link to our official Policies and Procedures, compliance with which is mandatory for both the IRB and the research community. The Policies and Procedures define important terms and define the roles, structure, and responsibilities of the Wright State University Human Research Protection Program (HRPP).

More guidance and recommendations can be found in the Guidance Documents or Templates, Checklists & Decision Trees sections of our website.

Human Research Protection Program

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HRPP Purpose and Authority_v2_Approved_08152022.pdf (193.32 KB)
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Maintenance of IRB Policies_V 1.0_Approved for Use_05172021.pdf (126.63 KB)
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External Research Approval_SOP_v2_10172022.pdf (163.29 KB)

Institutional Review Board Operations

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IRB Membership Policy_v2.2_Approved_05152023.pdf (181.01 KB)
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Collaborative Research Policy_v4_Approved_11032022.pdf (243.78 KB)
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CTGOV Policy_v1_Approved_04182022.pdf (285.97 KB)

IRB Submission and Review

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Investigator Credentialing_v3_Approved_08212023.pdf (173.93 KB)
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NHSR Policy_v2.1_Approved_08152022.pdf (152.94 KB)
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Exempt Review Policy_v4_Approved_11212022.pdf (257.98 KB)
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Expedited Review Policy_v3_Approved_11212022.pdf (296.42 KB)
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Convened Meeting Policy_v2_Approved_09192022.pdf (220.34 KB)
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IRB Study Closure_v2.2_Approved_02162023.pdf (155.15 KB)

Study Procedures

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Vulnerable Populations Policy_v3.0_Approved_03022023 (263.58 KB)
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Informed Consent_v12_Approved_10172022.pdf (263.72 KB)
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HSR Use and Disclosure of PHI_v2_Approved_10172022.pdf (223.4 KB)

FDA Regulated Research

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Drugs and Biologics_ V 5.0_Approved for Use_01252021.pdf (253.73 KB)
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Medical Devices_v4_Approved_08172020.pdf (309.55 KB)
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Emerg Use Policy_v2_Approved_10172022.pdf (205.73 KB)
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Expanded Access_v1_Approved_08172020.pdf (190.85 KB)
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HUD_v2_Approved_09012022.pdf (245.07 KB)

Reportable Problems & Noncompliance

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HSR Mandatory Reporting Policy_Approved_01232023.pdf (219.11 KB)
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Incidents_v3_Approved_10172022.pdf (264.92 KB)
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HSR Noncompliance Policy_v2.0_ Approved_03022023 (198.26 KB)