References
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1.22 Assessment of the Effectiveness and Efficiency of the HRPP
Last Revised: 9/25/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s ...
1.30 Use of the Rapid Response IRB
Last Revised: 10/17/2024 1.0 Purpose The purpose of this policy is to describe the constitution o...
2.1 Submission for Items for Review by the IRB
Last Revised: 7/19/2022 1.0 Purpose The purpose of this policy is to describe Organization’s requ...
8.2 Review of Study Related Complaints
Last Revised: 5/8/2023 1.0 Purpose The purpose of this policy is to describe the process for repo...
8.1 Review of Adverse Events and Adverse Device Effects
Last Revised: 10/2/2024 1.0 Purpose The purpose of this policy is to describe the process for rep...
8.3 Review of Unanticipated Problems Involving Risk to the Subject or Others
Last Revised: 8/6/2025 1.0 Purpose The purpose of this policy is to describe the process for repo...
1.32 Confidentiality of the Review Process
Last Reviewed: 11/26/2025 1.0 Purpose The purpose of this policy is to describe the Organization’...
1.31 Observers at IRB Meetings
Last Revised: 11/26/2025 1.0 Purpose The purpose of this policy is to describe the Organization’s...
Table of Contents
Section 1: General Human Research Protection Program Polices 1.1 Human Research Protection Progra...
1.2 Authority Granted to the IRB and/or the Office of Regulatory Affairs (ORA) by the Organization
Last Revised: 12/17/2025 1.0 Purpose The purpose of this policy is to describe the authority gran...
3.5 Subject Recruitment Through Advertisements
Last Revised 12/11/2024 For an abbreviated version intended for investigators, coordinators, and ...
7.3 Data Registries
Last Revised: 4/16/2025 For an abbreviated version intended for investigators, coordinators, and ...
1.5 Requirements for Research Conducted with International Sites
Last Revised: 5/9/2023 For an abbreviated version intended for investigators, coordinators, and s...
6.2 Research Involving Investigational and Marketed Devices
Last Revised: 1/23/2024 For an abbreviated version intended for investigators, coordinators, and ...
6.1 Research Involving Investigational and Marketed Drugs
Last Revised: 1/24/2024 For an abbreviated version intended for investigators, coordinators, and ...
4.4 Research Involving Children
Last revised: 9/3/2025 For an abbreviated version intended for investigators, coordinators, and s...
4.6 IRB Review of Research Involving Subjects with Impaired Decision-Making Capacity
Last Revised: 11/27/2024 For an abbreviated version intended for investigators, coordinators, and...
4.7 Research Involving Employees of the Organization and Students as Subjects
Last Revised: 1/29/2018 For an abbreviated version intended for investigators, coordinators, and ...
3.4 Use of Protected Health Information in Research
Last Revised: 4/9/2018 For an abbreviated version intended for investigators, coordinators, and s...
4.1 Additional Protections for Vulnerable Persons
Last Revised: 4/16/2025 For an abbreviated version intended for investigators, coordinators, and ...
5.2 Waiver or Alteration of Informed Consent and HIPAA Authorization
Last Revised: 2/7/2024 For an abbreviated version intended for investigators, coordinators, and s...
5.4 Waiver of Requirement to Obtain Signed Consent Form
Last Revised: 12/11/2024 For an abbreviated version intended for investigators, coordinators, and...
1.8 Investigational Activities Requiring IRB Review and Approval
Last Revised: 5/9/2023 For an abbreviated version intended for investigators, coordinators, and s...