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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...

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...

8.3 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 ...

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...

8.1 Review of Adverse Events and Adverse Device Effects

Last Revised: 3/24/2026 1.0 Purpose The purpose of this policy is to describe the process for rep...

1.5 Requirements for Research Conducted with International Sites

Last Revised: 6/10/2026 For an abbreviated version intended for investigators, coordinators, and ...

2.1 Submission for Items for Review by the IRB

Last Revised: 6/26/2026 1.0 Purpose The purpose of this policy is to describe Organization’s requ...