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References

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1.6 IRB Composition, Leadership, Qualifications, and Responsibilities

Last Revised: 2/15/2025 1.0 Purpose The purpose of this policy and procedure is to describe the O...

1.12 Sponsored Research

Revised: 6/12/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s requi...

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...

3.11 Collecting Data from Pregnant Partners of Research Subjects

Last Revised: 9/9/2019 1.0 Purpose The purpose of this policy is to describe the Organization’s r...

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’...

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 ...

2.4 IRB Review of Changes in Previously Approved Research

Last Revised 1/18/2025 For an abbreviated version intended for investigators, coordinators, and s...

2.7 Continuing Review of Research

Last Revised 1/12/2024 For an abbreviated version intended for investigators, coordinators, and s...

7.3 Data Registries

Last Revised: 4/16/2025 For an abbreviated version intended for investigators, coordinators, and ...

2.6 Exempt Research

Last Revised: 1/7/2024 For an abbreviated version intended for investigators, coordinators, and s...

2.2 Full IRB Review

Last Revised: 6/12/2024 For an abbreviated version intended for investigators, coordinators, and ...

6.3 Humanitarian Use Device (HUD)

Last Revised: 5/26/2021 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...

7.2 Collection, Storage and Use of Human Biological Material in Research

Last Revised: 9/24/2025 For an abbreviated version intended for investigators, coordinators, and ...

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...