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6.3 Humanitarian Use Device (HUD)

HRPP Policies and Procedures Section 6: FDA Regulated Research/Drugs...

Last Revised: 5/26/2021 1.0 Purpose The purpose of this policy and procedure is to describe the O...

Updated 3 weeks ago by Robert A Lewis

6.2 Research Involving Investigational and Marketed Devices

HRPP Policies and Procedures Section 6: FDA Regulated Research/Drugs...

Last Revised: 1/23/2024 1.0 Purpose The purpose of this policy and procedure is to describe the O...

Updated 3 weeks ago by Robert A Lewis

6.1 Research Involving Investigational and Marketed Drugs

HRPP Policies and Procedures Section 6: FDA Regulated Research/Drugs...

Last Revised: 1/24/2024 1.0 Purpose The purpose of this policy and procedure is to describe the O...

Updated 3 weeks ago by Robert A Lewis

5.4 Waiver of Requirement to Obtain Signed Consent Form

HRPP Policies and Procedures Section 5: Informed Consent

Last Revised: 12/11/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s...

Updated 3 weeks ago by Robert A Lewis

5.2 Waiver or Alteration of Informed Consent and HIPAA Authorization

HRPP Policies and Procedures Section 5: Informed Consent

Last Revised: 2/7/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s r...

Updated 3 weeks ago by Robert A Lewis

4.7 Research Involving Employees of the Organization and Students as Subjects

HRPP Policies and Procedures Section 4: Vulnerable Populations

Last Revised: 1/29/2018 1.0 Purpose The purpose of this policy and procedure is to describe the O...

Updated 3 weeks ago by Robert A Lewis

4.6 IRB Review of Research Involving Subjects with Impaired Decision-Making Capacity

HRPP Policies and Procedures Section 4: Vulnerable Populations

Last Revised: 11/27/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s...

Updated 3 weeks ago by Robert A Lewis

4.3 Research Involving Prisoners

HRPP Policies and Procedures Section 4: Vulnerable Populations

Last Revised: 01/17/2024 1.0 Purpose The purpose of this policy and procedure is to describe the ...

Updated 3 weeks ago by Robert A Lewis

4.2 Research Involving Pregnant Women, Human Fetuses, and Neonates (Nonviable or of Uncertain Viability)

HRPP Policies and Procedures Section 4: Vulnerable Populations

Last Revised: 9/25/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s ...

Updated 3 weeks ago by Robert A Lewis

3.12 Ethical Access

HRPP Policies and Procedures Section 3: Special Issues

Last Revised: 3/5/2025 1.0 Purpose The purpose of this policy is to define ethical access and to ...

Updated 3 weeks ago by Robert A Lewis

3.6 Subject Recruitment Through Direct Invitation

HRPP Policies and Procedures Section 3: Special Issues

Last Revised: 3/12/2025 1.0 Purpose The purpose of this policy is to describe the Organization’s ...

Updated 3 weeks ago by Robert A Lewis

3.5 Subject Recruitment Through Advertisements

HRPP Policies and Procedures Section 3: Special Issues

Last Revised 12/11/2024 For an abbreviated version intended for investigators, coordinators, and ...

Updated 3 weeks ago by Robert A Lewis

3.4 Use of Protected Health Information in Research

HRPP Policies and Procedures Section 3: Special Issues

Last Revised: 4/9/2018 1.0 Purpose The purpose of this policy and procedure is to describe the Or...

Updated 3 weeks ago by Robert A Lewis

3.3 Privacy Interests and Confidentiality of Research Data

HRPP Policies and Procedures Section 3: Special Issues

Last Revised 1/21/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s r...

Updated 3 weeks ago by Robert A Lewis

2.9 Closure of On-Going Research

HRPP Policies and Procedures Section 2: Process of Review

Last Revised: 08/10/2023 1.0 Purpose The purpose of this policy is to describe the criteria for, ...

Updated 3 weeks ago by Robert A Lewis

2.7 Continuing Review of Research

HRPP Policies and Procedures Section 2: Process of Review

Last Revised 1/12/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s r...

Updated 3 weeks ago by Robert A Lewis

2.6 Exempt Research

HRPP Policies and Procedures Section 2: Process of Review

Last Revised: 1/7/2024 1.0 Purpose The purpose of this policy and procedure is to describe the Or...

Updated 3 weeks ago by Robert A Lewis

2.5 Criteria for IRB Approval

HRPP Policies and Procedures Section 2: Process of Review

Last Revised: 1/24/2018 1.0 Purpose The purpose of this policy and procedure is to describe the O...

Updated 3 weeks ago by Robert A Lewis

2.4 IRB Review of Changes in Previously Approved Research

HRPP Policies and Procedures Section 2: Process of Review

Last Revised 1/18/2025 1.0 Purpose The purpose of this policy is to describe the Organization’s r...

Updated 3 weeks ago by Robert A Lewis

2.2 Full IRB Review

HRPP Policies and Procedures Section 2: Process of Review

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

Updated 3 weeks ago by Robert A Lewis