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References

Listed below is all the known content in the system that links to this item.

1.2 Authority Granted to the IRB by the Organization

HRPP Policies and Procedures Section 1: General Human Research Prote...

Last Revised: 5/28/2021 1.0 Purpose The purpose of this policy and procedure is to describe the a...

1.3 UNMC IRB Serving as the Single IRB for Multisite Research

HRPP Policies and Procedures Section 1: General Human Research Prote...

Last Revised: 11/13/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s...

1.5 Requirements for Research Conducted with International Sites

HRPP Policies and Procedures Section 1: General Human Research Prote...

Last Revised: 5/9/2023 1.0 Purpose The purpose of this policy is to describe the Organization’s r...

1.4 UNMC Ceding Review to an External Central IRB

HRPP Policies and Procedures Section 1: General Human Research Prote...

Last Revised: 1/22/2024 1.0 Purpose The purpose of this policy and procedure is to describe the O...

1.8 Investigational Activities Requiring IRB Review and Approval

HRPP Policies and Procedures Section 1: General Human Research Prote...

Last Revised: 5/9/2023 1.0 Purpose The purpose of this policy is to describe the investigational ...

1.22 Assessment of the Effectiveness and Efficiency of the HRPP

HRPP Policies and Procedures Section 1: General Human Research Prote...

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

HRPP Policies and Procedures Section 1: General Human Research Prote...

Last Revised: 10/17/2024 1.0 Purpose The purpose of this policy is to describe the constitution o...

1.31 Observers at IRB Meetings

HRPP Policies and Procedures Section 1: General Human Research Prote...

Last Revised: 2/26/2018 1.0 Purpose The purpose of this policy and procedure is to describe the O...

2.1 Submission for Items for Review by the IRB

HRPP Policies and Procedures Section 2: Process of Review

Last Revised: 7/19/2022 1.0 Purpose The purpose of this policy is to describe Organization’s requ...

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...

4.1 Additional Protections for Vulnerable Populations

HRPP Policies and Procedures Section 4: Vulnerable Populations

Last Revised: 1/26/2018 1.0 Purpose The purpose of this policy and procedure is to describe the O...

4.4 Research Involving Children

HRPP Policies and Procedures Section 4: Vulnerable Populations

1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for resear...

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

HRPP Policies and Procedures Section 4: Vulnerable Populations

1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for IRB rev...

4.7 Research Involving Employees of the Organization and Students as Subjects

HRPP Policies and Procedures Section 4: Vulnerable Populations

1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requiremen...

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...

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...

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...

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...

7.3 Data Registries

HRPP Policies and Procedures Section 7: Human Biologic Materials and...

Last Revised: 3/2/2018 1.0 Purpose The purpose of this policy and procedure is to describe the Or...

8.1 Review of Adverse Events and Adverse Device Effects

HRPP Policies and Procedures Section 8: AEs, Unanticipated Problems ...

Last Revised: 5/4/2023 1.0 Purpose The purpose of this policy is to describe the process for repo...

8.2 Review of Study Related Complaints

HRPP Policies and Procedures Section 8: AEs, Unanticipated Problems ...

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

HRPP Policies and Procedures Section 8: AEs, Unanticipated Problems ...

Last Revised: 5/8/2023 1.0 Purpose The purpose of this policy is to describe the process for repo...

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 ...