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5.7 Obtaining Informed Consent from Non-English Speaking Persons, or Persons with Additional Needs or Vulnerabilities

HRPP Policies and Procedures Section 5: Informed Consent

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

Updated 1 week ago by Robert A Lewis

1.18 Review and Approval of HRPP Policies and Procedures

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

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

Updated 1 week ago by Robert A Lewis

1.3 UNMC IRB Serving as the Single IRB for Multisite Research

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

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

Updated 1 week ago by Robert A Lewis

1.8 Investigational Activities Requiring IRB Review and Approval

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

1.0 Purpose The purpose of this policy is to describe the investigational activities that requir...

Updated 1 month ago by Robert A Lewis

1.7 IRB Member, Consultant, Staff and Guest Conflict of Interest Identification and Management

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

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

Updated 1 month ago by Robert A Lewis

1.22 Assessment of the Effectiveness and Efficiency of the HRPP

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

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

Updated 1 month 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

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

Updated 1 month ago by Robert A Lewis

8.4 Review of Noncompliance Involving the PI or Study Personnel

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

1.0 Purpose The purpose of this policy is to describe the process for reviewing and reporting in...

Updated 3 months ago by Robert A Lewis

6.5 Expanded Access to Investigational Drugs and Devices for Treatment Use

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

1.0 Purpose 1.1. The purpose of this policy and procedure is to describe the requirements for ut...

Updated 4 months ago by Robert A Lewis

5.2 Waiver or Alteration of Informed Consent and HIPAA Authorization

HRPP Policies and Procedures Section 5: Informed Consent

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

Updated 4 months ago by Robert A Lewis

Emergency Preparedness /Continuity of Operations Plan (EP/COOP)

HRPP Policies and Procedures

1.0 Emergency Preparedness /Continuity of Operations Plan (EP/COOP) 1.1. Purpose The UNMC Offi...

Updated 4 months ago by Robert A Lewis

3.8 Research Subject Compensation and Reimbursement

HRPP Policies and Procedures Section 3: Special Issues

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

Updated 4 months ago by Robert A Lewis

5.3 Use of a Remote Consent Process

HRPP Policies and Procedures Section 5: Informed Consent

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

Updated 5 months ago by Robert A Lewis

2.2 Full IRB Review

HRPP Policies and Procedures Section 2: Process of Review

1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for: 1) su...

Updated 5 months ago by Robert A Lewis

1.6 IRB Composition, Leadership, Qualifications, and Responsibilities

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

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

Updated 5 months ago by Robert A Lewis

1.12 Sponsored Research

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

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

Updated 5 months ago by Robert A Lewis

6.2 Research Involving Investigational and Marketed Devices

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

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

Updated 10 months ago by Robert A Lewis

1.4 UNMC Ceding Review to an External Central IRB

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

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

Updated 10 months ago by Robert A Lewis

6.1 Research Involving Investigational and Marketed Drugs

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

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

Updated 10 months ago by Robert A Lewis

2.3 Expedited Review

HRPP Policies and Procedures Section 2: Process of Review

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

Updated 10 months ago by Robert A Lewis