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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 2 months 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 3 months 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 3 months 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 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 5 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 5 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 6 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 6 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 6 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 6 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 6 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 6 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 11 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 11 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 11 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 11 months ago by Robert A Lewis

3.3 Privacy Interests and Confidentiality of Research Data

HRPP Policies and Procedures Section 3: Special Issues

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

Updated 11 months ago by Robert A Lewis

1.14 Research Subject to Department of Defense Regulatory Requirements

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

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

Updated 11 months ago by Robert A Lewis

6.4 Emergency Use of a Test Article

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

1.0 Purpose The purpose of this policy is to describe the requirements for utilization of a test...

Updated 11 months ago by Robert A Lewis

1.25 Financial Conflicts of Interest

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

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

Updated 11 months ago by Robert A Lewis