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Table of Contents
Section 1: General Human Research Protection Program Polices 1.1 Human Research Protection Progr...
8.6 Study Hold, Suspension, and Termination
1.0 Purpose The purpose of this policy is to describe the process for study holds, study suspens...
8.2 Review of Study Related Complaints
1.0 Purpose The purpose of this policy is to describe the process for reporting research related...
6.2 Research Involving Investigational and Marketed Devices
1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...
6.1 Research Involving Investigational and Marketed Drugs
1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...
5.7 Obtaining Informed Consent from Non-English Speaking Persons, or Persons with Additional Needs or Vulnerabilities
1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for the pr...
5.3 Use of a Remote Consent Process
1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...
5.2 Waiver or Alteration of Informed Consent and HIPAA Authorization
1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for granti...
5.1 Obtaining Informed Consent From Research Subjects
1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for the pr...
4.7 Research Involving Employees of the Organization and Students as Subjects
1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...
4.5 Local 407 Panel Review of Pediatric Research
1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...
4.1 Additional Protections for Vulnerable Populations
1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...
1.34 Emergency Preparedness for the Office of Regulatory Affairs and IRBs
1.0 Purpose The purpose of this policy is to describe the Emergency Preparedness and Continuity ...
Emergency Preparedness /Continuity of Operations Plan (EP/COOP)
1.0 Emergency Preparedness /Continuity of Operations Plan (EP/COOP) 1.1. Purpose The UNMC Offi...
3.6 Subject Recruitment Through Direct Invitation
1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for subjec...
3.4 Use of Protected Health Information in Research
1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...
1.25 Financial Conflicts of Interest
1.0 Purpose The purpose of this policy is to describe the Organization’s procedures for identifi...
2.9 Closure of On-Going Research
1.0 Purpose The purpose of this policy is to describe the criteria for, and process of, closing ...
2.8 Limited IRB Review
1.0 Purpose The purpose of this policy is to describe the Organization’s requirements and proced...
2.6 Exempt Research
2.6 Exempt Research 1.0 Purpose The purpose of this policy and procedure is to describe the Org...