Section 1: General Hum...

1.1 Human Research Protection Program (HRPP)

1.0 Purpose The purpose of this policy and procedure is to provide a basic description of the Org...

1.2 Authority Granted to the IRB by the Organization

1.0 Purpose The purpose of this policy and procedure is to describe the authority granted by the ...

1.3 UNMC IRB Serving as the Single IRB for Multisite Research

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

1.4 UNMC Ceding Review to an External Central IRB

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

1.5 Requirements for Research Conducted with International Sites

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

1.6 IRB Composition, Leadership, Qualifications, and Responsibilities

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

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

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

1.8 Investigational Activities Requiring IRB Review and Approval

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

1.9 Resources Necessary to Protect Subjects

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

1.10 Scientific and Other Committee Review of Research

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

1.11 HRPP Access to Legal Counsel

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

1.12 Sponsored Research

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

1.13 Compliance with ICH-GCP Guidelines

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

1.14 Research Subject to Department of Defense Regulatory Requirements

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

1.15 Research Subject to Department of Justice Regulatory Requirements

1.0 Purpose The purpose of this policy and procedure is to specify the Organizations requirements...

1.16 ORA Record Keeping Requirements

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

1.17 Retention of Research Records

1.0 Purpose The purpose of this policy is to describe the requirements for retention of research...

1.18 Review and Approval of HRPP Policies and Procedures

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

1.19 IRB Signature Authority

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

1.20 Community Involvement in Outreach Activities and Community Based Participatory Research (CBPR)

1.0 Purpose The purpose of this policy is to describe the Organization’s outreach activities to ...

1.21 Post-Approval Monitoring of Research

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

1.22 Assessment of the Effectiveness and Efficiency of the HRPP

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

1.23 HRPP Training Requirements

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

1.24 HRPP Training Requirements for IRB Members

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

1.25 Financial Conflicts of Interest

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

1.26 PI Qualifications and Responsibilities

1.0 Purpose The purpose of this policy and procedure is to describe the qualifications and respon...

1.27 Research Personnel Qualifications and Responsibilities

1.0 Purpose The purpose of this policy and procedure is to describe the qualifications and respo...

1.28 External Investigator Assurance

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

1.29 ClinicalTrials.gov Reporting

1.0. Purpose The purpose of this policy is to describe the requirements for registration and com...

1.30 Use of the Rapid Response IRB

1.0 Purpose The purpose of this policy is to describe the constitution of, the criteria for use o...

1.31 Observers at IRB Meetings

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

1.32 Confidentiality of the Review Process

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

1.33 Posting of Clinical Trial Consent Forms

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 ...

1.1 Human Research Protection Program (HRPP)

1.2 Authority Granted to the IRB by the Organization

1.3 UNMC IRB Serving as the Single IRB for Multisite Research

1.4 UNMC Ceding Review to an External Central IRB

1.5 Requirements for Research Conducted with International Sites

1.6 IRB Composition, Leadership, Qualifications, and Responsibilities

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

1.8 Investigational Activities Requiring IRB Review and Approval

1.9 Resources Necessary to Protect Subjects

1.10 Scientific and Other Committee Review of Research

1.11 HRPP Access to Legal Counsel

1.12 Sponsored Research

1.13 Compliance with ICH-GCP Guidelines

1.14 Research Subject to Department of Defense Regulatory Requirements

1.15 Research Subject to Department of Justice Regulatory Requirements

1.16 ORA Record Keeping Requirements

1.17 Retention of Research Records

1.18 Review and Approval of HRPP Policies and Procedures

1.19 IRB Signature Authority

1.20 Community Involvement in Outreach Activities and Community Based Participatory Research (CBPR)

1.21 Post-Approval Monitoring of Research

1.22 Assessment of the Effectiveness and Efficiency of the HRPP

1.23 HRPP Training Requirements

1.24 HRPP Training Requirements for IRB Members

1.25 Financial Conflicts of Interest

1.26 PI Qualifications and Responsibilities

1.27 Research Personnel Qualifications and Responsibilities

1.28 External Investigator Assurance

1.29 ClinicalTrials.gov Reporting

1.30 Use of the Rapid Response IRB

1.31 Observers at IRB Meetings

1.32 Confidentiality of the Review Process

1.33 Posting of Clinical Trial Consent Forms

1.34 Emergency Preparedness for the Office of Regulatory Affairs and IRBs

2.1 Submission for Items for Review by the IRB

2.2 Full IRB Review

2.3 Expedited Review

2.4 IRB Review of Changes in Previously Approved Research

2.5 Criteria for IRB Approval

2.6 Exempt Research

2.7 Continuing Review of Research

2.8 Limited IRB Review

2.9 Closure of On-Going Research

3.1 Assessing the Need for Increased Monitoring, Interim Continuing Review, and Verification from Sources Other than the PI

3.2 Data and Safety Monitoring

3.3 Privacy Interests and Confidentiality of Research Data

3.4 Use of Protected Health Information in Research

3.5 Subject Recruitment Through Advertisements

3.6 Subject Recruitment Through Direct Invitation

3.7 Finder’s Fees and Recruitment Bonuses

3.8 Research Subject Compensation and Reimbursement

3.9 Contraception Requirements

3.10 Pregnancy Testing

3.11 Collecting Data from Pregnant Partners of Research Subjects

3.12 Ethical Access

3.13 Use of Placebo or Wash-Out of Effective Therapy in Clinical Trials

3.14 Phase I and First-in-Human Studies

3.15 Managing Radiographic Incidental Findings in Human Subjects Research

4.1 Additional Protections for Vulnerable Populations

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

4.3 Research Involving Prisoners

4.4 Research Involving Children

4.5 Local 407 Panel Review of Pediatric Research

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

4.7 Research Involving Employees of the Organization and Students as Subjects

5.1 Obtaining Informed Consent From Research Subjects

5.2 Waiver or Alteration of Informed Consent and HIPAA Authorization

5.3 Use of a Remote Consent Process

5.4 Waiver of Requirement to Obtain Signed Consent Form

5.5 Use of the Short Form Consent Document

5.6 Exceptions from Informed Consent Requirements for Emergency Research

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

6.1 Research Involving Investigational and Marketed Drugs

6.2 Research Involving Investigational and Marketed Devices

6.3 Humanitarian Use Device (HUD)

6.4 Emergency Use of a Test Article

6.5 Expanded Access to Investigational Drugs and Devices for Treatment Use

7.1 Banking Human Biological Material

7.2 Use of Human Biological Material in Research

7.3 Data Registries