Section 6: FDA Regulated Research/Drugs & Devices

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...

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...

6.3 Humanitarian Use Device (HUD)

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

6.4 Emergency Use of a Test Article

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

6.5 Expanded Access to Investigational Drugs and Devices for Treatment Use

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

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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 at International Sites

1.6 IRB Composition, Leadership, Qualifications, and Responsibilities

1.7 IRB Member, Consultant, and Staff 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 Research & Outreach Activities

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

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

8.1 IRB Review of Adverse Events and Adverse Device Effects