1.13 Compliance with ICH-GCP Guidelines

Last Revised: 10/17/2025

1.0. Purpose

The purpose of this policy is to describe the Organization’s requirements for compliance with the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) E6 Guidelines.

2.0. Policy

It is the policy of the Organization that:

2.1. The Organization will apply ICH-GCP E6 guidelines to IRB/ORA review and the conduct of clinical research when the sponsored agreement requires adherence to ICH GCP. If the sponsored agreement does not require adherence to ICH-GCP then the Organization will apply ICH-GCP guidelines only to the extent that they are required by FDA.

3.0 Investigator and Sponsor Responsibilities

3.1. When compliance with ICH-GCP E6 is required by a sponsored agreement, investigators must follow ICH-GCP E6 (R3) sections 2.1 thru 2.13 (or equivalent sections in any subsequent revision of ICH-GCP E6). See https://database.ich.org/sites/default/files/ICH_E6%28R3%29_Step4_FinalGuideline_2025_0106.pdf

4.0. IRB/ORA Responsibilities

4.1. When compliance with ICH-GCP E6 is required by a sponsored agreement, the IRB/ORA will follow ICH-GCP E6 (r3) sections 1.1 through 1.5 (or equivalent sections in any subsequent revision of ICH-GCP E6). See https://database.ich.org/sites/default/files/ICH_E6%28R3%29_Step4_FinalGuideline_2025_0106.pdf
4.2. Additional IRB/ORA responsibilities include (but may not be limited to):
- 4.2.1. The IRB/ORA will review investigator’s current curriculum vitae or other documentation to be assured the PI is qualified by education, training, and experience to assume responsibility for the proper conduct of the trial.
- 4.2.2. The IRB/ORA will review the informed consent materials to be provided to participants to ensure they include discussion of:
  - 4.2.2.1. Participant's responsibilities
  - 4.2.2.2. Potential benefits and risks of alternative procedures or treatments that may be available to the subject
  - 4.2.2.3. Approximate number of participants involved in the trial
- 4.2.3. The IRB/ORA will ensure that the informed consent forms include signature of the person who conducted the IC discussion.

DOCUMENT HISTORY:

 Written: 1/25/2016 (Approved: 1/25/2016) - original author not recorded

 Revised: 2/2/2018 - revision not documented

 Revised 10/17/2025 – simplified to remove specific references to ICH-GCP sections; updated to ICH-GCP E6 (R3)

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

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 Persons

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 Collection, Storage and Use of Human Biological Material in Research

7.3 Data Registries