Section 8: AEs, Unanticipated Problems and Compliance

8.1 Review of Adverse Events and Adverse Device Effects

1.0 Purpose

The purpose of this policy is to describe the process for reporting research related Adverse Events (AEs) and Adverse Device Effects (ADEs) to the ORA and the IRB, and the process for review of AEs and ADEs.


2.0 Policy

It is the policy of the Organization that:


3.0 Definitions


4.0 Investigator Responsibilities


5.0 ORA Responsibilities


6.0 IRB Responsibilities


7.0 Reporting AEs/UADEs to Institutional Officials, OHRP, FDA, and Department or Agency Heads

All required reports will be submitted in accordance with HRPP policy 8.7 (Reporting Incidents to Institutional Officials and Federal Agencies).


DOCUMENT HISTORY:

 Written: 1/18/2016 (Approved: 1/18/2016) - original author not recorded

 Revised: 11/27/2017 - revision not documented

 Revised: 5/4/2023 - Clarified investigator responsibilities for reporting AEs that occur on studies for which the Organization is relying on another IRB; deleted expectation that reportable external AEs be followed by change request (since such AE reports often are made in the context of a change request) (section 4.2.1); stylistic changes.{Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

8.2 Review of Study Related Complaints

1.0 Purpose

The purpose of this policy is to describe the process for reporting research related complaints to the ORA and the IRB, and the process for review of complaints.


2.0 Policy

It is the policy of the Organization that:


3.0 Complainant (or Other Reporters’) Responsibilities


4.0 ORA Responsibilities


5.0 IRB Responsibilities


6.0 Reporting Complaints to Organizational Officials, OHRP, FDA and Department or Agency Heads

All required reports will be submitted in accordance with HRPP policy 8.7 (Reporting Incidents to Institutional Officials and Federal Agencies).


DOCUMENT HISTORY:

 Written: 1/20/2019 (Approved: 1/20/2016) - original author not recorded

 Revised: 1/19/2018 - revision not documented

 Revised: 1/18/2023 - Clarified definition of “complaints”; noted additional policies related to complaints by research personnel or other interested parties regarding the functioning of one or more components of the HRPP; clarified that the ORA only investigates complaints related to human subjects research; added that complaints that do not involve risk to participants or others, or do not change the risk-benefit profile of the study are reported to the IRB (either at the time of continuing review, or as a special notification item); added comment that all required reports will be submitted to Institutional Officials and Federal Agencies in accordance with HRPP policy 8.7; reorganized sections; stylistic changes.{Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Revised: 5/8/2023 - Changed “IRB Administrator” to “IRB Analyst”{Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

8.3 Review of Unanticipated Problems Involving Risk to the Subject or Others

1.0 Purpose

The purpose of this policy is to describe the process for reporting potential unanticipated problems (UPs) involving risk to the ORA and the IRB, and the process for review of potential UPs.


2.0 Policy

It is the policy of the organization that:


3.0 Definitions


4.0 Investigator (or Other Reporters’) Responsibilities


5.0 IRB/ORA Responsibilities


6.0 Reporting UPs to Institutional Officials, OHRP, FDA, and Department or Agency Heads

All required reports will be submitted in accordance with HRPP policy 8.7 (Reporting Incidents to Institutional Officials and Federal Agencies).


DOCUMENT HISTORY:

 Written: 4/4/2016 (Approved: 4/4/2016) - original author not recorded

 Revised: 11/27/2018 - revision not documented

 Revised: 1/18/2023 - Clarified that certain events are always referred to convened IRB for review and determination if the event constitutes a UP, and other events are first reviewed by the ORA and only referred if determined by the ORA to be potentially represent a UP; simplified text; stylistic changes.{Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Revised: 5/8/2023 - Corrected regulatory reference in section 2.1; modified section 5.1 to reflect IRB actions as opposed to investigator actions (eg, “requiring modification of the protocol” as opposed to “modifying protocol”); correcting misspellings.{Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

8.4 Review of Noncompliance Involving the PI or Study Personnel

1.0 Purpose

The purpose of this policy is to describe the process for reviewing and reporting incidents of noncompliance by the PI and/or study personnel.


2.0 Policy

It is the policy of the Organization that:


3.0 Definitions


4.0 Reporting an Noncompliance to the ORA


5.0 ORA Responsibilities


6.0 IRB Responsibilities


7.0 Reporting Noncompliance to Organizational Officials, OHRP, FDA and Department or Agency Heads

All required reports will be submitted in accordance with HRPP policy 8.7 (Reporting Incidents to Institutional Officials and Federal Agencies).


DOCUMENT HISTORY:

 Written: 1/20/2016 (Approved: 1/20/2016) - original author not recorded

 Revised: 1/19/2018 - revision not documented

 Revised: 1/18/2023 - Simplified purpose statement; corrected regulatory citations in section 2.4; added caveat that reporting will occur in accordance with the Organization’s FWA; clarified definition of noncompliance; clarified criteria for serious noncompliance in section 3.1.1; specified additional conditions which might be considered serious noncompliance (sections 3.1.1.1 and 3.1.1.2); clarified definition of continuing noncompliance; simplified description of reporting to ORA (section 4.0); revised to separate and delineate responsibilities of ORA and of IRB; minimized specific details of processes associated with ORA and/or IRB review (moved to SOP); stylistic changes for clarity.{Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Revised: 3/8/2023 – Deleted reference to “minor” non-compliance and substituted “neither serious nor continuing”; minor revisions in wording of definition of non-compliance, serious non-compliance, and continuing non-compliance; changes “alleged non-compliance” to “possible non-compliance”; simplified section on reporting non-compliance to ORA; deleted list of types of people who may report non-compliance and of possible ways to report non-compliance; simplified section on ORA responsibilities; clarified method of reporting non-compliance discovered at time of CRO or other audit; stylistic changes{Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

8.5 Noncompliance by the IRB or Other Components of the HRPP

1.0 Purpose

The purpose of this policy is to describe the process for reviewing and reporting incidents of noncompliance by the IRB and/or other components of the HRPP.


2.0 Policy

It is the policy of the Organization that:


3.0 Definitions


4.0 Responsibilities of the ORA, Chief Compliance Officer (CCO) and Institutional Official (IO)


5.0 Reporting Noncompliance to Organizational Officials, OHRP, FDA and Department or Agency Heads

All required reports will be submitted in accordance with HRPP policy 8.7 (Reporting Incidents to Institutional Officials and Federal Agencies).


DOCUMENT HISTORY:

 Written: 1/20/2016 (Approved: 1/20/2016) - original author not recorded

 Revised: 1/11/2018 - revision not documented

 Revised: 3/7/2023 – revised definitions; clarified that the ORA will conduct initial evaluation and pass recommendations to CCO; simplified throughout; stylistic changes.{Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Revised: 5/9/2023 – Deleted reference to “minor” non-compliance and substituted “neither serious nor continuing”; revised definition of serious non-compliance to include putting Organization at risk of significant regulatory, financial or reputational harm; revised definitions of serious non-compliance and continuing non-compliance to delete parts of the definition more appropriate for PI or research staff non-compliance; clarified possible actions of CCO.{Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

8.6 Study Hold, Suspension, and Termination

1.0 Purpose

The purpose of this policy is to describe the process for study holds, study suspensions, and study termination.


2.0 Policy

It is the policy of the Organization that:


3.0 Definitions


4.0 Study Holds by PI, Sponsor, DSMB, FDA or Other Funding Agency


5.0 Suspension of IRB Approval


6.0 Termination of IRB Approval


7.0 Organization Directed Termination of IRB Approval


8.0 Reporting Suspensions and Terminations to OHRP, Department and Agency Heads, and FDA

Suspensions and terminations are reported in accordance with HRPP policy 8.7 (Reporting Incidents to Institutional Officials and Federal Agencies).


DOCUMENT HISTORY:

 Written: 4/4/2016 (Approved 4/4/2016) - original author not recorded

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

 Revised: 1/20/2023 - Simplified Purpose statement; revised section 2.0 to reflect specific authorities granted in the body of the policy; removed reference to appeals panel and substituted option to seek consultation with the IRB or any other persons (section 7.8); stylistic changes. {Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

8.7 Reporting Incidents to Institutional Officials and Federal Agencies

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements to ensure prompt reporting of incidents to Institutional Officials, Federal Agencies (including OHRP and FDA) and other Common Rule Departments and Agencies, and to AAHRPP.


2.0 Policy

It is the policy of the Organization that:

3.0 Definitions


4.0 IRB/ORA Responsibilities


5.0 Institutional Responsibilities


6.0 Investigator Responsibilities


7.0 Contents of Reports


8.0. Reports to AAHRPP


Document History:

 Written: 1/20/2016 (Approved: 1/20/2016) - original author not recorded

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

 Revised: 8/15/2022 - Clarified that IO may (but is not required to) report incidents or noncompliance or UPs not associated with Federally funded research to Federal agencies; clarified that decision by the IO to report is made after due consideration of recommendations of the IRB, and in consultation with IRB Executive Chair and Organizational officials; clarified that copies of the report will be made available to the PI after submission to the agencies; referenced HRPP 1.3 for reporting of incidents where UNMC is the IRB of record for other relying sites; reorganized lists of responsibilities for clarity. {Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Board notified: 1/16/2023

 Revised: 8/1/2023 – added sections 2.4 and 8.0 regarding notification to AAHRPP.{Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}