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:

2.1. The ORA has the authority to accept a study hold imposed by the PI, sponsor, DSMB, FDA or other funding agency, and the IRB Executive Chair or the IRB has the authority to release that hold.
2.2. The IRB or the Executive Chair has the authority to suspend IRB approval of research, and the IRB has the authority to release that study suspension.
2.3. The IRB or the Organization has the authority to terminate IRB approval of research.
2.3. Suspensions or terminations of IRB approval as a result of noncompliance will be promptly reported to OHRP, FDA and sponsors or funding agency heads in accordance with the requirements of 45 CFR 46.108(a)(4), and 21 CFR 56.108(b), and the Organization’s FederalWide assurance, as specified in HRPP policy 8.7 (Reporting Incidents to Institutional Officials and Federal Agencies).

3.0 Definitions

3.1. Study Hold: A planned or unplanned temporary halt to subject accrual and/or research activities, that is imposed by the PI, sponsor, DSMB, or FDA or other funding agency. A study hold may be full (affecting accrual and all study activities), or partial (affecting only accrual, or only some study activities).

Note: A study hold which is not imposed by the IRB does not constitute a suspension or termination of IRB-approval of research under 45 CFR 46.113; 21 CFR 56.113.
3.2. Suspension of IRB Approval: A directive of the IRB at a convened meeting, or a directive of the IRB Executive Chair or designee (in consultation with the IO as appropriate), that all or some research activities in one or more protocols must be temporarily suspended.

Note: interruptions in human research resulting solely from the expiration of the IRB approval period does not constitute suspension of IRB-approval of research under 45 CFR 46.113 or 21 CFR 56.113.
3.3. Termination of IRB Approval: A directive by the IRB at a convened meeting that all research activities must permanently cease in one or more protocols.
3.4. Organization Directed Termination of IRB Approval: A directive by the Institutional Official (IO) that an IRB approved study be terminated.

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

5.0 Suspension of IRB Approval

5.1. The convened IRB or the IRB Executive Chair or designee may suspend IRB approval of research if such action is warranted due to concerns regarding the safety, rights, or welfare of human research subjects, investigators, research staff, or others, or due to noncompliance concerns, or other similar circumstances.
- 5.1.1. The IRB Executive chair may exercise his/her authority to suspend research when, in his/her judgement, such action is necessary the protect the safety, rights, or welfare of human research subjects, investigators, research staff, or others before the next convened IRB meeting.
5.2. The IRB will take appropriate action(s) to protect the rights and welfare of currently enrolled subjects.
5.3. The PI will be responsible for notifying all study personnel that the study has been suspended and that all, or some, research activities are suspended.
5.4. The PI must report to the IRB any adverse events or outcomes associated with the suspension.
5.5. The PI must notify research subjects currently on study of suspension of IRB approval of research activities. Subjects should be advised of any follow-up necessary for safety reasons.
5.6. The IRB, or the Executive Chair, has the authority to permit subjects currently on study to continue if it is in their best medical interest to do so.
5.7. If the study was suspended by the Executive Chair, the IRB will be notified at the next convened meeting of the suspension.
5.8. The PI may file a written appeal of the suspension to the IRB. The IRB has the final authority to act on any appeals and the decision of the Board cannot be overturned.
5.9. The convened IRB has the sole authority to release a study suspension.

6.0 Termination of IRB Approval

6.1. The convened IRB may terminate IRB approval of research if such action is warranted due to concerns regarding the safety, rights, or welfare of human research subjects, investigators, research staff, or others, which cannot be otherwise resolved, or due to serious or continuing noncompliance with the applicable federal regulations and HRPP policies, or due to other similar circumstances.
6.2. The IRB will provide the PI with written justification for termination of IRB approval of the research.
6.3. The IRB will promptly notify the IO and other appropriate Organization officials of the termination of IRB approval of research.
6.4. The IRB will take appropriate action(s) to protect the rights and welfare of currently enrolled subjects.
6.5. The PI will be responsible for notifying all study personnel that the study has been terminated and that all research activities must cease.
6.6. The PI must report to the IRB any adverse events or outcomes associated with the termination.
6.7. The PI must notify research subjects currently on study of termination of the study. Subjects should be advised of any follow-up necessary for safety reasons.
6.8. The PI may file a written appeal of the suspension to the IRB within 30 days of the termination. The IRB shall give the PI an opportunity to appear before the Board. The PI will be afforded due process and may bring legal counsel who will be restricted to observation only. The IRB has the final authority to act on any appeals and the decision of the Board cannot be overturned.

7.0 Organization Directed Termination of IRB Approval

7.1. In consultation with appropriate Organization officials the IO may direct that one or more of an investigator’s approved studies be terminated.
7.2. The IO will provide the PI with written justification for termination of the research.
7.3. The IO will notify appropriate the IRB Executive Chair, and Organization officials of the termination of the research.
7.4. The IRB will take appropriate action(s) to protect the rights and welfare of currently enrolled subjects.
7.5. The PI will be responsible for notifying all study personnel that the study has been terminated and that all research activities must cease.
7.6. The PI must report to the IRB any adverse events or outcomes associated with the termination.
7.7. The PI must notify research subjects currently on study of termination of the study. Subjects should be advised of any follow-up necessary for safety reasons.
7.8. The PI may file a written appeal of the suspension to the IO within 30 days of the termination. The IO has full authority to act on the appeal and may at his/her discretion seek consultation with the IRB or any other persons. The PI will be afforded due process and may be offered the opportunity to meet with the IO. The investigator may bring legal counsel who will be restricted to observation only. The decision of the IO regarding any appeal is final.

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)}

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