700-34-Administrative, Hold, Suspension, and Termination of Research

Title:	Administrative Hold, Suspension, and Termination of Research
Owner:	IRB
Last Update/Revised:	05/01/2024

Policy: The IRB has the authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB policies, is not in compliance with Federal Regulations, or has been associated with unexpected serious harm to participants. Suspensions and terminations will be reported to appropriate institutional officials when applicable as listed in 700-35: Institutional Reporting Procedures. An investigator may also place a voluntary administrative hold on previously approved research when, in the investigator's judgment, an administrative hold is appropriate to protect the rights or welfare of participants. In this policy, an IRB designee refers to the following: The IRB Chair, the Provost, or a person designated in writing to temporarily assume the role of one of these persons.

Definitions referred to in this policy are listed below.

Administrative Hold - An administrative hold is a voluntary action by an investigator to temporarily or permanently stop some or all approved research activities. Administrative holds are not suspensions or terminations. Protocols on administrative hold remain open and require continuing review.

Suspension - A suspension of IRB approval is a directive of the convened IRB, or IRB designee either to temporarily stop some or all previously approved research activities, or to permanently stop some or all previously approved research activities. Suspended protocols remain open and require continuing review.

Termination - A termination of IRB approval is a directive of the convened IRB or IRB designee to permanently stop all activities in a previously approved research protocol. Terminated protocols are considered closed and no longer require continuing review.

Purpose: This policy aims to explain the process around administrative holds, suspensions, and terminations of research.

Procedures:

Procedures for Administrative Holds
1. An investigator (or chair for a doctoral student) may place a research study on administrative hold. Some or all research activities may be placed on administrative hold until additional information can be obtained to determine if a change in the risk/benefit assessment of the research has occurred, or if potential areas of non-compliance exist in a currently approved research protocol.
2. The IRB or IRB designee in consultation with the investigator (and chair of a doctoral student) determines whether any additional procedures need to be followed to protect the rights and welfare of current participants.
3. The IRB or IRB designee in consultation with the investigator (and chair of a doctoral student) determines how and when currently enrolled participants will be notified of the administrative hold.
4. Investigators (or a chair of a doctoral student) must email the IRB at IRB@usuniversity.edu the following information:
  1. A statement that the investigator is voluntarily placing a study on administrative hold.
  2. A description of the research activities that will be stopped. Research activities may include but are not limited to recruitment, screening/enrollment, research intervention/interaction, follow-up, or all research activities
  3. A list of all currently enrolled participants’ status within the study and the proposed actions to be taken (if needed) to protect the rights and welfare of current participants during the administrative hold action.
  4. Actions that will be taken prior to IRB approval of proposed changes in order to eliminate apparent immediate harm.
5. After notification from the investigator (or chair of a doctoral student) has been received, the IRB Chair initiates an inquiry process and considers if the additional information gathered during the inquiry stage of an investigation determines that no change to the risk/benefit ratio has occurred, the rights or welfare of participants have not been compromised, and issues of noncompliance have been ruled out. The inquiry may necessitate a for-cause audit according to 700-37: For-Cause Audits to obtain the needed information.
6. The IRB Chair writes a report of the findings and notifies the investigator (and chair of a doctoral student) in writing via email of these findings and what corrective actions are necessary, if any, and allows the study to return to active status. Determinations of unanticipated problems involving risks to participants or others or non-compliance that are a result of these findings will be made according to 700-31: Unanticipated Problems Involving Risks to Participants or Others and 700-33: Non-Compliance and Research Misconduct.
Procedures for Suspension or Termination of IRB Approved Research by the Convened IRB or IRB Designee for Cause
1. If research is not being conducted in accordance with the policies, requirements, and determinations of the IRB, or federal rules or regulations governing human subject research, or has been associated with unexpected serious harm to participants, the convened IRB or designee may suspend or terminate some or all research activity to protect the rights or welfare of participants.
2. The IRB designee considers whether any actions need to be implemented to protect the rights and welfare of current participants and orders any actions that need to be taken during the investigation process.
  1. The IRB may require the investigator (via the chair for a doctoral student) to submit a proposed script or letter notifying all currently enrolled and former participants who are affected by the administrative hold, suspension, or termination. The convened IRB or IRB Chair reviews the proposed script or letter and may approve or request changes to the proposed script or letter.
  2. If follow-up of subjects for safety reasons is permitted/required by the IRB, participants should be so informed, and any unanticipated problems involving risks to participants or others must be reported to the IRB and others as required by the protocol and organizational policies and procedures.
3. The IRB Chair or designee notifies the investigator (and chair of a doctoral student) of the suspension in writing via email that there are reasonable concerns that infractions have occurred and an investigation has been initiated. This letter is drafted following Procedures for Communication of Terminations and Suspensions below.
4. The IRB Chair initiates an investigation process and considers if the additional information gathered during the inquiry stage of an investigation determines that no change to the risk/benefit ratio has occurred, the rights or welfare of participants have not been compromised, and issues of noncompliance have been ruled out. The investigation may necessitate a for-cause audit according to 700-37: For-Cause Audits to obtain the needed information. The IRB Chair writes a written report detailing the findings of the investigation as well as appropriate corrective actions for any problems or deficiencies. The written report is sent via email to the convened IRB, Provost, and other Institutional Officials and other units within the University or the covered entity as appropriate.
5. The convened IRB considers the report and whether any actions need to be implemented to protect the rights and welfare of current participants and votes on the actions to be taken. Possible actions the convened IRB considers may include, but are not limited to the following:
  1. Continuing interventions that are being administered to currently enrolled participants under the research protocol, at least temporarily, when those interventions hold out the prospect of direct benefit to the subjects or when withholding those interventions poses an increased risk to subjects.
  2. Transitioning currently enrolled participants to management outside of the research context. Determinations of unanticipated problems involving risks to participants or others or non-compliance that are a result of the findings will be made according to 700-31: Unanticipated Problems Involving Risks to Participants or Others and 700-33: Non-Compliance and Research Misconduct.
6. The convened IRB votes to lift the suspension, continue or modify the suspension, or terminate the study.
7. The IRB Chair documents in the IRB minutes the reasons for the suspension or termination and if applicable, any actions ordered to take place.
8. IRB staff communicates with the investigator following Procedures for Communication of Terminations and Suspensions below.
Procedures for Communication of Terminations and Suspensions to Investigators
1. The IRB Chair composes a letter to the investigator. Copies are to be provided to the Provost, IRB members, and the investigator's immediate supervisor or department chair. The letter includes:
  1. The activities to be stopped
  2. Actions to be taken by the investigator
  3. An explanation of the reasons for the decision
  4. A request to immediately notify the IRB Chair with a list of participants who might be harmed by stopping research procedures and a rationale as to why they might be harmed.
2. An investigator (or chair of a doctoral student) may appeal or respond to the convened IRB in writing via email to IRB@usuniversity.edu (see 700-38: Appeal of IRB Decisions).
3. regarding reporting the IRB's suspension or termination of approved research to appropriate organizational officials, sponsors, coordinating centers and regulatory agencies.700-35: Institutional Reporting Procedures. The IRB Chair will follow

Scope: This policy applies to research that is placed on an administrative hold, suspension, or termination.

Documents and Forms: None