Suspension and Terminations

V.02

 

 

Suspension and Terminations

 

 

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PURPOSE

1. The purpose of this policy and procedure is to describe the process of placing an approved research project on suspension or termination of CPHS approval.

SCOPE

2. This policy and procedure is applicable to investigators, CPHS Members and ORSC Staff.

DEFINITIONS

3. Definitions:

3.1. Suspension of approval: An action initiated by CPHS to stop the research study pending future action by CPHS or by the Principal Investigator or his/her study personnel.

3.2. Termination of approval: An action initiated by the CPHS to stop the research study.

3.3. Expiration of CPHS approval: If an investigator has failed to provide continuing review information to CPHS or CPHS has not reviewed and approved a research study by the specified continuing review expiration date, then the approval for the research study expires.

3.4. Sponsor-Imposed Termination / Suspension: A determination from the sponsor of the study to terminate a research study or place a specific research study on hold. This determination may be made as a result of interim data analysis, inadequate drug availability, response to a DSMB report/recommendation or any other reasons.

3.5. Principal Investigator-Imposed Termination / Suspension: A determination from the Principal Investigator of the study to terminate a research study or place a specific research study on hold. This determination may be made as a result of interim data analysis, inadequate drug availability, response to a DSMB report/recommendation or any other reasons.

POLICY

4. It is the policy of UTHealth that CPHS shall have authority to suspend or terminate approval of research that is not being conducted in accordance with CPHS requirements or that has been associated with unexpected serious harm to subjects.

PROCEDURE

5. Suspension or Termination of Approval by CPHS - The CPHS may decide to suspend or terminate approval for a study that is not being conducted in accordance with the CPHS requirements or that has been associated with unexpected serious harm to the research subjects, including, but not limited to:

  1. Inappropriate involvement of human subjects in research,
  2. Inhibition of the rights or welfare of participants,
  3. Serious or continuing noncompliance,
  4. New information regarding increased risk to human participants.

5.2. ORSC Staff will gather information about the problem and place the study on the agenda for the next meeting. All CPHS Members have access to all protocol related information in iRIS. ORSC Staff will assign the research to the same IRB Panel and if possible the same sub-committee that conducted the initial review or previous continuing review. The Reviewer will present the problems at the meeting and make a motion. The Chairperson will open the discussion. CPHS will make a decision about the study. Possible decisions include, but are not limited to:

  1. Suspend new recruitment;
  2. Suspending screening and enrollment;
  3. Suspend interaction with subjects or any intervention;
  4. Suspend follow-up of subjects;
  5. Suspend all research activities;
  6. Termination of approval,
  7. Require Principal Investigator or research staff to undergo training,
  8. Assign a mentor for the Investigator.
  9. Suspend other research conducted by the same Investigator.

5.3. The ORSC Staff will prepare a suspension or termination letter in iRIS with a statement of the reasons for the CPHS decision to hold, suspend or terminate approval. In this letter, CPHS may request information on the status of existing subjects, how the existing subjects will be notified of the suspension, and what impact the hold, suspension or termination will have on the care or participation of the existing subjects. In the event that hold, suspension or termination of the study would result in harm to subjects, CPHS will work with the Principal Investigator to devise other methods to protect the welfare of subjects. such as:

  1. Requiring the Principal Investigator to submit a corrective plan.
  2. Requiring the Principal Investigator to submit to CPHS proposed procedures for withdrawing currently enrolled subjects that takes into consideration their rights and welfare. CPHS will review the proposed procedures and may mandate oversight or transfer responsibility to another Investigator to ensure implementation of these procedures.
  3. Requiring the Principal Investigator to submit to CPHS a proposed script or letter notifying all currently enrolled participants that are affected by the hold, suspension or termination.

6. If ORSC Staff determines that the problem is serious and urgent, the Executive Chairperson or IRB Chairperson will be notified. The Executive Chairperson or IRB Chairperson may decide to suspend or terminate approval for a research to eliminate immediate harm to subjects or request for it to be placed on the agenda for the next Full Board meeting. When approval for research study is suspended or terminated by the IRB Chairperson or Executive Chairperson, the ORSC Staff will place it for review at the next convened IRB meeting.

7. Investigator Initiated or Sponsor-Imposed Suspension or Termination

7.1. The Principal Investigator submits notification to CPHS via iRIS if the research study is suspended or terminated.

7.2. ORSC Staff makes a determination of whether the suspension or termination is related to risk. When the suspension or termination is unrelated to risk, ORSC Staff review this administratively or assign for expedited review.

7.3. When the suspension or termination is related to risk, ORSC Staff will assign the submission for review by the subcommittee, if possible the same sub committee that initially reviewed the proposal or conducted previous continuing review. The subcommittee will determine whether full committee review is warranted at the next convened meeting or may postpone further review until such time as the sponsor and Principal Investigator provides further information. CPHS may require the Principal Investigator to submit a plan to manage the subjects who were enrolled. CPHS may also require Principal Investigator to submit a letter for communication the additional safety information to subjects who have completed the study.

8. Reinstatement – To reinstate the research study, the investigator must submit a written request to the CPHS. For holds and suspensions unrelated to risk, ORSC Staff will review administratively or assign the reinstatement request for expedited review.

8.1. For suspensions related to risk, the ORSC Staff will include the reinstatement request on the agenda for the next convened meeting. The possible actions that the CPHS may take include, but are not limited to:

  1. Reinstate approval,
  2. Reinstate approval with stipulations or additional restrictions, or
  3. Continue suspension.

9. Reporting – The ORSC Staff will notify appropriate department heads, sponsors, institutional officials, and applicable regulatory authorities of the termination as per policy and procedure Reporting.

RESPONSIBILITY

10. The Principal Investigator is responsible for timely notification of suspensions and terminations.

11. ORSC Staff are responsible for assigning, notifying and reporting of CPHS imposed holds, suspensions and terminations.

12. CPHS members are responsible for review of problems with approved research and for deciding when approval for a research study is suspended or terminated.

13. ORSC Staff and CPHS members are responsible for review of reinstating approval for research studies whose approval has been suspended or terminated.



Applicable Regulations and Guidelines

1. 45 CFR 46.113
2. 21 CFR 56.113

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