Procedure

Investigator Responsibilities

When an Administrative Hold applies, the Investigator:

Notifies the OIRB of the voluntary interruption of research enrollment and ongoing research activities by a facility official, investigator, or sponsor. (This does not apply to interruptions of research related to concerns regarding the safety, rights or welfare of participants, the research team or others).
Notifies IRB Chair in writing of study activities placed on hold in response to imposition of administrative hold.
Responds promptly to requests by the Chair for additional information.
Contacts the sponsor, if necessary, to assist in obtaining information addressing any questions concerning potential changes in the risk/benefit profile of the protocol.
Continues to submit reportable problems in accordance with POL006, UAB Policy to Ensure Prompt Reporting of Unanticipated Problems to Subjects or Others to the IRB, during the period of the administrative hold.

When a Sponsor-imposed Hold applies, the Investigator:

Forwards a notice of hold or removal of hold to the IRB using PRO148, Procedure for Review of Modifications to Previously Approved Research by the Convened IRB, as soon as possible but not later than 10 working days from notification.
Ceases research activities as specified in the sponsor’s hold until notified by the sponsor that the hold is removed.
Identifies clearly in the amendment submission the reasons for the sponsor’s hold and whether the study was interrupted for logistical purposes (e.g., data analysis, drug shortages) or for potential risks to subjects or others. (Note: Removal of hold due to logistical reasons may be performed using expedited procedures. Removal of hold imposed for changes in potential risks must be reviewed by the convened IRB).
Continues to submit to the IRB reportable problems in accordance with POL006 during the sponsor-imposed hold.

When Suspension of IRB Approval applies, the Investigator:

May have the opportunity to be heard at suspension proceedings in person or in writing.
Ceases research activities suspended by the IRB until the IRB reinstates approval of the suspended research activities.
Cooperates with the IRB to institute corrective actions as delineated by the IRB.
Notifies sponsor of the IRB imposed suspension and reinstatement.
Notifies any external sites, relying on UAB’s IRB approval, of IRB imposed suspension and reinstatement.
Notifies affected subjects of the suspension through IRB approved communications.
Develops orderly procedures for withdrawal of affected subjects considering the rights and welfare of the subjects and with IRB approval.
Informs subjects of any follow-up procedures permitted or requested by the IRB following the suspension with IRB approval.
Submits reportable problems to the IRB in accordance with POL006 during the IRB approved follow-up of subjects.
Submits reportable problems to the sponsor during the IRB approved follow-up of subjects.

When Termination of IRB Approval applies, the Investigator:

May be heard at termination proceedings in person or in writing.
Ceases all research activities and notifies sponsor of the IRB-imposed termination.
Notifies sponsor of the IRB imposed termination.
Notifies any external sites, relying on UAB’s IRB approval, of IRB imposed termination.
Notifies affected subjects of the termination through IRB-approved communications.
Develops orderly procedures for withdrawal of affected subjects considering the rights and welfare of the subjects and with IRB approval.
Informs subjects of follow-up procedures permitted or required by the IRB following termination and with IRB approval.
Submits reportable problems to the IRB in accordance with POL006 and the sponsor during IRB approved follow-up of subjects.
Submits reportable problems to the sponsor during IRB approved follow-up of subjects.

IRB Responsibilities

For Administrative Hold, the IRB Chair:

Receives information that justifies a halt in some or all research such as the occurrence of serious harm to a participant or non-compliance with IRB requirements.
Requests the investigator place one or more research activities on hold such as recruitment, screening/enrollment, interactions or interventions, or follow-up.
Notifies the investigator by telephone and written communication of the request for and extent of the administrative hold.
Reviews investigator response acknowledging halt to research activity in response to Chair’s administrative hold.
Requests additional information and/or monitoring review of the study.
Refers the matter to the IRB for review.
Notifies Institutional Official of administrative hold.
Note: An administrative hold expires automatically when the convened IRB takes up the matter leading to the administrative hold.

For Sponsor-imposed Hold, the IRB:

Reviews amendments of sponsor holds and reinstatements unrelated to potential risks to subjects (see PRO148).
Reviews amendments of sponsor holds and reinstatements of sponsor imposed holds related to potential risks to subjects or others via convened IRB review (see PRO148).
Considers whether additional restrictions are appropriate when sponsor-imposed hold involves potential risks to subjects or others.
Notifies the investigator in writing of its determinations.

For proceedings related to Suspension of IRB Approval, the IRB:

Notifies investigator of the location, time and place of proceeding and of the investigator’s opportunity to be heard at the meeting in person or in writing.
Reviews the pertinent protocol issues at a convened IRB meeting.
Reviews circumstances and findings relevant to possible suspension.
Reviews results of any monitoring review of study, if any.
Provides opportunity for investigators to be heard on the issues during the meeting either in person or in writing.
Reviews investigator responses requested by the IRB.
Notifies immediately the investigator, through the IRB Chair or its designee, of its decision to suspend the protocol.
Transmits promptly in writing to the investigator its decision, the reasons for the action, and expectations for corrective action.
Notifies immediately the Institutional Official of its decision to suspend the protocol.
Considers removal of suspension after investigator implementation of appropriate corrective action plans.

For proceedings related to Termination of IRB Approval, the IRB:

Notifies investigator of the location, time and place of proceeding and of the investigator’s opportunity to be heard at the meeting in person or in writing.
Reviews the pertinent protocol issues at a convened IRB meeting.
Reviews circumstances and findings relevant to possible termination.
Reviews the results of any monitoring review of the study.
Provides investigator opportunity to be heard on the issues during the meeting in person or in writing.
Notifies immediately the investigator, through the Chair or its designee, of its decision to terminate some or all of the research activities.
Reviews responses from investigator requested by the IRB.
Notifies immediately the Institutional Official of the decision to terminate some or all of the research activities.
Transmits promptly in writing to the investigator its decision, and the reasons for its action.
Transmits promptly in writing to the Institutional Official its decision, and reasons for its action.

OIRB Responsibilities

For Administrative Hold

Management Staff:

Acknowledges receipt of investigator confirmation of halt to research activity.
Drafts to investigator a letter for IRB Chair-imposed holds, stating:
- The protocol be placed on Administrative Hold,
- The extent of activities affected, and
- Requirement for investigator to send written confirmation that the hold has been applied.
Confirms the investigator has received the request in writing.
Notifies the investigator of IRB meeting date for response presentation.
Notifies OIRB Director of IRB Chair’s action.

For Sponsor-imposed Hold

Review Staff:

Reviews amendment submission for rationale of hold.
Processes holds based on logistical reasons through expedited review procedure (see PRO148).
Processes holds based on potential changes in risks or risk/benefit ratio to subjects through convened IRB review (see PRO148).

For Suspension of IRB Approval

Administrative Staff:

Drafts, and prepares for signature by the IRB Chair, letters which notify the investigator of the suspension, reasons for the suspension, and expected corrective action.
Notifies OIRB Director of suspension.
Enters changes in status of protocol into information database.

Management Staff:

Performs monitoring reviews of study as requested by the IRB Chair.

Review Staff, in addition to the duties performed by the Administrative Staff above:

Edits and revises letters to investigator for Chair’s signature.
Receives responses from investigator as requested by the IRB.
Notifies the investigator of meeting date for presentation to the IRB.
Completes the reporting requirements in accordance with POL006.

Performs monitoring reviews of study as requested by the IRB Chair.

OIRB Director:

Sends a written communication to Institutional Official concerning suspension.

For Termination of IRB Approval

Administrative Staff:

Drafts letters notifying the investigator of the termination and reasons for action.
Notifies immediately the OIRB Director of termination of the study.
Enters changes in status of protocol into information database.

Senior Staff:

Performs monitoring reviews of study as requested by the IRB Chair or IRB

Review Staff, in addition to duties performed by the Administrative Staff:

Receives response from investigator as requested by the IRB for orderly termination of the research including information for approval of any follow-up procedures and reports.
Edits and revises letters to investigator for Chair’s signature.
Notifies the investigator of meeting date for presentation to the IRB.
Completes the reporting requirements in accordance with POL006.

OIRB Director:

Notifies promptly the Institutional Official concerning termination and reasons for action.