IRB Manual
      3.3 Monitoring and Continuing Review
   

   

The IRB is responsible for ensuring appropriate monitoring the progress of research to help ensure compliance with the approved protocol and further the protection of the rights and welfare of human subjects and may observe or have a third party observe the consent process and the research.

3.3.1 Continuing Review
   

Federal regulations require that research protocols which involve human subjects must be reviewed by the IRB "at intervals appropriate to the degree of risk, but not less than once per year" (45 CFR 46.109(e)).  The IRB's written procedures must include details of how the IRB will determine which projects require review more often than annually. Such factors as the level and uncertainty of risks involved and the nature of the subject population should be considered in making this determination.

The IRB must determine whether any new information from the research or other sources could alter the IRBs previous determinations relating the approval criteria for research (see Section 3.1), particularly those that relate to risks to subjects.

See Section 9.1 sample Application for Continuing Review.

The continuing review must be substantive and meaningful and should generally involve the following:


 
(1)   
The protocol activities for the period since the last approval are evaluated.  The investigator should provide the following information:

     

(a) The number of subjects entered, completed, and ongoing.

(b) The number of subjects who did not complete the protocol and the reasons why.

(c)   Description of any unanticipated problems involving risks to subjects or others and unexpected or clinically significant adverse effects that occurred and their outcome/resolution. (Note: This does not replace the investigators' obligation to report this information to the IRB during the course of the study).  The IRB should also take into account reports of monitoring activity conducted by/for the IRB during the period since the last IRB approval.

(d) A summary of any amendments or modifications to the research approved by the IRB since the last IRB initial or continuing review.

(e) A summary of any complaints about the research since the last IRB review.

(f) A summary of any recent literature that may be relevant to the research.

(g) Any relevant multi-site trial reports.


 
(2)   
Future plans for the study are evaluated and the IRB assesses whether the study continues to meet the criteria for approval. The following information should be submitted by the investigator:

     

(a) A copy of the consent form(s).  This will allow the IRB to confirm that the previously approved form is being used, and confirm that all regulatory requirements continue to be met.  Any proposed changes (must be approved by the IRB prior to implementation) must be clearly identified by the investigator.

(b) Proposed changes to the protocol. (Note: investigators must obtain IRB approval before implementing changes in an approved protocol unless they are necessary to eliminate "immediate apparent hazards to the subject".)

(c) Any significant new information that has become available since the last IRB review that could affect the assessment of risks and benefits of the research.  (The IRB should also review any relevant reports from its monitoring activities) When appropriate, preliminary data analysis from the study should be provided.

(d) The anticipated completion date of the study (if known).


   

Continuing reviews should be conducted at a convened meeting of the IRB (full board review) unless the study otherwise qualifies for an expedited review. Some studies that originally required full board review may become eligible for an expedited review if the research activities change.  For example, a study which enters the data analysis phase and does not involve any further subject contact may be eligible for an expedited review.  When an expedited review is carried out the members of the IRB must be notified and the review recorded in the subsequent IRB minutes.

When studies continue over a period of years, there are often many amendments to the protocol which can result in complex paperwork documenting the details of the currently approved protocol.  Unless the IRB has a policy of requiring submission of  a complete revised protocol when amendments are made, it is recommended that every 3-5 years, in place of the continuing review documentation, the investigator should be asked to submit a complete new protocol which incorporates all of the approved changes and information about any developments in the field that have occurred since the original submission. This process ensures that the investigator and the IRB are clear about the current status of the protocol and can be extremely valuable during an audit by the FDA, DHHS etc.

A sample continuing review application form is contained in the Attachments to this manual. Facilities may develop their own form which reflects the type of research that is being conducted and the needs of the IRB.

Documentation of each continuing review must be sent to RFMH in a similar fashion to original approvals.

     
3.3.2

Continuing Review: Reports from multi center clinical trial monitoring

     
   

When a multi center clinical trial is subject to oversight by a monitoring entity (e.g., the research sponsor, a coordinating or statistical center,  a DSMB/DMC), investigators should submit to their IRBs a current report from the monitoring entity at the time of continuing review.  Such reports should include the following:

   

  1. a statement indicating what information (e.g., study-wide adverse events, interim findings, and any recent literature that may be relevant to the research) was reviewed by the monitoring entity;
  2. the date of the review; and
  3. the monitoring entity’s assessment of the information reviewed. 

It may also be appropriate for the IRB at the time of continuing review to confirm that any provisions under the previously approved protocol for monitoring study data to ensure safety of subjects have been implemented and are working as intended (e.g., the IRB could require that the investigator provide a report from the monitoring entity described in the IRB-approved protocol).   


     
3.3.3 Monitoring
     
 
(1)   
The Quality Management Director (or equivalent) shall be appointed to the IRB.  IRB membership may be delegated to a person appropriately qualified to carry out this function.  The overall responsibility for research monitoring may not be delegated.  The Quality Management Director must be kept informed about the monitoring activities and must sign off on the annual report.

 
(2)   
When the IRB reviews a study, the monitoring instrument and the timetable for monitoring (frequency and percentage) and reporting to the IRB should, if possible, be included in the submitted protocol.  The IRB may amend the monitoring instrument and/or timetable prior to approving the study and at any time that the study is amended or given an updated review. Protocol monitoring procedures must be approved by the IRB prior to the commencement of a study.

 
(3)   
The Quality Management Director, or another person acting under the direction of the Quality Management Director, is responsible for monitoring the study according to the approved protocol.  The monitor does not have to be a member of the QA staff.

 
(4)   
When an inconsistency with the protocol is found during monitoring, the recommended course of follow up is:

(a)  Discuss it with the investigator and document the results of the discussion on the monitoring instrument.

(b)  If this fails to resolve the issue, the Quality Management Director shall consult with the Chairperson of the IRB.

(c)  If the issue remains unresolved, the IRB Chairperson shall report to the full IRB. The IRB shall review the Quality Management Director’s concerns, the investigator's response and other available information and make a final determination.

(d)  When the issue involves an immediate apparent hazard to the subjects or to others the  Quality Management Director shall immediately report to the investigator, the Clinical Director (or equivalent) and the IRB.


 
(5)   
Monitoring reports for each study shall be submitted to the IRB by the Quality Management Director according to the schedule contained in the approved protocol.

 
(6)   
The IRB shall document, in its minutes, that the monitoring reports have been reviewed, and that appropriate follow up action has been approved.

 

Alternate monitoring programs which provide appropriate monitoring, such as those involving a dedicated IRB monitoring staff, may be also be approved.


3.3.4 Review of the IRB Documentation Process
     
   

At least annually, Facility/Institute Directors are responsible for reviewing the practices and procedures designed for the protection of the rights and welfare of human subjects to ensure that they are being effectively applied and are consistent with appropriate policies and regulations.

Each year every facility that has an Institutional Review Board must prepare a report of its review of the IRB for the calendar year.  The report must be prepared by a person who is independent of the administration of the IRB (chairperson and staff).  IRB chairpersons and staff may assist by providing information and documents requested by the person preparing the report.  In OMH facilities the report must be prepared by the Director of Quality Assurance (or equivalent) or his/her designee.  The report must include the following:


   
  1. A current list of IRB members in OHRP format.  Use the form here.  Include highest degree earned, scientific specialty (if any) and whether the member is affiliated with the institution.
  2. Alternate members:  specify which member(s) they serve as an alternate for.

    Report any anticipated future changes to IRB membership and effective date. 

  3. Number of new protocols submitted to the IRB. 
  4. The number of protocols approved by the IRB: 
  5.     Expedited Review [      ]            Convened Review [      ]

  6. The number of protocols which received a continuing review:
  7.      Expedited Review [      ]            Convened Review [      ]

  8. Summary of the review of the IRB documentation process. Use the checklist here.  
  9. Summary of protocol monitoring activities during the past year. 
  10. Summary of compliance with pharmacy procedures when investigational drugs are being administered.
  11. A statement of the extent to which patient/client rights were safeguarded. 
  12. A brief description of the training provided to IRB members, investigators, institutional officials, and other facility staff.


   

The report, the IRB response to the report, and a proposed plan of corrective action (if necessary to correct problems), must be signed by the Director of Quality Assurance (or equivalent) and the IRB chairperson and then submitted to the Facility/Institute Director.  On or before February 28 of each year, the Facility/Institute Director submits a copy of the annual report and certification of his/her review and approval of the report to:


   

Susan J. Delano, CIP
Deputy Managing Director
Research Foundation for Mental Hygiene, Inc.
Riverview Center, 150 Broadway, Suite 301
Menands, New York, 12204
SDelano@rfmh.org

Reports will be reviewed by RFMH and referred to OMH or OPWDD as appropriate.

     
       


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