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Office of Research Integrity

HRPP 3.5 Continuing Review Policy and Procedures

Policy Name:  Continuing Review Policy and Procedures
Approved:
Effective Date: 05/30/2014Page 1 of 6Section: HRPP 3.5
/Replaced Policy: Effective 01/27/2012

I.  POLICY

 A.   Introduction

Full Board review and approval is required for studies that initially went through review at a convened meeting of the IRB.  Continuing review of ongoing research may be expedited when the initial review of the protocol qualified for expedited review, as well as the following:

1. (Expedited Category 8) (a) Where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; OR (b) Where no subjects have been enrolled and no additional risks have been identified; OR (c) Where the remaining research activities are limited to data analysis

2. (Expedited Category 9) Unless the IRB or sponsor required full review: continuing review of research not conducted under an investigational new drug application or investigational device exemption where categories 2 through 8 of the expedited review categories do not apply and the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.

B. IRB Continuing Review

The IRB will conduct continuing review of research at intervals appropriate to the degree of risk, but not less than once per year.The same criteria used for initial review of protocols will be followed during protocol renewal review.This evaluation will include study accrual, revisions, unanticipated problems, subject complaints, conflict of interest, and any new information or findings relating to the risk/benefit assessment.Based on these findings, the informed consent process or document will also be reviewed to determine if it is still acceptable or whether new information that may have been obtained during the course of the study needs to be added.

C. MEMORANDUM OF UNDERSTANDING

In aspects where the MUSC IRB is being utilized by the Ralph H. Johnson VA Medical Center, both parties will abide by the agreements set forth in the current "Memorandum of Understanding Between The Ralph H. Johnson VA Medical Center And The Medical University of South Carolina Concerning Utilization of the Medical University of South Carolina's Institutional Review Boards".

D. VA Studies

Continuing review of research that are VA studies will address requirements of VHA 1200.05.

II. PROCEDURES

A. Notification to Principal Investigator

At 90, 60 and 30 days prior to the protocol's expiration date, a reminder of approval expiration will be sent to the Principal Investigator and/ or study contact person.

B. Submission Deadlines

Continuing review applications must be submitted at least one month prior to the protocol's expiration date.

C. Regulatory Compliance Review

1. IRB Administration

a) When received, the continuation application is assigned to the appropriate IRB staff member who:

(1) Documents receipt of the application

(2) Reviews the application for completeness, accuracy, regulatory compliance and congruency with previous applications. If the application is incomplete, the IRB staff will contact the study coordinator regarding the deficiencies. Incomplete or incorrect applications may need to be returned electronically to the study contact for editing.

b) Study personnel listed on the application are checked against the Compliance Office database to ensure that the required institutional training has been completed. The IRB will notify Principal Investigator in writing that continuation approval will not be released until documentation is received by the IRB that the training has been completed.

c) Once the administrative review is complete, the application is sent to the Primary Reviewer (IRB Chair/Vice-Chair) for review. The IRB Reviewer Checklist for Continuing Review Full Board and expedited Protocols is sent to the primary reviewer for reference in completing the review.

D. Review by the Primary Reviewer (Chair/Vice-Chair)

1. The Primary Reviewer will review the entire application, including the following, as applicable:

a) The initial application and previous continuing review applications,

b) Study protocol,

c) A summary of all adverse events reports,

d) Data safety monitoring reports,

e) Investigator drug brochures,

f) The current consent document(s), and

g) Any conflict of interest disclosures.

2. Any questions or concerns of the Primary Reviewer are summarized and submitted electronically to the study team.

3. The Primary Reviewer will review the PI response, which will be prepared by IRB staff for review with the continuing review application at the meeting. If the primary reviewer is unable to resolve issues with the study team, the Principal Investigator may be invited to attend the Board meeting.

E. Materials Provided to the convened IRB

The Continuing Review Application and any additional documents submitted by the study team in support of the renewal application are sent to all members of the board prior to the meeting, and are presented for review and discussion during the meeting.

F. Convened IRB

1. The continuation application submitted by the Principal Investigator and reviewed by the primary reviewer is included in the agenda distribution. The entire study protocol and minutes from the meeting at which the protocol was reviewed initially are available to all members upon request.

2. During the meeting, each continuation application is presented by the chair and/or primary reviewer(s), discussed and voted on individually. The chair and/or primary reviewer will present additional pertinent information regarding the studies applying for continuation such as recent published events. The Principal Investigator will be present if requested by any Board member or if any issues from the review remain unresolved or require clarification.

3. The Board may approve the continuing review. They may also request an independent audit of the study, require additional information regarding any of the Principal Investigator's responses on the application, and/or require substantive changes to the protocol. If there are concerns that have not been addressed, the Board may approve the study for a period less than one year, and have the modifications come back to an upcoming convened meeting. The PI can also be contacted by telephone during the meeting to answer any questions. If approved, the Board will stipulate the frequency of future continuation review. The Board may also suspend or terminate a study if there are serious concerns about the safety of subjects or noncompliance.

4. If the Board needs clarification on something that does not substantially impact the risk/benefit ratio, the Board may approve the continuation contingent on final review and approval by the Chair or the Chair's Designee. No required changes to the informed consent document will be deferred to the Chair's or Chair's Designee for approval unless the Board has stipulated the wording of these changes.

G. Post-IRB Meeting

1. If the continuation is approved without substantive changes, the IRB staff will prepare the approval for release and send documentation of approval to the study team.

IMPORTANT NOTE ABOUT CONSENT FORMS:

For protocols in ERMA, consent forms do not expire and are not re-stamped at continuing review time.

For protocols in eIRB, consent forms are approved on the same cycle as the study, and therefore expire at continuing review time. Study consent forms will be re-stamped at the time of the release of the continuing review approval, at which point the prior version will become obsolete.

2. If the continuation application requires further modifications that are minor in nature, IRB staff will notify the study staff in writing. When revisions are received, the IRB Chair will review them. If acceptable, the approval will be released.

3. If the Board suspends or terminates the study, the Chair will notify the Principal Investigator in writing that the continuation of the study has not been approved and to stop all research related activities including new enrollment, unless currently enrolled subjects will be placed at risk. This action by the Board will be reported to the appropriate agencies including FDA and OHRP, as applicable. The Associate Provost for research and the Department Chair will be copied on the correspondence. The Board will work with the Principal Investigator on an appropriate plan in the event that stopping research-related activities will place the currently enrolled subjects at risk.

H. Expedited Continuing Review

The IRB Reviewer completes the Continuing Review Full Board and Expedited Review Protocols Reviewer’s Checklist and electronically submits these documents along with review notes and decision upon completion of the review.

I.  Reporting of IRB Approval

Continuing Reviews approved by the expedited process will be reported to the full IRB board at a convened meeting.   Any board member may request further consideration of any protocol approved by the expedited process.

J. Expiration of IRB Approval

If the continuation application is not submitted prior the IRB deadline date or does not address the IRB's concerns, IRB approval of the study may expire.

1. IRB staff will send written notification to the Principal Investigator (Letter of Expiration) informing the Principal Investigator that the IRB approval has expired and all research activities must stop, including recruitment, advertisement, screening, enrollment, consent, intervention, interactions, and collection of private identifiable information. The Department Chair will be copied on this correspondence.

2. Interventions and interactions on current participants may continue only when the IRB, the IRB Chair or designee finds an overriding safety concern or ethical issue involved such that it is in the best interests of individual participants.

3. The Principal Investigator is requested to sign the letter indicating receipt of notification of approval expiration. If the Principal Investigator wishes to continue the study, he/she must submit a continuation application for review at the next convened meeting.

K. VA Protocols

1. Continuing Review Information Provided by PI In addition to the above information, the continuing review will include

a) The number of participants considered as members of specific vulnerable populations and

b) An assurance that all serious adverse events and unexpected adverse events have been reported as required.

2. Expiration of IRB Approval If an investigator does not provide continuing review information to the IRB or the IRB has not approved a protocol by the expiration date:

a) The IRB notifies the investigator to submit immediately to the IRB chair, a list of participants for whom stopping research activities will cause harm.

b) Interventions and interactions on current participants may continue only when the IRB or IRB Chair, in consultation with the local VA Chief of Staff, finds an over-riding safety concern or ethical issue involved such that it is in the best interests of individual participants.

c) The VAMC R&D Committee will notify the expiration to the sponsor.

III. CHECKLISTS

            A.  IRB Reviewer Checklist for Continuing Review Full Board and Expedited Protocols

IV. REFERENCES

 

A. 45 CFR 46.109 (e)

B. 21 CFR 56.108 (a)(1)

C. 21 CFR 56.109 (f)

D. Office for Human Research Protections (OHRP) – Expedited Review Categories

            E. FDA Expedited Review Categories