1.      The investigator must comply with all IRB requests and inquiries regarding the conduct of approved research.  Serious or continuing non-compliance with the IRB policies and requirements or research associated with unexpected serious harm to subjects may result in suspension or termination of IRB approval and shall be reported to all appropriate agencies.  The investigator and all appropriate governmental agencies and the institution will be notified in writing of any such action, including the reason for the action.

2.      The IRB requires the submission of progress reports at the end of an approval period.  The approval period is determined by the IRB committee at the time of initial review, based upon the type of study, the nature of the subject population and the degree of subject risk.  The approval period may be up to, but not to exceed, one (1) year.  A Continuing Review form (Appendix 7) must be submitted in order for an approved protocol to be extended beyond the existing approval period.  This form will be sent to the investigator two (2) months prior to the expiration date of the protocol.

3.      Each question on the form must be completed and the form returned to the IRB with the following:

·         a current copy of the consent form,

·         a clean copy of the consent for restamping and

·         the protocol face sheet which indicates the date of the most recent version of the protocol and any amendments. 

·         When a protocol is re-approved, the IRB will stamp a clean copy of the current consent form with the new expiration date. 

4.      These documents must be submitted to the IRB Committee at least one (1) month prior to the expiration date so that they can be reviewed at an IRB meeting prior to that date. If continuing review documentation is not received within 60 days of the IRB expiration date, the protocol will be automatically terminated and must be resubmitted as a new study.  Other documentation regarding the research may also be required by the IRB depending upon the type of study, the nature of the subject population and the degree of subject risk.

5.      IRB approval of research terminates without further notice at the end of the approval period unless extended by the IRB.  There is no retroactive reapproval of protocols by the IRB.  Federal regulations do not allow for continuation of a protocol beyond the termination date without IRB approval.  Once IRB approval has expired, research activities must stop.  No new subjects may be enrolled in the study and all data collection must cease.  If patient accrual and/or data collection does not cease, any information obtained is not considered sanctioned by the IRB and cannot be included in data analyzed for this research.  Where a reapproval is in process and safety concerns or ethical issues are involved, the IRB may permit the study to continue for a brief time until the continuing review process is complete.

Serious Adverse Events

1.      An investigator report adverse clinical events to the sponsor of the study and to the IRB Committee. Investigators are required to promptly report to the Chairman of the IRB any serious unanticipated problems encountered during the research involving risks to subjects or others. 

2.      The following definitions are provided for protocols involving investigational drugs, but the same reasoning is applicable to investigational devices and other research activities. 

3.      An adverse event (or experience) is:

·         Any unfavorable or unintended, although not necessarily unexpected, result occurring during the course of a research study.

·         The event or problem may represent an unfavorable sign, abnormal/ worsening laboratory value, symptom, or disease temporally associated with the use of the investigational drug.

4.      A serious adverse event is any untoward medical occurrence that, at any dose:

·         Results in death

·         Results in an event during which the subject was at risk of death

·         Results in hospitalization or prolongation of existent hospitalization

·         Results in persistent or significant disability or incapacity

·         Results in a congenital anomaly/birth defect

5.      An unexpected event is defined as:

·         Any adverse experience that is not previously observed and not identified in nature, severity or frequency in the current Investigator’s Brochure or in the informed consent document or protocol.

6.      All Serious Adverse Events occurring on site must be reported to the IRB within 48 hours of the occurrence.  Serious Adverse events occurring off site must be submitted to the IRB within three (3) business days of receipt by the investigator. The investigator must also forward all follow-up reports pertaining to adverse events, including an assessment of the relationship to the research, in a timely manner to the IRB.

7.      The Adverse Event Committee, a sub-committee of the IRB, meets monthly to review all adverse events submitted by investigators.  Additional information or clarification may be requested, such as Data Safety Monitoring Board reports, depending upon the nature of the event.  The IRB Chairman or his designee will send the investigator a letter acknowledging receipt of the Serious Adverse Event report.  The minutes of the Adverse Event Committee are presented to the full IRB Committee for comment and retained as part of the minutes of the IRB Committee.

Subject Complaints

Any complaints made by subjects, their legal representatives and families must be submitted in a timely manner to the IRB along with the investigator’s evaluation of this complaint and any follow-up action.

Monitoring

The IRB will randomly select protocols yearly to check for continuing compliance with IRB standards and policies, such as obtaining valid informed consent.  The investigator must comply with monitoring requests of the IRB within 15 business days. 

Investigators should forward to the IRB copies of audits performed by sponsors, cooperative groups or other review organizations.  In addition, the investigator must notify the IRB of unexpected problems involving risks to subjects or others and serious or continuing non-compliance.

The IRB may withdraw, terminate or suspend a protocol if research procedures are not followed, such as:

·         Reports not submitted as required (continuing review, amendments, adverse events)

·         Serious or continuing non-compliance with IRB regulations

·         Changes in the risk benefits of the protocol.

·         Subject complaints.

·         Reports to the IRB regarding the conduct of the research.

The investigator will be notified in writing if the IRB implements any of the above actions and the specific reason for the action.

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