INITIAL SUBMISSIONS

It is the investigators responsibility to submit the following documents to the IRB promptly:

1. Any correspondence from the investigator to the sponsor

2. Any correspondence from the sponsor to the investigator

This includes the results from the monitor visits that were conducted by the sponsor.

Changes in Initial Submission and Continuing Review Fees

Please be advised that effective February 1, 2009 the fee for Initial Submission of industry-sponsored studies will be $2500. The fee for Continuing Review of such studies will be $1,000. If you have an active industry-sponsored study on file, the Continuing Review of that study will remain at $750. We look forward to working with you to facilitate your success.

 

IRB review (Convened)

·         Any study involving greater than minimal risk requires a review by the convened IRB. This includes studies with vulnerable populations and sensitive questions as well as studies with the possibility of physical risk.

·         Studies assigned to full board review are reviewed by two IRB members prior to the scheduled IRB meeting.  The reviewers present their findings at the full IRB meeting; afterwards the full IRB Committee votes on whether or not to approve the study, and may requests changes or provide clarifications prior to full approval.

·         Please use the IRB Submission guidelines, and complete the New Submission Application.  

 

Expedited IRB review

·         Only research involving no more than minimal risk to subjects may be considered for expedited review.

·         An expedited review is conducted by an individual reviewer or a few reviewers, rather than going to the full board.

·         Federal guidelines Expedited review procedures are described in HHS regulations 45 CFR 46.110.  Examples of categories include:

o    blood sampling in minimal amounts

o    review of records collected for non-research purposes (such as chart reviews)

o    survey research

·         Please complete the Expedited Review Submission Form.  

Exempt from IRB review

·         A project is identified as exempt if the project:

 involves no more than minimal risk (Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests).

·         An exemption may be granted by the IRB upon review of the application.

·         Research activities involving human subjects that are exempt from IRB review are identified in 45CFR 46.101(b)(1)-(6).

·         Since this constitutes a review, protocols that are deemed exempt are effectively "exempt from continuing review."

·         If you believe your protocol is exempt from IRB review, please complete the Application for Exemption form.

 

ONGOING SUBMISSIONS

 

Continuing IRB review

·         Continuing review regulations are identified in 45 CFR 46.108(b), and 46.115(a)(2).

·         There can be no lapse in protocol approvals.  If your protocol has not received continuing approval, you CANNOT enroll new subjects, or conduct study visits.  Your protocol will be closed effective the date of expiration previously granted.  If it was not your intent to close the study, you will be required to submit as a new submission.   

·         The IRB considers the following during the continuing review:  Potential benefits, informed consent, safeguards for human subjects, new information that has emerged either from the research itself or from other sources that could alter the IRB previous determinations, particularly with respect to risk to subjects, information regarding any unanticipated problems involving risks to subjects or others.

·         Provide with continuing review, updated informed consent documents; number of subjects enrolled from all sites, and the number locally enrolled; any materials not previously submitted such as: DSMB reports, clarification letters, status report documents, adverse event reports provided by sponsor not previously submitted.

·         Please complete the Continuing Review Form.

 

 Amendments, Updated Materials, DSMB Reports

·         The IRB requires any proposed changes in approved research, during the period for which IRB approval has already been given, be reviewed and approved prior to implementing these changes.

·         Investigators may request approval of proposed changes by the completion and submission of a letter of explanation for the Amendment, Amendment form, and any amended documents.

·         IRB requires any new updated materials, DSMB reports be submitted for IRB review and record.

·         Please complete the Amendment/Revision form.

 

Unanticipated Problems (Adverse Events)

·         The HHS regulations at 45 CFR part 46 do not define or use the term adverse event, nor is there a common definition of this term across government and non-government entities.

·         Adverse events encompass both physical and psychological harms.

·         In general, an AE observed during the conduct of a study should be considered an unanticipated problem involving risk to human subjects, and reported to the IRB, only if it were unexpected, serious, and would have implications for the conduct of the study.  An individual AE occurrence ordinarily does not meet these criteria because, as an isolated event, its implications for the study cannot be understood. 

·         Investigators are required to report promptly "to the IRB… all unanticipated problems involving risks to human subjects or others," including adverse events that should be considered unanticipated problems.

·         The regulations state that for studies conducted under 21 CFR part 312, investigators must report all "unanticipated problems" to the IRB.  However, for multicenter studies, the sponsor is in a better position to process and analyze adverse event information for the entire study and to assess whether an adverse event occurrence is both unanticipated and a problem for the study.  Accordingly, to satisfy the investigator's obligation to notify the IRB of unanticipated problems, an investigator participating in a multicenter study may rely on the sponsor's assessment and provide to the IRB a report of the unanticipated problem prepared by the sponsor. 

·         You should use the adverse event reporting template provided by IRB to report unanticipated adverse events.

For more information about adverse events please refer to the documentation below

Requirements for Reporting Guidelines for Unanticipated Problems

Unanticipated Problems that ARE Adverse Events

Unanticipated Problems that ARE NOT Adverse Events

  

Protocol Deviations/Violations

·         Protocol deviations/violations are any alteration/modification to the IRB-approved protocol. The protocol includes the detailed protocol, protocol summary, consent form, recruitment materials, questionnaires, and laboratory tests or procedures relating to the research study.

·         Deviations may be considered Major or Minor. 

o   A major violation may impact subject safety, affect the integrity of study data and/or affect subjects's willingness to participate in the study.

o   A minor violation may not impact subject subject safety, compromise the integrity of study data and/or affect subject's willingness to participate in the study.

·         All protocol deviations must be reported to the IRB in a timely manner.  A timely manner would be as soon as the deviation is discovered, and/or within 10 days.

·         You should use the deviation reporting form to report any protocol deviation/violation.

IRB Reporting Guidelines for Protocol Deviations/Violations

 

PROTOCOL CLOSURE

 

Protocol Closures

·         The completion or termination of a research protocol is a change, and must be reported to the IRB.

·         A final report to the IRB allows the closure of all files as well as providing information that may be used by the IRB in the evaluation and approval of related studies.

·         Closure of a study means that no further research, follow-up or data analyses will be performed. If any subjects are ongoing, the study may not be closed. A study is not closed simply because no additional subjects will be enrolled.

·         The investigator must submit a final protocol report.  The closure report should include:  reason for protocol closure, total number of subjects enrolled locally and from all sites, any materials not previously submitted such as: DSMB reports, status report, adverse events.

·         Please complete the Research Closure Form.