Protocol

Protocols not submitted by a company sponsor or cooperative group must be prepared conforming to the Protocol Content Guidelines found in Appendix 1.

Protocol Summary

A lay summary of the proposed research (not more than 2 pages in length) explaining the proposed research must be submitted with the protocol. This document should briefly outline the reason for the study and the procedures involved including the randomization process, risks and benefits, duration of participation, recruitment and consent procedures.  The summary should cover what subject population will be included, especially any vulnerable populations.    Also include what compensation may be provided and the safety monitoring procedures that are in place.  This document is used by committee members to be able to understand the structure of the study and what is involved for the subject.

Protocol Application Form

All of the items on the form must be addressed (See Appendix 2).

Section A

Include the full name of the protocol as it appears on the protocol document or the 1572 form.

Indicate at which CKHS sites the protocol will be implemented.

Identify the anticipated start date of the protocol.  This may indicate the priority for review at the IRB meeting.

Include the current address for the principal investigator

List the names and credentials of all co- and sub-investigators

List the names and credentials of all study coordinators

Indicate where correspondence should be sent and address if other than principal investigator

Section B

Indicate if the study is funded; if not, indicate whether waiver of IRB fees is requested.

Identify sponsor of the study.

Section C

Indicate the type of IRB review requested

For drugs and devices, indicate the IND or IDE number.  If no IDE please provide rationale for exemption.  If the protocol involves a device, indicate if non-significant risk (NSR) and

this will need a determination. (See Section R, Medical Devices)

Identify any special study procedures involved in the protocol

Indicate all special subject populations involved in recruitment for the study.

Indicate the anticipated number of subjects to be enrolled at CKHS sites.

Indicate whether the subjects will be paid.

Indicate whether the protocol involves in-patients, out-patients or non patients.

Section D

Identify if minors will be participating in the study and indicate the use of an Assent form.

Sections E through J

Give specific information about the conduct of the study as indicated by the questions listed.  These areas must be completed in full, to address questions from the IRB Committee.

Section K

The Faculty Advisor signature is required for all research conducted by a student.

The Institutional Sponsor signature is required if the Principal Investigator is not affiliated with Crozer or one of its divisions.  The Institutional Sponsor agrees to be the contact person for the CKHS site and for verifying that Principal Investigator adheres to all IRB policies and procedures.  The Institutional sponsor does not need to be directly involved in the research.

The Administrative Signature is the signature of the Department Chairperson where the investigator is affiliated or where the majority of the protocol procedures will take place.  The signature indicates that the administrator is aware of the protocol’s implementation in his/her department.

Informed Consent Document

See Section F and Appendices 3 & 4 for the requirements of the informed consent document.

Meeting schedule

There are two IRB committees - IRB A and IRB B.  IRB A meets on the second Thursday of each month except in November and December when the meetings are changed to the first Thursday.  IRB B meets on the fourth Thursday of each month except in November and December when the meetings are on the third Thursday.

To be included on the agenda for an IRB meeting, documents must be submitted at least three (3) weeks in advance of the scheduled meeting.  Please contact the IRB office for specific submission dates.

Meeting Review

The investigator or a knowledgeable sub- or co-investigator must be available by telephone the day of the IRB meeting to respond to questions from the Committee or be prepared to attend the IRB meeting if requested by the Chairman.  Failure to be available to answer the IRB’s concerns may cause the protocol to be tabled for further review.

The principal investigator will be sent written notice of the IRB’s determination within fifteen (15) business days of the meeting.  The investigator must be prepared to revise or supplement the submitted protocol following notice of recommendations made during the IRB review.

Fees

The fee schedule for the IRB is as follows

New protocols

Full IRB Committee Review:                                $1,200.00

Expedited IRB Review:                                             $500.00

Amendments or Consent Revisions

Those that require full IRB Committee review:        $500.00

Those that qualify for expedited review:                    none

This fee may be waived for non-funded studies or cooperative group studies at the discretion of the IRB and after review of the protocol budget.  A request for waiver must be indicated on the Application Form in Section B - Funding.   Fee invoices will be sent to the PI by the IRB.