Submission Requirements

Overall Requirements

All research involving human subjects under the jurisdiction of the Lebanese American University and its affiliates (UMCRH) must be submitted to the Committee on Human Subjects in Research (CHSR) for review and approval prior to initiation.

Applications and all supporting documents must be sent both electronically and hard copy

• Electronically by email to Karmen Baroudy at karmen.baroudy@lau.edu.lb , and
• One Hard copy of all documents to the Office of the Chairman of the CHSR Dr. C. Daher (3rd floor Dorms A, Byblos Campus)

NB:  If a study involves extramural funding such as external Funding Agencies, Contract Research Organizations (CRO) or Pharmaceutical companies where  a contract in required, clearance must be secured from the legal department at UMCRH / LAU before submission to the CHSR.

Fee Schedule

The CHSR charges a fee for review of research studies involving human subjects as detailed below. Payment is expected independent of the CHSR decision and is due within 30 days of receipt of invoice. For any questions, please contact the office of the CHSR by email at christine.chalhoub@lau.edu.lb.

Effective February 2011, the fee schedule for LAU CHSR review is as follows:

Initial Submission - Pharmaceutical Sponsored Studies	$1500 plus VAT
Annual Continuing Review Submission - Pharmaceutical Sponsored Studies	$500 plus VAT

Initial Submission - Extramural Funding Agencies	$200 plus VAT
Annual Continuing Review Submission - Extramural Funding Agencies	$50 plus VAT

Initial Submission - submitted by Non-LAU faculty and staff and conducted outside LAU premises	$500 plus VAT
Annual Continuing Review Submission - submitted by Non-LAU faculty and staff and conducted outside LAU premises	$200 plus VAT

Summary Table

Type of Review*	Timelines**	Required Application***
Full Review	Review will take at least 30-45 days from date of submission (complete submission must be at least 2 weeks prior to the next scheduled meeting)	Initial Protocol Application - for new research project Protocol Amendment Application - for any changes or amendments to the protocol after approval Continuing Review Application - for renewal of previously approved research project, at least annually
Expedited Review	Review will take 20 days from date of submission	Initial Protocol Application - for new research project Protocol Amendment Application - for any changes or amendments to the protocol after approval Continuing Review Application - for renewal of previously approved research project, at least annually Request for Protocol Closure Form - notification of study closure, termination, or completion
Exempt Review	Review will take 5 days from date of submission	Protocol Exempt Application - for research projects that fit one of the exemption criteria

*Detailed explanation for the different Types of Review can be found under Guidance Documents
**Timelines noted are for complete submissions. If a submission is missing documents, the submission will be returned to the PI with clarifications. Timelines also vary if there are any major concerns to the project submitted
*** All submissions must include a Completed and Signed Application along with all required documents as noted at the beginning of each application.
*** Whenever required, all investigators on the application must complete and sign the Investigator Financial Disclosure Form