Procedures

The Ethics Committee (EC) was established in 2009, in response to a need to develop the pillars of the Hospital’s mission- Education, Innovation, and RESEARCH.

It acts as a forum assigned to consider, debate, study, take action on, or report on ethical issues that arise in patient care.

Human subjects research within Mount Lebanon Hospital is guided by regulations. The executive committee:

• Appoints a responsible for maintaining the development of and compliance with all human subjects research policies and procedures.
• Assumes responsibility for patient protection irrespective of the research
• Recognizes and establishes mechanisms of compliance with regulatory and professional requirements related to research.
• Ensures that there is a source of indemnity insurance to adequately compensate patients participating in clinical research who experience an adverse event.

Human subject research within Mount Lebanon Hospital is not conducted to inpatients but only outpatients; therefore admission and/or transfer criteria to a specialized ward due to research and/or another specialized program is not required (MA-P-18).

Patients and families are informed about how to gain access to clinical research/ investigation/ trials relevant to their treatment needs.

The investigator wishing to conduct clinical trial at Mount Lebanon Hospital, should fill in form MA-F-35 Clinical Trial Application Form in Human Subjects, to describe the elements of the trial to the Conducted and get access to Patient Information- MC-F-134.

The clinical trials (retrospective, prospective, interventional, etc..) are received by the Ethics Committee and the final decision is communicated to the Principal Investigator (see MA-P-20 Review of Clinical Trials).

The Ethics Committee operates under the understanding of Good Clinical Practice (GCP) under the guidance of the Declaration of Helsinki. And so, it requires that the medical personnel involved in human subjects research, is trained and proficient in the proper conduct of Human Research (obtaining NIH training or CITI training, or other validated GCP training..).

You can access the course on: https://gcp.nidatraining.org for each participant.

• March 10,2020
• June 09,2020
• September 08,2020
• December 08,2020

• MA-P-18 Human Subjects Research
• MA-P-17 Human Clinical Trial Submission
• MA-L-06 Ethics and Research Committee
• MA-F-36 Curriculum vitae for participation in a clinical trial
• MA-F-35 Clinical Trial Application Form in Human Subjects
• MA-F-32 Ethics committee clinical trials progress report
• MA-P-20 Review of clinical trials
• MA-L-07 Glossary of Clinical Research Terms
• PH-F-27 IMP Storage Temperature Log
• PH-P-08 Investigational Medicinal Product
• MC-F-134 Permission to access the patient’s medical information
• MA-P-24 Phone Interview in Human Sugject Research