The Human Research Protection Program (HRPP) at AUB is responsible to safeguard the rights and welfare of human subjects participating in Biomedical and Social and Behavioral Sciences (SBS) research activities conducted under the auspices of AUB/AUBMC. It is committed to protect, ensure respect and foster awareness for those rights. This is achieved by authorizing the conduct of research that follows the three ethical principles of the Belmont Report namely: Respect for Persons; Beneficence and Justice; and that abides by the principles of responsible research conduct and scientific integrity.
- The Institutional Review Board (IRB)
- The Compliance and Auditing office
- The Education, Training and Outreach office
- The Information Technology and Administrative Support office
The IRB was founded at AUB in 1994. It became the core component of the newly established HRPP in 2010.The IRB is the committee formally designated by HRPP to review and approve the conduct of research involving human subjects who are recruited to participate in research activities conducted at AUB/AUBMC and/or by AUB/AUBMC faculty, students and staff, regardless of the funding source or the location of the research.
All research studies that involve human subjects require review, governance and approval of the IRB. In addition to reviewing and approving all new research proposals, the IRB also conducts annual continuing reviews and issues renewals as appropriate. The IRB categorizes research submissions and thus IRB applications according to the level of risk for human subjects participating in research studies. For instance, studies that incur “less than a minimal risk” are processed as “Exempt” IRB applications, while those that are expected to incur “a minimal risk” are processed as “Expedited” research applications. Studies expected to incur “more than minimal risk”, as well as those referred to the board by the IRB chair and those disapproved after an expedited review, fall in the “Full Board Review”. The IRB has a specific mechanism to review and handle each of those categories, which also helps the researchers identify which category fit their research protocols best. Furthermore, the IRB has the authority to approve submitted research protocols, require modifications to submitted protocols, deny approval of submitted protocols, and/or suspend or terminate already approved protocols. The IRB processes amendments to approved research proposals, review reports of adverse events, handles instances of protocol deviations, non-compliance and assist HRPP in processing allegations and complaints; It also manages protocol specific and relevant conflict of interest.
The IRB has two boards that are supported by executive and administrative staff. The Biomedical IRB reviews and manages research studies that involve drugs, medical devices and Biological testing. The Social and Behavioral Sciences (SBS) IRB deals with research studies concerned with behavioral methodology, educational research, surveys and analysis. The two IRBs closely communicate with each other and cross refer certain studies when indicated.
The IRB members have various scientific and non-scientific backgrounds and have accepted to serve as volunteers on the IRB and support its mission. The board members meet on regular scheduled and occasionally urgent basis to review and decide on the approval of research applications referred to the full board.
For more information on IRB and research application submission, please visit: http://www.aub.edu.lb/irb/Pages/index.aspx
The Compliance and Auditing office strives to promote the highest ethical standards in the conduct of Research involving human subjects and to deter practices in opposition or violation of any of these standards.
The role the Compliance and Auditing Office is to protect the rights, safety, dignity, welfare and privacy of human subjects participating in Biomedical and Social and Behavioral research. While the compliance function was originally handled by the HRPP Director and IRB process, the Compliance and Auditing Office has been officially established as a separate entity in September 2016 to maintain the University’s commitment to adhering to the highest standards of ethics and integrity in research by:
- Investigating allegations of non-compliance during the conduct of research involving human subjects.
- Performing site audits (planned and unplanned, for-cause or non-cause).
- Helping faculty, staff and students comply with all applicable national, federal, local, and institutional requirements, laws and policies.
The Core Principles of the Compliance and Auditing Office are:
- Foster ethical conduct of research
- Ensure adherence to all standards, rules and regulations guiding research
- Enforce corrective and preventive plans
- Determine compliance procedures
The Education, Training and Outreach Office is responsible for the HRPP and IRB education and training mission and obligations. Its mission is to provide, organize and monitor education and training programs and sessions for Principle Investigators (PIs), research staff, IRB members and the community according to applicable standards and guidelines. This function is currently fulfilled by the HRPP director who provides orientation sessions to new faculty members who join AUB and AUBMC and by the IRB regulatory and senior regulatory analysts who also provide orientation and guidance to the PIs, research teams and IRB members. The education and outreach arm of the HRPP will be further expanded to become an independent body within the HRPP.
The Information Technology (IT) and Administrative Support office helps analyze, design, implement and maintain IT solutions that help optimize and streamline operations at the HRPP.
FACULTY & STAFF
Interim Provost, Prof Mohamed Harajli, Institutional Official (IO)
Professor Michael Clinton, SBS IRB Vice-Chair
Professor Ali Abu-Alfa, HRPP Director
Professor Rami Mahfouz, Biomedical IRB vice-Chair
Professor Fuad Ziyadeh, IRB chairperson
Dr. Deborah Mukherji, Biomedical IRB Vice-Chair
Jamal El-Eid, HRPP, Executive Administrator
Abeer Dakik, Biomedical IRB, Senior Regulatory Analyst and co-administrator
Mira Zantout, HRPP Compliance Officer
Lina El-Onsi, SBS IRB, Senior Regulatory analyst and co-administrator
Dalia Abu-Khzam, HRPP/IRB Administrative Assistant
Nadine Kamal, SBS IRB, Regulatory Analyst
Malak Basheer, Clinical applications specialist
Ms. Dana Fakhreddine, Assistant Regulatory Analyst
Rami Yehya, HRPP/IRB attendant
Ms. Zahraa Zadek, IRB Traffic Coordinator and SBS IRB Assistant
Ms. Karin Ismail, Biomedical IRB Regulatory Analyst
Biomedical IRB members are presented on the following link: http://www.aub.edu.lb/irb/Pages/Biomedical.aspx
SBS IRB members are presented on the following link: http://www.aub.edu.lb/irb/Pages/SocialandBehavioral.aspx