About Us
Overview:

AUB has a Federal-wide Assurance (FWA) with the Office of Human Research Protection (OHRP), in the Department of Health and Human Services (DHHS), as a domestic institution. In the FWA, the Institutional Official, that is the Provost, certifies that AUB assures that all activities related to human subjects’ research, regardless of the funding source, are guided by the ethical principles of the Belmont Report. In addition, research sponsored by Federal sources has to abide by the corresponding federal regulations. Under the umbrella of the AUB Human Research Protection Program, Institutional Review Boards (IRBs) are charged with the prior review and approval of all research involving human participants at AUB, unless the research was granted an exempt from IRB review status, upon review of submitted relevant information. 

Organization of the AUB HRPP:

AUB Provost is the Institutional Official (IO) responsible for HRPP at AUB. The IO has assigned an HRPP Director, who oversees, governs and manages all human subject research and reports directly to the IO. HRPP Director is also delegated to oversee protection of human subjects in research at the AUB medical center (AUBMC) as an integral part of AUB..

The HRPP operates in coordination with the Office of Grants and Contracts, University Counsel, and the Office of VP for facilities with regards to Environmental Health Safety and Risk Management issues, when applicable.


HRPP Divisions, Background and History:

The HRPP at AUB is composed of various bodies that work jointly under its director to meet the main HRPP mission and uphold its values. These are:

  • The Institutional Review Board (IRB)
  • The Compliance and Auditing office
  • The Education, Training and Outreach office  
  • The Information Technology and Administrative Support office

For any questions about the HRPP or IRB at AUB, please refer to the "Contact Us" section on the IRB website. 

IRB

​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 also reviews research by any faculty that involves FDA oversight, specifically clinical research involving an investigational device, drug or testing, research requiring an IND (Investigational New Drug) registration or any other research where the data will be submitted for FDA regulatory review.  Review of research by any of these Schools that involves FDA oversight is referred to the Biomedical IRB.

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.

Compliance

​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

Education and Outreach

​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.

IT and Administrative Support

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.