2024
June 19, 2024
Research Oversight During Leaves and After PI Resignation:
A new research oversight policy during and after PI's resignation is issued. For information about the policy details, please follow the link: "Research Oversight During Leaves and After PI Resignation".
April 16, 2024
IRB Review Fees:
IRB Review Fees policy is updated. For information about the updated review fees, please follow the link to the IRB Review Fees Policy.
February 27, 2024
Principal investigator eligibility requirements to conduct human subject research:
Principal Investigator eligibility requirements to conduct human subject research policy is issued. For information about the policy details, please follow the link: Principal Investigator Eligibility Requirements to Conduct Human Subject Research
2023:
December 13, 2023
The HRPP/IRB is pleased to announce significant enhancements to the IRB operations and workflow.
The HRPP/IRB is introducing an updated set of IRB applications and forms, along with new commonly used forms designed to assist researchers in their submissions. This will help streamline the IRB process.
These documents can be downloaded from the IRB website or at: Applications, forms, and templates.
The HRPP/IRB also announces the launch of its Online Submission Portal. This portal is designated to submit all types of documents and communications to the IRB. This platform will replace the current email submission process.
The portal can be accessed through the IRB website or at: IRB Submission Portal. A step-by-step guide for completing an IRB submission can be accessed from the portal.
During the transition period, the HRPP/IRB office will continue to review submissions using the old forms and those sent via email.
However, starting January 15, 2024, only submissions using the new forms and submitted through the IRB submission portal will be acknowledged and processed.
For assistance and support, please do not hesitate to contact the IRB office at 5445 or irb@aub.edu.lb
2022
April 11, 2022: HRPP and IRB Leadership Update:
We are pleased to share with the AUB community that Professor Rami Mahfouz, Professor of Pathology and Laboratory Medicine, will be assuming the role of IRB chair; and Professor Nathalie Khoueiry-Zgheib, Professor of Pharmacology and Toxicology, will be assuming the role of vice-chair for Biomedical-IRB as of April 16th, 2022. Professor. Fuad Ziyadeh, Professor of Medicine and Biochemistry, has decided to step down from his role as AUB IRB chair after serving as the AUB IRB chair since July 2012 (Read Complete Memo)
2021
March 24, 2021: Human Subject Research Conduct During COVID-19:
Research-related activities may proceed as approved by the IRB prior to the lockdown. It is the responsibility of the researchers and their teams to adhere to AUBMC-infection control mandated practices including the following:
- Implement hand hygiene before and after every interaction with participants.
- Screen research team members on a regular basis for COVID-19 exposure through temperature readings.
- Screen participants for COVID-19 exposure by asking them a set of questions as detailed in the attached memo.
- Face masks must be worn by researchers and participants at all times.
- Implement and maintain physical distancing for at least 2 meters.
- For high-risk participants, including those over 65 years of age or those with known comorbidities, who are not presenting for clinical purposes, the decision about in-person research visits to our site should be made by the study principal investigator on a case-by-case basis, weighing risks of person-to-person contact against the potential benefits of the study intervention and monitoring
- Limit the presence of participants at a given time to less than 3 while maintaining appropriate physical distancing.
- Regularly clean/disinfect high touch surfaces and when visibly dirty (shared materials, equipment, workstations, keypads, etc.) using approved AUBMC disinfectants.
- Ventilate the workplace daily, preferably with natural ventilation by opening the window. In case of AC, maintain recirculation with outdoor air. Avoid the use of individual fans.
For research protocols to be held outside AUBMC site, these will be approved on a case by case basis upon ensuring that appropriate arrangements have been put in place to protect participants and research team members during person to person encounters.
For more details on precautions that need to observed upon interacting with research participants, please refer to the following memo.
If for some reason researchers are not able to adhere to the above-mentioned guidelines, please contact the IRB office for guidance.
January 11, 2021: Human Subject Research Conduct During COVID-19 Lockdown:
To ensure the safety and health of both subjects participating in research and the research staff amidst the increase in COVID-19 cases, the IRB expects researchers and their team members to fully adhere to the following guidelines regarding human subject research during the lockdown and until further notice.
For studies with potential therapeutic benefit (examples: most interventional studies with drugs, devices, procedures):
- The decision about in-person research visits for existing study participants should be made by the study Principal Investigator on a case-by-case basis, weighing risks of person - to - person contact against the potential benefits of the study intervention and monitoring.
- Researchers must pause on enrolling new research participants that require person - to - person contact unless there is a compelling reason that was communicated to the IRB prior to initiating this enrollment.
For studies with no potential therapeutic benefit (examples: social and behavioral sciences research, observational studies, epidemiological studies and studies collecting non-time sensitive biospecimens):
- Person - to - person contact should be halted.
- Research procedures may be modified to reduce person - to - person contact interactions; such modifications should be first communicated to the IRB for review and approval.
2020:
Important Notice (December 7, 2020): Lifting of Restriction and Protection Measures:
Research-related activities may proceed as approved by the IRB prior to the lockdown. It is the responsibility of the researchers and their teams to observe the measures circulated on November 16, 2020 by AUBMC administration as well as abide by the below precautions while performing research-related activities.
- Implement hand hygiene before and after every interaction with participants.
- Screen research team members on a regular basis for COVID-19 exposure through temperature readings.
- Screen participants for COVID-19 exposure by asking them a set of questions as detailed in the attached memo.
- Face masks must be worn by researchers and participants at all times.
- Implement and maintain physical distancing for at least 2 meters.
- For high-risk participants, including those over 65 years of age or those with known comorbidities, who are not presenting for clinical purposes, the decision about in-person research visits to our site should be made by the study principal investigator on a case-by-case basis, weighing risks of person-to-person contact against the potential benefits of the study intervention and monitoring
- Limit the presence of participants at a given time to less than 3 while maintaining appropriate physical distancing.
- Regularly clean/disinfect high touch surfaces and when visibly dirty (shared materials, equipment, workstations, keypads, etc.) using approved AUBMC disinfectants.
- Ventilate the workplace daily, preferably with natural ventilation by opening the window. In case of AC, maintain recirculation with outdoor air. Avoid the use of individual fans.
For research protocols to be held outside AUBMC site, these will be approved on a case by case basis upon ensuring that appropriate arrangements have been put in place to protect participants and research team members during person to person encounters.
For more details on precautions that need to observed upon interacting with research participants, please refer the attached memo.
If for some reason researchers are not able to adhere to the above-mentioned guidelines, please contact the IRB office at 5445 to set up an appointment for assistance.
July 6, 2020
Lifting Restrictions on Research Related Activities:
As of July 6, 2020, research-related activities at AUBMC may proceed as approved by the IRB prior to the pandemic while observing the Infection Control department recommendations and precautions while conducting research-related activities. PI's are held responsible to apply the set forth precautions as below:
- Implement hand hygiene before and after every interaction with participants.
- Screen research team members on a regular basis for COVID-19 exposure through temperature readings.
- Screen participants for COVID-19 exposure by asking them a set of questions as detailed in the attached memo.
- Face masks must be worn by researchers and participants at all times.
- Implement and maintain physical distancing for at least 2 meters.
- For high-risk participants, including those over 65 years of age or those with known comorbidities, who are not presenting for clinical purposes, the decision about in-person research visits to our site should be made by the study principal investigator on a case-by-case basis, weighing risks of person-to-person contact against the potential benefits of the study intervention and monitoring
- Limit the presence of participants at a given time to less than 3 while maintaining appropriate physical distancing.
- Regularly clean/disinfect high touch surfaces and when visibly dirty (shared materials, equipment, workstations, keypads, etc.) using approved AUBMC disinfectants.
- Ventilate the workplace daily, preferably with natural ventilation by opening the window. In the case of AC, maintain recirculation with outdoor air. Avoid the use of individual fans.
Research protocols held outside AUBMC site will be reviewed and approved on a case by case basis upon ensuring that appropriate arrangements have been put in place to protect participants and research team members during person to person encounters.
For more details on precautions that need to observed upon interacting with research participants, please refer the following link
May 5, 2020:
Frequently Asked Questions Guide for Faculty, Staff and Students Conducting Human Subject Research During COVID-19 pandemic. please follow the link to access the guide
(link)
April 6, 2020:
Human Subject Research During Covid-19 Pandemic
To ensure the safety and health of both subjects participating in research and the research staff, please refer to the following guidelines regarding human subject research visits during the COVID-19 outbreak.
For studies with potential therapeutic benefit (examples: most interventional studies with drugs, devices, procedures:
- The decision about in-person research visits for existing study participants should be made by the study Principal Investigator on a case-by-case basis, weighing risks of person - to - person contact against the potential benefits of the study intervention and monitoring.
- Researchers must pause on enrolling new research participants that require person - to - person contact unless there is a compelling reason that was communicated to the IRB prior to initiating this enrollment.
For studies with no potential therapeutic benefit (examples: observational studies, epidemiological studies and studies collecting non-time sensitive biospecimens):
- Person - to - person contact should be halted.
- Research procedures may be modified to reduce person - to - person contact interactions; such modifications should be first communicated to the IRB for review and approval.
To access the complete instruction, please follow this
link
For Social and Behavioural Sciences (SBS) research studies:
For researchers working on social and behavioral research, please follow the following link to learn more about how your applications are being processed: (
SBS studies process)
March 16, 2020
Online Submissions:
In view of the evolving situation in Lebanon in regards to COVID-19 pandemic, the HRPP and IRB at AUB will be switching its operations to electronic communications.
Until further notice, please submit your IRB applications, research materials, continuing review forms, study closure forms, and serious adverse events reports (SAEs) as email attachments to irb@aub.edu.lb. In order to help IRB staff efficiently sort and route emails and thus avoid delays, please follow the attached instructions:
2019:
October 2019: IRB Submission Updates
September 2, 2019:
Announcement to Graduate Students planning to conduct research projects that involve human subjects.
The IRB has established a new student
support service to help graduate students submit research projects to the IRB and expedite the review and approval process. Please check the attached announcement for details. (
IRB announcement to graduate students)
August 2019
A new form and guidance document for reporting an "Unanticipated Problem Involving Risks to Subjects or Others (UPIRSOs), including Adverse Events (AEs)" has been released (
Click Here)
April 2017
JCI Accreditation
The Human Research Protection Program (HRPP) at the American University of Beirut achieved the desired excellent results in the Joint Commission International (JCI) surveillance that was held between April 3 and April 7, 2017 at the AUB Medical Center (
Read More)