Graduate Studies and Research

Institutional Review Board

 

IRB2.png

The Institutional Review Board (IRB) at the Lebanese American University (LAU) is responsible for reviewing and approving all research projects involving human subjects. This includes studies conducted at LAU, the LAU Medical Center–Rizk Hospital (LAUMC–RH), and the LAU Medical Center–Saint John’s Hospital (LAUMC–SJH), as well as any external research conducted by LAU faculty, students, or staff.

 

The primary mission of the IRB is to ensure that all proposed research complies with established ethical standards, including the core principles outlined in the Belmont Report, and aligns with national and international regulations and guidelines for the protection of human research participants.

 

IRB Meeting Dates & Deadlines for Submissions

Below is a list of meetings dates and deadlines for submission of research project that require Full Board Review at a specified and scheduled IRB meeting date.

Projects that fall under Exempt  or Expedited review category are reviewed under expedited review procedure and not during the Full Board Review.  Please check the review category for your study.

IRB Meeting Dates  Scheduled 2025 Deadlines for Research Project Submission
January 24, 2025 December 24, 2024
February 21, 2025 January 21, 2025
March 21, 2025 February 21, 2025
April 25, 2025 March 25, 2025
May 30, 2025 April 23, 2025
June 27, 2025 May 20, 2025
July 25, 2025 June 25, 2025

 

IRB Membership Roster

As of October 2024

Member Name Title and Affiliation Term of Appointment Member Designation
Joseph Stephan, PhD Associate Professor, Gilbert & Rose-Marie Chagoury School of Medicine

 

Director, IRB office, LAU
September 2016 -present

 

February 2019 - present

Scientific member

 

 

Chairperson, IRB

 

Vanda Abi Raad, MD, MHPE, EMBA Associate Dean for Faculty Affairs and Development
Clinical Professor and Chair for the Department of Anesthesiology Gilbert & Rose-Marie Chagoury  School of Medicine, LAU
June 2017 - present Vice Chair IRB, Scientific member
Aniella Abi Gerges, PhD Associate Professor, School of Medicine December 2019 - present Scientific member
Grace Dagher, PhD Associate Professor, School of Business - LAU December 2019 - present Scientific member
Maha Habre, DNP, RN, CEN Clinical Assistant Professor,
School of Nursing, LAU
October 2020 - present Scientific member
Abeer Hani, MD Assistant Professor and Pediatric Neurologist,
Gilbert & Rose-Marie Chagoury School of Medicine,  LAU
January 2016 - Present Scientific member
Fr. Ramy Wannous Saint George Church, Broummana October 2023 – present Non-Scientific and Not affiliated member
Maya Zeineddine, PhD Clinical Associate Professor, School of Pharmacy, LAU October 2024 - present Scientific member
Rami Smayra, LLM Smayra Law Office May 2019 - present Non-scientific and not affiliated member
Pia Tohme, PhD Assistant Professor, Psychology  Department, School of Arts & Sciences, LAU February 2022 - Present  Scientific member
Rana Rizk, PhD Assistant Professor, Natural Sciences  Department, School of Arts & Sciences, LAU October 2022 - Present Scientific member
Leen Baddour Student ad hoc non voting member. School of Arts & Sciences – Psychology Student October 2024 - Present Non-scientific
Sally Sarkissian Student ad hoc non voting member. School of Pharmacy – MS in Pharmaceutical Development and Management Student October 2024 - Present Non-scientific
Karmen Baroudy,  M.Sc., CIM IRB Lead Program Manager, LAU February 2012 - present Scientific, Non-voting member
 

 

Submission Requirements

1. Overall Requirements

All research involving human subjects under the jurisdiction of the Lebanese American University and its affiliates (LAU Medical Center - Rizk Hospital & LAU Medical Center - Saint John’s Hospital) must be submitted to the LAU Institutional Review Board (IRB) for review and approval prior to commencing the research.  This page provides you with easy checklists and processes for submission.  Please refer also to the Investigator’s Manual - Policies and Procedures.

LAU IRB does not review research conducted by non LAU/LAUMCRH/LAUMCSJH personnel. 

If a study involves extramural funding such as external funding agencies or sponsors, clearance must be secured from the relevant department at LAUMC–RH / LAUMC-SJH / LAU before submission to the IRB.  Please contact the IRB office / or the GSR office for further details.  For funding opportunities, please visit the Sponsored Program website

Please note the following critical points to be included in any research protocol for the IRB to assess 

2. LAU IRB Submission Checklist and Summary Presentation

The following information provides you with relevant information on what you need to submit as part of your LAU IRB Submission. For the Applications, Forms and Supporting Documents click here.

3. LAU IRB Submission process

For any funding queries, please contact the GSR office at gsrinfo@lau.edu.lb  for more information.

4. LAU IRB Submission Fee Schedule

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

Effective February 2011, the fee schedule for LAU IRB 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

5.  IRB Review Timelines - Summary Table

Type of Review* Timelines** Required Application***
Full Review Review will take at least 30-45 business 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 business days from date of complete 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 up to 10 business days from date of complete submission
  • Protocol Exempt Application - for research projects that fit one of the exemption criteria
  • Approvals are granted for a period of 2 years.  If the study will continue beyond expiry date, a request for extension must be submitted at least 2 weeks prior to Expiry date.

* 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.

 

Applications, Forms, and Supporting Documents

Signature pages and IRB Applications

1. New Mandatory Automated Cover Form (RPSF) and Signature Pages, as applicable:

      a. Research Proposal Submission Form (RPSF)

       This form is only required for submissions by a Faculty: Not applicable for student
        projects. 
      
 This form includes an option if the study is to be conducted at LAUMCRH & LAUMCSJH

     b. Other required Signature Pages, as applicable

     c. Adding LAUMCRH & LAUMCSJH as a research site after you have secured LAU IRB approval, please use the following form 

2. IRB Applications

ONLY One application should be submitted depending on the type of submission for review
Initial Protocol Application - Biomedical Research  
(For all research projects that require Full or Expedited review)
Initial Protocol Application – Social and Behavioral Research 
(For all research projects that require Full or Expedited review)
Protocol Exempt Application 
(For all research projects that fall under an Exempt review)
Supplemental Sheet - Study Personnel
Classroom Project Application
(For student projects in Research Methodology Courses)
 
Other required applications, as applicable and required, during the course of the Research Project and after Initial review and approval: 
Addition of Research Personnel to an already IRB Approved research study
Continuing Review Application
(For all research projects that have been approved under Full or Expedited review and requires renewal to continue past expiry date noted in the Approval letter)
Protocol Amendment Application
(For all research projects where the PI intends to amend the protocol,
informed consent, any change to the research project procedures)
Request for Protocol Closure Form
(For all research projects that have completed, closed, suspended or terminated)

Reporting Forms

Investigator Financial Disclosure Form
SAE/ Non-SAE Unexpected and Related Reporting Form
(For Adverse Events occurring at the site)

Supporting Guidance Documents and Templates

1. Informed Consent Templates

Please customize the informed consent document below relevant to your targeted population and research project
  *  Introductory Informed consent to surveys, questionnaires  (English)
  *  Introductory Informed consent to surveys, questionnaires  (Arabic)
  * Introductory Informed consent to interviews (English)
  * Introductory Informed consent to interviews (Arabic)
  *  Informed Consent Template for Minimal Risk Studies (English)
  *  Informed Consent Template for Minimal Risk Studies (Arabic
  *  Informed Consent Addendum in the event new information arose after initial consent
  *  Informed Consent Addendum in the event new information arose after initial consent (Arabic)
  * Parental Consent Form Less then Minimal Risk (English)
  * Parental Consent Form Less then Minimal Risk (Arabic)
  * Assent Form (English)
  * Assent Form (Arabic)
2.    Research Protocol Template
3.    Glossary - Medical Lay Terminology
4.    Glossary - Clinical Trials Terminology
5.    Letter to companies, Schools, centers, etc. (Template signature page to secure the necessary approval)
6.   Letter to companies, Schools, centers, etc. (Template signature page to secure the necessary approval) (Arabic)
7.    Delegation of Responsibility – Study Personnel
8.    Advertisement Template for Research

 

IRB Review Process

IRB  Review Process.jpg

Exempt, Expedited, Full IRB Review

The IRB follows three distinct review types while reviewing research involving human subjects. These types are based on the regulations governing research and relate to the degree of risk to research subjects. For Full and Expedited review, please use the Initial Protocol Application and for Exempt review, please use the Protocol Exempt Application.  You can refer to the explanation below and also you can also check the Investigator’s Manual - Policies and Procedures.

Exempt Review

Some human subject research might fall under an Exempt review process. In order to assess if your research project fits one of the exemption criteria, please see list below or 45CFR 46 101 (b) at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html. The IRB office will make the final determination if your research project falls under an Exempt Review.

Research may be exempt from review when the only involvement of human subjects in the research falls into one of the following categories:

Expedited Review

Some human subject research might fall under an Expedited Review process. The categories for Expedited review process are noted below and can be found at http://www.hhs.gov/ohrp/policy/expedited98.html

Applicability

Research Categories

In addition, expedited review is appropriate for minor changes in protocols and consent forms proposed for previously approved research during the period (one year or less) for which approval is authorized. Changes affecting risk, benefit, discomfort, or subject protections are not “minor” changes. Minor modifications include, for example, administrative changes to the protocol, changes to add follow-up calls when gathering initial data by telephone, or certain changes in the scheduling of medications.

Full IRB Review

Human subject research that does not fit any of the Expedited or Exempt review categories will require a Full IRB review at a convened meeting. The IRB meets once a month or as requested by the IRB chairman. Research applications are placed on the agenda and will be discussed at the next scheduled meeting. The IRB chairman might cancel a full IRB meeting if

The IRB uses a primary reviewer system for full IRB review. Application materials are sent to the IRB members scheduled to attend a meeting at least one week in advance of the meeting. Two members are selected by the chair, one as the primary reviewer and the other as a secondary reviewer for a research project.

The primary reviewer leads the discussion of each project at the full IRB convened meeting. The secondary reviewer adds any other relevant comments or clarifications. The members determine whether the project meets the criteria for approval or whether revisions to the study design are required. The Informed Consent Document is reviewed for accuracy, clarity, and inclusion of required and optional elements of consent. During the meeting, voting is by show of hands. By a majority of those present at the meeting, each project is either: (1) approved as submitted; (2) approved pending receipt of required minor revisions to study procedures, Informed Consent Document(s), or other written materials; (3) tabled pending review at a subsequent full board meeting after receipt of significant additional information or revisions, or (4) disapproved.

Written minutes of each full IRB meeting include: (1) attendance, (2) the number of votes to approve, table, disapprove, or abstain (without individual identification), (3) the basis for requiring changes in or disapproving the research, (4) the length of time until the next review, and (5) a summary of the discussion of controverted issues and their resolution.

Informed Consent Guidance

Informed Consent is a process in which researchers provide information to potential participants regarding the details of a research study prior to their enrollment in the study.  Please refer toe the Investigator’s Manual -  Policies and Procedures for a complete guidance.

Obtaining an informed consent involves:

The potential participant in a research study must participate willingly, having been adequately informed about the research. If the potential participant in a research study is part of a vulnerable population (i.e. pregnant women, cognitively impaired individuals, illiterate, children, or prisoners) special protections are required.

Special safeguards for Vulnerable Population

Special considerations must be in place to protect the rights and welfare of potential participants likely to be vulnerable to coercion or undue influence. The safeguards employed for vulnerable subjects include, among many other strategies, include the following as applicable, assessing the decision-making capacity of potential subjects, securing the involvement of a legally authorized representative, requiring parental permission from a parent/ legally authorized representative and in some studies from both parent, in addition to the child’s assent, and ensuring that incentives are not coercive.

The Informed Consent Document

The informed consent document is one aspect of the informed consent process, however it is very important. The Informed consent must

Please refer to the checklist below as a guide while you are preparing your informed consent document. To assist the investigators in preparing the informed consent document, the ILAU RB has generated an Informed Consent Template that address the elements noted below.

Basic elements are required (Per regulations) for all informed Consent forms

Additional elements as appropriate

Education & Training

All investigators /student investigators and support staff involved in the research project must complete the on-line training for the Protecting of Human Research Participants. 

LAU is now registered with the Collaborative Institutional Training Initiative (CITI) Program.  You can access the training through the CITI Home page.  Please click on “Register” and select Lebanese American University as your affiliated organization.  You can refer to the following Guidance documents to complete your registration.  If you are registered with CITI under a different organization, you can use the same log in information and add another affiliation under LAU.

NOTE: All human subject training and working with animals training  certification are valid for 3 years. Please make sure you re-take the training if 3 years have passed since the date on your Certificate of Completion.

Student Research and Classroom Projects

General Information

LAU students conducting research project at the Lebanese American University (LAU) or LAU Medical Center–Rizk Hospital (LAUMC–RH) must receive the necessary approval from the Institutional Review Board (IRB) at LAU as detailed below. Please read the following information carefully in order to identify which category your research falls under.

LAU students, conducting their research outside LAU or LAUMC–RH, must receive approval from the IRB at LAU as well as approval from the respective committee responsible for research involving human subjects or necessary approval where the study will be conducted.

Students are subject to the same requirements and policies set forth for the conduct of research as described below.

Definitions

Research, as defined in the Regulations - CFR Title 45, Part 46, is a systematic investigation (an organized, scientific way of collecting information, using a series of questions or observations) designed to develop or contribute to generalizable knowledge (i.e. knowledge shared by professionals in a given field which is designed to contribute to that field).

Data is collected from a “human subject”, who is a living individual about whom an investigator (a faculty member, staff or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.

Above definitions are important to remember when students (undergraduate and/or graduate) are planning to conduct independent class projects, senior or honor’s theses, master’s projects, doctoral dissertations, or participate in research methodology courses. Application and submission procedures and requirements for students to follow are described in below two categories:

Mentor / Faculty Advisor

Each student must have a mentor or a faculty advisor where the research will be taking place. The faculty advisor or mentor must be available to assist the student with developing their protocol, preparing all required documents for submission to the IRB and securing appropriate approvals prior to commencing their research.

Faculty advisors play an important role in the students’ design and development of human participant research projects. Faculty advisors are ultimately responsible for the protection of the subjects, even if the student is the primary researcher and actually directs the project, and are also responsible for research that is conducted as part of a course.

Faculty advisors and course instructors are required to review codes of ethics relevant to the discipline of study.

Categories of Research Projects by Students

Below are the two categories detailing submission requirement. Regardless which category your research project falls under, it is important to include an introductory information section prior to any data collection tool such as surveys, interview scripts, questionnaires etc. Sample introductions are available under Applications, Forms and Supporting Documents on the IRB website.

Category 1- Student Research

Student research activities include, but are not limited to, projects that result in undergraduate honors theses, masters theses, or doctoral dissertations.


Submission Requirements

Student researchers have the same submission options as any investigator. They may submit as Principal Investigator (PI) with a faculty advisor as co-signator, which may be appropriate for new projects where the student has a leading role.

Student researcher, co-investigators (if a group) and faculty advisor / classroom instructors are required to have current research ethics certification.


Common Scenarios

  • RESEARCH that involves direct interaction with individuals (e.g., in person, or via mail, email, web survey, or telephone), or data from human subjects for which the researchers will have access to identifiers.
  • RESEARCH-like activities using departmental subject pools (e.g., Psychology, Business, Political Science, Journalism and Mass Communication) even when the activity is conducted for educational purposes as a class requirement.
  • RESEARCH that is limited to secondary analysis of data, records or specimens that are either publicly available, de-identified or otherwise impossible to be linked to personal identities

Category 2- Classroom Projects

Classroom project activities as part of Graduate and undergraduate research methodology courses: Abbreviated Review Procedure


General Guidelines

The IRB recognizes that graduate and undergraduate research methodology courses are designed to teach students research skills through a combination of readings, lectures and research activities or projects. The purpose of such research projects is for the student to apply what is being taught (i.e. use skills outside of the classroom) rather than to contribute to existing research literature in a field. Accordingly, the IRB has developed special guidelines for such class projects.

An instructor who wishes to make use of this abbreviated review procedure:

  • must first diligently review each student’s proposal to determine its acceptability and then submit according to the procedures described below.
  • is responsible for providing the necessary training in respecting the privacy of the individuals, the confidentiality of the data along with training in the relevant professional ethics. Such training must be listed in the course syllabus and submitted to the IRB
  • Must ensure that instructor and all teaching assistants have completed the online CITI training course and have submitted their completion certificate to the IRB

Instructors are encouraged to contact the IRB for guidance about ways to handle topics such as privacy, confidentiality, informed consent, and professional ethics when class projects are part of the course syllabus. These issues may still remain even when IRB approval is not required, in which case instructors, advisors and department play an even greater role in providing the appropriate guidance and oversight.

Note: Students planning to use a class-based project as part of an undergraduate senior/honor’s thesis, master’s thesis, doctoral dissertation, independent study project, or for submitting it for off campus publication or presentation must follow the IRB review procedures before commencing the project (see Student Research Category 1 above)


Submission Requirements - Abbreviated Process

Course instructors must submit a Class Project Research Application each semester. This application will include a descriptive title of each student project, the student investigator’s name, and the type and estimated number of subjects who will be enrolled by using the Class Project Research IRB Application. The Class Project Research IRB Application form must be signed by the course instructor and submitted to the IRB Office at least one (1) week before the research is to begin. No student research project involving human subjects may begin until the instructor has submitted the application and it has been accepted by the IRB.


Common Scenarios

  • CLASS PROJECTS that involve direct interaction (e.g., in person, via mail, email, web surveys, or telephone), but where the purpose is training, an educational exercise or professional development, and not research. The project is not “research” even if students ask people questions as part of learning how to conduct interviews or surveys, take histories, administer assessments, or perform “in-house” evaluations.
  • Class Projects that involve direct interaction or secondary analyses of private identifiable data and are undertaken as both an educational experience and as research (e.g., results of these activities will be presented publicly or otherwise disseminated, or the data will be stored and used by the students or others as research data).
  • CLASS PROJECTS involving secondary data analyses that are assigned and conducted as educational exercises, i) using data that are either publicly available data, de-identified or otherwise impossible to be linked to personal identities or ii) include private information and codes that link to identifiers, but the students do not have access to the identifiers.

Note: Projects involving but not limited to vulnerable population, collecting data sensitive in nature, collecting information in which participant might feel physically or psychologically threatened are not acceptable under this review category and a Full IRB application must be completed for review.

 

IRB Registration

Lebanese Ministry of Public Health

The university obtained an official authorization from the Lebanese Ministry of Public Health registering the LAU Institutional Review Board as per the Minister Decision No.141 dated 27/1/2016 under LAU IRB Authorization reference 2016/3708

To directly access information about the Laws pertaining to Clinical Trials and Authorization of IRBs, please visit the Lebanese Ministry of Public Health Website at https://www.moph.gov.lb/en/Pages/3/4760/clinical-trial-regulations

U.S Office of Human Research Protection

The university obtained a Federal Wide Assurance (FWA) as an International institution under the US Office of Human Research Protection (OHRP) which signifies that the university is in compliance with federal regulations for the protection of human subjects in research (45CFR46.103) for federally funded research. Furthermore, the university has registered its IRB, Institutional Review Board, with the US Office of Human Research Protection (OHRP).

http://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/fwas/fwa-protection-of-human-subjecct/index.html

Links and References

Ethical Principles

Lebanese MOPH Regulations and CNRS Charter for Research

Registering your Clinical Trial

European Union Clinical Trial Directive

International Conference on Harmonization

International Committee of Medical Journal Editors (ICMJE)

UNESCO

U.S Office for Human Research Protection

U.S. Food and Drug Administration (FDA)

World Health Organization

Frequently Asked Questions

What is Research?

“Research” is defined as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” The regulations further clarify that “activities which meet this definition constitute research whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.” 45 CFR 46.102(d)

How do I know if my project involves human subjects?

“Human subjects” is defined as living individuals about whom an investigator (whether professional, faculty, staff, or student) conducting research obtains

  1. data through intervention or interaction with the individual, or
  2. identifiable private information.”

45 CFR 46.102(f)

When am I required to submit a research project involving human participants to the IRB?

All research projects that will involve human participants must be submitted for review and approval before beginning the study. This also includes proposed research involving existing data and previously collected human fluid and tissue samples, as well as any advertising or other recruitment procedures.

How long does a IRB review take?

The review varies depending on the research project. Please refer to the summary table under the Submission Requirements webpage

Who reviews my application?

The IRB reviewer depends on the type of review required.

The IRB Chair and/or an experienced member of the IRB reviews research studies that are eligible for exemption or expedited review.

For studies that require full committee review, a primary and a secondary reviewer are assigned to review the research study. A majority of the full committee (that is, a quorum) must be present at a convened meeting of the IRB in order to vote to approve or require modifications to a research study that is not exempt or eligible for expedited review.

What are the main concerns of the IRB while reviewing a research project?

The main concerns of the IRB while reviewing a research project are, but not limited to:

Who is considered part of a vulnerable population?

Children, pregnant women, fetuses and neonates, the mentally disabled, individuals with diminished autonomy, prisoners, students and employees, elderly, economically disadvantaged and educationally disadvantaged.

Who needs to be listed on the protocol application?

All researchers or individuals that will have some kind of contact with the subject or with the subject’s identifiable information as follows:

What is meant by “exempt” protocol?

Under certain circumstances, human participant research activities may be granted exempt status. There are certain categories of activities that are considered research, but can be declared exempt from further review by the IRB. These categories are listed under the federal regulations, 45CFR46 101(b), and are detailed in the Protocol Exempt Application. Under exempt status, the research activity is not monitored by the IRB. Assuming the project does not change, it also is not subject to continuing IRB review and oversight. Exempt status does not however affect the ethical obligations to subjects as detailed in the Belmont Report. Thus, depending on the circumstances, investigators performing exempt studies may need to make provisions to obtain informed consent, protect confidentiality, minimize risks, and address problems or complaints.

How do I confirm that my project is exempt from IRB review?

There are certain categories of activities that are considered research, but can be declared exempt from further review by the IRB. These categories are listed under the federal regulations, 45CFR46 101(b), and are detailed in the Protocol Exempt Application. If you believe that your research project might fit one of the exempt categories, complete the Protocol Exempt Application and submit to the IRB. The IRB administrators and chairman will confirm determination and not the researcher.

I will be collaborating with another institution. Do I need to submit to the LAU IRB and the other institution?

If you are a member of the LAU faculty or staff, or an LAU student, and you are the person responsible for the conduct of the study (PI), you must get the approval from the LAU IRB to conduct your research regardless of where the research takes place. Investigators should contact the IRB office whenever collaborative research is occurring. Separate applications for each institution may be necessary.

Do I need IRB approval if my work will be conducted off campus?

All research proposals that will involve research with human subjects and will be conducted by anyone affiliated with LAU/ LAUMC–RH must be submitted to the IRB for review and approval/exemption. This requirement applies regardless of the site of the research activity.

My research involves only reviewing medical records; do I need IRB approval?

Yes, if the project meets the criteria for research with human subjects as defined above. If the review is limited to existing data, and identifiers will not be recorded, the project may qualify for exemption under category 4 (D). If prospective data collection is involved, and/or identifiers will be recorded, the protocol may be eligible for expedited review. In either case, the determination must be made by qualified IRB personnel.

My research involves administering surveys/questionnaires; do I need IRB approval? Even if I am only interviewing a few people?

Yes. Any activity conducted by an individual who is affiliated with the Lebanese American University / LAUMC–RH or conducted at LAU / LAUMC–RH that involves research on human subjects (as defined above) must be prospectively reviewed by the IRB, including those studies involving only a few subjects.

Depending upon the types of data collected, the project may be eligible for exemption or expedited review. In addition, the IRB may require additional safeguards for vulnerable populations involved in this type of research.

Do I need IRB approval to put a survey online?

Yes. Computer and internet-based research protocols must ensure voluntary participation. They address the same level of risk such as violation of privacy, legal risks, and psychosocial stress and require the same level of protection as any other types of research involving human subjects. All studies, including those using computer and internet technologies, must

What is a continuing review?

Except for studies determined exempt from IRB oversight, all research project are required to undergo continuing review at least annually or as determined by the IRB at initial review based on the level of risk.

What do I need to do if I want to change or amend my research project?

Any changes or amendments to the protocol or any of the study documents must be submitted to the IRB for review prior to implementation.

Why is human subject training required and who must be trained?

Anyone who is listed as:

Furthermore, all members of the Institutional Review Board and staff must complete the human subject training

Does the training requirement apply to students conducting interviews?

Anyone who has contact with subjects or with confidential study data must satisfy the training requirements.

Is there an expiration date on the human subject training certificate?

Yes there is an expiration date on the Certificate and it is a 3 year validity.

Contact Us

 

Joseph Stephan, PhD
Director of the Institutional Review Board (IRB) and Research Ethical Compliance
Email: joseph.stephan@lau.edu.lb
Ext: 2845
Gilbert and Rose-Marie Chagoury School of Medicine, Level 4
 

Karmen Baroudy, M.Sc.,
CIM
IRB Lead Program Manager
Email: karmen.baroudy@lau.edu.lb
Ext. 2546
IRB Office, 2nd floor Dorms A, room 704, Byblos Campus
 

IRB Office
Email: irb@lau.edu.lb
IRB Office, 2nd floor Dorms A, Byblos Campus