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Student Research Guide

IRB Overview

What is an IRB?

IRB is an acronym for Institutional Review Board. The IRB is responsible for the review and approval of all research involving human subjects, as well as scientific validity and ethical review.

On behalf of Georgetown University in Qatar, the IRB's primary role is to safeguard the rights and welfare of all human subjects who participate in research studies conducted by Georgetown.The Georgetown University in Qatar IRB has the authority to approve, require modification in (to secure approval), or disapprove protocols based upon consideration of human subject protection.

All research with human subjects conducted by the faculty, the staff and students of the University must be prospectively reviewed and approved by the IRB. No human subject research may be initiated or continued at GU without prior approval of the IRB.

What is Research?

In general, research is defined by the Department of Health and Human Services and the Qatar Ministry of Public Health  as a "systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

What is a Human Subject?
The regulation defines a “human subject” as “a living individual about whom an investigator (whether professional or student) conducting research obtains...
 
  1. data through intervention or interaction with the individual, or
  2. identifiable private information….Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.”
To make a determination whether your study requires IRB approval, please email the IRB office or call 4457-8472.

What are the different types of review?

Research applications are reviewed at one of three levels, depending on the level of risk to the human participants and on the regulations that define the categories of review. The levels of review are exempt, expedited, and full board review. The determination of what level of review is required is determined by the IRB staff, NOT the researcher.

 

(link is externalTo help evaluate the needs for IRB review,please refer to the OHRP decision charts

All students approved to write a senior thesis must complete mandatory Human Subject Protection Training through the Collaborative IRB Training Initiative (CITI) online portal. If you do not have a CITI account, you will need to register and create your own username and password. Please select Georgetown University as your institution. You can print out a certificate upon completion for your own records. CITI automatically keeps track of Georgetown University participants and profiles us with completion data.

For more information on how to register and create your own account name and password for a CITI course, click here

IRB approval timeline for minimum risk studies/study admissions:
  • Review time for IRB members: 5 business days
  • Processing time for IRB Staff: 5 business days
     
Review timeline for greater than minimal risk studies/study admissions (full board review):
  • The study must be submitted before or on the deadline; the study will be reviewed at the meeting associated with the deadline. Please see Calendar of IRB Meetings.
  • Processing time for IRB staff, after the IRB meeting: 5 business days.

The Georgetown-Qatar IRB will be holding educational workshops to assist students, performing research or preparing their thesis, with the IRB process. Topics include:

  • Principles of research ethics
  • IRB policies and procedures
  • Types of IRB review
  • The eRIC submission system
  • Consent forms
  • Responsibilities as a researcher

Trainings are regularly scheduled for the SECOND Thursdays of each month at 12:30 pm.
Additional training sessions available for Honors students.

If you have questions, please email the IRB office or call 4457-8472.

Regulations use the term "investigator" to refer to an individual performing various tasks related to the conduct of human subjects research activities, such as obtaining informed consent from subjects, interacting with subjects, studying, interpreting, or analyzing identifiable private information or data for research purposes.

Investigators can include students, among others. In every human subjects research study, investigators have certain responsibilities regarding the ethical treatment of human subjects.

Investigators are responsible for obtaining IRB approval before beginning human subjects research.  Investigators are responsible for providing the IRB with sufficient information and related materials about the research (e.g., grant applications, research protocols, sample consent documents) so that the IRB can fulfill its regulatory obligations, including making the required determinations.

During the conduct of approved research, investigators are also responsible for ongoing requirements that include, in summary:

  • obtaining and documenting informed consent of subjects or subjects’ legally authorized representatives prior to the subjects’ participation in the research, unless these requirements have been waived by the IRB
  • obtaining prior approval from the IRB for any modifications of the previously approved research, including modifications to the informed consent process and document, except those necessary to eliminate apparent immediate hazards to subjects
  • providing to the IRB prompt reports of any unanticipated problems involving risks to subjects or others
  • providing to the IRB prompt reports of serious or continuing noncompliance with the regulations or the requirements or determinations of the IRB
  • keeping certain records as required by the regulations for at least three years after completion of the study

What are investigators’ responsibilities once a study is completed?
Once all research-related activities have been completed, including data analysis and paper writing, the investigator is no longer required to obtain continuing review approval for the study. Investigators should request a termination of the study by submitting a request for termination form.

All students conducting research projects are required to list their advisors/mentors in the IRB application under Responsible Participant. The Responsible Participant is considered to be a member of the research team and must complete a Study Specific Disclosure Form and fulfill all required training.

International human research refers to research conducted outside Qatar using participants from the local community. Such research involving Georgetown University in Qatar researchers requires review and approval from the GU-Q IRB.

International research applications should identify whether there is a local IRB, Ethics Committee (EC), or government entity that will perform review in the host country. If local review has been conducted, a copy of the approval letter/notice should be included in the application.

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