This page offers a broad overview of the mission, function and scope of the Institutional Review Board.
COVID-19 and Human Subjects Research Guidance
You can continue to engage in any research-related activities (e.g., recruitment, consent, data collection) that do not require in-person interaction. If you already have IRB approval to conduct these types of activities, then there is no need for any further action. If you need to make changes to your research to move interactions with participants from in-person to online, please submit a modification through the eIRB system available here.
For specific questions relating to IRB practices and procedures, please email us at email@example.com
|Items Requiring Prospective IRB Review and Approval||Items Requiring IRB and Notification||Items Which Do NOT Require IRB Review or Notification|
|Changes in IRB approved protocol procedures where there is a duration of time that would practicably allow for a modification to cover such changes||Changes in IRB approved protocol procedures implemented as necessary to eliminate apparent immediate hazards to subjects||Implementation of screening procedures for COVID-19 as per public health or institutional requirements|
|Closure of or restriction to a study site requiring a change in protocol procedures||Closure of or restrictions to a study site that does NOT require a change in protocol procedures|
|Voluntarily halting or delaying subject enrollment because of COVID-19 related public health recommendations, study team availability, and/or subjects considered to be at high risk for COVID|
Human subject research at Georgetown University School of Foreign Service in Qatar must be carried out in conformity with the basic ethical principles governing research involving human subjects.
The Georgetown University in Qatar Institutional Review Board (GU-Q IRB) is responsible for the review of and oversight of the conduct of human subject research that is conducted at GU-Qatar and/or by representatives of the University. The GU-Q IRB performs both prospective and continuing reviews of every study involving research with human subjects in order to assure that it is being conducted ethically, and in compliance with GU and Qatar’s Ministry of Public Health (MoPH) regulations , the requirements of applicable law, this institution’s Assurance, and this institution’s policies and procedures.
To fulfill its objectives, the GU-Q IRB reviews all human subject research protocols to assess the ethics of the research and its methods, to promote fully informed and voluntary participation by prospective subjects who are themselves capable of making such choices (or, if that is not possible, informed permission given by a suitable proxy) and to maximize the safety of subjects once they are enrolled in the project.All research with human subjects that is conducted at or by GU-Q must be prospectively reviewed and approved by the GU-Q IRB. No human subject research may be initiated or continued at GU without prior approval of the IRB.
Institutional Review Board (IRB) and the Scope of Its Authority
An IRB is an appropriately constituted group that has been formally designated to review and monitor research involving human subjects. In accordance with the applicable laws and regulations, the IRB has responsibility for approving, requiring modification in (to secure approval), or disapproving research. An IRB also has the authority to suspend or terminate research, if such action is believed to be in the best interest of research subjects; reasons for this action may include, but are not limited to, hazard to subjects, continued noncompliance with the applicable laws and regulations, or IRB findings, determinations, and initial and continuing review procedures.
A designated IRB’s primary responsibility is to protect the rights and welfare of participants involved in human subject research. In doing so, the designated IRB monitors human subject research to determine that it is conducted ethically, and in compliance with applicable laws and regulations, this institution’s Assurance, and this institution’s policies and procedures. The designated IRB fulfills these responsibilities by conducting prospective and continuing review of human subject research, including review of the protocol and grant applications or proposals, the informed consent process, procedures used to enroll subjects, as well as any adverse events or unanticipated problems reported to the IRB.
All human subject research conducted at GU-Q must be prospectively reviewed and approved by an IRB. No human subject research may be initiated or continued at GU-Q without prospective approval of a designated IRB.
Principal Investigator (PI) Responsibilities
As the individual responsible for the conduct of research, the principal investigator bears direct responsibility for protecting every research subject. This responsibility starts with protocol design, which must minimize risks to subjects while maximizing research benefits. In addition, the principal investigator and all members of the research team must comply with the findings, determinations, and requirements of the IRB.
The principal investigator also is responsible for the adequacy of both the informed consent document and the informed consent process, regardless of which members of the research team actually obtain and document consent. Principal investigators have the following responsibilities:
- Human subject research which they conduct in this institution has received prospective review and approval by an IRB designated by this institution;
- Continuing review and approval of the research has been secured in a timely fashion;
- The research is conducted at all times in compliance with all applicable regulatory requirements and the determinations of the designated IRB. No changes in approved research may be initiated without prior IRB approval, except where necessary to eliminate apparent immediate hazards to subjects; and no research may be continued beyond the IRB-designated approval period.
- Principal Investigator must notify the IRB promptly of (1) any unanticipated problems or serious adverse events involving risks to subjects or others, and (2) any serious or continuing noncompliance with applicable regulatory requirements or determinations of the designated IRB of which they become aware.
If you are the PI, before initiating research subject to IRB review you should determine whether or not you are engaged in research.
Research, as defined by the regulations, is any systematic investigation designed to develop or contribute to generalized knowledge. Do you intend to publish or otherwise share the results outside the institution? If the answer is “yes” then the activity is research.
You also need to determine if human subjects are involved in research. If you answer “yes” to the following questions, the activity is human subject research:
- Does the research involve obtaining private information through an interaction or intervention with individual subjects?
- Is private information obtained that is individually identifiable, meaning the identity of the subject is known and easily obtained.
Information is considered private in this context if the information collected includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record).
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