Institutional Review Board (IRB)

COVID-19 and Human Subjects Research
Guidance and FAQs

In light of the unfolding COVID-19 pandemic, and in order to sustain our research activities as efficiently as possible, the following guidelines are issued jointly by the Medstar Health Research Institute, and the Georgetown University Medical Center and Main Campus, for the benefit of investigators and associated staff in both institutions. Specific questions relating to IRB practices and procedures should be directed to your home institution’s IRB office.

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Guidance on Emergency Use of a Test Article for a Subject that has Tested Positive for COVID-19

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On behalf of Georgetown University, the Institutional Review Board’s (IRB) primary role is to safeguard the rights and welfare of all human subjects who participate in research studies conducted by Georgetown. In compliance with Federal law and institutional policy, all research projects involving human subjects or human material must be reviewed and approved by the IRB. All biomedical, social and behavioral research projects conducted by the faculty, the staff and students of the University are subject to the Policies and Procedures of the Institutional Review Board.

The Georgetown University IRB has the authority to disapprove, modify, or approve protocols based upon consideration of human subject protection. It also requires progress reports from the investigators at least annually and oversees the conduct of the study.

The overall criteria for IRB approval are:

  1. The risks to subjects are minimized as much as possible.
  2. The risks to subjects are reasonable in relation to anticipated benefits.
  3. The informed consent is adequate.
  4. Where appropriate, the research plan makes provisions for the safety of the subjects during the data collection process.
  5. Where appropriate, there are adequate provisions to protect the privacy of subjects and maintain the confidentiality of data.
  6. Appropriate safeguards are included within the study to protect the rights and welfare of the vulnerable subjects. 

Contact Information

Main IRB Office
Phone: (202) 687-1506
Email: irboard@georgetown.edu

Kristen Katopol, Director
Phone: (202) 687-0328
Email: krk63@georgetown.edu


Address & Hours

Building

Address
First Floor
SW104 Medical Dental Building
3900 Reservoir Road, NW
Washington, DC. 20057

Hours
M-F: 8:00am – 4:00pm
Sat and Sun: Closed


IRB Updates and News