NEW FDA/NIH Requirements
for Posting Clinical Trials onto ClinicalTrials.gov
For more information, please see the links below:
Lecture Series Available from ohrp
The Office of Human Research Protections (OHRP) is offering a new lecture series titled the "Luminaries Lecture Series". The series is intended to be of broad interest to investigators and IRB professionals, as well as anyone involved in human subjects research. For more information please see our Education page at https://ora.georgetown.edu/irb/education.
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:
- The risks to subjects are minimized as much as possible.
- The risks to subjects are reasonable in relation to anticipated benefits.
- The informed consent is adequate.
- Where appropriate, the research plan makes provisions for the safety of the subjects during the data collection process.
- Where appropriate, there are adequate provisions to protect the privacy of subjects and maintain confidentiality of data.
- Appropriate safeguards are included within the study to protect the rights and welfare of the vulnerable subjects.
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