Reportable Events in Research. Nancy C. LeGros Vinson & Elkins LLP Houston, TX. 2885446 . Background. Office for Human Research Protections. OHRP is an administrative unit within DHHS Public Health Service Act mandates that DHHS develop and implement a program to:
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Nancy C. LeGros
Vinson & Elkins LLP
Reportable Events in Research
Unexpected: Subjects with essential hypertension are enrolled in a trial testing a new investigational antihypertensive drug. When the trial is initiated, there is no evidence of gastro esophageal reflux disease (GERD) associated with the investigational drug. Three of the first ten subjects develop severe GERD symptoms within one week of starting the investigational drug, which are resolved a few days after drug was discontinued. PI determines that the GERD symptoms were most likely caused by the investigational drug, may alter the IRB’s risk:benefit assessment, and warrant modification of the informed consent document.
* In accordance with NIH Guidelines for Research Involving Recombinant DNA Molecules