IRB Approval, Yellow Fever

Early in March I met with a woman named Stephanie about Rice IRB approval for Josh’s and my upcoming clinical trial in April. IRB stands for Institutional Review Board, and this board of people gives permission to conduct different experiments associated with Rice University. I met with Stephanie for a few hours and addressed the areas that posed potential barriers when getting the IRB approval. It takes 2 weeks to get approval from Rice IRB, and that’s ONLY IF everything in the documents is correct. Luckily, I’d budgeted one month to manage the IRB approval process. And today, I received the Rice IRB approval! This was my last significant milestone before Josh and I travel to Brazil to conduct our clinical trial, and I’m really excited to visit the Barretos Cancer Hospital.

I also got a Yellow Fever vaccine as a precaution for this Brazil trip, since incidents of Yellow Fever have risen in parts of Brazil. In addition, there’s a nationwide shortage of the Yellow Fever vaccine. I was lucky enough that a clinic here in Houston had a European version of the vaccine, called Stamaril. The only way Americans have access to this European drug is through the IND (Investigational New Drug) program. Although this European vaccine is neither investigational nor experimental (the vaccine has been used for decades in Europe and in other countries), it isn’t licensed for use in the United States. However, the FDA created the IND program specifically for situations when global vaccine shortages arise!

Today, I’m extra grateful for the FDA.

 

 

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