Deciphering research clearance in Brazil.

A panic set in over me yesterday. In less than a month I'll be arriving in Rio, and I have yet to move forward on my research clearance process; it's a stress bubble that's been waiting to burst, and last night, at 11 PM, it popped.

Of course, I've known for some time that I was going to have to deal with the IRB (the United States' research ethics committee) and CONEP/CEP (the national and local research ethics committees of Brazil). But I only recently got my grant documents finalized, and terms and conditions set. Since then, I've been working fruitfully trying to make some headway into the clearance process.

For those of you who are unaware, researching with human subjects, in almost any aspect (from surveys to clinical trials) involves having to get your research protocol cleared by an ethics committee. My project involves surveying, so I have to submit my project for an expedited IRB review-it's the lowest and fastest level of review that an IRB can offer at an institution, but at some institutions, this review can take up to a month. If you are applying for research clearance to do research abroad, this involves having to get cleared by your institution in the US, and then in the host country (in my case, Brazil).

For Brazil, I have to go through two processes: CEP (the local ethics committee), and CONEP (the national ethics committee). CEP meets once a month, and not every institution has one. CONEP reviews applications on a rolling basis, and has up to 90 days to decide whether your research is worth approval. In any of these cases, whether in the US or Brazil, if your project is not up to snuff, reviewers give you suggestions on what to change and improve. You then have to resubmit for approval. This probably happens 95% of the time. Once you've cleared all of these-which you can imagine might take a few months-you can start. It's best to have all this done before you arrive, but, like most researchers, my project is far from unique in it's timeline, and my research is just now going through clearance in the US.

It comforts me to think that I didn't start this procedure after I arrive in Rio, but it's frightening to know that I might be delayed before I actually want to begin. Here's to hoping that my University sees my project as pitch perfect, and clears it with ease.

For more information on US and Brazil research clearance:

http://www.hhs.gov/ohrp/

http://www.fic.nih.gov/programs/research_grants/firca/country_instructions.htm

(a horror story)

https://webspace.utexas.edu/mbf239/www/Brazilian%20Ethic%20Committee%20Documents/Guide%20to%20Brazilian%20Research%20Ethics%20Committees.htm