Research and HIPAA

[Turtle62]

Hello, all. I am new to the message boards, and this is the first time I have ever posted. I work for a home health care company and my focus is mainly performance improvement. We work closely with a local physician who still makes house calls. This MD has recently started a research project on elderly patients who have cardiac disease, CHF mainly, that have been seen in the ER. His focus is to see what effect an ER visit has on the patient's health. We are meeting next week to discuss how our home health agency can assist in this project. What do we need to have in place for consents in relation to HIPAA? This physician is still paperbased for billing, and is not yet a covered entity, our agency however is a covered entity. Any input would be greatly appreciated. I have read the federal register, but never having done research before, I'm a little confused as to what is specifically needed. Thanks

[zambezi, BSN, RN]

I do some study coordinating for a local doctor, not quite what your doctor is doing but research all the same...I know that for most of our drug studies, we have had to add and addendum to our informed consents that talks about the release of medical information to our site, drug companies etc (though pts not id'ed my name use initials or number only...)it is about three pages long and i know that it was required by hipaa...

[katscan]

wWelcome to our board! I am a school nurse, so I am not involved in your area and cannot answer your question, I just want to welcome you here. I am sure someone will be able to give you the info you need. Good luck and welcome!

[betts]

http://www.ramana.com/hipaa_faq.htm

[Talino]

This link should take you direct to HHS HIPAA Q&A regarding Research and Disclosures...

http://answers.hhs.gov/cgi-bin/hhs.cfg/php/enduser/std_alp.php?p_sid=HDnTyWJg&p_lva=&p_li=&p_page=1&p_cat_lvl1=7&p_cat_lvl2=57&p_search_text=&p_new_search=1

just click on the subject which concerns you.

[Turtle62]

Zambezi, betts, & Talino,

Thanks for the information. This is a new venture and I want to make sure all the bases are covered.

Katscan,

Thanks for the welcome. The support I see here is wonderful. I appreciate the thought.

[Wren]

Turtle,

You might try going to a medical school web site and select their IRB office link and most have all of the HIPAA approved forms right on the web to download. You'd need to modify it to fit your requirements but at least it is a template to start with. If you have difficulty finding one PM me and I'll send you some samples. Good Luck!