<p>My son just called. He is doing research with a physician. The guy told my son that he needs a NIH certificate. My son was too embarressed to ask what that was. My guess is that it is some kind of confidentiality certificate regarding privacy issues.</p>
<p>Does anyone else know??? And, where would one get such a certificate???</p>
<p>I would encourage my son to call back and ask. Being too embarrassed to ask questions is a fatal flaw in research. This gives him a good chance to ask a low risk question.</p>
<p>I second going back and asking. Dealing with the governmental beurocracy is not an easy task until you clearly know the rules of the game. Is your son doing some sort of a research project where human subjects are involved? </p>
<p>[NIH</a> Guide: NIH ANNOUNCES STATEMENT ON CERTIFICATES OF CONFIDENTIALITY](<a href=“http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-037.html]NIH”>NIH Guide: NIH ANNOUNCES STATEMENT ON CERTIFICATES OF CONFIDENTIALITY)</p>
<p>[Frequently</a> Asked Questions (FAQs) on Certificates of Confidentiality](<a href=“http://grants.nih.gov/grants/policy/coc/faqs.htm]Frequently”>COC Redirection)</p>
<p>My son has already tried to call this doctor back… He’s VERY hard to get ahold of - he’s a neonate doctor. So, yes, the research involves “live subjects.” </p>
<p>So, since it’s unlikely my son is going to be able to reach this guy before his next meeting with him, I hope that someone here can point us in the right direction. My son found the website listed above, but he couldn’t figure out where you actually “get” the certificate. I looked at it, too, and it’s a mystery to me.</p>
<p>That’s good that he called back and he can chalk it up to “lesson learned” to never let a doctor off the phone until you have all the info you need!</p>
<p>I would call the hospital HR. If this is something that people who work there need, they’ll know the procedure to follow.</p>
<p>If he needs to create an informed consent form for a study with human subjects, it is definitely an “NIH Certificate of Confidentiality,” specific wording from NIH that needs to be added to his informed consent form to promise those who volunteer for the study that their data will be kept confidential.</p>
<p>He applies to the NIH institute that his research would fall under. I can help a bit on this if you need more information, but as an example if he is doing heart research, he needs to apply to the National Heart Lung and Blood Institute.</p>
<p>Reading this might help him.
[HIPAA</a> Privacy Rule and Its Impacts on Research](<a href=“http://privacyruleandresearch.nih.gov/resources_related.asp]HIPAA”>HIPAA Privacy Rule and Its Impacts on Research)</p>
<p>This explains how you apply if your study is not already a funded NIH study.
[Detailed</a> Application Instructions for Certificate of Confidentiality: Extramural Research Projects](<a href=“http://grants.nih.gov/grants/policy/coc/appl_extramural.htm]Detailed”>http://grants.nih.gov/grants/policy/coc/appl_extramural.htm)
and here is how you apply if you have a funded NIH study
[Detailed</a> Application Instructions for Certificate of Confidentiality: Intramural Research Projects](<a href=“http://grants.nih.gov/grants/policy/coc/appl_intramural.htm]Detailed”>http://grants.nih.gov/grants/policy/coc/appl_intramural.htm)</p>
<p>JL50ish: I sent you a PM.</p>
<p>Thanks for all the info… I think that we’re on the right track now…</p>
<p>Thank you all. :)</p>
<p>HIPAA? Don’t read, just sign. I have been working in research for many years and have had to fill these forms out every year. They just say that you won’t do anything unethical like divulge people’s private health information without their consent. These things are relevant because they could invalidate a study, require new certification through institutional review boards, prevent the physician from working with human studies, cause the school to be sued etc.</p>