Announcer    From the National Institutes of Health in Bethesda Maryland. This is All About Grants.

Megan:          Welcome to All About Grants. This is Megan Columbus from NIH's Office of Extramural Research.  I’m here, today, to talk about certificates of confidentiality with our resident expert, Dr. Ann Hardy, she coordinates certificates of confidentiality for NIH and she’s a Human Subjects Research Protection Officer.  Can you start by giving us an idea of what a certificate of confidentiality is and why should we care?

Ann:              Okay, sure, certificate of confidentiality allows NIH to give researchers the authorization to refuse to disclose identifiable research information.  For example, in response to a subpoena for identifiable data, allows them to legally refuse to do so.  So it’s an extra level of protection on the data which, I think, can be very important for certain kinds of studies to give subjects some reassurance that if they go into a study, particularly one on a very sensitive topic, that their data will be protected and kept confidential.

Megan:          And what projects are eligible for a certificate of confidentiality?

Ann:              Good question.  It has to be a research project.  They are only designed to protect data from research.  It has to be a project that is health-related, so within the broader mission of the Department of Health and Human Services because we’re the agency that issues these.  On a sensitive topic and collecting identifiable research information.  Interestingly, federal funding is not required.  I think when these were set up the main purpose was to help researchers recruit subjects into very sensitive, but important research by giving that extra level of protection. So federal funding is not actually required, but those other requirements must be met.

Megan:          So that means that people who are not NIH-funded could still come to NIH for a certificate of confidentiality?

Ann:              Ah, yes, they could. So within the department, several of the other agencies that fund research like the Centers for Disease Control, health research and services administration or HIRSA, they do issue certificates, but just for research they fund.  The FDA will issue them for research that falls under their jurisdiction, so clinical trials, primarily, if they’re not federally funded.  NIH issues certificates for research we do fund, but also will issue them as the main place in the department to issue certificates for projects that aren’t federally funded.

Megan:          If folks are confused about whether NIH is the appropriate place if they go onto the NIH website and search up certificates of confidentiality, there’s a decision tree or something.

Ann:              Right, there’s an entire website devoted to certificates. There’s a nice kind of step-wise chart that will help people decide where they need to go. There’s contact information both for NIH and for the other HHS agencies that will issue certificates.  So really everything someone needs to know is on that website.

Megan:          Great.  What kinds of information would you expect somebody to submit to receive a certificate of confidentiality?

Ann:              Okay, the kinds of information we need, the researcher has to have IRB approval for the project, they have to submit to us their consent form, and that’s primarily just to check that the consent accurately describes the certificate, and they have to submit a written, signed assurance from the investigator and their institutional official that just assuring that they’ll use the certificate and that they’ll follow the Human Subjects Regulations. There’s three or four different statements that they have to assure.  And, again, all of this is on our website.

Megan:          I believe that in the summer of 2015, we put in a new electronic system to receive applications.

Ann:              Yes, we did. That was a big change we made a few months ago to just make it easier for people. The application system is specifically for NIH.  So people can go to the website, find information broadly about certificates, but if they determine that NIH is the appropriate place to apply, then it will funnel them into our application system.  Now, at NIH we still handle applications in a decentralized way in that they’re actually—the applications are reviewed and the certificates are issued by all our individual institutes or centers. So once you come into the application, one thing you do have to know is which institute or center you need to apply to within NIH.

Megan:          How would I know which institute to apply to if I know that NIH is the right place?

Ann:              Okay, so, it’s pretty straightforward.  It’s either if you’re funded by NIH obviously you’re going to go to apply to the institute that’s funding your project.  If not, you need to go to the institute that supports similar research. And, again, on our website we have some information. There’s also a general mailbox that you can send a question to that I and my staff monitor if you’re not sure. Sometimes some projects cover a lot of topics that maybe would cross several institute lines, and we can help you sort that out.

Megan:          Can you tell me a little bit more about the application process then?

Ann:              The system allows you to save drafts if you’re not done, or you want to come back to it.  The system will also provide you with emails along the review and approval process, and will send you back a completed PDF of your entire application. So it’s a really nice way, not only of having us get all the information we need, but also saving it in a format that allows us to communicate and allows the applicants to know what their status is.

Megan:          And I believe that in order to log in, you need a password. And you can use your Google password if you’ve got a Google account already, or if you already have a PayPal account. There’s no charge to apply.  It’s just you can use that authentication, and if you don’t either one of those, you need just need to get a free account with one of those.

Ann:              Right.  We wanted to set them up so that the people could manage their accounts and be able to go back into to save drafts, go back to be able to see the status of this, and we had to do this through some sort of password.  And we decided to go with these public systems which NIH does use for other things as well. So it kind of removes NIH from having to manage those systems and just—you work it through Google or PayPal.  Many people have accounts already, and, if not, you can get one for free.  We actually do suggest that people not use their personal accounts, but maybe set up one for their whole research team so they can give access to other people that may be helping with the certificates or helping with the project. But that’s not required, but as long as you have a Google or a PayPal account, and, again, if not, you get one and they’re free.

Megan:          How long, once I’ve submitted and completed my application, does it vary a lot in terms of how long it takes to get?

Ann:              Um, yes, it does.  Um, I think for a couple of reasons. The ICs vary widely in terms of how many applications they receive, with some ICs only getting maybe 20 a year and some receiving hundreds. So it will vary a little bit.  So the ICs that receive a great number, it may take them a little bit longer to get through.  But, again, the good thing is you can see where in the process you are.  You have an easy way to email, you can email the folks at the IC where you applied very easily through the system. So you can see what the status is.  Now I do recommend to people if they are under some time pressure, they want to start their study quickly that they let the IC know that, or that they communicate directly with the contact person at the IC to see how long the process is going to take.

Megan:          Thank you, that’s really useful advice.  Is there anything else you think our listeners might want to know?

Ann:              I just think just to know about the certificates of confidentiality, it is a great, I think, additional protection that we offer for sensitive research.  I think it can be really reassuring to subjects and I think for many studies, it really enables people to recruit subjects into really sensitive types, but important types, of research—research on drug abuse, research on HIV and AIDs, things like that. But to get the subjects you need by giving them that extra level of confidence that the data will be protected.  So I think it’s a really useful [tool].

Megan:          Nice.  Well, thank you for the work you do on that  

Megan           For NIH and OER, this is Megan Columbus

Announcer   For more information on certificates of confidentiality, please visit Grants.NIH.Gov and search for “certificates of confidentiality” once again the website is GRANTS.NIH.GOV