Announcer:  From the National Institutes of Health in Bethesda, Maryland, this is All About Grants.



Megan:           Welcome to another addition of All About Grants.  This is Megan Columbus from NIH’s Office of Extramural Research.  Here today with Dr. Ann Hardy, NIH’s Extramural Human Research Protections Officer, to talk about the human subjects research requirements for education. So, Ann, what was the reason that NIH put this requirement into place?

Ann:                We have this requirement, I think, primarily to underscore the importance of appropriately protecting the participants in NIH funded research, and to make sure investigators know what the requirements are, and how to ensure that the research is conducted in the most ethical manner.

Megan:           Ann, I wonder if you could tell me a little bit about what NIH’s requirement is for education in human subjects research protection.

Ann:                Sure, NIH has a requirement for those involved in the conduct or design of research that involves human subjects that’s funded by NIH, that all those individuals must certify that they’ve had appropriate training in human subjects protection.

Megan:           So who exactly does this policy apply to?

Ann:                It applies to any of the key personnel involved in the award specifically those involved in the conduct and/or design of the human subjects research component of the grant or research and development contract. Those individuals must certify that they’ve had this education.

Megan:           When you say that there’s this education requirement, is it a specific course that they need to take?

Ann:                No. NIH doesn’t dictate what specific educational course folks have to take to meet this requirement. We leave that up to the institutions.The institutions often have a broader research training programs that will include human subjects.

Megan:           And so, we recently put out an online training that could fulfill this requirement.

Ann:                Right. As a public service NIH does have an online training module on human subjects protections. It’s called Protecting Human Research Participants. And taking that training is one way to meet this educational NIH grant requirement for human subjects education.

Megan:           And even better, my understanding is that you all recently went through the effort to get it so that investigators can receive continuing medical education credits.

Ann:                Yes. This is the newest feature of the online training, those investigators who successfully complete the course do have the option now of obtaining continuing medical education or CME credits for the training.

Megan:           So you can get CME credit, it’s actually in Spanish as well.

Ann:                Yes, that was another feature that we put into place a few years ago, we have the course available both in English and in Spanish.

Megan:           What topics does the training cover?

Ann:                The course primarily focuses on the human subjects regulations that NIH follows. It also covers the additional NIH requirements. For example, the need to have data and safety monitoring plans for clinical trials. It includes a lot of case studies that are very specific to the types of research that NIH funds.

Megan:           But just to be clear while we do offer this course there are many courses that may fulfill this requirement. How frequently do people need to be taking refreshers?

Ann:                Yes, again NIH doesn’t dictate the particular course our online training is one option, and there are lots of options that peoples can use to meet this requirement. We also don’t dictate how frequently someone needs to take this training sometimes the institutions have certain requirements. They just need to certify they completed it at the beginning of NIH award and it’s good for the period of that award. If the same investigator gets another grant from NIH they are going to have to certify that they completed this training for that grant again so an investigator has to certify for every award that involves human subject’s research. But it could be the same course that meets that requirement. Each time

Megan:           Technically, they could take it once in their lifetime as being an investigator, and that would technically fulfill our requirements?

Ann:                It would, although, I think I think you have to keep in mind that while we do not dictate the frequency, I think the intent of folks getting this training. Is that people remain up-to-date about this important area .so, with our course. For example you do have the option if you’ve already completed it once to go back at a later date and in a sense wipe it out what you’ve done taken over again and recertify And many institutions again have a requirement for training on a periodic say, every three-year basis.

Megan:           Right. So they… so investigators should always be checking in with their institution to determine what they should be doing in this regard.

Ann:                Yes. That’s a good idea

Megan:           In terms of documenting that somebody has taken the course, it’s really up to the investigator to make sure that their institution is aware of what they’ve done, right? Because the institution is the one to certify that these courses have been taken

Ann:                Yes this certification is done as one of the many of requirements in the Just- In-Time process. The institutional official generally signing off on a number of certifications and this human subject’s education requirement would be one of those.

Megan:           So we have lots of information about this on our website. We have FAQs. We certainly have links to the training itself. We have links to how you can get continuing medical education credits for the training. Is there anything else you want to add?

Ann:                I think it’s important for the researchers to have an understanding of human subjects protection and they have a lot of options, one of which is the NIH online tutorial and if they choose our tutorial. They can actually prints out a certificate of completion to show they successfully done the course. If they need to they can go back and print out the certificate at any time they can go back in and retake the course. So they have a lot of useful options. With our course again, just in general is important for them to have an understanding of this area

Megan:           Great. That sounds like a great service you’re providing Ann. Thank you so much for joining me today, Ann. For NIH and OER, this is Megan Columbus.


Announcer:  For more information on the human subjects research requirements for education and to access the protecting human research participants, training, please visit WWW.GRANTS.NIH.GOV  and click on the research involving human subject’s link located under the grants policy menu on the left hand side of the page