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