NIH All About Grants Podcast

Transcript – Human Subjects’ Research Part 3 – Post-Award

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

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>> Kosub: Hello.  And welcome to another edition of NIH's "All About Grants" podcast.  I'm your host David Kosub with the NIH's Office of Extramural Research. So we started off by helping you understand that what you are actually doing is human subjects research and then we moved into a bit into understanding how human subjects protections and monitoring plans are developed as part of your application, and now we're going to wrap it all up in a nice little bow and talk about life post award, part of our third and final episode in this human subjects research series. And I'm glad to say that we have with us, Lyndi Lahl again, she is a Human Subjects Officer within the NIH's Office of Extramural Research and I welcome you back to the "All About Grants".

>> Lahl: Thank you.

>> Kosub: Sure.  So let's start off with a softball, an easy question.  Generally speaking, why is it important to be thinking about human subjects protection throughout the life of your award?

>> Lahl: Yeah, we want to make sure that investigators are thinking about this because they have regulatory requirements and policy requirements associated with human subjects protections that we'll need to fulfill, so for instance, an investigator would need to know what to do if there's a change in the research after the award is made.  Knowing what needs to be reported and when and to whom to report the change is going to be important.

>> Kosub: All right.  You said the magic word about reporting there.  What should someone be thinking about as it relates to reporting in their research performance progress report, the RPPR?

>> Lahl: Yeah.  They're going to need to report significant changes in the use or care of human subjects.  This would include things such as significant deviations to the research, unexpected outcomes and changes in an approved protocol such as changes to their inclusion enrollment.

>> Kosub: So in addition to reporting, what other kind of requirements is NIH requiring of the grantees for human subjects protection throughout the life of the award?

>> Lahl: Yeah, there's quite a few requirements that pertain to research involving human subjects.  This would include things such as human subjects training for not only in the investigator but the key personnel, certificate of confidentiality obligations.  They would need to think about inclusion of women minorities and individuals across lifespan of their research.  There would be reporting of sex and gender, racial and ethnic participation, and if they're doing research with domestic sites in a multi‑site study, then they would also be subject to the NIH single IRB policy requirements and the revised common rule SIRB requirements. There's also some additional requirements if they're doing a clinical trial.  That would be a subset of human subjects research studies.  And then those requirements would include good clinical practice training, posting informed consent forms, data and safety monitoring plans and registration and results reporting.

>> Kosub: All right.  Thank you for that, to put a plug in for "All About Grants", many of these topics actually have been touched on in our series, so definitely check them out if you have questions.  Switching to the institutional side from the NIH side, specifically as they may relate to the Institutional Review Board, the IRB.  What might they need to know or what might you need to be thinking about regarding the IRB after the award?

>> Lahl: Yeah.  So as you might know, the revised common rule changed the requirements for continuing review for certain types of research; however, there is still annual IRB review required if the research is greater than minimal risk, and that would be the IRB's determination of the risk level.  And in addition, besides just having this annual IRB review, the investigator would need to get prior IRB approval of any proposed changes to the research before the investigator implements those changes.

>> Kosub: That's actually interesting that you say that.  If someone does have changes after the award, what is required from the NIH side? I assume they have to contact us.

>> Lahl: Yes, that's a great question.  And you are absolutely correct, they would need to contact NIH and get prior approval, for example, when there is going to be a change in the overall risk to the participants, if they're going to be adding a new vulnerable population, if their research goes from an exempt status to a nonexempt human subjects research status, if they're doing clinical research and that changes to a clinical trial, and if they've identified new information which indicates there is a higher level of risk for the participants for any of the study interventions that they're doing.

>> Kosub: So along the side of risk, you know, say someone is chugging along with their grant, they've gotten participants enrolled and the study has begun, but something happened, a serious event happened with one of the participants, an adverse event, how do they report this to NIH?

>> Lahl Great.  That is another really good question.  So there are different events that need to be reported to NIH, and this is included in the grants policy statement and would be a term and condition of their award.  And these types of events would include unanticipated problems involving risk to subjects or others, serious or continuing noncompliance and suspension or termination of IRB approval.  Now, your institute or center may have other reporting requirements such as reporting a serious adverse event or protocol deviation.

>> Kosub: You mentioned unanticipated problem, key word there, is that the same as adverse events?

>> Lahl: Yeah, that's a common misconception.  Unanticipated problems are defined as being unexpected, related or possibly related to the research, and there's a suggestion that the research places participants or others at a greater risk of harm than was previously known.  So unanticipated problems may be an adverse event, but it also just may be an incident that would not be an adverse event.

>> Kosub: I see.  I see.  And to close this all, what if someone or an investigator or grantee, what have you, is not reporting post award related to human subjects protections?

>> Lahl: Yeah, unfortunately these things happen sometimes, and NIH can take one or more enforcement actions depending on the severity.  It could be anywhere from disallowing costs, withholding of further award, or wholly or partly suspending the grant that would be pending the corrective actions that would need to be done at the institution level.

>> Kosub: Well, thank you very much, Lindy.  I greatly appreciate this opportunity to hear more about what our investigators and grantees need to be thinking about after getting their award as it relates to human subjects protections.  We encourage anyone out there, if you have questions, definitely feel free and reach out to the program or grants management staff at the NIH institute or center that funded your research, also check with your Institutional Review Boards, keep them in the loop, and of course you can always check out the NIH grant site as it relates to human subjects research for more information. This has been David Kosub with the NIH's "All About Grants".  Thank you very much.