New “All About Grants” Podcast – Am I Doing Human Subjects’ Research?

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Lyndi Lahl, R.N., Human Subjects’ Officer, NIH Office of Extramural Research

You have a promising research idea that may involve human participants to carry out the study. Do you know what to do next? Join us for the next NIH’s All About Grants podcast conversation about how you know you are doing human subjects’ research (MP3 / Transcript).

Lyndi Lahl, R.N., a Human Subjects’ Officer with the NIH’s Office of Extramural Research, will help you understand what exactly is meant by “human subjects’ research,” its relation to the recently revised Common Rule, what research may be exempted, what institutions need to have in place, where to find important resources to help you going forward, and so much more.

2 Comments

  1. Hi
    Thanks for this. One bit that would be useful would be a discussion of the relationship between “exempt” research and BESH Clinical Trial research. It is confusing because (I think) your research can be exempt, yet still qualify as clinical trial.

    1. Interesting question! We appreciate the suggestion. Yes, it is theoretically possible that some NIH defined clinical trials may be determined to be exempt human subjects research, including Basic Experimental Studies with Humans (BESH). If this situation occurs, we anticipate that this situation would most likely occur with the use of exemption category 3. Although clinical trials, including BESH, that are determined to be exempt human subjects research under exemption 3 do not need IRB approval, investigators still need to meet NIH’s requirements for clinical trials. See the NIH Frequently Asked Questions (FAQs) on exemptions for additional information.

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