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Supporting Education and QI in Research (SEQuR)

3. What is Human Research?

Department of Health and Human Services (DHHS)

  • A. Virtually all federally funded research with human subjects is governed by the (DHHS) regulations that are defined in 45 CFR 46.
  • 1. Human subjects are defined as "living individual(s) about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information."
  • 2. Research is defined as, "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge."

Food and Drug Administration (FDA)

B.  Clinical investigations are also regulated by the (FDA) under 21 CFR 50.

  • 1.  Human subject is defined by the FDA as "an individual who is or becomes a participant in research, either as a recipient of the test article or as a control.  A subject may be either a healthy human or a patient."
  • 2.  Clinical investigation is defined as "any experiment that involves a test article and one or more human subjects... the results of which are intended to be submitted later to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit."

 

MMC has developed a document to assist you in determining whether an activity is Human Research. The  Human Research Determination document and Is an Activity Research Involving Human Subjects Covered by 45 CFR part 46 can be used for guidance as to whether an activity meets either the DHHS or FDA definition of Human Research.  Keep in mind that the MMC IRB makes the ultimate determination in questionable cases as to whether an activity constitutes Human Research and is subject to IRB oversight.

Do not conduct Human Research without prior IRB review and approval (or an IRB determination that the Human Research is Exempt). If you have questions about whether an activity is Human Research, contact the administrative support for the MMC IRB at 207-396-8240 who will further assist you.

 

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Maine Medical Center Research Institute 81 Research Dr Scarborough, ME 04074 (207)396-8100

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