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Human Subjects Division (HSD)


Definition of Research

Under the federal Common Rule, “research” is defined as:

"A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge."

Activities that meet this definition constitute “research” for purposes of the UW Human Research Protection Program (HRPP), whether or not they are conducted or supported under a program which is considered research for other purposes. (For example, some demonstration and service programs may include research activities.) [45 CFR 46.102(d)]

Under the FDA regulations, the terms research, clinical research, clinical study, study, and clinical investigation are synonymous.  [21 CFR 56.102(c)].  Under FDA regulations activities are “research” when they involve:

  • Use of a drug other than the use of an approved drug (approved by the FDA for marketing) in the course of medical practice [21 CFR 312.3(b)]
  • Use of a medical device other than the use of an approved medical device (approved by the FDA for marketing) in the course of medical practice [Food, Drug and Cosmetic Act 530(g)(3)(a)(i)
  • Gathering data that will be submitted to or held for inspection by FDA in support of a FDA marketing permit for a food, including a dietary supplement that bears a nutrient content claim or a health claim, an infant formula, a food or color additive, a drug for human use, a medical device for human use, a biological product for human use, or an electronic product. [21 CFR 50.1(a) or 56.101(a)]

Change Notes

  • Noted 08/31/2010 @ 12:34pm
    Keyword newly added.
    - selsayed