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Human Subjects Research - Other Requirements - Inclusion, Human Subjects Education
Last Revised: October 7, 2010

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  1. For whom must documentation of human subjects education to meet the education requirement be provided?
    All individuals involved in the design or conduct of the research must meet the human subjects education requirement. The Frequently Asked Questions specific to the Required Education in the Protection of Human Research Participants policy may also be helpful.
  2. How often must individuals complete the human subjects education requirement?
    The Required Education in the Protection of Human Research Participants policy does not state how often human subjects education must be completed. It is up to each institution to determine how often investigators must complete human subjects education. Documentation of human subjects education for all investigators involved in the design and conduct of the proposed research must be submitted prior to each new award for research that will involve human subjects.
  3. My proposed studies meet the requirements for E4. What information is required about the population in the human subjects section?
    Provide any and all information you have about the sample, but there is no need to obtain additional, potentially identifiable, information for the NIH population sample information requirement that is not needed for your proposed studies.
  4. Will the OHRP Guidance about research conducted under FDA Interim Final Rule 21CFR50.23(e) impact research funded by NIH?
    The OHRP Guidance: Applicability of 45 CFR part 46 to Clinical Investigations Conducted Under FDA's Interim Final Rule at 21 CFR 50.23(e)

    • Clarifies that institutions whose employees or agents use an investigational device only to (1) identify a potentially life-threatening chemical, biological, radiological, or nuclear agent, (2) facilitate the treatment of individuals exposed to such an agent, and/or (3) report test results to a public health authority would not be engaged in human subjects research under 45 CFR part 46.

    • Clarifies that institutions whose employees or agents obtain or analyze identifiable private information derived from an investigational in vitro diagnostic device in order to evaluate the safety and effectiveness of the in vitro diagnostic device would be engaged in human subjects research under 45 CFR part 46.

    This should not impact research funded by NIH because these statements are consistent with the OHRP Guidance on Engagement of Institutions in Human Subjects Research

    (B) Institutions would not be considered "engaged" in human subjects research (and would not need an Assurance) if their involvement is limited to the following:

    Institutions whose employees or agents release identifiable private information or specimens to a State or Local Health Department or its agent for legitimate public health purposes within the recognized authority of that Department. However, utilization of such information or specimens by Department investigators for research purposes would constitute engagement in research, and would require an Assurance from the Department.

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This page last updated on October 7, 2010
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