Section II:

VCU Human Research Protection Program

WPP #: II-2

Title 2:

Determining What Constitutes Human Research Subject to IRB Approval

Effective Date:

07-28-14

Revision History:

06-20-00; 06-07-04; 12-06-04; 09-30-05; 06-21-06; 02-05-07; 06-30-07; 12-7-09; 02-25-14

Policy Statement

Activities that meet the regulatory definition of research involving human subjects or clinical investigation involving human subjects and conducted under the auspices of VCU must be reviewed and approved by the IRB prior to the onset of any human research activity. Principal investigators are responsible for utilizing this policy to determine whether an activity requires IRB review.

Definitions

  1. Definitions:
    1. Applicable DHHS Definitions: VCU conducts all research in accordance with any applicable DHHS definitions (as provided below).
      1. Human subject: a living individual about whom an investigator conducting research obtains: data through intervention interaction with the individual or identifiable private information.
      2. Research: a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research even if they are a component of a larger non-research activity (e.g., instruction, demonstration) [regulations at 45 CFR 46 as enforced by the Office for Human Research Protections].
      3. Supporting Definitions [45 CFR 46]
        1. Systematic investigation involves a predetermined system, method or plan for studying a topic, answering a question, testing a hypothesis, or developing theory.
        2. Generalizable knowledge is information that is collected or gathered to draw general conclusions; inform policy; inform professional knowledge in a discipline; or generalize outcomes beyond the specific group, entity, or institution being studied.
        3. Intervention includes both physical procedures by which data are gathered (e.g., drawing blood) and manipulations of the subject or the subject's environment that are performed for research purposes.
        4. Interaction includes communication or interpersonal contact between investigator and subject.
        5. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (e.g., medical record information). Since the definition of a human subject is a "living" individual, research involving autopsy materials or cadavers is not considered human subjects research and is not reviewed by the IRB.
    2. Applicable FDA Definitions [21 CFR 50]:
      1. Human Subject: an individual who is or becomes a participant in research, either as a recipient of the test article or as a control and/or an individual on whose specimen an investigational device is used. A subject may be either a healthy human or a patient. When medical device research involves in vitro diagnostics and unidentified tissue specimens, the FDA defines the unidentified tissue specimens as human subjects.
      2. Clinical Investigation: a ‘clinical investigation’ or experiment involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the Food and Drug Administration under section 505(i), 507(d), or 520(g) of the act, or is not subject to requirements for prior submission to the Food and Drug Administration under these sections of the act, but 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. The term does not include experiments that are subject to the provisions of Part 58 of this chapter, regarding nonclinical laboratory studies. The terms research, clinical research, clinical study, study, and clinical investigation are synonymous for purposes of FDA regulations [21 CFR 50.3(c), 21 CFR 56.102(c)].
      3. Test Article: any drug (including a biological product for human use, medical device for human use, human food additive, color, adaptive, electronic product, or any other article subject to regulation under the jurisdiction of the FDA.

Procedures and Guidance

  1. Research Subject to IRB Review:

    All research involving human subjects, regardless of sponsorship, in which the university is considered to be engaged must be approved by the IRB. The university is engaged in research when the project qualifies as human subjects research and one or more of the following apply:

    1. The research is sponsored by VCU;
    2. The research is conducted, in whole or in part, by members of the university faculty, staff or students acting in their university capacity regardless of the location of the research;
    3. The university receives a direct federal award to conduct human subjects research, even when all activities involving human subjects are carried out by a subcontractor or collaborator.

    An individual is engaged in the conduct of human subjects research when interacting or intervening with a living individual for research purposes or when using identifiable private information about a living individual for research purposes.

  2. Non-Research Activities That Are Subject to IRB Review at VCU:

    The following, highly specific activities qualify as human subject ‘non-research activities’ that DO REQUIRE VCU IRB REVIEW. Data from these activities must not be used for research purposes, however safety information may be collected and provided to the sponsor:

  3. Authorization to Make Determinations:

    Each activity undertaken on behalf of Virginia Commonwealth University should be evaluated by the individual most familiar with the planning and development of the activity. Therefore, it is the responsibility of individuals to make appropriate determinations following this policy. When an individual makes the determination that an activity does not constitute human research, the VCU IRB recommends that the individual document in writing that such a determination has been made and request Department Chairperson (or designee) acknowledgement. These records should be retained with activity/research records.

    If a determination cannot clearly be made, the individual should contact the Office of Research Subjects Protection (ORSP) for guidance or submit the activity to the VCU IRB for determination. If the activity is submitted to the IRB and the IRB subsequently determines that the activity does not constitute human research, their decision will be documented in writing to the principal investigator.

  4. Procedure for Determining What Constitutes Human Research:

    Activities that are regulated as human subjects research include those activities that meet the definitions - "research" and "human subject" under the DHHS regulations and/or those that meet the definitions of "clinical investigation" and "human subject" under the FDA regulations. The FDA regulations define "research" to be synonymous with "clinical investigation."

    Any individual planning an activity that may fall under these regulations must:

    Review the DHHS definitions, first considering whether the activity is research, and if so, whether it involves human participants.

    AND

    Review the FDA definitions and determine if the activity is regulated by the U.S. Food and Drug Administration.

    If the activity meets either the DHHS set of definitions or the FDA definitions (or both), then an application for approval of the activity must be submitted to the VCU IRB.

References

DHHS 45 CFR 46
FDA 21 CFR 50
FDA 21 CFR 56
OHRP Human Subject Research Decision Charts
OHRP Guidance Document: Engagement of Institutions in Research
OHRP Guidance Document: Coded Private Information or Biological Specimens