Changes in Definitions

Effective January 21, 2019 certain definitions are modified/addedChanges are noted in "quotes".

  • The definition of ‘human subject’ has been slightly modified; note the replacement of ‘data’ with ‘information or biospecimens’:

    Old Rule

    Human Subject. A human subject as defined by the Common Rule is a living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual or through identifiable private information [45 CFR 46.102(f)]

    New Rule

    "Human Subject. A human subject as defined by the Common Rule is a living individual about whom an investigator conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. [45 CFR 46.102(e)(1)]"

  • The definition of ‘research’ remains the same, however added to it are activities that are specifically ‘not deemed research’. This will not likely change decisions on what constitutes human research, it however codifies certain decisions already made at our institution. .

    Old Rule, with Revised Rule (addition in “quotes”)

    The Common Rule defines research as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalized knowledge. Activities, which meet this definition, constitute research whether 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. "For purposes of this part [the Common Rule], the following activities are deemed not to be research: "

    "(1) Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected. "

    "(2) Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during an event or crisis that threatens public health (including natural or man-made disasters). "

    "(3) Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes. "

    "(4) Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions. [45 CFR 46.102(l)]"

  • Added definition of ‘Clinical trial’, and new requirement for posting consent forms:

    "The IRB will determine if your study meets the definition of clinical trial. Per the Common Rule and NIH Policy, clinical trial means a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes."

    This definition is important because if your research is funded by a Common Rule agency, or the Federal department or agency component conducting the trial, and meets the definition of a clinical trial, the Revised Rule requires that one IRB approved informed consent form used to enroll subjects must be posted by the awardee on a publicly available Federal Web site. That will be established as a repository for such informed consent forms. The informed consent form must be posted on the Federal Web site after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject, as required by the protocol.

    At this time, two publicly available federal websites that will satisfy the consent form posting requirement, as required by the Revised Common Rule, have been identified: and a docket folder on (Docket ID: HHS-OPHS-2018-0021). HHS and other Common Rule departments and agencies are developing instructions and other materials providing more information to the regulated community about this posting requirement.

    Additional federal websites that would satisfy the Revised Common Rule’s clinical trial consent form posting requirement might be identified in the future.

  • Benign behavioral intervention – interactions that are brief, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing.
  • Interaction – communication or interpersonal contact
  • Intervention – physical procedures/environmental manipulations by which information or biospecimen are gathered.
  • Legally Authorized Representative – individual/judicial/boy authorized under applicable law to consent on behalf of prospective subject.
  • Vulnerable Subjects – vulnerable to coercion/undue influence.