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102.1 Organization Policy on Determination of “Human Subject Research” and Exempt Research

January 2019

The Organization requires that all human subjects research (HSR) projects in which JHM is engaged must be reviewed and approved by the JHM IRB prior to initiation.  HSR means any activity that under the DHHS regulations represents “research[1]” that involves “human subjects[2] ,” or any activity that under FDA regulations represents “research[3] ” that involves “human subjects[4] ”.  In accordance with the Revised Common Rule, JHM becomes "engaged" in human research when its employees, faculty, staff, or other agents[5] (i) obtains information or biospecimens through intervention or interaction with living individuals and uses, studies or analyzes the information or biospecimens; or (ii) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. When proposed research is to be funded by the DoD, JHM will additionally apply the DoD regulatory definition of an “experimental subject” [6]. When activities are covered under other law, the definition encompasses activities that are “research involving human participants” as defined by those laws.

Investigators are not required to seek a determination as to whether a proposed activity constitutes HSR from the IRB when the activity falls outside the DHHS and FDA regulatory definitions of research. One exception is projects that may qualify as public health surveillance activities. The requirements for IRB review of these activities is outlined in Organizational Policy 102.2. For all other projects that do not qualify as HSR, if a written determination from the IRB is required, an eIRB application may be submitted to request this determination.  The IRB will notify the PI of its determination. Note that for QA/QI projects, if the investigator intends to publish the results it is recommended that a determination from the IRB be sought as to whether the project would qualify for HSR. 

IRB members or alternate members may review submissions to determine if projects are HSR as defined above.  Additionally, OHSR compliance team members may advise investigators by telephone or email as to whether a project is HSR as defined above and whether to submit an application for JHM IRB review.  Projects submitted for a determination that the activity does not qualify as HSR that are determined to constitute HSR will be routed for appropriate IRB review.  An activity that will involve information solely from deceased individuals is not defined as HSR; however, the PI must submit a HIPAA Form 5, “Representations Form for Research Involving Only Decedents’ Information” for IRB acknowledgement of the proposal under HIPAA.

The JHM IRB website contains links to the regulations that are applied by the JHM IRB in the review process and in making determinations made about the proposed exempt research.


[1] Under the DHHS regulations “research” means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. 45 CFR 46.101(d)

 [2] Under the DHHS regulations “human subject” means a living individual about whom an investigator (whether professional or student) conducting research (i) obtains information or biospecimens through intervention or interaction with living individuals and uses, studies or analyzes the information or biospecimens; or (ii) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. Intervention includes both physical procedures by which information is gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. 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 that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (for example, a medical record). Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information. An identifiable biospecimen is a biospecimen for which the identity of the subject is or may be readily ascertained by the investigator or associated with the biospecimen.  

[3] Under the FDA regulations “research” means any experiment that 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) 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 terms research, clinical research, clinical study, study, and clinical investigation are deemed to be synonymous for purposes of this part. 21 CFR 50.3(c) and 21 CFR 56.102(c) (Note: Activities are subject to requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the FDC act when they involve any use of a drug or medical device other than the use of an approved drug or device in the course of medical practice).

[4] Under the FDA regulations “human subject” means 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 individual or a patient. 21 CFR 50.3(g) and 21 CFR 56.102(e). For clinical investigations involving medical devices, 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, human subject also means a human who participates in an investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control. A subject may be in normal health or may have a medical condition or disease. When medical device research involves in vitro diagnostics and unidentified tissue specimens, the FDA defines the unidentified tissue specimens as human subjects.

[5] According to OHRP guidance “agents” include all individuals performing institutionally designated activities or exercising institutionally delegated authority or responsibility.

[6] Department of Defense definitions will be applied for research funded by the DoD, as defined in 32 CFR 219.102 and 10 USC Section 980.  For DoD’s purposes, research involving a human being as an “experimental subject” is “[a]n activity, for research purposes, where there is an intervention or interaction with a human being for the primary purpose of obtaining data regarding the effect of the intervention or interaction.”