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

August 2010

The Organization requires that all human research projects in which JHM is engaged must be reviewed and approved by the JHM IRB prior to initiation. “Human research” 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] ”. JHM becomes "engaged" in human research when its employees, faculty, staff, or other agents[5] (i) intervene or interact with living individuals for research purposes; or (ii) obtain individually identifiable private information for research purposes. When proposed research is to be funded by the DoD, JHM will apply the DoD regulatory definition of an experimental subject [6].

Investigators are not required to seek a determination of human subject research from the IRB when research activity falls outside the DHHS and FDA regulatory definitions of research. Investigators may use the eIRB Wizards to determine whether an activity is or is not human subjects research. If the PI requires a written determination from the OHSR, then the PI may either submit an eIRB application and request a determination from the OHSR that the application is not human subjects research, or submit a “Research Determination Worksheet.” The eIRB application requesting a not human subjects research determination from the OHSR and the worksheet are tools and submission of either the eIRB application or the worksheet to the OHSR is not required. If the OHSR determines that the activity is human subjects research the PI will be notified.

The JHM IRB staff and IRB members may review submissions to determine if projects are human research as defined above. Also, staff may advise investigators by telephone or email as to whether a project is human research as defined above and whether to submit an Application for JHM IRB review. Some projects, such as single case reports, research on de-identified human specimens, research on deceased individuals, and quality assurance/quality improvement projects that do not involve drugs or medical devices other than the use of an approved drug or medical device in the course of medical practice or data that will be submitted to or held for inspection by the FDA are not defined by the Organization as human subject research. Projects submitted as “human subjects research,” but which may qualify as exempt research under DHHS Regulations are reviewed to determine if the exempt criteria are met. See, Policy 101.1 (Organization Policy on Exempt Research) for the determination process and requirements. An activity that will involve information solely from deceased individuals is not defined as human subjects research. However, the PI must submit a HIPAA Form 5, “Representations Form for Research Involving Only Decedents’ Information” for acknowledgement of the proposal.

Projects involving drugs or medical devices other than the use of an approved drug or medical device in the course of medical practice and projects whose data will be submitted to or held for inspection by the FDA will not be exempt from JHM IRB review UNLESS that use falls within the Emergency Use provisions of 21 CFR 56.102 (d): “Emergency use means the use of a test article on a human subject in a life-threatening situation in which no standard acceptable treatment is available, and in which there is not sufficient time to obtain IRB approval.” All emergency use requests should follow Organization policy.

The JHM IRB web site 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 obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. Intervention includes both physical procedures by which data are 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 which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects. 45 CFR 46.101(f)

[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.

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

[6] Department of Defense definition will be applied for research funded by the DoD. The definition will incorporate definitions defined in 32 CFR 219.102 and 10USC Section 980

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