May 2005 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. 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 and/or submit a “Research Determination Worksheet” if they wish to have a determination from the OHSR. This worksheet is a tool and submission to the OHSR is not required. 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 Exempt Application or a New Research 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 human research as defined above. Once staff determines that projects submitted are “human research,” IRB X will review the Exempt Research Application to determine whether, under the federal regulations, a project is or is not exempt from IRB review. If such projects are submitted for JHM IRB review, a response letter acknowledging the submission, and stating that the JHM IRB will not review the submission, will be sent in reply. If a project involves solely deceased individuals, the PI must submit a HIPAA Form 5, “Representations Form for Research Involving Only Decedents’ Information” for acknowledgement from an IRB member or a Regulatory Team specialist. Investigators pursuing projects that may qualify as exempt under 45 CFR 46.101(b) should use the eIRB Exempt Wizard to help determine whether to submit the Exempt Research Application. There are some populations for which regulations and organization policy require review by the IRB, even if the underlying project may qualify as an exempt research project. For examply, a project will not be exempt from review if the population to be studied includes prisoners. A project that involves children and “survey or interview procedures or observations of public behavior” will not be exempt unless it is an observational study of public behavior in which the investigator does not participate in the activities being observed. For certain exempt projects, organization policy prohibits enrollment of inpatients, outpatients, and employees. 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 and the Organization retain the right to determine when research proposals that may otherwise meet the DHHS criteria for exemption should be reviewed by the JHM IRB through an expedited process or at a convened meeting. All such studies will be reviewed by expedited process. The JHM IRB will review each project involving tissue specimens from the JHH Pathology Department or the JHBMC Pathology Department to determine whether or not it is human subjects research. The JHM IRB will provide the PI with written documentation of its determinations. The JHM IRB web site contains links to the regulations that are applied by the JHM IRB in the review process. IRB X will review the majority of Exempt Research Applications.
[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 |
