Definition of Research
The first step in determining whether COMIRB review is required is to determine whether your project involves "research," or a "clinical investigation."
Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Clinical investigation means any experiment that involves a drug, biologic, or medical device, and one or more human subjects.
Below are two special examples of activities that might not meet the definition of research:
1. Classroom projects that are designed to instruct students on research methodologies, and are not intended to generate novel findings or contribute to generalizable knowledge are generally not considered to meet the definition of research. It is the responsibility of the faculty teacher, department and school to ensure that all activities conducted in the classroom that involve interaction with the public are conducted in accordance with ethical principles. The IRB is available as a resource to help students develop appropriate class resources but the school is ultimately responsible for their conduct.
2. Quality Assurance/Quality Improvement projects and Program Evaluation projects may not meet the definition of research, if the findings are not intended to be generalized beyond the program under evaluation. For assistance in evaluating such projects, please refer to the QA/PE
checklist. Such projects can be evaluated by the department, school or affiliate using the QA/PE checklist to determine if the proposed project meets the definition of human subject research. Any project considered to potentially meet the definition of human subject research must be submitted to COMIRB for review. For any such project determined not to meet the definition of human subject research, the checklist should be signed by the researcher and the person within the department, school or affiliate that is making the determination. A copy of the determination should be kept by the deciding authority for future reference.
Definition of human subject
If your project meets the definition of research or a clinical investigation, the next step is to determine whether your project involves human subjects.
Human subject refers to:
1. 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.
2. An individual who is or becomes a participant in research, either as a recipient of a drug, biologic or device, or as a control
3. An individual (whether living or deceased) on whose specimen an investigational device is used
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, directly or through identifiers linked to the subjects) in order for obtaining the information to constitute research involving human subjects.
COMIRB policy requires the IRB to make the determination that private information or specimens are not individually identifiable when there is a direct or indirect link through a coding system. (See Guidance on research involving coded private information or biological specimens.) Such requests must be submitted using the ―Not human subject / request for exemption application form. Such research might not meet the definition of human subject research if the investigators and the holder of the key enter into an agreement prohibiting the release of the key to investigators under any circumstances, until the individuals are deceased, using a Coded Information Agreement.
Even if your project meets the definition of human subject research, COMIRB review may not be required if the local site is not considered to be "engaged" in research. Please refer to OHRP's Engagement Guidance for assistance in determining whether the local site is engaged.
The responsibility for the initial determination as to whether an activity constitutes human subjects research rests with the investigator. Since the University will hold them responsible if the determination is not correct, investigators are urged to request a confirmation that an activity does not constitute human subjects research from the COMIRB Office if there is any uncertainty. Informal requests may be made verbally, by phone contact, by email or through written communication. All requests must include sufficient documentation of the activity to support the determination. Informal requests represent the opinions of COMIRB personnel and are not formal endorsements of the project as Non-human Subject Research.
If an investigator wants COMIRB to make a formal determination that research does not meet the definition of human subject research, this must be submitted formally (through use of the Exempt and Non-human Subject Research application) to COMIRB for its consideration. Click the following link for directions on submitting to COMIRB for a human subject research determination.
If you believe your project requires COMIRB review, please click the following link to decide whether to apply for Exempt, Expedited or Full Board review.