All research and other activities, which even in part involve human subjects research, regardless of sponsorship, must be reviewed and approved by the UCI IRB, or registered exempt by the Office of Research (or designee) prior to initiation. This includes all interventions and interactions with human subjects for research, including advertising, recruitment and/or screening of potential subjects. Additionally, use of state death data records must be reviewed and approved by the UCI IRB prior to initiation. Please review the information in this section to understand what activities meet the definition of human subjects research.
Definition of Human Subjects Research
Human subjects research is any research or clinical investigation that involves human subjects.
Investigators conducting human subjects research must satisfy DHHS regulations [45 CFR Part 46] and FDA regulations [21 CFR Part 50 and 56] regarding the protection of human subjects research, as applicable.
Research
Research is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
A "systematic investigation" is an activity that involves a prospective plan that incorporates data collection, either quantitative or qualitative, and data analysis to answer a question.
Examples of systematic investigations include:
- Surveys and questionnaires
- Interviews and focus groups
- Analyses of existing data or biological specimens
- Epidemiological studies
- Evaluations of social or educational programs
- Cognitive and perceptual experiments
- Medical chart review studies
Investigations designed to develop or contribute to generalizable knowledge are those designed to draw general conclusions, inform policy, or generalize findings beyond a single individual or an internal program (e.g., publications or presentations). However, research results do not have to be published or presented to qualify the experiment or data gathering as research. The intent to contribute to "generalizable (scholarly) knowledge" makes an experiment or data collection research, regardless of publication. Research that never is published is still research. Participants in research studies deserve protection whether or not the research is published. Note: Thesis or dissertation projects involving human subjects conducted to meet the requirement of a graduate degree are usually considered generalizable, and require IRB review and approval.
Examples of activities that typically are not generalizable (not research) include:
- Biographies
- Oral histories that are designed solely to create a record of specific historical events
- Service or course evaluations, unless they can be generalized to other individuals
- Services, courses, or concepts where it is not the intention to share the results beyond the UCI community
- Classroom exercises solely to fulfill course requirements or to train students in the use of particular methods or devices
- Quality assurance activities designed to continuously improve the quality or performance of a department or program where it is not the intention to share the results beyond the UCI community.
Per federal regulations, the following activities are deemed not to be research:
- 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.
- 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 the course of an event or crisis that threatens public health (including natural or man-made disasters).
- 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.
- Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.
Clinical Investigation
FDA regulations define a clinical investigation as 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 FDA, or
- Not subject to requirements for prior submission to the FDA under these sections of the Federal Food, Drug, and Cosmetic Act, but the results of which are intended to be submitted later to, or held for inspection by, the FDA as part of an application for a research or marketing permit.
- A test article is any drug (including a biological product for human use), medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the Federal Food, Drug, and Cosmetic Act.
Human Subject
A human subject means a living individual about whom an investigator (whether professional or student) conducting research:
- Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
- Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
- Intervention includes both physical procedures by which data are gathered (e.g., 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.
FDA regulations define a human subject as 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 human or a patient. Examples of clinical investigations include:
- Investigational drug clinical trials
- Research testing the safety and effectiveness of an investigational device
- Medical outcomes study comparing approved drugs/devices
Note:
- Research testing the safety and effectiveness of an In Vitro Diagnostic (IVD) device using human tissue specimens (identifiable or unidentifiable) requires IRB review per FDA 21 CFR Parts 50 and 56, even though under DHHS regulations research involving unidentified tissue specimens would not be considered human subjects research.
- The state of California also requires IRB review of studies using state issued death records (certificates and indices). See the CA Health and Safety Code, Sections 102231-102232 for more information.
Educational Activities Human Subjects Research
If an instructor determines that there is a possibility that a student's proposed research project may result in a formal presentation or publication, he/she should recommend that the student submit the project for IRB review before beginning the study.
There may be instances when a student or instructor wishes to use data for research that was previously collected for educational purposes. An application should be submitted to the IRB when a student or instructor wishes to analyze the data with the intent of contributing to generalizable knowledge. For more information, please see the definition of human subjects research.
Examples:
- An instructor is surprised at some of the unique findings that appeared when students completed surveys as part of a classroom activity. The instructor would like to do additional analysis on the data and submit it for presentation or publication when the course ends. The instructor's intent has changed and an IRB application is necessary because the instructor will now be analyzing existing data that was collected for a non-research purpose.
- An undergraduate junior psychology major wishes to conduct research in the hopes of having a publication to list on her application to graduate school. She plans to devise an experiment, enroll subjects, analyze the results and write a manuscript. This is human subjects research. Prior IRB review and approval is necessary.
VS.
Educational Activities Human Subjects Research
Although all human subjects research requires prior institutional approval, not all data gathering by students constitutes human subjects research. To be research, an activity must be designed with the intent to develop or contribute to "generalizeable knowledge." Clearly, some classroom activities are designed to teach research techniques and have no such intent.
Simulations of human experimentation and course-assigned data collection do not constitute human subjects research if the activities are designed for educational purposes only; and
- the data will not be generalized outside the classroom (reporting of data within the class is acceptable because the activities were performed solely for teaching purposes); and
- the data will not result in a master's thesis, doctoral dissertation, poster session, abstract, or other publication or presentation; and
- the student volunteers or other participants are clearly informed that the activities are an instructional exercise, and not actual research.
Exceptions Any activity that is a clinical investigation or involves medical intervention or procedures, even when they are a part of a course curriculum, always constitutes human subjects research and requires prior IRB review and approval.