Research projects involving human subjects require review and approval by an Institutional Review Board. An IRB is an ethics committee composed of scientists and non-scientists who protect the rights of human subjects involved in research. The IRB is charged with the responsibility of reviewing and overseeing human subjects research conducted under the aegis of the University of Chicago. The first question to consider with respect to IRB review is whether the research project fits the definition of “research” with “human subjects,” as those terms are defined in the federal regulations that govern human subjects research. In light of the IRB’s mission to protect human subjects, and the potential regulatory consequences of not obtaining IRB review and approval for human subjects research, you should choose to err on the side of caution and consult the IRB when you are uncertain whether your study is human subjects research or not.
Research is defined as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." 45 CFR 46.102(d). Activities which meet this definition constitute research for purposes of the federal regulations that protect human research subjects, whether or not they are conducted or supported under a program which is considered research for other purposes. Some demonstration and service programs may include research activities.
Human Subject is defined as "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.” 45 CFR 46.102(f).
Living individual – Cadavers, autopsy specimens, or specimens/ information from subjects who are now deceased are not “human subjects.” Note, however, that the health information of deceased individuals is protected under federal and some state regulations. If you plan to analyze health information of deceased individuals for your project, you should determine whether the health information associated with the data is “protected health information” (PHI) under the HIPAA Privacy Rule.
About whom – to be considered research with “human subjects,” the data received from a living individual must be about the person. For example, if you are asking people for information on institutional policies, practices, and characteristics without obtaining data about the characteristics/opinions of the individuals providing the information, that does not involve research with human subjects (e.g., a survey asking institutional human resources offices about the number of individuals who work at an institution and what types of employee benefits are offered by the institution).
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.
Secondary analysis of data/specimens: If you will be obtaining identifiable private information or identifiable specimens that were collected in a prior research study so that you can conduct secondary analysis of the data/specimens, your study will be considered human subjects research.
In general, private information/specimens are considered to be individually identifiable when they can be linked to specific individuals by the researcher either directly, or indirectly through a coding system to which the researcher has access.
For additional guidance on research with existing datasets, see the SBS IRB Guidance on Secondary Analysis of Existing Data Sets at http://sbsirb.uchicago.edu/page/irb-guidance-documents-important-topics.
Multi-Institutional Research: In situations where multiple institutions are involved in carrying out a non-exempt research project, a question each institution has to consider is whether that institution's activities rise to the level of being "engaged" -- if engaged, IRB review is required of that institution’s activities; if not engaged, IRB review is not required of that institution’s activities. The HHS Office for Human Research Protections has issued a Guidance on Engagement of Institutions in Human Subjects Research which discusses when institutions are considered to be engaged or not engaged in research – the OHRP Guidance document is available at http://www.hhs.gov/ohrp/policy/engage08.html. The OHRP Guidance on Engagement states “In general, an institution is considered engaged in a particular non-exempt human subjects research project when its employees or agents for the purposes of the research project obtain: (1) data about the subjects of the research through intervention or interaction with them; (2) identifiable private information about the subjects of the research; or (3) the informed consent of human subjects for the research.” At least one institution must be determined to be engaged in any non-exempt human subjects research project that is funded by the U.S. Department of Health and Human Services (45 CFR 46.101(a)). The OHRP Guidance sets out examples of situations where institutions would be considered engaged and not engaged in research.Examples of studies that are NOT research with human subjects:
1. Data collection for internal departmental or other University administrative purposes. Examples: teaching evaluations, customer service surveys.
2. Information-gathering interviews where questions focus on things, products, or policies rather than people or their thoughts regarding themselves. Example: a survey of employers that asks whether the employers offer certain employee benefits programs, without asking for the opinions or thoughts of the individuals who respond to the survey.
3. Class projects and research practica whose purpose is to provide training in research methods as part of the overall educational mission of a program and are not designed to contribute to generalizable knowledge. However, if, for example, a student is involved in an activity designed to teach research methodologies and the instructor or student wishes to conduct further investigation and analyses in order to contribute to generalizable knowledge, the design of the project has changed such that it meets the above definition of research and requires IRB review, and the IRB must at that time review the research.
4. Program evaluation/Quality improvement/Quality assurance projects are generally not considered research if these activities are designed specifically to assess or improve performance within a department, hospital or classroom setting. The intention of the project is not to generate conclusions that can be applied universally, outside of the immediate environment where the project will occur.
If you are unsure whether or not a proposed quality improvement project should be classified as research, contact the IRB for guidance. If the data is re-examined or re-analyzed and new information surfaces that would contribute to generalizable knowledge, an application must be submitted to the IRB.Examples of studies that ARE research with human subjects:
1. Studies that utilize test subjects for new devices, products, drugs, or materials.
2. Studies that collect data through intervention or interaction with individuals, if the information is about the individuals (including their opinions/views/thoughts). Examples of this type of research include drug trials, internet surveys about alcohol consumption, studies that involve deception, research involving risky behaviors or attitudes, and open-ended interviews with minors that contribute to generalizable knowledge.
3. Studies using private information that can be readily identified with individuals, even if the information was not collected specifically for the study in question.
4. Studies that use bodily materials such as cells, blood, urine, tissues, organs, hair, or nail clippings, even if one did not collect these materials for the study. However, such research may be considered exempt or not human subjects research if the materials/data are coded and the investigator does not have access to the coding systems. Guidance on research involving coded private information or biological specimens is available on the web at: (http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.pdf.)
5. Studies that produce generalizable knowledge about categories or classes of subjects from individually identifiable information.
6. Studies that use human beings to evaluate environmental alterations, for example, weatherization options or habitat modifications to their living or working space or test chamber.
Special note on oral history projects and other ethnographic/qualitative interviews:
It can be especially challenging to determine whether projects that involve oral history/ethnographic/qualitative interviews are human subjects research. As with all studies, the question involves looking at the research design and procedures using the definitions of “research” and “human subjects” set out in the federal regulations. Generally speaking, if a project is limited to interviews that document a specific historical event or the experiences of individuals, the project would not be considered human subjects research because it is not designed to have predictive value or lead to development/testing of a hypothesis. Many oral history projects fall within the same area as journalism, biography, and documentaries -- that is, they are intended to create a historical record of individual lives or of individual or community experiences. If the project is intended to produce generalizable conclusions (i.e., data collection intended to test economic, sociological, or anthropological models/theories) or to inform policy, the project is considered human subjects research and should undergo IRB review. Because this is a particularly challenging area in which to determine whether IRB review is needed, we strongly recommend that you contact the IRB if you are unsure whether a project that will involve oral history/ethnographic/qualitative interviews should undergo IRB review.