All human subjects research conducted under the jurisdiction of the UW-Colleges must be reviewed by the UW Colleges IRB before any participants are recruited and/or before any data are collected. The institution is responsible for the activities of its researchers and must comply with federal and university regulations and policies. It is important that the IRB be aware of where and by whom such activities are being conducted, even in another country. To determine whether the activity is subject to UWCAP#15, three questions must be answered:
- Is the activity "research?"
- Does it involve "human subjects?"
- Is it under the jurisdiction of the UW-Colleges?
What is "research"?
- Under the federal Common Rule, "research" is defined as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." Activities that meet this definition constitute "research" for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities. [45 CFR 46.102(d)]
- Under the FDA regulations, the terms research, clinical research, clinical study, study, and clinical investigation are synonymous. [21 CFR 56.102(c)]. FDA regulations apply to "research" when they involve drugs, medical devices, foods, dietary supplements, infant formula, etc.
Examples of "research" activities:
- Formal investigations
- Some pilot projects
- Exploratory studies
- Student independent studies, theses, or dissertations
- Some demonstration activities
- Some service programs
Examples of activities that are generally NOT "research:"
- Classroom activities that teach research methodologies or simulate research activities
- Activities conducted to improve the quality of teaching in a particular classroom
- Activities required for quality assessment (QA) or quality improvement (QI)
What or who are "human subjects"?
- Under the Common Rule, a "human subject" is 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)]
- "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. [ 45 CFR 46.102(f)]
- "Interaction" includes communication or interpersonal contact between investigator and subject. [ 45 CFR 46.102(f)]
- "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 46.102(f)]
Examples of activities that qualify as "human subjects research" needing IRB review include:
- Human testing of drugs, devices, or products developed through research.
- Research using data collected through intervention or interaction with living individuals:
- Intervention includes not only physical procedures (like blood drawing), but also manipulation of the subject's environment.
- Interaction includes interpersonal contact, surveys, and other forms of communication.
- Research involving the collection and/or use of coded data, images or specimens in which the researcher DOES have access to a code or link to re-identify the source of the data, images or specimens.
- Research involving information collected for purposes other than the research being conducted (e.g. medical, educational or corrections records).
- Research involving identifiable bodily materials such as human cells, blood or urine, tissue, organs, hair, and nail clippings, even if they were not collected by the person using the materials for the research.
- Accessing medical or educational records, for research purposes.
- Extraction of individually identifiable information from medical or educational records, for research purposes.
- Establishment of a databank that includes individually identifiable data from living individuals.
- Case studies in social science research.
What or who are NOT "human subjects"?
a. The subjects must be living, so studies of cadavers or historical records are not included.
b. Public and completely de-identified data sets are not considered “human subjects.”
Defining UW Colleges IRB Jurisdiction:
Whenever UW Colleges “engages” in human subject research, the research must be reviewed and approved by the UW Colleges IRB before it can begin. The UW Colleges “engages” in human subject research when:
- any UW Colleges employee/s (including faculty, staff, students, or emeriti) or agents conducts human subjects research. [In a study with multiple researchers, if a UW Colleges employee will have access to identifiable human subjects data, then s/he is “engaged” in the research and should seek approval from the UW Colleges IRB.] "Agents" include all individuals performing institutionally designated activities (including students) or exercising institutionally delegated authority or responsibility;
- the UW Colleges receives a federal award to conduct human subject research, even when all activities involving human subjects are carried out by a subcontractor or collaborator.
The UW Colleges does not "engage" in human subject research when an individual with a minimal percentage UW Colleges appointment (e.g. 0% to 25%) conducts human subject research in his or her role as an employee of a non-UW Colleges entity or institution. Such individual may not refer to her/his UW Colleges affiliation in any grant applications, publications, or other oral or written material, including any material presented in a public forum, related to the research; and the research may not be conducted using any UW Colleges resource, property or facility. Additionally, such individual should take reasonable efforts to ensure that he or she is not improperly associated with the UW Colleges by a third-party in any of the materials identified above.
In the following two instances, the UW Colleges also does not directly “engage” in human subjects research but prior review by the UW Colleges IRB is required:
a. When the UW Colleges provides access to confidential student information and/or records for non-UW Colleges investigators.
b. when one of the populations being studied is UW Colleges students in their role as students (that is, recruitment is being conducted physically on campus(es) or virtually through UW Colleges related sites (e.g., a campus’ FaceBook page) or UWC communications (e.g., uwc email)).
Does student research require IRB review and oversight?
If the project meets the federal definition of “research” with living human subjects, regardless of the status of the principal investigator, it requires IRB review prior to any data collection.
What are some examples of student research?
a. Independent study projects – for example, a sociology student (after lengthy consultation with a faculty member about the appropriate wording of questions and how to obtain a “good” sample) interviews 50 people to see if gender stereotypes have changed from what they were 50 years ago.
b. Honors projects – for example, a physiology student compares blood pressure readings as other students watch different types of films (romance versus action versus horror). Again, this project is only “research” if the project is well-designed in terms of subject selection, assignment to conditions, appropriate experimental controls, etc.
c. Other class or group projects, assuming they are carefully designed, systematically carried out, and intended to have results that generalize to persons outside the original sample.
What qualifies as a pilot study?
A pilot study is a preliminary investigation of the feasibility of the study and/or of study instruments, normally done on a small scale (10 or fewer subjects). It is designed to help the investigator refine data collection procedures and instruments or prepare a better, more precise research design. Since a pilot study is by definition not yet “well-designed,” it would not contribute to generalizable knowledge and therefore is not considered research. Data collected from a pilot study cannot be used as research data and, of course, investigators must obtain IRB approval after the research design/instruments are refined and prior to any collection of actual research data.
IRB approval must be obtained prior to collecting pilot data if one or more of the following applies:
a) Medical interventions or interactions for research purposes, especially those involving invasive procedures;
b) any research activities, regardless of the size of the study, if the research is funded by the Veterans Administration.
Is there any penalty for failure to comply with IRB rules and regulations?
Possibly. Federal regulations require that each IRB has consequences and procedures in place for instances of egregious and/or ongoing non-compliance. The consequence for a single instance of minor, unintentional non-compliance is likely an effort to better educate the person about the regulations. Other consequences might involve working out a corrective action plan. The non-compliance policy (UWCAP#56) can be found on the “Guidance for Research” page of this website.