Determining whether or not a project meets the federal definition of human subjects research is a two-step process. The information below will help assess whether a project requires IRB review.
1. IS YOUR PROJECT CONSIDERED RESEARCH?
Does your project meet the federal definitions of research described below? If not, it may not need to be reviewed by the HSC. See below for examples of projects that are usually Not human subjects research.
Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Systematic investigation means a study or examination involving a methodical procedure or plan.
Generalizable knowledge means conclusions, facts, or principles derived from particulars (individual subjects, medical records, etc.) that are applicable to or affect a whole category (members of a class, kind, or group, a field of knowledge, etc.) and are intended for dissemination in the public domain, typically through publication.
2. DOES YOUR RESEARCH INVOLVE HUMAN SUBJECTS?
If you answered “yes” to whether your project is considered research, does your project meet the federal definition of a “human subject”?
Human Subject means a living individual about whom an investigator conducting research: (1) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (2) 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.
Identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.
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 (e.g., a medical or school record). In order to meet the above definition, private information must be individually identifiable (i.e., the identity of the subject is known or may readily be ascertained by the investigator or associated with the information) in order for the investigation to constitute research involving human subjects. In general, private information is considered to be to be individually identifiable when it can be linked to specific individuals by the investigator(s) either directly or indirectly through coding systems, or when characteristics of the information obtained are such that by their nature a reasonably knowledgeable person could ascertain the identities of individuals.
If you think your project does not require review and you require documentation for your records, then submit this form to the HSC for a formal determination.
ACTIVITIES THAT MAY NOT BE CONSIDERED HUMAN SUBJECTS RESEARCH
Below are examples of activities that are typically NOT human subjects research:
- Classroom projects that involve research methodology and/or course-assigned projects, where data is collected from and about living individuals as part of a class exercise and/or assignment and is not intended for use outside of the classroom. Course instructors are still expected to train students to conduct their project ethically with the three core principles of the Belmont Report in mind. Note: There may be instances where a student or instructor wishes to use data that was previously collected for non-research (i.e., educational) purposes. In these instances, an application should be submitted to the HSC when the intent of the project has changed and is intended to contribute to generalizable knowledge.
- Quality improvement/assurance activities or program evaluations that are conducted or collected for internal, departmental, and/or other administrative purposes that are intended to measure the effectiveness and/or improvement of programs or services such as teaching evaluations, evaluating curriculum, improving a practice or process within a particular institution, etc. Note: Certain activites may fall under the definition of human subjects research, for example, if the project involves untested interventions, informs policies and procedures, or other programs similar in nature, if the results will be compared with other assessments, are designed to prove a relationship or correlation, or if certain publishers require IRB approval.
- Unidentifiable/de-identified or coded private information or specimens if the research team cannot readily ascertain the identifies to whom the data or samples belong to. Coded information or specimens that are not individually identifiable to the research team are not considered human subjects research if the private information or specimens were not collected specifically for the proposed research through interaction or intervention with living individuals AND the research team cannot identify the individual(s) because the investigators do not have the key to the coded information, there are IRB policies or procedures in place for a repository or data management center that prohibit sharing the key to the coded private information, or there are other legal requirements prohibiting the release of the key to the investigators, until the individuals are deceased.
- Case reports which are published and/or presented at national or regional meetings are not considered research if the case is limited to a description of the clinical features and/or outcome of a single patient. As the collection and organization of information for such reports usually involves no data analysis or testing of a hypothesis, they do not involve systematic investigation.
- Fact-collecting interviews of individuals where questions focus on things, products, or policies, rather than on people or their opinions, behavior, characteristics or experiences (e.g., canvassing recycling company about e-waste policies).
- Biographies or autobiographies that involve interviewing a living individual about their experiences and is not generalizable beyond that individual.