Who Should Submit an Application?
You should submit a complete IRB application if you are conducting research that involves the use of human subjects or information obtained from human subjects. Your first step is to determine if what you are planning to do qualifies as research, or as a class activity. Please read the definitions below to make this determination.
What is Research?
According to the Department of Health and Human Services (2009), research involving human subjects as follows:
A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which 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.
According to this definition, a study must be systematic and designed to contribute to generalizable or transferable knowledge in order to be considered research that must meet the requirements of the human subject regulations. Although publication is often viewed as evidence of research status, it is not the only criterion. In general, activities that contribute to generalizable knowledge are those that:
- Attempt to make comparisons or draw conclusions from the gathered data;
- Attempt to reach for generalizable principles of historical or social development;
- Seek underlying principles of laws of nature that have predictive value and can be applied to other circumstances for the purpose of controlling outcomes;
- Create general explanations about all that has happened in the past; or
- Predict the future.
Generalizable knowledge is not limited to quantitative studies designed to produce generalizations. Qualitative studies may also contribute to generalizable knowledge through the use of focus groups, case studies, ethnographies, interviews, or other means to identify general themes that the reader can choose to transfer to another situation. A research project is also an original work that has never been conducted before using the exact same research design as the one proposed by the Principal Investigator.
Steneck (2007) clarifies the DHHS definition by saying that "a project or study is research if it is conducted with the intention of drawing conclusions that have some general applicability and uses a commonly accepted scientific method. The random collection of information about individuals that has no general applicability is not research" (p. 39).
Researchers conducting contract research or market research should contact the IRB at email@example.com check whether their activities fall under the definition of research for IRB purposes.
What is a Class Activity?
A class activity is defined as a homework assignment required for the completion of a course offered at Saint Leo University. It does not need to be submitted for IRB review if it falls under the following parameters:
- The activity is conducted by students only as part of the requirements for a course, and under the supervision of the course instructor.
- The results will only be shared in the context of the class; excluding any presentation or report to an audience outside of the classroom for which it is completed.
- The goal of the activity is NOT to contribute to generalize knowledge. Students may collect and analyze data using scientific methods, but the protocol is too limited to permit any valid contribution to the general body of scientific knowledge.
- The activity does not involve any risk to participants beyond those of daily life.
- The participants do not belong to a sensitive population.*
- The project guarantees complete anonymity to the participants.**
- The project does not involve the generation of original knowledge, i.e., does not result in new findings that could not be found in an existing publication, or does not use an innovative methodology.
Instructors are responsible for making sure that any participants in the activity are voluntary, and that any permission to conduct the activity has been properly obtained. They should check the IRB guidelines and application form for more information on populations, topics, and procedures that may involve risk to the participants. Instructors will be held responsible for any violations of the IRB guidelines.
*Sensitive populations are groups who may be at greater risk when participating in research, due to their special circumstances. They include (but are not limited to) minors, individuals diagnosed with a mental disorder or illness, terminally-ill patients, incarcerated individuals, undocumented immigrants, convicted felons. It is the responsibility of the instructor to assess, in the context of the class activity, whether or not other groups qualify as sensitive populations.
*Saint Leo University IRB does not review any studies which include incarcerated individuals as participants.
**Anonymity means that absolutely no information that could identify a participant individually will be collected or reported.
***Studies solely using publicly available databases do not need to be reviewed by the IRB since these do not involve human subjects.
**** Students cannot conduct research projects involving legal risk to subjects / participants. This would include those who are currently involved as offender / defendant in a criminal justice system (such as federal / military/ state / local) or others at legal risk or potential legal risk as a result of study participation.
***** In the event of a change in faculty advisor, the student PI will submit a modification that includes the name / contact information for the new faculty advisor along with the new advisor’s signature and current ethics certification / training (such as certificates from NIH or CITI).
Iowa State University Institutional Review Board. 2009. “Research Requiring IRB Review.” Ames, IA: Iowa State University. Retrieved October 21, 2010 (http://www.compliance.iastate.edu/irb/guide/docs/Definition%20of%20Research.pdf).
U.S Department of Health and Human Services.2009. Code of Federal Regulations Title45 Part 46 Protection of Human Subjects. Washington, DC: U.S Department of Health and Human Services. Retrieved November 8, 2010 ( http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.102).