Limestone University's IRB was developed in the Spring of 2009. It was officially registered with the DHHS/OHRP on October 14, 2019 (under Limestone College). Today it serves students in the undergraduate program, Professors, and off-campus graduate students.
The Limestone University IRB serves to oversee all research conducted on the Limestone University Campus in order to ensure compliance of that research with all federal regulations and ethical guidelines.
The Limestone University IRB is comprised of a membership selected from various disciplines across the University and two Co-Chairpersons:
For additional information regarding the Limestone University IRB or submission to the IRB please refer to the IRB FAQs section, or contact either of the Co-Chairpersons at the emails above.
Suggested Consent Forms
IRB Application Portal
To submit an IRB application or view the IRB Manual visit the IRB Application Portal below.
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. Generally, though, if you are in doubt, it is always better to apply than not to.
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.
The DHHS definition has been further clarified 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."
What is a Class Activity?
A class activity is defined as a homework assignment required for the completion of a course offered at Limestone 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 generalizable 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.
**Anonymity means that absolutely no information that could identify a participant individually will be collected or reported.