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 Forms and Links
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.
Who do I contact if I have serious concerns about the welfare and safety of research participants, or about misconduct involving human subject research?
You may contact either Co-Chair at the emails provided above; such communications may be kept confidential and anonymous if conditions permit.
What is the difference between Implied Consent and Informed Consent?
Implied consent is generally marked by an overt action towards participation in a study. For instance, proceeding past the implied consent statement to answer a survey question indicates your consent to answer that question and participate further. Informed consent requires a more in-depth explanation of the study on the part of the researcher, and is usually marked by the participant indicating their consent by marking so on a form, by their signature, or both. Implied consent is usually acceptable for anonymous studies, while informed consent used for studies that can only afford confidentiality at best.
How do I know if my research will be exempt, expedited, or will require a full board review?
Research that is exempt falls within 6 categories defined by federal regulation and involves little or no risk to the participants. Please refer to the IRB Manual on this website or refer to the U.S. Department of Health and Human Services Basic HHS Policy for Protection of Human Research Subjects.
Expedited review includes research for which each of the procedures falls within one of the Expedited review categories 1-7 as outlined by the Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA). See the IRB Manual on this website or refer to the U.S. Department of Health and Human Services Basic HHS Policy for Protection of Human Research Subjects.
Your study will require a full-board review if it involves vulnerable subjects such as children, pregnant women, persons with disabilities and/or mental illness, prisoners, and those who are institutionalized. It may also require Full-board review if the research procedures have a higher level of risk and may potentially cause harm to the subject.
If you are unsure of the category of your research, please contact the IRB Chair or Co-chair.
How long will the review process take?
Exempt reviews take about 3 days to complete. Expedited reviews will take 10 days to be completed. Full board reviews could take up to 15 days to complete
How do I submit a research proposal to the IRB?
Review the IRB Manual for a full description of the submission and decision process; then use the link on the website to access the IRB Application and all necessary submission instructions contained therein.
I think my research is exempt. Do I still need to submit my proposal to the IRB?
Yes. All research that involves human subjects must be submitted to the IRB Co-chairs for determination of exemption. Please refer to Who Should Submit an Application for clarification.
What do I need to do if I make changes to my study?
Some changes must be submitted for review and receive IRB approval before the changes can be implemented. Any change that is substantive such as a significant change to research protocol and participants, the risk-benefit ratio, and/or principle investigators may involve resubmission. Highlight any changes made to the protocol or informed consent form and submit with an e-mail noting the changes to a Co-Chair for further review and instruction.
What is the difference between anonymity and confidentiality?
Anonymity is when participants are not identifiable from the data collected. Confidentiality is when they may be identifiable but for the protections you have put in place.
What does minimal risk mean or imply?
Minimal risk is generally defined as “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life.”
Who do I contact if I have questions regarding research and the IRB?
You may contact either Co-Chair at the emails provided above.