What and why an IRB?
The Institutional Review Board (IRB) is a committee of faculty and community members who review the involvement/participation of individuals in research programs/projects conducted by any Furman University researcher, faculty, student or staff. This requirement is legislated and mandated by the federal legislation for any federally funded research. Federal legislation on human subjects' protection was enacted to protect research participants from violation of their human rights.
Is what I am doing research?
Research is any activity which gathers information on individuals participating in any activity. Research means a systematic investigation, any investigation designed to develop or contribute to knowledge or understanding about a question. It includes survey, testing, program evaluation, interviews, and focus groups. Research is collecting information (data) on people and using that data in reports presented, published, or reported outside of the activity. If the data are only for program/activity improvement and not reported to anyone or anywhere else ever, then it is not research and does not have to go to the IRB. If after conducting the programs/activity, the findings are so exciting that they just have to be communicated at the next annual meeting, then those findings become research and the IRB must be consulted.
Is it Human Subjects Research?
Here is a process to follow the regulatory definition of research involving human subjects.
STEP ONE: Ask yourself the following 4 questions in a stepwise process stopping if there is any "no" answer:
- Is the activity an investigation? (Investigation: A searching inquiry for facts: detailed or careful examination.)
- Is the investigation systematic? (Systematic: Having or involving a system, method, or plan.)
- Is the systematic investigation designed to develop or contribute to knowledge? (Designed: evaluate whether the activities will develop or contribute to knowledge. Develop: to form the basis for a future contribution. Contribute: to result in. Knowledge: truths, facts, information.)
- Is the knowledge the systematic investigation is designed to develop contribute generalizable? (Generalizable: universally or widely applicable.)
If you get to a yes after the 4th question, you may determine that the activity is research and go to STEP TWO. If stopped by saying no at any point, determine that there is no research and do not proceed with any further questions.
STEP TWO: If there is research, then ask the following:
Will the investigator gather information about living individuals?
- Will the investigator gather that data through either of the following mechanisms:
a. Physical procedures or manipulations of those individuals or their environment?
b. Communication or interpersonal contact with the individuals?
- Will the investigator gather data that is about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place?
- Will the investigator gather data that individuals have provided for specific purposes in which the individuals can reasonably expect that it will NOT be made public, such as a medical record?
- Can the individuals' identities be readily ascertained or associated with the information by the investigator?
If (1) and (2) are true, (1), (3) and (5) are true, or (1), (4) and (5) are true, then the research involves human subjects. Otherwise, the research does not involve human subjects.
I am the faculty adviser/sponsor of a student doing research involving human subjects. Why do I need to complete the NIH training?
Although your student may be doing the research, as a faculty sponsor you are responsible for ensuring appropriate research design when human subjects are involved and for assisting in development of the application to the Furman University IRB. In addition, you have responsibility for his or her conduct in the field, adherence to protocol, and any adverse events or problems that may occur. You should also be able to appropriately address any questions from subjects concerning their rights as a subject or potential violations of such rights.
All I'm doing is a survey; do I have to apply to the IRB?
The IRB has three levels of review: exempt, expedited, and full review. Much of what takes place at Furman University may fall under the "exempt" status. Exempt review covers things like surveys, classroom tests, and questionnaires. A program reviewed under the exempt category typically is a program of minimal risk to participants. An exception to this category is programs involving children. The Furman IRB defines children as anyone less than 18 years of age. Children, pregnant women, prisoners, and individuals with disabilities are all considered special population and require a Full IRB review.
What is minimal risk?
Minimal risk means that 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 or during the performance of routine physical or psychological examinations or tests.
My data collection is complete, but the project itself is not yet complete. The IRB approval for the data collection has expired. Do I need to apply to the IRB for approval to continue the project even though I am no longer collecting data?
Yes, you need IRB review because according to 45CFR46.102(f) you are still conducting research that involves human subjects (you are still using their identifiable private information).