Institutional Review Board |
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Frequently Asked Questions
How do I know if my project needs to be reviewed by the IRB?
I have a research study that needs to be reviewed. What do I need to do?
1. What is an Institutional Review Board?
The Institutional Review Board (IRB) is a campus committee empowered by federal regulations to oversee research activities involving human subjects. The IRB is responsible for the review and monitoring of research involving human subjects in order to assure the protection of the rights and welfare of the subjects participating in research. The IRB is dedicated to facilitating the ethical conduct of research.
The IRB is comprised of faculty and community members. The current list of IRB members may be found on the IRB website.
2. How do I know if my project needs to be reviewed by the IRB?
If your project involves research with human subjects, it needs to be reviewed by the IRB. Often investigators only consider traditional biomedical research, studies as needing IRB review, however, legal requirements to protect human subjects apply to a much broader range of research. Examples include:
- Data collected through intervention or interaction with individuals.
- Intervention and interaction include not only physical procedures (like drawing blood) but also interviews, observations, surveys, tests, manipulation of a subject's environment, and taste test options.
- Data collected to gain generalizable knowledge about categories or classes of people.
- Existing data or records of individuals, even if the information was not collected specifically for the study in question.
- Bodily materials such as cells, blood, urine, tissues, organs, hair, or nail clippings, even if you did not collect these materials.
As stated in the federal regulations (45 CFR 46.102) Research-means a systematic investigation, including
research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.Human Subject-means a living individual about whom
an investigator (whether professional or student) conducting research obtains:
- Data through intervention or interaction with the individual, or
- Identifiable private information.
If you are unsure if your project meets the definition of research or human subject, please contact the IRB Administrator.
3.I have a research study that needs to be reviewed. What do I need to do?
Visit the IRB Web site for guidance on what to submit and to obtain the necessary forms. You will also need to complete the required training in humans subjects protections.
Informed consent assures that potential subjects understand the nature of the research and their participation and can make an informed, voluntary decision about participating or not participating in the research project. Informed consent is an ongoing process, not just a form that is signed.
Consent documents must be clearly written in second person (e.g., you are asked to participate...) and at a reading level appropriate for your potential subjects. Any scientific or technical terms must be plainly defined using nontechnical language.
Please visit the IRB website to obtain the checklist of what needs to be included in the informed consent form and templates.
ISU's Federal Wide Assurance with Department of Health and Human Services, which oversees the work of IRBs, requires ISU to provide continuing education on research with human subjects. All PI's and co-PI's must complete the training before a research project or continuation request is approved. Initial certification is valid for 3 years and must be renewed every 3 years while working with human subjects. Information regarding training may be found on the IRB website.