Please contact the IRB at irb@carrollu.edu if your question is not answered.

Q. Do I need approval from the IRB?

A. Any faculty or staff member who intends to conduct research that involves people or animals must complete the IRB review process before beginning any research or accepting any funding for the research project. Any student conducting research outside of class that meets the definition of research must also complete the IRB review process before beginning any research. If you are not sure whether you need IRB review for your project, be sure to click on Do I Nee IRB Review? to learn more.

Q. How long does review take?

A. Please note: You may not being your research until the IRB review process has been formally completed and you have a letter from the committee chair. Review of Exempt or Expedited protocols takes about two to three weeks. The review process for protocols submitted for Full Review can take up to a month or longer to complete. You should include suffiient time in your research plan as allowance for any IRB-required hanges to the research protocol.

Q. How long is the approval for?

A. A standard approval is for a period of one year. However, the Board may grant approval for less than one year or request monitoring reports. At the end of the year, some projects will be eligible for an expedited renewal for a period of time up to one year as long as there is no change in research protocol. If, at any time, research protocol is changed, the IRB must be notified immediately and the Board may require additional review.

Q. Do I need any special training to use human participants/animal subjects in research?

A. All key personnel working with human or animal subjets receive training in ethical guidelines and regulations. "Key personnel" is defined as any individual responsible for the design and conduct of the study. This would include persons who have direct or substantive involvement in proposing, performing, reviewing, analyzing, or reporting research and includes students fullfilling these roles as well as their faculty advisors. CITI online free training will satisfy this training requirement for research involving human or animal subjects.

Q. Do I need approval for recording a participant?

A. If photographic/audio/video recordings will be used only for transcription of original study data, and only the lead investigator or research team members will have access to those recorded materials, then a Media Records Release Form is not needed. In such cases, the researcher's intent to photograph or record should be disclosed in the main study consent form, along with information about restricted use and access of the photos/recordings, as well as when they will be destroyed and/or how long they will be retained.

Q. What are the types of risks?

A. Risk: The probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study. Both the probability and magnitude of possible harm may vary from minimal to significant. Federal regulations define only "minimal risk".
Minimal Risk: A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed 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 [Federal Policy §___.102(i)]. For example, the risk of drawing a small amount of blood from a healthy individual for research purposes is no greater than the risk of doing so as part of routine physical examination. The definition of minimal risk for research involving prisoners differs somewhat from that given for non-institutionalized adults. [See 45 CFR 303(d) and Guidebook Chapter 6, Section E, "Prisoners."]

Q. What if I don't get IRB approval?

A. If an investigator's research proposal is rejected by the IRB committee or chair, the investigator will be able to reapply. The committee will work with the investigator to strengthen the protocol and find ways to avoid potential problems. But any investigator who does not go through the IRB will face sanctions. Aside from potential ethical implications for the subject and for the investigator, bypassing IRB review brings other risks. The University will not support unapproved research: Liability issues arising from unapproved research become the responsibility of the investigator. For more information, see the University's IRB policy.

Q. I'm conducting all or part of my research off-site (at a non-Carroll site). Should I apply for project approval through the other site's IRB and the Carroll IRB?

A. If the other site has an IRB:
Many hospitals, universities and other institutions have their own IRBs. If the site of your research has an IRB, you will have to go through the IRB review process at the site where you are doing the work. You must submit the protocol to the Carroll IRB after the other institution's review is complete. Carroll's IRB may accept the IRB materials from the other site without additional review or additional review might be required. Be sure to plan ahead and communicate with Carroll's IRB chair to avoid potential problems. Remember that review and approval requirements may vary among institutions, so you should familiarize yourself with each IRB's policies.
A. If the other site doesn't have an IRB:
You must go through Carroll's IRB review process. Elementary schools, nursing homes and community centers often serve as non-Carroll research sites, and rarely have IRBs. You should ask appropriate personnel (e.g., school principal, director of nursing home, community center director) at the research site to provide a letter indicating that (s)he has read your research proposal, and that you, the investigator, have permission to conduct your research at his or her facilities. The Carroll IRB requires evidence of site permission for its review and approval of your project.

Q. My protocol was approved, but now I want to modify it. How do I do that?

A. Changes to a research protocol must be reviewed and approved by the IRB prior to its implementation. If after submission you nee to make changes to your study, please make clear revisions to the original document and resubmit with an explanation as to why those changes are necessary. Attach new or revised instruments, measures, consent documents, etc., as appropriate.

Q. I'm not applying for funding for my research. Do I still have to go through IRB?

A. Yes. Any research involving human or animal subjects must be submitted to the IRB whether or not there is a funding source. Review for the protection of human subjects is made without regard for funding source.

Please contact the IRB at irb@carrollu.edu if your question is not answered.