Q. What is the Institutional Review Board (IRB?) A. It is a compliance committee responsible for the protection of the rights and welfare of individuals who participate as subjects in research conducted under the auspices of the Ball State University. The IRB is responsible for the review and approval of research if it involved human subjects. It is a compliance committee responsible for the protection of the rights and welfare of individuals who participate as subjects in research conducted under the auspices of the Ball State University. The IRB is responsible for the review and approval of research if it involved human subjects.
Q. What constitutes research with human subjects? A. As defined by the federal regulations, research is the systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
A human subject is defined as a living individual about whom an investigator (whether faculty or student) obtains either (1) data through intervention or interaction with the individual, or (2) identifiable private information.
The Office for Protection from Research Risks (OPRR) provides decision trees to help explain what constitutes research with human subjects.
Q. Are there different categories of review? A. There are three categories of review depending on the amount of risk to the subject:
Q. What is minimal risk? A. According to the federal regulations, 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. According to the federal regulations, 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.
Q. How often does the IRB meet? A. During the academic year when classes are in session, a subcommittee of the IRB meets every week to review exempt and expedited review protocols. The IRB does not meet during semester breaks or spring break. The full IRB meets once a month to review full review protocols. During the summer, the IRB meets at least twice a month to review exempt and expedited protocols and as needed for full review protocols. IRB Deadlines & Meeting Schedule
Q. How long does it take to be notified of the findings of the IRB review? A. The researcher will be notified within a week through an email generated by IRBNet. An official letter from the IRB will be attached to your protocol within IRBNet. To view the letter you must log back into your study through IRBNet and go to the Study Designer page. You will see a decision letter posted underneath the ‘Documents from Ball State University IRB' header.
Q. What do I submit for the review process? A. If you are creating a new study, you must provide the following:
Click here for instructions on how to create, modify, submit, etc. a study.
Q. When can I start my research? A. You can begin your project AFTER IT HAS RECEIVED IRB APPROVAL.You cannot begin collecting data prior to the approval of the research project by the IRB. Because the privacy issues remain until the data analysis is complete or the data have been de-identified, the investigator must maintain the approval of the project until the analysis is complete. If the data collection and analysis will exceed the original approval period, the researcher will need to request a Continuing Review of the project for an additional period as not to exceed twelve months. To maintain the continuous approval of the project, the Continuing Review must be submitted to the IRB in sufficient time (usually one month prior to the expiration date) to allow for the review and approval by the IRB of the Continuing Review.
Q. What may delay the review and/or approval of a research protocol? A. Frequently, protocols are approved during the initial IRB review. When protocols do not receive approval, however, it is usually because the IRB needs clarification and/or additional information. Some of the more common omissions are listed below.
Not following the guidelines for writing the protocol – The guidelines provide guidance as to the basic information required in the protocol. The narrative guidelines can be found in the Study Designer page within IRBNet from the Forms and Reference Library drop-down menu. Bear in mind that some of the members of the IRB may not be familiar with the area of your research. Therefore, the protocol should be written with sufficient clarity and detail that a person with no background in your field would understand the research. Do not assume that "everyone knows that…"
If the research is to be conducted at another university or at an institution such as a hospital, the researcher must contact the institution's IRB to determine whether that IRB must review and approve the research.
Q. Can I get retrospective approval for data collection I have already carried out? A. The IRB cannot give retrospective approval for research conducted in the past. IRB approval to conduct research must be obtained prior to any interaction with research subjects; this includes the recruitment of subjects to participate in the research.
Q. What is archival data? A. Archival data are data that were collected in the past, usually for a purpose other than research. The complete data set must exist prior to the initiation of a research project using the data.
Copyright © 2013 Ball State University 2000 W. University Ave. Muncie, IN 47306
800-382-8540 and 765-289-1241