1. What is the IRB?
IRB stands for the Institutional Review Board for the protection of human subjects. John Carroll University approved and adopted a policy statement for the IRB in 1997, applicable to all JCU faculty, staff, administrators, and students. See the statement of ethical principles, definitions, and general policy guidelines which can be found in the policy statement.
2. How is research defined?
Based on federal guidelines and as defined in the JCU IRB policy statement, “research” means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
3. What kind of research projects do I need to file with the IRB?
Any research project which involves human subjects which will result in generalizable knowledge conducted by JCU personnel or conducted on JCU property should be filed with the IRB. These projects include, but are not limited to, the use of interviews, surveys, questionnaires, behavioral analyses, and focus groups.
4. Why do I need approval from the IRB for my research involving human subjects? I’m an experienced researcher and I’ve never had to do this before.
Federal protection of human subjects developed from international concerns over the unethical treatment of humans participating in research studies. The Nuremberg Code responded to Nazi human experimentation. According to the code, voluntary consent is essential for any human research and the project should minimize any unnecessary risk to the subject. As adopted by the World Medical Assembly in 1964, the Declaration of Helsinki made similar recommendations. In the United States, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research issued The Belmont Report in 1969 stating basic ethical principles for biomedical and behavioral research.
The Office of Human Research Protections (OHRP) is the federal agency responsible for overseeing this area. Visit the IRB forms page to access The Declaration of Helsinki and The Belmont Report , and to explore the OHRP website. FDA regulated projects, whether funded or unfunded, must follow the appropriate human research regulations. Like most universities, JCU has voluntarily mandated IRB approval for all human subject research resulting in generalizable knowledge.
5. How do I know what forms to file with the IRB?
Our application for new projects is titled “IRB Application for Human Subject Research.” Forms are available to request an addendum or to request the continuation of an approved project. The IRB may ask for additional information and/or revisions of materials or procedures before approval is granted. See the IRB Forms page to download copies of the forms and Types of IRB Review for additional guidance.
6. What does “exempt from full board review” mean and how is it different from an “expedited review”?
The federal government has determined that some minimal risk human subject research resulting in generalizable knowledge may be categorized either as exempt or capable of receiving an expedited review. Like many universities, JCU requests full information on possible exempt or expeditable projects to ensure that the research is indeed minimal risk. Exempt projects are generally examined by the IRB Administrator and possibly one reviewer. Expedited category projects are generally reviewed by two reviewers. Non-minimal risk projects are reviewed by the entire board. The IRB reserves the right to make the final determination as to which review is appropriate.
7. What is “minimal risk”?
Based on federal guidelines, 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 for a healthy person.
8. How long will it take for the IRB to review my application?
It depends. The IRB realizes that many projects, such as minimal risk student research projects, have tight deadlines and is dedicated to providing a quick turnaround. A faster response time is dependant, in part, on whether
- the application is neatly and completely filled out and easy to understand
- copies of all pertinent materials are included in an ordered appendix
- the project is of minimal risk and complexity with the risk factors recognized and managed
- the project avoids the use of special population groups
An exempted project review may be completed within one week of receipt, a expedited review generally within two weeks of receipt, and a full board review within four to six weeks of receipt. Note that the board will make the final determination as to which category of review is most appropriate, and that a revise and resubmit decision is frequently given before an application receives approval.
9. What are the common reasons for a revise and resubmit decision by the IRB?
Additional information is often requested on the distribution and collection of consent forms and/or research instruments and on how the data, including the consent form, will be stored and who will have access to the data. The consent form may be missing items or may not differentiate between confidentiality and anonymity. Risk factors are not listed on the application or a management plan to mitigate risk is not listed on the application. There may be spelling errors on the consent form or research instruments.
10. Why does the IRB want to look at the design and analysis for my research project?
Bad science equals bad research and the IRB is mandated to protect human subjects from bad or unnecessary research. In the event that the IRB would question the design or analysis of the project, the researcher would be given the opportunity to explain or revise the project.
11. What is the difference between confidential and anonymous and why does the IRB insist on the correct terminology?
Data is confidential if the researcher can link the data to a particular participant but will protect the privacy of the participant. The data is anonymous if there are no identifiers connected to the data and the researcher is unable to link data to any one individual. Identifiers may include gender, religion, birth month, salary range, or ethnicity, especially if the subject pool is small. If the data is of a sensitive nature, the IRB would carefully examine the consent form to ensure that the participant is aware of study design. Projects may collect data in a confidential manner but analyze and/or report it in an anonymous manner, or the data may be collected and analyzed on an anonymous basis. The consent form should make these procedures clearly understood.
12. Why is the IRB so concerned with proper wording on the consent form?
Informed consent is one of the basic principles of ethical conduct for human subject research as stated in the Nuremberg Code , developed in response to human experimentation conducted by the Nazis. The Code states that “the voluntary consent of the human subject is absolutely essential.”
13. I’ve always conscientiously followed the ethical guidelines in my subject field. Why do I need to tell the IRB in detail how I will distribute and collect consent forms?
The IRB cannot evaluate a project unless the protocol is clearly explained. The investigator is expected to follow the written procedures which were approved.
14. How long should I keep my consent forms on file?
Federal regulations require consent forms to be kept three years after the completion of the project.
15. How do IRB members review an IRB application?
IRB reviewers pay particular attention to certain parts of the application as required by federal regulations. A reviewer will typically look for answers to the following questions:
- The subject pool: Are subjects representative of the general population? Can you justify narrowing the pool to a select segment of the population? Can you justify the use of vulnerable subjects, such as the mentally disabled?
- The protocol: Is your protocol fully described? Can it be validated? Can any risk to the subjects be justified by the outcome of the research? Who will analyze the research and by what method?
- The consent form: Does the consent form provide all the information required? See informed consent information.
- The data: Will the data be carefully collected to protect the privacy of the subjects? Is the data collected in an anonymous or in a confidential manner? Who will have access to the data? Where will the data be stored? When and how will the data be destroyed? How many identifiers are collected and does that raise the risk level?
- The results: What will you do with the results of the data? Who will have access to results and for what purpose?
16. Several of my students want to conduct a research project involving human subjects. Do they need to file with the IRB?
Individual student projects, including research for independent study and theses, involving the collection of data from human subjects (e.g., opinions, behaviors, feelings, personal information) which will also be generalized (e.g., by publishing — including master’s theses; presenting outside the class; citing in another paper; poster presentations) require students to file an IRB application with the IRB. These projects may be eligible for exempt or expedited review. The final decision on review category will be made by the IRB. Projects not presented outside of the classroom will not result in generalizable knowledge and do not need IRB review; however, the data collected cannot be used in an future presentation or publication.
17. I generally require my entire class to conduct research projects involving human subjects. Does each student need to file an application with the IRB?
In most cases, class projects involving human subjects are not intended to contribute to generalizable knowledge and therefore are not covered under the federal regulations for IRBs (see also question 16 above).
However, IRB approval should be obtained for class research projects if (1) data will be collected from a human subject (e.g., opinions, behaviors, feelings, personal information), regardless of the sensitivity of the data, AND (2) the results of the classroom research project will contribute to generalizable knowledge (e.g., by publishing — including master’s theses; presenting outside the class; citing in another paper; poster presentations). If IRB approval is necessary and a class will be conducting one basic project, the instructor can file one IRB application covering the entire class. If individual students or small groups of students conduct varying types of projects that require IRB approval, then an IRB application from each student or group is required.
18. The semester is really short. My students don’t have time to file an application with the IRB and wait for a response before beginning their projects. Why can’t I just approve the projects since they will be conducted under my supervision?
The IRB’s primary charge is the protection of human subjects in research and is especially concerned when inexperienced researchers are conducting greater than minimal risk studies involving human subjects for those projects which fall under IRB jurisdiction. With a well-designed protocol and a well-written application, the IRB can quickly and efficiently process an application.
19. My student is working off-campus (e.g, at the Cleveland Clinic) on a project that would fall under the jurisdiction of the IRB and wants credit for the internship or plans to present the work in a thesis. Does the JCU IRB need to approve the entire project before the student begins the internship?
No, the JCU IRB does not need to review the project. However, the project should have received IRB approval from the host institution; a copy of the IRB approval letter should be submitted with the request for credit or thesis approval.
20. I’m working on a project with faculty from another university. If my co-investigators receive IRB approval from their university, do I still need to file with JCU?
Yes. The federal guidelines are meant to be a starting place from which institutions should develop their own policies and procedures regarding the use of human subjects in research. Since JCU would not know if another institution’s policy is compatible with ours, the JCU IRB will conduct its own review of the project. If available, the researcher should submit the other institution’s IRB approval to the JCU IRB. However, to avoid duplication of effort, JCU often accepts the final approval by a collaborating IRB without changes.
21. The IRB form at another university is much simpler (or much more complex) than the one at JCU. Why does JCU have different questions on their form?
Each institution develops their own policies, forms, and procedures using the federal guidelines as a basis. Some institutions will take a more stringent look at certain areas of the project; other will request minimal information. The policies, procedures, and forms developed by the JCU IRB will be used to evaluate JCU research projects. The IRB will, however, continue to revise the forms and procedures as necessary.
22. What happens if I don’t file my research with the IRB?
You will be in violation of university policy and will need to respond to university administration as with any other serious ethical violation.
23. I’ve already started a research project and didn’t realize that I needed to receive IRB approval first. What should I do?
Contact the IRB administrator as soon as possible with information on your project.
24. Why can’t I begin my research as soon as I file the application with the IRB?
The IRB may request that you revise your consent form or your protocol for selecting subjects. If you have already started your project, you may have placed your participants in harm and may need to start the project again using approved procedures and research instruments.
25. I’m conducting a project for my department chair where I interview staff members or students and I don’t plan on presenting the results at a conference or publishing the results. Do I need to file this project with the IRB?
No. Projects done for internal review only where the results will not be made public (such as those for program review) do not need IRB review as they are technically not research. However, the results cannot at a later date be presented at a conference or published in an article.
26. Why are there so many biomedical conditions listed in the exempt and expedited regulations?
The guidelines created by the federal government do not separate biomedical research from social and behavioral science research. The exempt and expedited categories cover all disciplines.
27. If my research project is disapproved by the JCU IRB, what recourse do I have? Can University Administration override the IRB’s ruling?
In the rare event that the IRB would disapprove your project, it is not possible for university administration to override that decision according to our policy statement as mandated by the federal guidelines. However, the IRB would hope to work with the researcher to come to a mutually agreeable revision of the project before taking the step of disapproval. Note that IRB approval does not indicate university administration approval. The IRB evaluates a project in regard to the protection of human participants only. University administration may disapprove a project which is acceptable to the IRB.
28. I just received notification that my grant has been approved. I don’t have time to file an application with the IRB and wait for a response before beginning the project and I didn’t know which part of the grant proposal would be funded in advance. Why should I jeopardize my funding by delaying the project?
University policy mandates that the IRB oversee all research involving human participants. The protection of human subjects takes priority over any monetary awards. When you develop your grant proposal, you may contact the IRB in advance to discuss a preliminary application along general guidelines for your project. The IRB can advise you on the requirements of consent forms and which areas are likely to be of concern in your program, which may reduce the amount of revisions requested when you file your application. With a well-designed protocol and a well-written IRB application, the IRB can process your application in a timely and efficient manner in most cases. Note that you may not begin your project until you have received IRB approval. Most federal agencies require IRB approval for human subject research projects.
29. Is there a time limit on IRB approvals?
The IRB can approve a research protocol for one year only. If your project will run longer than 12 months, you should submit a Continuation Request Form to the IRB for review before the approval expires.
30. What happens if I want the change the protocol for the project after I receive IRB approval?
If you would like to implement a significant change in your protocol (for example, greatly expanding the sample size, selecting another subject pool, using a different survey instrument), you should submit an Addendum Request Form to the IRB. No significant changes, either to procedures, methodology, materials, or subject pools, should be made to your project until you have received approval from the IRB.
31. What should I do if I receive a complaint from a participant about the project or if a participant is injured in some way during the course of the project?
Incidents of complaint or injury should be reported to your supervisor and to the IRB administrator as soon as possible.
32. All of the horror stories in the news about research gone bad seem to be biomedical in nature. Why would the federal government be worried about behavioral and social science research?
Social science/behavioral studies which have harmed participants include the Milgram Study on obedience and authority which used deception instead of informed consent and caused extreme psychological stress to some of the participants. Participants can also be harmed by revealing personal or sensitive information.
33. I’m doing a minimal risk study. Do I still need to take the CITI training?
Yes. All IRB researchers listed on the an IRB application (including faculty sponsors) need to complete the appropriate CITI training course regardless of the level of risk. Certain higher risk studies may require additional project-relevant modules . OHRP strongly recommends that researchers maintain continuing knowledge relating to the ethical conduct of human subjects research.
34. I’m still not sure if my project should be filed with the IRB or what form I should use. Who can I talk to about my project?
If you have additional questions, contact the IRB Administrator.