Frequently Asked Questions about IRB
The following is a list of general answers to common questions. After reviewing, if you have questions not answered below, or that are more specific to your research, please contact the Office of Institutional Effectiveness, firstname.lastname@example.org.
Q: How do I know if I should submit an application to the CF IRB?
A: You should thoroughly read and understand the CF IRB process, including the federal IRB regulations, particularly focusing on whether the proposed project meets the federal definition of research. The federal definition of research is: a systematic investigation which is intended to develop or contribute to generalizable knowledge. If your activity meets this definition, then an IRB application should be submitted.
Q: Who decides whether an IRB application should be submitted?
A: The investigator self-determines whether to submit an application to CF’s IRB based on his/her understanding of IRB regulations and the CF IRB process. The IRB chair and the IRB members may offer guidance, but the investigator makes the final decision to submit an application.
Q: If I determine that I don’t need to submit an IRB application, may I submit one anyway?
A: Yes. Even if their current intent does not involve contributing to generalizable knowledge, sometimes an investigator may elect to submit an application so that they receive an official IRB determination “just in case” they decide in the future that they would like to include their activities and data in a project that meets the federal definition of research.
Q: Do my students need to submit IRB applications if I assign them to do research projects as part of my class?
A: Yes, but only if the projects meet the federal definition of research.
Q: I think my research qualifies for “exempt” status. Do I still need to submit an IRB application?
A: Yes. Only the IRB committee can officially issue an “exempt” determination.
Q: I don’t know how to answer some of the questions on the IRB application but I am in a hurry to get started. Can I submit it anyway to begin the process and take care of the details later?
A: No. The application is designed to ensure that the IRB has sufficient information to make a judgment regarding compliance with federal Human Research Protections regulations. Investigators who submit incomplete applications will be informed that their applications will not be reviewed until all the information is received. Investigators are encouraged to build sufficient time for IRB review into their research timetable.
Q: May I start on my research before receiving an official IRB determination?
A: Yes. There are certain steps in the research process that you may complete prior to submitting an application to the IRB, but you cannot begin recruiting participants or collecting data until you receive the official IRB determination for your application.
Q: Do all survey projects have to be submitted to the IRB for review?
A: No. Whether an IRB application needs to be submitted is based on whether the proposed project meets the federal definition of research; it is not based on the research process.
Q: Must I submit an IRB application if my survey will be anonymous or if the data I’m collecting will be aggregated?
A: Not necessarily. Whether an IRB application needs to be submitted is based on whether the proposed project meets the federal definition of research; it is not based on the research process.
Q: What happens if I submit my application but the IRB requests changes?
A: The IRB chair, on behalf of the IRB, conducts an initial review of all applications to determine if the application: (1) is complete; (2) is eligible for exemption; (3) is eligible for expedited review; or (4) must receive full IRB review. Based on the federal regulations, changes to the application may be requested in any of these situations. If changes are needed to meet compliance requirements, a detailed explanation is provided; a determination cannot be issued until the investigator submits additional information and/or materials that satisfy the changes requested.
Q: Does receiving an “exempt” determination mean that I do not have to worry about informed consent?
A: No. All research projects that receive a determination of “exempt” or “approval” (expedited or full) must still comply with informed consent requirements. Projects that do not fall under the federal definition of research involving human subjects are not required to comply with federal informed consent regulations, although compliance is encouraged.
Q: How long is IRB approval effective?
A: When you submit your application, you can request any period of time up to 10 years. Based on federal regulations, projects longer than 12 months that receive approval under the expedited or full review process will be required to submit periodic reports (minimum: annually) as a condition of approval.
Q: Someone has asked me to participate in his/her research. How do I know it has been through IRB review?
A: IRB review is documented by a stamp placed on informed consent forms submitted at the time of application. The stamp contains the IRB application number assigned to the project and the determination given. If no stamp is evident on the informed consent document that you receive, you can email email@example.com and ask if an IRB application has been submitted for the project in question.
Q: Who should complete IRB training?
A: Regulations require that investigators administering research that has been approved via either expedited or full review must complete training in a timely manner as a condition of the approved research. However, investigators may complete training even if no research is currently planned.
Q: Do I have to take CF’s IRB training if I completed IRB training elsewhere?
A: Federal regulations indicate that other formal IRB training may satisfy the training requirement imposed on investigators of approved research protocols as long as the training was completed within the past three years. Any form of IRB training is accepted, you can decide to take CF PowerPoint training or you may register for free a formal assessment at: http://phrp.nihtraining.com/users/login.php.
Q: What happens if my application is disapproved?
A: Before a determination is issued, the IRB strives to communicate with investigators to request or suggest modifications that will bring the application into compliance as needed. Should an application be subject to full review by the IRB, and the board issues a disapproval, the determination cannot be overridden based on federal regulations. Based on the pre-determination communication process with investigators, CF’s IRB does not have an appeals process.
Q: Can I still try to do my research if my application is disapproved?
A: Technically, yes, but not without consequences. The IRB process is designed to place the burden on the investigator; just as with any regulation or policy, ultimately it is the individual’s responsibility to comply. Investigators are expected to submit an IRB application, to comply with the regulations when the application is approved, or to not proceed if the application is disapproved. Receiving disapproval from the IRB cannot physically stop an investigator from moving forward if he/she so chooses; the IRB can only exempt, approve, disapprove, or terminate IRB approval. However, it is important to be aware that a disapproval or the absence of a formal IRB determination from CF’s IRB means that the researcher will not be protected from any individual risk or liability that IRB approval provides. In addition, the investigator will be at risk for not having their study accepted for publication or presentation. Also, by having a process whereby a summary of IRB applications and determinations is shared, the CF community is informed and thus may take any action that they believe is appropriate separate from the IRB application process.
Q: I have agreed to serve as a project director on a CF grant. Do I need to submit an IRB application?
A: IRB review of research conducted as part of institutional grant proposals is now integrated into the final review process before grants are submitted to the 17 federal agencies that have agreed to follow the Common Rule regarding Human Research Protection. As a result, project directors should follow the direction given to them by the Office of Grants Funding.
Q: How long does it take to receive a determination after I submit my application?
A: The IRB committee meets quarterly, we request that applications be submitted at least three weeks prior to the IRB meeting. The timing of the determination will vary based upon the completeness of the application, current workload, and other factors. Determinations for some applications involving complex protocol, needing input from special resources, and/or going to the full board for review could take several months. Investigators should not begin the participant recruitment process or data collection until they receive their official IRB determination, but they may work on other aspects of their research while waiting.