Frequently Asked Questions
Who are the members of the IRB?All members of the IRB, with one exception, are full-time Loyola Faculty and Staff Members. There is one individual considered the “community” member who has no formal relationship with Loyola outside the IRB. Members come from the following disciplines: psychology, nursing, classical studies, social work, sociology/anthropology, and business. A prisoner advocate also serves on our Board. An attorney, from the Office of the General Council, serves as the IRB’s legal resource, but is not an IRB member.
- How often does the IRB meet?
The IRB meets once per month to review applications submitted for Full review. The IRB does meet through the summer provided that enough members are present. There must be a quorum present to review protocols.
- Where do I send my research materials for review?
All research applications for IRB approval, Exemption, Instructor Facilitated course projects, etc, should be sent to IRB@luc.edu.
- How is expedited review conducted?
Expedited review is an IRB review mechanism which does not take place at a convened IRB meeting. Rather, protocols are assigned to either the Board Chair or Board Vice-Chair. A review decision will be made and feedback will be subsequently sent to investigators. Expedited review is conducted on a rolling basis, and Investigators may submit Expedited Review applications at any time. Expedited Review applications will be reviewed within fifteen business days of being received. These are the only differences between full and expedited review. Criteria for IRB approval remain the same.
- How long will it take to receive feedback from the IRB?
If a protocol is submitted for full review, it will take at least 1 week past the IRB meeting to compile the minutes of that meeting and draft individual letters to investigators. Letters are sent via email, so it is important to make sure that the email address you provide on your application is the email address where you would like to receive correspondence from the IRB.
If a protocol is submitted for Expedited Review, the IRB will email the review decision and feedback to the Investigator within fifteen business days of receiving the application.
- How do I decide whether I should submit my protocol for expedited or full review?
Only certain types of research can be reviewed via an expedited procedure. There are very specific criteria that a project must meet in order to qualify for expedited review. These are outlined in the Review Mechanisms Section of this Manual. You should consult these guidelines carefully. If your project meets all criteria, you may apply for expedited review. If not, you must apply for full review. If you are not sure, contact the Research Services Compliance Manager for further guidance. Do not apply for expedited review if you are not certain that your project qualifies. You may waste valuable time in the review process.
- If I am doing a study using census data or other data sets that have been archived and are publicly available, do I need to submit a proposal for review?
Absolutely. Although this kind of research is usually considered “exempt” it must be declared as such by the Research Services Compliance Manager and never by individual investigators.
- If I am an undergraduate student conducting research with human subjects for purposes of a Mulcahy Scholarship, honors thesis, or independent study, must I submit an application for IRB Review?
Yes. Undergraduate students are bound by the same policies and procedures as graduate students, faculty and staff.
- What does "conditional" approval mean?
If an investigator receives feedback from the IRB indicating that the proposal has been conditionally approved, this does not mean you can go ahead and begin your research. You have certain conditions to meet in order to achieve approval. You must respond to the IRB chair in writing. Your response will be reviewed by the Compliance Manager and IRB Chair (or designated IRB members). Provided that the Chair accepts your responses and addition revisions are not required, she will grant final approval of the project. Only after final approval has been granted may an investigator begin the research.
- What if I don't understand or disagree with the feedback I receive from the IRB, and/or feel my project has been misconstrued?
The IRB welcomes an open dialogue between it and the Loyola community of which it is a part. Thus, investigators are welcome and strongly encouraged to contact the IRB Chair or Compliance Manager to discuss the feedback they’ve received, express any concerns or, to clarify something they believe has been misconstrued by the IRB.
- Must an investigator obtain letters from cooperating institutions prior to submitting an application to the IRB?
Not necessarily, but final approval to collect data at a specific site will not be granted until a letter is received. Investigators are strongly encouraged to speak with the appropriate person at the institution(s) to determine if the project would be allowable, at the very least. In some instances Investigators may find that other institutions they are cooperating with will not approve a project until Loyola has granted a project final approval. In these instances the IRB will approve a project before a letter of cooperation is received. However, Investigators are required to submit all letters of cooperation or approvals from other IRBs to the Loyola IRB before beginnning any research activities.
- When reviewing a proposal, will the IRB consider the soundness of the research methodology?
Yes. Although the IRB's primary focus is on the ethical aspects of the research, the IRB is required by regulations to determine that "the research design is scientifically sound and does not expose subjects to unnecessary risk." In addition, in order to approve a proposal, the IRB must also determine that the benefits of the research outweigh any risks to participants. Thus, the IRB must be able to make a determination that the research design will yield beneficial information. If the research design is so flawed that it will not yield useful information and there is more than minimal risk to participants, then the benefits do not outweigh the risks and the research may not be approved.
- Under what conditions must I continue to submit annual renewal applications for purposes of Continuing Review?
Annual Continuing Review applications must be submitted as long as research-related interventions or interactions with human subjects are on-going or as long as data collection and analysis of identifiable private information are on-going.
- What if I need to make a change in my consent form or research protocol?
All changes must be submitted for IRB approval prior to implementation. Investigators should use the Application for Amendment to Research Protocol form to submit these changes. IRB review of these applications may be subject to submission deadlines and meeting dates; please consult with the IRB Chair or Compliance Manager.
- Must I have IRB approval for my research prior to submitting a proposal for external funding?
For most funding agencies, applications may be submitted pending IRB review. Funding sources understand that researchers should know whether or not a project will be funded before submitting for IRB review. However once an investigator has reasonable assurance that the research will be funded, IRB approval must be sought. Funds will not be released until IRB approval has been granted.
- What happens if my faculty sponsor leaves the University?
If your sponsor leaves the University you must find another full-time faculty member to oversee the conduct of the research. The new sponsor should provide written documentation to Research Services indicating a willingness to accept the role of faculty sponsor.
- How should data be stored?
Data should always be stored in a locked location and cleansed of any identifying participant information. Consent forms or any other items which could link individual participants to the data, should be stored separately.
- How long should I keep consent forms and other research materials?
It is strongly recommended that consent forms and substantive data be kept in accordance with the legal and professional standards of a particular field. If no guidance is available, it is recommended that you keep such materials for an indefinite period of time. Any master code lists or tapes linking participants to individual data should be destroyed once analysis and transcription have been completed.