|Amendments to Approved IRB Applications
|Human Subjects Research
|Human Subjects Research Training
IRB is the acronym for Institutional Review Board for Human Participants. Any institution that receives federal funding to conduct research with human participants is required to establish an IRB to review all research that directly or indirectly involves human participants, and to set forth institutional policy governing such research. The University of Redlands IRB operates under a charge.
The IRB has the responsibility to review, approve, disapprove or require changes in research or related activities involving human participants. Research reviewed by the IRB may also be subject to other review and approval or disapproval by officials at the University of Redlands, such as the Provost. However, those officials may not approve research that has not been approved by the IRB. The IRB primary role is to ensure the protection of human participants as subjects of research.
The IRB is a board appointed by Provost of the University of Redlands. The composition consists of representatives from the natural sciences, social sciences, humanities, School of Business, School of Education, Graduate School of Theology, and the broader Redlands community. This last member, the “community” or “unaffiliated” member, cannot be affiliated with the University of Redlands—meaning that they do not work at the University or have any immediate family member who currently attends or works at the University.
For new applications, log into Sitero Mentor IRB using your University of Redlands credentials and follow the instructions on the Info page. Applications that require Full IRB Review are due on the dates listed on the IRB webpage. Applications for Exempt and Expedited review may be submitted any time.
The preparation and submission process differs for students and faculty, administrators, and staff.
Faculty, administrators, and staff should should start their application in Sitero Mentor IRB and follow the instructions provided in the system to complete and submit it
Questions from faculty, administrators, and staff about the IRB and IRB applications may be directed to either the IRB Chair or IRB Administrative Coordinator.
Students should start a new application in Sitero Mentor IRB. The system will instruct students to identify their Faculty Sponsor during the application creation process. During application setup, students should also identify the appropriate Unit IRB Coordinator for their project:
To complete and submit their application, students should follow the instructions provided in Axiom Mentor IRB.
Questions from students about the IRB application process should be directed to the appropriate unit coordinator or the IRB Administrative Coordinator.
Note: Multiple amendment requests should be consolidated into one submission. Each amendment request submitted to the IRB is treated as a separate submission. Accordingly, repeated requests over a short time period can delay approval of all the amendments.
Expedited, exempt, and amendment reviews are completed 10 – 14 days after application submission. Review of applications that require full board review are completed 10 – 14 days after the relevant IRB meeting date. All applications undergo preliminary review by the IRB Administrative Coordinator, who may ask for revisions and corrections before the application is assigned to an IRB member for review. Preliminary reviews generally are completed within 1 – 3 days after application submission.
Visit the Forms section of the IRB website.
Follow the same procedure as during the traditional academic calendar. If your project meets the criteria for expedited review, the IRB Chair review it. Note that reviews may take longer during the summer months. Applications requiring full board review will be discussed during the September IRB meeting.
That depends on the nature of your study and the characteristics of the people you intend to recruit. Research projects that involve only minimal risks are eligible for expedited review, for which you should allow at least 3 – 4 weeks from submission to completion. Applications requiring substantial revisions may take considerably longer. Accordingly, it is important to submit a well-formulated and thoughtful application.
Research projects that involve greater than minimal risk to participants go to the full board for review. Full board meetings are scheduled the third Friday of every month during the academic year. Thus. the board does not meet during June, July, and August. Applications requiring full board review must be submitted at least 1 week in advance of a meeting. Applicants are notified by email of the outcome of the IRB’s decision within 10 – 14 days after the IRB meets.
No. There is no provision in the federal regulations that allow for IRB approval of research that has already been conducted. If data was collected for purposes that the IRB determines to be non-research (e.g., program evaluations for library or educational programs not initially intended to be used for research), IRB approval can be sought for the data analysis going forward.
All research projects that will involve human participants must be submitted for review and approval before beginning the study, even if you believe it might be exempt. This includes proposed research involving existing data and previously collected human fluid and tissue samples, as well as any advertising or other recruitment procedures.
According to IRB Policy, research is defined as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." Activities which meet this definition constitute research for this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
Human subjects are "living individuals about whom an investigator (whether professional or student) conducting research obtains:
Intervention includes both physical procedures by which data are gathered (e.g., hormone assay) and manipulations of the subject or the subject's environment that are performed for research purposes (e.g., providing stimuli to gauge reaction and response).
Interaction includes communication or interpersonal contact between investigator and subject (for example, surveys and interviews).
Private information includes
If you are unsure if your project involves research with human subjects, please consult with IRB members who can provide guidance in making this determination.
Yes, if the study meets the definition for research with human participants, as explained above. The University of Redlands’ Federalwide Assurance (FWA) with the U.S. Department of Health and Human Services states that all research being conducted under the auspices of this institution is subject to review and approval by the IRB. Written approval from the IRB must be in place before any interventions or interactions with human participants (e.g., recruitment) actually begin.
Most IRB applications at the University of Redlands fall into the exempt or expedited categories. Consult with the IRB Administrator if you do not know whch type of review to requests. You may also refer to the Human Subject Regulations Decision Charts: 2018 Requirements published by the HHS Office For Human Subjects Protections (OHRP) for guidance.
Under certain circumstances, human participant research activities may be granted exempt status. Technically, exemption means that all the research activities fall under one or more of the exemption categories specified by the federal regulations.
The significance of exempt status is that the research activity is not monitored by the IRB. Assuming the project does not change, it also is not subject to continuing IRB oversight. Exempt status does not, however, lessen the ethical obligations to subjects as articulated in the Belmont Report and in disciplinary codes of professional conduct. Thus, investigators performing exempt studies still need to make provisions to obtain informed consent, protect confidentiality, minimize risks, and address problems or complaints.
In order to have a research project recognized as exempt, investigators will need to submit their IRB application, along with other study related materials (e.g., consent forms, surveys, questionnaires, interview scripts/outlines, etc.) to the IRB chair. If the project is eligible, the chair will contact investigators with the appropriate documentation.
Please note that for each change that is proposed or occurs during the execution of the research activity, the investigator may need to consult with the IRB to determine if the change affects the eligibility of the research activity to continue to be exempt from IRB review and approval.
No. The Federal Regulations do make certain categories of research exempt from IRB review. However, University of Redlands policy does not allow investigators to self-exempt their human participant research projects. Instead, determining if a project is exempt from IRB review is an administrative review process handled by the IRB.
A waiver of documentation of informed consent is a waiver of the requirement to get a signature on a paper informed consent form or a validated digital signature on an electronic document (e.g., on a PDF via Adobe Sign or DocuSign). A waiver of documentation of informed consent may be appropriate for low-risk studies in which a physical or certified signature would be difficult to obtain. In such cases, consent may be noted by a subject clicking a box on an online form or providing verbal assent to participate in the research.
CITI on-line training is required for all project personnel who will have contact with subjects or will handle identifiable data from subjects. If you are new to the CITI training site. Click the Register button to create to a new account. Search for the University of Redlands as your organizational affiliation.
Completion of two courses is required:
Review the step-by-step guide on how to register and choose courses on the CITI Training site for help on getting started with IRB
Yes, if your research project involves active data collection. Federal regulations and University of Redlands policy require that ALL research involving intervention or interaction with human participants, regardless of whether or not identifying information is being collected, must be submitted for review prior to beginning the research study.
Research data may be stored in cloud services such as OneDrive and Dropbox if access to the service and folder is password protected. A folder stored in the cloud may not be shared publicly or with research personnel who are not approved to work with identifiable data.
Audio and video recordings of research subjects are identifiable data because the images and voices of the subjects may be recognized. Accordingly, PIs must use procedures to protect the confidentiality of any research subjects who are recorded. Such procedures include:
Yes. However, the following human subjects protections should be observed:
Yes! The University of Redlands has an institutional license for the online Qualtrics software. To request access to Qualtrics, send an email to email@example.com that includes a one-sentence description of the type(s) of survey(s) you plan to implement.
Debriefing happens at the conclusion of a human subject's participation in a study. The process gives the PI an opportunity to thank research participants, educate them about the research being conducted, check in about the subjects' welfare, and give them an opportunity to ask questions and/or reflect on their experience. When deception is used in a research study, debriefing is required. A debriefing statement will include the following information:
Possibly. Projects conducted by Redlands undergraduate and graduate students need IRB approval if the project fits the definitions of "research" and "human participants" as described above. See the IRB Manual for guidance on course projects.
Possibly. Seethe IRB Manual for guidance on course projects.
If you are a member of the University of Redlands faculty or staff, or student, and you are the person responsible for the conduct of the study (PI), you must get Redlands IRB approval to conduct your research regardless of where the research takes place. Investigators should contact the IRB office whenever collaborative research is occurring. Separate applications for each institution may be necessary; however, in order to avoid duplicate review, an IRB Authorization Agreement may be arranged with the other institution to establish one IRB as the designated IRB to review and approve the research. If it has already been approved at another university and you are going to collect data here, please submit your application as an expedited review with the other institutions FWA number included.
Yes. If you are a member of the University of Redlands faculty or staff, or a student, and you are the person responsible for the conduct of the study (PI), you must get Redlands IRB approval to conduct your research regardless of where the research takes place. You should also be aware that your project may need local IRB approval (or the equivalent ethical review) in addition to ours.
The IRB Administrative Coordinator, Steven Moore, and IRB chair, Riaz Tejani, can answer questions about your project and IRB review. You can also explore the IRB website for detailed information about the IRB Standard Operating Procedures, policies and procedures (in the IRB manual), application forms, templates, sample applications, CITI Training, meeting schedule and other important information.