University of Redlands

Frequently ASKED QUESTIONS ABOUT THE IRB

Index

Amendments to Approved IRB Applications IRB Applications
Confidentiality IRB Background
Human Subjects Research IRB Review
Human Subjects Research Training Research Methods
Informed Consent Student Research
International Research Support

IRB Background

What is the IRB?

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.

Who makes up the IRB?

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.

IRB Applications

How do I prepare and submit an IRB application?

For new applications, log into Axiom Mentor IRB using your University of Redlands credentials and follow the instructions on the Info page.  Completed applications are due on the dates listed on the IRB webpage.

The preparation and submission process differs for students and faculty, administrators, and staff. 

Faculty, Administrators, and Staff

Faculty, administrators, and staff should should start their application in Axiom 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

Students should start a new application in Axiom 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.

How do I submit an amendment to an approved IRB application?

  1. Log into Axiom Mentor.
  2. Open the approved application.
  3. Find the Amendments tab at the bottom of the application.
  4. Click Create New Amendment to open the amendment form.
  5. Check the amendment type, upload any revised documents, and then click Create Amendment.
  6. Answer the questions in the amendment form.

Where can I download forms for IRB applications?

Visit the Forms section of the IRB website.

What are the most common reasons for not approving an application?

  • Applicants fail to provide information, such as a signed letter of Agreement from a gatekeeper, that they have permission to recruit participants in the manner they describe. For example, if you plan to recruit students from the University’s dorms or the library, then you need a signed letter of agreement from Student Life stating that you can recruit participants in the manner you describe. Or, if you plan to use students who are attending a local school, then you need permission from the school principal and/or school district supervisor stating that you can recruit the students in your project. Different organizations will have different authority figures who are responsible for giving a researcher permission to recruit participants at a particular site. Gatekeeper letters need to be included with applications submitted to the IRB. If you are unsure from whom you need to obtain permission, ask your faculty sponsor or email the Chair of the IRB.
  • The application is incomplete. Please answer all questions.
  • Questionnaires, surveys, or sample interview questions were not included with the application. Please include these materials.
  • Applicants have not made a compelling case for their research project. Do not resort to hyperbole (e.g., “My goal is to invalidate the SAT using 5 volunteers from the University of Redlands”). Be honest about what you can accomplish with your project. In many cases, it may be nothing more than replicating a study to see whether you can get the same result. This is the same reason, for example, why students in biology, chemistry, and physics have lab components for their courses. Students in courses with labs are not trying to discover something new; they are trying to learn basic lab skills.
  • The project has no chance whatsoever of meeting its stated objective. The University of Redlands’ guidelines state that the IRB cannot approve a project that is a waste of participants’ time. A project that is overtly flawed that it cannot achieve its objective is a project that will waste participants’ time. Projects of this sort are misleading (because they cannot achieve their objective) and thus unethical.
  • The IRB cannot approve that which we cannot understand. Write for a lay audience. At best, one member of the IRB might be familiar with your discipline and its jargon. Assume that the members of the IRB are educated, but not steeped in the traditions and vocabulary of your discipline. Explain things clearly in everyday language.

I need my application evaluated over the summer. How does the IRB handle applications submitted during June, July, and August?

Follow the same procedure as during the traditional academic calendar. If your project meets the criteria for expedited review, the IRB chair will handle it. But be aware that the wait time may be longer.

How long will it take for me to obtain approval to do my study?

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 weeks. However, many if not most projects involve more than minimal risk (and amount of risk is determined by the chair of the IRB, not the investigator).

Research projects that involve greater than minimal risk to participants will need to go to the full board for review, which is scheduled for the third Friday of every month (excepting June/July/August). For applications requiring full board review. The IRB needs completed applications at least 1 week in advance of a meeting. Applicants are notified by email of the outcome of the IRB’s decision within 1 week after the IRB meets, often sooner. If you do not hear back from the IRB within a week after we meet, then you should assume that we never received your application. A rough estimate for a majority of applications is 6-8 weeks from completed draft to approved project. Do not forget to give your supervisor time to read your application and provide feedback before submitting it.

Can the IRB approve a project "retroactively?"

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.

Human Subjects Research

When am I required to submit a proposal involving research with human participants to the IRB?

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.

How do I know if I am conducting research with human participants?

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:

  • data through intervention or interaction with the individual,
  • identifiable private information."

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

  • information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and
  • information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record).

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.

I am just doing a simple survey; do I need to submit my proposal to the IRB?

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.

IRB Review

How do I know what kind of IRB review I need?

Axiom Mentor IRB has a built-in survey to help you decide what kind of IRB review is needed for your project. Choose Use Pre-Protocol Survey 2019 to work through the survey before you start your application. 

axiom_mentor_review_type.png

Alternatively, you may use the Human Subject Regulations Decision Charts: 2018 Requirements published by the HHS Office For Human Subjects Protections (OHRP).

What is meant by "exempt" protocol? What are the requirements?

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.

If my research qualifies as exempt, does this mean that I don't have to submit a protocol for review?

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.

Informed Consent

What is a waiver of documentation of informed consent and when can I request one?

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. 

Human Subjects Research Training

What training is required before conducting research with human subjects?

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:

  • ‘Investigators – Human Subjects’ basic course and
  • Social and Behavioral Responsible Conduct of Research’ modules

Where can I find help with CITI Training?

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 

Confidentiality

I am not collecting any identifying information in my human participant research project. Do I need to submit my proposal to the IRB for review?

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.

Can I store research data in the cloud?

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 Recording of Human Research Subjects

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:

  • Only using audio recordings whenever possible
  • Using pseudonyms in recordings of research subjects
  • Transcribing recordings into de-identified data and destroying recordings as soon as possible
  • Using dedicated, password-protected devices rather than phones to record conversations with research subjects

Can I use Zoom or a similar communication tool to record interviews with human research subjects?

Yes. However, the following human subjects protections should be observed:

  • Create private, password-protected meetings for the interviews.
  • Enable a waiting room function so that new attendees must be approved by the host.
  • Establish ground rules for subjects so that they do not record or take screen shots of sessions they participate in.
  • If recording a meeting, disable cloud recording so that the recording will be saved directly to a password-protected computer.
  • To protect the confidentiality of research subjects, conduct audio-only interviews and delete the recordings as soon as they are transcribed.
  • When using cloud recording to generate an automatic transcript from Zoom or a similar tool, delete recordings and transcripts from the cloud as soon as possible.
  • Inform subjects if recordings of meetings will be made, where such recordings will be stored, and when and how the recordings will be deleted. If cloud recordings will be created during the meetings, inform subjects that such recordings are accessible by the service provider until deleted.

Research Methods

What is debriefing and why should I debrief human research subjects?

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:

  • Study title and names and contact information of the study team
  • Goals of the research
  • How to ask questions and/or provide feedback about the research
  • How to withdraw from the study
  • Where research subjects may find help if the study has caused discomfort or distress
  • How research subjects may receive a description of the results of the study
  • A thank you for participating

Student Research

Do research projects conducted by Redlands students need IRB approval?

Yes. 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. If the project is to be used in classroom setting only to teach research methods, the project may be submitted under the Course Research umbrella with its shorter form (see the IRB website to download the Course Project form). However, this means that at no point during or after the conclusion of the course can the results or the data be used for publication, presentation or other research purposes. Therefore, students should discuss these limitations with their instructor or faculty advisor so that they can determine whether IRB review is necessary.

If I have students doing research as part of a course project, do I need to complete IRB forms and if so, which ones?

Yes, research done as part of a class still requires IRB review. There is a specific form for courses that include research on the IRB website. If you have questions about completing it, please contact the IRB chair as indicated on the IRB website.

Collaborations

I will be collaborating with another institution. Do I need to submit to Redlands’ IRB and the other institution?

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.

International Research

My research will be conducted in another country. Do I have to obtain IRB review and approval from Redlands?

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.

Support

Who can I talk to if I have a question about my research project involving human participants?

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.