Resources and FAQs

Federal regulations require that research projects involving human subjects be reviewed by an IRB. So, if your research involves using human subjects, or engaging with them in any way, or requires access to their personally identifiable information, then you need approval. If you are not sure, always err on the side of caution” reach out to IRBhelpdesk@cuw.edu to discuss your project.

New applications must be submitted electronically through Cayuse. Use your Single Sign On (SSO) login on the CUWAA Portal to access Cayuse.

We know it takes time to complete CITI Training. But it is not only required – it is essential to make sure you understand how to design and conduct your research to reduce participant risk and keep your research ethical.

All researchers wishing to submit an IRB application, and anyone planning to serve as project personnel, must first complete CITI training in an appropriate category (Biomedical or Social & Behavioral) for the research project. Find instructions here. If you are submitting a CUWAA IRB protocol, you need CUWAA CITI training. We do not accept certification from other institutions, as it is a liability for the university.

Faculty: you must have the correct CITI modules completed in order to be a student’s Co-PI and oversee their research. For example, if you are overseeing Social and Behavioral research, then you must have that certification.

Exempt applications take about 10 business days to complete, but will take longer if you submit a protocol that is incomplete, unclear, or missing crucial considerations.

Expedited and Full Board studies take about a month to complete. An initial administrative evaluation is carried out on each IRB application. This assessment will determine the completeness of your application, and whether the project qualifies as "Exempt". The reviewer may ask for further information or ask questions about a specific part of your protocol, which will appear to you and be answerable within Cayuse.

You may begin your research after you receive a letter of approval through Cayuse.

Absolutely not. Before you may proceed with your research (recruitment, data collection, etc.), the IRB must approve your protocol application. Submit your application well in advance of your planned recruitment, data collection or fieldwork time. For Exempt studies, allow a minimum of 2 weeks (10-14 business days) for review. For Expedited studies, allow 2 weeks (14 business days) and for Full Board studies, allow a minimum of one month.

Faculty: many of you engage in Scholarship of Teaching and Learning (SOTL). This kind of research requires review just like any other. Be aware that if you collect data one semester without IRB permission, then you cannot go ahead and use it for research in a future semester by calling it “archival data”. If you are unsure about what kinds of course materials might become data for your research, please consult the IRB administrator for advice on how to properly prepare.

While a good researcher always considers feasibility for their projects, please do not try to fit your research into a particular category just because you think it will be easier and faster to get IRB permission. Consider, rather, what the ideal research design would look like and start from there. Don’t be afraid to go for an Expedited or Full Board level project, if that is where your research is headed. Just give yourself extra time for review!

The IRB committee must be satisfied that the research is of sound design, is feasible, the participant risks and benefits are fairly balanced, and the researcher will adequately obtain informed consent from participants. Reviewers will often make suggestions to researchers (through Cayuse, directly on the protocol application) and ask clarifying questions that help improve your research design.

Doing research with human subjects is a privilege – you are asking someone to give you their precious time, information and effort. If you have access to a potential research participant because of your job or position, you need to take extra care in considering coercion in your project.

For example, if you are a teacher or professor, that does not automatically give you permission to use your students for your research. All participants must have the opportunity to opt out of research and not face any repercussions for doing so.

After the IRB has reviewed your application, you will receive written notification of its status via Cayuse. At that time, the IRB committee will specify any adjustments that are necessary or will approve your application. Each time your application has to be reopened for you to answer reviewer questions or make adjustments, the clock for review starts over. We encourage you to take great care in the drafting of your application before submission and plan for the need to resubmit an updated version after IRB initial review.

Use the Modification submission feature on Cayuse to modify an existing protocol. You will be able to see your proposed modifications side-by-side with the original application. Ensure that you have adequately explained and answered all questions. The modifications will be reviewed by the IRB and you will receive an approval via Cayuse if reviewers are satisfied. Allow 5-10 business days for approval of modifications.

Consent is always required for human subjects research.

Informed consent is almost always required for human subjects research. In most cases the federal regulations require that informed consent be documented, but they also provide for some important exceptions. In some circumstances, the IRB may approve a waiver of documentation of informed consent. Exceptions can also be made for certain research projects involving deception.

You must always document the process of obtaining informed consent (unless you have a waiver from the IRB). Documenting informed consent usually occurs after explaining the research and assessing participant comprehension. For many studies, it involves obtaining the signature of the participant (or the legally authorized representative, when IRB approved) as well the signature of the person obtaining consent. The signature of the person obtaining consent indicates they have explained the research to the participant, ensured that the participant understands the research and the participant freely consents to participate.

How you will document informed consent is somewhat flexible depending on your research. Your options are written, oral/verbal, electronic, or implied consent. Exempt studies do not require written consent (participant signatures) if it is not appropriate or conducive to the research. For example, if you are collecting data via anonymous/confidential online survey, you will use electronic consent – typically, this just means making your first survey question into a consent question. Adding a document with participant signatures to such a study actually introduces identifiable data into the research, which is often unnecessary for a simple online survey. Other times, it is appropriate and necessary to get participant signatures for your research. For example, if you are meeting participants in person for an interview, collecting identifiable data or taking photos, you should obtain written informed consent. Implied consent can be appropriate in research fields such as SOTL (Scholarship of Teaching and Learning); for example, if a professor would like to have the option of using de-identified coursework for data collection and research, including an informed consent statement in the syllabus with an opt-out choice typically covers the documentation requirements.

Be sure to use the template(s) provided on the CUWAA IRB webpage. Do not create your own.

No, if your intent is to complete IRB human subject protection training, be sure to select "Social and behavioral research-Basic/refresher" / "Biomedical Research- Basic/refresher" from the CITI curriculum page.

Responsible Conduct in Research (RCR) training covers topics integral to the preparation and development of current and future scientists in all areas of research (not just human subjects). It is a requirement of certain funding agencies such as the National Science Foundation (NSF).

No, every investigator in the research should have required CITI training based on their research type. RCR alone is not considered for IRB approval.

All key personnel (researchers, student researchers, and their advisors) who are engaged in human subjects research must complete CITI training before an IRB application is considered complete. All Members of the IRB must complete the member training as well.

No, both the PI and CO PI should have the required CITI training related to the research type. It is required to obtain training for all the investigators in the research as per the IRB guidelines.

A refresher module will appear in your CITI account before your CITI certificate expires, you can be able to take the refresher at that time and update immediately with the IRB.

Review our Appropriate CITI Trainings Guide here.