Submitting Protocol

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 do need an IRB

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

All researchers wishing to submit an IRB application must first complete CITI training. Find instructions here. 

Exempt applications take about 10 business days to complete. 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.

Before you may proceed with your research, the IRB committee must approve your application. Submit your application well in advance of your planned fieldwork time. For Exempt studies, allow a minimum of 2 weeks (10-14 business days) for review. For Expedited and Full Board studies, allow a minimum of one month.

The IRB committee must be satisfied that the research is of sound design, is feasible, that the participant risks and benefits are fairly balanced, and that the researcher will adequately obtain informed consent from participants.

After the IRB committee 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.

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 committee and you will receive an approval via Cayuse. Allow 5 business days for approval of modifications.

Portal

Log in to the Concordia Portal > Click the Resource Tab > Find "Institutional Review Board (IRB) Human Ethics" the CAYUSE Image > Using your CUWAA single sign-on username and password, log in to Cayuse.

Direct link

Click here to log in to Cayuse using your CUWAA single sign-on username and password.

• Once logged in to Cayuse, click on the blue "+ New Study" button in the upper right-hand corner. This will create a new folder.
• Enter the title of your study in the next box and then click on the blue check box
• Click on the blue "+ New Submission" button in the upper right-hand corner, then select "Initial" This will begin a new study submission. You are automatically assigned as the PC (Primary Contact) for the study.
• Click on "Assign PI" to access the full submission. You can also access the full submission by clicking the "Edit" button in the study details page

The landing page for Cayuse Human Ethics. Once you are logged in, you will be able to see all your studies, tasks, submissions, and more.

In this section you will review basic information about using Cayuse, find upcoming IRB committee meeting dates, and acknowledge that you have read the information. Select "Yes" and click on the forward arrow to continue.

• You will indicate what type of submission you are filling out. Most research at CUWAA will fall into the first category, Research Proposal. This includes theses, dissertations, and other kinds of research projects
• Next you will indicate whether your study is multi-institutional, meaning that it involves more than one institution. If you click "Yes" , you will be asked a series of questions about the institutions involved in the study. If a different institution is the IRB of Record, you will be asked to attach documentation showing the required permissions
• Section 2 ends with a question about Study Category Determination. The category you select (Exempt, Expedited, Full Board) will prompt you to select a sub-category or provide more information about your study. If after reviewing all the options you are still not sure what category your research falls into, please contact the CUWAA IRB Administrator

Note: Exempt studies are reviewed by the IRB Administrator; Expedited studies are reviewed by the IRB Administrator and a minimum of two IRB Committee members; and Full Board studies are reviewed by the full IRB Committee.

• This section includes questions about your status at CUWAA, your study personnel, study site(s), and dates of research. You must select a Principal Investigator (PI), and if you are a student, you must also add your advisor as a Co-PI
• If you are conducting research in a campus classroom, you will be asked to read through a script that should be read to students ahead of data collection. This acts as an informed consent process to help minimize coercion. You must agree to follow these requirements and read the script to students prior to data collection
• The last part of Section 3 is your research start and end dates. Remember that you cannot begin research until your submission is approved

You will indicate how many subjects you intend to enroll in the study, and their age range. Next, you will see a list of possible types of research participants and select all that apply.

• You will answer questions about your research project characteristics, including data collection methods, anonymity & confidentiality, whether you plan to present data in aggregate form
• The most important part of your application is also in Section 5: the Narrative Description. Here you will describe the purpose of your study, a justification and brief literature review, a concise description of methods, and a list of references

Note: Do not copy and paste large sections of text from a thesis, dissertation, or paper in lieu of answering the questions concisely.

• This section includes listing the person/people responsible for contacting subjects, your recruitment procedures, and copies of any advertisements or recruitment materials. You will also be asked to describe any incentives or compensation that participants may receive
• You will also be asked questions about Consent in Section 6, including being asked to upload copies of forms and language being used. If you are working with children, you will also be asked to upload a copy of an Assent form
• At the end of Section 6, you must agree to store your data for seven years in a secure location in accordance with CUWAA policy

• This section asks for further information on participant opportunities, as well as potential risks and expected benefits of participating in the research. You will be asked whether you intend to use deception as a method of gathering data, as well as how you plan to protect the identity of participants.
• You will answer questions about specific risks that research can entail, and agree to the federal guidelines for handling those risks. You will also explain how you plan to handle any raw (identifiable) research materials.

This section is for disclosing any financial or other conflicts of interest that may exist between the research and PIs.

• You will attach your CITI training certificate in this section. This is mandatory for each personnel involved in the study
• The rest of this section will show what you have attached to the submission so far. You must make sure that all required documents are attached

Once you complete all the questions on the form, "Routing" and "Complete Submission" buttons will appear. You will use the "Routing" button if you have a co-PI.

Note: if you are a student, your advisor must be listed as a co-PI in your application.

You must route your submission to them for approval before your application will be processed. Next, you will be asked to Certify your application. Click "Certify" to finish your submission.