INFORMATION FOR
All faculty, staff and students are encouraged to review this step by step guide on how to prepare and submit a protocol using the Cayuse Human Ethics module (Cayuse HE) to the William Paterson Institutional Review Board.
CITI Training for use of Human Subjects is required for all investigators engaged in human subjects research at WP. All users must use their William Paterson University email address as the primary email when registering.
Training on how to access and use the Cayuse Human Ethics Module is offered to all Faculty, Staff and Students.
Visit IRB Training and Certification Program for More Information.
Once you have completed training and learned about how to protect human subjects in research, your next step is to Consult the IRB Decision Tree to determine if your project needs IRB review.
If you determine that your project needs IRB review, your next step is to classify your study into one of three Federally defined categories. The level of review required for a study depends on the specific activities to be undertaken in the study. For the exemption and expedited levels of review, the study must present no greater than minimal risk to the subjects, and all activities must fall within specific categories of research activities. Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
For more information about classifying your study, please visit the links below to view details about each level of review.
If you have concerns about the determination, contact the IRB Administrator
*Note: Students are expected to meet with your Faculty Advisor and review your research protocol and, review this PowerPoint: “WP IRB Basics for Students”
WP Faculty and Staff have access to the Cayuse system. Contact the IRB if you are unable to access the system.
WP students need to request an account in order to access Cayuse. Please complete the Registration Form to Request a Cayuse User Account. Please allow 3 business days for this account to be created.
Faculty Advisors can request access for classes where IRB may be needed.
For more information on navigating in Cayuse, visit the page for the Cayuse Human Ethics Module.
To prepare your application in the system, develop the following materials to support your protocol:
The recruitment plan is how you plan to engage participants in your research Include copies of any social media scripts, email/letter template, posters/advertisements, or other materials that will be used to recruit participants.
*Note: do not upload your research plan or sections of your thesis as part of your IRB protocol in Cayuse. Use this document to answer the questions in the application.
Include copies of any survey(s), interview questions or checklists, forms or other data collection tools.
The Cayuse Human Ethics page includes detailed instructions on how to submit and certify your protocol to the IRB for review.
Upon submission of a protocol, faculty advisors and all co-Principal Investigators will receive an automated email from Cayuse letting them know that there is a protocol that needs their approval before it can submitted to the Institutional Review Board. They must login to Cayuse to review and certify your application in the system.
Watch the Cayuse Tutorials Here
The IRB administrator/designee will evaluate your application for completeness. Incomplete applications run the risk of being returned to the applicant without IRB review. Complete applications will be forwarded to IRB members for review.
It may take up to 3 weeks to complete the review process.
The IRB administrator/designee will contact you by email once the IRB reviews your protocol.
The Cayuse Human Ethics page contains detailed instructions on how to access your approval notice.
Within Cayuse HE, there is one form for each type of actions regardless of the category of review or type of investigator. All actions will now occur within Cayuse HE including the following submission types:
Creation of a protocol in Cayuse HE involves the creation of both a workspace and an initial application. The initial application covers all categories of review. All future actions, including those listed below, will occur in this workspace, identified by an IRB number. The review process must be complete and an approval notice issued for Initial applications before additional actions may occur in the workspace.
Renewals must be submitted to the IRB prior at least 30 days prior to the anniversary date of the protocol’s approval for each year the study is active. To request approval to extend the project beyond the approved study period, complete a renewal request through Cayuse HE.
Research protocols that have been approved by the IRB must have prior approval for any deviation from the original approved protocol. A modification must be submitted for non-exempt research to request approval to implement changes to a previously approved protocol. Such changes may include:
For non-exempt human subjects research, an incident whether an unanticipated problem or an adverse event Must be reported to the IRB within one week of its occurrence. It is the responsibility of the PI to report all incidents to the IRB through Cayuse HE. The IRB will review the all incidents, adverse events and unanticipated problems and notify the investigator if any further actions are needed.
Adverse Event: Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research. Adverse events encompass both physical and psychological harms. They occur most commonly in the context of biomedical research, although on occasion, they can occur in the context of social and behavioral research.
Unanticipated problem: In general, to include any incident, experience, or outcome that meets all of the following criteria:
For all non-exempt studies, a closure report must be completed in Cayuse HE within 30 days of the project’s expiration date, unless the study was approved for exemption.
