�鶹ԭ��

• All faculty, staff, and students conducting research with human subjects that does not meet the criteria for Classroom Research must submit an application to the IRB.

Classroom Research – Student projects intended to provide an educational experience, when the project is intended to fulfill a course or degree requirement and is not designed to contribute to generalizable knowledge. The intended benefit is to the student. Resulting presentations do not take place outside of the University and are designed to document the educational experience only. **Classroom Research Projects must meet the criteria listed in the Classroom Research checklist. Independent studies, masters theses, and doctoral dissertations do not meet the criteria for classroom research.

• Regular faculty (assistant professor, associate professor, or professor) may be designated as Principal Investigator (PI).
• Special faculty (lecturer, senior lecturer, instructor, adjunct, visiting professor, senior mentor, or professor emeritus) and staff can serve as PI with an approved PI Eligibility Exception Form – available on the IRB website.
• Graduate students can serve as PI with a Faculty Advisor who is eligible for PI status.
• NOTE: Undergraduate students are not eligible to serve as PI.

• Applications must be approved or determined Exempt BEFORE any research activities with humans begin.
• The IRB cannot grant retroactive approval for human subjects research. Any data collected prior to IRB review and approval cannot be determined Exempt or approved at a later date.

• Complete CITI Human Subjects Research Training. All research personnel who interact with human subjects through obtaining consent, collecting data, or accessing identifiable data must complete CITI training. Training is valid for 3 years.
• Log into the Cayuse Human Ethics system to start a new application.
• Be sure to upload the following documents as applicable with your online application:
  • Informed Consent Letter (and child assent letter if working with children)
  • Waivers of Documentation of Written Consent
  • Final copies of all recruitment materials (flyers, emails, social media posts, scripts, etc.)
  • Any site permission letters
  • Any written instruments and/or other data collection measures (e.g., interview protocol/s or other verbal instructions, survey questionnaire/s, debriefing statement, or other measures)

• Application goes through a pre-review process where we check for completeness, PI eligibility, required training evidence, relevant attachments, permissions, etc.
• Once complete, the application is routed to the IRB Chair who makes a determination as to the level of review and assigns a reviewer:

1. Level One – EXEMPT – Research that qualifies as Human Subjects Research but is not subject to IRB oversight. This research must still be reviewed by the IRB and determined to be Exempt. Researchers are not permitted to make their own Exempt determinations. Exempt does not mean “Exempt from IRB review.”
2. Level Two – Expedited – Research that qualifies as Human Subjects Research but does not meet the criteria for Exemption. Subject to IRB oversight.
3. Level Three – Full – Research determined to be greater than minimal risk and/or involves a vulnerable population. Reviewed by the full convened IRB committee.

All applications are processed on a rolling basis as they are submitted through Cayuse. 

The Review Process involves several steps including submitting the application, determining the level of review needed (Exempt, Expedited, or Full Board), receiving feedback, and potentially amending the study before receiving approval.  Please allow sufficient time for review. The length of time for review and approval depends on the type of human research, the level of risk, and the complexity of ethical or technical questions that arise during review.

Step 1: Pre-Review Process (approximately two (2) weeks)

The IRB office utilizes an initial pre-review screening process, during which the IRB analyst reviews each submission for completeness and compliance. This can consist of several rounds of comments, if necessary. IMPORTANT NOTE: The pre-review process does not include scientific or scholarly review.

Step 2: IRB Committee Member Review (approximately 4-6 weeks)

Once the pre-review process is complete and the submission has been determined to be Exempt or Expedited, it will be assigned to an IRB Committee Member for review.  This can also include several rounds of comments from the reviewer. Each round of comments will re-start the overall review time.

Please allow approximately eight (8) weeks for a Full Board Review.

• Ensure that there are adequate resources to carry out the research safely.
• Ensure Research Staff are trained and qualified to perform duties assigned to them.
• Personally conduct or supervise the Human Research. Recognize that the PI is accountable for the actions of any study team member.
• Do not modify the Human Research without prior IRB review and approval unless necessary to eliminate apparent immediate hazards to subjects.
• Report any “reportable” events that could result in harm to subject's rights, safety or welfare to the IRB within 5 business days of becoming aware of the event.
• Submit continuing review application or Study Closure as requested in the approval letter.
• Keep all research records for at least 3 years from the close of the study

A lot! We’re happy to help. Please contact the IRB to discuss research involving:

• Vulnerable populations (children, undocumented persons, prisoners, etc.)
• Research collaborations with other institutions / Reliance Agreements
• International research, including data collected in the EU
• Data collected via social media or off-site
• Research subject to HIPAA or FERPA regulations
• Program Evaluation/development
• Secondary analysis of data using a restricted dataset
• Data Use Agreements