How to Submit

The IRB reviews all types of applications (exempt, expedited, full, modifications, renewals) from September to December and from February to May. During the summer months, the IRB will review only exempt or expedited reviews and modifications to the exempt or expedited protocols. No full reviews are considered in the summer. The turnaround time for review is approximately one month. Full Review Applications must be submitted 14 business days before the date of a listed meeting in order to be reviewed. Please view dates of scheduled meetings here.

Individuals seeking IRB approval of research activities involving human research participants must submit an electronic application along with all supporting documentation. The appropriate forms can be found on the forms page.

Any documents requiring an electronic approval stamp (i.e., application, consent documents, recruitment documents, etc.) must be submitted in doc/docx format. The application and all supporting documents must be free of grammar and spelling errors. Submissions that do not comply with these requirements will be returned to the researchers. All documents submitted for review are uploaded to an electronic location accessible by all IRB members and will be kept for record-keeping purposes.

At a minimum, the following documents must be provided:

• Application Form: Individuals should use the most current electronic application form that matches the appropriate category of review. All information must be complete, accurate, and in sufficient detail to allow IRB members to understand the research activities and assess the risk to human participants.

• Consent Documents: Individuals should submit electronic copies of all informed consent, broad consent, assent, and release documents with the application. All consent documents must meet the criteria established in the policy and in 45 CFR 46.116, 46.117, and subpart D and must follow the templates posted on the Caldwell University IRB webpage.

• Data Collection Instruments: Applicants should submit an electronic copy of all data collection instruments to be used in the study.

• Recruitment Materials: Individuals should submit electronic copies of all recruitment materials with the application. This includes flyers, emails, letters, wording for social media, etc.

• External Site Approvals: When appropriate, individuals should submit copies of all external site permission letters and/or IRB approvals.

• Conflict of Interest Disclosure: When appropriate, individuals should submit a conflict of the interest disclosure form.

• Departmental Review Committee Approval: When applicable, individuals should submit any approvals and/or support letters from their Departmental Review Committee.

• External Funding Proposals: Individuals should submit a copy of the complete proposal with the application.

• Evidence of Training in the Protection of Human Research Participants: Caldwell University requires all individuals involved in collecting, handling, or analyzing the data go through CITI training in the standards that protect human research participants. The completion of this training must be dated within the past three years from the date of submission. Evidence of such training must be submitted with the application. 

• Additional documentation: Individuals should submit any additional supporting documents that might aid the IRB in the review process. The IRB may also request additional documents as needed.