How to Submit

The IRB reviews applications from September to December and from February to May. Full Review Applications must be submitted 14 business days before the date listed in order to be reviewed.

Individuals seeking IRB approval of research activities involving human research participants must submit an electronic application along with all supporting documentation to the Caldwell University IRB email address (irb@caldwell.edu). Any documents requiring an electronic approval stamp (i.e., application, consent documents, recruitment documents, etc.) must be submitted in doc/docx format. 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:

Current Application: 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 template posted on the Caldwell University IRB webpage.

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: All individuals must submit evidence of education/training in the standards that protect human research participants. This applies to all investigators in a project. The completion of this training must be dated within the past three years from the date of submission.

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.