Institutional Review Board (IRB): Helpful Hints​


The IRB forms you need to complete depend on your study design.

  • ALL submissions to the IRB require a complete protocol and data collection instrument(s).
  • Some studies may require a draft script for talking with patients (separate from the consent form).
  • If you plan to use advertising to recruit subjects (e.g., social media posts, study flyer) you must submit those materials for review.
  • You must complete your research ethics training (CITI – click here for more details) prior to submitting your proposal.

For specific questions contact irb@mchs.com.

If unsure whether your project is research, review this guidance and contact irb@mchs.com. Don’t assume your project is quality improvement or evidence-based practice. Even if it seems straightforward, many conferences and journals require a letter from your institution’s IRB verifying that your project did not need prior IRB review and approval.

Think your research study is exempt? (Examples include collection of anonymous, pre-existing data and some types of surveys.) Complete this Request for Exemption.

Does your study involve an analysis of retrospective data? You most likely need to complete:

  • Application for Human Subjects Research
  • HIPAA Waiver of Authorization Request
  • Request for Waiver of Informed Consent

Does your study involve prospective data collection and interaction with your study subjects? Plan to complete:

  • Application for Human Subjects Research
  • HIPAA Waiver of Authorization Request
  • MCHS Informed Consent

The Mount Carmel IRB meets on the first Tuesday of the month. Submission deadlines are three weeks prior to the meeting date.