Forms

Which Form Do I Choose?

Everyone must fill out the required Cover Sheet. Then, choose one of the two protocol forms: 1) Exempt, or 2) Non-exempt.

Important: all cover sheet signatures, approvals and letters of support must be obtained before submitting a protocol.

Access the Faculty & Staff Cover Sheet
Access the Student Investigator Cover Sheet
Access the Exempt Form
Access the Non-Exempt Form
Access the Informed Consent Form

Other Forms

Amendment or Modification of Protocol
Continuing Review Form
Child Assent Form Ages 12-17
Child Assent Script Ages 5-11


Exempt Research

(For less than minimal risk; only the IRB can determine if the study falls into the Exempt category): Although the category is called "Exempt," this type of research does require IRB approval. The Exempt registration process is much less rigorous than full IRB review. To qualify, research must fall into at least one of six (6) federally defined Exempt categories under §46.101 (b). These categories present the lowest amount of risk to potential subjects because, generally speaking, they involve either collection of anonymous or publicly available data, or conduct of the least potentially harmful research experiments. PER GONZAGA POLICY, ONLY THE IRB CAN MAKE AN EXEMPT DETERMINATION.

Examples:

  • Anonymous surveys or interviews
  • Passive observation of public behavior without collection of identifiers
  • Retrospective chart reviews with no recording of identifiers
  • Analyses of discarded pathological specimens without identifiers

Non-Exempt Research

To qualify for a non-exempt review, research must be no more than minimal risk and should fall into one of nine (9) federally defined non-exempt categories. These categories involve collection of samples and data in a manner that is not anonymous and that involves no more than minimal risk to subjects.

Examples:

  • Surveys and interviews with collection of identifiers
  • Collection of biological specimens (e.g., hair, saliva) for research by noninvasive means
  • Collection of blood samples from healthy volunteers
  • Studies of existing pathological specimens with identifiers

Full Board Review

(For greater than minimal risk protocols; the IRB can also use this method at its discretion for any protocol.)
Proposed human research that does not fall into expedited review categories must be submitted for full IRB review. This is the most rigorous level of review and, accordingly, is used for research projects that present greater than minimal risk to subjects. The majority of biomedical protocols submitted to the IRB require full IRB review.

Examples:

  • Clinical investigations of drugs and devices
  • Studies involving invasive medical procedures or diagnostics
  • Longitudinal interviews about illegal behavior or drug abuse
  • Treatment interventions for suicidal ideation and behavior

Regulations and References

DHHS 45 CFR 46.110
FDA 21 CFR 56.110
FDA 21 CFR 56.111(a)(1-2)
OHRP IRB Guidebook, Chapter 3: Basic IRB Review, Section A, Risk/Benefit Analysis