This section of the Investigator Manual describes research not requiring a standalone protocol. The IRB does not typically require a standalone protocol for most minimal risk research, including most international research.

For minimal risk studies, the IRB may determine that a protocol is necessary if the study involves multiple physical interventions, drugs, biological products, nutritional supplements, or devices. Non- exempt international research studies also may require a protocol depending on the complexity of the study. Studies not requiring a protocol should be submitted using the non-protocol-based IRB application option in ARROW.

Exempt Projects (including health care records research and not human research)

The federal Common Rule identifies eight categories of research that may be eligible for exemption from IRB review (45 CFR 46.104(d) (1-8)). UW-Madison currently allows projects that fall into exemption categories 1-6 and are no more than minimal risk to qualify for an exempt determination. Exemptions do not apply to FDA-regulated research or research involving prisoners (45 CFR 46, Subpart C).

Research that qualifies as exempt must satisfy UW-Madison’s ethical standards for the protection of human research participants. The HIPAA Privacy Rule (45 CFR Parts 160 and 164) applies to all exempt research that uses protected health information (PHI).

Before preparing your application, refer to HRP 312 – WORKSHEET – Exemption and Limited IRB Review to help you determine whether your project may qualify for an exempt determination. The Exemption Category Tool also can assist you in assessing what exemption category may apply to your study.

If you believe your project falls into one of these exemption categories, you must submit an application to the IRB since only the IRB can determine whether the research is exempt from review.

Non-Exempt Minimal Risk Research (including community-based participatory research)

Minimal risk studies that do not qualify for exemption may qualify for expedited review. To determine whether your study may qualify for expedited review, refer to HRP 313 – WORKSHEET – Expedited Review. Even if the study falls into an expedited review category(ies), the IRB reserves the right to refer such applications for review by the convened IRB.

Additional requirements may apply to community-based participatory research projects, such as the need for site permissions and IRB of record arrangements.

For sites engaged in human research that do not have their own IRB and for which the UW is not serving as the IRB of record, a letter of cooperation from the community partner is required. This letter ensures the IRB that the site is aware of and supports the study.

Even if a letter of cooperation is not required, you should still obtain permission from external sites at which study activities such as recruitment and consenting will be conducted to be sure that the site is aware and supportive of the research.

International Research

Your application or protocol must include a description of the international research location and the levels of protection appropriate for the location (i.e., appropriate access, consent options, etc.). The IRB prefers that a local ethics committee or similar review board oversee the research in addition to the UW-Madison IRB to help ensure that the research is culturally acceptable. Please refer to HRP 336 – WORKSHEET – International Research for specific considerations that need to be addressed in your application or protocol.

The convened IRB or designated reviewer may review and/or consult with other UW- Madison departments/offices and local or national experts to determine if the research is appropriate based on the laws and knowledge of the location in which the research will take place. Given that review by the full IRB and consultation with experts may be required, international research projects should be submitted 2-3 months before the research is planned to begin.