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.

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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 and the list below for specific considerations that need to be addressed in your application or protocol.

Note: 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.

Data Security

• The application or protocol should include a description of how data will be securely stored electronically and/or in paper format at all stages: while collecting it in the host country, while traveling back to the US, and once in the US. When possible, research data should be stored on a UW server.

Non-English Speakers

• See Enrolling Participants with Limited English Proficiency.
• If local translators will be used to facilitate the research, the application or protocol should include details about how translators are trained in confidentiality and protocol adherence.
• In a small population, the relationship between the interpreter and the participants should be considered.

Mandatory Reporting

• If it is possible that researchers might witness child abuse or neglect in an international setting, the following information should be included in the application or protocol:
  • A description of local laws governing reporting of child abuse in the country of study, if applicable
  • A plan should researchers encounter suspected child abuse or neglect
  • The consent form should include their plan for reporting suspected child abuse or neglect to local authorities, if applicable.

Remuneration

• The description of the remuneration (payment, gifts, incentives, etc.) should include:
  • Value both in US and local currency
  • Local household income information (e.g. how much an average household earns in a month or a year in US and local currency)
  • This section of the protocol should also include a description of payment in relative terms (i.e., payment equates to a day’s work, hourly salary, or another local reference).

Consent

• In some instances, it may be appropriate for the IRB to waive some or all requirements for written consent in favor of a verbal consent for cultural, religious or literacy reasons. (E.g. societies where no written language is used, countries/communities where consent is by community leaders, or communities were signing legal documents is considered risky).
• The consent form should include local contact information that is appropriate and feasible for the subject populations. Examples include phone and/or email for local co-investigators, name of community leader, Ministry of Health, coordinator for a non-governmental organization (NGO), and local IRB or ethics committee. This local contact must be willing to relay questions or complaints from subjects to the PI and should be a person or organization that will be easily available to subjects.
• The consent form does not have to include the UW IRB contact information on studies where that is not a reasonable requirement, e.g. participants do not speak English and/or they do not have access to international calling or email.

When considering local cultural norms, equivalent protections are required (see OHRP guidance for equivalent protections). For example, age of majority varies by country and the IRB would generally apply that country’s age of majority. The definition of who may provide ‘parental permission’ to participate may appropriately be adjusted based on cultural norms. It is possible, that grandparents or even tribal leaders may be the cultural head of household and may ethically serve as the designated guardian for a minor participating in research. That said, the cultural norms in question must be identified in the research protocol and the exception to policy anticipated.

Additional Resources

• Multi-Site International Research
• HIPAA & International Research
• VA International Research
• GDPR

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