Procedure 9: Local and Participant Context Review

Title: IRB Procedure for Local and Participant Context Review

Effective Date: 19 August 2026

Responsible Office: Office of the Vice Provost for Research

Last Updated: 03 September 2026

I. Scope & Purpose

This procedure applies to all faculty, staff, students, and affiliated researchers, working within the scope of their roles at William & Mary (W&M), to complete research with human subjects.

The purpose of this procedure is to detail W&M’s procedure to address the review of research that involves people considered contextually vulnerable or those in international settings This document details information regarding the additional review procedures, how they occur, and what they contribute to the IRB review process.

II. Definitions

• Local Context Review: An additional review within the IRB process for research occurring in international settings. This review is completed by an independent expert in the culture, language, customs, norms, accepted activities, and laws and expectations of the proposed participant population who assess the appropriateness of the research design given the international location and participant population. For example, the research may take place in a small city in Algeria or France where the IRB does not have the expertise needed to assess the risks to participants as related to the research occurring.
• Participant Context Review: An additional review within the IRB process for research occurring with unique and/or vulnerable populations. This review is completed by an independent expert in the culture, language, customs, norms, experiences, accepted activities, laws, expectations, and community and national climate affecting the target population who assess the appropriateness of the research design given the participant population. . For example, the research may take place with participants seeking asylum, those who have been diagnosed with autism, or those who reside in a rural area within the US where the IRB does not have the expertise needed to assess the risks to participants as related to the research occurring.

III. Procedure

The completed Local or Participant Context Review is used to aid the IRB in its evaluation of the risks and benefits to participants, thus enabling the criteria for approval to be addressed in relation to the local culture or the inclusion of a unique population. 

The review process involves requesting an independent expert reviewer. 

A. Local or Participant Context Review will occur when: 

1. The study design includes a foreign location or unique participant population that is beyond the expertise of the IRB, and
2. The study requires expedited or full board review. On a case-by-case basis, the IRB office or committee may request a local context review to determine if an exemption determination can be made.If required, the IRB Office/Committee will notify the research team during the IRB review process.

B. Independent Expert Reviewer

1. The expert must understand the culture, language, customs, norms, accepted activities, and laws and expectations of the proposed international location or unique participant population. The identified expert reviewer should be someone familiar with the local culture who can identify any context or culture-specific risks to human participants that might otherwise go unrecognized.  
2. The expert can be a research ethics committee, a local researcher, a colleague at a local university, a senior researcher at W&M with extensive experience, or a knowledgeable community member
   1. Reviewers are not required to have a Ph.D. or other terminal degree, but they must have expertise in the local context in which the research will be conducted. An example of expertise would be an individual who, for a lengthy period, is a current or former participating member of the community targeted for research. 
3. The expert must be unaffiliated with the research team or have a stake in the research project.
4. The expert reviewer will be selected by the investigator, or, in some circumstances, by the IRB.
5. The expert reviewer must be able to identify any context- or participant-specific risks to human participants.

C. Review Process

1. The contact information of the identified expert is included in the IRB protocol. (In some cases, the IRB office may verify the appropriateness of the identified reviewer.)
2. Once the expert agrees to the review, the researcher provides the expert with the IRB protocol, all study documents, and an IRB form to complete that contains a list of questions for the reviewer to address. 
   1. Depending on the population, both English and officially translated documents are provided to the reviewer.
   2. In some cases, multiple reviewers may be required due to study design and research questions.
3. The expert(s) reviews and evaluates all materials. The assessment from the expert may result in required changes to the protocol or supplemental documents. Any changes suggested or required as a part of this context review must be made by the researcher.  
4. The expert’s responses to the set questions must be:
   1. digitally or physically signed,
   2. saved as a read-only or digitally locked document, and
   3. uploaded to the IRB application by the researcher.
5. All local or participant context reviews occur before the IRB makes their final determination regarding the approval of a research project.
6. Once the IRB Office receives the completed local/participant context review, the information is provided to the IRB reviewer(s). 
7. The IRB reviewer(s) may require changes to the study design based on the Local or Participant Context Review suggestions or requirements

D. Additional Considerations during the Expert and IRB Review Process:

1. If an ethics committee will provide review after the W&M IRB does, this review must be provided to the W&M IRB as an amendment to the approved IRB application and any required changes from the committee must be made to the protocol.
2. If an ethics committee provides review before the W&M IRB does, this review must be provided to the W&M IRB with the IRB application.  

 

IV. Authority & Amendment

This procedure was approved by the W&M Institutional Review Board on August 19, 2026. This procedure will be reviewed every 2 years to ensure it remains relevant, usable, and in compliance with university policy and relevant law.

 

V. Related Policy & Procedures

•  Federal Regulations Governing Research with Human Subjects 45.CFR.4
• The Belmont Report  
•  Nuremberg Code of 1947
• Office for Human Research Protections (OHRP)
• Code of Virginia, Research with Human Subjects
• W&M Policy for Conflicts of Interest  
• W&M Policy for Financial Conflicts of Interest  
• W&M Data Classification and Protection Policy  
• FDA Regulations 
  • 21.CFR.50 Protection of Human Subjects  
  • 21.CFR.56 Institutional Review Boards
  • 21.CFR.312 Investigational New Drug Application
  • 21.CFR.812 Investigational Device Exemptions  
  • 21.CFR.600 Biologics
• DoD Regulations Governing Research with Human Subjects 32.CFR.219
• DoD Instructions 3216.02
• NIH Website for Human Subjects’ Research
• NSF Website for Human Subjects’ Research 
• W&M’s Policy for Research with Human Subjects
• W&M’s Policy for Research Misconduct 
• W&M’s IRB Procedure for International Research 
• W&M’s IRB Procedure for Research with People who are Incarcerated 
• W&M’s IRB Procedure for Research with Minors 
• W&M’s IRB Procedure for Research with People who are Pregnant 

Appendix A

 What to Include in the IRB Application about Local Context for International Research Relevant local context information should be included in the IRB protocol. This includes, but is not limited to, the following:

• A description of the research team’s knowledge of or experience in the host country, local community, or protected population as well as any relevant qualifications for conducting the proposed research within the international setting
• Cities, regions countries where research will be conducted
• Scientific/ethical justification for conducting the research in an international setting
• Economic status of the country/community
• Current events or socio-political environment in the country that may impact research conduct or alter the risks or benefits to participants
• Societal and cultural beliefs in the country that may impact research conduct or alter the risks or benefits to participants
• If women and children are part of the participant population, their role in the society, including their autonomy and legal capacity to make decisions.
• If there are circumstances in which women or community members do not have the autonomy to make decisions for themselves, the plan for obtaining informed consent from both the study participant and any additional authority figures should be included.
• Literacy rate of the potential participant population
• Languages and dialects of the potential participant population and plan for translation and use of interpreter if needed
• Involvement of organizations, community leaders, or experts in engaging the participant population or conducting the research
• Relevance of the research to the area’s health, economic, educational, or other needs
• A description of how the plan for recruitment and participant selection will avoid undue influence or favoritism within the participant population.
• If it is possible that researchers might witness child or elder abuse or neglect in an international setting, the following information about mandatory reporting should be included:
  • Indicate what local laws govern reporting of child or elder abuse in the country of study, if applicable.
  • Provide a plan if you encounter suspected child or elder abuse or neglect.

On the consent form, state the plan for reporting suspected child or elder abuse or neglect to local authorities, if applicable