W&M IRB Guidance

Below is a list of guidance/policies developed by the W&M IRB. To find specific guidance, you can use the "control F" (Dell computers) or "command F" (Mac computers) feature on your computer to search for key words.

• .118 Determination

  46.118 Determinations can be granted to satisfy federal sponsor requirements (e.g., Just-In-Time) to allow investigators to have access to funding to begin aspects of the project that do not involve human subjects.

• Informed Consent Forms and Process

  Informed consent is more than just a form; it is a process that actively involves the participant. It is an "ongoing exchange of information between the investigator and [participant]" per the OHRP. The process begins with recruitment all the way to the end of their participation in the study.

• Exempt Research: Study Information Sheets

  Exempt studies do not require signatures of participants, but a consent or study information sheet should be provided to participants prior to enrolling in the study.

• Non-Exempt Studies: Informed Consent Templates

  Non-exempt studies are required to meet all requirements of informed consent as defined in 45 CFR 46.116 unless a waiver/alteration has been noted and strongly justified within the protocol application.

• Management and Retention of Data

  Researchers may refer to this guidance when determining how to handle the collected research data from human subjects, and what steps need to be taken after data collection is complete. Updated: 07.03.2025

• External Members and Engagement in Research 

  Purpose: Occasionally, external research personnel perform services that would not qualify them to count as officially part of the “research team.” However, situations are not always clear when those personnel communicate or interact with potential participants. This guidance provides some clarity around when external members count as “engaged” in the research.

• Suicidal Ideation and/or Behavior in Research Protocols

  This guidance provides directions for researchers using measures that involve questions related to suicidal ideation. Research shows that asking questions related to suicidal ideation (SI) does not increase suicidal risk; however, research studies or surveys that inquire about SI require additional monitoring of responses to ensure the safety of participants during the study.

• Reporting of Deviations and Incidents

  Reports of noncompliance or protocol deviations must be submitted to the IRB within 48 hours of discovery. Please see this guidance document on how to submit reports.

• Paying Research Participants

  When compensating human research subjects/participants, there are certain guidelines that need to be followed in regard to obtaining and tracking payments.

• Recruiting on SONA

  SONA is a recruiting system used by the Psychological Sciences and Business school to recruit participants for studies in turn for course credit. Researchers posting to SONA will be asked to fill out a description of their study. In protocol applications to the IRB, researchers should be explicit in (1) what SONA platform they'll be using, (2) number of course credits, and (3) what will be shared with participants.

• Roles of Students and Other Personnel on IRB Studies/Submissions

  The purpose of this guidance is to explain the roles and responsibilities of both undergraduate and graduate students when submitting protocols to be reviewed by the Institutional Review Board (IRB). This guidance also defines the roles of personnel in SPARCS and who is required to certify submissions.

• IRB Reliance Agreements

  Occasionally, protocols require investigators or other institutions to rely on one another to perform an IRB review. Please see this guidance if wanting more information about Individual Investigator Agreements (IIA) or IRB Authorization Agreements (IAA)

• Translating Materials for Non-English Speakers

  Federal regulations mandate that information given to potential research participants or their representatives be in a language that they can understand. Translation of research documents, thus, is necessary to comply with such regulations in order to effectively engage non-English speaker populations in research and address some of the barriers to participation.

• IRB & International Research

  Research with human participants in countries outside the United States must comply ethical standards. Additional considerations may be required depending on the country of research. Furthermore, attention must be given to the cultural context and local regulations.

• IBC and IRB Protocols

  Occasionally, researchers will need to submit their research to more than one research committee. This guidance addresses when submitting to the IBC and IRB is required.