Background
Many studies have more than one participant group. Participant groups may involve “Primary,” Secondary and Incidental participant groups. For example, in pediatric studies, children are generally the main subject of the research and the primary participant group while parents may be secondary or incidental subjects. Caregivers and pregnant partners are increasingly becoming a secondary participant group. Incidental participants are those who are not the main subject of the research but about whom identifiable information may incidentally be captured in the research record. If a study obtains information from and/or about secondary (or incidental) participants like Caregivers, Parents or Pregnant partners these individuals may be considered Human Subjects by regulatory definition. It is important to ensure that the IRB application and Informed Consent address all participant groups.
How to ensure that multiple participant groups are adequately identified:
IRB Application:
Ensure the following sections of the IRB application to document all potential participant groups:
- Focus on section: "Research Plan and Procedures"
- Design
- Procedures/Methods
- Sample Size & Eligibility
- Recruitment & Consent
Data Collection Tool Review:
Include data collections tools in the Submission Components such as:
- Surveys and Questionnaires
- Questions included in surveys intending to obtain information about secondary or incidental participant groups indicate that there are multiple participant groups.
How to ensure incidental and secondary participants are adequately consented:
- It is important that the Informed Consent process adequately captures consent from all participant groups.
- Depending on the level of involvement, documentation (signature) of consent may not be necessary.
- For some participant groups, a full waiver of consent may also be approved if the criteria are met.
- It is important that the study application outlines a plan for informing all participant groups who require prospective consent about the research and how the opportunity to give voluntary consent will be provided.
- For pediatric research in which Parents are incidental participants it may be adequate to include components of Parental consent in the main consent document.