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Vulnerable Participants

A “vulnerable participant” is any individual who lacks the ability to fully consent to participate in a study.  There are some groups who have been identified by the federal regulations as “vulnerable populations”: pregnant women and fetuses, minors, prisoners, persons with diminished mental capacity, and those who are educationally or economically disadvantagedPregnant women, prisoners, and minors have specific sections in the federal regulations that provide additional rules for studying these participants. However, instead of broadly classifying various groups as “vulnerable”, the IRB-SBS assess each participant’s ability to consent regardless of whether they fit into the above categories or not.  Instead of labeling one particular group as “at risk," creating the potential for stigmatization and unjustly limiting participation in a study, the IRB-SBS uses an analytical framework to provide each study with a tailored response that is more specific to the needs of the study’s population. As you develop your study, consider the needs of the participants and be aware of issues that may arise regarding their ability to provide full consent. Ultimately the Board will approve studies that demonstrate sensitivity to the participants’ needs, minimize unnecessary risks, and provide them with an appropriate consent procedure.

Inability to consent does not limit participation in a study but instead requires that additional safeguards and consent procedures are followed.The information on this page and in the subsequent sections provides additional information and suggestions for working with various populations. If you have additional questions about your population, please contact our office.

Section Topics

Eight Categories of Vulnerability
Minors in Research
>>Why Are Minors Unable to Consent?
>>Who Is a Legally Authorized Representative?
>>Can a Minor Participate in My Study?
>>Special Rules for Including Minors
>>Consent
Prisoners in Research Studies
>>Why are Prisoners Unable to Consent?
>>Can a Prisoner Participate in My Study?
>>What Happens if One of My Participants Becomes a Prisoner?
>>Special Rules for Using Prisoners
>>Consent Form
Pregnant Women, Fetuses, etc. and SBS Studies
Participants with Diminished Capacity to Consent
>>Why Are Participants with Diminished Capacity Unable to Consent?
>>Who is a Legally Authorized Representative?
>>Can an Individual with Diminished Capacity Participate in My Study?
>>Special Rules for Using Participants with Diminished Capacity
>>Consent
Potential for Coerced Consent
>>Employees as Participants
>>Students as Participants
>>Doctor/Patient (or client) Relationship

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