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Vulnerable and Risk Sensitive Participants

Deciding who to include in your study can play a major role in determining the level of risk in a study. Often there are many factors to consider as to who will make a valuable subject for a study and what challenges will need to be addressed in order to protect that subject. For most studies that include healthy adults who are able to consent and whose life situations are not inherently risky, basic consent and data collection procedures are often enough to protect the participant from harm. However, there are some participants whose life situations make it difficult for them to receive adequate consent and/or collecting data from them is inherently risky. This section describes the populations in which the Board is likely to require additional safeguards and suggestions for providing those safeguards. Please note that this section is not inclusive of all possible vulnerable and/or high risk participants and a determination will need to be made on a protocol-by-protocol basis.

Section Topics

Vulnerable Participants: Inability to Consent
>>
Minors in Research
>>Prisoners in Research Studies
>>Pregnant Women, Fetuses, etc. and SBS Studies
>>Adults with Diminished Capacity to Consent
>>Potential for Coerced Consent: Employees, Students, and Patients

Risk Sensitive Participants
>>How to Include Risk-Sensitive Populations in a Research Study
>>Child Abuse
>>Abused Adults with Diminished Capacity
>>Domestic Abuse: Emotional, Physical, and Sexual Abuse of Adults
>>Specific and Immediate Threats
>>Suicide Threat
>>Participants with Stressful Health Conditions
>>Participants in Dire Economic and/or Social Situations
>>Considerations for Minority and/or Ethnic Groups

Additional Topics

Understanding Risk in Research
Undesirable Research Events
Certificate of Confidentiality

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