Informed Consent in Clinical Investigations of Devices

Question 1

Assent

Answer 1

an individual’s positive agreement to participate in a research study. Mere failure to object may not be construed as assent. Assent is given when a subject lacks the cognitive ability or maturity to legally give informed consent

Question 2

Informed Consent

Answer 2

to permit, approve, or agree to participate in a research study with knowledge regarding what the research entails. Informed consent is a process

Question 3

Legally Authorized Representative (LAR)

Answer 3

an individual, judicial, or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research.

Question 4

vulnerable subject

Answer 4

an individual whose willingness to volunteer in a study could be unduly influenced by the expectation, justified or not, of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to volunteer

• Patients in emergency situations
• Subjects who are marginalized in society
• Members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, and members of the armed forces
• Patients with fatal or incurable diseases
• The elderly
• Persons in nursing homes
• Unemployed or impoverished persons
• Ethnic minority groups
• Homeless persons, nomads, refugees
• Individuals with impaired decision-making capacity