EthicsGlossary Term
ICH E6(R3) Section 1.61
An individual whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation of benefits or fear of negative consequences, or who may have diminished capacity to provide informed consent.
Vulnerable subjects require additional protections in clinical research because their circumstances may compromise their ability to provide truly voluntary and informed consent. Vulnerability may arise from various sources: diminished decision-making capacity, economic disadvantage, educational limitations, illness severity, hierarchical relationships with researchers, incarceration, or other conditions that may impair autonomous decision-making or increase susceptibility to coercion.
Categories of vulnerable subjects explicitly recognized in regulatory guidance include children, prisoners, pregnant women, mentally disabled persons, economically disadvantaged persons, and those who are very ill. However, vulnerability is not limited to these categories; the concept extends to any individual whose circumstances might unduly influence their consent decision or limit their understanding of the trial. For example, students or employees in a subordinate relationship to an investigator may feel implicit pressure to participate.
Research involving vulnerable populations requires enhanced protections beyond standard informed consent procedures. Ethics committees must include members knowledgeable about the specific vulnerable population and its needs. Consent processes may need to involve legally authorized representatives when subjects cannot consent for themselves. Additional safeguards such as participant advocates or consent monitors may be appropriate. The scientific justification for including vulnerable populations must be compelling, and the research must offer prospect of direct benefit or minimal risk when vulnerable individuals are enrolled.
Pediatric research
"For the pediatric study, the IRB required age-appropriate assent forms for children seven and older, in addition to parental permission, and appointed a child advocate to observe the consent process."
Economically disadvantaged subjects
"The ethics committee scrutinized the compensation structure to ensure that payments to participants from economically disadvantaged backgrounds were not so high as to constitute undue inducement."
An independent body constituted of medical/scientific professionals and non-medical/non-scientific members whose responsibility is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial.
A process by which a subject voluntarily confirms willingness to participate in a clinical trial after being informed of all aspects relevant to the decision.
An independent body constituted of medical, scientific, and non-scientific members whose responsibility is to ensure protection of the rights, safety, and well-being of human subjects involved in research.
ICH E6(R3) Section 1.61
An individual whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation of benefits or fear of negative consequences, or who may have diminished capacity to provide informed consent.
Vulnerable subjects require additional protections in clinical research because their circumstances may compromise their ability to provide truly voluntary and informed consent. Vulnerability may arise from various sources: diminished decision-making capacity, economic disadvantage, educational limitations, illness severity, hierarchical relationships with researchers, incarceration, or other conditions that may impair autonomous decision-making or increase susceptibility to coercion.
Categories of vulnerable subjects explicitly recognized in regulatory guidance include children, prisoners, pregnant women, mentally disabled persons, economically disadvantaged persons, and those who are very ill. However, vulnerability is not limited to these categories; the concept extends to any individual whose circumstances might unduly influence their consent decision or limit their understanding of the trial. For example, students or employees in a subordinate relationship to an investigator may feel implicit pressure to participate.
Research involving vulnerable populations requires enhanced protections beyond standard informed consent procedures. Ethics committees must include members knowledgeable about the specific vulnerable population and its needs. Consent processes may need to involve legally authorized representatives when subjects cannot consent for themselves. Additional safeguards such as participant advocates or consent monitors may be appropriate. The scientific justification for including vulnerable populations must be compelling, and the research must offer prospect of direct benefit or minimal risk when vulnerable individuals are enrolled.
Pediatric research
"For the pediatric study, the IRB required age-appropriate assent forms for children seven and older, in addition to parental permission, and appointed a child advocate to observe the consent process."
Economically disadvantaged subjects
"The ethics committee scrutinized the compensation structure to ensure that payments to participants from economically disadvantaged backgrounds were not so high as to constitute undue inducement."
An independent body constituted of medical/scientific professionals and non-medical/non-scientific members whose responsibility is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial.
A process by which a subject voluntarily confirms willingness to participate in a clinical trial after being informed of all aspects relevant to the decision.
An independent body constituted of medical, scientific, and non-scientific members whose responsibility is to ensure protection of the rights, safety, and well-being of human subjects involved in research.