ETHICAL ASPECTS OF VULNERABLE GROUPS OF PATIENTS IN CLINICAL TRIALS
Definition of Vulnerable Subjects
According to ICH E6 (R1) Guidelines definition for vulnerable groups.
Individuals whose desire to volunteer in clinical studies may be improperly influenced by the expectation, whether justified or not, of benefits associated with involvement or of a reciprocal response from senior members of a hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, secondary hospital and laboratory employees, employees of the pharmaceutical industry, members of the armed forces, and persons kept in custody. Other vulnerable subjects include patients with eternal diseases, persons in nursing homes, unemployed or needy persons, patients in emergency situations, ethnic minority groups, homeless persons, travelers, immigrants, juveniles, and those incapable of giving consent.
Determine Vulnerability.
Researchers are encouraged to consider all potentially relevant factors to determine the vulnerability
Willingness can be influenced by the expectation of benefits or retaliation
Intrinsic and extrinsic factors
Intrinsic: race, gender, Income, educational attainment, low literacy, health status, housing, legal status
Extrinsic: what does the study require, where does it take place, who is conducting it, could there be a risk of retaliation.
Different approaches to define vulnerable populations
Determining which individuals or groups should be considered vulnerable and in need of additional protection as research participants is an ongoing challenge for researchers and IRBS. There are different approaches to defining vulnerable populations that might be appropriate in different contexts. These include:
Categorical approach
Contextual approach
Categorical vulnerability.
The categorical (or sub-group) approach defines vulnerable populations as those groups in society whose members share features that might make them vulnerable. For example, the U.S. Code of Federal Regulations lists "children, prisoners, pregnant women, mentally disabled persons, and economically and educationally disadvantaged persons" as a vulnerable group.
Contextual vulnerability.
In its 2001 report, Ethical and Policy Issues in Human Subjects Study, the National Bioethics Advisory Commission (NBAC) suggested an alternative to the categorical description of the vulnerability, underlining the extent to which vulnerability in research subjects is delicate to context. NBAC described six types of vulnerability that could apply to research participants in different situations:
Cognitive and communicative vulnerability: the incapability to understand information and make decisions, either due to capacity (e.g., young children), or circumstances (e.g., a stressful emergency or language barrier).
Institutional vulnerability: being subject to an authority association in a formal hierarchal structure (e.g., prisoners or military personnel).
Deferential vulnerability: being subject to the authority of others (e.g., children or military personnel).
Medical vulnerability: having a serious health condition for which there is no satisfactory standard treatment.
Economic vulnerability: being deprived in the distribution of social goods and services such as income, housing, or health care.
Principles of Ethics.
Respect-autonomy, decisions are made free of Influence.
Beneficence-do no harm: benefits versus risk
Justice protection from exploitation for access to participate
Wrong to target poor populations because the least will be spent
Recruit all those who might benefit even it is hard to recruit, engage and retain.
Ethical Considerations.
Voluntary participation-Consenting process
Benefits and risks
Compensation: Use of Incentives benefit to motivate action!
Retention strategies.
Handling unanticipated events-any experience of this? threats, crime, high expectations
Withdrawal
Post research obligations-
Provision of related knowledge, capacity building income generating activities
Sensitization, dissemination of results, follow up
Strategy
Interventions.
Informed Consent & Vulnerable Populations.
When seeking consent from participants in vulnerable populations, researchers should confirm that the participants will not be exploited, including being placed in conditions which compromise their safety or dignity and which place them in a position of even greater powerlessness.
Researchers may need to make extra allowance to ensure that the consent is genuine and does not place extra risk or stress on the participant.
Informed Consent of Special Population
When a clinical trial (therapeutic or non- therapeutic) includes subjects who can only be enrolled in the trial with the consent of the subject's legally acceptable representative (e.g., minors, or patients with severe dementia), the subject should be informed about the trial to the extent compatible with the subject's understanding and, if capable, the subject should sign and personally date the written informed consent
Special Considerations For Children
Regulations that protect the children, so as to prevent their exploitation are:
If the parents of the children are died, or not known then the legal guardian must give consent.
Stepparents, grandparents, adult siblings, adult aunts and uncles may not consent a child to research.
In case of life-threatening events only consent from parents would be adequate, as there is the expectation of direct benefit. The trial details should be explained completely to the child.
Special Considerations For Women
Regulations that protect women, so as to prevent their exploitation are: OHRP 45 CFR 46 Subpart B
Research studies involving pregnant women and fetuses should accomplish the following requirements to obtain IRB agreement: Preclinical studies should include pregnant animals and clinical studies should include non-pregnant women to deliver data for assessing potential risks to pregnant women and fetuses
Risk of the fetus is mainly produced by interventions or procedures which hold direct benefit for the women or the fetus.
REFERENCES:
https://gsdrc.org/topic-guides/social-protection-2/vulnerable-groups-needs-and-challenges/
https://www.slideshare.net/mahmoudShakria/vulnerability-238803409
https://www.sciencedirect.com/science/article/pii/S2212420920313285
Written by: Ruhina Tabassum
Pharm D
Student ID: 172/0922
Comments