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Vulnerable subjects

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persons who "have difficulty providing voluntary, informed consent arising from limitations in decision-making capacity ... or situational circumstances ..., or because they are especially at risk for exploitation."

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What is the first question when thinking about conducting research on vulnerable subjects?

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To ask whether the research could include a less vulnerable population instead, and still answer the research question

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Vulnerable Populations

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pregnant women, human fetuses, neonates, prisoners, children, individuals with physical disabilities, individuals with mental disabilities or cognitive impairments, economically disadvantaged, socially disadvantaged, terminally ill or very sick, racial or ethnic minorities, institutionalized persons (correctional facilities, nursing homes, mental health facilities)

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Physical control

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subjects who are physically forced to participate in research

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Coercion

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The use of a credible threat of harm or force to control another person

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Undue influence

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The misuse of a position of confidence or power to lead or influence others to make a decision they would not otherwise make

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Manipulation

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The deliberate design and management of conditions or information intended to lead subjects to make decision they would not otherwise make (lying, withholding information, exaggerating)

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Exploitation

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the action of treating someone unfairly in order to benefit from them in some way

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What does vulnerability arise from?

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Intrinsic factors, characteristics, or attributes of the individual

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Capacity-related cognitive vulnerability

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subjects to some extent lack capacity to make informed choices

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Situational cognitive vulnerability

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subjects do not lack capacity, but are in situations that do not allow them to exercise their capacities effectively (distraction or emergency)

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Communicative vulnerability

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subjects do not lack capacity, but due to limited ability to communicate with the researchers are not able to exercise their capacities effectively

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Institutional Vulnerability

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Subjects who are subject to the formal authority of others (prisoners, enlistees, employees, college students) subordinate

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Deferential Vulnerability

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Authority over the prospective subject is due to informal power relationships rather than formal hierarchies (gender, race, class, and knowledge inequalities)

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Medical Vulnerability

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prospective subjects have serious health conditions for which there are no satisfactory standard treatments (research vs. treatment)

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Economic vulnerability

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subjects are disadvantaged in the distribution of social goods and services (income, housing, or health care) (possibility of payment or attainment of these services)

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Social Vulnerability

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Prospective subjects who belong to undervalued social groups (reduced concern for them)

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HHS Criteria for Approval

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Should be cognizant of the special problems of research involving vulnerable populations; additional safeguards should be included in the study to protect the rights and welfare of these subjects

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T/F Consideration should be given to the inclusion of one or more individuals who are knowledgeable about and experienced with working with vulnerable subjects

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True

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Subpart B

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Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research

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Subpart C

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Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects

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Subpart D

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Additional Protections for Children Involved as Subjects in Research

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Vulnerability Due to Critical Illness

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Vulnerability in emergency research may be due to intrinsic factors and situational factors

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Vulnerability Due to Terminal illness

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Cognitive and physical impairments; desperation; perception of burden and risk may change

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Vulnerability Due to Decisional Impairment

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result from many causes including stroke and other Central Nervous System (CNS) disorders, trauma, medical treatment, and substance abuse.; situational factors (stigma, lack of insurance, education, discrimination)

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Vulnerability due to Physical Disabilities or Impairment

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The diminished participation in society --> intrinsic factor (physical limitation) or a situational factor (lack of accommodation)

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Vulnerability Due to Economic Disadvantage or Social Marginalization

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Situational factors (under-resourced, disparities, inequalities); trying to gain access to monetary compensation or services

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Vulnerability Due to Social Hierarchy

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issues centered around power/control, coercion, undue influence, and manipulation (subordination - students, residents, employees, prisoners, soldiers)

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Gender or Sexual Minority Status

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Prejudice or discrimination; GSD subjects; principle of beneficence or "do no harm"

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Vulnerability Due to Uncertain Immigration Status & Individuals Involved in Illegal Activities

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Potential consequences of exposure/retaliation

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Inducements

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Offers that influence people to make decisions, or do things they would not otherwise do

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When do inducements constitute an "undue influence"?

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if they alter a potential subjects decision-making processes such that they do not appropriately consider the risk-benefit relationship of the research

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Issues related to risks of harm in vulnerable populations

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Changes in the magnitude of an already identified risk; unrecognized risks that arise

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Primary group issue

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a vulnerable group may be the primary group on which the research is conducted because the investigation is focused on the source of vulnerability

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Undervalued group issue

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vulnerable may become the focus of study merely for ease or convenience of access, or because risks of harm or burdens to them are trivialized because the group is undervalued

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Exclusion Issue

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designing studies to exclude individuals or vulnerable groups from the research because of the complications and additional requirements for studying them is problematic

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Guidance for IRBs and Reviewers

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Are subjects vulnerable? Is inclusion of vulnerable subjects appropriate? Are vulnerable subjects adequately protected? (risks of harm and benefits)

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Practice

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interventions that are designed solely to enhance the wellbeing of an individual patient or client and that have a reasonable expectation of success

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Research

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designates an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge

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Experimental

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sense of new, untested or different (not automatically research)

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Basic ethical principles

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Respect for persons, beneficence, justice

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Respect for persons

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Individuals should be treated as autonomous agents; persons with diminished autonomy are entitled to protection (informed consent)

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Beneficence

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do not harm and maximize possible benefits and minimize possible harm (risk/benefit assessment)

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Justice

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Fairness in distribution or what is deserved; people should be treated equally (selection of subjects)

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Informed consent

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All subjects, to the degree that they are cable, should be given the opportunity to choose what shall and shall not happen to them; information, comprehension, and voluntariness

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Information

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the research procedure, their purposes, risks and anticipated benefits, alternative procedures, and a statement offering the subject the opportunity to ask questions and to withdraw at any time from the research

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Incomplete Disclosure

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Needs to be truly necessary, have no undisclosed risks that are more than minimal, have to have an adequate debrief

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Comprehension

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The manner and context in which information is conveyed; adapt to subject's capabilities; seeking permission from third parties

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Voluntariness

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An agreement to participate in research constitutes a valid consent only if voluntarily given; free of coercion and undue influence

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Undue influence (2)

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occurs through an offer of an excessive, unwarranted, inappropriate or improper reward or other overture in order to obtain compliance

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Assessments of Risks and Benefits

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Relevant data; systematic and comprehensive information about proposed research (proper design, justified risks, participation) (relation to beneficence)

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Risk

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A possibility that harm may occur (probability and magnitude)

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Benefit

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Something of positive value related to health or welfare (anticipated)

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Federal regulations require that risks to subjects be...

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Outweighs by the sum of both the anticipated benefit for the subject and society (knowledge)

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Systematic Assessment of Risks and Benefits

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decisions about the justifiability of research to be thorough in the accumulation and assessment of information about all aspects of the research

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Assessment of the justifiability of research

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- Brutal or inhumane treatment of human subjects is never morally justifiable - Risks should be reduced to those necessary to achieve the research objective - Justification of significant risks - Appropriate involvement of vulnerable populations - Relevant risks and benefits must be throughly arrayed in documents and procedures for informed consent

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Individual justice in the selection of subjects

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Researches need to exhibit fairness

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Social justice in the selection of subjects

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requires that distinction be drawn between classes of subjects that ought, and ought not, to participate in any particular kind of research, based on the ability of members of that class to bear burdens and on the appropriateness of placing further burdens on already burdened person

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Institutional Review Board (IRB)

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a review committee established to help protect the rights and welfare of human research subjects

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T/F IRB review and approval is required for research involving human subjects if it is funded or regulated by the federal government

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True

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Human subjects

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a living individual about whom an investigator conducting research obtains: data through intervention or interaction OR identifiable private information

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Private information

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- behavior that occurs in a setting in which the individual can reasonably expect the no observation/recording is taking place - info that is provided where the individual can reasonably expect that it will not be made public

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Clinical Investigation

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any experiment that involves a test article and one or more human subjects and that either must meet the requirements for prior submission to the FDA

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Authority of the IRB

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approve/disapprove/modify research; conduct continuing review; observe/verify changes; suspend/terminate approval; observe the consent process and research procedures

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Composition of the IRB

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- At least five members - Members of both sexes, that come from varied professions - At least two members whose primary concerns are in nonscientific and scientific areas - At least one member that is not affiliated with the institution - Reviewers with experience in all areas of research (may require consultants) - Diversity of backgrounds - Sensitivity to community attitudes - Knowledge of institutional commitments, and regulations - Knowledge and experience with vulnerable populations

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Minimum Federal IRB Requirements

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- Risk/anticipated benefit analysis - Informed Consent - Assent (affirmative agreement of a minor or decisionally impaired individual to participate) - Selection of subjects (equitable) - Safeguards (privacy and confidentiality) - Research plan for collection storage, and analysis of data - Research design/methods - Additional information (special populations)

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In addition, the IRB must review

answer

- The qualifications of the principal

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