Populations in Research Requiring Additional Considerations and/or Protections

The NBAC looks at characteristics individuals might have that would prevent them from being able to provide voluntary informed consent. The traits may be thought of as falling into six broad areas: cognitive or communicative, institutional, deferential, medical, economic, and social. Prospective research subjects who are not able to comprehend information, deliberate, and make decisions about participation in a proposed research study have a:

Cognitive or communicative vulnerability Prospective research subjects who are not able to comprehend information, deliberate, and make decisions about participation in a proposed research study have a cognitive or communicative vulnerability.

A subject participates in a drug study because treatment is available at no or reduced cost, and he could not otherwise afford it. This is an example of:

Economic vulnerability Economic vulnerability arises when prospective subjects are disadvantaged in the distribution of social goods and services (income, housing, or healthcare). Participation in research offers the possibility of payment or attainment of healthcare or other services that are otherwise not available, and induce persons to enroll in a research study when it might be against their better judgment and when otherwise they would not do so. These inducements to enroll threaten the voluntary nature of consent and raise the danger of exploitation. Prospective subjects who belong to undervalued social groups may be subject to social vulnerability. The perception of these groups as less valuable to society could lead to reduced concern (by researchers) for risks of harm and burdens on those groups, and increase the risk of exploitation. Prospective subjects in research who are subject to the formal authority of others may have an institutional vulnerability. These individuals have the cognitive capacity to consent but may not be able to make a truly voluntary choice, and may be unduly influenced (or coerced) to participate when they otherwise might not have done so. Prospective research subjects who are not able to comprehend information, deliberate, and make decisions about participation in a proposed research study have a cognitive or communicative vulnerability.

Subjects with a serious illness may be at risk for exploitation because they may be desperate for a possible cure. This is an example of:

Medical vulnerability Medical vulnerability arises when prospective subjects have serious health conditions for which there are no satisfactory standard treatments. Subjects with serious health problems may not be able to adequately weigh the risks and potential benefits of the research. Subjects are at risk of exploitation because they may overestimate potential benefit. Deferential vulnerability is similar to institutional vulnerability, but the authority over the prospective subject is due to informal power relationships rather than formal hierarchies. Economic vulnerability arises when prospective subjects are disadvantaged in the distribution of social goods and services (income, housing, or healthcare). Therapeutic misconception occurs when subjects blur the roles played by physician-researchers and fail to appreciate the difference between research and treatment.

According to the authors, there are four common abuses that historically are described as giving rise to vulnerability. Which response below contains the correct four?

Physical control, coercion, undue influence, and manipulation There are four common abuses that historically are described as giving rise to vulnerability 1) physical control, 2) coercion, 3) undue influence, and 4) manipulation. These exist along a continuum of severity with physical control being the most severe and undue influence and manipulation being the least (Nelson and Merz 2002, V69-80). The other abuses- prejudice, neglect, and disrespect - should still be avoided in research.

In considering NBAC's analytic approach, an otherwise competent person who is acutely ill might be considered at especially high risk of harm for:

Situational cognitive vulnerability Subjects who do not lack capacity, but are in situations that do not allow them to exercise their capacities effectively, may suffer situational cognitive vulnerability. This might occur when a subject is distracted or during an emergency situation, such as an acute illness or injury. Capacity-related cognitive vulnerability can occur when subjects to some extent lack capacity to make informed choices. Communicative vulnerability can occur when subjects do not lack capacity, but due to limited ability to communicate with the researchers are not able to exercise their capacities effectively. Economic vulnerability arises when prospective subjects are disadvantaged in the distribution of social goods and services (income, housing, or healthcare).