Research Design and Statistics Citi Program 2

Which is true of inducements in research?

Inducements constitute an "undue influence" if they alter a potential subject's decision-making processes, such that they do not appropriately weigh the risk-benefit relationship of the research. Inducements are offers that influence people to make decisions, or do things they would not otherwise do. Inducements and the influence they cause may be acceptable, or they may be "undue," and the distinction is not always clear or universally agreed upon. Offering $10 may be acceptable for an hour long research study; offering $1000, or a better grade in a class, is probably not appropriate. In general, inducements constitute an "undue influence" if they alter a potential subjects decision-making processes such that they do not appropriately consider the risk-benefit relationship of the research.

Risk of harm in social and behavioral sciences generally fall in three categories, which are:

Invasion of privacy, breach of confidentiality, and study procedures

The Belmont principle of beneficence requires that:

Potential benefits justify the risks of harm.

The researcher's failure to protect research subjects from deductive disclosure is the primary ethical violation in:

Harvard "Tastes, Ties, and Time (T3)" study (2006-2009)" study

An example of how the principle of beneficence is applied to a study involving human subjects

Ensuring that risks are reasonable in relationship to anticipated benefits.

A researcher wishes to study generational differences in coping mechanisms among adults who experienced abuse as children. Adequate measures will be instituted to obtain informed consent and ensure that there is no breach of confidentiality. The most likely additional risk is that some subjects may:

Experience emotional or psychological distress.

When an IRB is reviewing a research study and they are considering if a potential subject population is vulnerable, they should consider:

Is there a power differential between researchers and subjects? IRBs should assess if there is a power differential and if it would affect the potential subjects, making them vulnerable to coercion. According to the module authors, it is important for IRBs to ask researchers to fully describe the population to be studied and the situations in which the potential research subjects find themselves. This should answer both the question about the intrinsic factors or attributes as well as the situational forces that may give rise to different types of vulnerability. The other responses (b, c, and d) should also be considered by the IRB during their review of the research, but do not relate to identifying if the subject population is vulnerable.

Example of a situation where deferential vulnerability might be a factor

A physician recruiting his patients In deferential vulnerability the authority over the prospective subject is due to informal power relationships rather than formal hierarchies. The power relationship may be based on gender, race, or class inequalities, or they can be inequalities in knowledge (such as in the doctor-patient relationship). Like institutional vulnerability, deferential vulnerability increases the risk of harm that informed consent would be compromised because it is not fully voluntary.

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 health care). 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.

According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of:

Justice

Subjects with a serious illness may be at risk for exploitation since 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 health care). Therapeutic misconception occurs when subjects blur the roles played by physician-researchers and fail to appreciate the difference between research and treatment.

NBAC proposed a concept of vulnerability in research based on features of potential subjects or of their situation.

NBAC specifically states a person may be vulnerable "because they 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" While high potential for individual benefit from participating in research might increase the likelihood that a person might participate despite high risks, the root cause of their vulnerability is the potential for exploitation. Next, the NBAC looked 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.

Identify the following groups that are protected in the federal regulations (45 CFR 46), specifically in Subparts B, C and D with additional protections

Neonates (Pregnant women), Prisnoners, Children

If disclosure of a subject's involvement in a specific research study can be potentially harmful to the subject, and the consent form is the only record linking the subject to the research, which of the following would be most helpful:

Obtain a waiver of documentation of informed consent.

According to the authors, there are four common abuses that historically are described as giving rise to vulnerability

Physical control, coercion, undue influence, and manipulation There are four common abuses that historically are described as giving rise to vulnerability1) 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 & Merz 2002). The other abuses- prejudice, neglect and disrespect - should still be avoided in research.

The primary purpose of a Certificate of Confidentiality is to:

Protect identifiable research information from compelled disclosure.

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 health care).

Linked Most directly to the establishment of the National Research Act in 1974 and ultimately to the Belmont Report and Federal regulations for human subject protection

The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male.