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Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects?

Determining that the study has a maximization of benefits and a minimization of risks. The principle of beneficence includes the obligation of researchers to strive to do no harm and to maximize benefits and minimize harms. "Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being" (The National Commission 1979). The principle of beneficence can be applied to a study employing human subjects by determining that the study has a maximization of benefits and a minimization of risks. Providing detailed information during consent and ensuring persons with diminished autonomy are protected would be examples of applying the principle of respect for persons. Ensuring the selection of subjects is equitable is an example of applying the principle of justice.

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

Pregnant women, prisoners, children The HHS federal regulations at 45 CFR 46 includes three subparts (B, C, and D) that specifically provide additional protections to vulnerable groups. The vulnerable groups identified are: Subpart B. Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research Subpart C. Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects Subpart D. Additional Protections for Children Involved as Subjects in Research. The regulations do not provide specific additional protections for elderly, mentally disabled or terminally ill.

Which of the following are the three principles discussed in the Belmont Report?

Respect for Persons, Beneficence, Justice

Which of the following studies has the LEAST potential to create group harm?

A Phase 3 clinical trial of a new anticancer agent in middle-aged women diagnosed with breast cancer. A Phase 3 clinical trial of a new anticancer agent in middle-aged women diagnosed with breast cancer is unlikely to cause group harms. It is unlikely that such a study will be harmful to women with breast cancer or to women in general who do not participate in the study. The results from other hypothetical studies listed have the potential to be distressful, to stigmatize or in another way harm individual members of the Group who did not actively participate in the research.

The results from research have been known to produce harms to members of the sampled population who do not actually participate in the research study. An example of the type of research that could result in group harms by stigmatizing members of the group (even for individuals who do not participate in the research) is:

A study of the types and prevalence of sexually transmitted infections (STIs) in small rural towns in a midwestern state. The research results from the study of types and prevalence of STIs in the midwestern state could potentially stigmatize individuals who are members of rural communities in the state being studied, even if they did not participate in the research. The research results from the other studies (including about sleeping patterns and productivity, glucose monitoring, or absenteeism) would not be stigmatizing.

A researcher wants to invite therapists to participate in small focus groups to discuss their perceptions regarding "troubled" adolescent girls and the relationships they have with their parents. Specific clients of the therapists will not be discussed. Which of the following will be the most important issue for the researcher to consider when planning the research?

Breach of confidentiality from the focus group subjects (therapists) Most risks of harm from SBR research results from invasion of privacy and breaches of confidentiality. Researchers should design strategies to minimize the possibility of breaches of confidentiality and inform all subjects about the potential for these breaches especially in a focus group situation. While emotional distress, compensation and recruiting strategies are all important issues for the researcher to consider in this situation, the potential for breach of confidentiality is the most important.

Which of the following is considered a SBR data collection method?

Interviews Hearing screenings, blood draws, and other physical exams are usually designed to collect physiological data, not information about attitudes and beliefs. Interviews are designed to collect information about attitudes, beliefs, and behavior and are data collection methods typically used by SBR researchers.

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.

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).

Which of the following practices can be effective in minimizing group harms?

Community consultation is used with the community of interest to make sure that potential harms are recognized and understood, and that the study is designed to provide benefits to the community. Collaborative IRB review with tribal IRB's will also maximize the likelihood that group harms are minimized. On-going consultation ensures that group leaders are provided with accurate information about the research as it progresses. By planning disclosure of the research, the researcher informs the community about how the research results will be disclosed early on in the process to reduce the possibility of harms to the group as the research is published or presented.

A researcher is conducting a written survey about people's attitudes toward walking as an exercise option at the local shopping mall that supports a walking program. The survey is anonymous (without codes, names, or other information) and subjects may complete the survey and place it in a box at the shopping mall exits. Which of the following is the most important issue that the researcher addressed in planning the research?

Confidentiality of the individual subject's responses The most important issue that the researcher addressed in planning the research is the confidentiality of the individual subject's responses. By making the survey anonymous, no one, even the researcher, has knowledge of the individual's identity. While recruitment strategies, minimizing emotional distress, and having a large sample size are important issues to address, the confidentiality of the individual subject responses is the most important in this example.

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 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.

Which of the following most accurately describes the risks associated with SBR?

Less predictable, more variable, and less treatable than physical harms It is more difficult to predict how individuals will react to questions and situations in which their behavior is observed or manipulated than to physical data collection methods such as blood draws. The reactions may be of considerable duration. Once those reactions happen, they may be difficult to assess, serious enough to require treatment and may even be untreatable compared to treating physical harms.

The Belmont Report's principle of respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that: Persons with diminished autonomy are entitled to protection.

Persons with diminished autonomy are entitled to protection. The Belmont Report's principle of respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection. Persons with diminished autonomy should not be excluded from participating in research, because then they would be excluded from receiving the benefits of research. The Belmont Report does not limit persons with diminished autonomy with participating in greater than minimal risk research. The Belmont Report also does not limit persons involved in research from benefitting financially.