History & Ethical Principles- SBE

A study was submitted to the IRB designed to evaluate the effect of background noise on an individual's ability to concentrate and answer questions. The IRB approved the study and consent form. The consent form includes all the required information. The use of a consent form is an example of the Belmont principle of:

respect for persons (The principle of respect for persons requires that subjects understand that participation is voluntary and that they are provided detailed information about the study before giving consent to participate. The principle of beneficence requires that risks are reasonable in relationship to anticipated benefits. The principle of justice requires that the benefits and burdens of research are equitably distributed and subject populations are not chosen because of convenience.)

Humphreys' collecting data for the Tearoom Trade study under the pretense that he was a lookout is an example of a violation of the principle of:

respect for persons (Humphreys' collecting data for the Tearoom Trade study while posing as a lookout is an example of a violation of the principle of respect for persons. Respect for persons requires that subjects freely choose to participate in research (voluntariness) and that they are adequately informed about a study (informed consent). The principle of beneficence requires balancing the risk of harms with the potential benefits. The principle of justice requires that benefits and burdens are equitably distributed and subject populations are not chosen due to convenience.)

The researcher's failure to protect research subjects from deductive disclosure of identity (that is, the re-identification of subjects by other researchers) is the primary ethical violation in which of the following studies?

tastes, ties, and time (T3) study (Although no students were identified by name in the T3 study, some data were specific enough to allow for re-identification of students by an outside researcher. This is an example of the failure to protect subjects from deductive disclosure of their identities. The primary ethical problems of the other studies include physical harms and unanticipated psychological harm.)

According to the Belmont Report, the requirement that the benefits and burdens of the research are equitably distributed, expresses the principle of:

justice (According to the Belmont Report, the requirement that the benefits and burdens of the research are equitably distributed, expresses the principle of justice. The principle of beneficence requires minimizing the risk of harms and maximizing the potential benefits. Respect for persons requires that subjects freely choose to participate in research (voluntariness) and that they are adequately informed about a study (informed consent).)

An example cited in the Belmont Report (The National Commission 1979) stated that "During the 19th and early 20th centuries the burdens of serving as research subjects fell largely upon poor ward patients, while the benefits of improved medical care flowed primarily to private patients." This is an example of a violation of which Belmont principle?

justice (This example demonstrates a violation of the principle of justice which requires that the benefits and burdens of research are equitably distributed and subject populations are not chosen because of convenience. In simple terms, the principle of justice requires that the selection of subjects is fair.) (The principle of beneficence requires that risks are reasonable in relationship to anticipated benefits. The principle of respect for persons requires that subjects understand that participation is voluntary and that they are provided detailed information about the study before giving consent to participate.)

A researcher submits a study to the IRB that proposes to evaluate a new after-school on-line tutoring program for middle-school students in a local school district examining the effect on student grades. She proposes to perform this assessment at the school that her children attend, because she is familiar with the school district. Students may use either their personal smartphone or computer to participate in the program. This study might be determined to be violating which principle of the Belmont Report?

justice (This proposal would violate the principle of justice which requires that the benefits and burdens of research are equitably distributed and subject populations are not chosen because of convenience. Choosing a single school that her children attend might be viewed as providing a subject population of convenience. Evaluating the program in multiple schools across a school district could avoid this problem.) (If the schools in the district have wide variations in household income, this study might eliminate students from less affluent families without access to internet service and electronic tools, failing to ensure that benefits and burdens of research are equitably distributed.) (The principle of beneficence requires that risks are reasonable in relationship to anticipated benefits. The principle of respect for persons requires that subjects understand that participation is voluntary and that they are provided detailed information about the study before giving consent to participate.)