Belmont Report
provides the ethical framework for the federal regulations designed to protect human research subjects.
Belmont Report and Its Principles
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.
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.
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
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.
Which of the following are the three principles discussed in the Belmont Report?
Respect for Persons, Beneficence, Justice
The three principles discussed in the Belmont Report are
Respect for Persons, Beneficence, Justice.
Students in Research
A master’s degree candidate needs to conduct a research project for her master’s thesis. She is interested in the types of junk food available to the public. She plans on going to the local convenience stores and asking the owners what types of junk food the store normally stocks and which are the biggest sellers. Identifiers will not be collected. This study would fall under which of the following?
Not Human Subjects
This study would qualify as not human subjects because
the data that the student is collecting does not meet the definition of human subjects research as stated by federal regulations. She is not collecting any information about the store owners, but her study mainly seeks to find information about the items in the store.
The history of ethical regulations in human subjects research began with the
Nuremberg Code
Nuremberg Code
Prior to the Nuremberg Code in 1949, the U.S. did not have a set of ethical regulations in human subjects research. The Nuremberg Code paved the way in creating the human subjects research guidelines and regulations we follow today.
How can faculty researchers avoid undue influence of student subjects?
Avoid using their own students in their research
Avoid using their own students in their research
By recruiting students from other classes, faculty researchers can minimize the potential of undue influence. Students from the faculty’s own classroom may feel coerced to participate so to protect them, students who do not have any courses with the faculty should be recruited when possible.
Per federal regulations, which of the following elements must be included in an informed consent document?
All foreseeable risks and discomforts.
The federal regulations require
all foreseeable risks and discomforts must be included in an informed consent.
Which type of IRB review does not require an IRB approval but does require a determination by the IRB or an IRB designee?
Exempt
Exempt research is
research with human subjects. However, it is “exempt” from the provisions stated in Title 45, Part 46, Subpart A (the Common Rule). Federal guidance recommends that investigators not be allowed to self-determine whether a study qualifies for exemption. Therefore, exempt studies generally are reviewed and determined by the IRB, or its representative. Expedited and Full/Convened Board reviews both require IRB approval.
History and Ethical Principles
The Belmont principle of beneficence requires that:
Potential benefits justify the risks of harm.
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 which of the following studies?
“Tastes, Ties, and Time (T3)” study (2006-2009)
“Tastes, Ties, and Time (T3)” study (2006-2009)
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 moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of:
Justice
Justice
According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of justice.
Which of the following studies is 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 Study of Untreated Syphilis
The Public Health Service Study of Untreated Syphilis
The Public Health Service Study of Untreated Syphilis is 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.
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
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).
Defining Research with Human Subjects
A medical record is an example of:
Private information
Private information includes
information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects. 45 CFR 46.102(e).
A medical record is considered private because it includes identifiable information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public. A medical record is not considered public information, nor is it considered a behavior.
According to the federal regulations, which of the following studies meets the definition of research with human subjects?
A developmental psychologist videotapes interactions between groups of toddlers and their caregivers to determine which intervention methods most effectively manage aggression.
The study of passenger lists is
a study of individuals who are no longer living. A human subject is a living individual. Questioning individuals to acquire data about the number of newly diagnosed HIV cases is asking “about what” questions rather than “about whom” questions. Conducting a linguistic analysis of comments posted on a public blog involves neither interaction with individuals nor collecting private identified information and thus does not meet the definition of research with human subjects. The study proposed by the developmental psychologist does meet the definition of research with human subjects. It involves interactions with living individuals and is designed to contribute to a field of knowledge.
According to the federal regulations, which of the following studies meets the definition of research with human subjects?
A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem-solving behaviors.
A cognitive scientist studying the effect of moods on problem-solving behaviors is
asking a research question and is interacting with living individuals. Questioning a superintendent of schools to acquire data about the ethnic composition of a school system is asking “about what” questions rather than “about whom” questions. (If a study proposed interviewing the superintendent of public schools about his or her experience in the field of education or about his or her perceptions about the current problems within the school system and possible solutions, the questions would become “about whom.”) Analyses of public behavior such as writing for a blog or a newspaper do not meet the definition because there is no interaction or intervention with a human subject and no collection of private information. Finally, in the class exercise described, the intention is pedagogical (to learn how to conduct and interview) rather than to answer a research question.
A professor at Big State University is writing a biography about Bill Gates and conducting oral histories with all of Bill Gates’ friends, family members, and business acquaintances. The researcher submits the research proposal to the institution’s IRB. What action can he expect by the IRB?
The IRB will not review this study because it is not research as defined by the federal regulations.
The IRB will not review this study because it is not research as defined by the federal regulations.
This proposal is obtaining data from human subjects, but this project is not research since it is not “a systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” This project will not be reviewed by the IRB.
According to the federal regulations, which of the following studies meets the definition of research with human subjects?
A study of twenty 4th grade classrooms in which researchers ask the schools to systematically vary the time of day reading is taught, and collect weekly assessments of reading comprehension for each child over a three-month period.
The study in the 4th grade classrooms
The study in the 4th grade classrooms about the relationship between the time of day reading is taught and reading comprehension does meet the definition of research with human subjects. The study is designed to contribute to generalizable knowledge about student performance and the research question can only be answered using a systematic investigation.
Information collected by the playground designer does not involve any information about human subjects even though it does involve interaction between the designer and school staff. An analysis of aggregate data doesn’t involve interactions with living individuals nor the collection of private identifiable data. An economic feasibility study will gather information from people with relevant information and expertise but does not meet the definition of research with human subjects, because the intention of the study is to answer “about what” questions rather than “about whom” questions.
The Federal Regulations
According to federal regulations, the expedited review process may be used when the study procedures pose:
No more than minimal risk and the research activities fall within regulatory categories identified as eligible.
No more than minimal risk and the research activities fall within regulatory categories identified as eligible.
Research is eligible for expedited review when it poses no more than minimal risk to the participants and when all the activities fall within categories identified as eligible. Studies with more than minimal risk do not qualify for expedited review even if the subjects are adults, the sponsor is in a hurry, or the study replicates previously approved research.
Which of the following statements about the relationship between an institution and the institution’s IRB(s) is correct?
Officials of the institution may overrule an IRB approval.
Officials of the institution may overrule an IRB approval.
If an IRB has disapproved a protocol, that disapproval may not be overturned by an institutional official or anyone at that institution, such as a department chair. However, an IRB-approved protocol may be subject to other reviews at the institution and may be disapproved (overruled).
Continuing review of an approved and ongoing study posing more than minimal risk that was initially approved by a convened IRB:
Must occur within 12 months of the approval date.
Must occur within 12 months of the approval date.
Continuing review of an approved protocol must occur within 12 months of the approval date even if no additional risks have been identified. Review by a convened IRB is not always required (for example, if the study was complete and in data analysis only). Any unanticipated problems must be addressed during the continuing review process, but the review must include other information such as the number of subjects accrued, any relevant recent literature, and a copy of the current consent form.
According to the federal regulations, research is eligible for exemption, if:
The research falls into one of eight categories of research activity described in the regulations.
Research is only eligible for exemption if
all the activities associated with the research fall into one of eight categories of activities described in the federal regulations. The regulations do allow some research with children to be exempt (although institutional policy may not). The duration of the study and the experience of the researcher are not criteria for determining eligibility for exemption.
In addition to pregnant women, fetuses, and neonates, another subpart of the HHS regulations provides additional protections for which of the following vulnerable populations?
Prisoners
Prisoners
Prisoners are provided additional protections in the HHS regulations. The HHS regulations do not have specific additional protections for elderly, for students, or for persons whose decision-making capabilities are impaired. Researchers may consider and the IRB may require additional safeguards for these populations.
Assessing Risk
Additional safeguards that may be included in a social and behavioral study may include:
Remove all direct identifiers from the data as soon as possible.
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