CITI Social & Behavioral Research - BasicRefresher Social & Behavioral Research - Basic-Refresher

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CITI Social & Behavioral Research - Basic/Refresher Belmont Report and Its Principles Question 1 Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects? Your Answer Determining that the study has a maximization of benefits and a minimization of risks. Comment 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. Question 2 Which of the following are the three principles discussed in the Belmont Report? Your Answer Respect for Persons, Beneficence, Justice Comment The three principles discussed in the Belmont Report are Respect for Persons, Beneficence, Justice. Question 3 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: Your Answer Persons with diminished autonomy are entitled to protection. Comment 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. Defining Research with Human Subjects – SBE Question 1 According to the federal regulations, which of the following studies meets the definition of research with human subjects? Your Answer A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem-solving behaviors.

Comment 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. Question 2 According to the federal regulations, which of the following studies meets the definition of research with human subjects? Your Answer An experiment is proposed on the relationship between gender-related stereotypes in math and the subsequent performance by males and females on math tests. Comment In the study of the effects of evoking stereotypes on subsequent performance, the researcher has a research question and will be manipulating the behavior of individuals. An in-house study conducted with the intention of improving a department's mentoring programs is not research with human subjects, but rather program improvement. Receiving data with no identifiers is not research with human subjects because there is no interaction or intervention with a living human being and no collection of private identifiable data. In addition, creating a report for a membership organization does not involve a research question, as defined by the federal regulations, so it too is not research with human subjects. Question 3 A researcher is interested in assessing risk-taking by individuals. The researcher is sitting on a bench near a busy four-way stop intersection. She plans on recording the number of bike riders wearing a safety helmet and whether they stop at the intersection before proceeding in order to correlate use of safety apparel with risk-taking. This collection of information is an example of: Your Answer Public behavior Comment Public behavior occurs in a place where one does not reasonably expect privacy. The riders here are observed on public streets. These observations are public behavior. If the observation and recording of similar information occurred in a private training facility it could be considered private behavior and private information. Examples of public information would be donor lists in a concert program or names and addresses in telephone directories. Private information includes information that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place. Question 4 According to the federal regulations, which of the following studies meets the definition of research with human subjects?

Your Answer A developmental psychologist videotapes interactions between groups of toddlers and their caregivers to determine which intervention methods most effectively manage aggression. Comment 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. Question 5 A census is a regularly-occurring and official count of a particular population. Census data available at the United States Census Bureau website are an example of: Your Answer Public information Result Correct Comment Census data is a public source of data. The summarized data presented are available to individuals via the web without requiring a password.. When an individual completes the census form, there is no expectation that the data will remain private. Census data do not describe behaviors, but provide information about members of a given population. Students in Research Question 1 In the U.S., the first federal regulations for human subjects research began in 1991 with the codification of the ________. Your Answer Common Rule Comment The first federal regulations for human subjects protections was the Common Rule. The Nuremberg Code resulted from the 1940s Nuremberg Military Tribunal, during which Nazi physicians were convicted of unlawful experimentation on concentration camp prisoner. The Declaration of Helsinki (developed by the World Medical Association in 1964 and last revised in 2013) sets forth morally binding ethical principles for medical doctors engaged in biomedical research involving human subjects, as well as identifiable human biospecimens and data. The Belmont Report (The National Commission 1979) underscores similar ethical considerations for protecting human research subjects. In the United States, the Common Rule, which is the informal name of the U.S. Department of Health and Human Services (HHS) Policy for the Protection of Human Subjects (45 CFR 46, Subpart A) was codified in 1991 and revised in 2018. Question 2 Identify one way faculty researchers can possibly avoid undue influence of student subjects? Your Answer Avoid recruiting their own students in the research

Comment 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. Question 3 Under the U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) regulations, what is the Institutional Review Board (IRB) charged with? Select all that apply. Correct Answer - Protecting the rights and welfare of human subjects. - Assuring that researchers follow all applicable institutional policies and federal regulations related to research with human subjects. - Reviewing subject recruitment materials and strategies. Comment Under the U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) regulations, the IRB is charged with protecting the rights and welfare of human subjects and reviewing and overseeing human subjects research. IRBs do not investigate scientific misconduct nor do they review manuscripts prior to submission for publication. Question 4 Your informed consent form must describe _______. Your Answer All foreseeable risks and discomforts. Comment Per the federal regulations, the informed consent form must describe all foreseeable risks and discomforts. Question 5 A student is conducting a research project that involves the use of a survey. The survey asks subjects about their highest level of education, political affiliation, and views on various social issues. The student will not collect identifiable information. This study would be subject to which type of review? Your Answer Determination for Exemption Comment This study would qualify for a determination for exemption (under Category 2). This exemption category states that any research study involving educational tests, surveys, interviews, or observations of public behavior can be deemed exempt, unless the data is recorded in a way that identifies human subjects, directly or through identifiers linked to the subjects, and disclosure of any human subjects' responses outside the research could reasonably place participants at risk of criminal or civil liability or damage their financial standing, employability, or reputation. Question 1 Where could student researchers and/or student subjects find additional resources regarding the IRB approval process? Select all that apply. Your Answers - Faculty Advisor/Research Mentor - IRB Office Comment

Student researchers can find resources on various websites dedicated to human subjects research, including their institution's human subject protections website (if applicable). They may also contact their faculty advisor and IRB office for immediate assistance. Some institutions have a staff member or student mentor specifically charged with assisting student researchers during the IRB process. Question 2 Which type of IRB review does not require an IRB approval but does require a determination by an individual designated with that task (such as an IRB member or experienced staff person)? Your Answer Exempt Comment Exempt research is human subjects research that is "exempt" from the Common Rule provisions. Per federal guidance, the recommendation is that researchers should not be able to self-determine whether a study qualifies for exemption. Institutional policy should clearly designate who is responsible for making exemption determinations – and it could be an IRB member or experienced staff person with knowledge of the exemption categories and the research activity. Expedited and convened reviews both require IRB approval. Question 3 Your informed consent form must describe _______. Your Answer All foreseeable risks and discomforts. Comment Per the federal regulations, the informed consent form must describe all foreseeable risks and discomforts. Question 4 Which of the following studies would need IRB approval? Your Answer Studies collecting identifiable information about living individuals. Comment If a study intends to collect identifiable or information about a living individual, you would need IRB review and approval. History and Ethical Principles - SBE (ID 490) Question 1 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: Your Answer Respect for persons Result Correct Comment 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.

Question 2 According to the Belmont Report, the requirement that the benefits and burdens of the research are equitably distributed, expresses the principle of: Your Answer Justice Comment 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). Question 3 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? Your Answer "Tastes, Ties, and Time (T3)" study Comment 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. Question 4 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? Your Answer Justice Comment 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. Question 5 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?

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