Citi Certifications for Psychology
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? PHS Tuskegee Study
In the U.S., news that researchers deceived and withheld treatment from subjects who suffered from syphilis in the PHS Tuskegee Study led to the creation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission or "the Commission"). The Commission was charged with establishing a code of research ethics for U.S. research involving human subjects and created the Belmont Report that ultimately informed federal regulations for the protection of human subjects.
Your informed consent form must describe _______. All foreseeable risks and discomforts.
Per the federal regulations, the informed consent form must describe all foreseeable risks and discomforts.
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 are provided additional protections in the HHS regulations. The HHS regulations do not have specific additional protections for the 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.
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).
A researcher is examining the quality of life for prisoners who are HIV-positive using surveys followed by interview. The IRB must ensure that: Confidentiality of the prisoners' health status is maintained.
By participating in the research, it is possible that subjects will become publicly identified as HIV-positive. This breach of confidentiality could lead to negative consequences for the prisoner. One method for the investigator to preserve this confidentiality is to interview a larger sample of offenders, some who are HIV-positive and some who are not. While the survey should be validated and reliable, it does not have to be standardized. Because the research is behavioral only, there is no need for a medical doctor. The prison's HIV testing procedures are not part of the study.
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: Public information
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.
The primary purpose of a Certificate of Confidentiality is to: Protect identifiable research information from compelled disclosure.
Certificates of Confidentiality protect sensitive information provided by research subjects from civil, criminal, or administrative subpoena.
Which of the following studies would need IRB approval? Studies collecting identifiable information about living individuals.
If a study intends to collect identifiable or information about a living individual, you would need IRB review and approval.
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.
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).
A researcher wants to do a web-based survey of college students to collect information about their sexual behavior and drug use. Direct identifiers will not be collected; however, IP addresses may be present in the data set. Risk of harm should be evaluated by: Both the magnitude (or severity) and the probability (or likelihood) of harm.
Risk must be determined by assessing both the magnitude (or severity) and the probability (or likelihood) of harm. Both elements must be considered. Although the probability that an individual subject could be identified is low, the magnitude of the possible harm is high given the sensitivity of the information.
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. - 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.
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.
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.
When a possible disclosure of subjects' responses is the primary source of potential harm, collecting data anonymously may provide the best protection and removing direct identifiers is an additional safeguard. The other responses are additional safeguards, but refer to studies that may involve investigational drugs or are biomedical and not social behavioral.
According to the federal regulations, human subjects are living individuals about whom an investigator conducting research obtains information through interaction or intervention with the individual, and uses, studies, or analyzes the information; or: Obtains, uses, studies, analyzes, or generates identifiable private information.
In order to meet the definition of research with human subjects a researcher must obtain data about a living individual through interaction or intervention or, alternatively, obtain individually identifiable private information. If a researcher obtains public information or de-identified information about individuals, and has not interacted or intervened with the individuals, those individuals are not considered human subjects for the purposes of the research.
What statement about risks in social and behavioral sciences research is most accurate: Risks are specific to time, situation, and culture.
Research in the social and behavioral sciences sometimes does pose risks to subjects. Risks can be time, situation, and context specific. What may be a socially sensitive issue or topic at a given time and/or place may not be so at another time and/or place. The risk of emotional distress cannot be managed by anonymizing data, but rather by developing a plan to respond to the distress should it occur. Risks must always be minimized to the extent possible, regardless of the potential for benefit.
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.
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.
A researcher asks an IRB to waive the requirement for parental permission for a study conducted in schools because the nature of the research requires participation of all the children present in classrooms on the day the research will take place. Assuming that the basic research design could be approved by the IRB and the school, which of the following requirements must be met before an IRB could waive parental permission? The research must pose no more than minimal risk.
One of the four criteria for waiving parental permission is that the research must pose no more than minimal risk. Although it may be appropriate to notify parents that the study is taking place, and many researchers do so, it is not required by the regulations when a waiver of parental permission has been approved. While children must provide assent to participate, depending upon the age of the children there are multiple strategies for accommodating children who do not want to participate other than alternate classroom activities. It is not required that an independent consultant approve waivers of parental permission.
Data are made anonymous by Destroying all identifiers connected to the data.
Reporting data in aggregate form, while protecting the identity of subjects, does not make the data anonymous. Keeping keys in secure locations and requiring members of the research team to sign confidentiality agreements are methods for protecting identifiable information but they do not involve destroying all identifying information so that the link between identity and data is gone forever. The only way to render data entirely anonymous is to remove all identifying information from the data and completely disconnect any links between the subjects and data about the subjects.
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.
https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html
https://www.hhs.gov/ohrp/index.html https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html
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.
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)? Exempt
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.
A graduate student wants to examine the effect of print media versus televised media on individuals' position on several social issues. The superintendent of a local work release facility, a family friend, will allow the graduate student access to the prison population to help her quickly accrue subjects. The student's IRB should: Not approve this project because the prisoners are merely a population of convenience for the student.
Factors such as the level of risk and proposed facility are irrelevant if the prison population is simply a population of convenience as it is in this case. Research taking place in prisons must be material to the lives of the prisoners. Therefore, according to the regulations, an IRB could not approve this protocol.
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.
As part of the consent process, the federal regulations require researchers to: Provide potential subjects with information at the appropriate reading comprehension level.
Researchers must provide information to subjects in a manner that facilitates comprehension. Therefore, the material must be written at the appropriate reading comprehension level. Researchers may not impose penalties for non-participation because to do so would violate the ethical principle of respect for persons. In some circumstances it may be appropriate to ask subjects to discuss the research with their families before making a decision about whether to participate, but it is not a regulatory requirement. Finally, researchers are not required to provide a list of the IRB members who reviewed the research.
Where could student researchers and/or student subjects find additional resources regarding the IRB approval process? Select all that apply. - Faculty Advisor/Research Mentor- IRB Office
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.
A general requirement for informed consent is that no informed consent may include any exculpatory language. Exculpatory language is that which waives or appears to waive any of the subject's legal rights or releases or appears to release those conducting the research from liability for negligence. Which of the following statements in a consent form is an example of exculpatory language? Taking part in the research is voluntary, but if you choose to take part, you waive the right to legal redress for any research-related injuries.
A statement in a consent form that says that subjects who agree to take part in the research waive their legal rights constitutes exculpatory language. Statements about the voluntary nature of consent, about the possible need to remove subjects from a study in order to protect their welfare, and statements about providing referrals do not waive subjects' rights.
A criterion for waiving informed consent is that, when appropriate, subjects are provided additional pertinent information after the study. In which of the following studies would it NOT be appropriate to provide subjects with information about missing elements of consent: A study in which subjects were assigned to study activities based on an undesirable or unflattering physical characteristic as assessed by members of the research team.
If subjects were to learn that the research team assigned them to study conditions based on undesirable or unflattering physical characteristics, the knowledge that their appearance was judged negatively by the research team could be very distressing and, therefore, it would not be appropriate to inform subjects after the study about how they were assigned. Informing subjects about the actual research procedures in the other studies would be unlikely to cause them harm.
When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct? The researcher cannot control what participants repeat about others outside the group.
It is not possible for a researcher to promise confidentiality in a focus group setting. Participants may choose to repeat sensitive information outside the group setting even if they have signed confidentiality agreements. This is true even if the participants know each other. Using pseudonyms in the report does not remove concerns about what group members might say outside the group.
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.
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.
According to Subpart D, research with children may be eligible for exemption under Category 2 when: The research involves the use of educational tests
Subpart D restricts the use of exemptions when children are research subjects. Research that involves interviews, surveys, or participant observation when the researcher interacts with the children is not eligible for exemption under Category 2.
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.
A researcher wants to contact former prisoners who are now on parole. She wants to study the difficulty of obtaining employment based on whether the subjects had been convicted of felony versus misdemeanor crimes. She needs to: Do nothing in regards the Subpart C because the research does not meet the criteria for prison research -- individuals on parole are not considered prisoners. The definition applies to both minors and adults.
The potential subjects do not meet the definition of prisoners and they are not considered a vulnerable population based on the regulations. While there are other considerations with respect to limits on their autonomy that may require additional protections, the prisoner regulations do not apply.
The specific U.S. Department of Health and Human Services (HHS) regulations that apply to research with children are known as Subpart D: Additional Protections for Children Involved as Subjects in Research. True
The provisions of Subpart D, of the HHS regulations, Additional Protections for Children Involved as Subjects in Research are the specific U.S. Department of Health and Human Services (HHS) regulations that apply to research with children.
A waiver of the requirement for documentation of informed consent may be granted when: The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality.
The requirement to document informed consent can be waived if the only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality. The requirement may also be waived if the study poses no more than minimal risk to subjects and involves no procedures for which written consent is normally required outside of the research context. With regard to non-English speakers, if documentation is required, investigators must provide informed consent materials in the subjects' language. If a researcher anticipates that subjects might be embarrassed by questions, this concern should be addressed in the consent process. Finally, identifying secure storage space for consent forms is an investigator's responsibility.
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 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.
The provisions of Subpart D, of the HHS regulations, Additional Protections for Children Involved as Subjects in Research apply to: All research funded by HHS
The provisions of Subpart D must be applied to all research funded by the HHS (which includes NIH). However, not all federal agencies that have adopted the Common Rule have also adopted Subpart D. In addition to HHS, only the U.S. Food and Drug Administration and the Department of Education have adopted it. Institutions may elect to apply the subpart to all research, regardless of the source of funding.
In a longitudinal study that will follow children from kindergarten through high school and will collect information about illegal activities, which of the following confidentiality procedures would protect against compelled disclosure of individually identifiable information? Securing a Certificate of Confidentiality
Although data encryption, using pseudonyms, and waiving documentation of consent, provide data protection, the researcher can link individuals to their responses. Therefore, the data are vulnerable to subpoena in civil, criminal, and administrative court proceedings. Unless the researcher has a Certificate of Confidentiality, he or she may be compelled to release individually identifiable information about research subjects. The Certificate provides the highest level of protection.
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.
Identify the example of when situation and time are key to assessing risk of harm in a research study: Asking women if they have had an abortion
Asking women if they have had an abortion would carry very different risks in a country where abortion is a routine medical practice, a country where it is illegal, and a country in which it is legal but the issue is fraught with religious and political controversy. Purchasing tobacco products is generally illegal for persons under 18 years of age, so any assessment of the risk for teenagers will have to consider that the research focuses on an illegal activity and is assessing the subject population, not situation and time. Similarly, a survey about sexually transmitted diseases would carry different risks for middle class suburban men, clergy, and gang members and is assessing risk through the idea of subject population, not situation and time. Research on the prevalence of harassment in different academic disciplines may stigmatize the community being studied in certain extreme cases, but the risk should be assessed as subject population, not situation and time either.
Which of the following statements about prison research is true? Researchers may study the effects of privilege upgrades awarded by the prison.
Because studies of the effects of processes of incarceration are allowed under the regulations, researchers may study the effects of privilege upgrades awarded by the prison. The regulations do not prohibit payment of prisoners for their participation. However, the amount of compensation cannot constitute undue influence to participate. Many correctional institutions may prohibit payment. The decision to participate in research may not be considered during parole hearings, as this practice would clearly constitute undue influence to participate. The regulations require that IRBs determine that risks involved in research with prisoners are commensurate with risks that would be accepted by non-prison volunteers.
Which of the following constitutes both a breach of confidentiality (the research data have been disclosed, counter to the agreement between researcher and subjects) and a violation of subjects' privacy (the right of the individuals to be protected against intrusion into their personal lives or affairs)? A faculty member makes identifiable data about sexual behavior available to graduate students, although the subjects were assured that the data would be de-identified.
No agreements were made regarding confidentiality with the subjects who were unknowingly audio-taped; whose interactions were recorded, or whose cocaine use was revealed by another. Therefore, there was no breach of an agreement about confidentiality, but the subjects' right to decide who can access their personal information was violated. If a researcher told subjects that only he or she would have access to identifiable data and then gives identifiable data to others that action constitutes a breach of confidentiality and a violation of privacy - the subjects' right to control who has access to personal information.
A researcher's study uses an identifiable dataset of prisoner demographic characteristics. This dataset includes criminal history data that predates incarceration and includes data on disciplinary behavior while in prison. There is no interaction with prisoners. The researcher claims, and the IRB chair agrees, that the study is exempt from IRB review. This decision: Is wrong because 46.104 states that research conducted in prisons is not exempt if the subject population is only prisoners.
Research conducted in prisons is not exempt under 46.104 if the subject population only includes prisoners. For research governed by the Common Rule, the exemptions at 46.104 (Protection of Human Subjects 2018) "do not apply to research subject to Subpart C, except for research aimed at involving a broader subject population that only incidentally includes prisoners." This means that the research does not include only prisoner subjects or aim to recruit prisoners as subjects. The research questions being answered also do not involve prisoners. It does allow that the research may happen to include a prisoner subject (or a subject who becomes a prisoner) and the prisoner subject's data may still be used without IRB approval for Subpart C.
A study that involves interviews of adults is eligible for expedited review. The researcher wants to add an adolescent population (aged 12 to 17) to the study and has designed a parental permission and assent process. No additional changes are planned. Which of the following statements about review of the revised protocol is accurate? Unless the nature of the questions would raise the level of risk to more than minimal for adolescents, the research would still qualify for expedited review.
Research involving children may be expedited if the level of risk is no more than minimal and if the research falls into a category of research identified as eligible for expedited review. Therefore, unless the nature of the topic would raise the level to more than minimal risk to the adolescent subjects, the study previously approved for adults through expedited review procedures would also be eligible for expedited review. It is not necessary for adolescents to have obtained some adult rights through emancipation procedures, nor must the reading level of the subjects be predetermined in order for a study involving minors to be eligible for expedited review. Consent forms, including the readability of the information, must always be tailored to the particular subject population of a study.
The Belmont principle of beneficence requires that: Risks to subjects are reasonable in relation to anticipated benefits.
The Belmont principle of beneficence requires that risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. This principle is applicable in both minimal risk and greater than minimal risk research. The principle does not address a requirement for significant contribution to generalizable knowledge nor does it require that subjects derive individual benefit from study participation.
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.
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.
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.
A researcher leaves a research file in her car while she attends a concert and her car is stolen. The file contains charts of aggregated numerical data from a research study with human subjects, but no other documents. The consent form said that no identifying information would be retained, and the researcher adhered to that component. Which of the following statements best characterizes what occurred? There was neither a violation of privacy nor a breach of confidentiality.
The subjects' privacy has not been violated because the identity of subjects was not included in the file. The confidentiality of the data has not been breached because the data could not be linked to identifiers. Therefore, the correct answer is that there was neither a violation of privacy nor a breach of confidentiality. The release of aggregate data with no identifiers does not constitute a violation of privacy or a breach of confidentiality.
A therapist at a free university clinic treats elementary school children with behavior problems who are referred by a social service agency. She is also a doctoral candidate who proposes using data she has and will collect about the children for a case-based research project. Which of the following statements about parental permission is correct? The parents of the children might feel pressure to give permission to the therapist to use their children's data so that she will continue to provide services to their children.
When a care provider becomes a researcher, both the child clients and their parents may not feel free to choose not to participate in the provider's study. A researcher who is also a care provider needs to be very clear that a decision not to participate in a study, or to allow records to be used, will not affect the care provided in the future. The fact that the therapist has access to her clients' records as a clinician does not entitle her to use information in the records for research purposes without parental permission and child assent. A school authority's permission to conduct the research does not replace the need for permission or assent. Finally, the children's right to choose cannot be overridden in the pursuit of an indeterminate community interest.
