CITI Training
Which is an example of a situation where deferential vulnerability might be a factor? An army medical officer recruiting subjects among lower ranks An employer recruiting among persons who directly report to them A physician recruiting patients to be subjects A college professor recruiting among their students
A physician recruiting patients to be subjects
Consent to participate in research is an ongoing process. Which of the following strategies would help ensure that participation in a survey about a sensitive personal topic remains voluntary throughout a study? Providing a thorough debriefing at the end of the study. Including the institution's privacy policy on the survey site. Designing the survey so that subjects are not forced to answer one question before going to the next. Giving examples in the consent process of the kinds of questions that will be asked.
Designing the survey so that subjects are not forced to answer one question before going to the next.
Who might be a good disability representative who can consult with or be a member of an IRB? An advocate for individuals with disabilities. A person from the local elementary school. A person concerned with early childhood education. A staff member at a local Center for Healthy Living.
An advocate for individuals with disabilities.
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. Providing detailed information about the study and obtaining the subject's consent to participate. Ensuring that the selection of subjects includes people from all segments of the population. Ensuring that persons with diminished autonomy are protected.
Determining that the study has a maximization of benefits and a minimization of risks.
The U.S. Public Health Service (PHS) requires institutions to: Block faculty from owning any equity interest in a company that sponsors research. Collect information about the significant financial interests of all faculty and staff. Disclose their investigators' new financial conflicts of interest to the PHS awarding component within 60 days of discovering them. Post the significant financial interests of all researchers to a publicly available website.
Disclose their investigators' new financial conflicts of interest to the PHS awarding component within 60 days of discovering them
In addition to the general provisions of the Common Rule (the federal regulations for protecting research subjects), the following regulations also govern research in the public schools: FERPA and Subpart D of the federal regulations FERPA, PPRA, and Subpart D of the federal regulations FERPA, PPRA, and No Child Left Behind Act PPRA and Subpart D of the federal regulation
FERPA, PPRA, and Subpart D of the federal regulations
If the research is subject to Subpart D, which of the following research activities with children would qualify for an exemption under Category 2 (research that includes educational tests, surveys, interviews, observation)? Observation of public behavior when the researcher participates in the activities being observed Interviews Survey procedures Research about aptitude testing
Research about aptitude testing
Which of the following are the three principles discussed in the Belmont Report? Informed Consent, Institutional Assurance, Researcher Responsibility Privacy, Confidentiality, Equitable Selection of Subjects IRB Review, Federal Regulations, Declaration of Helsinki Respect for Persons, Beneficence, Justice
Respect for Persons, Beneficence, Justice
Which of the following statements most accurately describes the requirement for the documentation of minors' assent to participate in research? Parents must approve written documentation. Federal regulations do not require the documentation of minors' assent. Documentation is required unless waived by an IRB. To protect minors documentation is always required.
Federal regulations do not require the documentation of minors' assent.
Which federal regulation or law governs how researchers can obtain data about subjects' disciplinary status in school from academic records? The Family Educational Rights and Privacy Act. The No Child Left Behind Act. The Protection of Pupil Rights Amendment. Subpart D of 45 CFR 46.
The Family Educational Rights and Privacy Act.
Which of the following is an example of how the principle of beneficence is applied to a study involving human subjects? Ensuring that risks are reasonable in relationship to anticipated benefits Ensuring that the selection of subjects is fair Providing detailed information about the study to potential subjects Ensuring that subjects understand that participation is voluntary
Ensuring that risks are reasonable in relationship to anticipated benefits
PPRA gives parents some level of control over their child's: Medical records Educational records Participation in third-party survey research or exposure to instructional materials developed by researchersAbility to opt out of health education (specifically, sexual health education)
Participation in third-party survey research or exposure to instructional materials developed by researchers
A research study is targeting a disabled population when it does which of the following? Enrolls only individuals from an outpatient emergency treatment center. Enrolls only individuals who are legally blind in order to study their attitudes towards the workplace for reasonable accommodations of their blindness. Enrolls only individuals from the orthopedic clinic of the local university medical center. Enrolls at least one deaf person in a protocol studying a new cancer drug.
Enrolls only individuals who are legally blind in order to study their attitudes towards the workplace for reasonable accommodations of their blindness.
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 researcher asks cocaine users to provide names and contact information of other cocaine users who might qualify for a study. A researcher, who is a guest, audio-records conversations at a series of private dinner parties to assess gender roles, without informing participants. 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. In order to eliminate the effect of observation on behavior, a researcher attends a support group and records interactions without informing the attendees.
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.
What is true about employment of individuals with physical disabilities that impacts research? Individuals with disabilities have a high rate of unemployment, and research that may involve them missing work in order to participate could be putting them at risk. There is no employment-related impact. Individuals who have physical disabilities and are employed should not be asked to participate in research. Individuals who have physical disabilities are typically employed in high-paying positions and have the flexibility to take time off from work to participate in research.
Individuals with disabilities have a high rate of unemployment, and research that may involve them missing work in order to participate could be putting them at risk.
In the U.S., the first federal regulations for human subjects research began in 1981 with the codification of the ________. Belmont Report Nuremberg Code Declaration of Helsinki Common Rule
Common Rule
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 Zimbardo's "Stanford Prison Experiment" PHS Tuskegee study Milgram's "Obedience to Authority" study
"Tastes, Ties, and Time (T3)" study
According to the U.S Public Health Service, a "significant financial interest" includes royalty income paid to an investigator and its disclosure is required: Only if it relates to income from publicly traded companies. Only if it relates to income from governmental agencies. Except if that income is from the institution that currently employs the investigator. Regardless of the source of the income.
Except if that income is from the institution that currently employs the investigator.
Continuing review of an approved and ongoing study posing more than minimal risk that was initially approved by a convened IRB: Must be conducted by a convened IRB. Is limited to review of unanticipated problems. Is not required unless additional risks have been identified. Must occur within 12 months of the approval date.
Must occur within 12 months of the approval date.
According to the authors, there are four common abuses that historically are described as giving rise to vulnerability. Which response below contains the correct four? Coercion, undue influence, neglect, and disrespect Physical control, coercion, undue influence, and neglect Prejudice, physical control, manipulation, and coercion Physical control, coercion, undue influence, and manipulation
Physical control, coercion, undue influence, and manipulation
Identify one way faculty researchers can possibly avoid undue influence of student subjects? Avoid recruiting their own students in the research Provide extra credit to those who participate Conduct research for less than ten minutes during class Offer more monetary compensation to those who participate
Avoid recruiting their own students in the research
Institutions are required by the U.S. Public Health Service to do which of the following: Update their financial conflict of interest policy every four years. Apply the same financial conflict of interest policy to all researchers regardless of their funding source. Eliminate any and all conflicts of interest. Evaluate whether a significant financial interest is related to an investigator's research and constitutes a financial conflict of interest.
Evaluate whether a significant financial interest is related to an investigator's research and constitutes a financial conflict of interest.
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? Respect for persons Beneficence Justice
Justice
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. Frequent monitoring of the subject's heart through ECG after administration of the study drug. Requiring a legally authorized representative to provide signed consent for an incapacitated subject. Requiring pregnancy tests before administration of the study drug.
Remove all direct identifiers from the data as soon as possible.
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. All the subjects are adults and the risk is minimal. Participation in the research will involve ten minutes or less of the subjects' time. The researcher is experienced in the field of inquiry.
The research falls into one of eight categories of research activity described in the regulations.
The provisions of Subpart D, of the HHS regulations, Additional Protections for Children Involved as Subjects in Research apply to: All research funded by any federal agency All research involving children All research funded by HHS All research that is more than minimal risk
All research funded by HHS
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? Determination for Exemption Not Human Subjects Expedited Review Convened Review
Determination for Exemption
The procedures for reporting potential unanticipated problems involving risk to subjects or others to the IRB are: Determined by research staff Determined by the institution in its written policies and procedures Stated in the human subject protection regulations, but not in the drug or device regulations Included in the consent process
Determined by the institution in its written policies and procedures
A researcher wishes to study generational differences in coping mechanisms among adults who experienced abuse as children. Adequate measures will be instituted to obtain informed consent and ensure that there is no breach of confidentiality. The most likely additional risk is that some subjects may: Feel that their privacy has been invaded. Lose their employment. Experience emotional or psychological distress. Lose their legal status.
Experience emotional or psychological distress.
Regulations require that IRB membership include at least one member who is an older adult. True False
False
When reviewing research funded by the US. Department of Education (ED) that involves children with mental disabilities, an IRB must: Apply only the subpart of 45 CFR 46 that calls for additional protections of children participating in research. Include an individual who is primarily concerned with the welfare of the disabled subjects. Include an individual with expertise in physical therapy. Apply only the U.S. Department of Education requirements for research involving individuals with mental disabilities.
Include an individual who is primarily concerned with the welfare of the disabled subjects.
Which of following most accurately describes when investigators pursuing U.S. Public Health Service funding are required to disclose their significant financial interests to their institution? No later than the time of applying for funding. Within 90 days of discovering or acquiring a new significant financial interest. Twice per year. After they receive funding but before they start their research.
No later than the time of applying for funding.
A researcher conducts a focus group to learn about attitudes towards hygiene and disease prevention. Two weeks after the focus group, the researcher learns one of the subjects had a heart attack at home and was hospitalized, but made a full recovery. Based on HHS regulations, should the researcher report this event to the IRB? No, this does not need to be reported because two weeks have passed. No, this does not need to be reported because the subject recovered. No, this does not need to be reported because it is unrelated to participation in the study. No, this does not need to be reported because the subject had the heart attack when they were home, not at the focus group.
No, this does not need to be reported because it is unrelated to participation in the study.
A researcher conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students. The data are stored on a laptop computer without encryption, and the laptop computer is stolen from the researcher's car on the way home from work. This is an unanticipated problem that must be reported because the incident was (a) unexpected (in other words, the researchers did not anticipate the theft); (b) related to participation in the research; and (c) placed the subjects at a greater risk of psychological and social harm from the breach in confidentiality of the study data than was previously known or recognized. According to OHRP, this unanticipated problem must be reported to the IRB in which timeframe? Within 24 hours Within two weeks Within 48 hours Promptly
Promptly
The Belmont principle of beneficence requires that: Risks are managed so that they are no more than minimal. Risks to subjects are reasonable in relation to anticipated benefits. Subjects derive individual benefit from study participation. The study makes a significant contribution to generalizable knowledge.
Risks to subjects are reasonable in relation to anticipated benefits.
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? Using pseudonyms in research reports Waiving documentation of consent Securing a Certificate of Confidentiality Using data encryption for stored files
Securing a Certificate of Confidentiality
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 Economic vulnerability Communicative vulnerability Capacity-related cognitive vulnerability
Situational cognitive vulnerability
Which of the following studies would need IRB approval? Studies that use publicly available census data from the years 1890-1910. Studies collecting identifiable information about living individuals. Studies that involve cadavers. Studies that use data collected for internal department use only and the aim of the study is quality improvement for the department only.
Studies collecting identifiable information about living individuals.
A waiver of the requirement for documentation of informed consent may be granted when: The investigator has no convenient place to store signed consent forms separate from the research data. Potential subjects might find some of the research questions embarrassing, personal, or intrusive. The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality. The subjects are literate in their own language; however, they do not read, write, or speak English.
The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality.
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 students must be offered an optional classroom activity. An independent consultant must approve the waiver. Parents must be notified that the study is taking place. The research must pose no more than minimal risk.
The research must pose no more than minimal risk.
A researcher wants to observe preschoolers at a local public playground to evaluate levels of cooperation. The researcher will not interact with the children or record information in such a manner that the identity of the subjects can be readily ascertained. Which of the following statements is true? This research would be eligible for expedited IRB review because the researcher is not interacting with the children and the playground is public. This research would require full committee review because it involves children. This research would be eligible for exemption because the researcher is not interacting with the children and the playground is a public setting. This research would be eligible for expedited IRB review because the researcher is participating in the activities observed.
This research would be eligible for exemption because the researcher is not interacting with the children and the playground is a public setting.
What are some potential limitations for individuals who are older in participating in research? (Check all that apply) Vision and hearing loss can deter older adults from considering participation in research due to embarrassment about an inability to respond properly to research questions or participate in research activities. Mobility and access to transportation can be impedances to research participation. Fatigue and physical strain of participation may create barriers if travel and wait times are involved in research participation. All of the above None of the above
All of the above
Parental notification, in lieu of active parental permission, is allowed when: The researcher anticipates a low response rate. An IRB has approved a waiver of the requirement for parental permission. The superintendent of schools and the principals have approved the study. The researcher has conducted a similar study at another institution.
An IRB has approved a waiver of the requirement for parental permission.
At a minimum, how often are investigators funded by the U.S. National Institutes of Health required to receive conflict of interest training? Every two years. Annually. Every four years. Once per career stage.
Every four years.
An aging population has resulted in the need to: Limit the age range for health research to younger healthier populations Expand the scope of the NIH to an older population Develop more federal regulations on capacity to consent Include more older adults in research to ensure generalizability of research results
Include more older adults in research to ensure generalizability of research results
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: Therapeutic misconception Economic vulnerability Deferential vulnerability Medical vulnerability
Medical vulnerability
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. A minor increase over minimal risk and the sponsor needs approval before the next IRB meeting. Any level of risk, but all the subjects are adults. More than minimal risk, but the study replicates previously approved research.
No more than minimal risk and the research activities fall within regulatory categories identified as eligible.
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 be excluded from research. Persons with diminished autonomy should only participate in no more than minimal risk research. Persons involved in research cannot financially benefit.
Persons with diminished autonomy are entitled to protection.
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 Adults with decisional impairments The elderly College students
Prisoners
Which of the elements listed below is acceptable for a study including individuals with a physical disability? Asking a subject in a wheelchair to complete surveys verbally because the tables in the science room are too tall for the subject to easily complete a written form. Scheduling study visits for individuals in wheelchairs in a building that includes a wheelchair ramp and an elevator. Informing visually impaired subjects that the researcher will fill out surveys for them because the researchers think it will take a long time for the blind person to complete them. Asking a subject in a wheelchair to use the restroom in the building next door because the facility where the study takes place does not have an accessible restroom.
Scheduling study visits for individuals in wheelchairs in a building that includes a wheelchair ramp and an elevator.
Which of the following financial conflict of interest information must be made available by institutions on a public website or within five business days upon request? The financial interests of all faculty at an academic center. The conflicts of commitment of researchers funded by the U.S. Public Health Service. The financial conflicts of interest of senior/key personnel on projects funded by the U.S. Public Health Service. The financial interests of all research administrators at an academic center.
The financial conflicts of interest of senior/key personnel on projects funded by the U.S. Public Health Service.
When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct? If group members know each other confidentiality is not an issue. Using pseudonyms in reports removes the concern about any confidences shared in the group. The researcher cannot control what participants repeat about others outside the group. If group participants sign confidentiality agreements, the researcher can guarantee confidentiality.
The researcher cannot control what participants repeat about others outside the group.
Data are made anonymous by Reporting data in aggregate form in publications resulting from the research. Keeping the key linking names to responses in a secure location. Requiring all members of the research team to sign confidentiality agreements. Destroying all identifiers connected to the data.
Destroying all identifiers connected to the data.
According to federal regulations, "children" are defined as: Persons who have not yet attained the legal age of consent under the applicable laws in the jurisdiction in which the research will be conducted. Persons who are under 21 years of age. Persons who have not yet attained the legal age of consent under the applicable laws in the jurisdiction in which the research was approved. Persons who are under 18 years of age.
Persons who have not yet attained the legal age of consent under the applicable laws in the jurisdiction in which the research will be conducted.
Which of the following statements most accurately describes a mitigation report? A report from the U.S. Public Health Service to an institution of what must be done to deal with financial conflicts of interest of its PHS-funded researchers. An annual report to the U.S. Public Health Service of all the significant financial interests of the institution's PHS-funded researchers. A report from an institution telling the U.S. Public Health Service how bias will be minimized before a research project begins. A report to the U.S. Public Health Service of efforts that will be taken by the institution to deal with any bias that was found in research conducted while there was an unreported financial conflict of interest.
A report to the U.S. Public Health Service of efforts that will be taken by the institution to deal with any bias that was found in research conducted while there was an unreported financial conflict of interest.
Which of the following on-line research strategies raises the most concerns regarding the ethical principle of respecting the autonomy of research subjects and the corresponding federal regulations requiring informed consent? A researcher posts a notice on an open on-line support group for interracial adoptees asking anyone who would be interested in being interviewed for her study to contact her. A linguist copies portions of postings on a political blog to document the use of expletives, abbreviations, and the use of irony in the postings. A researcher proposes to join a moderated support group for cancer survivors posing as a survivor. She plans to insert comments to see how the members respond. A researcher observes the communications in an open support group without announcing her presence. She is interested in observing how long members participate and how the membership shifts over time.
A researcher proposes to join a moderated support group for cancer survivors posing as a survivor. She plans to insert comments to see how the members respond.
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 researchers told students that they would be given a quiz after reading some study materials when the researchers did not intend to use a quiz, but were attempting to focus subjects' attention on the material. 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. A study in which subjects were told that they performed in the third quartile on an anagram task when in reality students were randomly assigned scores that were not related to their actual performance. A study involving decision-making games in which subjects were led to believe that they were interacting with another student in another room, but were actually interacting with a computer programmed to provide consistent responses to all subjects.
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.
According to the U.S. Public Health Service, which of the following would be considered a significant financial interest? An equity interest valued at $10,000 or more that is not related to the investigator's institutional responsibilities. Income from the university where the investigator is currently employed. Travel expenses reimbursed by a U.S. institution of higher education. An equity interest valued at $5,000 owned by the investigator's spouse in a company that produces products related to the investigator's institutional responsibilities.
An equity interest valued at $5,000 owned by the investigator's spouse in a company that produces products related to the investigator's institutional responsibilities.
The internet can be used as a research tool or as the object of a study. Which of the following examples best describes an investigator using the internet as a research tool? An investigator designs a computer program to extract work experience information from LinkedIn profiles. An investigator registers an account on SecondLife to observe the way people interact with each other. An investigator uses his Facebook wall to post a URL link to a survey he is hosting on SurveyMonkey. An investigator analyzes user comments on articles posted on her university's website.
An investigator uses his Facebook wall to post a URL link to a survey he is hosting on SurveyMonkey.
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 Research on the prevalence of individuals who have been harassed in different academic disciplines A study on the efficacy of a behavioral intervention for smoking cessation involves both adults and teenagers A survey about sexually transmitted diseases
Asking women if they have had an abortion
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: Neither the magnitude or probability of harm. Solely by the magnitude or severity of expected harm. Both the magnitude (or severity) and the probability (or likelihood) of harm. Solely by the probability of expected harm.
Both the magnitude (or severity) and the probability (or likelihood) of harm.
Federal regulations require that additional safeguards have been included in a study to protect the rights and welfare of these subjects: Children, prisoners, pregnant women, or older adults Children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons Children, prisoners, pregnant women, fetuses, embryos or senior citizens supported by social security benefits Children, prisoners, women of child-bearing potential, or cognitively impaired persons of any age
Children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons
Which of the following examples of using the internet to conduct research meets the federal definition of research with human subjects? Gathering data to supplement an oral history project about a local civil rights activist. The activist passed away while the researcher was in the process of conducting in-person interviews with the individual's social network. Analyzing a website visitor report from several pro-anorexia blogs to determine the popularity of each blog. Access to the blogs is not restricted. Downloading a publicly available dataset that includes high school students' academic achievement rates. The data are in aggregate and were derived from multiple school districts from different states. Conducting an on-line focus group with cancer survivors to determine familial support systems. The researcher also invites subjects' significant others to be a part of the focus group.
Conducting an on-line focus group with cancer survivors to determine familial support systems. The researcher also invites subjects' significant others to be a part of the focus group.
A student plans on interviewing 15 principals in neighboring high schools. The student plans to collect data about the personal experiences the principals have had with disruptive students, including the types of disciplinary actions that were taken (including decisions they may have personally made) and their feelings or thoughts regarding whether those actions were appropriate. The research data collected could have an impact on the principals' careers. The student will collect identifiers. This study would be subject to which type of review? Convened Review Determination for Exemption Not Human Subjects Expedited Review
Convened Review
Researchers endeavoring to conduct an on-line study should consider that there are some potential risks of harm to subjects unique to internet-based research. One of these risks is: Online studies do not require the documentation of informed consent. Individuals may post private identifiable information about themselves on-line without intending it to be public and available to researchers. People assume pseudonymous on-line identities, such as an avatar in an MMORPG. Recruiting, consenting and debriefing subjects takes place on-line, and may require little to no interaction with the subjects.
Individuals may post private identifiable information about themselves on-line without intending it to be public and available to researchers.
Which of the following statements is true regarding the reporting of outside interests and the management of conflicts? Investigators are responsible for developing their own management plans for significant financial interests. Investigators must disclose all of their financial interests regardless of whether they are related to a research project. The institution must report identified financial conflicts of interest to the U.S. Office of Research Integrity. Investigators must disclose their significant financial interests related to their institutional responsibilities and not just those related to a particular project.
Investigators must disclose their significant financial interests related to their institutional responsibilities and not just those related to a particular project.
When an IRB is reviewing a research study and they are considering if a potential subject population is vulnerable, they should consider: Are the research procedures greater than minimal risk of harm? Is there a power differential between researchers and subjects? Are there adequate resources to conduct the study? Has the researcher completed required training?
Is there a power differential between researchers and subjects?
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? Beneficence Justice Respect for persons
Justice
A researcher conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students. One of the subjects is in an automobile accident two weeks after participating in the research study. Is this an example of an unanticipated problem that requires reporting to the IRB? Yes, this must be reported because it was not listed as a risk of study participation in the consent form (was unexpected) and the subject experienced harm. Yes, this must be reported because it involved a subject in a research study and it is up to the IRB to determine if it was related to participation. No, this does not need to be reported because it was assessed by the researcher as unrelated to the research study. No, this does not need to be reported to the IRB since the researcher reported it to the sponsor of the study.
No, this does not need to be reported because it was assessed by the researcher as unrelated to the research study.
If disclosure of a subject's involvement in a specific research study can be potentially harmful to the subject, and the consent form is the only record linking the subject to the research, which of the following would be most helpful: Code the subjects' responses. Obtain a Certificate of Confidentiality. Have the subject sign the consent form under an assumed name. Obtain a waiver of documentation of informed consent.
Obtain a waiver of documentation of informed consent.
Which of the following statements about the relationship between an institution and the institution's IRB(s) is correct? Institutional priorities take precedence over all IRB determinations. Officials of the institution may overturn an IRB disapproval. Officials of the institution may overrule an IRB approval. Department chairs can overturn an IRB disapproval.
Officials of the institution may overrule an IRB approval.
As part of the consent process, the federal regulations require researchers to: Describe penalties that may be imposed for non-participation. Recommend that potential subjects discuss their decision to participate with family members. Provide a list of the IRB members who reviewed the protocol. Provide potential subjects with information at the appropriate reading comprehension level.
Provide potential subjects with information at the appropriate reading comprehension level.
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? The researcher may stop you from taking part in this research without your consent if you experience side effects that make your emotional condition worse. If you become too emotionally distressed during the research, you may have to drop out. Your participation in this research is voluntary. If you choose not to participate, or change your mind later, your decision will not affect your relationship with the researcher or your right to other services that you may be eligible for. In the event of any distress you may have related to this research, you will be given access to appropriate resources. 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.
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.
An investigator received $4,000 of consulting income from a publicly traded drug company over the past 12 months. The investigator also owns stock in that company valued at $2,000. The investigator is submitting a grant to the National Institutes of Health that involves evaluating the effectiveness of a drug produced by the same drug company. Which of the following is true? The investigator does not have a significant financial interest related to the grant because the stock's value is less than $5,000. The investigator does not have a significant financial interest related to the grant because the consulting income is less than $5,000. The value of stock is not calculated when determining significant financial interests. The aggregate of the consulting income and the stock exceeds $5,000 and therefore is a significant financial interest.
The aggregate of the consulting income and the stock exceeds $5,000 and therefore is a significant financial interest.
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 therapist creates her clients' records; therefore, she does not need parents' permission to use the information for research purposes. The superintendent of the school system can give permission for children to be in the study; therefore, the therapist doesn't have to ask the parents for permission. 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. If it is the best interests of the community that the children participate in the study, parental permission is optional.
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.
Older adults have been excluded from research participation because: Research sponsors cannot rely on Medicare to pay for injuryI t is difficult to recruit older adults to research They are unreliable and non-compliant with medication Their conditions are considered to confound research protocols
Their conditions are considered to confound research protocols
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? The subjects' privacy has been violated. There was neither a violation of privacy nor a breach of confidentiality. Confidentiality of the data has been breached. There was both a violation of privacy and a breach of confidentiality.
There was neither a violation of privacy nor a breach of confidentiality.
According to OHRP, a problem is an "unanticipated problem" when it meets which of the following criteria: Expected, related or possibly related to the research, suggests the research puts others at greater risk Unexpected, unrelated to the research but still occurring with a subject, suggests the research puts others at greater risk Unexpected, related or possibly related to the research, suggests that the research does not put the subjects or others at greater risk Unexpected, related or possibly related to the research, suggests the research puts subjects or others at greater risk
Unexpected, related or possibly related to the research, suggests the research puts subjects or others at greater risk