N_437_Social and Behavioral Research
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 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
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. 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.
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. Comment 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 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. Comment 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.
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.Comment The study in the 4th grade classrooms about the relationship between the time of day reading is taught and reading comprehension does meet the definition of research with human subjects. The study is designed to contribute to generalizable knowledge about student performance and the research question can only be answered using a systematic investigation. Information collected by the playground designer does not involve any information about human subjects even though it does involve interaction between the designer and school staff. An analysis of aggregate data doesn't involve interactions with living individuals nor the collection of private identifiable data. An economic feasibility study will gather information from people with relevant information and expertise but does not meet the definition of research with human subjects, because the intention of the study is to answer "about what" questions rather than "about whom" questions.
When workers are asked to participate in a research study, vulnerabilities related to the subject's employment may include:
All of the above Comment Workers who serve as research subjects at their place of employment are vulnerable to numerous kinds of pressure from their co-workers, unions, and employers. Pressure can be applied to workers in subtle ways (such as, an employer who comments that if the research concludes that the organization is spending more on healthcare than other similar organizations, there may be lay-offs).
Researcher access to confidential records adds to the vulnerability of workers who participate in workplace studies. Inappropriate release of identifiable private information could adversely affect a worker's retention of a job, insurance, or other employment related benefits. To avoid or minimize these risks, the study design must include adequate safeguards to protect the confidentiality of the information collected. A plan for the proper management of study data and records should clearly define:
All of the above. Comment Researchers must recognize that the primary harm in social and behavioral research is the breach of confidentiality. This risk of harm is especially significant when the data being collected involves an employee's experiences at their place of employment (for example, a situation where the employer has ongoing efforts to reduce healthcare costs by getting rid of employees who they believe will cause their healthcare insurance premiums to rise).
Parental notification, in lieu of active parental permission, is allowed when:
An IRB has approved a waiver of the requirement for parental permission. Comment Parental permission must be secured or waived in accordance with criteria established by federal regulation. When a waiver has been approved, investigators may wish to, and IRBs may require, that parents be notified that the study will take place, giving them the opportunity to withdraw their children from the study. Parental notification can never be substituted for active parental permission if the criteria for a waiver have not been met.
According to the federal regulations, which of the following studies meets the definition of research with human subjects?
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.
An example of an institutional COI is:
An industry sponsor pays for the construction of a new research laboratory at the organization Comment An institutional COI can arise when the financial interests of an organization or institutional official (acting within his or her authority on behalf of the organization) may affect or appear to affect the research conducted under the organization's auspices. This could include significant gifts received by the organization from the sponsor of human subjects research.
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 uses his Facebook wall to post a URL link to a survey he is hosting on SurveyMonkey. Comment Investigators use the internet as a research tool when they actively engage, or interact, with their participants on-line. This can include distributing an instrument via email or hosting a web-based survey on an on-line survey provider, recruiting subjects from on-line panels, conducting interviews on-line, facilitating focus groups in private chat rooms, and posting on-line experiments or interventions on web-based service providers.
If you're unsure about the particulars of HIPAA research requirements at your organization or have questions, you can usually consult with:
An organizational IRB or Privacy Board, privacy official ("Privacy Officer"), or security official ("Security Officer"), depending on the issue. Comment If you are unsure about the particulars, consult with your organization's IRB, Privacy Board, or privacy official. For data security issues, consult with your organization's security official. Consulting with an experienced colleague can always be helpful, but their advice is not authoritative. Do not assume that a representative of the funder will know all the rules, or that the generic advice of a professional association will be applicable to your organization's particular rules.
Neither Subpart C (Prisoners) nor Subpart D (Children) applies to juveniles in the correctional systems because wardens of juvenile prisoners (unlike those for adult prisoners) act in loco parentis for juvenile offenders. This statement is false because
Both subparts apply, as these individuals are under the legal age of consent and are incarcerated. Comment This population is considered doubly vulnerable due to their age and status as prisoners. Both subparts need to be carefully considered. There is no in loco parentis status for prisoners. Having a warden give consent would violate the basic tenets of informed consent. The regulations also prohibit the involvement of staff in prisoner selection for research. Parental signatures are not required.
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. Comment 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.
Which of the following examples of using the internet to conduct research meets the federal definition of research with human subjects?
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. Comment The federal regulations define both a human subject and research separately, but both definitions must be met to quality as human subjects research. Thus, research with human subjects is defined as a systematic investigation (intent to contribute to generalizable knowledge) involving living individuals about whom a researcher conducting research obtains information through intervention or interaction with the individual, and uses, studies, or analyzes the information or obtains, uses, studies, analyzes, or generates identifiable private information (Protection of Human Subjects 2018). Conducting an on-line focus group with live human beings to research familial support systems would therefore meet the definition of research with human subjects. Analyzing the number of visits to a website provides information about the website itself not about the people who visit it and does not meet the federal definition of research with human subjects. Neither does gathering information about deceased individuals. Using data that are publically available and de-identified are no longer private or personally identifiable, and would also not meet the federal definition of research with human subjects.
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. Comment 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 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 Comment This study would qualify for convened review because the IRB must conduct a careful analysis. The study involves an interview where the data collected could have an impact on the principals' careers and it contains subject identifiers.
To minimize potential risks of harm, a researcher conducting an on-line survey can:
Design the survey so that no direct or indirect identifiers are collected. Comment In most internet-based research, the primary risk of harm is a breach of confidentiality. A simple way to help maintain the confidentiality of a subjects' identity is not to collect direct or indirect identifiers. Suggesting to subjects that they should print a copy of the informed consent form does not protect them from an inadvertent breach of identifiable responses. Similarly, complying with the Terms of Service does not protect against a breach. Specifying that all subjects be of legal adult age does not ensure compliance.
Data are made anonymous by
Destroying all identifiers connected to the data. Comment 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.
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 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.
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. 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
Which of the following types of information may schools disclose without consent from the parent or student to a researcher at a local university?
Directory information. Comment Schools may disclose, without consent, directory information such as a student's name, address, telephone number, date and place of birth, honors and awards, and dates of attendance. However, schools must tell parents and eligible students that directory information is not protected, and they must allow parents and eligible students a reasonable amount of time to request that the school not disclose directory information about them. FERPA allows schools to disclose identifiable records without permission to certain parties, including organizations conducting research initiated by a school district or a state department of public instruction.
During an Institutional Review Board (IRB) meeting, any IRB member who may have a potential COI with a study under review should:
Disclose their potential COI and may answer questions, but recuse themselves from voting. Comment IRB policies and procedures generally specify that members with conflicts of interest related to an agenda item must disclose their conflicts of interest, and may answer questions from the IRB about the item with which they have a conflict, but are prohibited from voting on that item.
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 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.
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:
Experience emotional or psychological distress. Comment Subjects may experience emotional or psychological distress. The fact that the subjects have consented to participate in the study makes it unlikely that they would feel that their privacy was being invaded. Because confidentiality procedures have been built into the protocol it is also unlikely that the subjects might lose legal status or employment.
A researcher proposes to conduct a study at a foreign site. The research has been determined to be exempt from the federal regulations by institutional policy. According to federal regulations, is review required at the foreign site?
If a proposed study qualifies for exemption, federal regulations do not require review at the foreign site where it will be conducted. Comment A great deal of research in the social and behavioral sciences may qualify for exemption, depending upon institutional policy. If a proposed study qualifies for exemption, federal regulations do not require review at the foreign site where it will be conducted. Federal regulations do not require exempt research to be reviewed by an institution's IRB or an institutional official - those decisions are left to institutional policy.
What are some considerations for a U.S. researcher conducting a study in a non-U.S. setting when obtaining informed consent from subjects?
In addition to the consent of the research subjects, are there other individuals or groups whose permission must be sought? Comment The points to consider when obtaining informed consent in non-U.S. settings include in addition to the consent of the research subjects, are there other individuals or groups whose permission must be sought? Sometimes, in non-U.S. communities, people other than the individual taking part in the research may be required to give permission before the potential subject may be asked to participate. These individuals may include a spouse, a head of household, or a group leader. However, another individual's permission should not substitute for a subject's voluntary informed consent unless an IRB or equivalent local review committee has waived that consent process. The witness signature line is an issue in documentation of informed consent; ensuring that consent process does not slow down recruitment is an issue in study design and not a non-U.S. setting specific issue; and maintaining confidentiality is a privacy/confidentiality issue.
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:
Individuals may post private identifiable information about themselves on-line without intending it to be public and available to researchers. Comment Information posted on-line could, conceivably, be accessible to anyone with an internet connection. However, people may post their private identifiable information on-line without the intention of this information being public. Private identifiable information that can be accessible to anyone can create the potential for several different risks of harm to subjects who may not be aware that their information is public. Assuming a pseudonymous on-line identity does not pose any risks of harm to subjects. Though it is true that researchers can recruit, consent and debrief subjects on-line with little to no-interaction, this in of itself, would also not pose any risks of harm to subjects. Similarly, waiving the documentation of consent does not pose any potential risks of harm to subjects, and is not unique to internet-based research.
What is the term for management controls that are built in to a research study (for example, independent data analysis)?
Inherent controls Comment When developing conflict of interest management plans, COI committees typically examine the study design to determine whether it includes inherent controls that mitigate the researcher's opportunity to bias the research. Inherent controls may include independent data analysis, randomization, blinding, or low subject enrollment percentage at a local site for a large multi-center trial.
Under HIPAA, "retrospective research" (a.k.a., data mining) on collections of PHI generally ...
Is research, and so requires either an authorization or meeting one of the criteria for a waiver of authorization. Comment HHS has reiterated in its guidance that use or disclosure of PHI for retrospective research studies may be done only with patient authorization -- or with a waiver, alteration, or exception determination from an IRB or Privacy Board. However, remember that you generally cannot proceed on your own without some approval from an IRB, Privacy Board, or other designated governing entity.
A researcher's membership on an advisory board with an organization sponsoring research can create a COI because:
It may be difficult for the researcher to appear neutral, as the researcher may have an interest in the research's success. Comment A researcher's membership on an advisory board of an entity sponsoring research can create a conflict of interest because there may be a perception that the researcher has a motive to bias the research to create an outcome that is favorable for the sponsor.
An example cited in the Belmont Report (The National Commission 1979) stated that "During the 19th and early 20th centuries the burdens of serving as research subjects fell largely upon poor ward patients, while the benefits of improved medical care flowed primarily to private patients." This is an example of a violation of which Belmont principle?
Justice Comment This example demonstrates a violation of the principle of justice which requires that the benefits and burdens of research are equitably distributed and subject populations are not chosen because of convenience. In simple terms, the principle of justice requires that the selection of subjects is fair. The principle of beneficence requires that risks are reasonable in relationship to anticipated benefits. The principle of respect for persons requires that subjects understand that participation is voluntary and that they are provided detailed information about the study before giving consent to participate.
Which of the following activities constitutes engagement in research?
Obtaining informed consent and conducting research interviews. Comment If an institution obtains informed consent and conducts research interviews it is engaged in research.
A researcher submits a study to the IRB that proposes to evaluate a new after-school on-line tutoring program for middle-school students in a local school district examining the effect on student grades. She proposes to perform this assessment at the school that her children attend, because she is familiar with the school district. Students may use either their personal smartphone or computer to participate in the program. This study might be determined to be violating which principle of the Belmont Report?
Justice 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.
The age of majority in international research is determined by the
Laws, customs, and norms in the area in which the research will be conducted. Comment The age of majority should be the recognized age of majority in the country or region where the research takes place.
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. Comment Continuing review of an approved protocol must occur within 12 months of the approval date even if no additional risks have been identified. Review by a convened IRB is not always required (for example, if the study was complete and in data analysis only). Any unanticipated problems must be addressed during the continuing review process, but the review must include other information such as the number of subjects accrued, any relevant recent literature, and a copy of the current consent form.
According to 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. Comment 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.
A researcher proposes a study and wants to recruit subjects from health care clinics in Jamaica. The survey will be conducted by the U.S. researchers at the clinic. The nurses at the clinic will inform prospective subjects about the availability of the research, but will not consent the subjects nor perform any research procedures (even screening procedures). Are the nurses engaged in the research according to federal regulations?
No, they are not engaged because they are only informing the subjects and not consenting or performing any research procedures, or receiving or sharing any private, identifiable information. Comment No, they are not engaged because they are only informing the subjects and not consenting or performing any research procedures, or receiving or sharing any private, identifiable information. An institution is not engaged if its only involvement is to provide space for the U.S. researchers to conduct their own research.
A graduate student needs to conduct a research project for her master's thesis. She is interested in the types of junk food available to the public. She plans to go to the local convenience stores and ask the owners what types of junk food the store normally stocks, and which are the biggest sellers. She will not collect identifiers. This study would be subject to which type of review?
Not Human Subjects Comment This study would qualify as not human subjects because the data that the student is collecting does not meet the definition of human subjects research. She is not collecting any information about the store owners and her study seeks to find information about the items in the store.
A researcher is studying women recently admitted to a state prison. All potential subjects must have children under the age of five. Research subjects will be given a basket of toys to use at their children's first visit that the children can then take home. In assessing this proposal, the IRB needs to determine that the toys are:
Not an excessive incentive. Comment Mothers who may have recently separated from their children may find the prospect of doing something special for their children more important than making a considered decision about becoming a research subject. Thus the toys may be an undue influence to participate. The issue of the toys being educational, of high quality, and age appropriate are not the focus of the study. The IRB focus needs to be on any undue influence on the women.
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. Comment 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.
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:
Obtain a waiver of documentation of informed consent. Comment If the only identifier collected in the course of a study would be the signature on the consent document and the principal source of harm would be a breach of confidentiality disclosing one's participation in the study, a waiver of documentation of informed consent should be sought. With such a waiver, the informed consent process could be conducted verbally with no written evidence of the subject's participation in the research.
Which of the following statements about the relationship between an institution and the institution's IRB(s) is correct?
Officials of the institution may overrule an IRB approval. Comment 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).
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 Comment 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. The Stanford Prison Experiment occurred prior to the codification of federal regulations, and is not directly linked to the establishment of the National Research Act of 1974.
If research in a private school is directly funded by the Department of Education, then:
PPRA applies. Comment If research in a private school is directly funded by the Department of Education, PPRA applies, regardless of the risk level of the research (more than minimal or no more than minimal). A private school that does not receive any federal funding is not subject to the provisions of FERPA or PPRA.
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. 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.
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 Comment Prisoners are provided additional protections in the HHS regulations. The HHS regulations do not have specific additional protections for elderly, for students, or for persons whose decision-making capabilities are impaired. Researchers may consider and the IRB may require additional safeguards for these populations.
The purpose of the Family Educational Rights and Privacy Act (FERPA) is to:
Provide parents certain rights over their children's educational records. Comment The purpose of FERPA is to give parents certain rights with regard to the release of their children's educational records. School personnel such as teachers, counselors, and principals may access student records for legitimate school functions. Generally, schools must have written permission from a parent before releasing any identifiable information from a student's record.
As part of the consent process, the federal regulations require researchers to:
Provide potential subjects with information at the appropriate reading comprehension level. Comment 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.
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 Comment Census data is a public source of data, and an individual could not reasonably expect it would not be made public.
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. Comment 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.
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)?
Research about aptitude testing Comment Subpart D, Additional HHS Protections for Children, specifically prohibits the use of exemption for research involving survey procedures, interview procedures, or participant observation when the researcher participates in the activities being observed.
Which of the following statements about prison research is true?
Researchers may study the effects of privilege upgrades awarded by the prison. Comment 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 are the three principles discussed in the Belmont Report?
Respect for Persons, Beneficence, Justice Comment The three principles discussed in the Belmont Report are Respect for Persons, Beneficence, Justice.
Humphreys' collecting data for the Tearoom Trade study under the pretense that he was a lookout is an example of a violation of the principle of:
Respect for persons Comment Humphreys' collecting data for the Tearoom Trade study while posing as a lookout is an example of a violation of the principle of respect for persons. Respect for persons requires that subjects freely choose to participate in research (voluntariness) and that they are adequately informed about a study (informed consent). The principle of beneficence requires balancing the risk of harms with the potential benefits. The principle of justice requires that benefits and burdens are equitably distributed and subject populations are not chosen due to convenience.
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 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.
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 Comment 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.
Which of the following studies would need IRB approval?
Studies collecting identifiable information about living individuals. Comment If a study intends to collect identifiable information about a living individual, you must obtain IRB review and approval.
HIPAA's protections for health information used for research purposes...
Supplement those of the Common Rule and FDA. Comment HIPAA's relatively new data-focused protections, which took effect starting in 2003, supplement Common Rule and FDA protections; they are not a replacement. Institutional Review Board (IRB) protocol reviews using Common Rule and FDA criteria remain as before, including aspects related to data protection. IRBs may have the responsibility for addressing HIPAA's additional requirements in their reviews when those apply; or some responsibilities may be given to another kind of body that HIPAA permits (a Privacy Board) or to an institutional official that HIPAA requires (a privacy officer). These federal standards complement states' and accreditation bodies' requirements.
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. Comment 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.
Which of the following methods could be considered a "best practice" in terms of informing respondents how their answers to an on-line survey about personal information will be protected?
The investigator uses the informed consent process to explain how respondent data will be transmitted from the website to his encrypted database without ever recording respondents' IP addresses, but explains that on the internet confidentiality cannot be absolutely guaranteed. Comment Although there are no guaranteed methods to assure absolute confidentiality of research data collected on-line, some internet-based research experts have identified "best practices" for describing commonly accepted confidentiality protections, such as including explanations about how data are transmitted from the subject to the investigator, how the investigator will maintain and secure the data. Consent processes should also include a discussion to emphasize that there is no way to guarantee absolute confidentiality if data are of a personal or sensitive nature.
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. Comment 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.
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. Comment 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.
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. Comment 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.
According to Subpart D, research with children may be eligible for exemption under Category 2 when:
The research involves the use of educational tests. Comment 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.
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. Comment 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.
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. Comment 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.
The peer review process can create conflicts of interest because the choice of who reviews a potentially publishable project may show:
There may be bias by the peer reviewer as to the area of research. Comment Conflicts of interest may arise in the peer review process (for example, bias causes a reviewer to respond positively to a manuscript because it involves research or methodology in which the reviewer has a personal interest).
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. Comment 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 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 exemption because the researcher is not interacting with the children and the playground is a public setting. Comment The exemption categories that may be used with children include observations of children in public settings, as long as the researcher does not participate in the activities being observed or record information in such a manner that the identity of the subjects can be readily ascertained. Research does not require full committee review when it involves children, unless it does not fall into an exempt or expedited category.
The HIPAA "minimum necessary" standard applies...
To all human subjects research that uses PHI without an authorization from the data subject. Comment Uses and disclosures of data for research that are allowed to bypass the authorization requirement are still subject to the "minimum necessary" standard - that is, the uses/disclosures must be no more than the minimum required for the described research purpose. A covered entity may rely on a researcher's documentation - or the assessment of an IRB or Privacy Board - that the information requested is the minimum necessary for the research purpose. By contrast, research information obtained using an authorization is not bound by the minimum necessary standard - on the theory that the data subject has given explicit permission in accordance with the signed authorization. However, be aware that while HIPAA may not require a minimum necessary justification at all times, an IRB's evaluation of risks and burdens on human subjects arguably does.
When a research project includes the collection of biological samples, all planned future uses of the samples, identifiers, and the data obtained from the samples, must be fully explained to the research subject.
True Comment Genetic information has the potential to cause significant harm to research subjects if inappropriately disclosed, including harm to a subject's privacy, social standing, family obligations, employment/employability, or insurance/insurability.
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 Comment 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 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. Comment 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.
Vulnerable persons are those who are less able to protect themselves than other persons in a given situation. The Common Rule (45 CFR 46, Subpart A) has specific requirements for the following vulnerable populations, except:
Workers Comment The Common Rule does not classify workers as a vulnerable population. The categories of vulnerable populations provided for in the Common Rule are children, prisoners, and individuals with impaired decision-making capacity.
When required, the information provided to the data subject in a HIPAA disclosure accounting ...
must be more detailed for disclosures that involve fewer than 50 subject records. Comment Where fewer than 50 subjects' records are involved, the listing must be more specific and detailed, commensurate with the requirements for other kinds of PHI disclosure accounting, including: specific date(s) of disclosures; names of entities to which PHI was disclosed; description of the PHI involved in the disclosure; and purpose of the disclosure.
Risk of harm in social and behavioral sciences generally fall in three categories, which are:
nvasion of privacy, breach of confidentiality, and study procedures Comment Invasion of privacy, breach of confidentiality, and study procedures are the three categories that risks of harm in SBE research generally fall in. Invasions of privacy can occur if personal information is accessed or collected without the subjects' knowledge or consent. Confidentiality can be compromised through an unauthorized release of data, which could have a negative impact on the subjects' psychological, social, or economic status. In some cases, simply taking part in research can put subjects at risk. For example, if a researcher is conducting interviews with individual gang members, it may be necessary to find places to meet where other members of the gang could not observe the interaction.
