CITI

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.

According to Subpart D, research with children may be eligible for exemption under Category 2 when:

The research involves the use of educational tests

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.

The IRB will not review this study because it is not research as defined by the federal regulations.

This proposal is obtaining data from human subjects, but this project is not research since it is not "a systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." This project will not be reviewed by the IRB.

According to the federal regulations, which of the following studies meets the definition of research with human subjects?

A study of twenty 4th grade classrooms in which researchers ask the schools to systematically vary the time of day reading is taught, and collect weekly assessments of reading comprehension for each child over a three-month period.

Unexpected, related or possibly related to the research, suggests the research puts subjects or others at greater risk

An unanticipated problem, in keeping with OHRP's guidance, is unexpected, related or possibly related to the research, and puts subjects or others at greater risk of harm.

Identify the example of when situation and time are key to assessing risk of harm in a research study:

Asking women if they have had an abortion

How can faculty researchers avoid undue influence of student subjects?

Avoid using their own students in their research

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.

The research must pose no more than minimal risk.

One of the four criteria for waiving parental permission is that the research must pose no more than minimal risk. Although it may be appropriate to notify parents that the study is taking place, and many researchers do so, it is not required by the regulations when a waiver of parental permission has been approved. While children must provide assent to participate, depending upon the age of the children there are multiple strategies for accommodating children who do not want to participate other than alternate classroom activities. It is not required that an independent consultant approve waivers of parental permission.

The Belmont principle of beneficence requires that:

Potential benefits justify the risks of harm.

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

A medical record is an example of:

Private information

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.

What statement about risks in social and behavioral sciences research is most accurate:

Risks are specific to time, situation, and culture.

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.

A professor at Big State University is writing a biography about Bill Gates and conducting oral histories with all of Bill Gates' friends, family members, and business acquaintances. The researcher submits the research proposal to the institution's IRB. What action can he expect by the IRB?

The IRB will not review this study because it is not research as defined by the federal regulations.

Which of the following studies is linked most directly to the establishment of the National Research Act in 1974 and ultimately to the Belmont Report and federal regulations for human subject protection?

The Public Health Service Study of Untreated Syphilis

The federal regulations require

all foreseeable risks and discomforts must be included in an informed consent.

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.

Which type of IRB review does not require an IRB approval but does require a determination by the IRB or an IRB designee?

Exempt

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.

Which of the following statements most accurately describes the requirement for the documentation of minors' assent to participate in research?

Federal regulations do not require the documentation of minors' assent.

The researcher's failure to protect research subjects from deductive disclosure is the primary ethical violation in which of the following studies?

"Tastes, Ties, and Time (T3)" study (2006-2009)

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.

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.

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.

Justice

According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of justice.

Securing a Certificate of Confidentiality

Although data encryption, using pseudonyms, and waiving documentation of consent, provide data protection, the researcher can link individuals to their responses. Therefore, the data are vulnerable to subpoena in civil, criminal, and administrative court proceedings. Unless the researcher has a Certificate of Confidentiality, he or she may be compelled to release individually identifiable information about research subjects. The Certificate provides the highest level of protection.

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

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.

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.

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.

Must occur within 12 months of the approval date.

Continuing review of an approved protocol must occur within 12 months of the approval date even if no additional risks have been identified. Review by a convened IRB is not always required (for example, if the study was complete and in data analysis only). Any unanticipated problems must be addressed during the continuing review process, but the review must include other information such as the number of subjects accrued, any relevant recent literature, and a copy of the current consent form.

Data are made anonymous by

Destroying all identifiers connected to the data.

The procedures for reporting potential unanticipated problems involving risk to subjects or others to the IRB are:

Determined by the institution in its written policies and procedures

Respect for persons

Humphreys collecting data for the Tearoom Trade study while posing as a lookout is an example of a violation of the principle of respect for persons. Respect for persons requires that subjects freely choose to participate in research (voluntariness) and that they are adequately informed about a study (informed consent).

Officials of the institution may overrule an IRB approval.

If an IRB has disapproved a protocol, that disapproval may not be overturned by an institutional official or anyone at that institution, such as a department chair. However, an IRB-approved protocol may be subject to other reviews at the institution and may be disapproved (overruled).

A researcher's study uses a dataset of prisoner demographic characteristics. This dataset includes criminal history data that predates incarceration and includes data on disciplinary behavior while in prison. There is no interaction with prisoners. The researcher claims, and the IRB chair agrees, that the study is exempt from IRB review. This decision:

Is wrong because 46.104 states that research conducted in prisons is not exempt if the subject population is only prisoners.

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 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. 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?

No, this does not need to be reported because it was assessed by the researcher as unrelated to the research study.

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.

Which of the following are the three principles discussed in the Belmont Report?

Respect for Persons, Beneficence, Justice

The history of ethical regulations in human subjects research began with the

Nuremberg Code

Promptly

OHRP guidance (2007) states that the federal regulations do not specify a timeframe for reporting, except to say this must be done "promptly." For a more serious incident, this may mean reporting to IRB within days. For a less serious incident, a few weeks may be sufficient. Researchers should check with their local IRB to determine their institution's procedures.

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.

Risks are specific to time, situation, and culture.

Research in the social and behavioral sciences sometimes does pose risks to subjects. Risks can be time, situation, and context specific. What may be a socially sensitive issue or topic at a given time and/or place may not be so at another time and/or place. The risk of emotional distress cannot be managed by anonymizing data, but rather by developing a plan to respond to the distress should it occur. Risks must always be minimized to the extent possible, regardless of the potential for benefit.

No more than minimal risk and the research activities fall within regulatory categories identified as eligible.

Research is eligible for expedited review when it poses no more than minimal risk to the participants and when all the activities fall within categories identified as eligible. Studies with more than minimal risk do not qualify for expedited review even if the subjects are adults, the sponsor is in a hurry, or the study replicates previously approved research.

Provide potential subjects with information at the appropriate reading comprehension level.

Researchers must provide information to subjects in a manner that facilitates comprehension. Therefore, the material must be written at the appropriate reading comprehension level. Researchers may not impose penalties for non-participation because to do so would violate the ethical principle of respect for persons. In some circumstances it may be appropriate to ask subjects to discuss the research with their families before making a decision about whether to participate, but it is not a regulatory requirement. Finally, researchers are not required to provide a list of the IRB members who reviewed the research.

A general requirement for informed consent is that no informed consent may include any exculpatory language. Exculpatory language is that which waives or appears to waive any of the subject's legal rights or releases or appears to release those conducting the research from liability for negligence. Which of the following statements in a consent form is an example of exculpatory language?

Taking part in the research is voluntary, but if you choose to take part, you waive the right to legal redress for any research-related injuries.

A waiver of the requirement for documentation of informed consent may be granted when:

The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality.

The principle of beneficence

The principle of beneficence includes the obligation of researchers to strive to do no harm and to maximize benefits and minimize harms. "Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being" (The National Commission 1979). The principle of beneficence can be applied to a study employing human subjects by determining that the study has a maximization of benefits and a minimization of risks. Providing detailed information during consent and ensuring persons with diminished autonomy are protected would be examples of applying the principle of respect for persons. Ensuring the selection of subjects is equitable is an example of applying the principle of justice.

Subpart D: Additional Protections for Children Involved as Subjects in Research

The provisions of Subpart D, of the HHS regulations, Additional Protections for Children Involved as Subjects in Research are the specific Department of Health and Human Services (HHS) regulations that apply to research with children. Subpart B specifies Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research, Subpart C specifies Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects and Subpart A is the Basic HHS Policy for Protection of Human Research Subjects (generally referred to as the Common Rule).

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.

One of your subjects is half way through a study of an investigational antidepressant that is injected weekly. The drug requires a taper-down regimen, that is, it should not be stopped abruptly. You learn that the subject will be admitted to prison next week prior to the next scheduled injection. What is the appropriate response for the researcher?

The researcher should contact prison authorities about the medical issue , and report the events to the IRB of record.

There was neither a violation of privacy nor a breach of confidentiality.

The subjects' privacy has not been violated because the identity of subjects was not included in the file. The confidentiality of the data has not been breached because the data could not be linked to identifiers. Therefore, the correct answer is that there was neither a violation of privacy nor a breach of confidentiality. The release of aggregate data with no identifiers does not constitute a violation of privacy or a breach of confidentiality.

The parents of the children might feel pressure to give permission to the therapist to use their children's data so that she will continue to provide services to their children.

When a care provider becomes a researcher, both the child clients and their parents may not feel free to choose not to participate in the provider's study. A researcher who is also a care provider needs to be very clear that a decision not to participate in a study, or to allow records to be used, will not affect the care provided in the future. The fact that the therapist has access to her clients' records as a clinician does not entitle her to use information in the records for research purposes without parental permission and child assent. A school authority's permission to conduct the research does not replace the need for permission or assent. Finally, the children's right to choose cannot be overridden in the pursuit of an indeterminate community interest.

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.

Private information includes

information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects. 45 CFR 46.102(e). A medical record is considered private because it includes identifiable information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public. A medical record is not considered public information, nor is it considered a behavior.

Belmont Report

provides the ethical framework for the federal regulations designed to protect human research subjects.

Exempt research is

research with human subjects. However, it is "exempt" from the provisions stated in Title 45, Part 46, Subpart A (the Common Rule). Federal guidance recommends that investigators not be allowed to self-determine whether a study qualifies for exemption. Therefore, exempt studies generally are reviewed and determined by the IRB, or its representative. Expedited and Full/Convened Board reviews both require IRB approval.