Q1) 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

Justice
Beneficence

Question 2

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:

Beneficence
Justice
Respect for persons

Question 3

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
Beneficence
Respect for persons

Question 4

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

Tearoom Trade Study (Humphreys)
Stanford Prison Experiment (Zimbardo)
All of the above
None of the above

Question 5

The Belmont principle of beneficence requires that:

Risks to subjects are reasonable in relation to anticipated benefits.

Subjects derive individual benefit from study participation.
Risks are managed so that they are no more than minimal.
The study makes a significant contribution to generalizable knowledge.
Question 1

A researcher is interested in assessing risk-taking by individuals. The researcher is sitting on a bench near a busy
four-way stop intersection. She plans on recording the number of bike riders wearing a safety helmet and whether
they stop at the intersection before proceeding in order to correlate use of safety apparel with risk-taking. This
collection of information is an example of:

Public behavior
Private information
Public information
Private behavior

Question 2

According to the federal regulations, human subjects are living individuals about whom an investigator conducting
research obtains information through interaction or intervention with the individual, and uses, studies, or analyzes
the information; or:

Obtains, uses, studies, analyzes, or generates identifiable public information.

Observes public behavior.
Obtains, uses, studies, analyzes, or generates identifiable private information.
Obtains, uses, studies, analyzes, or generates de-identified private information.

Question 3

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

A researcher sets up a meeting with the superintendent of a large and diverse public school system to get data
about the ethnic composition of the school system and the number of students receiving free lunches.
A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on
problem-solving behaviors.
A researcher conducts a comparison of the comments made in a publicly available blog and the blogger's
comments on a similar topic in a weekly magazine.
Undergraduate students in a field methods class are assigned a research question and asked to interview another
classmate, to be followed by a class discussion on interview techniques.

Question 4

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.
The IRB will not review this study because it does not involve an investigational new device.
The IRB will review this study because it includes human subjects and is considered research.
The IRB will not review this study because it does not include human subjects as defined by the federal
regulations.

Question 5
A medical record is an example of:

Private information
Public behavior
Private behavior
Public information

Question 1

According to federal regulations, the expedited review process may be used when the study procedures pose:

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.
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.

Question 2

In addition to pregnant women, fetuses, and neonates, another subpart of the HHS regulations provides additional
protections for which of the following vulnerable populations?

The elderly
Prisoners
Adults with decisional impairments
College students

Question 3

Which of the following statements about the relationship between an institution and the institution's IRB(s) is
correct?

Officials of the institution may overturn an IRB disapproval.

Officials of the institution may overrule an IRB approval.
Institutional priorities take precedence over all IRB determinations.
Department chairs can overturn an IRB disapproval.

Question 4

According to the federal regulations, research is eligible for exemption, if:

Participation in the research will involve ten minutes or less of the subjects' time.
All the subjects are adults and the risk is minimal.
The researcher is experienced in the field of inquiry.
The research falls into one of eight categories of research activity described in the regulations.

Question 5

Continuing review of an approved and ongoing study posing more than minimal risk that was initially approved 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 be conducted by a convened IRB.

Assessing risk - SBE

Instructions: Please provide an answer for all questions. Each question is one point. Click on the Submit button
to register your answers. After submitting your answers, the correct answer to each question and an explanation
will be displayed. Navigational links to the next module will also be provided.

All quiz questions count towards your score. You should answer all questions.

Question 1

The primary purpose of a Certificate of Confidentiality is to:

Protect researchers from disclosing conflicts of interest.

Allow law enforcement to investigate abuse cases.
Prevent subjects from knowing the purpose of a study.
Protect identifiable research information from compelled disclosure.
Question 2

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

Research on the prevalence of retired individuals who have been harassed in different academic disciplines
A study asking women if they have completed an advanced degree and what city they were born in
A study on the efficacy of a behavioral intervention for smoking cessation that involves both adults and
teenagers (who are underage to purchase tobacco) in the United States
A survey with educators on their experience about implementation of a novel preschool program
Question 3

Risk of harm in social and behavioral sciences generally fall in three categories, which are:

Invasion of privacy, adverse reaction to study drug, and discrimination

Breach of confidentiality, loss of autonomy, and study procedures
Invasion of privacy, breach of confidentiality, and study procedures
Study procedures, breach of confidentiality, and loss of employment
Question 4

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.

Requiring pregnancy tests before administration of the study drug.
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.
Question 5

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

Risks are specific to time, situation, and culture.

Anonymizing data effectively manages the risk of creating emotional distress.
There are never any risks.
If a study offers potential benefits, it is not necessary to minimize risks.

Question 1

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:

Lose their employment.

Experience emotional or psychological distress.
Feel that their privacy has been invaded.
Lose their legal status.
Question 2

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:

Solely by the probability of expected harm.

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.
Question 3

Risk of harm in social and behavioral sciences generally fall in three categories, which are:

Invasion of privacy, breach of confidentiality, and study procedures

Breach of confidentiality, loss of autonomy, and study procedures
Study procedures, breach of confidentiality, and loss of employment
Invasion of privacy, adverse reaction to study drug, and discrimination
Question 4

The primary purpose of a Certificate of Confidentiality is to:

Allow law enforcement to investigate abuse cases.

Prevent subjects from knowing the purpose of a study.
Protect identifiable research information from compelled disclosure.
Protect researchers from disclosing conflicts of interest.
Question 5

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:

Have the subject sign the consent form under an assumed name.
Obtain a Certificate of Confidentiality.
Obtain a waiver of documentation of informed consent.
Code the subjects' responses.

Informed consent – SBE

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.
The therapist creates her clients' records; therefore, she does not need parents' permission to use the information
for research purposes.
If it is the best interests of the community that the children participate in the study, parental permission is
optional.
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.
Question 2

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?

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.
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.
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.
In the event of any distress you may have related to this research, you will be given access to appropriate
resources.
Question 3

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 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.
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.
Question 4

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 subjects are literate in their own language; however, they do not read, write, or speak English.
Potential subjects might find some of the research questions embarrassing, personal, or intrusive.
The investigator has no convenient place to store signed consent forms separate from the research data.
Question 5

As part of the consent process, the federal regulations require researchers to:

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.
Describe penalties that may be imposed for non-participation.

Question 1

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:

Solely by the probability of expected harm.

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.

Q2)

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.

Q3)Additional safeguards that may be included in a social and behavioral study may include:

Requiring pregnancy tests before administration of the study drug.

Requiring a legally authorized representative to provide signed consent for an incapacitated subject.
Frequent monitoring of the subject’s heart through ECG after administration of the study drug.
Remove all direct identifiers from the data as soon as possible.

Q4) Risk of harm in social and behavioral sciences generally fall in three categories, which are:

Study procedures, breach of confidentiality, and loss of employment

Breach of confidentiality, loss of autonomy, and study procedures
Invasion of privacy, breach of confidentiality, and study procedures
Invasion of privacy, adverse reaction to study drug, and discrimination
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:

Q10) Have the subject sign the consent form under an assumed name.
Code the subjects' responses.
Obtain a Certificate of Confidentiality.
Obtain a waiver of documentation of informed consent.
Privacy and Confidentiality - SBE (ID 505)

Question 1

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 both a violation of privacy and a breach of confidentiality.
Confidentiality of the data has been breached.
There was neither a violation of privacy nor a breach of confidentiality.

Question 2

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)?

In order to eliminate the effect of observation on behavior, a researcher attends a support group and records
 interactions without informing the attendees.
A researcher, who is a guest, audio-records conversations at a series of private dinner parties to assess gender roles,
without informing participants.
A researcher asks cocaine users to provide names and contact information of other cocaine users who might qualify
for a study.
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.

Question 3

When a focus group deals with a potentially sensitive topic, which of the following statements about providing
confidentiality to focus group participants is correct?

Using pseudonyms in reports removes the concern about any confidences shared in the group.
If group participants sign confidentiality agreements, the researcher can guarantee confidentiality.
If group members know each other confidentiality is not an issue.
The researcher cannot control what participants repeat about others outside the group.

Question 4

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?

Waiving documentation of consent

Securing a Certificate of Confidentiality
Using data encryption for stored files
Using pseudonyms in research reports

Question 5

Additional protections researchers can include in their practice to protect subject privacy and data confidentiality
include:

Requiring all members of the research team to sign confidentiality agreements.

Keeping the key linking names to responses in a secure location.
Reporting data in aggregate form in publications resulting from the research.
Destroying all identifiers connected to the data.
All of the above

Unanticipated Problems and Reporting Requirements in Social and Behavioral Research (ID
14928)

Question 1

According to OHRP, a problem is an “unanticipated problem” when it meets which of the following criteria:

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, unrelated to the research but still occurring with a subject, suggests the research puts others at greater
risk
Expected, related or possibly related to the research, suggests the research puts others at greater risk

Question 2

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 involved a subject in a research study and it is up to the IRB to determine if it
was related to participation.
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.
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.

Question 3

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 48 hours
Within two weeks
Promptly

Question 4

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

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
Determined by research staff

Question 5

Researchers must report potential unanticipated problems that involve risks to others directly to the:

American Psychological Association

Institutional Review Board (IRB)
 Institutional Risk Manager
HIPAA Compliance Officer

Q6) 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 had the heart attack when they were home, not at the
focus group.
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.

Populations in Research Requiring Additional Considerations and/or Protections (ID 16680)

Question 1

In considering NBAC’s analytic approach, an otherwise competent person who is acutely ill might be considered at
especially high risk of harm for:

Economic vulnerability
Communicative vulnerability
Situational cognitive vulnerability
Capacity-related cognitive vulnerability
Question 2

Which is an example of a situation where deferential vulnerability might be a factor?

An army medical officer recruiting subjects among lower ranks

A physician recruiting patients to be subjects
An employer recruiting among persons who directly report to them
A college professor recruiting among their students

Question 3

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

Question 4
Which is true of inducements in research?

Inducements constitute an “undue influence” if they alter a potential subject’s decision-making processes, such that
they do not appropriately weigh the risk-benefit relationship of the research.
Inducements, like coercion, are always inappropriate, as they violate the ethical principle of respect for persons.
Like coercion, undue inducement is easy for IRBs to determine.
Offering $10 for an hour long research study constitutes undue inducement.

Question 5

A subject participates in a drug study because treatment is available at no or reduced cost, and he could not
otherwise afford it. This is an example of:

Institutional vulnerability
Economic vulnerability
Social vulnerability
Communicative vulnerability

Conflicts of Interest in Human Subjects Research (ID 17464

Question 1

The PHS regulations about financial conflict of interests require which party to disclose significant financial
conflicts of interest?

Sponsor
Applicants submitting marketing applications for drugs, biologics, or devices
Researcher
Organization
IRB Member

Question 2

What is the term for management controls that are built in to a research study (for example, independent data
analysis)?

Mandated controls
Objective controls
Required controls
Inherent controls

Question 3

The FDA regulations governing disclosure of individual COIs require:

Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical
studies
Researchers to annually self-disclose financial COIs to the FDA
 Sponsors to annually disclose to the FDA financial COIs of researchers who conducted clinical studies
Organizations to disclose financial COIs to the FDA no later than the time of submission of the IND application

Question 4

During an Institutional Review Board (IRB) meeting, any IRB member who may have a potential COI with a study
under review should:

Leave the meeting immediately

Disclose their potential COI, but not answer any questions about the study
Disclose their potential COI and not participate in any action
Disclose their potential COI and may answer questions, but recuse themselves from voting

Question 5

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

Their connections to the journal may yield some concern
The project has a limited scope
They are not informed of the area of work