Essential Element
answer
Essential Element 1: Quiz
1. Which elements are necessary for a research
study?
 All of the above Your correct answer
2. A relevant study question
 Should be formally stated in the
objectives and hypotheses in the
protocol Your correct answer
3. If related elements are already discussed in
designated sections of the protocol, it may still be
helpful to introduce a special ethical section wi…
 True Your correct answer
4. Which of the following queries should be
considered for writing relevant study questions?
(Check all that apply)
 Does it contribute to a development
program or medical knowledge? Your
correct answer
 What is the justification for the
study? Your correct answer
 What is the unmet need? Your correct
answer
5. Which of the following is/are NOT a good
example/s of addressing relevant questions in a
research protocol?
 Drug A has shown to have much more
serious undesirable effects than Drug B
in a prior study on cancer with more
than 1,000 participants. Both drugs have
the same ability to produce the desired
result. A new study of Drugs A and Drug
B is proposed to confirm this
result. Your correct answer
Essential Element 2: Quiz
1. When evaluating the ethics for a clinical trial,
active comparator, placebo, and standard of care
should be considered.
 True Your correct answer
2. There is general agreement that placebo-
controlled trials pose less risk of harm to individual
research participants than active control trials.
 False Your correct answer
3. All of the arms of a study should be evaluated
against the standard of care that research
participants would or could receive if not enrolled
in re…
 True Your correct answer
4. In a clinical trial, the choice of control impacts:
(Check all that apply)
 Ethical acceptability Your correct
 Endpoint that can be studied Your
correct answer
 How results can be interpreted Your
correct answer
 Degree to which bias can be
minimized Your correct answer
 Public and scientific credibility of
results Your correct answer
 Acceptability of results by regulatory
authorities Your correct answer
5. The Council for International Organizations of
Medical Sciences (CIOMS) and the World Medical
Association (WMA) recommend that research
participant…
 True Your correct answer
6. What can influence the selection and use of active
controls?
 All of the above Your correct answer
7. Which of the following statements are true?
(Check all that apply)
 When the use of placebo control can
reasonably be expected to result only in
temporary or minor discomfort, it is
generally considered ethical to use
placebo. Your correct answer
 A placebo-controlled trial can be justified
if there are no established effective
interventions for the treatment of the
disease or condition under study. Your
correct answer
8. What does “standard of care” refer to? (Check all
that apply.)
 What a reasonable physician would do
in prescribing care to a patient. Your
correct answer
 Consensus of the medical speciality or
accepted treatment guidelines in a
particular part of the world. Your correct
answer
 Regimen chosen by the physician if no
single standard exists. Your correct
answer
9. Which of the following questions should be
considered for choosing a control?
 All of the above Your correct answer
10. For multi-regional clinical trials, researchers need
to consider whether the proposed active control is
available to all study sites and accessible…
 True Your correct answer
Essential Element 3: Quiz
1. At the population level, it is important to determine
if the study can achieve the stated outcomes and
has the potential to answer the questions being
asked.
  True Your correct answer
2. At the individual participant level, the study should
be reasonable and ethical, and safeguards against
unnecessary or unacceptable risk or undue b…
 True Your correct answer
3. A participant in a study is informed that there is a
broad range of options early in the trial and that
the options will change as the study progre…
 Adaptive trial designs Your correct
answer
4. A single arm, open-label efficacy study of a novel
drug with patient-reported outcomes of mental
health issues:
 Cannot easily be replicated and is
potentially biased Your correct answer
5. Which points should be considered in the choice
of study design? (Check all that apply.)
 Is the chosen study design adequate to
answer the question defined by
objectives and hypotheses? Your
correct answer
 Are all the assessments, and their total
number, necessary and not overly
burdensome? Your correct answer
 Does the design in any way compromise
the individual or expose the participant
to harm? Your correct answer
6. It is critically important in a first-in-human (FIH)
study to justify the choice of dose given for the first
time and the safety of any increase in…
 True Your correct answer
7. Using unequal randomization by exposing two
times or three times as many participants to the
experimental drug or therapy than to the placebo
is no…
 False Your correct answer
Essential Element 4: Quiz
1. Individuals who enroll as participants in clinical
studies are always exposed to risk and
inconvenience that they would not otherwise
experience.
 True Your correct answer
2. Which of the following statements are NOT true
about the fair selection of research participants?
(Check all that apply)
 Fair selection of research participants
does not apply to vulnerable populations
such as children, prisoners, pregnant
women, mentally disabled, or
economically or educationally
disadvantaged persons. Your correct
answer
 The fair distribution of burdens and
benefits applies to the selection and
recruitment of study participants, but not
to the study design or conduct of the
research. Your correct answer
3. Which of the following questions should be
considered for selecting the target population?
 All of the above. Your correct answer
4. A protocol for research involving a potentially
vulnerable population should contain information
about: (Check all that apply.)
 Scientific justification for including the
vulnerable group Your correct answer
 Inclusion and exclusion criteria Your
correct answer
 How the inclusion of the vulnerable
group is necessary for answering the
scientific question Your correct answer
 Steps taken to protect individuals who
may have diminished capacity to
consent Your correct answer
5. Ease of participant recruitment is considered an
ethical justification for selection of a population,
country or region.
 False Your correct answer
6. Research is sometimes conducted with
participants who are not competent to give
informed consent. Considerations include: (Check
all that apply.)
 If the research is not expected to directly
benefit participants then risks should be
minimal (such as those no greater that
would normally be posed by routine
medical or psychological examination of
such persons) Your correct answer
 If the research poses more than minimal
risk, there must be a justification for why
the research is being conducted in this
population Your correct answer
 If the research is expected to directly
benefit the participants, a minor
increase above minimal risk may be
considered acceptable by the
IEC/IRB Your correct answer
7. How can first use of a new drug or therapy in
humans be justified?
 All of the above. Your correct answer
8. How can a first use of a new drug or therapy in
women be justified, considering the possibility of
pregnancy and the potential risk to the unborn c…
 f) A, B and C only. Your correct answer
9. Populations at special risk because of underlying
disease or other issues (e.g., pacemakers):
 Should be identified in the study
protocol, together with measures
identified to make their participation
safe. Your correct answer
10. For healthy participants and participants with
significant medical problems, the ethical
consideration of a drug study protocol should:
 Recognize the potential risks and
indicate why it is important and
 acceptable for these participants to be
studied. Your correct answer
11. Overprotection or underrepresentation of study
populations (e.g., men, elderly) can result in
misleading conclusions of studies.
 True Your correct answer
Essential Element 5: Quiz
1. If a proposed study has no direct benefit to the
individual study participant:
 The risks must be reasonable and
balanced by the benefit to society and
the knowledge to be gained. Your
correct answer
2. The interests of science and society should take
precedence over considerations for the well-being
of the study participants.
 False Your correct answer
3. Potential benefits to individual study participants
may include: (Check all that apply.)
 More frequent monitoring of participants’
disease or condition Your correct
answer
 Positive response to study
intervention Your correct answer
 Possibility of life-style
modifications Your correct answer
Essential Element 6: Quiz
1. The process of obtaining participants’ informed
consent: (Check all that apply.)
 is the primary responsibility of the
investigators and their institutions Your
correct answer
 must explain benefits and risks of the
trial and consequences of participating
in the local language understood by the
target population Your correct answer
2. The Protocol should include the following
information about informed consent: (Check all
that apply)
 whether informed consent can be
waived, including the justification or
rationale for any waiver Your correct
answer
 how consent will be documented from
illiterate populations and/or individuals
unable of giving informed consent, if
applicable Your correct answer
 whether local ethics review board or
Community Advisory Board approval of
consent document and/or consent
process is required Your correct answer
 whether secondary use of biological
specimens is a possibility and how
consent will be sought for secondary
use Your correct answer
3. Cultural considerations—such as the role of family
leaders, tribal leaders, and local standards for
signatures—need to be taken into ac…
 True Your correct answer
Essential Element 7: Quiz
1. When can communities be meaningfully engaged
in research?
(Check all that apply)
 Early (e.g., during protocol design and
development) Your correct answer
 Throughout all phases of research Your
correct answer
 For the dissemination of research
results Your correct answer
2. People who live in the target community and are
characterized by the following should be included
in community engagement in research:
 f) All of the above Your correct answer
3. If a researcher gained consent from the
community, in local language and face-to-face
meetings, it is not necessary to obtain individual
consent fr…
 False Your correct answer
4. Good practices for community engagement
include the following. (Check all that apply).
 The Institutional Review Board (IRB) /
research ethics committee determines
the appropriate level of community
engagement in the consent
process. Your correct answer
 Researcher discusses with community
members how study data and samples
will be stored and who controls them
after the study is complete. Your correct
answer
 Community members may become co-
authors on papers discussing results
and may review drafts of journal articles
about the research in their
community. Your correct answer
Essential Element 8: Quiz
1. A study set up to test the effectiveness of a drug
for heart disease found unexpectedly that some
study participants have other significant health …
 Incidental Findings Your correct answer
2. The study protocol for the return of research
results might include how the following will be
handled: (Check all that apply.)
 Disclosure of general research
results Your correct answer
 Disclosure of individual research
results Your correct answer
 Disclosure of incidental findings Your
correct answer
 Options for participants to opt-in or opt-
out of receiving research results Your
correct answer
3. Researchers need to clarify to study participants
that the participants’ individual care and treatment
is not the primary goal of the researc…
 True Your correct answer
4. Clearly spelling out the scope of obligation for an
investigator to return results to study participants
can help manage the expectations of partic…
  True Your correct answer
5. A study found that an existing medication can be
used to reduce the health threat of Lassa Fever.
This is an example of what kind of returnable
res…
 Medically actionable Your correct
answer
6. Which of the following should be considered in a
proposal about how to handle individual research
results and incidental findings?
All of the above Your correct answer
7. A good plan for returning information to
participants will discuss how to deal with general
research results, individual research results, and
inci…
 False Your correct answer
8. Which of the following is/are an example/s of
incidental finding?
 e) A and B only Your correct answer
Essential Element 9: Quiz
 Should be developed in advance. Your
correct answer
 May be included in informed consent
materials, sponsor policies, study
protocols. Your correct answer
2. What should be addressed in a protocol in terms
of study-related injury or impairment?
 All of the above Your correct answer
3. Injury refers to longer-term, not resolvable but
potentially manageable harm which may result
from participation in a study.
 False Your correct answer
4. Most advisory bodies and international groups
agree that:
 there is an obligation to ensure that
participants do not individually bear the
costs of medical care directly resulting
from their participation in clinical
research, regardless of fault Your
correct answer
5. Approaches to dealing with study-related injury:
 d) All of the above. Your correct answer

1. Post-trial access refers to any medical benefits

provided after the study has ended.
 True Your correct answer
2. What are external sponsors ethically obligated to
provide, according to the Council for International
Organizations of Medical Sciences (CIOMS)?
 e) A and B only. Your correct answer
3. What should researchers consider including in
their study protocol?
 d) All of the above. Your correct answer
4. The availability of post trial access for continuing
health care usually does not influence a person’s
decision-making to participate in a st…
 False Your correct answer

Essential Element 10: Quiz

1. A study in a developing country includes healthy

participants. What should be considered when
preparing the protocol?
(Check all that apply)
 Participation should be cost neutral to
the participant, including no lost income
or unreimbursed expenses for
participation. Your correct answer
 The ethical implications of any direct
payments to study participants should
be addressed in the protocol. Your
correct answer
 Justification for any payments to
participants beyond cost reimbursement
should be included in the protocol. Your
correct answer
2. Concerns about undue inducement may arise
 All of the above Your correct answer

Essential Element 11: Quiz

1. Strategies for managing study-related injuries and

impairments:
(Check all that apply)