Essential Element 1: Quiz

Results
Score for this question group: 100%
1. Which elements are necessary for a research study?
○ a) Scientific integrity
○ b) Social value
○ c) Contribution to medical knowledge
○ d) All of the above​ Your correct answer
○ e) A and B only
2. A relevant study question:
○ Should be formally stated in the objectives and hypotheses in the
protocol​ Your correct answer
○ Need not be stated as it can be assumed to be obvious in studies
comparing the efficacy of two drugs.
○ Is not necessary for studies that provide useful, non-trivial
information.
○ None of the above.
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
○ False
4. Which of the following queries should be considered for writing relevant
study questions? (Check all that apply)
○ What is the unmet need?​ Your correct answer
○ Does it contribute to a development program or medical
knowledge?​ Your correct answer
○ What is the justification for the study?​ Your correct answer
○ How does the study recruit and compensate the research
participants?
5. Which of the following is/are NOT a good example/s of addressing
relevant questions in a research protocol?
 ○ Drug X offers greater potential advantages than Drug Y for
long-term treatment of disease Z. Drug X is a new therapy that is
longer acting and does not require refrigeration. This requires
less frequent office visits for patients with disease Z who will be
participant of this study. A comparison between Drug X and Drug
Y is planned to study the ability of both drugs to produce the
desired result.
○ 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
○ Drug D will be given to healthy participants to study how the body
processes it (pharmacokinetics) at the current dose. This
proposed study will provide valuable information in regard to

Essential Element 2: Quiz

Results
Score for this question group: 80%
1. When evaluating the ethics for a clinical trial, active comparator,
placebo, and standard of care should be considered.
○ True​ Your correct answer
○ False
2. There is general agreement that placebo-controlled trials pose less risk
of harm to individual research participants than active control trials.
○ True
○ 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
○ False
4. In a clinical trial, the choice of control impacts: (Check all that apply)
○ Ethical acceptability​ Your correct answer
○ 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
○ False
6. What can influence the selection and use of active controls?
○ a) Ineffective comparator (type, dosage, regimen)
○ b) Selection of patient population
○ c) Availability and accessibility of effective intervention
○ e) All of the above​ Your correct answer
○ f) A and C only
7. Which of the following statements are true? (Check all that apply)
○ A trial with an active comparator is considered one of the least
reliable ways to demonstrate safety and efficacy of an intervention
because it provides a valid baseline to distinguish between
effective treatment and ineffective treatment.
○ 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. ​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.​ Correct answer
○ When a placebo-controlled trial is preferred scientifically, but
there is greater than temporary or minor discomfort, it is ethical to
proceed without establishing risk management strategies. ​Your
answer
8. What does “standard of care” refer to? (Check all that apply.)
○ The best available care for a specific condition anywhere in the
world.
○ 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.​ 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?
○ Is standard treatment considered to be effective?
○ Are there medically sound reasons to use placebo?
○ Could this trial benefit future patients to the point that a
reasonable person with an average degree of altruism and
risk-aversiveness would consent to being randomized in this
trial?
○ 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
○ False
 ○ dosing Drug D for patients with disease E.

Essential Element 3: Quiz

Results
Score for this question group: 100%
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 be…
○ True​ Your correct answer
○ False
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
○ False
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…
○ Use of unequal randomization
○ Washout period for participants who need therapy
○ Adaptive trial designs​ Your correct answer
○ Continuing treatment with a failed therapy
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
○ Is a scientifically valid, ethical study
5. Which points should be considered in the choice of study design? (Check all
that apply.)
○ Will the individual study participant improve his/her health through this
study?
○ 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
○ False
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…
○ True
○ False​ Your correct answer

Essential Element 4: Quiz

Results
Score for this question group: 82%
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
○ False
2. Which of the following statements are NOT true about the fair selection of
research participants? (Check all that apply)
○ The Belmont Report demands the fair distribution of burdens and
benefits of research.
○ The selection of research participants must be equitable to ensure fair
distribution of risks and burdens.
○ 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
 ○ Selection criteria should ensure that research participants adequately
represent the population that may benefit from the research.
○ 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?
○ What is the scientific basis for targeting the specific study population
○ Are healthy participants to be studied?
○ Is the participant population being exposed for the first time?
○ 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
○ Relationship between Principal Investigator and vulnerable population
○ 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.
○ True
○ 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
Correct answer
○ A significant amount of risk may be acceptable, even if research that is
not expected to directly benefit participants, if the expected benefits to
society in terms of generalizable knowledge are sufficient, and if the
legal guardian agrees
○ 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?
○ a) Animal studies and toxicology studies indicate good reason to move
to human trials and exposure has been well thought through.
○ b) International guidelines have been used to calculate the dose and
escalating the dose.
○ c) Rules for stopping and use of monitoring committees have been
defined.
○ d) When appropriate, tolerability of the dose has been shown in healthy
participants before giving it to participants with the disease.
○ e) All of the above.​ Your correct answer
○ f) A, B and C only.
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…
○ a) Ask women of childbearing potential to use a double-barrier method
of birth control.
○ b) Involve surgically sterile women.
○ c) Involve postmenopausal women.
○ d) Do never involve women in studies of new drugs and therapies.
○ e) All of the above.
○ 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
○ Should be encouraged to participate in clinical trials as they may
benefit particularly from the therapy.
10. For healthy participants and participants with significant medical problems, the
ethical consideration of a drug study protocol should:
○ Include the Curriculum Vitae of the Principal Investigator.
○ Recognize the potential risks and indicate why it is important and
acceptable for these participants to be studied. ​Correct answer
○ Describe how the drug has been tested in animals prior to the current
study.
○ All of the above.​ Your answer
○ None of the above.
11. Overprotection or underrepresentation of study populations (e.g., men,
elderly) can result in misleading conclusions of studies.
○ True​ Your correct answer
○ False

Essential Element 5: Quiz

Results
Score for this question group: 100%
1. If a proposed study has no direct benefit to the individual study participant:
○ The study should not be conducted.
○ The risks must be reasonable and balanced by the benefit to society
and the knowledge to be gained.​ Your correct answer
○ The study participant must receive a significant payment for
participation to compensate for the risk.
 2. The interests of science and society should take precedence over
considerations for the well-being of the study participants.
○ True
○ False​ Your correct answer
3. Potential benefits to individual study participants may include: (Check all that
apply.)
○ Medical care at higher costs
○ 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

Results
Score for this question group: 100%
1. The process of obtaining participants’ informed consent: (Check all that
apply.)
○ must be in the language of the investigators of the study
○ 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
○ is no different for studies that target young children, adults with severe
mental or behavioural disorders, or persons who are unfamiliar with
medical concepts and technology than for studies that do not include
those populations
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
○ False