The basic requirement(s) for informed consent is/are:

Your answer : Competence, information and voluntariness.

Correct. All three requirements must be fulfilled if consent is to be valid.

Your answer : Informed consent is a basic human right but its application should take
into account cultural differences.
Correct. As long as the basic requirements of informed consent are fulfilled, cultural
factors can be accommodated.

The most suitable person for seeking informed consent to participate in research is:
Your answer : An independent third party.
Correct. Ideally the one seeking consent will be knowledgeable about the study but not
in a conflict of interests between the study's success and the potential participant's well-
being. If no such person is available, the researcher or study nurse may have to seek
consent; if so, they should be very careful to allow the potential subjects to freely decide
whether or not to participate in the study.

Which of the following items is not required for informed consent:

Your answer : Disclosure whether the research subject will receive the experimental
treatment or a placebo.
Correct. Most studies are blinded so that the research subject, and often the researcher,
does not know who is receiving the experimental treatment.

If a significant number of research participants want to withdraw from a study after it has
begun because of an unfounded rumour that the experimental treatment is harmful,
would it be acceptable for the researcher to offer them a large cash payment to continue
in the study?
Your answer : No. This would constitute undue inducement.
Correct. The payment might constitute undue inducement. The researcher is advised to
deal with the situation by providing correct information to the research participants
through enhancement of communication. This new information should be submitted for
evaluation to the competent research ethics committee.

Which of the following categories of potential research subjects is/are always incapable
of informed consent to participate in a study:
Your answer : Comatose accident victims.
Correct. As long as accident victims are in a coma, they cannot provide informed
consent. However, consent should be sought for continuation of the study once they are
no longer comatose.

Which of the following research studies involving individuals with severe dementia
should not be permitted:
Your answer : A study to evaluate the efficacy of a vaccine for HIV.
Correct. This study is probably high-risk, is highly unlikely to benefit individuals with
dementia, and can better be conducted with other populations.

A researcher wants to enrol children aged ten to sixteen in a study comparing

interventions aimed at reducing the prevalence of sexually transmitted diseases. Many
of the children in the target population are "AIDS orphans" living on their own or with
their grandmothers. Whom should the researcher approach to seek informed consent
for participation in the study:
Your answer : All of the above.
Correct. However, the consent of the grandmothers may be waived under certain
conditions. Moreover, the researcher and the REC may want to seek independent legal
advice.

Sepsis is a critical disease without satisfactory treatment. An investigator submitted an

application to a REC for a clinical trial of a novel drug for treatment of sepsis. The trial is
a phase 3, randomized, placebo-controlled trial, in combination with the standard care
provided by the investigator’s hospital. Since the research participants will be in
unconscious state, obtaining prior informed consent will not be possible. Considering
that the research participants will all be provided the standard care and some of them
may be benefited from the novel drug, the REC decided to approve the trial and also
grant a waiver of obtaining prior informed consent from the participants. Notwithstanding
the above, what types of measures could be taken to procure ethical recruitment of
participants into the trial?
Your answer : a, b and c above
Correct: All a, b and c are feasible measures that could be taken.
The pathology laboratory of a university-affiliated hospital routinely retains blood and
tissue samples from patients in case they need to be studied at a later date for
therapeutic purposes. A researcher wants to use some of these samples in a genetics
study. Is individual informed consent from the source individuals of the samples
required?
Your answer : Yes, but only if the source individuals can be easily identified and
contacted.
Correct. Informed consent is normally required for research on bodily substances that
were originally taken for therapeutic purposes. However, both the Declaration of
Helsinki and the CIOMS Guidelines allow an exception to this requirement if the source
individuals cannot be easily identified and contacted, although the approval of
an REC is required. In some countries, the law authorises, under certain conditions,
such secondary use for research without consent.

Illiterate individuals should not be included in research studies because they do not have the
intellectual capacity to make an informed decision whether or not to participate:
Your answer : False.
Correct. Illiteracy is not a decisive factor in one's ability to understand what participation in
research involves. With the help of oral explanations and pictorial devices, sufficient information
can be provided to ensure an informed decision about participation.

Genetic research studies should only be approved if:

Your answer : All potentially affected individuals that can be identified and contacted are
informed about the research even if they are not asked to provide samples.
Correct. Ideally all potentially affected individuals will have an opportunity to discuss the
project and decide whether it should go ahead. If a majority is in favour but a minority is
opposed and the project does proceed, efforts should be made to protect the interests
of the minority, e.g., by not publicizing potentially stigmatizing results.