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Quiz 5

The document discusses potential benefits and harms in human research. It notes that protocols should provide sufficient information to assess whether there is a reasonable balance of risks and benefits. Risks may include those from experimental drugs, procedures, vulnerable populations, and non-physical harms. Benefits may include potential benefits to individual participants, such as positive responses or additional care, and benefits to society, such as increased knowledge or community resources. The ethical discussion should consider risks and benefits to ensure the well-being of participants is prioritized over scientific interests.

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Melodia Turqueza Gandeza
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81 views8 pages

Quiz 5

The document discusses potential benefits and harms in human research. It notes that protocols should provide sufficient information to assess whether there is a reasonable balance of risks and benefits. Risks may include those from experimental drugs, procedures, vulnerable populations, and non-physical harms. Benefits may include potential benefits to individual participants, such as positive responses or additional care, and benefits to society, such as increased knowledge or community resources. The ethical discussion should consider risks and benefits to ensure the well-being of participants is prioritized over scientific interests.

Uploaded by

Melodia Turqueza Gandeza
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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Essential Element 5: Potential Benefits and


Harms
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Contents
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1. Contents
2. Introduction
3. Points to Consider
4. Risks
1. Risks
5. Benefits
6. Summary
7. Finished - Potential Benefits and Harms

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Essential Element 5: Potential Benefits and


Harms
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Introduction
Every protocol should provide sufficient information to allow assessment of whether there is
a reasonable balance of benefit and risk. The evolving safety profile should have been
provided and the monitoring and protections for participants  should have been described. The
ethical discussion should focus on the potential risks and benefits that have ethical
implications. CIOMS 2002 indicates that interventions that may provide benefit should be at
least as advantageous as available alternatives. If there is no direct benefit to the individual, the
risks must be reasonable and should be balanced by the benefit to society and the knowledge
to be gained.
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Essential Element 5: Potential Benefits and


Harms  What are the risks to human research
participants that are beyond minimal
risk or that require specific attention?
38% complete
 What steps have been taken to
minimize or to mitigate risks?
Points to Consider  What risks will immediate others or
the community be exposed to from the
conduct of the research, if any?
 What benefits accrue to the research
participants, if any? If there will be no
benefits, what justifies asking the
potential subjects to participate?
 What benefits will the community
receive from the conduct of the
research, if any?

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Risks
Risks inherent to the experimental drug or therapy:

 Safety profile: In every research study in which participants receive an experimental


drug, there is a potential for harm that the participants  would not face outside the study.
If the safety profile is well described for the dose and regimen, there may not be
particular ethical issues that need to be brought up in the ethical section. However,
any special concern and the mitigations planned to deal with the concern should be
acknowledged in the ethics section. Examples would be an unusual pre-clinical finding or
a serious problem seen with other members of the drug class. Adverse events of special
interest should be highlighted. Administration of an experimental therapy to individuals
for the first time such as women, children, the elderly, or a sensitive population such
as poor metabolizers or renal/hepatic impaired should be justified. Even if the drug is
well-tolerated, a new formulation or supratherapeutic dose may need discussion.
Radiation exposure from a radioactively labeled drug needs to be minimal such as no
more than background exposure.  

 Risks to others: In some studies, there may


be risks to health workers, family members, or others in close contact with the
participant.  Examples would be the risks of radiation exposure, any risks associated with
gene transfer studies, or the risks in vaccine studies.
 Risks to vulnerable populations: See Essential Element 4: Choice of Participant
Population

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Risks
Risks from study procedures:  

 The procedures in
many studies will involve only minimal risks such as drawing blood. Taking large
volumes of blood or blood sampling in children will need justification in the protocol and
mention of why this is acceptable in the ethics section. Other procedures may be more
invasive such as tissue biopsies, lumbar punctures, or excessive exposure to multiple x-
rays or CAT scans. These should be appropriate and acceptable.

 Non-physical harm:

 Risks can also involve non-physical harm, such as breach of confidentiality and


privacy, damage to reputation, monetary harm, legal risk, loss of insurance coverage,
emotional stress, genetics issues such as paternity, and discrimination. Information might
be published that could stigmatize a group or expose its members to discrimination. For
example, the information gained from a study could indicate, rightly or wrongly, that the
group has a higher than average prevalence of alcoholism, mental illness or sexually
transmitted disease, or is particularly susceptible to certain genetic disorders.  There
may be risks to family members from knowledge gained in genetics studies.

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Benefits
Potential benefits to the individual participant:

 Ethically, considerations for the well-being of the participants should take precedence


over the interests of science and society (CIOMS 2002, Declaration of Helsinki 2000,
para 5). If there is lack of potential benefit, this should be stated. Benefits
to participants might include positive response to the study intervention (both
products and procedures), additional medical care and oversight, possibility of life-
style modifications (e.g., programs for diabetes or obesity), coverage of costs of
additional medical care, payment for participation, or post-study continued access
to study interventions.

Potential benefits to others including the community and society:

Knowledge: The knowledge that results from a study and the application of that


knowledge may benefit society. The kinds of knowledge may be the resolution of a safety
issue or the proof that a new mechanism of action is relevant in a hard-to-treat disease. In
spite of societal benefit, there may be some risks to the individual that are too great to support
conducting the study, so how the balance is achieved is properly discussed in the ethical section. 

Community building: Community benefit might include capacity building for local


sites, increased medical and scientific capabilities and training of local investigators and
study staff, or brick and mortar facilities such as clinics or laboratory equipment.

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Summary
 Every protocol should provide sufficient information to allow assessment of whether there is a
reasonable balance of benefit and risk, and the ethical discussion should focus on the potential
risks and benefits that have ethical implications.
 If there is no direct benefit to the individual participant, the risks must be reasonable and should be
balanced by the benefit to society and the knowledge to be gained.

 If participants receive an experimental drug, the safety protocol should describe dose and regimen,
special concerns and mitigations planned; adverse events of special interest should be highlighted,
and administration of experimental therapy to women, children, the elderly, or a sensitive
population should be justified.
 Risks to health workers, family members, or others in close contact with the participant should be
addressed, if relevant. Risks from study procedures such as drawing blood, biopsies, or multiple x-
rays should be appropriate and acceptable. Risks can also include non-physical harm such as
stigmatization or discrimination or a risk to family members from knowledge gained in genetics
studies.
 Potential benefits to participants may include: positive response to study intervention, additional
medical care and oversight, possibility of life-style modifications, coverage of costs of additional
medical care, payment for participation, continued access to study interventions.
 Potential benefits to community and society may include: Knowledge that may contribute to the
resolution of a safety issue to hard-to-treat disease, capacity building for local sites, increased
medical and scientific capabilities, training of local investigators, and facilities such as clinics or
laboratory equipment.
 Above all, considerations for the well-being of the participant should take precedence of the
interest of science or society.

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Essential Element 5: Quiz


RESULTS RETAKE
Essential Element 5: Quiz
Please do not start this quiz unless you have taken all the quizzes for the previous
modules -- you will not be able to get your certificate unless you take the quizzes in
order

Results
Score for this question group: 100%

1. If a proposed study has no direct benefit to the individual study participant:


o The study should not be conducted.
o The risks must be reasonable and balanced by the benefit to society and the
knowledge to be gained. Your correct answer
o 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.
o True
o False Your correct answer
3. Potential benefits to individual study participants may include: (Check all that apply.)
o Medical care at higher costs
o More frequent monitoring of participants’ disease or condition Your correct
answer
o Positive response to study intervention Your correct answer
o Possibility of life-style modifications Your correct answer

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