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Essential Element 10: Payment for

Participation
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Contents
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1. Contents
2. Introduction
3. Payment for Participation- Examples
4. Payment for Participation - Points to Consider
5. Summary
6. Finished - Payment for Participation

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The name that will appear on your certificate is Melodia Gandeza.

Essential Element 10: Payment for

Participation
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Introduction
The ethical implications of providing any direct compensation to a participant in a clinical trial
should be addressed in every protocol. Participants should be reimbursed for any expenses
associated with participating in a study. This may be especially important for individuals
with limited resources who might need additional support such as replacement for lost
income. Participation should be revenue neutral and costs including lost income should not be
a barrier to inclusion in studies and thus result in underrepresentation of people who might
benefit now or in the future. The ethical discussion begins when there is concern about “undue
inducement.” Although this is touched on in various guidelines such as the “Common Rule”,
or CIOMS (Guideline 7), there is no accepted definition of “undue inducement” and there is
little agreement about the approach to compensation. (Emanuel) 

For example, healthy individuals who will receive no benefit from a clinical trial often receive
compensation beyond expenses. Although this may be acceptable, are people who are poor more
likely to enroll because of the financial reward and thus bear a larger burden of the risks of
early drug development? (Elliot) Does paying participants really influence judgment about
participating or understanding the risks involved? (Grady)
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The name that will appear on your certificate is Melodia Gandeza.

Essential Element 10: Payment for

Participation
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Payment for Participation- Examples

The other essential ethical elements should be addressed and found to be reasonable before
compensation is considered. The circumstances for each study should
be considered individually, but it should be clear in the protocol why the approach to
compensation is considered warranted.

Examples:

 In a Phase 2 trial, participants were required to come to the clinic every two weeks over a 3-month
duration for blood draws. Participants were compensated for transportation and parking for these
visits as well as a $100 gift card to compensate them for the inconvenience of frequent visits.

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The name that will appear on your certificate is Melodia Gandeza.

Essential Element 10: Payment for

Participation
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Payment for Participation - Points to Consider

If applying directly to a protocol please open your Points to Consider Workbook/checklist:

 Is the compensation being offered beyond reimbursement for expenses? What is the
justification?
 Is there reason to be concerned that the decision to participate is overly influenced by the
compensation offered?
  Is the compensation approach adequate to allow participation of groups that might be
underrepresented? Are minor children acknowledged for their participation?

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The name that will appear on your certificate is Melodia Gandeza.

Essential Element 10: Payment for

Participation
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Summary
 Ethical implications of providing any direct compensation to a participant in a clinical trial should
be addressed in every protocol.
 Participation should be well-justified and include reimbursement for expenses associated with
participating in the study and replacement for lost income or inconvenience. It is important to
provide a local context for the compensation provided (timing, inconvenience) as part of the
justification.
 Appropriate compensation must be fair and be at a level that would not prevent a participant from
appropriately weighing risks and benefits of enrolling in a study. This will vary by community and
population.
 There is no accepted definition for “undue inducement.” Considerations when reimbursing healthy
participants beyond expenses include whether poor people bear a larger burden of risk, whether
payment influences judgment about participating and understanding the risk involved.
 After other essential elements are addressed, circumstances for compensation should be considered
individually and it should be clarified in the protocol why the approach to compensation is
considered warranted.

eLearning Courses
The name that will appear on your certificate is Melodia Gandeza.

Essential Element 10: Quiz

RESULTS RETAKE

Essential Element 10: 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. A study in a developing country includes healthy participants. What should be considered when
preparing the protocol? (Check all that apply)
o No payment for participation should be offered.
o Participation should be cost neutral to the participant, including no lost income or
unreimbursed expenses for participation. Your correct answer
o The ethical implications of any direct payments to study participants should be
addressed in the protocol. Your correct answer
o Compensation should be considered first before addressing other essential elements of
the protocol.
o 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
o When study participants receive significant financial compensation (beyond expenses)
when participating in research
o If poorer participants are enrolling in research solely because of the financial benefit.
o If a decision about what would amount to undue inducement in one setting is applied a
very different setting without careful consideration
o All of the above Your correct answer
o None of the above