Improving Informed

Consent Forms
INTRODUCTI
ON :
One of the main responsibilities of clinical research sites is asking
for permission of subjects participating in a trial, and giving
informing them about all the trial details. This practice is called an
informed consent, and every clinical research site has to have
signed informed consent forms of all participants before starting the
trial.

In this presentation, you'll learn what an informed consent is, the

history and purpose of informed consents, what to include in an
informed consent form, and tips to help you make these forms in a
way that your patients are completely informed about everything.

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Defining Informed Consent

'A formal agreement (consent)

signed by a patient
(participant,subject) as a
permission for participating in a
medical procedure (such as
surgery) or medical experiment
after being informed of all the
details regarding the procedure
(risks, benefits, and similar).'

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Defining Informed Consent

Remember - the consent form is not a legally

binding
You shouldcontract!
think of this form more as a reference than a
contract.

Consent is an ongoing process!

The most important thing to do is communicate openly with
your subjects and make sure they're always satisfied with
the answers you provide.

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 Informed Consent Historical Notes

Important historical moments that led to the

informed consent forms that we have today:

- Belmont Report: Respect for Persons

- Nuremberg Code: 'The voluntary consent
of the human subject is absolutely
essential'

In the past, we have examples of

many research studies that made
the mistake of not asking consent,
or given the wrong/insufficient
information to patients entering a
trial.

- the PHS Syphilis Study

- the Holocaust
- the Willowbrook Study.

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Requirements and Regulations for Informed Consent
U.S. Federal Regulations on
Informed Consent (45 CFR
46.116)
''no investigator may involve a human
being as a subject in research unless
the investigator has obtained the legally
effective informed consent of the
subject''
Requirements for Informed
Consent
(45 CFR 46.116)
- The future subject should enjoy the
opportunity of being able to consider and
decide whether or not to participate in the
study;
- Minimizing of the possibility of undue
influence and coercion;
- Information given to subjects has to be in
an understandable language;
- No language which waives/appears to
waive the legal rights of the subject;
- No language that releases/appears to
release the investigator/sponsor/institution
or its agents from liability for negligence;
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 Elements Included in Informed Consent
(45 CFR 45.116)
Basic (Required) Elements:
- A statement that shows that the study involves
research;
- Research purposes;
- Expected duration time of participating subjects;
- Procedures description (with pointing any
experimental procedures);
- Expected risks or discomforts;
- Benefits to the subject (payment is NOT considered
as a benefit);
- Alternative replacement procedures or treatment
courses (if existent);
- Confidentiality of records;
- For researches with risks greater than minimal
compensation, plus available medical treatments in
case of injuries;
- Contact information for any additional research
questions;
- Contact information for research-related subject
injuries;
- A statement that grants/shows: voluntary
participation, no penalty or loss of any benefits for
patients who refuse to participate, no penalty of loss
of benefits for patients who decide to discontinue;
Additional (Optional) Elements:
- Informing of suspecting unforeseeable risks to the
subject (or subject's embryo or fetus) from a
specific procedure or treatment;
- Anticipated circumstances for the investigator
terminating the participation regardless of the
subject's consent;
- Any additional costs to the subject related to
participation;
- Any consequences that will arise if the subject
decides to discontinue participation;
= Procedures needed for termination of
participation by the subject;
- A statement that shows the willingness to provide
to the subject any new findings developed
during the course of the trial that are related to the
subject's motivation to continue participation;
- The approximate number of subjects in the study;
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 Readability of Consent Forms

- 12% of Americans are

proficient in health literacy;

- 53% of Americans have

''Health literacy represents the
degree to which a person has
the capacity to obtain, process,
and understand basic health-
related information needed to
make informed health
decisions.''
intermediate skills;
- 35% of the whole population
cannot interpret a prescription
label;
- 50% of Americans cannot read
at the level of an 8th grader;

These numbers and statistics

(according to the U.S. Department of
Health and Human Services) show us
the importance of readability of
consent forms.

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 Readability of Consent Forms

Know your targeted Make the form more Good organization of Get feedback from
subject population! readable! the consent form! different sources!
- Age; - Adjust the content for the - Place the most - Built-in readability
older population; important information statistics in word
- Gender/Sex; (the 'must-knows') in processors;
- Replace large and the front, so that you're
complicated words with sure that the subjects - Ask for feedback from
- Culture (race, remember it;
smaller ones; fellow colleagues and
ethnicity,
researchers;
geographic - Provide a place for quick
location); - Minimize the use of
acronyms; summary and facts - Ask a linguist;
about the research;
- Economic status;
- Use pictures as a helping - Focus groups to read the
tool for illustrating concepts; - Key areas to point out: consent form and give
- Level of education; why is the research you feedback and
being done, what are opinions;
- If possible, simplify words
- Occupation; you doing exactly (in
(utilize use, to determine
practice), risks, benefits;
to see...); - Take notes of unknown
words;
- Use visual aids to help with
the understanding of - Take notes of
procedures; misunderstood ares
from your text (content);
- Provide videos explaining
the procedures/treatments;
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 Consent Forms vs Actual Consent

Include not only the

subject, but also the
caregivers or people
Decide your most who've come to support
important talking points the participant (spouse,
and elaborate your family members, etc.).
answers.

If possible, encourage
the future participant to
take the consent form
Figure out the most home in order to have
frequently asked more time to think and
questions (FAQs) and the decide if he wants to join
answers to these. the study.

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 Conclusion

Informed consent is the most vital and crucial part of conducting a human subject
research in an ethical and humane way. The consent form as a document is a key
element in every ethical procedure, as well as obligatory in compliance with federal
regulations.

Consent is much more than a document. Informed consent is a process that will serve
as a tool for maximum patient understanding.

Take into consideration your targeted subject population and adjust the content
according to your subjects' level of health-literacy. Having in mind that most people
aren't health-literate, your consent form should almost always be simplified.

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