This document discusses the informed consent process. It begins by explaining that informed consent is a process, not just a form. It then provides an IRB submission flow chart and discusses the rules and guidelines that must be followed for informed consent. The document outlines best practices for authoring informed consent forms, including using plain language and avoiding medical jargon. It discusses informed consent considerations for vulnerable populations like children, prisoners, non-English speakers, and cognitively impaired individuals. The document also covers topics like obtaining consent from legally authorized representatives, waiving or altering elements of informed consent, revoking consent, and responsibilities at the end of a study.

1. Informed Consent Process
Dr. Ghiath
Alahmad

2. Is Informed Consent a Form or a
Process?

3. IRB Submission Flow Chart
Principle
Investigator
Submission
Department
IRB review
IRB Office IRB Meeting Approved
Incomplete:
Put On Hold
Refer to PI
and/or
Medical
Writer
Complete:
Add to
Meeting
Agenda
Modification
Requested:
Back to PI
Missing
Elements
Goes to IRB
Chair or IRB
Meeting
Industrially
Funded: Wait
for
Indemnification
to Clear
APPROVAL
RELEASED TO
PRINCIPLE
INVESTIGATOR
Missing
Elements
Consent
Revision
Needed
Refer PI to
Medical
Writer

4. Need to know!
• Informed Consent is a process - not just a form.
• Informed Consent is necessary to conduct ethical
research.
• Informed Consent is the fundamental mechanism to
ensure respect for persons through provision of
thoughtful consent for a voluntary act.

5. Need to know!
• Informed Consent is government regulated
• The IRB is responsible for ensuring policies are being
followed.
▫ Reviewing of the Informed Consent form, is it…?
 Clear, easy-to-read, accurately reflects the project
▫ Reviewing the process of obtaining Informed Consent
 Who, what, where, when, and how…….

6. What rules do I follow?
National
Regulations
Research
Ethics
Guidelines
Institutional
Policy
Sponsor
Request

7. Authoring the Informed Consent Form

8. Do not do!Do!
 Use complicated terms
 Write above an 8th grade level
 Put or leave unnecessary
information in the form
 Forget “Respect” for subjects
 Write simply
 Use small words
 Include details
 Describe timeframes
 Use standardized language
 Define risks
 Define acronyms
Many (Do`s) & (Don`ts) need to be considered in processing the Informed
Consent.
Conclusion
SCENE
Authoring the Informed Consent Form

9. More Do’s
• See the examples
• Use the glossary
▫ http://irb.ufl.edu/glossary.htm
• Use the standardized text
▫ http://irb.ufl.edu/irb01/forms.htm#standard
Instead of This Use This
Empty words
Along the lines of Like
For the purpose of For
For the reason that Since
Because
On the basis of By
Difficult words
Currently Now
Demonstrate Show
Effectiveness Success
Following After
Indicate Show
Prior to Before
Terminate End

10. Various terms
• Patient Information Sheet
▫ Provides only the information
• Informed Consent Form
▫ Used to document consent
Both integrated in to one document called the
Informed Consent Form

11. Research Consent Document
Consent Document
Consent Discussion

12. Avoid informal speech
Limit medical terminology
Research Consent Document
• Language that is easily understood
• Language must be appropriate to the
population being studied
• Language translators should be qualified
and IRB authorized
Readability
Consider comprehension as well as
readability

13. Research Consent Document

14. • When do you need a witness?
• When presenting the informed consent document
orally
• If required by the IRB
• Who can be the witness?
A person who is independent of the trial, who cannot be
unfairly influenced by people involved in the trial, who
attends the informed consent process…
Research Consent Document

15. Discussion Review Concerns Time Signatures
Informed Consent Process
Discussion between
the physician and
the participant
Review of
information by
research nurse/
coordinator
All questions and
concerns addressed
Allow adequate time
Signature obtained

16. Informed consent must be obtained prior to any
protocol specific testing being conducted.
If protocol specific testing done the same day as
informed consent document signed, must be clear
documentation of the chronological order in the
medical record.
Informed Consent and Screening
Procedures

17. Interview Where?
• Choose a quiet, private, safe place to talk to the
prospective subject
▫ An investigator shall seek such consent only under
circumstances that provide the prospective subject or
the representative sufficient opportunity to consider
whether or not to participate and that minimize the
possibility of coercion or undue influence. The
information that is given to the subject shall be in
language understandable to the subject or
representative.

18. Interview Who?
Who can conduct the Interview to obtain
Informed Consent?
The PI
A sub investigator
A study staff person, listed with the IRB, whom
the investigator has documented is fully aware
with the study and is able to answer subjects
questions.

19. Re - Consenting
Participants must be informed about any new
information that may affect their willingness to
take part in the research.

20. Informed Consent & Vulnerable
Populations
Unable to make free
informed consent
Can be easily forced or have limited
freedom

21. Vulnerable Populations
Children
Prisoners
Non-English
(Arabic) speaking
persons
Pregnant Women
and fetuses
Cognitively
Impaired
Financially
impairedTerminally ill

22. DO NOT enroll prisoners unless you check with the IRB first
Informed Consent & Prisoners
Prisoners, due to the lack of
control of their circumstances
are considered vulnerable
There MUST be a prisoner representative on the IRB if a prisoner is enrolled
If a person becomes a prisoner during a trial, notify the IRB immediately
Must state that risks for prisoner in this study same as for a non-prisoner

23. Informed Consent & Pregnant Women
The purpose of
the study is to
meet the health
needs of the
mother
The father is not
reasonably
available
The pregnancy is
the result of rape

24. Informed Consent & Cognitively Impaired
The signature
of Representative
Cognitive
impairment
mental retardation
dementia
coma
individual’s
Capacity to give
informed consent
Persons with diagnosed
cognitive impairment such as
mental retardation, dementia,
and coma, can participate in
research.
This type of research must
specifically address how an
individual’s capacity to give
informed consent will be
determined.
The signature of a legally
authorized representative will
be required

25. Informed Consent & Cognitively Impaired
Cognitive
Impairment
Regains
ability
Re-consent

26. Informed Consent & Sedated Patients
As a rule, consent should
not be obtained from a
sedated or anesthetized
patient for an elective
procedure—let the sedative
wear off!
If delay is not feasible,
consent should be obtained
from a surrogate.
Anesthetized
patient
Research can`t
be delayed
Surrogate

27. Informed Consent & Non-English Speakers
Get an interpreter!
Witness
Translator’s name should be noted in the medical
record

28. Understandable Language
Non-English speaking subjects may not be excluded
on the basis of language
The IRB requires a translated consent document be
submitted with the original protocol for approval.
It is the investigator’s responsibility to ensure that
the translation is accurate.
Informed Consent & Non-English Speakers

29. A copy of the consent document must be given to each
subject
Verbal translation of the consent document must not be replaced with for a
written translation.
Informed Consent & Non-English Speakers

30. Informed Consent & Special Cases

31. informed consent
process
(on the child’s behalf)
the parent/s or
legal guardian
Participant
under 18 y
Informed Consent Minors

32. Informed Consent Minors
Age >/=18
Subject and Person obtaining
consent sign the IC
Parent/Guardian, witness, and Person
obtaining consent sign the IC
Child Age 7-12 – Verbal Assent Only
Child Age 13-17 – Written Assent Required
Yes
No

33. • Waiving (omitting) or altering some or all the basic
elements of informed consent, including the entire
informed consent process
Waiver of Informed Consent
• Minimal risk
• Rights and welfare of participants protected
• Research not possible without a waiver
• Appropriate information provided

34. Revocation of Consent
• Patient may revoke at any time, either orally or in
writing.
• If revoked during a procedure, the procedure should be
terminated as soon as reasonably possible.

35. Telephone Consent
Telephone consents are acceptable, but they must be well
documented.

36. Informed Consent in a Teaching Situation
1. Have the attending physician and house staff visit the
patient together, prior to the procedure. Clarify the
resident’s role in the procedure to the patient and
his/her family.
2. Spell out the resident’s qualifications to reinforce
patient confidence.

37. 3. Clarify that the attending physician will be present at
all times in a directly supervisory capacity and that
he/she is the responsible doctor.
4. Inform the patient of the identity of personnel in the
operating room.
5. Prepare for some patients to insist on the attending
physician performing the procedure.
Informed Consent in a Teaching Situation

38. End of Study
• The process of informed consent does not end once the
participant signs
• It is the PI’s responsibility to keep the participant
updated on study changes
• IC does not obligate participant to finish the trial

39. • Participant needs to be given a copy of the IC after
signing the form
• At each interaction, the investigator must reassure
▫ Voluntary participation continues
▫ New information is given to the subject
End of Study

40. • Are subjects provided with overall/individual results?
• Do you plan on keeping their contact information for
future studies?
• Do you plan on giving them your contact information for
future problems?
End of Study

41. The Informed Consent Process Finished when the
study is closed and final reports are issued!
End of Study