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Informed consent process
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Informed Consent Process
Dr. Ghiath Alahmad
Is Informed Consent a Form or a Process?
IRB Submission Flow ChartPrinciple
Investigator
Submission
Department IRB review
IRB OfficeIRB
MeetingApproved
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 INVESTIGATO
R
Missing Elements
Consent Revision Needed
Refer PI to Medical Writer
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.
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…….
What rules do I follow?
National Regulation
s
Research Ethics
Guidelines
Institutional Policy
Sponsor Request
Authoring the Informed Consent Form
Do not do!Do not do!Do!Do!
Use complicated terms Write above an 8th grade level Put or leave unnecessary
information in the form Forget “Respect” for subjects
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
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.
Con
clu
sion
Con
clu
sion
SCENE
Authoring the Informed Consent Form
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 SinceBecause
On the basis of By
Difficult words
Currently Now
Demonstrate Show
Effectiveness Success
Following After
Indicate Show
Prior to Before
Terminate End
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
Research Consent Document
Consent Document
Consent Discussion
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
Research Consent Document
INFORMED CONSENT
(FINAL VERSION)
IRB
PI Sponsor
• 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
Discussion Review Concerns Time Signatures
Informed Consent ProcessDiscussion between the physician and the participant
Review of information by research nurse/ coordinator
All questions and concerns addressed
Allow adequate time
Signature obtained
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
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.
Interview Who?Who can conduct the Interview to obtain
Informed Consent?The PIA sub investigatorA 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.
Re - Consenting
Participants must be informed about any new information that may affect their willingness to take part in the research.
Informed Consent & Vulnerable Populations
Unable to make free informed consent
Addi
tiona
l saf
egua
rds
in th
e re
sear
ch
info
rmed
con
sent
pro
cess
Can be easily forced or have limited freedom
Vulnerable Populations
Children
Prisoners
Non-English (Arabic) speaking persons
Pregnant Women and
fetuses
Cognitively Impaired
Financially
impairedTerminally
ill
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
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
Informed Consent & Cognitively Impaired
The signatureof
Representative
Cognitive impairment mental retardation
dementiacoma
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
Informed Consent & Cognitively Impaired
Cognitive Impairme
nt
Regains ability
Re-consent
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
Informed Consent & Non-English Speakers
Get an interpreter!
Witness
Translator’s name should be noted in the medical record
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
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
Informed Consent & Special Cases
informed consent process (on the child’s behalf)
the parent/s or legal guardian
Participant under 18 y
Informed Consent Minors
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
YesNo
• 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
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.
Telephone Consent
Telephone consents are acceptable, but they must be well documented.
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.
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
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
• 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
• 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
The Informed Consent Process Finished when the study is closed and final reports
are issued!
End of Study