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