Basics of Informed Consent (Part 1)
Paula Bistak, DMH, RN, MS, CIP, CHRC
Executive Director, HSPP
Donna Hoagland, LPN, BS, CIP, CCRC, CHRC
IRB Director, New Brunswick/Piscataway and Stratford/Camden
Carlotta Rodriguez, BS, CIP, CHRC
IRB Director, Newark Campus IRB
Cheryl Forst, RN, BSN, CCRP
HSPP Analyst Director
Christine Asmann-Finch, DMH, MS
Program Development Specialist/Medical Humanist
Session Overview
Introduction
– Ethical Principles
– Regulations
– Consent as a Process
 Specifics
– Required Elements
– Documentation
– Waivers
 Common Findings
 Subject Perspectives

Informed Consent

Basic Ethical Principles for the Protection
of Human Subjects in Research
– Belmont Report
 Established in 1979 by the National Commission
for the Protection of Human Subjects of Biomedical
and Behavioral Research
 Ethical Principles and Guidelines for the Protection
of Human Subjects in Research
 Respect for Persons
 Beneficence
 Justice
Informed Consent

Respect for Persons
– “Informed consent for persons requires that subjects,
to the degree that they are capable, be given the
opportunity to choose what shall or shall not happen
to them. This opportunity is provided when adequate
standards for informed consent are satisfied”.
* Ethical and Regulatory Aspects of Clinical Research
Respect for Persons

Application through Informed Consent
– Information
– Comprehension
– Voluntariness
Informed Consent

Informed consent results
– when a full disclosure of the role, benefits,
risks, choices, and outcomes are explained in
understandable ways.

Voluntary informed consent cannot be
realized until
– differentials of power, class, economics,
desperation, and other possible sources of
coercion are considered and addressed.
Legally Effective Informed Consent
 Consent by
 Research Subject
or
 Research Subject’s Legally Authorized
Representative for Research (LAR) under State
Law
 State of New Jersey
– Access to Medical Research Act
Legally Effective Informed Consent
– No coercion or undue influence (recruitment)
– Obtained by Investigator/Staff trained and
authorized by IRB
– Language understandable to the subject
 Use lowest level vocabulary and syntax
 Avoid jargon
– No exculpatory language
– Contains required elements
– If applicable - Six additional elements
General Requirements for
informed consent
45 CFR 46.116 Common Rule
21 CFR 50. 25 FDA
ICH E-6 Section 4.8.10 (GCP)
Informed Consent
Informed consent is a process,
not just a signed document.
Informed Consent Process

The process should:
– Provide adequate information
 generally, what a reasonable person would want to
know before making a decision
– Confirm the participants comprehend the
information
– Assure consent is given voluntarily
Elements
Statement that the activity is research
 Purpose of the study
 Description of the study procedures
(identifying those that are experimental)
 Duration of subject involvement

Elements (continued)
Potential risks and discomforts of
participation
 Potential benefits of participation (to the
subject and others)
 Alternatives (if any)
 Confidentiality of records description
 Number of subjects (if it may have an
impact on the decision)

Elements (continued)
Compensation for injury statement (for
greater than minimal risk studies)
 Statement of voluntary participation
 Contact person for questions

– About research
– About rights
– About injury
Required Elements
If the study is a clinical trial, the
following must be included:
"A description of this clinical trial will be available
on ClinicalTrials.gov, as required by U.S. Law. This
Web site will not include information that can
identify you. At most, the Web site will include a
summary of the results. You can search this
website at any time."
Additional Elements
– Statement that there may be risks which are
unforeseeable
– Under what circumstances investigator could
terminate subject’s participation (include plan
to exit subjects)
– Additional costs to subject
Additional Elements (cont.)
– Consequences of subjects withdrawal from
research (include plan to exit subjects)
– Statement that will be told of new findings
– Approx. number of subjects in study
Documentation of informed consent
(46.117)

…informed consent shall be documented
by the use of a written consent form
approved by the IRB and signed by the
subject or the subject’s legally authorized
representative. A copy shall be given to
the person signing the form
Waivers
Waiver of Informed Consent
 Waiver of the Requirement to Obtain
Documentation of Consent

– no signature
Waiver or Alteration of Informed
Consent
The research involves no more than
minimal risk to the subjects;
 The waiver or alteration will not adversely
affect the rights and welfare of the
subjects;
 The research could not practicably be
carried out without the waiver or
alteration; and

Waiver or Alteration (continued)

Whenever appropriate, the subjects will be
provided with additional pertinent
information after participation
Waiver of Documentation
The only record linking the subject and the
research would be the consent document and
the principal risk would be potential harm
resulting from a breach of confidentiality.
 The research presents no more than minimal
risk of harm to subjects and involves no
procedure for which written consent is normally
required outside of the research context.

Waiver of Documentation
(continued)
In cases in which the documentation
requirement is waived, the IRB may
require the investigator to provide
subjects with a written statement
regarding the research.
Passive Consent

Federal regulations do not support the
concept of passive consent. There is no
such thing as passive consent from the
regulatory standpoint.
Informed Consent Process

Process can vary but should generally include:
– Research team member provides the informed
consent document for the participant to read
– A member of the study team explains the study to the
participant
– The participant is given an opportunity to ask
questions
– The participant is given the opportunity to review the
consent document with family and consider
participating
– Participant is given a copy of the signed consent
document
Informed Consent Process

Process:
– Ongoing
 Researcher should determine the subjects
willingness to continue throughout the trial
 Participation is voluntary
– Subject can refuse to continue
– Subject can withdraw at any time
Informed Consent Audit
Privacy & Confidentiality :
Location matches IRB approved protocol
 Confidentiality maintained
 Limited Access – Electronic enrollment
 Original consent form locked in separate location
from other study data

Validate
Source Documents :





Consent forms equal number of subjects
Confirmed as signed prior to the start of
activities
Appropriately Executed (Signatures & dates)
Study personnel who are obtaining consent are
named on the IRB approved protocol.
Content of executed consents corresponds to
IRB approved versions(current IRB stamp).
Consent Process
Documentation:






Mirrors the description in IRB approved protocol
Truly represents the consent process
Subject questions answered
Given time to voluntarily decide to participate
Copy of the consent form given to subject
Auditors may visit to observe the process
45CFR 46.117
Informed Consent Form
ICF:
 Contain all required elements
 In language understandable to the study
subject.
 Study activity represents what the subject has
been informed( recruitment, study visits ,
procedures, risks, benefits, payment for
participation ect…)
Top 10 Consent Audit Findings
10. Subject signature and person obtaining consent on different dates
9.
8.
7.
6.
5.
4.
3.
2.
1.
Subject consented with wrong version of consent/expired consent
Subject consented by individual not named on the IRB protocol
Check boxes within consent incomplete (future use of samples)
Crossed out or white out anywhere on the consent document
Unable to locate consent(s) for subject(s) on study
Subjects not re-consented with revised consent
Ineligible subjects enrolled
Wrong contact telephone number listed in consent
Copy of the consent document NOT provided to the subject
Strive for the BEST Informed Consent





It starts with you !
It is the first instructional piece of information
provided to the subject
Should be clearly written and presented to
promote decision making
Understand that each interaction is
different(circumstances, questions,
communication style)
Take it serious and fully inform & document !
CONSENT TO PARTICIPATION
IN CLINICAL TRIALS
FROM A SUBJECT’S POINT OF VIEW
•CONTENT
– What terms and ways of writing are difficult to
comprehend?
•CONTEXT
– What does participation mean in the context of
a person’s life?
The Obvious Problems

Language
 Key Concepts, Procedures & Rights

Literacy
 Reading level

Health & Research Literacy
 Randomization
 Placebo
 Probabilities
 HIPAA Authorization
Confusing Terms/Phrases

“Experiment”, “research”, “new treatment”, “study”, “investigation”

“We are experimenting with this drug to determine if it will lengthen
time to disease progression.”

“Some ‘side effects’ of the experimental drug are…”

“We would like to keep track of your medical condition for x years.”

“You can withdraw from the clinical trial at any time.”

Active v Passive verbs: “Improving the Treatment of Disease X with
Drug Y” v “Drug Y in the Treatment of Disease X”
Listener Harm
Fortune
Telling
 “Ninety-five percent of the people diagnosed with this cancer
will not be alive 5 years later.”
Point
of View Phrases
 “Some ‘side effects’ of the experimental drug are…”
 We would like permission to store your ‘left-over’ tissue.”
 “You will be randomized to an arm of the trial, like a ‘flip of a
coin’.”
 “We are researching ways to improve our procedures
because patients like you are usually not compliant with our
instructions (or you are difficult to work with).”
Listener Harm

Metaphors
 War – “The experimental drug will fight the invasive cells and
try to kill/destroy them.”
 Kitchen – “Think of your intestines as a bowl of spaghetti.
Through our surgery we will strain and cut…”
 Container – “You will be randomized to an arm of the trial…”

Other
 Curb your enthusiasm – “Plastic is ubiquitous in our homes.
Exposure to the chemicals in plastic may be harmful to you
and your children. We would like to measure your newborn’s
exposure to plastic while in the hospital and see if there are
any correlations with markers in the blood.”
What Subjects Would Like or Would Like to
Know






Permission
Knowledge (about self, others, disease)
Research results
Out-of-Pocket Costs for treatments, tests,
transportation & incidentals
Accurate estimation of time commitment to
participate (including office wait-time)
Who will pay if I am injured as a result of
participation (please make me/my family whole)
Motives and Meaning of Participation in
Clinical Research
Motives:


Coercion by Disease
Personal Benefit
– Restore Health
– Income & Access
– Knowledge

Relationships
– Health Care Provider
– Family & “Community”

Altruism
Motives and Meaning
Meaning:

Mistrust
– research as a metaphor for past transgressions

Stigma
– disease as a metaphor for social disgrace/discrimination/taboo

Meaning in suffering
Contact Information
http://www.umdnj.edu/hsp
 HSPP – (973) 972-1149
 New Brunswick IRB (732) 235-9806
 Newark IRB – (973) 972-3608
 Stratford IRB – (856) 566-7196
