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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

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Basics of informed consent part 1
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
Session Overview

  • Introduction

    • Ethical Principles

    • Regulations

    • Consent as a Process

  • Specifics

    • Required Elements

    • Documentation

    • Waivers

  • Common Findings

  • Subject Perspectives

Informed consent
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 consent1
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
Respect for Persons

  • Application through Informed Consent

    • Information

    • Comprehension

    • Voluntariness

Informed consent2
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
Legally Effective Informed Consent

  • Consent by

    • Research Subject


    • Research Subject’s Legally Authorized Representative for Research (LAR) under State Law

    • State of New Jersey

      • Access to Medical Research Act

Legally effective informed consent1
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
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 consent3
Informed Consent

Informed consent is a process, not just a signed document.

Informed consent process
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


  • 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
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 continued1
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
Required Elements

If the study is a clinical trial, the following must be included:

"A description of this clinical trial will be available on, 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
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
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
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


  • Waiver of Informed Consent

  • Waiver of the Requirement to Obtain Documentation of Consent

    • no signature

Waiver or alteration of informed consent
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
Waiver or Alteration (continued)

  • Whenever appropriate, the subjects will be provided with additional pertinent information after participation

Waiver of documentation
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
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
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 process1
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 process2
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
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


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
Consent Process


  • 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

    45 CFR 46.116

Informed consent form
Informed Consent Form


  • 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
Top 10 Consent Audit Findings

10. Subject signature and person obtaining consent on different dates

9. Subject consented with wrong version of consent/expired consent

8. Subject consented by individual not named on the IRB protocol

7. Check boxes within consent incomplete (future use of samples)

6. Crossed out or white out anywhere on the consent document

5. Unable to locate consent(s) for subject(s) on study

4. Subjects not re-consented with revised consent

3. Ineligible subjects enrolled

2. Wrong contact telephone number listed in consent

1. Copy of the consent document NOT provided to the subject

Strive for the best informed consent
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



What terms and ways of writing are difficult to comprehend?


What does participation mean in the context of a person’s life?

The obvious problems
The Obvious Problems


Key Concepts, Procedures & Rights


Reading level

Health & Research Literacy




HIPAA Authorization

Confusing terms phrases
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
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 harm1
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
    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 and Meaning of Participation in Clinical Research


    • Coercion by Disease

    • Personal Benefit

      • Restore Health

      • Income & Access

      • Knowledge

    • Relationships

      • Health Care Provider

      • Family & “Community”

    • Altruism

    Motives and meaning
    Motives and Meaning


    • Mistrust

      • research as a metaphor for past transgressions

    • Stigma

      • diseaseas a metaphor for social disgrace/discrimination/taboo

    • Meaningin suffering

    Contact information
    Contact Information


    • HSPP – (973) 972-1149

    • New Brunswick IRB (732) 235-9806

    • Newark IRB – (973) 972-3608

    • Stratford IRB – (856) 566-7196