Basics of informed consent part 1
This presentation is the property of its rightful owner.
Sponsored Links
1 / 41

Basics of Informed Consent (Part 1) PowerPoint PPT Presentation


  • 75 Views
  • Uploaded on
  • Presentation posted in: General

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

Download Presentation

Basics of Informed Consent (Part 1)

An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -

Presentation Transcript


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

      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 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


Elements

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

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 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

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


Waivers

Waivers

  • 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


Validate

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

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

    45 CFR 46.116


Informed consent form

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

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

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

The Obvious Problems

Language

Key Concepts, Procedures & Rights

Literacy

Reading level

Health & Research Literacy

Randomization

Placebo

Probabilities

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

    Motives:

    • Coercion by Disease

    • Personal Benefit

      • Restore Health

      • Income & Access

      • Knowledge

    • Relationships

      • Health Care Provider

      • Family & “Community”

    • Altruism


    Motives and meaning

    Motives and Meaning

    Meaning:

    • Mistrust

      • research as a metaphor for past transgressions

    • Stigma

      • diseaseas a metaphor for social disgrace/discrimination/taboo

    • Meaningin suffering


    Contact information

    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


  • Login