basics of informed consent (part 1) paula bistak, dmh, rn, ms, cip, chrc executive director, hspp...

Basics of Informed Consent (Part Basics of Informed Consent (Part 1)1)

Paula Bistak, DMH, RN, MS, CIP, CHRCPaula Bistak, DMH, RN, MS, CIP, CHRC

Executive Director, HSPPExecutive Director, HSPP

Donna Hoagland, LPN, BS, CIP, CCRC, CHRCDonna Hoagland, LPN, BS, CIP, CCRC, CHRC

IRB Director, New Brunswick/Piscataway and Stratford/CamdenIRB Director, New Brunswick/Piscataway and Stratford/Camden

Carlotta Rodriguez, BS, CIP, CHRCCarlotta Rodriguez, BS, CIP, CHRC

IRB Director, Newark Campus IRBIRB Director, Newark Campus IRB

Cheryl Forst, RN, BSN, CCRPCheryl Forst, RN, BSN, CCRPHSPP Analyst Director

Christine Asmann-Finch, DMH, MSChristine Asmann-Finch, DMH, MS

Program Development Specialist/Medical Humanist

Session OverviewSession Overview

IntroductionIntroduction– Ethical PrinciplesEthical Principles– RegulationsRegulations– Consent as a ProcessConsent as a Process

SpecificsSpecifics– Required ElementsRequired Elements– DocumentationDocumentation– WaiversWaivers

Common FindingsCommon Findings Subject PerspectivesSubject Perspectives

Informed ConsentInformed Consent

Basic Ethical Principles for the Basic Ethical Principles for the Protection of Human Subjects in Protection of Human Subjects in ResearchResearch– Belmont ReportBelmont Report

Established in 1979 by the National Commission Established in 1979 by the National Commission for the Protection of Human Subjects of for the Protection of Human Subjects of Biomedical and Behavioral Research Biomedical and Behavioral Research

Ethical Principles and Guidelines for the Ethical Principles and Guidelines for the Protection of Human Subjects in ResearchProtection of Human Subjects in Research

Respect for PersonsRespect for Persons BeneficenceBeneficence JusticeJustice


Respect for PersonsRespect for Persons

– ““Informed consent for persons requires that Informed consent for persons requires that subjects, to the degree that they are capable, subjects, to the degree that they are capable, be given the opportunity to choose what shall be given the opportunity to choose what shall or shall not happen to them. This opportunity or shall not happen to them. This opportunity is provided when adequate standards for is provided when adequate standards for informed consent are satisfied”. informed consent are satisfied”.

* Ethical and Regulatory Aspects of Clinical * Ethical and Regulatory Aspects of Clinical ResearchResearch

Respect for PersonsRespect for Persons

Application through Informed Application through Informed ConsentConsent– InformationInformation– ComprehensionComprehension– VoluntarinessVoluntariness


Informed consent resultsInformed consent results– when a full disclosure of the role, benefits, when a full disclosure of the role, benefits,

risks, choices, and outcomes are risks, choices, and outcomes are explained in understandable ways.explained in understandable ways.

Voluntary informed consent cannot be Voluntary informed consent cannot be realized untilrealized until– differentials of power, class, economics, differentials of power, class, economics,

desperation, and other possible sources of desperation, and other possible sources of coercion are considered and addressed.coercion are considered and addressed.

Legally Effective Informed Legally Effective Informed Consent Consent

Consent by Consent by Research Subject Research Subject

oror

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

State of New Jersey State of New Jersey – Access to Medical Research ActAccess to Medical Research Act

Legally Effective Informed Legally Effective Informed ConsentConsent

– No coercion or undue influence No coercion or undue influence (recruitment)(recruitment)

– Obtained by Investigator/Staff trained and Obtained by Investigator/Staff trained and authorized by IRBauthorized by IRB

– Language understandable to the subject Language understandable to the subject Use lowest level vocabulary and syntaxUse lowest level vocabulary and syntax Avoid jargonAvoid jargon

– No exculpatory languageNo exculpatory language– Contains required elementsContains required elements– If applicable - Six additional elementsIf applicable - Six additional elements

General Requirements for General Requirements for informed consentinformed consent

45 CFR 46.116 Common Rule45 CFR 46.116 Common Rule

21 CFR 50. 25 FDA21 CFR 50. 25 FDA

ICH E-6 Section 4.8.10 (GCP)ICH E-6 Section 4.8.10 (GCP)


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

Informed Consent ProcessInformed Consent Process

The process should:The process should:– Provide adequate informationProvide adequate information

generally, what a reasonable person would generally, what a reasonable person would want to know before making a decisionwant to know before making a decision

– Confirm the participants comprehend Confirm the participants comprehend the informationthe information

– Assure consent is given voluntarilyAssure consent is given voluntarily

Elements Elements

Statement that the activity is Statement that the activity is researchresearch

Purpose of the studyPurpose of the study Description of the study procedures Description of the study procedures

(identifying those that are (identifying those that are experimental)experimental)

Duration of subject involvementDuration of subject involvement

Elements (continued)Elements (continued)

Potential risks and discomforts of Potential risks and discomforts of participation participation

Potential benefits of participation (to Potential benefits of participation (to the subject and others)the subject and others)

Alternatives (if any)Alternatives (if any) Confidentiality of records description Confidentiality of records description Number of subjects (if it may have an Number of subjects (if it may have an

impact on the decision)impact on the decision)

Elements (continued)Elements (continued)

Compensation for injury statement Compensation for injury statement (for greater than minimal risk (for greater than minimal risk studies)studies)

Statement of voluntary participationStatement of voluntary participation Contact person for questionsContact person for questions

– About researchAbout research– About rightsAbout rights– About injury About injury

Required ElementsRequired 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 ElementsAdditional Elements

– Statement that there may be risks which Statement that there may be risks which are unforeseeableare unforeseeable

– Under what circumstances investigator Under what circumstances investigator could terminate subject’s participation could terminate subject’s participation (include plan to exit subjects)(include plan to exit subjects)

– Additional costs to subjectAdditional costs to subject

Additional Elements (cont.)Additional Elements (cont.)

– Consequences of subjects withdrawal Consequences of subjects withdrawal from from research (include plan to exit research (include plan to exit subjects)subjects)

– Statement that will be told of new Statement that will be told of new findingsfindings

– Approx. number of subjects in studyApprox. number of subjects in study

Documentation of informed Documentation of informed consent (46.117)consent (46.117)

……informed consent shall be informed consent shall be documented by the use of a written documented by the use of a written consent form approved by the IRB consent form approved by the IRB and signed by the subject or the and signed by the subject or the subject’s legally authorized subject’s legally authorized representative. A copy shall be representative. A copy shall be given to the person signing the formgiven to the person signing the form

WaiversWaivers

Waiver of Informed ConsentWaiver of Informed Consent Waiver of the Requirement to Obtain Waiver of the Requirement to Obtain

Documentation of Consent Documentation of Consent – no signatureno signature

Waiver or Alteration of Waiver or Alteration of Informed ConsentInformed Consent

The research involves no more than The research involves no more than minimal risk to the subjects;minimal risk to the subjects;

The waiver or alteration will not The waiver or alteration will not adversely affect the rights and adversely affect the rights and welfare of the subjects;welfare of the subjects;

The research could not practicably The research could not practicably be carried out without the waiver or be carried out without the waiver or alteration; andalteration; and

Waiver or Alteration Waiver or Alteration (continued)(continued)

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

Waiver of DocumentationWaiver of Documentation

The only record linking the subject and the The only record linking the subject and the research would be the consent document research would be the consent document and the principal risk would be potential and the principal risk would be potential harm resulting from a breach of harm resulting from a breach of confidentiality.confidentiality.

The research presents no more than The research presents no more than minimal risk of harm to subjects and minimal risk of harm to subjects and involves no procedure for which written involves no procedure for which written consent is normally required outside of the consent is normally required outside of the research context.research context.

Waiver of Documentation Waiver of Documentation (continued)(continued)

In cases in which the documentation In cases in which the documentation requirement is waived, the IRB may requirement is waived, the IRB may require the investigator to provide require the investigator to provide subjects with a written statement subjects with a written statement regarding the research.regarding the research.

Passive ConsentPassive Consent

Federal regulations do not support Federal regulations do not support the concept of passive consent. the concept of passive consent. There is no such thing as passive There is no such thing as passive consent from the regulatory consent from the regulatory standpoint.standpoint.


Process can vary but should generally Process can vary but should generally include:include:– Research team member provides the informed Research team member provides the informed

consent document for the participant to readconsent document for the participant to read– A member of the study team explains the study to A member of the study team explains the study to

the participant the participant – The participant is given an opportunity to ask The participant is given an opportunity to ask

questionsquestions– The participant is given the opportunity to review The participant is given the opportunity to review

the consent document with family and consider the consent document with family and consider participating participating

– Participant is given a copy of the signed consent Participant is given a copy of the signed consent documentdocument


Process:Process:– OngoingOngoing

Researcher should determine the subjects Researcher should determine the subjects willingness to continue throughout the trialwillingness to continue throughout the trial

Participation is voluntaryParticipation is voluntary– Subject can refuse to continueSubject can refuse to continue– Subject can withdraw at any timeSubject can withdraw at any time

Informed Consent AuditInformed Consent Audit

Privacy & Confidentiality :Privacy & Confidentiality :Location matches IRB approved protocolLocation matches IRB approved protocolConfidentiality maintained Confidentiality maintained Limited Access – Electronic enrollment Limited Access – Electronic enrollment Original consent form locked in separate Original consent form locked in separate location from other study datalocation from other study data

ValidateValidate

Source Documents :Source Documents :Consent forms equal number of subjectsConsent forms equal number of subjectsConfirmed as signed prior to the start of Confirmed as signed prior to the start of activitiesactivitiesAppropriately Executed (Signatures & dates)Appropriately Executed (Signatures & dates)Study personnel who are obtaining consent Study personnel who are obtaining consent are named on the IRB approved protocol.are named on the IRB approved protocol.Content of executed consents corresponds to Content of executed consents corresponds to IRB approved versions(current IRB stamp).IRB approved versions(current IRB stamp).

Consent ProcessConsent Process

Documentation:Documentation:Mirrors the description in IRB approved protocolMirrors the description in IRB approved protocolTruly represents the consent processTruly represents the consent processSubject questions answeredSubject questions answeredGiven time to voluntarily decide to participateGiven time to voluntarily decide to participateCopy of the consent form given to subjectCopy of the consent form given to subjectAuditors may visit to observe the process Auditors may visit to observe the process

45CFR 46.11745CFR 46.117

45 CFR 46.11645 CFR 46.116

Informed Consent FormInformed Consent Form

ICF:ICF:Contain all required elementsContain all required elementsIn language understandable to the study In language understandable to the study subject.subject. Study activity represents what the subject Study activity represents what the subject has been informed( recruitment, study has been informed( recruitment, study visits , procedures, risks, benefits, payment visits , procedures, risks, benefits, payment for participation ect…)for participation ect…)

Top 10 Consent Audit Top 10 Consent Audit Findings Findings

10. Subject signature and person obtaining consent on different 10. Subject signature and person obtaining consent on different datesdates

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

8. Subject consented by individual not named on the IRB protocol8. Subject consented by individual not named on the IRB protocol

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

6. Crossed out or white out anywhere on the consent document6. Crossed out or white out anywhere on the consent document

5. Unable to locate consent(s) for subject(s) on study5. Unable to locate consent(s) for subject(s) on study

4. Subjects not re-consented with revised consent 4. Subjects not re-consented with revised consent

3. Ineligible subjects enrolled3. Ineligible subjects enrolled

2. Wrong contact telephone number listed in consent2. Wrong contact telephone number listed in consent

1. Copy of the consent document NOT provided to the subject1. Copy of the consent document NOT provided to the subject

Strive for the BEST Informed Strive for the BEST Informed ConsentConsent

It starts with you !It starts with you ! It is the first instructional piece of It is the first instructional piece of

information provided to the subjectinformation provided to the subject Should be clearly written and presented to Should be clearly written and presented to

promote decision making promote decision making Understand that each interaction is Understand that each interaction is

different(circumstances, questions, different(circumstances, questions, communication style)communication style)

Take it serious and fully inform & document Take it serious and fully inform & document !!

CONSENT TO PARTICIPATION CONSENT TO PARTICIPATION IN CLINICAL TRIALS IN CLINICAL TRIALS

FROM A SUBJECT’S POINT OF VIEWFROM A SUBJECT’S POINT OF VIEW

•CONTENTCONTENT– What terms and ways of writing are What terms and ways of writing are

difficult to comprehend?difficult to comprehend?

•CONTEXTCONTEXT – What does participation mean in the What does participation mean in the

context of a person’s life? context of a person’s life?

The Obvious ProblemsThe Obvious Problems

LanguageLanguage Key Concepts, Procedures & RightsKey Concepts, Procedures & Rights

LiteracyLiteracy Reading levelReading level

Health & Research LiteracyHealth & Research Literacy RandomizationRandomization PlaceboPlacebo ProbabilitiesProbabilities HIPAA AuthorizationHIPAA Authorization

Confusing Terms/PhrasesConfusing Terms/Phrases ““Experiment”, “research”, “new treatment”, “study”, Experiment”, “research”, “new treatment”, “study”,

“investigation”“investigation”

““We are experimenting with this drug to determine if it will We are experimenting with this drug to determine if it will lengthen time to disease progression.”lengthen time to disease progression.”

““Some ‘side effects’ of the experimental drug are…”Some ‘side effects’ of the experimental drug are…”

““We would like to keep track of your medical condition for x We would like to keep track of your medical condition for x years.”years.”

““You can withdraw from the clinical trial at any time.”You can withdraw from the clinical trial at any time.”

Active v Passive verbs: “Improving the Treatment of Disease Active v Passive verbs: “Improving the Treatment of Disease X with Drug Y” v “Drug Y in the Treatment of Disease X” X with Drug Y” v “Drug Y in the Treatment of Disease X”

Listener HarmListener HarmFortune Telling Fortune Telling

““Ninety-five percent of the people diagnosed with this Ninety-five percent of the people diagnosed with this cancer will not be alive 5 years later.”cancer will not be alive 5 years later.”

Point of View PhrasesPoint of View Phrases ““Some ‘side effects’ of the experimental drug are…”Some ‘side effects’ of the experimental drug are…” We would like permission to store your ‘left-over’ We would like permission to store your ‘left-over’

tissue.” tissue.” ““You will be randomized to an arm of the trial, like a You will be randomized to an arm of the trial, like a

‘flip of a coin’.”‘flip of a coin’.” ““We are researching ways to improve our procedures We are researching ways to improve our procedures

because patients like you are usually not compliant because patients like you are usually not compliant with our instructions (or you are difficult to work with).” with our instructions (or you are difficult to work with).”

Listener Harm Listener Harm

MetaphorsMetaphors War – “The experimental drug will fight the invasive War – “The experimental drug will fight the invasive

cells and try to kill/destroy them.”cells and try to kill/destroy them.” Kitchen – “Think of your intestines as a bowl of Kitchen – “Think of your intestines as a bowl of

spaghetti. Through our surgery we will strain and cut…” spaghetti. Through our surgery we will strain and cut…” Container – “Container – “YouYou will be randomized to an arm of the will be randomized to an arm of the

trial…”trial…”

OtherOther Curb your enthusiasm – “Plastic is ubiquitous in our Curb your enthusiasm – “Plastic is ubiquitous in our

homes. Exposure to the chemicals in plastic may be homes. Exposure to the chemicals in plastic may be harmful to you and your children. We would like to harmful to you and your children. We would like to measure your newborn’s exposure to plastic while in the measure your newborn’s exposure to plastic while in the hospital and see if there are any correlations with hospital and see if there are any correlations with markers in the blood.” markers in the blood.”

What Subjects Would Like or Would What Subjects Would Like or Would Like to KnowLike to Know

PermissionPermission Knowledge (about self, others, disease)Knowledge (about self, others, disease) Research results Research results Out-of-Pocket Costs for treatments, tests, Out-of-Pocket Costs for treatments, tests,

transportation & incidentalstransportation & incidentals Accurate estimation of time commitment Accurate estimation of time commitment

to participate (including office wait-time)to participate (including office wait-time) Who will pay if I am injured as a result of Who will pay if I am injured as a result of

participation (please make me/my family participation (please make me/my family whole)whole)

Motives and Meaning of Participation in Motives and Meaning of Participation in Clinical ResearchClinical Research

Motives:Motives: Coercion by DiseaseCoercion by Disease Personal BenefitPersonal Benefit

– Restore HealthRestore Health– Income & AccessIncome & Access– KnowledgeKnowledge

RelationshipsRelationships– Health Care ProviderHealth Care Provider– Family & “Community”Family & “Community”

AltruismAltruism

Motives and MeaningMotives and Meaning

MeaningMeaning:: MistrustMistrust

– researchresearch as a metaphor for past transgressions as a metaphor for past transgressions StigmaStigma

– diseasedisease as a metaphor for social as a metaphor for social disgrace/discrimination/taboodisgrace/discrimination/taboo

MeaningMeaning in sufferingin suffering

Contact InformationContact Information

http://www.umdnj.edu/hsphttp://www.umdnj.edu/hsp HSPP – (973) 972-1149HSPP – (973) 972-1149 New Brunswick IRB (732) 235-9806New Brunswick IRB (732) 235-9806 Newark IRB – (973) 972-3608Newark IRB – (973) 972-3608 Stratford IRB – (Stratford IRB – (856) 566-7196