Presentation on theme: "Basics of Informed Consent (Part 1)"— Presentation transcript:
1 Basics of Informed Consent (Part 1) Paula Bistak, DMH, RN, MS, CIP, CHRCExecutive Director, HSPPDonna Hoagland, LPN, BS, CIP, CCRC, CHRCIRB Director, New Brunswick/Piscataway and Stratford/CamdenCarlotta Rodriguez, BS, CIP, CHRCIRB Director, Newark Campus IRBCheryl Forst, RN, BSN, CCRPHSPP Analyst DirectorChristine Asmann-Finch, DMH, MSProgram Development Specialist/Medical Humanist
2 Session Overview Introduction Ethical Principles Regulations Consent as a ProcessSpecificsRequired ElementsDocumentationWaiversCommon FindingsSubject Perspectives
3 Informed ConsentBasic Ethical Principles for the Protection of Human Subjects in ResearchBelmont ReportEstablished in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral ResearchEthical Principles and Guidelines for the Protection of Human Subjects in ResearchRespect for PersonsBeneficenceJustice
4 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
5 Respect for Persons Application through Informed Consent Information ComprehensionVoluntariness
6 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 untildifferentials of power, class, economics, desperation, and other possible sources of coercion are considered and addressed.
7 Legally Effective Informed Consent Consent byResearch SubjectorResearch Subject’s Legally Authorized Representative for Research (LAR) under State LawState of New JerseyAccess to Medical Research Act
8 Legally Effective Informed Consent No coercion or undue influence (recruitment)Obtained by Investigator/Staff trained and authorized by IRBLanguage understandable to the subjectUse lowest level vocabulary and syntaxAvoid jargonNo exculpatory languageContains required elementsIf applicable - Six additional elements
9 General Requirements for informed consent 45 CFR Common Rule21 CFR FDAICH E-6 Section (GCP)
10 Informed ConsentInformed consent is a process, not just a signed document.
11 Informed Consent Process The process should:Provide adequate informationgenerally, what a reasonable person would want to know before making a decisionConfirm the participants comprehend the informationAssure consent is given voluntarily
12 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
13 Elements (continued) Potential risks and discomforts of participation Potential benefits of participation (to the subject and others)Alternatives (if any)Confidentiality of records descriptionNumber of subjects (if it may have an impact on the decision)
14 Elements (continued)Compensation for injury statement (for greater than minimal risk studies)Statement of voluntary participationContact person for questionsAbout researchAbout rightsAbout injury
15 Required ElementsIf 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."
16 Additional ElementsStatement that there may be risks which are unforeseeableUnder what circumstances investigator could terminate subject’s participation (include plan to exit subjects)Additional costs to subject
17 Additional Elements (cont.) Consequences of subjects withdrawal from research (include plan to exit subjects)Statement that will be told of new findingsApprox. number of subjects in study
18 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
19 Waivers Waiver of Informed Consent Waiver of the Requirement to Obtain Documentation of Consentno signature
20 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
21 Waiver or Alteration (continued) Whenever appropriate, the subjects will be provided with additional pertinent information after participation
22 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.
23 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.
24 Passive ConsentFederal regulations do not support the concept of passive consent. There is no such thing as passive consent from the regulatory standpoint.
25 Informed Consent Process Process can vary but should generally include:Research team member provides the informed consent document for the participant to readA member of the study team explains the study to the participantThe participant is given an opportunity to ask questionsThe participant is given the opportunity to review the consent document with family and consider participatingParticipant is given a copy of the signed consent document
26 Informed Consent Process OngoingResearcher should determine the subjects willingness to continue throughout the trialParticipation is voluntarySubject can refuse to continueSubject can withdraw at any time
27 Informed Consent Audit Privacy & Confidentiality :Location matches IRB approved protocolConfidentiality maintainedLimited Access – Electronic enrollmentOriginal consent form locked in separate location from other study data
28 Validate Source Documents : Consent forms equal number of subjects Confirmed as signed prior to the start of activitiesAppropriately 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).
29 Consent Process Documentation: Mirrors the description in IRB approved protocolTruly represents the consent processSubject questions answeredGiven time to voluntarily decide to participateCopy of the consent form given to subjectAuditors may visit to observe the process45CFR45 CFR
30 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…)
31 Top 10 Consent Audit Findings 10. Subject signature and person obtaining consent on different dates9. Subject consented with wrong version of consent/expired consent8. Subject consented by individual not named on the IRB protocol7. Check boxes within consent incomplete (future use of samples)6. Crossed out or white out anywhere on the consent document5. Unable to locate consent(s) for subject(s) on study4. Subjects not re-consented with revised consent3. Ineligible subjects enrolled2. Wrong contact telephone number listed in consent1. Copy of the consent document NOT provided to the subject
32 Strive for the BEST Informed Consent It starts with you !It is the first instructional piece of information provided to the subjectShould be clearly written and presented to promote decision makingUnderstand that each interaction is different(circumstances, questions, communication style)Take it serious and fully inform & document !
33 CONSENT TO PARTICIPATION IN CLINICAL TRIALS FROM A SUBJECT’S POINT OF VIEW CONTENTWhat terms and ways of writing are difficult to comprehend?CONTEXTWhat does participation mean in the context of a person’s life?
34 The Obvious Problems Language Literacy Health & Research Literacy Key Concepts, Procedures & RightsLiteracyReading levelHealth & Research LiteracyRandomizationPlaceboProbabilitiesHIPAA Authorization
35 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”
36 Listener Harm Fortune Telling Point of View Phrases “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).”
37 Listener Harm Metaphors Other 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…”OtherCurb 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.”
38 What Subjects Would Like or Would Like to Know PermissionKnowledge (about self, others, disease)Research resultsOut-of-Pocket Costs for treatments, tests, transportation & incidentalsAccurate 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)
39 Motives and Meaning of Participation in Clinical Research Coercion by DiseasePersonal BenefitRestore HealthIncome & AccessKnowledgeRelationshipsHealth Care ProviderFamily & “Community”Altruism
40 Motives and Meaning Meaning: Mistrust Stigma Meaning in suffering research as a metaphor for past transgressionsStigmadisease as a metaphor for social disgrace/discrimination/tabooMeaning in suffering