HISTORY OF INFORMED CONSENTEXPOSE IN NEW ENGLAND JOURNAL OF MEDICINE, 1966CODES IN RESPONSE TO ETHICAL VIOLATIONSINFORMED CONSENTREQUIREMENTSBASIC ELEMENTS OF RESEARCH CONSENTADDITIONAL ISSUESWHAT IS AN IRB?INSTITUTIONAL REVIEW BOARD SPECIFIC FUNCTIONS:WAIVERS TO THE FULL IRB Studies of Minimal RiskSTUDIES ON PREGNANT WOMENFETAL STUDIESOTHER SPECIAL RESEARCH POPULATIONSANIMAL REGULATIONS1993 NIH REGULATIONSPATIENT SELF DETERMINATION ACT, 1990RESEARCH ON NEWBORNSCONSENT FOR CHILDREN RESEARCH/TREATMENTCONCRETE OPERATIONALISMYOUNG CHILDRENASSENTVULNERABLE CHILDRENNEW PEDIATRIC PROBLEMADOLESCENTSSlide 25Slide 26Slide 27NEW ADOLESCENT ISSUESRISK TO ADOLESCENTSTUDIES OF CONSENTCOST FOR ACTIVE PARENTAL CONSENTLEGAL STANDARDS OF COMPETENCYPASSIVE CONSENTCONFIDENTIALITYCERTIFICATES OF CONFIDENTIALITYStatutory AuthorityIdentifying InformationEligibilityExamples of research with potential adverse consequences for subjectsOther issuesPROJECTS NOT ELIGIBLE FOR A CERTIFICATEREQUIREMENTSASSURANCESBOUNDARIES OF PROTECTIONAN IMPORTANT CAVEATFOR ADDITIONAL INFORMATIONPARENTAL AUTHORITYPARENTAL AUTHORITYDECISION MAKING FOR CHILDRENSURROGATE DECISION MAKINGTHREE CONDITIONS MAY OVERRIDE PARENTAL AUTONOMY IN THE USAOVERRIDING PARENTAL CONSENTAMERICAN ACADEMY OF PEDIATRICSSONOMA STATE UNIVERSITY INTERESTSHISTORY OF INFORMED CONSENTHISTORY OF INFORMED CONSENT–Human subjects research has a checkered past–Nazi experiments 1935-1945–“Extensive, willfully harmful experimentation”–Nuremberg war trials for participants–USA government testing in World War II to develop vaccines, malaria drugs, long acting penicillin on non-consenting orphaned children, retarded and mentally ill persons, prisoners and conscientious objectorsEXPOSE IN NEW ENGLAND JOURNAL OF MEDICINE, 1966EXPOSE IN NEW ENGLAND JOURNAL OF MEDICINE, 1966–Jewish Home for the Aged residents injected with live cancer cells–Willowbrook children’s home residents given hepatitis virus–Tuskagee syphilis study 1972; African American men with untreated syphilis–Tea room trade 1967: Observation of sexual activityCODES IN RESPONSE TO ETHICAL VIOLATIONSCODES IN RESPONSE TO ETHICAL VIOLATIONS–Nuremberg code 1949–Geneva convention –Belmont report 1979–NIH Title 45 1981-1991–International ethical guidelines from the Council for International Organizations of Medical Sciences in Collaboration with the World Health Organization 1993–Helsinki code 1964, 1997, 2001INFORMED CONSENTINFORMED CONSENTRanges from nod of headSpoken to written From general to specific To ultra specificTreatment treated more lightly than research, but equally importantREQUIREMENTSREQUIREMENTSPatient must receive explanation of risks, consequences, benefits, and alternativesMust be written and spoken in a language that the patient understandsPatient must give consent without coercion or persuasionBe competent / have legal right to competenceShould not have received narcotics x amount time priorAdvance directive or will may not be witnessed by anyone having financial interestsWitnesses need to be 18 years of ageFor treatment issues, it is also appropriate to discuss when the decision will be revisitedBASIC ELEMENTS OF RESEARCH CONSENTBASIC ELEMENTS OF RESEARCH CONSENT–Study involves research purpose–Procedure risks and benefits to subject and others–Appropriate alternatives–Confidentiality of records, discs, tapes, papers–Compensation and medical treatment–Whom to contact–Voluntary–Refusal = no loss of benefits–Expected duration; Withdraw at any time–IRB approval and approval of agency–Consents may need to be anonymous or verbal, “By participating in this, I grant consent..”ADDITIONAL ISSUESADDITIONAL ISSUESCosts to subjectApproximate number of subjectsGovernment or program approvalConsequences of withdrawalFuture risks, to person, pregnancy, fetus, embryoWhen can the researcher terminateHow new findings may affect studyWHAT IS AN IRB?WHAT IS AN IRB?Helsinki declaration of 41st world medical assemblyCommittee membership must include scientists, non scientists, institutional, and non institutional membersMust be at least five members, must be of ethnic diversity to reflect surrounding community, all five may not be of same gender or professionThe IRB must keep written records and respond to submitted proposals in writingINSTITUTIONAL REVIEW BOARD SPECIFIC FUNCTIONS:INSTITUTIONAL REVIEW BOARD SPECIFIC FUNCTIONS:Approve , disapprove, or modify research proposalsConduct continuing review of research involving human subjectsObserve adequacy of the consent processSuspend or terminate approval of research which violates ethical principles or that is associated with any potential or unexpected serious harm to participantsWAIVERS TO THE FULL IRBStudies of Minimal RiskWAIVERS TO THE FULL IRBStudies of Minimal RiskHair, nails, plaque, excreta, secretions18 or older, non pregnant, good healthNot more than 450 ml of blood in 8 weeksRecorded speechExercise by healthy individualRecords, charts, specimensStudies of perceptions Non stressfulSTUDIES ON PREGNANT WOMENSTUDIES ON PREGNANT WOMENMust be preceded by animal studiesPreceded by studies on non-pregnant personsMust meet the health needs of fetus or motherMust not be related to termination of pregnancyCannot be given money to terminateFETAL STUDIESFETAL STUDIESMust be of minimal riskFetus must need health careMother and father must be fully competent and fully informedOther regulations for fetal tissue, placenta materialOften dependent on political process, i.e., Bush and Reagan versus ClintonOTHER SPECIAL RESEARCH POPULATIONSOTHER SPECIAL RESEARCH POPULATIONSPrisoners (non coercion)Non competent persons (permission of guardian)Animals (special regulations regarding pain and sacrificing)Children have special regulations, but rather than forbid research with children as was done after Nuremberg trials, now this is being encourages to test appropriate drug dosages, etc.ANIMAL REGULATIONSANIMAL REGULATIONSExtremely strictEnormous amount of work done to secure rights of animalsExtremely well treated, well cared for in laboratoriesMay not be allowed to suffer from painMust die with dignity1993 NIH REGULATIONS1993 NIH REGULATIONSStress inclusion of women and minorities in researchInclude peer panel review, I.e., breast cancer
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