research ethics & new investigators melody lin, ph.d. dec. 12, 2012
TRANSCRIPT
Research Ethics Research Ethics & New & New
InvestigatorsInvestigatorsMelody Lin, Ph.D.Melody Lin, Ph.D.
Dec. 12, 2012Dec. 12, 2012
ObjectivesObjectives
Research Ethics & HSPResearch Ethics & HSP Pharmaceutical IncentivesPharmaceutical Incentives Conflict of InterestConflict of Interest Tissue IssuesTissue Issues
Research EthicsResearch Ethics
Definition Definition A set of guidelines to assist the A set of guidelines to assist the
researcher conduct ethical researchresearcher conduct ethical research
Research EthicsResearch Ethics
Ethical concerns Ethical concerns Relationship Between Society and Relationship Between Society and
Science Science Professional Issues Professional Issues Protection of Research SubjectsProtection of Research Subjects
Relationship Between Relationship Between Society Society
and Scienceand Science SocietySociety
Government funding researchGovernment funding research Congressional influence on which studies Congressional influence on which studies
are fundedare funded Corporate funding research Corporate funding research
CultureCulture ScientistScientist’’s own culturally based s own culturally based
interestsinterests
Professional IssuesProfessional Issues
Scientific MisconductScientific Misconduct Fabricating, Falsifying or Plagiarizing Fabricating, Falsifying or Plagiarizing
(FFP) (FFP) proposingproposing performingperforming reviewingreviewing reporting reporting
Protection of Research Protection of Research SubjectsSubjects
Right and welfare of the research Right and welfare of the research subjects ought not be disregarded in subjects ought not be disregarded in favor of sciencefavor of science
TrustTrust
Researchers maintains a relationship Researchers maintains a relationship of trust with the subjectsof trust with the subjects
CompromisedCompromised DeceptionDeception Confidentiality not maintainedConfidentiality not maintained
Monitoring ResearchMonitoring Research
Sponsor Sponsor Regulatory agencies Regulatory agencies IRBIRB DSMBDSMB Public interest groups Public interest groups
Sponsor ResponsibilitiesSponsor Responsibilities
Monitor the conduct of the Monitor the conduct of the researchresearch
MonitorsMonitors
Check the work of the EC or IRBCheck the work of the EC or IRB Make sure the protocol is followedMake sure the protocol is followed Verify dataVerify data Check safety issuesCheck safety issues
Regulatory AgenciesRegulatory Agencies
Government agencies have oversight Government agencies have oversight responsibilities responsibilities
FDA monitors clinical trialsFDA monitors clinical trials
Pharmaceutical Incentive Pharmaceutical Incentive $$$$$$
Recruit & retain subjects vs ss. Recruit & retain subjects vs ss. Vulnerability Vulnerability
May stretch inclusive/exclusive May stretch inclusive/exclusive criteriacriteria
Influence professional judgmentInfluence professional judgment Finder’s feeFinder’s fee
Physician InvestigatorsPhysician Investigators Prospects of PeerProspects of Peer
RecognitionRecognition PublicationPublication Financial gainFinancial gain
Economic incentives may create Economic incentives may create pressurespressures CompromiseCompromise Appearance of compromiseAppearance of compromise
IntegrityIntegrity ResearchResearch ResearcherResearcher
Issues need AddressIssues need Address
RespectRespect BeneficenceBeneficence JusticeJustice
Conflict of InterestConflict of Interest
Situation in which the integrity of academic activity, especially research, may be, or may be perceived to be, compromised by financial or other interests.
Conflicts of Interest
vs
Government Scientist Pleads Guilty
Senior Alzheimer’s Researcher Admits
Taking $285,000 In Fees, Expenses
A senior government scientist working in Alzheimer’s disease research pleaded guilty today to accepting $285,000 in consulting fees and travel expenses from the world’s largest drug manufacturer without proper approval from his bosses.
As part of his agreement with federal prosecutors, Pearson “Trey” Sunderland III, chief of the geriatric psychiatry branch of the National Institute of Mental Health, which is part of the National Institutes of Health, will be sentenced to two years of supervised probation and must forfeit $300,000.
Baltimore Sun December 8, 2006By Matthew Dolan
Sources of Potential Conflict
Consultant Speaker Stock or Other
Equity Management
Position Income from
Royalties or Licensing Fees
Board or Scientific Advisory Board Member
Gift Relationship with
Competitor Loans (To or From) Family Member has
Relationship
Does conflict of interestDoes conflict of interestpresent a legitimate concern?present a legitimate concern?
Financial interests steer the Research Financial interests steer the Research activity to the point where it is activity to the point where it is compromisedcompromised
Financial interest gives the appearance Financial interest gives the appearance that the research activity may be that the research activity may be compromisedcompromised
Maintaining full research integrity would Maintaining full research integrity would compromise the business plan and/or compromise the business plan and/or require excess resourcesrequire excess resources
What’s the worst that could What’s the worst that could happen?happen?
JesseGelsinger
Spectrum of Conflicts
Financial DisclosureFinancial Disclosure
Not meant to censor investigators Not meant to censor investigators from participationfrom participation
May reduce likelihood of May reduce likelihood of investigators biasing results of their investigators biasing results of their clinical studiesclinical studies
Financial DisclosureFinancial Disclosure
Questions of concern:Questions of concern: Does compensation to the Does compensation to the
investigator/study staff affect the investigator/study staff affect the value of the study outcome?value of the study outcome?
Is there proprietary interest by Is there proprietary interest by investigators/study staff in tested investigators/study staff in tested product?product?
Is there significant equity interest in Is there significant equity interest in sponsor of the study?sponsor of the study?
Financial DisclosureFinancial Disclosure
Is there significant payments by Is there significant payments by sponsor of other sortssponsor of other sorts Grant to fund ongoing researchGrant to fund ongoing research Compensation in the form of equipmentCompensation in the form of equipment Retainers for ongoing consultation or Retainers for ongoing consultation or
honorariahonoraria Disclosure statements also apply to Disclosure statements also apply to
investigator/study staff spouse and investigator/study staff spouse and dependent children.dependent children.
Tissue IssuesTissue Issues
Collection of new samples vs. use Collection of new samples vs. use of existing samplesof existing samples Plans for linking samples to medical Plans for linking samples to medical
records, identifiable informationrecords, identifiable information Use/disclosure of research resultsUse/disclosure of research results
Informed consentInformed consent Adequate disclosureAdequate disclosure
ProspectiveProspective Existing, stored samplesExisting, stored samples
Classification of samplesClassification of samples
Not identifiedNot identified No “human subject” if truly not No “human subject” if truly not
identifiedidentified How much clinical and demographic How much clinical and demographic
data can be retaineddata can be retained IdentifiedIdentified
Directly (name/ID)Directly (name/ID) Coded/linkableCoded/linkable
Risks of using identified Risks of using identified datadata
DisclosureDisclosure To third partiesTo third parties
Potential for breach of privacy and Potential for breach of privacy and confidentialityconfidentiality
To patients/subjectsTo patients/subjects Privacy intrusion from undesired Privacy intrusion from undesired
contactcontact Harm from disclosure of resultsHarm from disclosure of results
Research design Research design to reduce these risksto reduce these risks
Maximize confidentialityMaximize confidentiality The “least necessary” or “least identifiable” The “least necessary” or “least identifiable”
datasetdataset Use of intermediary to hold link between code Use of intermediary to hold link between code
and identifiersand identifiers Obtain maximal legal and practical protectionsObtain maximal legal and practical protections
e.g., data placed on computers not linked to the e.g., data placed on computers not linked to the InternetInternet
Develop approach for re-contacting Develop approach for re-contacting subjectssubjects Clinical relevance or valueClinical relevance or value Adequate counselingAdequate counseling
Informed consent for Informed consent for research on human research on human biological materialsbiological materials
If/when?If/when? For prospective collectionFor prospective collection Maybe for existing samples, depending on:Maybe for existing samples, depending on:
IdentifiabilityIdentifiability Adequacy of prior consentAdequacy of prior consent Setting in which collected (research vs. Setting in which collected (research vs.
clinical)clinical)
How?How? Extent of detail Extent of detail FrequencyFrequency
ResearchResearch
Conducted with Conducted with unidentifiedunidentified samples samples is not human subjects research and is not human subjects research and is not regulated by the Common is not regulated by the Common Rule.”Rule.”
““Using Using coded or identified samplescoded or identified samples requires the consent, unless the requires the consent, unless the criteria for a consent waiver have criteria for a consent waiver have been satisfied.”been satisfied.”
NBAC NBAC (1999)(1999)
Waiver of informed Waiver of informed consentconsent
for use of existing for use of existing samples samples
(see 45 CFR 46.116)(see 45 CFR 46.116) Protocol must pose minimal riskProtocol must pose minimal risk Determination of whether it might be Determination of whether it might be
desirable to communicate directly with desirable to communicate directly with patientspatients If yes, then > minimal risk, and consent should be If yes, then > minimal risk, and consent should be
obtainedobtained
Cannot adversely affect rights and Cannot adversely affect rights and welfarewelfare
Impracticability of obtaining consentImpracticability of obtaining consent From some or all participantsFrom some or all participants
New Physician New Physician InvestigatorsInvestigators
Ethical principlesEthical principles Right, safety & welfare as Right, safety & welfare as
paramountparamount Do no harmDo no harm