Presentation on theme: "Human Subject Research Ethics"— Presentation transcript:
1 Human Subject Research Ethics Colleen M. Gallagher, PhD, FACHEChief & Executive Director, Section of Integrated EthicsAssociate Professor, Department of Critical Care
2 Definition of Research Research is designated as an activity that permits conclusions to be drawn, and develops or contributes to generalizable knowledge.
3 Research: Code of Federal Regulation(CFR)Definition Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
4 Human SubjectsHuman subject means a living individual about whom an investigator (whether professional or student) conducting research obtains(1) Data through intervention or interaction with the individual, or (2) Identifiable private information.
5 Clinical Care and Clinical Research Clinical care based on individual patient well being and “best interests”Clinical research based on developing new knowledge not individual patient well being and “best interests”
6 Human Subject Research Ethical Guidelines 1947 Nuremburg Code1964 Declaration of Helsinki (amended most recently 2004)1979 The Belmont Report-Respect for persons,beneficence, non-maleficence,justice1982 International Guidelines-International Organization of Medical Sciences (amended 2004)
7 Belmont Report Principles Three basic principles1.Respect for Persons (Autonomy):This principle acknowledges the dignity and freedom of every person.It requires obtaining informed consent from research subjects (or their legally authorized representatives)
8 Belmont Report Principles Beneficence and Nonmaleficence: This principle requires that researchers maximize benefits and minimize harms associated with research. Research-related risks must be reasonable in light of expected benefits.
9 Belmont Report Principles Non-MaleficenceOne ought not to inflict evil or harmGenerally the “do nots”Do not killDo not injureDo not violateDo not cause pain and sufferingDo not cause offense
10 Belmont Report Principles Justice:This principle requires equitable selection, recruitment and fair treatment of research subjects.
11 What makes clinical research ethical? Social or scientific valueScientific validityFair subject selectionFavorable risk - benefit ratioIndependent review has been conductedInformed consent processRespect for potential and enrolled subjects
12 Investigators Responsibilities Follow the protocolSubmit research to the IRB and have approval prior to initiation of researchComply with IRB policies, decisions, conditions, and requirementsObtain and document informed consentProvide a copy of the IRB approved consent form to each subject
13 Investigators Responsibilities Ensure that assent is obtained from research participants who are minors (18 years of age and under)Report progress of approved research annuallySubmit any modifications to a protocol or consent formMaintain a protocol file
14 Special Considerations Vulnerability “When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged person, additional safeguards have been included in the study to protect the rights and welfare of these subjects”(45 CFR b)
15 Types of Vulnerability IncapacitationalJuridicDeferentialSocialSituationalMedicalAllocational
16 IncapacitationalLacks the capacity to deliberate about and decide whether to participate in the study.Pediatric patientsMentally/cognitively impaired
17 JuridicLiability to the authority of others who may have an independent interest in participation in the study.Minor – parentAdult child – parent in some culturesWife – husband in some culturesElderly parent – adult child
18 DeferentialGiven to patterns of deferential behavior that may mask an underlying unwillingness to participate.Child to parentFemale to malesYoung to eldersDeference to all doctors
19 SocialBelongs to a group whose rights and interests have been socially disvalued.Racial/ethnic minorityWomenDisabled
20 SituationalIn a situation in which medical exigency prevents the education and deliberation needed to decide whether to participate.A number cancer patients – especially leukmias and CNS tumors
21 MedicalSelected, in part, because of the presence of a serious health-related condition for which there is no satisfactory remedies.Many relapsed/refractory cancer patients
22 AllocationalLacking in subjectively important social goods that will be provided as a consequence of participation in research.
23 Additional Research Risks Pregnant women and fetusesResearch carries additional or special risksGestating women’s bodies may have special needs or respond differently.Potential conflict between woman’s health needs and the fetus – what is a risk or benefit for one may not be for the other
24 Additional Research Risks Subpart BRequire more preliminary studies (higher burden to do research) (46.204a)Any risk is the least possible for achieving objectives of the research (46.204c)Greater than minimal risk to fetus has to be justified by prospect of direct benefit to pregnant woman or fetus, and by the fact that there is no other means to obtain that knowledge. (46.204d)
25 Targeting for Wrong Reasons Being asked to take participate in research because it is expedient (cheaper, more convenient, less administratively burdensome) and not for scientific reasons (condition being studied affects this group more often)Think about Havasupai situation as an example.Subject Selection Fairness (45 CFR a.3)
26 Targeting for Wrong Reasons Subpart C (prisoners)Research has to be about one of the following:Causes, effects, etc, of criminal behaviorPrison structuresConditions particularly affect prisoners as a classPractices that have intent of improving health or well-being of prisoners (46.306a)
27 IRB and Vulnerability Recognize different types of vulnerability Use different strategies to address different vulnerabilities.Research protocol designEmpowering subjects in the research process
28 Questions Ask for Research Ethics Consultation 713-792-8775 contact one of the ethicists using the paging system