lists and definitions research ethics Flashcards
1
Q
Vivisection (Lederer):
A
Cutting into live organism
2
Q
Human vivisection (Lederer):
A
experiments on humans not to benefit the individual but to gain medical information (used up to 1930s)
3
Q
Justification of human subjects research (Jonas)
A
- Access to goods research
- Justified by social contract theory
- Need for public good = duty (our only duty maintenance of current state)
4
Q
Rule of Descending order (Jonas)
A
- Pts id with and are aware of the cause of research (med professional)
- Highly educated
- Least dependent
- Those serious illness always last
5
Q
4 Stages of Research
A
- Toxicity
- Efficacy and safety small #
- Large number of participants
- Post-marketing surveillance trials
6
Q
Good choice study (Wertheimer):
A
Person could probably participate for self-interested reasons because of expected benefits to herself
7
Q
Bad choice study (Wertheimer):
A
Person can’t expect net positive benefits to herself, not in medical interest
8
Q
Equipoise:
A
No reason to think on intervention is more efficacious than the other
9
Q
Research:
A
Activity to test hypothesis, draw, conclude, contribute to generalizable knowledge
10
Q
3 Principles govern human subjects research (Belmont Report)
A
- Respect for persons - autonomy, protection depends on degree of risk
- Beneficence
- Justice - burdens/benefits research on populations
11
Q
Requirements from belmont report
A
- Informed consent (information, comprehension, voluntariness)
- Assessment of risks and benefits (nothing brutal, reduce risks, be more cautious as risks increase, more cautious on vulnerable population, include risks and benefits on forms)
- Selection of subjects (individual justice, all equal chance to participate, social justice, no group bears disproportionate burden
12
Q
7 principles ensure research is ethical (Emanuel, Wendler, Grady)
A
- Social/scientific validity
- Scientific validity
- Fair subject selection
- Favorable risk-benefit ratio
- Independent review
- Informed consent
- Respect pts
13
Q
4 Requirements informed consent
A
- Competent
- Voluntary
- Informed
- Comprehending
14
Q
What Empirical research reveals about informed consent (Candilis)”
A
- Give info in parts
- Education improves dmc
- Written material and pics
- People can’t guess wishes of another person
- Physicians underestimate pt competence and satisfaction with informed consent
- People can’t understand risks, benefits, or standards
- Therapeutic misconception
15
Q
3 Theories of autonomy (Beauchamp)
A
- Autonomous person theories - emphasize agent
- Autonomous action - acting intentionally with understanding
- Split level theories - consists of capacity to control - identify with one’s first order desires by means of second order desires
16
Q
Theory of autonomy (Beauchamp)
A
- Intentional
- Understanding
- Voluntary
17
Q
Consent Transaction (Wertheimer, Miller):
A
Interaction between 2 people allow A to do X to B, question is if consent creates moral transformation both parties
18
Q
Lock and Key/Autonomous Authorization model (Wertheimer, Miller):
A
Valid consent is necessary and sufficient for moral transformation valid consent is key opens lock to moral transformation
19
Q
Fair Transaction Model (Wertheimer, Miller):
A
A can proceed on basis of B’s consent if A has treated B fairly and responds reasonably to B’s expression of consent if consent is flawed but fair, it is allowable (authorizes consent even with therapeutic misconception)
20
Q
2 Reasons to defend soft paternalism (Wertheimer)
A
- Depends on valid/reasonable judgment, decisional defect impair voluntary consent
- Numerous good reasons eschew paternalistic influence with competent adults even if decision-making is impaired
21
Q
7 ethical requirements in clinical research (Emmanuel)
A
- Social value
- Scientific validity
- Far subject selection
- Favorable risk benefit
- Independent review
- Informed consent
- Respect subjects
22
Q
Decisional deficits make difficult for competent adults protect interests
A
- Lack scientific/clinical knowledge
- Prospective subjects suffering from disease vulnerable therapeutic misconception
- Pt-subjects who desperate for chance medical benefit from access experimental treatment over estimate benefit
23
Q
Soft paternalism:
A
Limits liberty on grounds person’s decision making is impaired
24
Q
Hard Paternalism:
A
Limits liberty someone decision making NOT impaired
25
Direct Paternalism:
Limits liberty of person whose interest and we are trying to protect
26
Indirect Paternalism:
Limit liberty one person to offer choices to another to protect interests of latter
27
Types of Review
1. Exempt
2. Expedited (only 1 reviewer)
3. Full Board (more than minimal risk research)
28
Types of Approval:
1. Full approval
2. Approval with contingencies (most)
3. Tabled/deferred
4. Disapproved
29
Sources Variability in IRBS (Pritchard)
1. Local circumstances
2. Members unaware some facts relevant to assessment
3. Members differ in their application of regulatory provisions
4. Varying levels support to IRB
5. Legitimate differences in moral perspective
30
Rational choice theory (Pritchard):
People seek good and avoid bad
31
Risk Preference (Pritchard):
easily manipulated by language
32
Maximizers (Pritchard):
Review all possible options making a decision
33
Satisfiers (Pritchard):
Willing choose an option when looks ‘good enough’
34
Minimal Risk Research:
Probability and magnitude of harm/discomfort anticipated in research not greater than risks ordinary life
35
Signal Potential (Slovik):
People perceive things without statistical risk but large impact like nuclear power plants as riskier than everyday events that are statically risky like car travel
36
SERR (Systematic evaluation of research risks) (Rid, Emanuel, Wendler)
1. ID potential harms
2. Categorize magnitude each potential harm with their harm scale
3. Estimate likelihood of potential harms
4. Compare likelihood of potential harms from research with harm comparable activity, if likelihood comparable, risks of research may be acceptable
37
Reasons IRBs bad at balancing risks and benefits (Williams)
1. Bias in favor of approval HHS guidelines
2. Composition of IRBs - strong incentive institutional success
3. Psychological effect of committee decisions, group polarization
38
Confidentiality (Levine):
A mode of management of private information, if a subject shared private information with an investigator, the investigator is expected to refrain from sharing information with an investigator, the investigator is expected to refrain from sharing this information with other without the subjects authorization or some other justification
39
Confidentiality 4 premises (Levine)
1. We respect on individual’s autonomy regarding personal information
2. It is legitimate to have personal secretes and to be able to share them with whom we choose
3. We must keep our promises
4. Professionals take a pledge of silence regarding confidential info
40
3 Agencies Issue Confidentiality Certificates (Levine)
1. DHHS confidentiality certificate provide immunity from subpoenas
2. DOJ grants of confidentiality- authorizes investigator to withhold info from subjects in drug trials
3. DOJ privacy certification - imposes positive duties and obligations on recipients funds from law enforcement
41
4 methods contacting potential subjects (Levine)
1. Drafting letter
2. Letter with telephone postcard
3. Letter return if not interested
4. Letter will call you 2-3 weeks
42
Differences between common rule and HIPAA (Nosowksy Giordano)
1. HIPAA more demanding, implies greater risk than actually exists
2. Privacy Rule HIPAA interpreted differently
3. HIPAA limits use identifiable data sets
43
Deidentification (Rothstein):
info altered to remove certain data elements with individuals (unregulated)
44
Anonymous:
No direct or indirect identifiers and cannot be linked to any individual
45
Direct Identifiers:
Name, SSN
46
Risks with De-identified information (Rothstein):
1. People doing the de-identifying
2. Its possible to re-identify large number of cases with computerized network databases
3. Group harms - could id group with stigmatizing condition
4. Objective uses - gene selection and abortion
5. Commercial exploitation
6. Abuses loss trust researchers
47
People v. Newman (Beskow):
Only case when certificate of privacy was honored
48
Privacy:
What participants don’t want researchers to have, touch, or know
49
Exceptions to Physician-pt privilege
1. Mandatory reporting battered children, communicable disease, gun shot wounds
2. Tarasoff v. Board Regents
3. Commonwealth v. Kobrin - records can be subpoenaed in medicaid fraud cases
50
Flow Chart of degrees of protection of Information (high to low)
1. Anonymous
2. Anonymized (made anonymous)
3. Deidentified
4. Linked by source
5. Linked by researcher
6. Direct identifiers
51
Justification of use of vulnerable subjects (Levine)
1. Negotiating/enhancing consent
2. Research done on vulnerable subjects should be relevant condition causes vulnerability
3. Community consultation
4. Lottery system who gets therapy
52
Subparts of the Common Rule
A) regulations of human subjects research
B) pregnant women
C) prisoners
D) Children
53
6 Types of vulnerability (Kipnis)
1. Cognitive - immaturity, mental illness, mental retardation
2. Juridic - liable to authority of other (military, prisoner, children, wives)
3. Deferential patterns of deferential behavior may mask underlying unwillingness to participate
4. Medical
5. Allocation, lacks social goods
6. Infrastructural vulnerability, organizational context
54
Ways to respond to vulnerability (Kipnis)
1. Reduce vulnerability
2. Involve less vulnerable subjects
3. Distribution of benefits to participants
4. Community consultation
55
DHHS Recommendations for Children (82)
1. First research on animals, adults, older children
2. Protect privacy
3. Need assent of children
4. Minimal risk, incremental with direct benefit prospects
56
DHHS Recommendations for Prisoners
1. Need good investigators
2. Need do research meant to to help prisoners
3. Need prisoner representation on IRB
4. Seek alternative populations first
5. Minimal risk as compared with children
57
IOM Recs for Prisoners
1. Expand definition of prisoner to parole and probation
2. Ensure universal, consistent ethical protection
3. Shift from a category based to a risk based approach
4. Include collaborative responsibility
5. Enhance oversight
58
4 problems with risk and prisoners (Chwang)
1. Coercion
2. Undue inducement
3. Exploitation
4. Paternalism
59
Reasons why pregnant women HIV difficulty getting into trials (Kass, Taylor, King)
1. Eligibility criteria
2. Under represented minorities
3. Lack funding ancillary services
4. Few studies are done
60
Evolution of Exclusion pregnant women (Kass, Taylor, King)
1. 77 FDA exclusion women with childbearing potential from phase 1 and 2 trials
2. 86 researchers must justify exclusion
3. 93’ mandate inclusion women and minorities
61
Recommendations for Pregnant women (Kass)
1. Animal research include reproductive studies
2. Phase 1 unchanged
3. Allow into phase 2
4. Expand phase 3
5. Place burden on proof on IRB to include women
62
4 Levels of Risk with Children (Grodin, Alpert)
1. No greater than minimal risk
2. Greater than minimal risk but offering direct benefit to subject
3. Minor increases over minimal risk and likely yield generalizable knowledge about subject’s disorder or condition AND experiences reasonably commensurate with actual/expected circumstance of child
4. Not otherwise approvable, IRB cannot approve goes to national committee
63
4 concerns economically disadvantaged (denny)
1. Uneducated = impaired decision making
2. Services and goods too attractive
3. Exploitation offering unfair levels benefit
4. Only enroll because limited economic options ( = exploitation)
64
3 Models payment for subjects (Dickert and Grady)
1. Market model (pay well be competitive)
Pros - good numbers recruitment, fair pay
Cons - harms become irrelevant
2. Wage payment model (pays like job)
Pros- inducement less, standard payment
Cons - still attractive to poor
3. Reimbursement model -
Pros - alleviates undue inducement
Cons - insufficient number
65
2 worries about undue inducement (Emanuel)
1. Excessive risks
2. Poor informed consent
3. Subject selection (justice)
66
3 Ethical Considerations involving human whole-genome sequencing (McGuire, Caufield, Cho)
1. Circumstances under which research results are disclosed to research participants
2. Obligations, if any, are owed to relatives
3. Options regarding how feature uses of samples are dealt with
67
3 Problems with giving pts info of genetic results (McGuire, Caufield, Cho)
1. Results subject misinterpretation
2. Process disclosure and follow up
3. How store information and integrate into health record
68
Broad Consent (Maschke)
Consent process designed describe biobank practice with regard to future use and then ask prospective participants whether wish to contribute to biobank under those conditions
69
Tiered Consent (Maschke):
Permit use specimens in current study only allow contact for future use
70
Waived Consent (Maschke):
May be allowed if no more minimal risk, done without waver,
71
Challenges to standard consent to genetics/biobanking (Haga, Beskow)
1. Right to withdraw
2. Separate between sample collection/informed consent and actual research - hypothesis and methods unforeseeable and risks, benefits unforeseeable
3. Risks benefits group based
72
Moore v. Regents University of California (91):
physician obligated disclose fiduciary interests to patients
73
Greenberg v. Miami Children’s hospital (03):
Individual not have ownership of donated research
74
Washington University v. Catalona:
Donors not control over samples beyond consent and withdrawal, institution owns samples, not researcher
75
Databases:
Contain only genetic clinical info
76
Biobanks
Contain actual samples
77
Unidentified:
Anonymous
78
Unlinked:
Anonymized
79
Coded:
Linked or identifiable
80
CLIA: Clinical laboratory Improvement Amendments:
CMS regulatory system covers lab tests on humans in US; is certified like hospitals without quality control
81
Interaction Principle (Wertheimer, Miller):
One can have obligation or moral reasons to provide super-contractual benefits to those with whom one engages in mutually beneficial and consensual transaction. Even if A has no obligation to B without interaction, A acquires obligation in interaction (rejects NWC)
82
Nonworseness Claim (NWC) (Wertheimer, Miller)
It cannot be morally worse of A to interact with B than not to interact with B if the interaction or package deal is beneficial to B if B consents to interaction
83
Greater obligation Claim (GOC) (Wertheimer, Miller)
among potential beneficiaries of A’s action or resources, A has greater obligations to provide super-contractual benefits to A whereas others have received no benefit from A
84
Types of Greater obligation (Wertheimer)
1. Responsiveness
2. Standards of care
3. Post-trial obligations
4. Ancillary care
5. Fair benefits to community
85
“Final Rule” 1996 How to obtain waiver in ER (Richardson)
1. Subject in life-threatening condition and can’t consent
2. No proven available treatment
3. Evidence prove safety and efficacy of intervention
4. No way id patients ahead of time
5. Research will directly benefit subjects and can’t be done any other way
86
Novel Therapy (Dickens)
Trying something new for pts benefit when no standards of care exist (only need implied consent, and do not need full disclosure)
87
Experimental Treatment (Dickens):
Trying something you think better when standard exists (informed consent received)
88
Behavioral and Social science research (Dubois):
Quality assessment not continue unless intent to share info gained; may be qualitative studies, mostly treated as research
89
Population based research (Gostin):
All research and practice performed on or which affect, groups of people or populations (epidemiological research and surveillance, intervention epidemiology, field trials for drugs and vaccines)
90
Principles to Protect populations (Gostin)
1. Protect health and well being. Do not harm
2. Respect population right self-determination
3. Protect vulnerable population and need special justifications in research
4. protect privacy, integrity, and self esteem of population
5. Distribute benefits equally to population and build infrastructure for research
91
Finder’s fees (Christensen, Orlowski):
Payment to physician who refers a pt to a study and pt actually enrolls
92
Bayh-Dole act (1980) (Loewenberg)
allows universities researchers and research institutions to pt NIH funded work
93
Concerns about Bahy-Dole Ac (Loweenberg)t:
1. Profit motives compete with scientific inquiry
2. May not foster new discoveries only new patients never cash out in products, has created lawsuits, but research and universities not a test money
3. Some universities have united to make suggestions for licensing technology
