Research Ethics Flashcards
Beecher’s article
1966, argues that medical research involves unethical designs. such studies shouldn’t be published. researchers need consent and also need to be responsible.
- Article gave people a sense of the reality of vulnerable populations.
- Rothman’s article comments on this, argues that WW2 laid foundation for utilitarian mentality and thus exploitative research.
SFNO and criteria for choices
stakeholders, facts, norms, options
procedural. layus out elements of ethical situation, but doesn’t give solution. prudence needed.
disagreement comes bc diff pppl have diff interests, disagree about facts, disagree about norms. Criteria = effectiveness, necessity, proportionality, least infringement, transparency
Jonas on research
research uses subject as a passive thing therefore is problematic. we overstate the justification for research. if people are going to self-sacrifice, it is because it comes out of a sense of the holy.
MEdical progress is not necessary, but an optional goal. if progress slows, society is not harmed. proceed by rule of descending order (researchers are subjects first, poor last)
phases of research
1 - toxicity or side effects
2 - tests efficacy and safety; small number of subjects
3 - tests safety and efficacy on larger number of subjects; RCTs
4- post-marketing surveillance trials after drug is on the market.
Eisenberg
research is a social imperative bc it relieves suff and death. it shouldn’t be regulated to constrain progress, because this will also be harmful to people.
belmont report - principles and their applications
respect for person (acknowledge self-determination and protect those with < aut)
beneficence - don’t harm, maximize benefits minimize burdens
justice - distribution of research benefits and burdens; selection of subjects should be fairi; those who have burdens need access to benefits.
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applications:
Informed consent; balance benefits and burdens; select subjects so that there is ind justice (all have chance to participate) and social justice (no group has disproportionate benefits/burdens)
Informed consent (belmont report vs Levine)
Belmont: information (disclosure), comprehension, voluntariness
levine: IC has four requirements: competent. voluntary, informed, comprehending
Miller on therapeutic misconception
TM is of incremental, not categorical, concern. It’s ideal to have no TM, but it does not necessarily invalidate consent or exclude participation.
TM is unacceptable when the person would ahve made a different decision without TM.
beachamp on autonomous action
conditions for autonomous action:
intentional (corresponds to what is willed, including neg consequences)
understanding
voluntariness (no one is totally voluntary)
*understanding and voluntariness vary in degrees. we can make cut-offs, but not clear categories. we have to balance.
Jansen on unrealistic optimism
optimistic bias is present and is not related to misunderstanding. optimism is an independent cause of expecting therapeutic effects of research, and can’t be addressed with more information. it has to be addressed at a higher level about research
Miller and Wertheimer on consent
The central Q about consent is not if its valid, but whether a bilateral consent transaction between 2 people is morally transformative. moral transformation comes from fair transaction, not autonomous authorization.
- consent transaction = interaction that lets a do x to b.
- lock and key /autonomous authorization model - valid consent is necessary and sufficient. valid consent is voluntary, informed, understanding, competence
- *They propose fair transaction model - A can proceed on basis of B’s consent if A has treated B fairly and responds reasonably to B’s consent/appearance of B’s consent. Flawed but fair consent is OK.
- criteria for moral transformation is different in diff contexts
application - their model allows for research when there is a ther misconception, whereas valid consent (lock and key) model does not.
Miller and Wertheimer on paternalism in research
research regs are paternalistic (Soft) and justafiably so.
Soft paternalism justifies protective regs. warns against nonvoluntary judgment of subjects and defect in DM that make a choice less autonomous.
paternalism doesn’t necessarily conflict with atunomoy
kinds of paternalism (Miller and WErt)
soft - limiting liberty bc person’s DM is nonvoluntary or nonautonomous
hard - limiting liberty of someone not impaired for their own good
direct / individual- limiting liberty of person you want to protect
indirect / group - limiting liberty of one person to give choices/protection to another
minimal risk research
probability and magnitude of harm is not greater than those ordinarily encountered in daily life (the q is whose daily life)
Kim argues that IRB review is not of sufficient value for min risk studies.
Edgar and Rothman on IRBs
current process needs to be more nationalized; Suggestions:
*we need a national ethics committee to address the broader political sanction of research
improve irbs to account for entrepreneurial nature of research
strengthen outsdie elements of IRBs but leave review in the institution.
Rid, Emmanuel, and Wendler on assessing risk
right now, we rely on intutiion to assess risk. they propose SERR method to assess risk in a more standardized way. (Systematic Evaluation of Rsrch risks)
- identify harms
- categorize magnitude of harms with harm scale
- estimate likelihood of potential harms
- compare potnetial harms with harm of comparable activity. if similar, risks may be acceptable.
Slovic on risk
most people perceive and assess risks without an emphasis on mortality rates. empirical evidence won’t convince them.
people assess risk with characteristics like familiarity, control, catastrophic potential, threat to future genertions. people tolerate more risk for things they see as beneficial.
Williams on IRBs
IRBs are bad at assessing risks and benefits compared to their ability to protect rights.
group vs. community
group = exists bc a shared trait, doesn't have structured leadership community = group that has organizational structure and leadership regardless of research; may form around a shared trait.
privacy vs confidentiality
privacy = what people don’t want researchers to have or know. deals with what can be withheld, what should not be gained without permission.
confidentiality = management of private information.sharing private information appropriately, protecting it.
HIPAA and research
hipaa privacy rule doesn’t apply directlyt o research, but it does specify circumstances under which providers can disclose info. HIPAA is not harmonized with the Common Rule. hipaa forms discourages subjects from enrolling in research. hipaa does not give privacy protection to human subjects, but creates many obstacles to recruitment (and therefore creates a selection bias)
deidentification
info that has been altered to remove certain data elements with an individual. between anonymous (has no direct/indirect identifiers and can’t be linked to an ind) and personal information (which is identifiable)
deidentification may not be sufficient bc:
who is doing this?
easy to re-ID people
group harms
objectionable uses (abortion, cloning, etc)
commercial exploitation (Henrietta Lacks, etc)
trust/transparency
public opinion of research
Rothstein - on deidentifiable information
identifiable info has legal protections; deidentified info does not.
Rothstein we needs a continuum of protections, not black and white categories.
Privacy rule and common rule are inconsistent about deidentified info - common rule - anonymous or deidentified info is exempt. privacy rule - it’s exempt only if consent is first given. and its’ exempt only for a limited purpose.
Rothstein argues that de-IDed info has lots of risks to inds and groups; so, current system needs revision and clarification.
certificates of confidentiality
make researchers exempt from disclosing PHI in civil, criminal, administrative, legislative, or other proceeding.
in reality, they haven’t always worked this way. courts don’t always honor them.
HAvasupai
DNA samples given to ASU researchers to help with diabetes. then used for other things, like mental illness and discovering the tribes’ origins. found that they were not consistent with tribal stories.
- IC was not sufficient
- IRBs have to consider group harms
- Ended in a settlement
Tuskegee
syphilis study
Coleman on vulnerability
people are vulnerable to consent, risk, and justice.
typically, vulnerable is applied to groups - pregnant women, kids, prisoners, poor, etc. the assumption is that you are vulnerable bc you are part of a group or population. OR, bc of consent (you aren’t competent)
But, there are consent based vulnerability (which soemtimes can be remedied)
risk based vulnerability
justice based vulnerability - ex, rsrch in other countries
Kipnis on vulnerability
we shouldn’t think of vulnerability in subpopulations, but through an analytical approach that considees circumstances.
Six kinds of vulnerabilty:
1 cognitive (capacity to consent)
2 juridic (is participant subject to authority of others who have interest in their participation?)
3 deferential (does subject have readiness to accede bc of external factors or patterns of deference/submission?)
4 medical - (subject is selected bc she’s in desperate health condition)
5 allocation - subject lacks social goods, and this lack leads her to participate.
6 infrastructural vulnerability - does the political, organizational, social, or economic context contain integrity? (ex, rsrch in communities without medical access)
IOM report on prisoners
there’s a need to expand protections to prisoners.
- expand def of prisoner to include those on parole or probation
- shift from category to risk based approach to research review (and therefore disallow phase 1 and 2)
- enhance oversight on prisoner research
Chwang on prisoner research
additional risk-benefit constraints on prisoners are not necessary. Common Rule and IOM recs are enough.
-IOM compares prisoners and kids. Prisoners are not kids.
