Human Subject Research

Human Subject Research

1. History

   • Willowbrook
     • 1950s Involved intentionally infecting health children with hepatitis by feeding them a solution of feces and active hepatitis
   • Nuremberg
     • informed consent (voluntary, legal capcity, compreh) Should produce fruitful results Avoid uneccessary suffering and risk  Favorable risk/ benefit ratio Subject can leave at any time Scientific professionals need to conduct research
   • Jewish Chronic Disease Hospital
     • 1960s Live cancer cells injected into chronically ill (eldery, demented) designed to determine the influence of a weekended immune system on the spread of cancer
   • Tuskegee
     • Funded ended and gave them fake treatment Didn't know they had syhpilis or penicilin avail or subject of study Subjects from vulnerable population Rights of subjects violated No informed consent
   • Guatemala Studies
     • US PH officials infected soliders, prostitutes, prisoners, and mental patients with syphilis and other STDs without informed consent and treated most with antibiotics. 83 deaths.
   • Beecher's Article
     • Outlines ethically problematic experiements that were published by Drs and prestigious journals more reliable safeguard of a patient's rights than just getting informed consent:  Presence of a truly responisble infestigator-Shouldn't get published if work not ethical-Ends don't justify means -IC is only reliable if patients know ALLL risks
   • The Belmont Report
     • 3 Principles 1) Respect of person:           1) Voluntary consent         2) Must be informed consent         3) Privacy and confidentiality              must be protected         4) Right to withdraw without                penalty2)Beneficience 3)Justice 
   • San Antonio Contraception Study
     • 1970s Eval of efficacy of various types of oral contraceptive pills in a randomized, blind, placebo controlled study. Patient's indigence rendered them unable to seek advice. Many had pregnancies bc they weren't informed of placebo

2. Stages to Approve a Drug

   • Animal Research
   • Phase 1: Safety
     • 20-80 healthy volunteers
   • Phase 2: Efficacy
     • 12 - 300 sick
   • Phase 3: Safety and Efficacy in Numbers
     • hundreds - thousands sick.  FDA approval after this stage
   • Post- Marketing
     • Gathering data on large numbers

3. Emmanuels et al.

   • 7 Requirements
     • Value
     • Informed Consent
     • Favorable Risk Benefit Ratio
     • Scientific Validit
     • Fair Subject Selection
     • Independent Review
     • Respect for Enrolled Subjects

4. Vaccine Allocation

   • Field
     • Why?
       • -New outbreaks mean there isn't vaccines -Study of disease course, transmission, and treatment take a long time -Exp. of vaccine safety can take a long time -May be limited production ability
     • 4 Ethical Considerations
       • 1) Beneficence 2) Nonmaleficence  3) Justice 4) Utilitarianism
     • 5 Allocation Strategies
       • Most vulnerable
       • Essential to PH
       • Respect Needs of Disadv
       • Most likely to benefit
       • Most productive
   • Persad
     • Allocation Strategies
       • Favor Worst Off
         • Sickest
         • Youngest
       • Treat People =
         • Lottery
         • 1st come
       • Maximize Total Benefits
         • Prognosis of LY Saved
         • # lives saved
       • Promoting and Rewarding Social Usefulness
         • Instrumental Value
         • Recripocal Value
     • Flawed principle
       • -Inherently flawed: recognize irrelevant considerationsex) recognizing ability to pay, being a relative of vaccine maker-Practically flawed: allow irrelevant considerations to affect allocation
     • Insufficient Principle
       • ignores morally relevant considerations ex) ignoring whether or not someone is already disadv.
     • 3 Allocation Schemes
       • QALYS
         • Prognosis (comparing states of health by adjusting years of life via QOL) ADV: Maximises future benefits DISADV: disadv disabled, is it more important to maximize QALYS or treat people =
         • Prognosis
       • UNOS Points
         • Combines sickest 1st, 1st come 1st served, and prognosis DISAD: well off place themselves on multiple lists, docs can overstate the patient's level of sickness
         • Prognosis
         • 1st come
         • SIckest
       • Disability LY
         • Similar to QUALYs but incorporates age(prognosis + age)
         • Prognosis
         • Age
       • Complete Lives System!
         • Youngest 1st, prognosis, save the most lives, lottery, instrumental value  DISADV: discrimination against older people, (but not bc life states), insensitive to international differences in a typical lifespan, needs to be publicly understandable and accessible
         • Youngest
         • Prognosis
         • Most lives
         • Lottery
         • Instrumental Value