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  1. Genetic Information Nondiscrimination Act (GINA-2008)
    federal law that prohibits discrimination in health coverage and employment based on genetic information
  2. Health Insurance Portability and Accountability Act (HIPAA)
    protects patients from unlawful disclosure of private health information
  3. Exception to Informed Consent
    Storing tissues from diagnostic procedures does not require informed consent
  4. Criteria for the use of unidentifiable data and biological specimens
    • 1. research is not regulated by the FDA
    • 2. key is destroyed or release of the key is prohibited; IRB-approval which prohibits the release of the key; legal requirements prohibiting the release of the key
  5. Activity is exempt if...
    research is involved on existing (already collected tissue at time of proposal) and the subjects cannot be identified directly or indirectly
  6. Activity is NOT exempt if...
    • 1. specimens/data can be linked to individuals
    • 2. Provider is collaborating
    • 3. specimens are actively being collected
  7. De-identified or coded specimens
    investigators have no access to private information and there is no subject contact
  8. Limited Private Information
    where investigators do not record or keep this information and there is no subject contact
  9. 45 CFR part 46
    HHS regulations for the protection of human subjects
  10. 45 CFR parts 160 and 164
    HIPAA regulations for standards for privacy of individually identifiable health information
  11. 42 CFR part 50
    Subpart F HHS Regulations for Responsibility of Applicants for Promoting Objectivity in Research for Which PHS funding is sought
  12. 21 CFR part 50
    FDA regulations for the protection of Human Subjects
  13. 21 CFR part 56
    FDA regulations for IRBs
  14. Vulnerable Populations
    pregnant women, children, fetuses, neonates, decisionally impaired, prisoners, and students
  15. Minimal Risk
    minimal if "not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests"
  16. Greater than minimal risk with prospect of direct benefit
    • clinical care model
    • does the benefit justify the risks
  17. greater than minimal risk with no prospect of direct benefit
    • IRBs approve with conditions including...
    • -risks at most a minor increase over minimal
    • -research addresses a condition that affects the subject
    • -experience of participating resembles the experience in clinical care
  18. Medical Therapy
    • aims at relieving the suffering of people and restoring them to health
    • attempts to cure, correct, and bring about normal functionality
    • focus is on the individual as a patient
  19. Medical Research
    • scientific enterprise that aims to acquire a better understanding of the biochemical and physiological processes involved in human functioning¬†
    • focuses on theories, not the patient
  20. What happens if there is an adverse event?
    Investigators have AN ETHICAL DUTY TO REPORT
  21. Belmont Report (1979) Assumptions
    • 1. concepts of clinical research and clinical medicine are distinct
    • 2. distinct groups of patients and future populations
    • 3. distinct methodologies
  22. 3 cornerstones of clinical trial design
    • Controls
    • Randomization
    • Blinding
  23. Equipoise
    • balance or equitable distribution
    • uncertainty regarding which arm will provide more favorable outcomes
    • clinical (balance in treatment options)
    • scientific (balance in the scientific question)
  24. Doctrine of Clinical Equipoise
    bridge between medical care and scientific experimentation making it possible to conduct randomized control trials without sacrificing therapeutic obligation of physicians to provide treatment according to a scientifically validated standard of care
  25. Superiority
    • most common type of comparison
    • demonstrating superiority to a placebo
  26. Non-inferiority
    efficacy of an investigational product is no worse that an active comparative treatment
  27. Equivalence
    response to two or more treatments differs by an amount that is clinically unimportant
  28. Parallel Group Trial Design
    randomization to treatment groups with equal chance to be allocated to either treatment section
  29. Cross-over trail design
    • both treatments in sequence
    • patients serve as their own control
  30. open-label trial design
    randomized but participants and investigators know which treatment is being administered
  31. Phase I
    • small populations of healthy participants
    • higher risk of harm
    • determines drug toxicity, absorption, distribution, metabolism, excretion, duration of action, drug-to-drug interaction, drug-to-food interaction
  32. Phase II
    • drug tested for safety and efficacy in a large population afflicted with a specific disease/condition
    • short, close monitoring is required, aim is to determine proper dosing and therapeutic efficacy
  33. Phase III
    • compared to current standard treatments
    • 500-3000 and randomized
    • prevention trials may require up to 20,000 participants
    • demonstrate or confirm the therapeutic benefit from using important clinical endpoints rather than surrogate endpoints
  34. Phase IV
    • after drug is approved for distribution or marketing
    • post-marketing surveillance trial
    • safety surveillance or pharmacovigilance
    • used to explore new uses for drugs
  35. Privacy
    free from interference by others
  36. Confidentiality
    responsibility to protect personal information from unauthorized access, use, disclosure, modification, loss, or theft
  37. Indemnity
    contract to compensate persons for losses or damage
  38. Clinical trial insurance
    • professional negligence
    • product liability
    • no-fault liability
  39. Three key ethical principles in US Research
    • Respect for Persons
    • Beneficence
    • Justice
Card Set:
2016-09-20 15:52:16

laws and policies to remember
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