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Genetic Information Nondiscrimination Act (GINA-2008)
federal law that prohibits discrimination in health coverage and employment based on genetic information
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Health Insurance Portability and Accountability Act (HIPAA)
protects patients from unlawful disclosure of private health information
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Exception to Informed Consent
Storing tissues from diagnostic procedures does not require informed consent
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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
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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
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Activity is NOT exempt if...
- 1. specimens/data can be linked to individuals
- 2. Provider is collaborating
- 3. specimens are actively being collected
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De-identified or coded specimens
investigators have no access to private information and there is no subject contact
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Limited Private Information
where investigators do not record or keep this information and there is no subject contact
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45 CFR part 46
HHS regulations for the protection of human subjects
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45 CFR parts 160 and 164
HIPAA regulations for standards for privacy of individually identifiable health information
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42 CFR part 50
Subpart F HHS Regulations for Responsibility of Applicants for Promoting Objectivity in Research for Which PHS funding is sought
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21 CFR part 50
FDA regulations for the protection of Human Subjects
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21 CFR part 56
FDA regulations for IRBs
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Vulnerable Populations
pregnant women, children, fetuses, neonates, decisionally impaired, prisoners, and students
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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"
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Greater than minimal risk with prospect of direct benefit
- clinical care model
- does the benefit justify the risks
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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
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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
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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
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What happens if there is an adverse event?
Investigators have AN ETHICAL DUTY TO REPORT
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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
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3 cornerstones of clinical trial design
- Controls
- Randomization
- Blinding
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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)
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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
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Superiority
- most common type of comparison
- demonstrating superiority to a placebo
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Non-inferiority
efficacy of an investigational product is no worse that an active comparative treatment
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Equivalence
response to two or more treatments differs by an amount that is clinically unimportant
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Parallel Group Trial Design
randomization to treatment groups with equal chance to be allocated to either treatment section
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Cross-over trail design
- both treatments in sequence
- patients serve as their own control
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open-label trial design
randomized but participants and investigators know which treatment is being administered
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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
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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
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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
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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
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Privacy
free from interference by others
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Confidentiality
responsibility to protect personal information from unauthorized access, use, disclosure, modification, loss, or theft
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Indemnity
contract to compensate persons for losses or damage
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Clinical trial insurance
- professional negligence
- product liability
- no-fault liability
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Three key ethical principles in US Research
- Respect for Persons
- Beneficence
- Justice
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