10:832:356 Lecture Notes - Lecture 10: Genetic Testing, Employment Contract, Medical Procedure
9 May 2018
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Lecture #10: The Ethical and Legal Considerations for Testing and Population Based Screening
I. Testing Versus Screening
• Clinical Testing:
• Medical procedure.
• Determines presence or absence of disease.
• Individual patient.
• Screening:
• Systematic application of a medical test.
• Geared to a defined population.
• Objective: Identify those with the disease/infection.
• Goal: Offer education, counseling, or treatment. Monitor epidemics.
II. Screening is NOT Perfect: Can be Unreliable, Intrusive, and/or Unjust
• Can be unreliable if the testing instrument is technically deficient.
• May produce a false positive.
• May lack predictive value in area of low-prevalence.
• Example: Early HIV testing for marriage license was cost ineffective and had many
false positives.
• Can by intrusive if done without informed consent.
• Undermines personal autonomy and bodily integrity.
• Possibility of data breach and unintended discrimination.
• Can be unjust if vulnerable populations are targeted.
III. Screening Programs: Five Categories
• 1.) Completely Mandatory:
• Most stringent level.
• Requires citizens to undergo an intervention, with sanctions (civil and legal) if they fail to
comply.
• Example: Probationary drug testing.
• 2.) Conditionally Mandatory:
• Government or private sector.
• Required to obtain what is offered.
• Example: Drug testing welfare recipients- ethical?
• 3.) Routine Without Notification:
• Intervention done routinely and automatically, with a right of refusal by participant (rare,
due to lack of notification).
• Can waive right of refusal contractually.
• Example: Employment contract at hospital.
• 4.) Routine With Notification:
• Participants are informed of their participation and right to refuse (rarely used).
• 5.) Voluntary:
• Must have authorization of participants.
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Document Summary
Completely mandatory: most stringent level, requires citizens to undergo an intervention, with sanctions (civil and legal) if they fail to comply, example: probationary drug testing, 2. ) Conditionally mandatory: government or private sector, required to obtain what is offered, example: drug testing welfare recipients- ethical, 3. ) Routine without notification: intervention done routinely and automatically, with a right of refusal by participant (rare, due to lack of notification), can waive right of refusal contractually, example: employment contract at hospital, 4. ) Routine with notification: participants are informed of their participation and right to refuse (rarely used), 5. ) Page !1: consent is implied or explicitly obtained, consent is implied because person goes to be tested, example: brca2 testing for breast cancer gene. Establishing a screening program: wilson and jungner classic screening criteria, 1. ) The condition sought should be an important health problem: 2. ) There should be an accepted treatment for patients with recognized disease: 3. ) Facilities for diagnosis and treatment should be available: 4. )
