Dealing with Vulnerable Populations. Lyn Hardy, PhD Director, Research Administration Texas Children’s Hospital. Goals. Persons attending this session will have an understanding of the: definition(s) of vulnerability background for protection of vulnerable populations
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Lyn Hardy, PhD
Director, Research Administration
Texas Children’s Hospital
Persons attending this session will have an understanding of the:
Do we agree?
Axis of evil
Tengo una pregunta de la investigación.
J'ai une question de recherches.
Increased scrutiny for vulnerable individuals is from the basic premises of the Belmont Report – respect for persons and justice
Trigger Events Ethics Milestones
*Syphilis Study Begins
*The Nazi Experiments
*Human Radiation Exp.
Nuremberg Code 1947
*The Thalidomide Tragedy
Amendments to the Food, Drug, Cosmetic Act 1962
Willowbrook Study Declaration of
Jewish Chronic Dis. Study Helsinki 1964
San Antonio Contraceptive Study
EX-CHIEF DEFENDS SYPHILIS PROJECT; Says Alabama Plan Was Not Unethical or Unscientific
Doctor Says He Was Told Not to Treat Men in V.D. Experiment
AT LEAST 28 DIED IN SYPHILIS STUDY; Reports on Tuskegee Tests Indicate Much Higher Toll
U.S. Syphilis Study Called 'Ethically Unjustified'; Report of Tuskegee Panel to Congress Urges a Board to Guide Human Research
REGULATION URGED IN HUMAN TESTING; Panel Calls for Controls on Federally Aided Research Need for Protection Cited
New York Times New York, N.Y.: Aug 8, 1972. pg. 16, 1 pgs
New York Times. New York, N.Y.: Jul 28, 1972. pg. 29, 1 pgs
New York Times New York, N.Y.: Sep 12, 1972. pg. 23, 1 pgs
New York Times New York, N.Y.: Jun 13, 1973. pg. 21, 1 pgs
By NANCY HICKS. New York Times New York, N.Y.: Mar 21, 1973. pg. 30, 1 pgs
Asks for parental permission to allow child to participate in research
“A child’s affirmative agreement to participate in research”…..”Failure to object, absent affirmative agreement, should not be construed as assent.” (45 CFR 46.402(b))
Having ‘capacity’ to agree for one’s self to participate in a given situation, e.g., research
Understands risks and benefits of participation and agrees to potential consequencesConsent or Not Consent!
age 16 or 17
Living apart from parent
Pregnant (r/t preg)
Minor parent (consent for medical consent for child)
Living apart from parent (managing own affairs)
Tex. Rev. Civ. Stat. §313.004
Tex. Fam. Code Ann. §31.01
Tex. Fam. Code Ann. §32.003(a)(4)
Tex. Fam. Code Ann. §32.003(a)(6)
Tex. Fam. Code Ann. §32.003(a)(2)
Tex. Fam. Code Ann. §32.003(a)(1)Texas State Law
45 CFR 46 - Subpart C
“In many industrialized countries, the obsession with independence devalues people with disabilities, who are believed to personify weakness or vulnerability.” Jennifer Kern