Monday 4 October 2010

human subjects research


News: Patricia Backlar appointed to OHSU Stem Cell Research Oversight Committee


patricia has brought in from OHSU

chief integrity officer

human subjects research

ethics

contemporary cases

http://www.pdx.edu/news/patricia-backlar-appointed-to-ohsu-stem-cell-research-oversight-committee

animal research has more laws
4x

human subjects can exit
vote with feet

cancer bone marrow

http://ohsr.od.nih.gov/guidelines/nuremberg.html
http://en.wikipedia.org/wiki/Nuremberg_Code

http://en.wikipedia.org/wiki/Josef_Mengele

1932 tuskegee syphilis
http://en.wikipedia.org/wiki/Penicillin
sir alexander fleming
1919

pathogenesis of syphilis

federal regulations
http://ohsr.od.nih.gov/guidelines/belmont.html

too late for tuskegee

too late for guatamala

belmont report
http://ohsr.od.nih.gov/guidelines/belmont.html
non-malefeasance
beneficence

FDA
http://nihroadmap.nih.gov/clinicalresearch/

http://www.fda.gov/

http://www.aboutlawsuits.com/seroquel-951/

http://www.coreynahman.com/atypical-antipsychotic-lawsuits.html

backlar recommends
http://bioethics.net/mt/mt-search.fcgi?tag=Alta%20Charo&IncludeBlogs=1
http://www.law.wisc.edu/profiles/racharo@wisc.edu

http://en.wikipedia.org/wiki/Alta_Charo

SSRI's

for children
http://www.safecosmetics.org/

can restrict
via audit
http://www.hhs.gov/ohrp/

animal protections more extensive

human subject research without federal funding

practical---hard to do
publish
practice

or get approved or licensed

private practice research
split

sued for malpractice
exceeded malpx insurance

IRB
institutional review board
defined

common rule
ir

5 members
no conflict of interest

must have a nonscientist
reflect the nonscience coming t us

every subspecialty coming to us

state mental hospital

high rate of suicide
FDA approved for kids based on adult only research

they were dissuaded from research on kids

take limited testexpand
effects fatal

same thing with overprotecting women of childbearing age
no tests then
damage to women
HIV
cardiovascular

FDA 30 yrs out of sync

the common rule

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