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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