Human Subject Protection

Posted by Ochsner on 12/07/11

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The Friday 1/13/2012 OHRP-Ochsner Research Community
Forum has been approved for 6.25 hours of CLE credit by
LASCMCLE. Register now at www.ochsner.org/cme with a full
schedule and printable flyer available on that site. Please
forward this to any colleagues who may be interested.

This OHRP conference co-sponsored by Ochsner is at
the Canal Place Westin in the French Quarter on Friday
1/13/2012. $125 registration fee includes breakfast, lunch,
coffee breaks. $5 Canal Place parking (up to 10 hours)
available by getting your parking ticket stamped at the
registration desk. Questions? contact cme@ochsner.org A
block of rooms at the Canal Place Westin have been reserved
at the group rate of $179 per night. Please call the hotel
at (888) 627-8180 and mention you are attending the OHRP
Protecting Human Research Subjects conference. Please note
that the special rate will be available until Tuesday,
December 13, 2011 after which reservations will be on a
space available basis.

Highlights that will be of special interest to lawyers:
-Dr. Jerry Menikoff (a JD & OHRP Director) on the proposed
changes to the Common Rule, esp. informed consent
-Dr. Jim Wilson (Univ. Penn. gene therapy investigator who
supervised the famous study with the first human death from
gene therapy) on Lessons learned from the OTC trial. See
weblinks on him in the flyer at www.ochsner.org/cme
-Dr. Carolyn Compton (NCI Biorepositories Director) on
Ethics and regulation of specimen research
-DHHS OHRP Staff on Overview of 45 CFR Part 46 (Common
Rule)
-DHHS OHRP Director (a JD) on Legal case law and human
subject protection
-Dr. Sohail Rao at Ochsner on Conflict of interest issues
in research
-Dr. Ken Kratz at LSUHSC-NO on FDA mechanisms for use and
approval of FDA investigational products
-Dr. Maryellen Romero at Tulane on Cognitively Impaired
subjects
-DHHS OHRP Staff on Flexibility in the regulations
-An Ask the Feds Q&A hour emceed by Elyse Summers, JD, of
OHRP and will include the FDA headquarters person who
supervises CBER's inspections of investigators, sponsors,
IRBs, and nonclinical labs.

Protecting Human Research Subjects