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    Human Subject Protection

    Posted by Ochsner on 12/07/11

    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 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 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
    -Dr. Carolyn Compton (NCI Biorepositories Director) on
    Ethics and regulation of specimen research
    -DHHS OHRP Staff on Overview of 45 CFR Part 46 (Common
    -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
    -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

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