Many
of our recently held briefings are available on audiocassette files.
Visit our Tapes Library for our highly regarded series
on:
|
 Audio
Library
Human
Research Protections: Pre-screenng
and Case Identification Under HIPAA |
|
|
Speaker: |
Lawrence
Muhlbaier, PhD Clinical Research Institute, Duke University |
| Date
of Briefing: |
July 24,
2003 |
| Approximate
length: |
One
hour |
|
Description: |
The Health Insurance Portability
and Accountability Act (HIPAA) seemingly touches nearly
every part of the health care industry. Clinical research
is no exception. HIPAA regulations cover research through
privacy notices, use/disclosure, patient identification,
waiver criteria, and authorizations. Limited Data Sets
will play a new role in providing pre-screening logs to
sponsors. Researchers also must be aware that, despite
the far-reaching impact of HIPAA, other relevant rules
remain in effect, e.g., HIPAA provisions do not supersede
the FDA regulations nor the “Common Rule.” |
| Price: |
$195
Tape |
| ttttttttttttt
|
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Order Form |
Audio
Library
Human
Research Protections:
Beyond
IRBs: Human ResearchProtection in the Post Gelsinger/Roche
Era
|
|
|
Speaker: |
Adil
Shamoo, Ph.D., Univesrity of Maryland School of
Medicine, foremost national expert in human research
protections and Ned Rubin, MSW, RN, Friends Research
Institute, Expert on QI in Clinical Trials |
|
Date
of Briefing: |
June
25 , 2003 |
|
Approximate
length: |
One
hour |
|
Description: |
Hundreds of deaths
in clinical research are said to go unreported in
the United States each year. The recent tragedies
of Jessie Gelsinger and Ellen Roche humanized this
statistic and have resulted in a demand for increased
federal scrutiny and better human research protection.
One response has been the Kennedy-Kreiger bill.
Stiff civil and criminal penalties, an activist
plaintiff’s bar, and media interest now require
not only due diligence but real protection mechanisms.
Safeguards beyond traditional IRB structures are
also being advocated. Other responses include enacting
selected HIPAA provisions and OHRP's QI Initiative. |
|
Price: |
$195
Tape |
|
ptovvvvv |
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to the
Order Form |
|
Audio
Library
Human
Research Protections:
Making
HIPAA Research Disclosures to Registries
|
|
|
Speaker: |
D.M.L.
Lee |
|
Date
of Briefing: |
March
11, 2003 |
|
Approximate
length: |
One
hour |
|
Description: |
This
audiobriefing features Diane Lee –
a specialist on HIPAA, eHealth and health
care compliance. She provides practical
information on how to make HIPAA-related
disclosures to both public and private registries,
and the roles that institutional review
boards (IRBs) may play in the process.
|
|
Price: |
$195
Tape |
|
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to the
Order Form |
|
|
|
|
Audio
Library
Human
Research Protections:
How To Reduce IRB-related Risks in Clinical Trials |
|
| Speaker: |
Ann
M. Begley, Esq., a specialist on IRBs and the FDA |
| Date
of Briefing: |
January
14, 2003 |
| Approximate
length: |
1
3/4 hours |
| Description: |
Begley
explains how to reduce IRB-related risks through strong
standard operating procedures, education of IRB members
and indemnification agreements with research sponsors. |
| Price: |
$325
Tape |
|
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|
|
Audio
Library
Human
Research Protections: International Clinical Trials: Ethical
and Legal Issues |
|
| Speaker: |
Stuart
Kim, attorney, McKenna & Cuneo |
| Date
of Briefing: |
March
1, 2002 |
| Approximate
length: |
1
hour |
| Description: |
Find
out from attorney Stuart Kim the often conflicting laws,
regulations, and guidelines regarding the protection
of human research participants worldwide, and the legal
and ethical issues sponsors and clinical investigators
must consider when conducting clinical research in
an international context. |
| Price: |
$195
Tape |
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Order Form |
|
|
Audio
Library
Human
Research Protections: Ethical, Legal and Effective Patient
Recruitment |
|
|
Speaker: |
Christine
Pierre, President, Rx Trials
|
| Date
of Briefing: |
February
28, 2002 |
|
Approximate
length: |
1
hour |
|
Description: |
There
is growing concern about the methods clinical trial
recruiters use to fill their subject rolls. Amid
heightened scrutiny, how should recruiters solicit participation
in trials, what must be disclosed to prospective subjects,
how can "standard of care" requirements be
met during trials that use placebos? Get answers
to these and other questions from Christine Pierre,
President, RxTrials, and co-chair of the Association
of Clinical Research Professionals' ethics and regulatory
forum.
|
| Price: |
$200
CD |
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|
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|
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last updated
October 16, 2006
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