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- HRPP announces new
guidelines for billing for research-related procedures under NCD/SB37.
For some
cancer-related clinical trials, the PI may be eligible to bill Medicare
or private insurer for rountine costs associated with the trial under
the Medicare Clinical Trials Policy National Coverage Decision (NCD)
and SB37 (California state) rules. Cancer-related projects that
intend to bill Medicare or private insurers for routine care must
qualify. HRPP has posted a fact sheet on the regulatory
background and instructions for revising the biomedical research plan
to ensure compliance with federal, state, and UC policies. Effective
immediatly, IRB applications involving a clinical trial for cancer that
include a provision to bill participants or their insurer for
research-related procedures must include a separate Billing Addendum. The Billing
Addendum is reviewed by the Research Compliance Office and must be
approved prior to initiating the trial.
- Pediatric IRB
Information. The Pediatric IRB "D"
Committee was launched in May 2007. As announced, IRB submissions
involving children and adolescents will be assigned to this Committee
because of expertise. As the "D" Committee only meets once per month,
please ensure careful review of due dates and meeting dates to avoid
significant delay or any lapse in approval. (In general, no research
may be conducted if a protocol has been allowed to expire.) The meeting
due dates can be found here.
- PLEASE NOTE: Only complete
submissions will be assigned to an IRB agenda. Submissions will only
be considered complete if all materials including signed application
face sheet, completed Research Plan, Master Protocol (as applicable),
consent documentation, etc. are received by 4:00 pm no later than the
meeting due date. The same applies to continuing review documentation:
to be considered complete, signed Continuing Review Facepages,
Narrative, consent documentation, as appropriate, etc. must be received
approximately 45 day prior to experation for consideration to be placed
on an IRB agenda.
- HRPP announces new
guidelines for reporting adverse events to the IRB. Investigators often
engage in a popular strategy of over-reporting and relying in the IRB
triage mechanisms for deciding what reports go to convened meetings.
OHRP notes that because most individual adverse events (AEs) do not
appear to represent unanticipated problems, the vast majority of AEs do
not need to be reported to the IRB. UCSD's HRPP has revised its
Standard Operating Policies and Procedures in response to recent
guidance provided by OHRP, the FDA and the VA Office of Research
Oversight. Guidance for Prinicipal Investigators and research staff
when reporting unanticipated problems or adverse events to the IRB is
provided in this fact sheet.
- VA Privacy and Data
Security Plan. VA investigators are
now required to include procedures in their Research Plans for
ensuring safety and security of VA research data. Guidelines and
recommendations for this VA requirement can be found here.
- As a reminder,
please ensure that
complete continuing review materials are submitted approximately 45
days prior
to expiration (check the most recent approval letter) to avoid any
lapse in approval or the need to submit a NEW application should the
study's
approval expire. Also,
if there is no lapse
in approval, a study may receive up to 4 IRB
reviews. A study may undergo an Initial and 3 Continuing Reviews.
Please check the status of the study carefully before submitting
Continuing Review materials.
- HIPAA
(Health Insurance Portability and Accountability Act of 1996)
information
for researchers. Details
here...
- More...
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