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- Updated SOPP:
SOPP, section 4.2,
Categories of Action, has been updated to more specifically define the
four categories an IRB can take when reviewing research and the
procedures regarding the review of responses to Committee requests.
These procedures include that if the response alters/affects
risk/benefit to subject; equitable and non-coercive
selection/recruitment of subject; privacy and confidentiality; process
and documentation of consent/assent; and/or additional safeguards for
vulnerable subjects, the response will be placed on an agenda for
review at the next appropriate IRB meeting. This SOPP can be found on
the SOPP page. (Released 5/11/12)
- Updated Forms and
SOPP: The Narrative Summary
of Progress to Date for both Biomedical and Social and Behavioral
studies has been revised include a separate section for more clearly
provide a summary of any subject complaints since the last IRB review.
In addition, SOPP, section 3.4, Informed Consent, page 5, has been
updated to include ClinicalTrial.gov wording required by the FDA for
applicable trials. The revised forms can be found on the Forms page. The updated SOPP can be found on
the SOPP page. More information about the
required FDA wording can be found here.
(Released 4/23/12)
- Updated Form:
The Biomedical
Standard Application Facesheets have been revised to include an
additional Yes/No checkbox to indicate whether the study will recruit
potential participants using ResearchMatch. The updated form is
available on the Forms page. (released
03/27/12)
- Updated SOPP:
SOPP, section 3.10,
Expedited Review, has been updated to include additional information
regarding expedited review of sponsor provided annual reports and
DMC/DSMB reports. This SOPP can be found on the SOPP
page.
(Release 2/3/12)
- Updated SOPP:
SOPP, section 3.2,
Full IRB Review, has been updated to include procedures for rapid-cycle
review of adult Cancer Cooperative group trials reviewed by the
National Cancer Institute (NCI) Central Institutional Review Board
(CIRB). This SOPP can be found on the SOPP page.
(Released 01/31/12)
- Additional
FDA-required consent wording: Additional wording
regarding a statement informing participants about the
ClinicalTrial.gov trial registry for applicable clinical trials must be
included in the consent of applicable trials initiated on or after
March 7, 2012. For more information, please see the FAQ, Frequently
Asked Questions--FDA Final Rule: Clinical Trials.gov Consent Wording. (Released 01/17/12)
- HIPAA
(Health Insurance Portability and Accountability Act of 1996)
information
for researchers. Details
here...
- More...
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About
HRPP
