The
HRPP
has both paper and electronic forms; in some cases the data from the
form
can be submitted online directly to HRPP as well as printed.
These
documents are in Adobe Acrobat 5.0 format. If you do not have the
Acrobat
reader, you can get it here.
Macintosh users please note: the online
PDF forms are compatible with Adobe Acrobat 6.0. Earlier versions
of Acrobat for the Macintosh may not support for PDF forms (form is
viewable but there is no functioning Submit button on the last
page).
Biomedical
Research Forms
Biomedical Research Application forms
- Standard Forms for UCSD and VASDHS research
- Hybrid Consent
Information Update: The
VA R&D review process is currently undergoing a transition and that
office has contacted researchers directly. As a result of the changes
in process, studies including both UCSD and VA sites and/or
investigators may be affected. Therefore, during this period, it has
been determined that it may be best for researchers to continue to
submit separate UCSD and VA/VMRF consents rather than use the newly
proposed VA hybrid consent when submitting NEW applications for IRB
review. In addition, institutional contractual agreements (such as
clinical trial agreements or CTAs) may differ between institutions that
can impact consent language. A review by these offices of the proposed
hybrid consent is underway. Please note: should you already have an
approved hybrid consent, continued use is acceptable at this time
through the expiration period until further notice.
- Continuing Review Facepages, Continuing
Review
Narrative Summary of Progress, and as
applicable, currently approved consent forms and clean consent forms
(for stamping) are to be submitted approximately
45 days prior to expiration date (365 days from initial approval
or as outlined in the approval letter). These must be reviewed in
conjunction with an IRB meeting. To avoid any expiration or lapse in
approval, please ensure submission according to IRB due dates, not
meeting dates. To avoid suspension of study, again, it is strongly
suggested that the submission process begin 45 days prior to expiration.
-
It is the PI's responsibilty to gain
continuing approval for projects
lasting longer than one year. Therefore, the PI's department should
maintain internal systems to track when continuing reviews must be
submitted. Although e-IRB systems can be useful, they should not be
relied upon to avoid lapses in approval (due to volume of data and
access by multiple users).
Federal regulations require that IRB review and re-approval of projects
be accomplished at intervals not greater than 365 days. If
Initial and
Continuing Reviews are granted, the maximum project lifespan is up to 4
years (i.e., up to three cycles of Continuing Review after Intial
approval). No later than 45 days prior to the fourth anniversay of
Initial approval, the project must be resubmitted as a New
Application. The title should include the word "Resubmission" after the
title on the new application facepages.
- Experimental
Subject's Bill of Rights
- Forms for Research involving San
Diego
Children's Hospital and Health Center (these forms are for UCSD
salaried faculty, staff and students who are planning research where
CHHC is
a site of performance). Effective June 1, 2004 use of these forms
for a new project submission enables "dual IRB tracking" by both UCSD
and Children's IRBs, using a single submission through UCSD's
application process. Projects submitted using these forms should
be submitted to UCSD and will be assigned both a UCSD project number
and a Children's project number.
- Specialized
Supplementary Consents (in MS Word format)
- Informed
Consent Checklist
- Sample Investigational Drug Fact Sheet
- General Clinical Research
Center
(GCRC) forms
Supplementary VA
Investigator forms
MXT - Application for Use of Existing
Pathological
or Diagnostic Specimens
MXP - Application for Approval in Principle--to be
used
only for funding proposals in which definite plans for the involvement
of
human subjects will not be set forth; i.e., training grants,
institutional type grants, or projects in which the involvement of
human subjects will depend
upon completion of instruments, prior animal studies, or purification
of
compounds.
Adverse Event Report and Addendum to Report
forms
Social
and Behavioral Sciences Forms
SOI
- Social and Behavioral Sciences Application Form
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About HRPP
