Submit a New Project Application
For Biomedical Research Projects -
Studies typically conducted by UCSD faculty, staff, and students
affiliated with the UCSD Health System:
The New Project Submission (and 10-year resubmission of an
existing project)
includes the following steps:
- Download the Instructions
for filling out the Research Plan template.
- Download
a Word template for describing your Research Plan.
This is the document that contains contains headings for each of the
areas
on which the IRB must base its judgement of safety and ethics.
- Fill in the template document using the
Instructions,
the same way
you would if producing a paper submission and save it on your
computer. The difference between the e-IRB and paper-based review
process is that
you will upload this Word document to this website rather than printing
multiple copies of it.
- Create your consent document(s) in Word for Windows
format. Save the informed
consent(s)
and adolescent or child assents, if needed, one consent document per
file,
on your computer. You will have the opportunity to upload each
consent
or assent separately.
- Once your Research Plan document and consents are ready and
saved on
your
workstation, fill out the Biomedical
Application Facesheets.
These
face pages are in Adobe Acrobat format and must be submitted online via
your web browser. Please note
that Facesheets
signed by the Principal Investigator and the Department Chair are
required as a hardcopy document unless they
can be provided as an uploaded document. If provided as a hardcopy
document, the document should be mailed to the HRPP Office, mailcode,
0052. (Macintosh users please note:
The online PDF
form may be uploaded using the latest version of Adobe Acrobat or
Reader, Version X, and the latest version of Safari, Firefox or Chrome.
To
obtain the latest version of Adobe Reader, go to www.adobe.com. When installing the
latest Reader, please ensure that the Reader is chosen as the default
PDF reader. If you are using Chrome for Mac, you will need to disable
the built-in PDF viewer. Per Google, "To disable the built-in viewer,
enter about:plugins
in the address bar and click Disable underneath
the entry for 'Chrome PDF Viewer.' The Adobe Reader plug-in will
automaticlly be enabled, if you have it installed." For step-by-step
instruction for using Safari, please see here. For
step-by-step
instructions for using Firefox, please see here. For
step-by-step
instructions for using Chrome, please see here.)
- When you
submit
the Facesheets online, the system will give you a Temporary Project ID
(a
"T-number"). Once your information has been imported into the HRPP
database, usually within 1-2 working days, the project will receive a
HRPP project number, and you will receive an e-mail noting the HRPP
project number. You will then
need to log into your "My Protocols at a Glance" through eIRB services. Click on the
link for
your "new" project and you may begin to upload your documents.
Step-by-step
directions for submitting a new Biomedical Research project application
with visual aids.
For Social
and Behavioral
Science Projects - Studies typically conducted by UCSD faculty, staff,
and students affiiated with the UCSD campus:
- Download the Instructions
for filling out the Research Plan template.
- Download
a Word template for describing your Research Plan.
This is the document that contains contains headings for each of the
areas
on which the IRB must base its judgement of safety and ethics.
- Fill in the template document using the
Instructions,
the same way
you would if producing a paper submission and save it on your
computer. The difference between the e-IRB and paper-based review
process is that
you will upload this Word document to this website rather than printing
multiple copies of it.
- Create your consent document(s) in Word for Windows
format. Save the informed
consent(s)
and adolescent or child assents, if needed, one consent document per
file,
on your computer. You will have the opportunity to upload each
consent
or assent separately.
- Once your Research Plan document and consents are ready and
saved on
your
workstation, fill out the SBS Application
Facesheets.
These
facesheets are in Adobe Acrobat format and must be submitted online via
your web browser. Please note that Facesheets
signed by the Principal Investigator, Department Chair and Faculty
Advisor (if appropriate) is required as a hardcopy submission unless it
can be provided as an uploaded document. If provided as a hardcopy
document, the document should be mailed to the HRPP Office, mailcode,
0052. (Macintosh users please note:
The online PDF
form may be uploaded using the latest version of Adobe Acrobat or
Reader, Version X, and the latest version of Safari, Firefox or Chrome.
To
obtain the latest version of Adobe Reader, go to www.adobe.com. When installing the
latest Reader, please ensure that the Reader is chosen as the default
PDF reader. If you are using Chrome for Mac, you will need to disable
the built-in PDF viewer. Per Google, "To disable the built-in viewer,
enter about:plugins
in the address bar and click Disable underneath
the entry for 'Chrome PDF Viewer.' The Adobe Reader plug-in will
automaticlly be enabled, if you have it installed." For step-by-step
instruction for using Safari, please see here. For
step-by-step
instructions for using Firefox, please see here.
For
step-by-step
instructions for using Chrome, please see here.)
- When you
submit
the Facesheets online, the system will give you a Temporary Project ID
(a
"T-number"). Once your information has been imported into the HRPP
database, usually within 1-2 working days, the project will receive a
HRPP project number, and you will receive an e-mail noting the HRPP
project number. You will then
need to log into your "My Protocols at a Glance" through eIRB services. Click on the
link for
your "new" project and you may begin to upload your documents.
Step-by-step
directions for submitting a new Social and Behavioral Science project
application with visual aids.
For RCHSD
Only Projects - Studies conducted by RCHSD researchers that have no
affiliation with UCSD and are requesting UCSD IRB oversight
For exempt status studies -
Studies that are minimal, minimal risk and that satisfy criteria for
exemption from IRB review
Submit a Response to a Letter from the
IRB
Responses consist of a cover letter addressing the Committee's requests
for clarification/revisions on a point-by-point basis, and revised
project-associated documents such as the Research Plan, consent,
advertisements,
etc.
Responses should be submitted online as a series of
protocol-associated
documents via the e-IRB
services.
- Federal Regulation required that projects undergo Continuing Review at intervals not
greater than 365 days. Courtesy reminders regarding upcoming
expiration
dates may be sent electronically at intervals set by users of the HRPP
system. The default reminders are sent 75, 60 and 45 days before
a project expires, but these intervals, and the entire reminder
service, can be set to a user's preference using our e-IRB
services. However, this courtesy
notification should not substitute
for the researcher's own internal tracking of expiration dates.
Ultimately, it is the PI's responsibility to submit documentation
within the due dates provided.
- A Continuing Review submission has three or more components:
- A cover letter for submission of Continuing Review
documents
- Continuing Review
Facepages. There are two different Facepages, one for a Biomedical project and one for a SBS project. The Facepages must be
signed by
the PI and submitted to HRPP at mailcode 0052, if provided as a
hardcopy document, or uploaded as a pdf file through eIRB services.
- A Narrative
Summary of Progress made since the most recent IRB review. This
is
a Word document that can be downloaded and saved on your
workstation. There are two different Narrative Summary forms, one for a
Biomedical project and
one for a SBS project.
- A copy of the IRB-stamped,
approved
blank consent/assent form
currently in use by the project. (Note: although HRPP has a copy
of this on file, federal regulations require that you send us the
current
consent/assent so that the IRB can determine that you are using the
correct
version.) Do not send a consent/assent that has been signed by a study
participant.
- A "clean" copy of the
consent/assent form, as a Word document, for "restamping."
- Associated study documentation, including a copy of any site monitoring reports, progress reports,
audits, communication to/from the FDA, and/or publications
associated with the project, as applicable, since the most recent IRB
review.
- The items should be uploaded to the HRPP not less than 45
days before expiration of the current IRB
approval.
Step-by-step
directions for submitting Continuing Review for a Biomedical Research
project with visual aids.
Step-by-step directions
for submitting Continuing Review for a Social and Behavioral Science
project with visual aids.
Submit a 10-year project "Resubmission"
application for an
existing approved project
Important! A project "Resubmission" is in essence of
New
Project Application. Studies may receive up to 10 reviews (1
initial approval and 9 continuing review approvals).
Therefore, DO NOT submit the revised project application as a
set of
documents associated with an existing application. Rather, on the
Facesheets, please list the number of the protocol being renewed in the
appropriate place on the form and submit the application as a New
Project
submission. The steps for doing this are listed at the top of
this
page.
Submit a Study Withdrawal or
Closure
- To withdraw a study before initial approval has been
granted by the IRB, a letter signed by the PI must be submitted to the
HRPP. The letter must indicate that the PI is asking for the study to
be withdrawn and describe the reason(s) for the withdrawal. Upon
receipt of the letter, the IRB Director, Associate Director, or HRPP
staff
designee will review the submission for completeness. A request to the
PI may be made to clarify any questions or to provide additional
information. Once any answers to questions and/or additional
information has been submitted, the study withdrawal submission will be
reviewed by the IRB Chair, or by the IRB Chair's designee, and
the PI will be provided with written notice of the review of the
withdrawal
and/or acceptance of the withdrawal, as appropriate.
- To close a study that has received IRB approval, but no
study procedures have been done, such as enrolling participants, a
letter signed by the PI must submitted to the HRPP. The letter must
indicate that the PI is asking for the study to be closed and
describe the reason(s) for the study closure. Upon receipt of the
letter, the IRB Director, Associate Director, or HRPP staff designee
will review the submission for completeness. A request to the PI may be
made to clarify any questions or to provide additional information.
Once any answers to questions and/or additional information has been
submitted, the study closure submission will be reviewed by the IRB
Chair, or by the IRB Chair's designee, and the PI will be provided with
written notice of the review of the closure and/or acceptance of the
closure, as appropriate.
- To close a study that has received IRB approval and has
performed study procedures such as enrolling participants, PI completed
Study Closure Facepages and Narrative Summary of Progress at Study
Closure must be provided to the HRPP. For Biomedical studies, the Biomedical Study Closure Facepages and
Narrative must be
used. For Social and Behavioral studies, the Social and Behavioral Study Closure
Facepages and Narrative must
be used. These forms can be found on the HRPP website "Forms" page. In addition, copies of relevant
associated information, such a copy of the stamped, approved consent if
participants have been enrolled since the last review by the IRB
(initial or continuing), formal study closure from the sponsor, site
monitoring reports, audits, other reviews, etc. must also be submitted
for review. The Study Closure submission must be submitted within 30
days of study closure. For more information, see the HRPP fact sheet, Closure/Withdrawal of Study. The
study closure submission will be reviewed by a convened IRB, IRB Chair,
or by the IRB Chair's designee, and the PI will be provided with
written
notice of the review of the closure and/or acceptance of the closure,
as appropriate.
Step-by-step
direction for submitting a Study Withdrawal or Closure for a Biomedical
Research project with visual aids.
Step-by-step direction
for submitting a Study Withdrawal or Closure for a Social and
Behavioral Science Research project with visual aids.
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