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HRPP
Institutional Review Board (IRB)
LSUHSC-NO’s Human
Research Protection Program and Institutional Review Board (IRB) are responsible
for reviewing all research projects involving the use of human subjects,
with the purpose of protecting the rights and welfare of individuals
participating in those projects. It is the policy of LSUHSC-NO that all
projects involving human beings and/or information or tissue collected
from human beings must be presented to the IRB for a determination as to
whether: 1) The project is human subjects research, 2) The human subjects
research project can be given Exempt status under the Federal regulations,
or 3) The human subjects research project must have IRB review, approval,
and continued oversight.
IRB Policies and Procedures
IRB Forms
There are
now three versions of the IRB Application Form. Instructions given in How to Submit will show you how to start the application
process and will clarify which version (1, 2 or 3) of the IRB Application
Form is appropriate for your research.
1. Exempt
Research Application
o
Information
Sheet for Exempt Research
2. Minimal
Risk (Expedited) Research Application
o
Information
Sheet for Expedited Research
3. Greater
than Minimal Risk (Full Board Review) Research Application
o
Information
Sheet for Full Board Review
As part
of the application process, the following forms must be completed
for all studies:
·
The Demographic Form
·
Addendum - Conflict of Interest Attestation [Note: This form must be
completed by all study team members.]
Other IRB
forms that may be required during the application process include:
·
Addendum
- Additional Personnel
·
Waiver of Informed Consent, Waiver of
HIPAA Authorization, and Waiver of Documentation of Informed Consent
·
Consent Form Template
○ Consent
Form Instructions
·
Non-English Speaking
Subjects Short Form Instructions
o
English Version
o
French Version
o
Spanish Version
o
Vietnamese Version
Other IRB
forms:
·
Adverse
Event Reporting Form
o
Unanticipated Problem/SAE Reporting Form
·
IRB
Re-Approval or Closure Form
·
Notification of Protocol Deviations/Violations Form
Human Subjects Protection ─ Links to Training
Resources
LSUHSC-NO Human Subjects Protection Program – Emergency
Readiness
Other Useful Links
·
Food And Drug Administration
(FDA)
·
Office of Human Research
Protections (OHRP)
When
Conducting Research at Ochsner
Health System Facilities
·
Requirements
·
Joint
Informed Consent Template
·
Joint HIPAA Authorization
When
Conducting Research at Children’s
Hospital
·
Joint
Informed Consent Template (CH)
·
Joint
HIPAA Authorization (CH)
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