|
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)
|
