Amendment: Change in Personnel (CIP)
[Version 1/22/2016]
Request to remove or add personnel to IRB, IACUC, and IBC Projects
INSTRUCTIONS: ALWAYS download the latest version. DO NOT make any changes to this form. Complete
appropriate sections and submit this form in its original format to one of the following addresses.
IRB projects, submit this form AND all required supporting documents to IRBoffice@lsuhsc.edu or by campus mail #RCB206.
IACUC projects, email this form to IACUCoffice@lsuhsc.edu
Projects not associated with an IRB or IACUC, email this form to IBCoffice@lsuhsc.edu
Electronic Submission Date:
Principal Investigator:
Email:
Office Telephone:
Copy email correspondence to:
at Email:
[Coordinator/Co-investigator submitting forms/documents in behalf of the PI must cc the PI on the email.]
By submission of this amendment, the Principal Investigator of this project attest that the information below is accurate and
complete and attests to the following statements. I accept the responsibility for the safe conduct of work with this study at the Biological Safety
Level practices and procedures assigned by the IBC. I will inform all personnel, who may be at risk of potential exposure of the conditions of this
work. I assure that all personnel will receive adequate training to perform all activities safely and proficiently. I will not carry out the work
described in the attached application until it has been approved by the IBC/IACUC/IRB, where applicable, and all requirements have been met.
Where applicable, I agree to comply with the NIH requirements pertaining to conducting research and the shipment and transfer of recombinant
DNA materials. I acknowledge my responsibility for the conduct of this research in accordance with LSUHSC-NO policies and the NIH
Guidelines.
This amendment was administratively approved. Annual re-approval will be bound to the approved
date of the application which this document amends.
__________________________________________________
Approval Signature
______________________
Date of Approval
1. Complete the table for all applicable projects affected by this change.
IBC #
A#
IACUC#
A#
IRB#
A#
Project Title
2. To remove individuals from participation, list their full name. If removing investigator(s) from an IRB study
whose name was previously listed on the consent form, attach a revised consent form.
If only removing personnel at this time, STOP here and submit the form(s).
3. To authorize participation of an individual, provide the demographic information of the individual and
complete applicable items 4 through 7.
Name:
Degree:
School of:
Department of:
Email:
Office Phone:
Mobile Phone:
Campus Office Address and Room Number:
Fax:
If Off-Campus, provide US Mail Address:
Indicate personnel status/classification (check all that applies):
Faculty
Staff
Gratis Appointment
Non-LSUHSC-NO (complete #4)
Medical Student
Graduate Student
Fellow
Resident
For student/fellow/residents, indicate the type of project.
Project is a thesis or Capstone/Dissertation (Masters/PhD)
Project is for the course:
Other – Explain:
4. Approval by the LSUHSC-NO IRB for LSUHSC-NO employees, appointees, and students does not extend to
individuals on the project who are not LSUHSC-NO employees, appointees, or students.
Non-LSUHSC individuals must seek IRB review from their IRB of record. If the individual you wish to
add to the study does not have an IRB of record, contact the LSUHSC-NO IRB before submitting this form.
For those individuals that have an IRB of record, provide the following information.
a)
b)
c)
d)
e)
Institutional Affiliation:
Department:
Institution’s Mailing Address:
IRB of Record:
(Submit a copy of the approval when available.)
Submit a copy of the individual’s CV.
Submit documentation of required training (see table in #7).
5. Indicate the role and list the activities the individual is trained and authorized to perform in this project.
a) Role:
Co-investigator
Study Coordinator/Clinical
Student Investigator
Study Coordinator/Data
b) Activities this individual has been trained to perform:
Lab Technician/Assistant
Other, specify:
6. If amending an IRB protocol, indicate what other required IRB documents are included with this form.
(The IRB full Demographic Form is not required when using this form).
Conflict of Interest Attestation Form (Required for all team members)
Attestation Signature Page from IRB Demographic Form (Required when adding Co-investigators)
Certification of Department Review (Required when changing PI)
Revised informed consent form(s) (Required when changing PI and/or Co-investigators)
NOTE: IRB CIPs will not be processed unless the above required documents are submitted as one packet in an
email to IRBoffice@lsuhsc.edu or by paper submission to the IRB Office, 433 Bolivar St. #206, NOLA 70112
7. In the following training table, enter the date of completion of training required to participate in
research and to perform the activities listed above. Enter any other relevant training received.
To determine which training modules are required, refer to the training guide on the ORS webpage:
http://www.lsuhsc.edu/administration/academic/ors/docs/TableTrainingRequiredResearch.pdf
Contact your Department Manager or email IBCoffice@lsuhsc.edu for online KDS training completion dates.
Individuals can supply their CITI, Animal Care and other specific training dates. Individuals without KDS access and
non-LSUHSC participants may submit documentation of comparable training from other institutions or may download
the self-study courses from ORS web page: http://www.lsuhsc.edu/administration/academic/ors/training.aspx
Name of Personnel:
List PI’s Lab-Specific, SOPs, or Other Training Received:
From PI or Lab
Manager
Date Completed
Enter who and when personnel was oriented to the protocol, lab, and/or clinic
Other specific training:
Other specific training:
EH&S and Biological Training Module
Bloodborne Pathogen – (High Risk required for researchers; Low Risk for all others)
Biological Safety Basic Training (Required when working with humans, animals or
Type
KDS HR annual or
LR every 5 years
biological materials, toxins, pathogens, radiation, rDNA)
KDS every 3 years
IBC and rDNA Compliance Program (Required for PI & key personnel)
KDS once
Shipping Biological Materials (Personnel preparing shipments)
EH&S once
Radiation Safety (Required where applicable)
EH&S once
Laser Safety (Required for Class 3B or 4 lasers)
EH&S once
Laboratory Safety (General/Basic Training) (Required if working in a lab)
KDS once
Date Completed
Other training:
Institutional Required Training Modules
KDS
Date Completed
Conflict of Interest in Sponsored Projects (Required for all team members
participating in research projects, whether sponsored or not, human, animal or other)
KDS every 4 years
HIPAA Privacy in Research (human research projects)
KDS every 3 years
Human Subject Research Training
CITI
Date Completed
Complete applicable courses related to type of research to be performed, initial and then the Refresher every 3 years
Biomedical Research - Initial Course
Choose at least one elective:
Social and Behavioral Research for Biomedical Researchers
Vulnerable Subjects - Involving Prisoners
Vulnerable Subjects - Involving Children
Vulnerable Subjects - Involving Pregnant Women, Human Fetuses, Neonates
Internet Research - SBR
Biomedical Research - Refresher Course
Social & Behavioral Research - Initial Course
Choose at least one elective:
Research with Prisoners - SBR
Research with Children - SBR
Research in Public Elementary and Secondary Schools - SBR
Vulnerable Subjects - Involving Pregnant Women, Human Fetuses, Neonates
Internet Research - SBR
CITI once – For: staff
involved in:
 clinical trials
 drug/device trials
 tissue use or
banking
 medical chart review
any medically-oriented
investigation
CITI every 3 years
CITI once – For: staff
involved in:
 survey/questionnaire
 focus groups
 interview
 psychological or
other testing
 educational testing
 epidemiological
reviews
Social & Behavioral Research-Refresher Course
GCP - Drug Development Gradebook - Initial Course: Conducting Studies
According to FDA Regulations & Good Clinical Practices
CITI every 3 years
CITI once
GCP - Drug Development Gradebook - Refresher Course
GCP - Device Development Gradebook - Initial Course: Conducting Studies
According to FDA Regulations & Good Clinical Practices
CITI every 3 years
CITI once
GCP - Device Development Gradebook - Refresher Course
Other specific training:
Other specific training:
CITI every 3 years
Animal Research Training
DoAC or CITI
Division of Animal Care (DoAC)
Occupational & Health Risk Assessment for Exposure to Animal Use or Care
(Anyone exposed to research animals)
DAC Form - Initial
DAC Orientation (Required for access into any part of the Animal Care facilities)
required, update as
needed
Classroom
DAC Aseptic Surgery (Required if performing survival surgery)
Classroom
Other training assigned by veterinarian:
Working with the IACUC (Investigators, Staff, Students) -Initial Course
CITI once
Working with the IACUC (Investigators, Staff, Students) -Initial Course
CITI once
Working with Animals In Biomedical Research-Refresher Course
CITI every 3 years
Complete applicable courses related to activities to be performed. (Required only once)
Aseptic Surgery
CITI
Reducing Pain and Distress in Laboratory Mice and Rats
CITI
List Species Working with in Research Settings:
List Species Working with in Research Settings:
CITI
List Species Working with in Research Settings:
CITI
Other specific training:
Other specific training:
CITI
Date Completed