Amendment: Change in Personnel(CIP)[Version 5/31/2017]
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 inits original format to one of the following addresses.IRB projects, submit this form AND all required supporting documents to or by campus mail #RCB206.
IACUC projects, email this form to
Projects NOT associated with an IRB or IACUC, email this form to
Electronic Submission Date:
Principal Investigator:
Email:Office Telephone:
Copy email correspondence to:atEmail:
[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 box is for Office of Research Services IRB, IACUC, IBC, COI use only.This amendment was administratively approved. Annual re-approval will be bound to the approved date of the IRB/IACUC/IBC applications which this document amends.
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IRB/IACUC/IBC Approval SignatureDate of Approval
1.Complete the table for all applicable projectsaffected by this change.
IBC # / A# / IACUC# / A# / IRB# / Project Title / Funding Source, if applicable / IRB Staff: FB/EXP/EXM2.To remove individualsfrom 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 all applicable items.
Name: Degree:
Email: Office Phone: Mobile Phone: Fax:
LSUHSC-NO School of: Department of:
If On-Campus, enter Building address and Room Number:
If Off-Campus, provide full US mailing address:
Indicate personnel status/classification (check all that applies):
Faculty Staff Gratis Appointment Non-LSUHSC-NO
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.Indicate the role and list the activities the individual is trained and authorized to perform in this project.
a)Role: Co-investigatorStudy Coordinator/ClinicalLab Technician/Assistant
Student InvestigatorStudy Coordinator/Data Other, specify:
b)Date Conflict of Interest Formsubmitted to :
c)List the activities this individual has been trained to perform.
5.If authorizing a Non-LUSHSC-NO individual, provide name of the institution (or company).
a)Institution: Department:
b)Institution’s Mailing Address:
c)Does the institution/company know that this individual will participate in this project? Yes No
d)For HUMAN STUDIES, has this individual applied to their institution’sIRB of Record? Yes No(Submit a copy of theirapproval when available to complete the approval process of this form.)
NOTE: If this is an IRB project, approval by the LSUHSC-NO IRB for LSUHSC-NO employees, appointees, and studentsdoes not extend to individuals on the project who are notLSUHSC-NO employees, appointees, or students. Non-LSUHSC individuals must seek IRB review from their IRB of record (their institution). 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.
6.If amending an IRB protocol, indicatewhich other documents and which sections fromtheIRB DemographicCertificationAttestation Formare included with the submission of this form.
The Attestation Signature page (Required when adding Co-investigators)
TheCertification of Department Reviewpage (Required when changing PI)
Revised informed consent form(s) (Required when changing PI and/orCo-investigators)
A copy of the individual’s CV.
NOTE: IRB CIPs will not be processed unless the aboverequired documents aresubmitted as one packet in an email to or by paper submission to the IRB Office, 433 Bolivar St. #206, NOLA 70112
7.Enter the date of completion of training required to participate in research and to perform the activitieslisted above. Enter any other relevant training received.
Individuals can supply you with their KDS and CITI training dates.
The IBC/IACUC/IRB staff can look up Animal Care, EH&S and other specific training dates NOT accessible by the individual on-line.
KDS: CITI:
Individuals without KDS access and non-LSUHSC participants may submit documentation of comparable trainingfrom other institutions or download theself-study trainingcourses from ORS web page.
ORS Training Requirements:
EH&S Training web page:
Check for COI acceptance of NON-LSUHSC personnel: FDPwebsite
LSUHSC Conflict of Interest Form
Enter name of personnel:PI’s Lab/Clinic Specific Training (SOPs or other training): / PI/Named Trainer
Enter “PI” or name the person who will train/orient the above personto thisprotocol,lab, and/or clinic prior to conduct any work. / Required for every person participating
List other specific training given: ; ;
Institutional Required Training Modules / KDS / Date Completed
LSUHSCConflict of Interest in Sponsored Projects(Required for ALL team members participating in ALLresearch projects, whether sponsored or not, human, animal or other) / KDSevery 4 years
EH&S and Biological Training Module / Type / Date Completed
Bloodborne Pathogen –(High Risk required for researchers; Low Risk for all others) / KDSHR annual or LR every 5 years
Biological Safety Basic Training (Required when working with humans, animals or biological materials, toxins, pathogens, radiation, rDNA) / KDSevery 3 years
IBC and rDNA Compliance Program (Required for PI & key personnel) / KDS once
Laboratory Safety (General/Basic Training) (Required if working in a lab) / KDS once
Shipping Biological Materials (Personnel who prepares package, ships and/or delivers biologicals, chemicals, pathogens, etc.) / EH&Sonce
Radiation Safety (Required where applicable) / EH&Sonce
Laser Safety (Required for Class 3B or 4 lasers) / EH&Sonce
Other training:
Human Subject Research Training / CITI / Date Completed
LSUHSC HIPAA Privacy in Research (human research projects) / KDSevery 3 years
CITI Human Research Courses:
Complete applicable courses related to type of research to be performed, initial and then the Refresher every 3 years
Biomedical Research - Initial Course / CITI once – For: staff involved in:
- clinical trials
- drug/device trials
- tissue use or banking
- medical chart review
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 / CITI every 3 years
Social & Behavioral Research - Initial Course / CITI once– For: staff involved in:
- survey/questionnaire
- focus groups
- interview
- psychological or other testing
- educational testing
- epidemiological reviews
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
Social & Behavioral Research-Refresher Course / CITI every 3 years
GCP - Drug DevelopmentGradebook - Initial Course: Conducting Studies According to FDA Regulations Good Clinical Practices / CITI once
GCP - Drug DevelopmentGradebook - Refresher Course / CITI every 3 years
GCP - Device DevelopmentGradebook - Initial Course: Conducting Studies According to FDA Regulations Good Clinical Practices / CITI once
GCP - Device DevelopmentGradebook - Refresher Course / CITI every 3 years
Other specific training:
Other specific training:
Animal Research Training / DoAC or CITI / Date Completed
Division of Animal Care (DoAC)
Occupational & Health Risk Assessment for Exposure to Animal Use or Care(Although participation is voluntary, anyone exposedto research animals must either complete the form or sign the “election not to participate”.) / DAC Form -Initial required, update as needed or every 3 yrs
DAC Orientation & Barrier Training (Required for access into any part of DOAC facilities) / Classroom
DAC Aseptic Surgery (Required if performing survival surgery) / Classroom
Other training assigned by veterinarian:
Other training:
CITI Animal Courses:
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 once
Reducing Pain and Distress in Laboratory Mice and Rats / CITI once
List Species Working with in Research Settings: / CITI once
List Species Working with in Research Settings: / CITI once
List Species Working with in Research Settings: / CITI once
Other specific training:
Other specific training:
ConflictofInterestTeamMemberForm
Principal Investigator Name:
IBC # / IACUC# / IRB# / Project Title / Funding Source, if applicableTeam Member Name / Institution Name / For External Institutions Only
Is the institution listed on
theFDPwebsite? / E-mail Address
First / Last / Yes / No
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