New Protocols

Under the Freedom of Information Act and the Georgia Open Records Act, protocol applications, including information incorporated by reference, may become accessible by the general public.  Steps to securing committee approval follow:

The PROTOCOL APPLICATION must be submitted for review.  Note the institute policy regarding eligibility for the role of Principal Investigator on an animal  protocol (See Policies & Procedures).  Occasionally, a large Program or Center grant to a single Principal Investigator will fund multiple faculty members’ activities, and the Program or Center grant PI may not be a member  of the research team on animal protocols that the grant funds.  For these “umbrella” programs, the IACUC accepts protocols from Principal Investigators who are not PI on the supporting Program/Center grant.

ATTACHMENTS:

• Statement of Work or Project Description:  A copy of the funding proposal or final grant pages sent to the funding agency is required.  Federal regulations require the IACUC to compare the protocol to the funding proposal Statement of Work or Project Description. Substantive differences must be satisfactorily addressed prior to IACUC approval.

• Current Credentials Form:  Faculty, including affiliates, should attach a current credentials form unless one has been submitted in the past five years.  A credentials form is not required for students.

REQUIRED TRAINING:  Everyone named on the protocol—including students, lab techs, Visiting Scholars, and affiliates—is required to complete the online CITI training course, “Working with the IACUC” and the other CITI training modules appropriate for the planned work.  For example, if the protocol proposes the use of mice or rats, all named personnel must complete “Post-Procedure Care of Mice and Rats in Research:  Reducing Pain and Distress” and “Working with Mice (or Rats) in Research Settings.” The online training link is located on our Mandatory Training page.

ENROLL IN OCCUPATIONAL HEALTH PROGRAM:  Everyone named on the protocol must enroll in the Georgia Tech Occupational Health Program, managed by Environmental Health & Safety and provided by contract with Concentra Health Services. An opt-out provision is available.

DEPARTMENTAL SIGN OFF:  The prepared IACUC application is to be signed by the applicant’s department head or, in lieu of a written signature, department heads may send an email to the office of Research Compliance stating that they are aware of the proposed work and concur with its submittal to the IACUC.  When the department chair is the Principal Investigator named in the protocol, no other sign-off is required.

PRELIMINARY PROTOCOL SUBMISSION:  Submit the protocol application and attachments to the Office of Research Compliance via email.

INITIAL REVIEW PROCESS:  The protocol application will be given a preliminary review by the Office of Research Compliance and then will be forwarded to the Georgia Tech Attending Veterinarian/Director of Animal Resources for veterinary consultation.  The Principal Investigator may be contacted for clarification or additional information.  Following veterinary consultation, the protocol will be returned to the Principal Investigator for modifications, if necessary.

FINAL PROTOCOL SUBMISSION:  If modifications are required, the Principal Investigator should revise the protocol in accordance with the veterinary consultation and then submit the revised protocol to the Office of Research Compliance via email for distribution to the committee.   If none are needed, the protocol will be forwarded by the Veterinarian to the Office of Research Compliance for distribution to the committee.   

COMMITTEE REVIEW:  All protocols are distributed to the committee in the order in which they are received.  If a committee member calls for full committee review, the protocol will be placed on the agenda for that month’s meeting, unless it was received without sufficient lead time.  Generally, protocols requiring full committee review are due no later than the first week of the month for review at that month’s meeting.

For assistance, contact the Office of Research Compliance at 404.385.7316 or 404.894.6944.  Please note that Institutional Animal Care and Use Committee approval is required prior to procurement or use of animals.

If the project involves the use of any infectious agent or hazardous chemical (including chemical carcinogen) is proposed, review by the Institutional Biological Materials Safeguards Committee is required.  Protocols involving rDNA require review by the Institutional Biosafety Committee.  See guidance at located Institutional Biosafety Committee (IBC) portion of our site. In cases where other reviews or approvals are required (i.e., Institutional Biosafety Committee, Material Transfer Agreement, Office of Technology Licensing, Radiation Committee), those should be sought in parallel.  If there are any transgenic animals, organisms/agents or proprietary issues necessitating a Material Transfer Agreement (MTA), consult the Office of Technology Licensing for guidance.

IACUC Guidelines and other useful information is found maybe found on our site under the
Policy/Procedure section of our site.

Applications should be saved as a Word file and submitted to the
Office of Research Compliance by email