Vertebrate Animal Use in Research

Submission to the IACUC

 

Protocol Submission Requirements

 

Protocols must be deemed “complete” before they are considered as received by ORRC.

Do not use jargon, terms of art, or technical language when completing the protocol. The project description must be written in a style suitable for presentation to a freshman class. If the narratives are not provided in layperson’s terms, the protocol will be returned to the investigator.

A complete protocol includes the following:

- The most current version of submission and supplemental forms (as found on the website);
- Original signatures (investigator, faculty advisor, department chair, etc.);
- CITI training report for each person engaged in research;
- All related supplemental forms;
- Complete grant application (no excerpts), including cover page(s);
- Financial Conflict of Interest Form (for protocols that are, or are expected to be, grant-funded).

Institutional Animal Care and Use Committee (IACUC) protocols must also include:
- One protocol per grant application;
- Flowchart describing/reflecting the study
- Standard operating procedures (if not IACUC approved).

Modification and continuation requests must include:
- The revised protocol;
- Revised support materials.

All modifications and continuation requests must be reviewed and approved by the attending veterinarian (AV) as part of planning research protocols involving vertebrate animals. AV approval must be received BEFORE protocols, modifications, or continuations may be submitted to the IACUC for review.

Updated June 19, 2012.

Attending Veterinarian Review

 

Consistent with the Animal Welfare Act (AWA), investigators must consult with the attending veterinarian (AV) as part of planning research protocols involving vertebrate animals. AV approval must be received BEFORE protocols, modifications, or continuations may be submitted to the IACUC for review.

Investigators are required to consult with and receive approval from the AV regarding plans for the following:

- regimens for use of anesthetics, analgesics, and tranquilizers, including monitoring;
- review of method(s) of euthanasia;
- how to recognize species-specific signs of pain and distress;
- surgical approaches and asceptic techniques;
- post-procedural monitoring and intensive care.

Contact the University at Albany's Attending Veterinarian, Antigone McKenna, D.V.M., (518) 437-4417, amckenna1@albany.edu, with any questions.

The AV may request changes or clarifications of specific issues. Once the results of the AV review have been received by the PI, any revisions are to be incorporated into a final version of the protocol.

IACUC Protocol Submission

Following the AV review, the PI will submit the original IACUC Protocol Submission and related documents/forms with all required signatures, including:

PI and co-investigator (if applicable);
attending veterinarian;
dean or department chair

The Form and related documents/forms should be sent to:

The Office of Regulatory Research Compliance
Attn: Institutional Animal Care and Use Committee
LCSB 28

Forms may be mailed or hand-delivered. Incomplete applications will be returned to the sender without review.

ORRC Administrative Review

ORRC staff will triage the protocol to ensure that the protocol submission is complete; i.e., that all required elements (e.g., training certificates, grant application, etc.) have been submitted. The protocol will then be referred to a research compliance administrator (RCA) for administrative review. The RCA will notify the PI when the protocol is accepted for IACUC review.

The purpose of the administrative review is to identify issues that are either incomplete or unclear, thereby preventing or delaying approval by the IACUC. Once issues are identified, the PI must respond to and/or revise the protocol before it can be referred on for IACUC review. Protocols that require extensive revision or are missing a significant amount of information will take longer to review.

Although the administrative review process will materially improve the probability that the protocol will be approved, it does not guarantee approval. It is to the PI’s advantage to follow this submission format to avoid delaying the review process.

A protocol will be considered complete and accepted for review if it meets ALL the following criteria:

■   the protocol form and related documents/forms, signed by the appropriate parties, and the signed veterinarian checklist are received by ORRC. E-mail submissions are no longer accepted. The protocol will be returned to the PI if it is incomplete;
■   an administrative review by an RCA has determined that the PI has submitted all information necessary for the IACUC to adequately review the protocol;
■  a grant review has determined that the information presented in the proposed protocol is congruent with the research proposed in the grant application;
■   training requirements for the PI and all research personnel have been met.

Submissions Requiring Full Committee Review

The IACUC is notified of all incoming protocol and amendment applications by the ORRC. Species, pain category, and a brief description of the activities covered in the application are included in the notice. The IACUC is given the opportunity to request designated member review of the application or to call for full committee review.

Protocols accepted for review which require full committee review are placed on the agenda of the next scheduled meeting.

The PI will receive an e-mail from the RCA indicating the date of the meeting at which their protocol will be reviewed. PIs are invited to attend the meeting time to address any IACUC questions or concerns.

 

IACUC Animal Use Training

 

All personnel involved in animal care and use must undergo training that includes an on-line training course as well as training with the animal care staff. Certification from another institution may be considered but must be submitted and approved prior to animal use.

Required Basic Course

All those involved in the care and use of vertebrate animals in research, regardless of species, must complete the following course:

Working with the IACUC.

Required Species-Specific Trainings

All those involved in the care and use of vertebrate animals in research must complete the appropriate species-specific course(s), depending upon the type of vertebrate animal(s) involved and the nature of the research. On entering the CITI Animal Care and Use Course site, investigators and research staff will choose the appropriate species from the “Working with …” series.

Those using mice and rats in research must also complete the following course:

Post-Procedure Care of Mice and Rats in Research: Reducing Pain and Distress.

 

Click on the link below and follow the registration instructions on the CITI site. Once you have completed the required modules, a Completion Report will be generated for you by CITI. Please print a copy of the Report for your records and have it available upon request. A copy of the Report for each person named in the protocol must be submitted with the protocol to the Office of Regulatory Research Compliance.

Click below to go to the CITI training website:

Collaborative Institutional Training Initiative (CITI)

PLEASE NOTE: When choosing an institution to affiliate with, you must pick SUNY - University at Albany. DO NOT CHOOSE Albany State University.

Instructions for CITI (for assistance with registration)

Additional Training Requirements

Laboratory Animal Resources (LAR) requires additional trainings for all new animal users, including faculty, technicians, and graduate and undergraduate students.

Contact Laboratory Animal Resources at:
Phone:   (518) 591-8817
Fax:        (518) 591-8810
sunyvet@albany.edu
http://www.albany.edu/laboratoryanimalresources

Principal investigators and research staff must provide sufficient proof of qualifications on vertebrate animal care and use to the LAR facility manager before beginning ANY research involving vertebrate animals. Investigators or research personnel lacking sufficient qualifications will be provided with appropriate or remedial training from the LAR director or the LAR facility manager.

ORRC strongly encourages researchers to call or visit the office for answers to specific questions. You may contact the office to schedule an appointment to speak with a staff member.

 

IACUC Review Forms

Initial/New Submission Primary Protocol | Word or RTF

Additional Key Personnel for Initital or De Novo Submission | Word

Request for Modification of Approved Research | Word or RTF
IACUC Continuing Review | Word or RTF

Request to Add or Delete Key Personnel | Word

IACUC Protocol Closure | Word or RTF

Supplemental Forms

1 - Collection or Receipt of Biological Samples | Word or RTF
2 - Behavioral Testing | Word or RTF
3 - Pain or Distress to Animals | Word or RTF
4 - Drug Administration | Word or RTF
5 - Biological Toxin Administration | Word or RTF
6 - Surgery | Word or RTF
7 - Alternative Housing Request | Word or RTF
8 - Breeding Colony (Establishment and Maintenance) | Word or RTF

 

Coming Soon.