PROTOCOL SUBMISSION


Public Health Service Policy on Humane Care and Use of Laboratory Animals (2015)
http://www.grants.nih.gov/grants/olaw/references/phspol.htm

“ It is the Policy of the Public Health Service (PHS) to require institutions to establish and maintain proper measures to ensure the appropriate care and use of all animals involved in research, research training, and biological testing activities...”

“the IACUC shall confirm that the research project will be conducted in accordance with the Animal Welfare Act insofar as it applies to the research project, and that the research project is consistent with the Guide…”

What kinds of activities require an Animal Study Protocol, and who must submit?

Activities at UMD that involve animals in research, training, or testing must be reviewed and approved by the IACUC prior to ordering animals for the purposes of the activity and before beginning any work involving animals. Specifically, Animal Study Protocols must be submitted for the following:

Faculty Research - All animal research activities performed at UMD must be conducted under an IACUC-approved Animal Study Protocol. Most principal investigators (PIs) are faculty (tenured/tenure track or professional track), with a few exceptions.

Student research - Animal research activities carried out by students must also be conducted under an approved IACUC protocol, which must be submitted by their faculty advisor. This includes research performed by graduate or undergraduate students, or students working as part of a research team (e.g., GEMSTONE). In all cases, the faculty advisor must sign off on the research protocol submitted to the IACUC.

If the student will perform animal research at an outside (PHS-assured) institution, the protocol may be submitted to and approved by that institution’s IACUC; however, a copy of the protocol, the protocol approval (if separate from the protocol document), and any external funding information must be submitted to the UMD IACUC. For student research at non-PHS assured institutions/agencies/facilities, see Non-assured Performance Sites, below.

Non-assured Performance Sites
Any awardee (faculty member or student) who is planning to perform research funded by the PHS at an outside institution/agency/facility that does not have it’s own PHS assurance must ensure that the outside institution either negotiates its own PHS Assurance or becomes covered in the UMD PHS assurance. This places the un-assured institution under the UMD PHS assurance, and UMD must then treat it the same as all other facilities included in their program (perform semi-annual inspections, include in reports to OLAW, etc.).

Teaching-Courses taught at UMD that involve the use of animals must also be covered under an IACUC-approved protocol, which should be submitted by the faculty member in charge of the course.

Field Studies -An IACUC-approved protocol is required for any study that involves the capture, handling, or other direct manipulation of animals in the wild. If animals will not be handled or manipulated, but only observed, a research protocol may not be required. It is recommended that any PI planning observational-only field studies contact the IACUC office to confirm whether or not they need to submit a protocol.

External Collaborations -PIs participating in external collaborations at PHS-assured institutions, where the animal research has been submitted to and approved by the outside institution’s IACUC, do not need to submit a full protocol to the UMD IACUC. However, the UMD PI must submit a copy of the protocol, the protocol approval (if separate from the protocol), and a copy of any funding proposal in support of the work.

Agricultural Extension Activities –Animal teaching/demonstration activities conducted either with UMD-owned animals or at UMD facilities must be reviewed and approved by the IACUC.