Protocols for Observation-Only Studies

 
An observational study is exempt from PSU RP04 and IACUC review if it does not involve animal handling or manipulation of the animal’s environment. Examples of Observational studies include projects in which data is collected passively for practices that are already occurring regardless of the research (ex: milking data is collected from cows that are milked daily for production purposes), population monitoring without animal handling or modifying the animal’s habitat, camera trapping without using any form of bait or attractant, etc. No IACUC approvals are required for observational studies as per PSU RP04, however the Office for Research Protections and the IACUC recognize that sometimes IACUC review is requested for funding applications or for publication purposes. For these situations, an IACUC protocol may be submitted and administratively approved to provide requested documentation of review. 

Step-by-Step Guide 

IACUC and/or Occupational Health training is not required by the IACUC for the PI or protocol team members when the protocol only outlines observational studies. However, for the occupational health and safety of personnel working near or around animals, it is recommended that the PI review potential risks and recommended personal protective equipment and safety practices with personnel prior to beginning work. 

Answer all relevant and required questions throughout the protocol form and indicate N/A when not applicable. See specific instructions below.  

On the Basic Information Page: 

In question 3, Title of the protocol: 

• All titles should be named starting with “OBSERVATION ONLY” before the actual protocol title. 
• Note, some sponsors require the title of the protocol to match the title of the proposal. If this review is requested for funding purposes, please ensure title of protocol meets sponsor requirements. 
• The protocol type should be selected as “Experimental Research.” 

On the Protocol Team Members Page: 

Only the PI is required to be listed on observational studies. However, if you chose to list additional personnel, their role should all be selected as no for “involved in animal handling.”

On the Funding Sources Page: 

If the project is externally funded, click the Add button and list sponsor and award number. 

On the Experiments Page: 

1. Click the Add button to add a new Experiment. 
2. In the response to the Describe the experiment question, include: 
   • A statement that no animals will be handled and no manipulation of the environment will occur through the course of the experiment. 
   • A brief description of the observation to occur. If passively sampling animals from procedures already being performed (i.e. collecting milk samples from bulk tanks of cows that are already being milked for commercial purposes), describe how passive sampling is occurring.  
3. In the select procedures question, no procedures should be selected or added.*
4. In the Total number of animals question: 
   • Provide your best estimate of the number of animals to be observed in the next 3 years. 
   • All observed animals will be Pain Category C. 
5. Click OK on the Experiment pop-up window. 

*Note: Procedures and substances do not need to be created within a research team for observational protocols.

On the Training and Occupational Health Requirements Page: 

Since some training requirements are automatically added to protocols by the CATS IACUC system, this page may indicate trainings are needed or expired. As indicated above, trainings are not required for this administrative review and any training notifications can be disregarded. 

The ORP may contact you regarding your protocol submission to ensure it qualifies as an observational study. The above reference material is designed to help guide you; however, the IACUC has final authority to determine if full IACUC review and approval is required.