Office of Research Research Management System (RMS) • Online protocol submission for the IACUC is almost here! • The software is in the final production stages and will be available for use very soon! • Take a look at the following slides to see how the online system compares to existing paper forms….. 1 Old Protocol Form: Application Section A: Title B-F: Personnel G: Funding H: Animal Numbers I: Procedures J: Hazardous Agents K: Controlled Substances L: Housing Locations (including outside of vivarium) Narrative Sections Section 1: Project Overview Section 2: Justification/Rationale for Use of Animals/Lit Search/Consideration of Alternatives Section 3: Experimental Design 1. Rationale behind the experiments 2. Groups and number of animals per group 3. How number of animals was determined 4. Sequence and Timing of all Procedures 5. Procedural Endpoints Section 4: Non-Surgical Procedures Section 5: Surgical Procedures Section 6: Clinical Signs/Pain and Distress/Monitoring and Management Section 7: Drugs and Agents (tables) Section 8: Euthanasia Section 9: Personnel roles/responsibilities and training Online AUP: Basic information about the protocol is gathered together on the General Information tab: funding/peer review, lay summary and Progress Report Simple branching questionnaires have been incorporated into General Information, replacing several Appendices. Old Protocol Form: Online AUP: Application Section A: Title B-F: Personnel These two tabs are specific to G: Funding certain kinds of protocols – if H: Animal Numbers they don’t apply they can be I: Procedures skipped. J: Hazardous Agents K: Controlled Substances L: Housing Locations (including outside of vivarium) Narrative Sections Section 1: Project Overview Section 2: Justification/Rationale for Use of Animals/Lit Search/Consideration of Alternatives Section 3: Experimental Design 1. Rationale behind the experiments 2. Groups and number of animals per group 3. How number of animals was determined 4. Sequence and Timing of all Procedures 5. Procedural Endpoints Section 4: Non-Surgical Procedures Section 5: Surgical Procedures Section 6: Clinical Signs/Pain and Distress/Monitoring and Management Section 7: Drugs and Agents (tables) Section 8: Euthanasia Section 9: Personnel roles/responsibilities and training Certification by PI and Department Chair is electronic – no more wet signatures! This tab provide information not currently available to researchers – where your AUP is in the review cycle! Old Protocol Form: Online AUP: Personnel are added to the Application Section protocol on the Personnel tab, A: Title by opening a drop-down list of B-F: Personnel eligible personnel. Individuals G: Funding are grouped together by “teams” representing each H: Animal Numbers laboratory I: Procedures J: Hazardous Agents K: Controlled Substances L: Housing Locations (including outside of vivarium) Narrative Sections Section 1: Project Overview Section 2: Justification/Rationale for Use of Animals/Lit Search/Consideration of Alternatives Section 3: Experimental Design Required training for 1. Rationale behind the experiments Animal Use (CITI 2. Groups and number of animals per group training modules) and 3. How number of animals was determined LAOHP enrollment are 4. Sequence and Timing of all Procedures automatically imported 5. Procedural Endpoints and recorded within Section 4: Non-Surgical Procedures the AUP. Section 5: Surgical Procedures Section 6: Clinical Signs/Pain and Distress/Monitoring and Management Section 7: Drugs and Agents (tables) Section 8: Euthanasia Section 9: Personnel roles/responsibilities and training Old Protocol Form: Online AUP: Application Section A: Title B-F: Personnel G: Funding H: Animal Numbers I: Procedures J: Hazardous Agents K: Controlled Substances L: Housing Locations (including outside of vivarium) Narrative Sections Section 1: Project Overview Section 2: Justification/Rationale for Use of Animals/Lit Search/Consideration of Alternatives Section 3: Experimental Design 1. Rationale behind the experiments First define the species, then 2. Groups and number of animals per group provide a justification/rationale 3. How number of animals was determined and consider alternatives – questions have been reproduced 4. Sequence and Timing of all Procedures from the old forms (but 5. Procedural Endpoints streamlined to remove Section 4: Non-Surgical Procedures redundancies) Section 5: Surgical Procedures Section 6: Clinical Signs/Pain and Distress/Monitoring and Management Section 7: Drugs and Agents (tables) Section 8: Euthanasia Section 9: Personnel roles/responsibilities and training Old Protocol Form: Application Section A: Title B-F: Personnel G: Funding H: Animal Numbers I: Procedures J: Hazardous Agents K: Controlled Substances L: Housing Locations (including outside of vivarium) Online AUP: “Study Segments” are the individual components of what was known as the Experimental Design in the old forms – but with step-by-step organizational tools and a built-in animal numbers calculator in table format. Each “study segment” also includes procedural descriptions for both surgical and nonsurgical procedures. As we move forward, more IACUC-approved procedural descriptions will be added to the library, where they will be available for copy-and-paste. Narrative Sections Section 1: Project Overview Section 2: Justification/Rationale for Use of Animals/Lit Search/Consideration of Alternatives Section 3: Experimental Design 1. Rationale behind the experiments 2. Groups and number of animals per group 3. How number of animals was determined 4. Sequence and Timing of all Procedures 5. Procedural Endpoints Section 4: Non-Surgical Procedures Section 5: Surgical Procedures Section 6: Clinical Signs/Pain and Distress/Monitoring and Management Section 7: Drugs and Agents (tables) Section 8: Euthanasia Section 9: Personnel roles/responsibilities and training Monitoring for Pain/Distress is described by experiment, to ensure appropriate care of animals. Endpoints and euthanasia are also described per experiment. Office of Research Stay tuned for updates! 7