Protocols
Approval of research protocols by the appropriate Administrative Panel is required before beginning research that involves: human subjects; recombinant DNA molecules; human stem cells; human embryos or their derivatives; laboratory animals; infectious or biohazardous agents; radioactive isotopes; or ionizing, ultraviolet laser, and/or microwave radiation.
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Protocol Submission, Review and Approval
The eProtocol system is used to submit, review, and approve research protocols. You need a SUNet ID and a Web browser to use eProtocol. The eProtocol system will guide you through the specific process for each Administrative Panel, and provides a convenient place to manage your protocols.
Administrative Panels
- IRB for human subjects
- IRB/SCRO for human stem cells, human embryos, or other derivatives
- APLAC for laboratory animals
- APB for infectious or biohazardous agents and/or recombinant DNA
- APRS for radioactive isotopes or ionizing, ultraviolet laser, and/or microwave radiation
Human Subjects, Human Stem Cells, Human Embryos, or their Derivatives
Studies that meet the definition of human subject research must be submitted to the IRB and must receive IRB approval before any study activities take place. Use the chart, form, and policy found on the RCO (Research Compliance Office) website to determine whether and what type of review your research requires.
Effective March 1, 2013 New Extended Approval of Protocols
Effective March 1, 2013, the IRBs discontinued annual renewal of chart review protocols that involve minimal risk for non-federally sponsored human subject research until the end of year three of ongoing research.
visit ScRO: Human Subjects Research and IRB site
Animal Subjects
All research and teaching activities involving live or dead vertebrate animal use must be reviewed and approved by the APLAC (Administrative Panel on Laboratory Animal Care) prior to commencement of the activity. In order to obtain approval for your activities, you'll need to complete and submit an electronic protocol application form detailing your intended use of animals. In general, protocol applications received by the first of the month will be reviewed at the APLAC meeting that month. Please see the Panel Meeting Dates & Deadlines for a complete list of protocol submission deadlines and APLAC meeting dates.
The Laboratory Animal Occupational Health Program (LAOHP) is administered through Stanford’s Department of Environmental Health & Safety (EH&S) in the onsite Stanford University Occupational Health Center (SUOHC), in close cooperation with the Department of Comparative Medicine (DCM) and the Institutional Program for Animal Care and Use (IACUC). The LAOHP provides information and safeguards for personnel working with laboratory animals. See the RPH 6: Laboratory Animals in Research.
View the Veterinary Service Center Training Programs
Infectious or Biohazardous Agents and/or Recombinant DNA
Any work using biological agents classified as BSL-2 or above must have APB approval prior to commencing work. Any work using rDNA that is deemed by the NIH to be non-exempt from the rDNA Guidelines must have APB (Administrative Panel on Biosafety) approval prior to commencing work.
To determine if your research requires APB approval, check:
- the NIH rDNA Guidelines
- Safety Data Sheets (SDS) for Infectious Chemicals
- CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition
You can also check with the biosafety personnel at Environmental Health and Safety (EH&S) (esegal@stanford.edu).
Viruses and viral vectors have become a staple of the molecular biology community. As such, it is important for users to understand the origins of these tools and potential implications of their use. The following viral vector-related documents are available:
- Working with Viral Vectors - Sections for each virus contain information on virology, clinical features, epidemiology, treatment, laboratory hazards, Personnel Protective Equipment (PPE), disinfection, and use with animals.
- Recombinant Viral Vector Biosafety Levels - Information on recombinant viral vectors and the resulting biosafety levels.
- The APB uses the eProtocol Biosafety application process, a web-based system that coordinates new protocols, updates, renewals and reminders. To learn more about eProtocol biosafety and access the system, go to eProtocol Biosafety
- Human subjects protocols involving gene transfer or gene therapy must be reviewed and approved by the Panel prior to initiation of protocol.
- Applications to the APB must be under the name of a faculty member.
Radioactive Isotopes or Ionizing, Ultraviolet Laser, and/or Microwave Radiation
Guidance and detailed information about radiation safety and protection is available on Stanford’s EH&S website under Research & Laboratory Safety for Health Physics.
Genomic Data Sharing
NIH Genomic Data Sharing Policy is effective January 25, 2015. For guidance see the Stanford HRPP (Human Research Protection Program) Guidance (GUI-G1) document ‘NIH Genomic Data Sharing for NIH Grant Submission.
This document contains guidance and information on Genomic Data Sharing and links to teh following resources:
- Memorandum from Vice Provost and Dean of Research, and Senior Associate Dean for Research, SoM
- Institutional Certification
- Genomic Data Sharing Plan template
- Guidances
- FAQs (see Genomic data sharing)
You can access standard forms related to Institutional Certification Genetic/Genomic Data Sharing on the RMG website.
