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Medical Research
Forms
The eProtocol System is used for:
- New Protocol applications - see Sample
Medical Application Questions.
For VA research also complete and attach Required Questions-VA Research. - Modifications to approved protocols; need prior IRB approval to implement.
- Continuing Review applications.
- Reports - unanticipated problems, events/information requiring prompt reporting.
- Final Reports - to close a protocol; not required for Exempt research.
Forms and TemplatesClick here for eProtocol
Questions about eProtocol? See eProtocol Help.
- Medical Consent - Consent Form Templates and Consent Process Information
- Determination of Human Subject Research application
Federal regulations require IRB review of all human subject research. Some categories of research are difficult to discern as to whether they qualify as human subject research. The IRB has established policies and procedures to assist in this determination. Complete this form and return it to the IRB Coordinator if you want the IRB to determine whether your activity constitutes human subject research. For help, contact the Research Compliance Office.
- Scientific Review:
- Review of Scientific and Scholarly Validity, and Oversight (by Faculty Sponsor)
- Review of Scientific and Scholarly Validity (Dept Chair or School Dean)
- Scientific Review Protocol (questions for projects not otherwise undergoing scientific review)
- Letter of Agreement
Use for STANFORD sponsored research in cooperation with other organizations or agencies.
Protocols using Biological Agents or Recombinant DNA Vectors
All submissions for these protocols must be done via eProtocol - contact the IRB 1 Manager (650-724-8943) before preparing a new protocol or a modification application, or with any other questions about these protocols.
- New Protocol application -
In the eProtocol application:
a) complete the entire eProtocol application
b) complete and attach the Gene Transfer Protocol Application Supplemental Questions to Section 16 of the eProtocol application. This combined application for studies which include human participants and the use of biological agents or recombinant DNA vectors will be reviewed by both the IRB and the Biosafety Panel.
- Modifications to approved protocols - submit via eProtocol.
You may not implement a protocol modification without Panel approval.
- Report Form - this also contains the NIH report template. It is used to report all serious adverse events to the IRB and to the IBC (Biosafety). Complete this form, and "attach" it to the eProtocol Report Form.
Human Subjects Federalwide Assurance Number: FWA00000935, 8/14/2001 - 3/5/2012
Medical IRB Nos. 01, 03, 04, 05, 06, 07 & 08 Nonmedical IRB No. 02
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Last modified: Monday, 15-Jun-2009 14:14:26 PDT