IRB Protocol Resources – Stanford Office of Research Compliance

Research Resources

Office of Research Administration Resources (ORA)
Megan Dietrich, Client Advocacy & Education, ORA

Research Compliance Office
Michael Levesque, IRB Education Specialist

Office of Research Administration

We’re here to help!

What to know: Applying for sponsored research (grants, contracts, fellowships etc.) nearly always requires a 5 business day Stanford internal review of the complete proposal BEFORE submission.

  • We HIGHLY recommend reaching out to the ORA CAE Team and starting the internal proposal routing process as soon as you have any inclination of pursuing a sponsored research opportunity.

Where to go: ORA Proposal Resources

Who to contact: ORA Client Advocacy & Education – We’re comprised of former Central Office and Department Research Administrators that have worked with hundreds of different sponsors and a myriad of project and agreement types. We are happy to guide applicant teams through the administrative logistics of pursuing sponsored research and/or connect applicant teams to any peer groups with whom they should be working.

What is an Institutional Review Board (IRB)?

An Institutional Review Board (IRB) is a committee that ensures the ethical conduct of research involving human participants. IRBs are guided by the principles of the Belmont Report—respect for persons, beneficence, and justice—core ethical standards that protect the rights and welfare of research participants.

When does your project require IRB Review?

  • If your project is human subjects research, then you need to submit an application to the IRB.
  • Research: Your project is a systematic investigation that is designed to develop or contribute to generalizable knowledge.
  • Human Subjects: Your project uses or collects data from individuals that contain identifiable private information.

For more information, check out this FAQ. Click here for information about student projects, pilot studies, oral history projects, or quality assessment/quality improvement project.

Non-Stanford Collaborators and IRB Review

An organization is engaged in research when it is involved in designing the research, conducting the research, analyzing and interpreting the results, or gaining informed consent from human subjects.

If you are working with a non-Stanford partner and they are engaged in research, that partner organization may require an external IRB review.

External IRB Review

  • If the collaborating institution is a University, their IRB can provide a review of their project.
  • If the collaborating institution does not have an IRB, they can work with an independent IRB:
  • If Stanford is the primary awardee of a Federal grant and both Stanford researchers and the collaborating institution are engaged in research, then Single IRB (sIRB) review may be required.

Types of IRB Review

  • Exempt Review: Minimal risk human subjects research that doesn’t involve a prohibited research population (generally prisoners and/or children) and can fit into one or more of the federal exemption categories.
  • Expedited Review: Minimal risk human subjects research that does not fall into one of the exempt research categories and does fit into one or more of the expedited categories.
  • Normal (or Full) Review: If a project does not qualify for exempt or expedited review, then a normal or “full review” is required.

Examples of Exempt and Expedited Research

Exempt 2: Investigator wants to conduct an online anonymous survey of social media usage amongst adults.

  • Minimal risk research where private information is recorded in such a manner than human subjects cannot be identified.

Expedited 5: Investigator wants to use data from a social media company to study human behavior on the platform.

  • Minimal risk research that involves materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes

Materials to be included in your IRB Review

  • Research Instruments: Surveys, questionnaires, and/or interview guides
  • Recruitment Materials: Email or phone scripts use to recruit participants to the study
  • Consent/Assent Form(s): Use one of the templates we provide on our Forms and Templates page.
  • Letter of Agreement: If you are working with a collaborating institution, you may also need a signed letter of agreement demonstrating that you have appropriate institutional/agency approval to conduct research at that site. This template can also be found on the Forms and Templates page.

Final Thoughts and Contacts