Initial Steps for Submitting a Protocol through WIRB
1. Determine Type of Review Required
The first step is to identify the level of review required so you can submit the appropriate form. WIRB only has two levels of review: Exempt or Full Committee.
Full Committee Review is required on all protocols submitted to WIRB unless the protocol meets an exemption under 45 CFR 46.101.
Researchers have found WIRB's Request for Exemption Determination form to be an informative tool in determining whether a protocol is exempt. U.S. Health & Human Services also has a decision chart intended to assist researchers in determining whether an activity is “research” that must be reviewed by an IRB. These are included in this guide in order to assist researchers in understanding the process involved in making an exempt determination. OHRP guidance cautions that exempt determinations should not be made by the faculty researcher because of the potential for conflict of interest.
Exempt Certification may be allowed if the research fits into one of four federally defined categories. For example, these categories include research conducted in established or commonly accepted educational settings, research where the subjects are elected or appointed public officials or candidates for public office, and the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
2. Complete the Appropriate Online Form
Full Committee Review: The form for most submissions will be called the “Initial Review Submission Form.” If the protocol is for multiple research sites or a commercial sponsor, a different form may be used. Please contact WIRB Client Services for additional information if your research involves multiple research sites.
Exempt Determination: If you think your research is exempt from IRB review, you may still need to receive an official certification from WIRB. The form for this is called the “Request for Exemption Determination.”
All forms are available on the WIRB website.
3. Submitting a Request for Exempt Determination
The Request for Exempt Determinations may be submitted either through Connexus or more simply via email to email@example.com. Copy Jennifer Dunn (firstname.lastname@example.org) on all email submissions to WIRB.
After submitting request through Connexus or by email, skip to Step 6.
4. Submitting a Protocol Requiring Full Committee Review
All Protocols for Full Committee Review must be completed and submitted online via WIRB’s online portal: WIRB Connexus.
If you have not previously used WIRB Connexus, you must register for a Connexus account and establish a Connexus Client LogIn on the WIRB website. WIRB submissions are done entirely online, although staff are available to answer questions and are generally immediately accessible.
5. Protocols Requiring Full Committee Review Only: Complete Human Subjects Training
All key personnel must complete training in human research subject protection. WIRB requires evidence of training before consideration of any research protocols. Please note that HIPAA training, prior research experience, or teaching in the area of human subjects protection does not waive this requirement. Training is also generally recommended to help researchers understand and navigate the review process, including Step 1.
Free training is provided online through NIH.
Researchers should expect to spend no more than 3 hours on training. Researchers must pass a brief quiz in order to obtain certification that training was completed. Retain this certificate in your study files.
6. After WIRB Approval
Once a completed Initial Review Submission Form is submitted, WIRB takes approximately 12 business days to respond. They may approve the protocol, approve the protocol with modifications, or disapprove the protocol. Depending on the WIRB response, there may be follow up work required.
Processing the Request for Exemption Determination is generally faster than full committee review.
Once you receive notice of exemption or approval is secured, please forward a copy of the notice or letter to Jennifer Templeton Dunn (email@example.com) and Elise K. Traynum, General Counsel (firstname.lastname@example.org).
7. Maintaining Study Records
Faculty Principal Investigators or their study coordinator must maintain copies of their study files. This may be in in hard copy, electronic or other media form.
8. UC Hastings Institutional Contact at WIRB
The following institutional contact at WIRB is available to answer questions from UC Hastings researchers:
Director – Institutions
360-252-2446 (direct line)
See below for general website and contact information:
University of California Hastings College of the Law in San Francisco is redefining legal education through our experiential, interdisciplinary, and international approach to the law. We integrate rigorous academics with hands-on practice, preparing our graduates to tackle the legal challenges—and leverage the opportunities—of the 21st century.
UC Hastings. Made in San Francisco. Ready for the World.