Initial Steps for Submitting a Protocol through UCSF’s IRB

1. Work with Your UCSF Investigator or Contact
2. Determine the Type of CHR Review Required
3. Complete Human Subject Protection Training
4. Complete an IRB Authorization Form
5. Continue to Work in Collaboration with Your UCSF Investigator or Contact
6. After CHR Approval

1. Work with Your UCSF Investigator or Contact

If you are submitting a research protocol through UCSF’s IRB, this means that you are working on a collaborative research project with a UCSF investigator or Investigator from a UCSF-Affiliated Institution.  The first step is to work with the UCSF investigator, project coordinator or project manager who will guide you through the UCSF IRB process.

2. Determine Type of CHR Review Required

The next step is for the investigators to identify the level of review required – that is, Exempt, Expedited or Full Committee.   The level of review reflects the level of risk to the subject. The risk level is compared to “minimal risk” as defined by the federal regulations:

Minimal risk is the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests (45.CFR.46.102(i)).

Examples:  Studies involving treatments or procedures that are more invasive than a routine blood draw generally have more than minimal risks. Risks are also greater than minimal when identifiable information, if revealed outside the study, could be a risk to a subject’s employment, insurance, financial standing or reputation or put a subject at legal risk unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.

Full Committee Review is required for all studies involving greater than minimal risk. Examples include randomized studies, phase I, II, III and IV trials, studies using investigational drugs and/or devices, and some behavioral interventions.

Expedited Review is appropriate when studies involve no greater than minimal risk and fit into one of nine specific categories, as defined by the federal government. Examples include blood sampling by finger stick, heel stick, ear stick, or venipuncture from healthy individuals, collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, and low risk behavioral research.

Exempt Certification may be allowed if the research involves the minimal risk and if it fits into one of four federally defined categories. For example, these categories include research conducted in established or commonly accepted educational settings, 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.

Note:  Although UCSF’s CHR provides three levels of review, WIRB only provides full committee review or exempt certification.  Additionally, if a study involves greater than minimal risk, UCSF may not agree to serve as IRB of record and Hastings researchers may need to seek coverage from an outside (non-UCSF) IRB, such as WIRB.  Exceptions may apply where the Hastings researcher has a joint appointment with UCSF or a UCSF-affiliated institution, so this is best addressed with UCSF’s CHR on a case-by-case basis.

3. Complete Human Subjects Training

Whether you are submitting a protocol through UCSF or WIRB, all key personnel must complete training in human research subject protection.  UCSF requires the UCSF On-Line CITI training for all researchers where UCSF has agreed to act as IRB of record.  Training from another institution may be valid, but this must be ascertained on a case-by-case basis.  You must go through your UCSF partner or contact to verify whether the non-UCSF training course is transferable.  Please note that HIPAA training, prior research experience, or teaching in the area of human subjects protection does not waive this requirement.     

For information on completing human subjects protection training, please visit the CHR website at http://www.research.ucsf.edu/chr/Train/chrTrain.asp.

UCSF maintains a list of personnel who have completed UCSF-approved human research subject protection training, including expiration dates.  Key research personnel must “refresh” their training every three years.  For more information, please visit http://www.research.ucsf.edu/chr/Train/CITI_Training_Completed.pdf.

4. Complete an IRB Authorization Form

You must complete a new IRB Authorization Agreement for each specific study or UCSF research project. This is a short, one page form.  Your UCSF partner or contact for the research project should provide you with this form.  It can also be found at http://www.research.ucsf.edu/chr/.  Please check that the agreement is “limited to the specific UCSF IRB Approved protocol(s)” and list the name of the specific UCSF Research Project that will be covered by the agreement.   All four UCSF IRBs must be listed on the Agreement.

The form must be signed by the Signatory Officials at both UCSF and UC Hastings and filed at both sites.  John Heldens is the Signatory Official at UCSF and Elise Traynum is the Official Signatory for UC Hastings.  Your UCSF partner or contact will obtain the necessary UCSF signature(s). 

Please contact Jennifer Dunn at dunnj@uchastings.edu or Elise Traynum at traynume@uchastings.edu to complete the IRB Authorization Agreement. 

5. Continue to Work in Collaboration with Your UCSF Investigator or Contact

Continue to work in collaboration with your UCSF Partner or Contact.  The UCSF investigator or his or her designee will have on-going discussions and interactions with UCSF’s CHR throughout the IRB application process.  The UCSF project coordinator or manager should be able to guide you through the CHR process and will serve as the “go between” between you and UCSF’s IRB. 

6.  After UCSF CHR approval

Please provide a copy of your CHR Approval Letter to UC Hastings General Counsel’s Office:

Elise K. Traynum, General Counsel
Phone: 415.565.4787
Email: traynume@uchastings.edu

Where to go for additional information and/or assistance:

For general assistance and questions, please contact Jennifer Dunn at dunnj@uchastings.edu or UC Hastings General Counsel at traynume@uchastings.edu.