Human Research Protection Program
IRB Application for Continuing Review of Human Research


Welcome to the Electronic Continuing Protocol Application Module!

Please do not use the "Back" button of your Browser to navigate through the module. Use the "Save" buttons to navigate within the application.


Information:

Drafts will be deleted after 120 days if they are not submitted. Deleted drafts cannot be recovered.

Full committee and expedited IRB protocols must be submitted for IRB review at least annually. Investigators should plan ahead to meet required continuing review dates. For full committee review protocols, please submit 60-90 days prior to the expiration date to guard against a lapse in IRB approval. For expedited review protocols, please submit 30-45 days prior to the expiration date.

Seven-Year De Novo Review:

Any protocol in its 6th year of IRB approval requires Seven-Year De Novo Review where in addition to completing this e-CPA application, submission of updated protocol documentation is needed. Instructions for submitting for De Novo Review are available online.

What happens if there is a lapse in IRB approval?

If the IRB has not approved a research study by the study expiration date, all research activities must stop*. This includes:

  • Recruitment and informed consent procedures
  • Collection of data/information from or about living individuals
  • All research-related interventions or interactions with currently enrolled subjects (unless the IRB finds that it is in the best interests of the individual subjects to continue participating in the research interventions or interactions.)
  • Analyses involving human subjects data

*Exception: Research-related interventions or interactions with enrolled subjects may continue if the IRB determines that stopping the research would jeopardize the rights or welfare of current subjects. The IRB will decide which subjects should continue receiving the intervention during the lapse in approval. A request for such an exception must be submitted in the writing to the IRB by the Lead Researcher.


Instructions:

  1. To create or submit an electronic Continuing Protocol Application (e-CPA), users must login with their UCINetID and password.
  2. Any member of the study team may create and save an e-CPA. Only The LEAD RESEARCHER or FACULTY SPONSOR can electronically submit the application to the IRB.
  3. A signed hard copy of the e-CPA along with any other required hard copy documents must be sent to the IRB at the Office of Research before the continuing review process can begin. Signatures of the Lead Researcher, Faculty Sponsor (if applicable), Department Chair or Research Unit Head (as applicable) are required on the e-CPA. To print the .PDF version of the submitted e-CPA, click here.

Create, review and/or submit an electronic Continuing Protocol Application



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