(updated 7/28/2014)

Contents


Prior to Submission

1. Who can access eProtocol?

Berkeley eProtocol uses CalNet authentication. Anyone with a CalNet ID and password can access the system. Persons not affiliated with UC Berkeley must be entered in the Human Resources Management System and obtain a CalNet ID to access Berkeley eProtocol. For additional guidance, please contact  OACU at 642-8855 or acuc@berkeley.edu.


2. Who can create or edit a protocol?

Those listed in the protocol as Principal Investigator (PI), Lab Contact, and Alternate Lab Contact can create,  edit and submit a protocol. Those listed as Other Personnel will only have viewing access to the protocol.

There are, however, two sections of the protocol that only the PI can complete:

  • Only the PI of the grant or subcontract can add his or her own SPO Funding information in the Funding Sources section of the protocol. The PI of the grant or subcontract must also be listed in the Personnel Information section of the protocol in one of the following roles: Principal Investigator, Lab Contact or Alternate Lab Contact. Training grants can be added by anoone in the one of the aforementioned roles.
  • Before the eProtocol system will permit the protocol to be submitted, the PI must log into the system and check the appropriate box in the Certification section of the protocol, accepting the responsibilities of the PI. This requirement exists as an electronic substitute for an ink signature from the PI.

For instructions on how to create a protocol, see the eProtocol Quick Guides for Investigators.


3. Who can submit the protocol?

A protocol may be submitted by a Principal Investigator, Lab Contact, or Alternate Lab Contact.

There are, however, two sections of the protocol that only the PI can complete:

  • Only the PI of the grant or subcontract can add his or her own SPO Funding information in the Funding Sources section of the protocol. The PI of the grant or subcontract must also be listed in the Personnel Information section of the protocol in one of the following roles: Principal Investigator, Lab Contact or Alternate Lab Contact. Training grants can be added by anyone in the one of the aforementioned roles.
  • Before the eProtocol system will permit the protocol to be submitted, the PI must log into the system and check the appropriate box in the Certification section of the protocol, accepting the responsibilities of the PI. This requirement exists as an electronic substitute for an ink signature from the PI.

For instructions on how to submit a protocol, see the eProtocol Quick Guides for Investigators.


4. Who can be listed as Principal Investigator (PI)?

The person listed on the protocol as Principal Investigator (PI) must be an employee of UCB (usually with an academic appointment) who is eligible under University policy to submit proposals for extramural support of a research, training, or public service project, and to teach or perform research involving the use of live vertebrate animals.

As a general rule, the PI on the grant funding the research must be listed as PI on the Animal Use Protocol (AUP). All Academic Senate faculty members, and a few other categories listed in the policy, have PI status by title (i.e., as part of their appointment). Those who do not have PI status by title may be granted status by exception through the Office of the Vice Chancellor for Research.


5. Why does eProtocol say that the PI listed is not eligible?

eProtocol checks the name of the PI on the protocol against a list of existing eligible Principal Investigators. PI’s who are new to the University or new to eProtocol will need to be added to the eProtocol system by the OACU. If you receive a message that says, “Please add a Principal Investigator who is eligible to be a PI”, and you believe that it is an error, please contact OACU at acuc@berkeley.edu.


6. How are the personnel roles in eProtocol defined?

Principal Investigator (PI)

The Principal Investigator is the person who has primary responsibility for the design, execution, and management of a research or teaching project and is involved in the project in a significant manner. The PI is also responsible to ensure the proper care and use of vertebrate animals and adherence by all research or teaching personnel to ACUC requirements, as well as applicable university policies, state statutes, and federal regulations.

The PI can create, edit, submit and view protocols that on which they are listed as PI.

Lab Contact

The Lab Contact is the person primarily responsible for managing all the day-to-day research or teaching operations. This is may be a senior staff Research Assistant or Post-doctoral Fellow, and is the liaison for ACUC communications (e.g., Animal Use Protocol updates, scheduling semi-annual inspection).

The Lab Contact can create, edit, submit and view protocols that on which they are listed as Lab Contact.

Alternate Lab Contact

This person is a back-up to the Lab Contact. This may be a staff Research Assistant, a Graduate Student, or an Administrative Assistant who is familiar with all research or teaching operations.

The Alternate Lab Contact can create, edit, submit and view protocols that on which they are listed as Alternate Lab Contact.

Other Personnel

Other (Research or Teaching) Personnel includes any and all individuals who will be handling and/or conducting procedures on live vertebrate animals.

All Other Personnel have view only access to all protocols on which they are listed as Other Personnel.

NOTE: Those listed in the protocol as PI, Lab Contact, and Alternate Lab Contact can create, edit and submit a protocol. There are, however, two sections of the protocol that only the PI can complete:

  • Only the PI of the grant or subcontract can add his or her own SPO Funding information in the Funding Sources section of the protocol. The PI of the grant or subcontract must also be listed in the Personnel Information section of the protocol in one of the following roles: Principal Investigator, Lab Contact or Alternate Lab Contact. Training grants can be added by anyone in the one of the aforementioned roles.
  • Before the eProtocol system will permit the protocol to be submitted, the PI must log into the system and check the appropriate box in the Certification section of the protocol, accepting the responsibilities of the PI. This requirement exists as an electronic substitute for an ink signature from the PI.

7. I am having trouble submitting my protocol, what can I do?

Note: eProtocol permits only the persons listed as Principal Investigator, Lab Contact or Alternate Lab Contact to submit the protocol.

Step 1 – Before you start, make sure that you are using a web browser that is compatible with eProtocol:

  • Use Mozilla Firefox if your computer is a PC
  • Use Safari if your computer is a Mac

Step 2 – Check that your pop-up blocker is turned off. Here are instructions for disabling your pop-up blocker:

  • Mozilla Firefox
    • From the toolbar, select Tools > Options.
    • In the Options dialog box, choose the “Content” tab.
    • Uncheck the box next to “Block pop-up windows.”
    • Click “OK.”
    • Restart Firefox.
  • Safari
    • From the toolbar, select Safari > Block Pop-up windows.
    • A check mark by the Block Pop-up windows label indicates that pop-up blocking is enabled. Click on the label to turn off pop-up blocking.
    • Restart Apple Safari.

Step 3 – Carefully follow the instructions in the Submit Protocol Application Quick Guide and give the system a few extra seconds to process during each step. eProtocol can be a little bit slow and if you click on a button a second time while the system is processing, this will sometimes cause an error.

If after completing these three steps, you are still unable to submit, please call OACU at 642-8855.


After Submission - During Review

8. What is the timetable for reviewing and approving a Protocol or Amendment?

Submission deadlines for full committee meetings are set six (6) weeks in advance of the meeting. All new protocols and AUPs undergoing de novo review are always reviewed at the ACUC meetings. The ACUC meets a maximum of eleven times a year with no meeting in July. Please note that the December meeting is generally only used for reviewing revisions.

Amendments are initially triaged for Designated Member Review (DMR) or Full Committee Review (FCR) every other Monday. The timeline for review and approval of revisions that go DMR is variable, as it depends on the response time of the PI and reviewers; however the time frame can be as short as two (2) weeks. Depending on the date at which the revision is submitted, revisions that go FCR can be reviewed and approved in a minimum of six (6) weeks.

Review and approval of annual continuing renewals are variable.

Please refer to the ACUC Meeting Dates and Deadlines Calendar for submission deadlines and meeting dates.

9. How will I know if ACUC/OACU has questions about my protocol or when my protocol has been approved?

eProtocol generates automated emails at each step of the review process. However, the email notices are only sent to the following personnel: Principal Investigator, Lab Contact, and Alternate Lab Contact. The emails will include links to relevant instructions (for example, how to respond to comments, how to print the approval letter).

These instructions can also be found in the Quick Guides for Investigators.


10. Who can respond to the ACUC/OACU during the protocol review?

The Principal Investigator, Lab Contact or Alternate Lab Contact can respond to questions during the protocol review. eProtocol generates automated emails when questions are sent from ACUC/OACU and provides instructions on how to respond.

11. Can I withdraw a protocol or an amendment once it has been submitted?

Yes, you can withdraw a protocol or amendment once it has been submitted. These instructions can be found in the Quick Guides for Investigators.

12. Can I clone a withdrawn protocol?

The system will not allow for a withdrawn protocol to be cloned. Information will need to be copied and pasted into a new protocol application.


After Approval

13. When can I submit an amendment?

You can submit an amendment at any time. Amendment submission will be triaged on alternating Mondays (see Protocol Submission, Deadlines and Meeting Dates for submission deadlines).


14. Can I let my protocol expire?

Yes, you can let your AUP expire. To do this, please send an email to acuc@berkeley.edu and the Attending Veterinarian indicating: 1) the date you will cease animal work, and 2) what should happen to any remaining animals that are still in the animal facility under your protocol.


15. What do I do if my protocol expires?

If your protocol expires, all work with vertebrate animals must stop immediately. The funding agency for any grants associated with your protocol must be notified that your protocol has expired. You are no longer allowed to do any vertebrate animal work nor will you (or your lab personnel) be permitted in the animal facilities.


16. If my protocol expires, can I reactivate it?

Expired protocol cannot be reactivated. A new AUP must be submitted for review.


17. What if I have started an Annual Continuing Review application but did not submit it before my study’s expiration date?

If an Annual Continuing Review application has been started but not submitted before expiration, it becomes uneditable. Please contact OACU to reactivate the protocol.


18. Can I submit an Amendment and Annual Continuing Review application at the same time?

The system will not allow simultaneous Amendment and Continuing Review applications for the same protocol. Please begin a Continuing Review application first. If you have minor changes to make, you can include these as part of the Continuing Review. If you have significant changes, however, this may delay your Continuing Review because they may need to be reviewed by the Full Committee or by Designated Member Review (see the ACUC Policy & Procedure on Protocol Review. If you have significant changes to make, first submit and obtain approval of the Continuing Review application, then submit an Amendment. If an Amendment Application has already been started, you must withdraw it before eProtocol will allow you to begin a Continuing Review application.

Types of minor changes that can be made during the Annual Continuing Review include reducing animal numbers, deleting species, deleting procedures, adding or deleting personnel.


19. Will my protocol be available to the public?

Under State law and campus policy, an approved AUP for research or instruction is available on written request to members of the public once activity has begun.