Protocols
All research and teaching activities involving live or dead vertebrate animals use must be reviewed and approved by the APLAC prior to activity commencement. In order to obtain approval for your activities, you'll need to complete and submit an electronic protocol application form, detailing your intended use of animals. The name of Stanford's electronic protocol system is eProtocol Animal Subjects.
New in eProtocol:
- Conflict of Interest section, (under Protocol Information)
Referral information for Stem Cell work (under Are you using)
Referral information for cell screening (under Are you using) - Changes in eProtocol
SPO#s can now be entered for fellowships (funding section)
Biohazardous and Radiological compound sections, request additional information (under Are you using). - IE7 users may need to make browser adjustments to download PDF Print View of protocol. Click here for directions.
If you have questions on how to complete these sections, contact Valerie.Fratus@Stanford.edu.
If you have technical difficulties in completing these new or revised sections, contact Eugenia.Lazarenko@Stanford.edu.
Frequently Asked Questions (FAQs)
Who can log in to eProtocol?
Anyone with a Stanford University Network (SUNet) ID may log in to the eProtocol application. A SUNetID and password provide access to the Stanford University Network and its services, and identifies authorized users of these services. See the SUNet ID website for more information. top
What computer/browser do I need?
To access the eProtocol application, you'll need a computer with an Internet connection.
If on a Windows machine, use Internet Explorer (IE) as your browser.
If on a Macintosh machine, use Safari as your browser.
Pop-up blocking software must be disabled (pop-ups must be allowed) while using eProtocol. See instructions for allowing pop-ups in your browser.top
How can I see certain protocols?
Once logged in to eProtocol, you will have access to see all those (and only those) protocols on which you have been listed in the Personnel Info section. You will only have access to edit those protocols on which you are listed as either: Protocol Director, Administrative Contact, Co-PD, or Other Submitter. You must have edit access for a particular protocol in order to start a Modification (Revision) or Continuing Review (Renewal) application for that protocol.
PLEASE NOTE: If you are listed in the "Other Personnel" section of a protocol, you only have read access to that protocol.
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What kind of training is available?
Hands-on eProtocol Training classes are generally offered several times throughout the year. Dates and registration info are posted on the resources page as classes are scheduled. See a copy of the handout from the training class. All new personnel are expected to attend the general introductory Animal Care and Use training seminar. Depending on what type of work you do, there may be other relevant cources (e.g. non-human primate use and safety course) you'll need to attend. For more information on VSC classes and registration, see the VSC site.top
When is a protocol required?
A protocol is required if you are proposing the use of any vertebrate animal for teaching or research. This includes animals in both the field and the laboratory or classroom.top
When will my protocol be reviewed?
APLAC meetings are held once a month. In general, protocols submitted before the first of the month will be reviewed and considered at that month's meeting. See the schedule for submission deadlines and meeting dates.
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For how long is a protocol approved?
Protocol approval is valid for a maximum of one year.top
Any tips before I start?
1) Use a recommended browser.
eProtocol works best when using Internet Explorer or Safari. You may experience difficulties when using Firefox, Mozilla, or Netscape. These browsers are NOT fully supported.
2) Allow pop-up windows.
Pop-up blocking software prevents the eProtocol application from opening certain windows. You'll need to make sure that your browser has all pop-up blocking software disabled while using eProtocol.
3) Read the Instructions.
Many pages in the application offer instructions right on the page to help guide you and answer the most common questions. You can also see our frequently asked questions page.
4) Avoid using your browser's BACK button.
Instead, use the menus and links within the application to navigate.
5) SAVE frequently.
eProtocol will time out after 45 minutes of inactivity. Only actions which cause the page to refresh or reload (such as saving or navigating to a new section) are indications to the system that your session is active.
6) Be patient.
Some processes can take a minute to run. Although data is loading, your browser may not indicate activity.
7) Sign Out when done.
To protect your private information, always log off and shut down your browser completely (close all browser windows) when you are finished using eProtocol.top
Can you explain my HOME page?
The first page you encounter after logging in to eProtocol is your HOME page. Your HOME page has two main sections that display all of the protocols on which you have been listed in the Personnel Info section. This is how the sections appear:
You can expand or collapse these two sections by clicking on the arrows on the right of the gray section bar as shown above.
Protocols (In-Preparation/Submitted)
Think of this as your "work-in-progress" area. It displays all of your protocol applications that are not yet approved. This includes applications you have just begun working on (new, revisions, renewals), as well as those that have been submitted and are in various stages of the APLAC review process. Protocol applications will be displayed here until they are officially approved in the system. Please note that in some cases this may be after you have received your hard-copy approval letter.
Protocols (Approved)
Think of this as your "work-completed" area. It displays a listing of your approved protocol applications. Click on a protocol number from the list to have the option to view the most recent approved version of the protocol, or to start a revision or renewal application. Remember, the option to start a revision or renewal application is only available to those listed on the protocol in a personnel role that grants EDIT access .top
Create a new protocol.
There are two ways you can create a new protocol.
1) Create a new protocol from scratch
To create a new protocol, simply click on the CREATE PROTOCOL button in the upper right-hand corner of your HOME page. You'll need to enter basic information (such as Protocol Title, Personnel Information) before your application form is generated and a protocol number assigned. Once you have your protocol application number, you may continue to complete the application, or exit the system and return at a later time to complete.
2) Create a new protocol from an existing protocol.
To create a new protocol from an existing protocol, click on the CLONE PROTOCOL button in the upper right-hand corner of your HOME page and follow the instructions on the page.
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Submit a new protocol.
After completing your protocol application form, you can submit it to APLAC by clicking on the SUBMIT PROTOCOL button in the left-hand menu of the protocol application form as shown below. You will need to have the protocol application open in EDIT mode.
Please be patient after clicking submit. The application will automatically check to make sure that all parts of the application form are complete. If the application is complete, a small window will open thanking you for submitting your protocol. If the application is not complete, then a window will open indicating the portions of the application that remain to be completed. Navigate to those areas and answer the questions before attempting to submit again. PLEASE NOTE: If you are listed in the "Other Personnel" section of a protocol, you only have read access to that protocol.
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Re-submit a returned protocol.
After your protocol has been submitted, it will undergo an initial check by APLAC Office intake staff before it is assigned to an APLAC member for review. The protocol is checked to make sure the correct type of application form was used, that the application is complete, and that it includes all of the necessary attachments, etc. Sometimes it is necessary to Return a protocol. This releases the protocol back to you (with full EDIT capability) so that you may make any necessary adjustments. If a protocol is returned, an email notification is sent alerting you to the return. Also the Protocol Status that displays on your HOME page will be "Submission returned". You'll need to open the protocol and click the link in the left-hand menu labeled "IACUC Return Notes " as shown below.
This will open a small window with information on the reason for the protocol return and instructions on how to proceed. When you are ready to re-submit the protocol, you simply click the SUBMIT PROTOCOL button, just as you did for the initial submission.top
Respond to APLAC comments.
Once your protocol has been accepted it will be assigned a meeting date and assigned to APLAC member(s) for review. Check your email regularly. You will receive an email for each major event in the review process, alerting you to when you need to log into the system and take a particular action. You can also see the status by looking at the protocol listing on your HOME page in the eProtocol application:
Click on the link in the Protocol Status column to access the comments page. A sample of what the comments page looks like is shown below:
You'll need to:
1) make the adjustments to the protocol itself (click the GET PROTOCOL button to open up a new window with the protocol)top
2) enter a response for each comment (and SAVE)
3) click the SUBMIT TO MANAGER button to send your responses back to the APLAC.
PLEASE NOTE: Clicking SAVE will save your responses to the comments. However, these responses are not sent to APLAC until you click the SUBMIT TO MANAGER button.
REVISE a protocol.
Before you begin a revision, you should consider the date that the current protocol approval will expire. Keep in mind that once a revision is submitted, you will not be able to start a renewal application until the revision has been reviewed and approved. If the expiration date of your protocol is near, you should start a Renewal application instead. As part of the renewal application, you may include any proposed changes to the protocol.
To start a Revision, follow these steps:
- On your eProtocol HOME page (the page you see when you first log in), look at your Protocols (Approved) listing. You may need to click the
at the right-side of the section header to expand this section.
- Click on the number of the protocol you wish to modify. A small window should open as shown below:
If the option to "Start Revision" is not available (you cannot click on it) then:- You may not have EDIT access to this protocol. Select "Open in View mode" and click on the left-hand menu option "Personnel Info". Only those folks listed in the first four roles (PD, Admin Contact, Co-PD, Other Submitter) have access to EDIT the protocol and start revisions.
- A revision or renewal may have already been started or is in-process for this protocol. Check on your HOME page in the Protocols (In-Preparation/Submitted) section to see if the protocol is listed there.
- Select "Start Revision" and click OK.
PLEASE NOTE: If a protocol revision application does not open when you click OK, then you have pop-up blocking software on in your browser. Even if you believe you have allowed pop-ups, there may be additional toolbars, etc. that are blocking your pop-ups. See instructions for allowing pop-ups in your browser.
- Make the desired changes/additions to the protocol application form.
- Submit the revision when ready by clicking the SUBMIT PROTOCOL option in the left-hand menu.
RENEW a protocol.
To start a Renewal application, follow these steps:
- On your eProtocol HOME page (the page you see when you first log in), look at your Protocols (Approved) listing. You may need to click the at the right-side of the section header to expand this section.
- Click on the desired protocol number. A small window should open as shown below:
If the option to "Start Renewal" is not available (you cannot click on it) then:- You may not have EDIT access to this protocol. Select "Open in View mode" and click on the left-hand menu option "Personnel Info". Only those folks listed in the first four roles (PD, Admin Contact, Co-PD, Other Submitter) have access to EDIT the protocol and start renewal applications.
- A revision or renewal may have already been started or is in-process for this protocol. Check on your HOME page in the Protocols (In-Preparation/Submitted) section to see if the protocol is listed there.
- Select "Start Renewal" and click OK.
PLEASE NOTE: If a renewal application does not open when you click OK, then you have pop-up blocking software on in your browser. Even if you believe you have allowed pop-ups, there may be additional toolbars, etc. that are blocking your pop-ups. See instructions for allowing pop-ups in your browser.
- Answer all of the questions on the Renewal Form page, including any changes that you wish to make. You will also need to go to the appropriate sections in the protocol application form and update your answers to reflect those changes.
- Submit the renewal form when ready by clicking the SUBMIT PROTOCOL option in the left-hand menu.
Update protocol personnel.
If there has been a change in the personnel related to a particular protocol, you'll need to include these changes as part of a Revision or Renewal application. Follow the instructions on the top of the Personnel Info page in the application form. top
Print a protocol.
You may generate an Adobe .pdf file of your protocol application form that can be printed or saved on your computer. In the left-hand menu of the protocol application form, click on the Print View option (shown below):
A small window will open:
Select an option and click OK. The Adobe .pdf file will be created and opened. You may save it to your computer by clicking File, then save as in the upper left-hand corner of the window.top
File a Multiple Project Protocol (MPP).
You will need to create and submit an eProtocol application that will serve as your MPP. Here’s how:
- Log in to the eProtocol Animal Subjects application.
- Click CREATE in the upper right-hand side of the page.
- Title: Enter a title that is the same as the proposal title, but add “MPP” at the end.
- Personnel:
Enter the contact information for the PI of the grant in the Protocol Director section. In the experience section, just write Grant PI.
Enter the contact information for the Administrative Contact. Be sure to select Not working with Animals. - Species:
Species Name = Mouse
Daily Census = 0
Housing Location = Other, then enter MPP on the next line
Number of animals per year should = 0 - Funding sources: Complete all the proposal information. Include:
SPO# (can be obtained by contacting your Research Process Manager)
Grant Number
Grant Title
NOTE: If it is a Federal funding source, attach the new or competitive renewal proposal under Protocol Information, Attachment Tab. Please use SPO# in the name. - Rationale: Insert MPP in all boxes.
- Procedure: Complete one procedure.
Type = Other
Title = MPP
Pain/Distress = C
- Attachments: Attach a complete listing (Excel or Word format) of all protocols that will be funded by this MPP. List should include:
Protocol Number
Principal Investigator Name
Protocol Title
Save this document as it will need to be updated and resubmitted with every renewal of the MPP. - Certification: Click agree.
Protocol does not open .
You have pop-up blocking software on in your browser. Even if you believe you have allowed pop-ups, there may be additional toolbars, etc. that are blocking your pop-ups. Contact your departmental IT support person or call the Stanford Help Desk at (650) 725-4357 and ask for assistance in configuring your browser to allow pop-up windows.
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Can't see approved protocols .
Your approved protocols appear on your eProtocol HOME page (the page you see when you first log in) in the section labeled Protocols (Approved). It should appear towards the middle of your page. You may need to click the
at the right-side of the section header to expand this section.top
Can't start revision/renewal .
The option to Start Revision or Start Renewal is not available; it appears gray.
- You may not have EDIT access to this protocol. Select "Open in View mode" and click on the left-hand menu option "Personnel Info". Only those folks listed in the first four roles (PD, Admin Contact, Co-PD, Other Submitter) have access to EDIT the protocol and start continuing review applications.
- A revision or renewal may have already been started or is in-process for this protocol. Check on your HOME page in the Protocols (In-Preparation/Submitted) section to see if the protocol is listed there.
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Can't see comments .
You might be confusing the IACUC Return Notes button in the left-hand side of the application form (used for returned protocol notes) with the APLAC (IACUC) Comments page, which is used during the official review cycle. If you are attempting to access comments from the APLAC for a protocol that has already been assigned to a meeting date, please see the instructions on how to respond to APLAC comments. If your protocol was returned, please see instructions for returned protocols.
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Can't open print view (PDF) to see my protocol.
Recent changes in security may require Internet Explorer 7 users to change settings to download PDFs using the Print View function in eprotocol. Please do the following to adjust your settings.
- In IE7 click on “Tools” in the Menu Bar
- Choose “Internet Options”
- Click on the “Security” tab at the top of the window
- Click on the “Custom Level” button
- In the Security Settings Window make sure the following are set to “Enable”
- ActiveX controls and plug-ins – “Binary and script behaviors”
- ActiveX controls and plugons – “Automatic prompting for ActiveX controls”
- Downloads – “Automatic prompting for file downloads”
- Downloads – “File download”
- Click “OK” in the Security Settings Window
- Click “Yes” to the Warning about changing security settings
- Click “OK” in Internet Options Window
Now you should be able to open the PDF of your protocol using Print View.
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Received system error message .
While you are entering information, the system will often notify you that you have entered information incorrectly or are missing information. These kinds of messages will appear in red text towrds the top of your application form page. Sometimes, however, you might attempt to navigate within the system or perform another type of action and you receive a message alterting you to contact the system administrator. If you receive this kind of message, close ALL browser windows and then re-open one window and try logging in again. Make sure that all of the email addresses entered in on the Personnel Info page are accurate. The system encounters difficulty when attempting to send automated email alerts to protocol personnel if the email addresses are incorrect. If you are still having problems, please contact the eProtocol Help Desk at (650)724-8964. top
Can Stanford laboratory animal studies be conducted at non-Stanford facilities?
To determine if a Stanford protocol can be conducted at a non-Stanford site, an eProtocol application form must be submitted for A-PLAC review. An approved protocol from the non-Stanford Institutional Animal Care and Use Committee (IACUC) must be attached. In addition, proof of the following is required as applicable:
- Public Health Service Assurance for PHS-funded projects;
- Association for Assessment and Accreditation of Laboratory Animal Care, International (AAALAC) accreditation;
- USDA license registration number for USDA-covered species;
- Certificate of Registration from the State of California for certain studies;
- Other documentation, as deemed necessary by A-PLAC.
Depending upon the nature of the animal studies to be performed, a contract or sub-contract may need to be established with the Office of Sponsored Research; contact the A-PLAC office (Valerie.Fratus@stanford.edu) for more information.
What happens when my protocol expires?
No further animal studies can be performed. Any pending animal orders will be cancelled. Any animals at Stanford, registered to your protocol will be transferred to the Veterinary Service Center holding protocol. If there are active sponsored agreements listed on the protocol, the Research Management Group or Office of Sponsored Research will be notified.top
What is needed to add personnel to protocols?
The form requests that you “Describe experience/training have had or will have with this specific animal model(s)” per each individual If the individual does not have experience with the specific animal model, indicate who in the lab will provide training/supervision until the individual has been deemed competent. Training is also available from the veterinary staff. If training will be provided by the veterinary staff, indicate this as: John Smith will be trained by veterinary staff in bleeding techniques, prior to conducting them on his own. A mix of training experience can also be explained. State the prior sentence, then indicate who from the lab will train, e.g., Mary Johnson, laboratory manager, with 20 years rodent surgical experience will train and supervise John Smith in conducting craniotomies. If the new individual hasn’t yet attended the Veterinary Animal Care and Use Seminar, you can indicate the date they are enrolled to attend. top
Is custom antibody production considered an activity under Public Health Sevice (PHS) policy? Do I need to file a protocol at Stanford?
Yes, custom antibody production is considered an activity under PHS policy. For PHS policy requirements, go to Office of Laboratory Animal Welfare website at http://grants.nih.gov/grants/olaw/faqs.htm#App_2. You will need to file an eProtocol application at Stanford.top
Can I use non-pharmaceutical grade compunds?
Yes, but their use must be explained and justified in the protocol, preferably in the procedure description in which they are used. You must also prepare these under aseptic conditions and inject aseptically, by using sterile diluent, sterile filtration (.2um). Such products should be used immediately after preparation and any unused material discarded.
The following in an excerpt from the USDA, Animal Resource Guide, Policies Veterinary Care, Policy #3:
Pharmaceutical-Grade Compounds in Research
Investigators are expected to use pharmaceutical-grade medications whenever they are available, even in acute procedures. Non-pharmaceutical-grade chemical compounds should only be used in regulated animals after specific review and by the IACUC for reasons such as scientific necessity or non-availability of an acceptable veterinary or human pharmaceutical-grade product. Cost savings alone are not an adequate justification for using non-pharmaceutical-grade compounds in regulated animals. top
My faculty member is leaving the University and needs to transfer the responsiblities of Protocol Director to another faculty member. How can I do this?
You can change the Protocol Director by submitting a protocol revision which includes the necessary personnel updates.
You will need to attach brief statements from the incoming and outgoing PD acknowledging the transfer. Here is a sample format:
Outgoing PD: I am transferring my role as Protocol Director on APLAC protocol (enter number here) entitled (enter title here) to (new PD name) as of (enter date here).
Incoming PD: I am assuming the role of Protocol Director on APLAC protocol (enter number here) entitled (enter title here) as of (enter date here). I have reviewed a current copy of the protocol and agree to comply with all the terms and conditions of the protocol.
The revision will be reviewed at the next scheduled APLAC meeting. top
What do I need to know about Material Transfer Agreements (MTA) and animal studies?
The Industrial Contracts Office will contact the APLAC office to verify that you have APLAC approval for the use of the materials.
If the materials are new animals to be brought onto campus, contact the animal buyer, 723-3876 for instructions. If the materials are other biological materials, go to: http://med.stanford.edu/compmed/word-pdf/guidelines/Biological_Materials_Nov_04.pdf and obtain the necessary screening prior to bringing the biological materials onto campus. If the material has not yet been approved in your animal studies protocol, e.g., new drug, submit a revision or file a new protocol in eProtocol to address the study with the new material. top
What is a Multiple Project Protocol (MPP)?
MPP stands for Multiple Project Protocol. An MPP is needed when there is more than one protocol referenced to a funding source. To provide sponsors with one animal subjects approval date, an MPP is set up. It is considered an umbrella protocol and its purpose is to maintain a list of protocols for a funding source.
When the funding source sponsor requests Institutional Animal Care and Use Committee (IACUC) verification or animal subjects approval, the approval date of the MPP is given. This avoids having to provide multiple approval dates from the individual protocols.
You cannot order or study animals under an MPP; it is established for administrative purposes only.
The grant PI, or his/her administrator, should submit an MPP at the same time the funding source is being added to the individual protocols. MPPs must be renewed annually, and should include an updated list of approved protocols under the MPP.
Each PD with a protocol under the MPP umbrella is responsible for obtaining approval for their own protocol which may include review of the relevant grant proposal. top
Can I use Avertin (a non-pharmaceutical grade compund)?
Yes, however, please consider the following regarding the use of Avertin as the anesthetic agent:
- According to a recent review (Lab Animal 34(10):47-52) tribromoethanol (avertin) has been associated with serious post-anesthetic effects and inconsistent and variable anesthetic effects.
- Have these effects been observed by your laboratory?
- Have alternative anesthetic for this procedure, been reviewed? If so, why has tribromoethanol (Avertin) been chosen over these alternatives?
- Veterinary consultation on the use of anesthetic agents is available at 723-3876.
In view of these concerns it is recommended that your laboratory adhere to the following precautions when using tribomoethanol (Avertin):
- The stock solution (100%) of tribromoethanol should be dated at the time of preparation from reagent chemicals and discarded after one year.
- It should be refrigerated in a light-safe vial/bottle.
- The working solution (2.5%) should be prepared using a sterile diluent (e.g. sterile saline) and prepared fresh for each application, or stored refrigerated in a light-safe vial/bottle for less than 2 weeks.
- The working solution should be filter (0.2 um) sterilized.
- A morbidity and mortality log should be maintained for all mice anesthetized to better document any post-anesthetic effects and inconsistent and variable anesthetic effects.
- The stocks of Avertin (tribromoethanol ) should be prepared, handled and stored to make sure that they are sterile and do not decompose.
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Do I need to describe rodent breeding in my protocol?
Yes, this is considered a procedure and a procedure of type Breeding and Genotyping must be added to your protocol. Most conventional breeding that involves only observation and weaning can be described in your procedure in a manner similar to this example:
Mice may be kept in compatible breeding pairs and offspring are weaned at 21-28 days. Animals will be monitored daily for any abnormalities.top
I am using human stem cells in my animal research, what do I need to do?
In addition to your eProtocol Animal Subjects application, you'll need to submit an eProtocol Stem Cell application and a Stem Cell tracking form. See http://scro.stanford.edu for more information.
California law prohibits breeding any animal into which stem cells from a covered stem cell line have been introduced. If you will be using human pluripotent (capable of differentiation into mesoderm, ectoderm, and endoderm) cells or their derivatives:
- In the Husbandry section of the eProtocol Animal Subjects application form, describe how animal populations will be managed to prevent breeding. Each PI should consult with the veterinary staff, (723-3876) to determine the best methods and age at which the gender of the animals can be confidently identified. The following management practices are considered sufficient:
- Animals will be separated by sex.
- Any pregnancies will be terminated or animals sacrificed as soon as pregnancy is detected.
Why am I asked to attach my current Federal proposal to the protocol?
Per Public Health Service (PHS) policy, the APLAC is required to review the experimental aims and vertebrate animal section of the grant to assure congruency with the protocol contents. Please attach the grant (with face page included for identification) to your eProtocol Animal Subjects application for review. When your protocol is approved, the approval can be sent to the necessary funding agencies. top
I will be using nanotechnology in my animal studies. What do I need to know?
See EH&S Guidance (draft) on the use of nanotechnology in animals. top
Is photography of animal studies permitted?
Only under certain conditions, based on prior approval from the Veterinary Service Center. See section on recording devices at http://med.stanford.edu/compmed/animal_care/husbandry.html. top
What should I do if Federal agency representatives (not in context of a formal University-wide inspection) either arrive in my laboratory or notify me of an impending site visit to review experiments involving animal studies?
Contact the Veterinary Service Center, (650) 723-3876 to coordinate interviews and review of laboratory space. Notify the Stanford Internal Audit Department of the impending site visit. See the Internal Audit memo on Supplying Information to Government & External Auditors.top
How do I report a complication (anticipated or unanticipated) that occurs during an animal study?
1) Immediately notify veterinary staff, (650) 723-3876.
2) Submit an email to Felicia Gentile, Deputy Director, Research Compliance. The email should include:
- Protocol Number
- Protocol Director/PI name
- Name of individual reporting the complication
- Date of occurrence
- Brief description of what transpired.
My sponsoring agency is requesting an "IACUC verification/approval". How can I get this?
The APLAC office (723-4550) can provide a verification for any approved protocol that includes the sponsoring agency. If you have not yet created your protocol or it is currently in-process, be sure to include the appropriate funding information (agency name, proposal title, SPO#, if known). If your protocol is approved, but does not include the appropriate funding information, you'll need to submit a revision (only if animal studies are identical between proposal and protocol) to the protocol to include this information.
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