Following the completion of your application, please thoroughly review compliance information with your research advisor and submit appropriate documents approving any research involving humans or animals, or the handling of radioactive isotopes, combining DNA, or hazardous biomaterials.
WE CANNOT RELEASE YOUR FUNDING UNTIL THE APPROPRIATE COMPLIANCE INFORMATION IS RECEIVED. This means that your name must be on a protocol form generated and approved by the appropriate committee (human subject, animal care, etc.). It is best to begin this process as early as possible so that the approval documentation can be turned in with the proposal.
Stanford University and state and federal law require that any person engaging in research receive appropriate approvals if their research involves humans or animals, or if they will be handling radioactive isotopes, recombinant DNA, or hazardous biomaterials. Note that except for radioactive isotope training, all approvals are project-specific. Even though your advisor may be cleared for his or her research, you must receive approval for your project or be cross-referenced on his protocol by name. Below is basic information to help you determine what is required and how to obtain approvals. If you have specific questions, you are encouraged to contact the coordinators listed below. You will find them helpful and knowledgeable. Generally, compliance panels meet monthly.
You must file for compliance clearance by the Medical Scholars application deadline. Approval of protocols or certification of training must be received prior to releasing funding. In cases where all compliance approvals are not in place by the second week of the quarter in which the project is to begin, the project will become ineligible for MedScholars funding. In this case, at the request of the student and with approval of the MedScholars program, projects can typically be deferred until the following quarter.
Things to note:
- If/when you publish, make sure your work matches your protocol!
- Changes in the scope of your project need to be approved by IRB/APLAC.
- If you and your mentor agree you'll need compliances from IRB/APLAC, you can work ahead by taking the CITI courses required BEFORE you apply for your MS funding (or during the review process).
Stanford University and state and federal law requires research involving human subjects be reviewed by the IRB (Institutional Review Board).
Under federal regulations Research is defined as systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. A human subject is defined as "living individual(s) about whom an investigator conducting research obtains: (1) data through intervention or interaction with the individual; or (2) identifiable private information."
A copy of the IRB Certification of Approval Letter, Certification of Exemption, or Notice of Human Subjects Determination is required to release Medical Scholars Funding.
My MS project may not meet the definition of “human subject research,” so am I exempt?
If you believe that your study might NOT meet the definition of human subject research, you should complete a Determination of Human Subject Research - Application to the IRB. This application form, guidance, and a self-help human subject research determination flow chart are available at Do I need an IRB Submission? on the For Researchers page.
If you have any questions about whether your project requires IRB review submit a Determination of Human Subject Research - Application to the IRB, or contact IRB Education (IRBeducation@stanford.edu, 724-7141).
My MS project DOES meet the definition of Human Subject research. What now?
You must either submit a new protocol application to the IRB or have your name added to an existing human subject protocol. The IRB uses an electronic application system called eProtocol. Instructions and information for using the eProtocol system are available at: How do I use the eProtocol system?under FAQs on the navigation bar.
- Create a new protocol application here. A faculty sponsor must be listed on your protocol application (under “Academic Sponsor”).
- IRB approval is contingent on each person involved in the project, including faculty sponsors, completing the Human Subjects (CITI) training. CITI training is required to be completed every two years. Information and the link to the CITI training are available from the human subject website underCITI Tutorial on the navigation bar.
My Research Advisor is already cleared for his/her research. Do I need to do anything special for IRB approval?
Even though your advisor may be cleared for his or her research, if your project does not relate to your advisor’s approved research, you need to submit a protocol and obtain separate IRB approval for your project. If your research is part of or consistent with the research activities in your advisor’s approved protocol, then your advisor can add you to his or her protocol.
Below is basic information to help you determine what is required and how to obtain approvals.
- If your research is not related to or does not fall under your advisor’s approved research, you must submit a new protocol application (via the eProtocol system) for IRB approval of your project. Go hereto create a new protocol application. A faculty sponsor must be listed on your protocol application (under "Academic Sponsor"). Instructions and information for using the eProtocol system are available here.
- If you are requesting to be added to an already approved study, please have the current Protocol Director submit a Modification to add your name and funding to the protocol. If your role in the study introduces new procedures or activities to the project, these changes should also be included in the modification, but they must be related to work that is already taking place on the study.
If you have any questions about whether your project falls under an existing approved IRB protocol contact IRB Education (IRBeducation@stanford.edu, 724-7141).
I’m not sure what kind of protocol application or form I should submit.
In order to create an eProtocol application form for submission to the IRB you will need to pick a protocol type (medical or nonmedical) and a review category (regular, expedited, chart review, or exempt). Generally, if you are enrolled in the School of Medicine, or doing your research at SHC, the VA or LPCH, you should submit a medical eProtocol application form, whether or not your protocol involves medical intervention, drugs, or devices.
Regarding the protocol review type, all research is subject to regular review unless it qualifies for expedited or exempt review. There are seven (7) categories expedited review categories and six (6) exempt review categories. Generally, the expedited and exempt review categories describe research that present no more than minimal risk to participants (e.g., simple blood drawing, retrospective review of existing data or specimens and survey and questionnaire studies).
See FAQs on Submitting a Protocol, including Review Type: What is it and why do I need to know? which explains the expedited (including chart review), and exempt review categories.
Contact IRB Education (IRBeducation@stanford.edu, 724-7141) if you have any questions about the appropriate protocol review category for your research.
Who reviews the protocols? How long does it take?
Protocols are reviewed by both IRB staff and the IRB members. Comments or questions the IRB may have about your project will be sent for your response prior to a meeting date assigned to your protocol. All protocols subject to Regular review must be presented and voted on at a monthly convened meeting. It generally takes between 4-6 weeks from submission to approval of a protocol subject to regular review. For protocols subject to expedited and exempt review it takes from 2-3 weeks from submission to approval. Time for approval may be delayed if the initial protocol submission is incomplete and has to be returned for additional information.
Can I get underway with my research while I await word about my IRB?
Under no circumstances may you begin your research until you have been notified of IRB approval (or certification of exemption for protocols subject to exempt review) or that your project does not require IRB submission (determination of non-human subject research).
1. I have a group of students who will be submitting human research protocols to the IRB. What resources are available?
To request classes and presentations geared towards your needs, or to request individual appointments, please contact IRBeducation@stanford.edu. For information on the eProtocol system, review categories, guidance documents, and information go here.
2. What is the Institutional Review Board (IRB)?
The IRB is the committee that reviews and approves protocols that involve human subject research. Federal regulations require that all protocols which involve human subjects be reviewed to ensure the protection of the participants. The IRB membership represents a variety of backgrounds, training and experience. At least one IRB member must be unaffiliated with the University (a community representative) and at least one member must be a non-scientist.
3. I want to submit a new protocol application. When is the next due date?
The next due date for protocol submissions can be found on the Human Subjects Research website:What are the panel meeting dates & deadlines? Generally, new protocol applications submitted for regular review by the first of one month will be reviewed in the following month. That is, if you submit a protocol application by July 1, it will be reviewed sometime in the month of August. Protocols are reviewed in the order that they are received by the IRB.
4. How long does it take for a protocol to be approved?
It generally takes between 4-6 weeks from submission to approval of a protocol subject to Regular review. For protocols subject to Expedited and Exempt review it takes from 2-3 weeks from submission to approval. Time for approval may be delayed if the initial protocol submission is incomplete and has to be returned for additional information.
5. I am trying to log on to the CITI Training and it is not recognizing my SUNet ID. What’s wrong?
The CITI system is not linked to the Stanford system. You will need to select/create a login and password to register for the training and before the system will recognize you as a return user. For more information on CITI and links to the training and completion data base go the Human Subjects Research website under CITI Required Tutorial from the navigation bar.
6. Can I make changes to my approved protocol?
If you would like to make changes to a protocol that has already been approved, you will need to submit a Modification and wait for IRB approval before implementing the change.
7. How can I avoid protocol processing delays?
In the eProtocol application form, make sure that all email addresses are valid. Without valid email addresses the IRB will not be able to effectively communicate with you. Also, remember to include a faculty/academic sponsor in the personnel section of the application. Lastly, remember to attach all necessary documents in the consent, assent, and HIPAA sections, and in the last section of the application (e.g., advertisements, surveys, questionnaires, Investigator's Brochure, Sponsor's protocol, etc.)
8. I am planning on applying for a medical scholars to write a book. Will I have to submit an IRB proposal?
Students planning a writing project should run the idea by the appropriate human subjects committee (an email is fine) and ask if they need to submit a protocol. In the event a protocol is not necessary, the student should forward the e-mail the to the Med Scholars program, as well as save the email response.
9. I have a project that needs multipurpose submissions to Human Subjects, Animal Care, and Hazardous Agents. Should I apply for all three protocols separately?
If your proposal involves more and one area of research (such as human subjects, animals, and/or stem cells) you will need to submit separate applications to the oversight committees of each discipline for review and approval. See the following:
Animal Care and Use
Please click here for the Animal Care and Use Site
I’m going to be working with animal subjects during my MS fellowship.
Here are the items you need to do:
Enroll in the general Animal Care and Use Training Seminar. You can see information about this at: http://med.stanford.edu/compmed/education/vet.html#ACU.
You may need assistance from your advisor’s administrative or laboratory manager to enroll in this seminar.
Your name and description of qualifications or training plan, and your Medical Scholars proposal need to be added to the relevant currently approved protocol.* Ask your PI to have your name and your Medical Scholars proposal added to the protocol via a revision. A revision can be submitted to the protocol as follows: go to eProtocol, open the currently approved protocol, select revision form, then 1) add personnel 2), add funding source, (add the Medical Scholars proposal under fother funding.) contact Stephanie Mar.
When adding your name to the protocol, there is a box underneath where the PI describes what training you will have or have had with this specific animal model. Once your name has been added and approved, you can view the protocol on line. Make sure you review it carefully and any guidelines that are attached to it. (eProtocol can be accessed at https://eprotocol.stanford.edu/.
The Veterinary Service Center can also provide hands-on training in various techniques. The well-being of animals used in research is very important. You can contact the veterinary staff at 723-3876 and ask for training assistance to conduct the studies with animals on your advisor’s protocol. If Veterinary staff will provide training to you, please have this included in your personnel revision training description section.
The personnel and funding revision is submitted to the Stanford Administrative Panel on Laboratory Animal Care (APLAC). The APLAC will review the personnel and funding revision and may have questions or may approve.
The Medical Scholars Office has access to eProtocol so they will be able to view the approved protocol with your name and funding revision added to it.
You will also need to participate in the Lab. Animal Occupational Health Program (LAOHP). Contact Environmental Health and Safety, at 725-5308, for instructions.
Can I get underway with my research while I await word about my protocol approval?
All research and teaching activities involving live or dead vertebrate animals use must be reviewed and approved by the APLAC PRIOR to activity commencement. No animal work can be conducted, nor animals purchased, without a currently approved APLAC protocol.
You must fill out all relevant screens. If your eProtocol is incomplete, review delays will occur.
Who can I contact with questions?
Contact Valerie Fratus (650-723-4550) if you are using animals in your research. For questions concerning training and working with animal models, access to the animal facility, contact the Veterinary Service Center, 723-3876.
*Infrequently, there is a need to file a completely new animal studies protocol since either: the animal model has not yet been approved in a protocol, or the Medical Scholar plans to do animal studies outside of Stanford.
Relevant websites: http://labanimals.stanford.edu/ and http://med.stanford.edu/compmed/animal_care/support.html
Protocol deadline is the first of every month.
If there are problems with the eProtocol application:
Go to HelpSU.stanford.edu. Fill in the Problem Category as "Administrative Applications" and the Problem Type as "eProtocols - Lab Animals." Your request will be assessed to determine the nature of the problem. Some problems may take more time to resolve than others but someone will contact you as soon as possible.
Reminder: No animal work can be conducted, nor animals purchased, without a currently approved APLAC protocol.
Please click here for the Radioactive Materials Site
Every lab handling radioactive materials has a license and a CRA number, which should be posted in the lab. A few labs on campus have been certified as "low activity source" labs, and are exempt from requiring special training of their staff. These labs carry the prefix of "LS" before their CRA number.
I will be doing my research in a lab that is designated as “low source,” what should I do to get my protocol approval in place?
If you are handling sources defined as "low activity", Health Physics will return a form to your advisor delineating the training requirements to provide you. A copy of this form must accompany your Med Scholars application.
I will be doing my research in a lab that is not designated as “low source,” what should I do about my approval?
If you are planning on handling radioactive materials in a lab not designated as "low source" (LS), your advisor must send a complete Statement of Training and Experience to Health Physics, Environmental Safety Facility, Stock Farm Road, Mail Code 8006 (or fax it to 723-0632). This form can be downloaded from the Environmental Health and Safety Website (http://www.stanford.edu/dept/EHS/prod/researchlab/radlaser/).
If you are handling sources in excess of those stipulated as "low activity", Health Physics will determine what, if any, training you will be required to take before being allowed to handle radioactive materials. If you have had a previous training and handled radioactive material in other institution you can take an open book test at Health Physics, if not you need to sit in the class to take RAD training. The maximum training is two four-hour sessions. After you have been trained, by taking the test or attending class, you will receive a form indicating you are "certified" to handle materials in the lab. If the panel does not require you to take further training, you must request a memo from the panel indicating that no further training is required. Either the memo from the panel indicating no training is required to release Medical Scholars funding, or you can use the certificate showing that you are cleared to use radioactive materials.
Who do I contact with any questions or where do I look for more information?
Contact Lance J. Phillips (650-725-1412) for more information.
For more information on general radiation safety, check out the on line safety manual (http://www.stanford.edu/dept/EHS/prod/researchlab/radlaser/manual/rad_safety_manual_2004.pdf). Don't worry that it's from 1997 - its principles are timeless (and it is reviewed frequently and updated when necessary)!
Please click here for the Biohazards Site.
I will be working with biohazards during my research. What should I do about protocols?
For work involving agents categorized as biosafety level (BL) 2-4, these protocols must be reviewed and approved by the campus Administrative Panel on Biosafety (APB) prior to starting research. For more details, refer to the SU biosafety web site at: http://www.stanford.edu/dept/EHS/prod/researchlab/bio/
By the way!
Bloodborne Pathogen Training (EHS1600-Prog) and DOT: Shipping Dangerous Biological Goods (EHS-2700-WEB) are now available via Axess.
Check out the latest Biohazard Waste Disposal Guidelines Poster
Who should I contact with further questions?
Contact Ellyn Segal (650-725-1473) for more information.
Please click here for the Chemical Hazards Site.
The School of Medicine recognizes the sensitive nature of health and safety training and compliance when receiving a medical education or conducting research within a University setting. We are aware that practices and conditions vary, regulations and inspections intrude, liabilities startle, and opinions clash. Nevertheless, health and safety is everyone’s responsibility and all of us have roles to play.
We further acknowledge our obligation to furnish our students with a safe teaching and research environment. We have a responsibility to provide you with training, information, and resources that will enable you to undertake your education and research safely and compliantly. The School’s faculty continues this process by providing you with specific training related to the techniques, procedures, and equipment used in conjunction with your course work, clinical practice, and laboratory research.
What is my first step in getting approval to start my research that involves chemical hazards?
Please begin your participation by registering in the AXESS Learning page (STARS). Register for General Safety and Emergency Preparation (EHS-4200), Chemical Safety (EHS-1900), Biosafety (EHS-1500), and Compressed Gas Safety (EHS-2200).
To determine if you need to take additional Health and Safety Training, please go to the following link and go through the first two Training Advisors: http://www.stanford.edu/dept/EHS/prod/training/training_need.html
After your initial introduction to health and safety you will have a better understanding of your role in implementing good health and safety practices during your stay at Stanford. Please refer to the Health and Safety website at (http://med.stanford.edu/somsafety/) for additional information on the School’s Health and Safety Program and your role in contributing to a healthy, safe and compliant environment.
I’m not sure if my research procedures follow the policies. Where can I get more information?
If you are unsure of a procedure or not clear on the exact meaning of a policy, discuss it with your Principal Investigator. If you need further clarification, please call the School’s Health and Safety Programs Office at 723-0110 or send an email to: email@example.com.
I received my completion notice, now what?
Once you receive your completion notice in STARS, please forward a copy to the Medical Scholars Research Program. NOTE: It can take up to two weeks for STARS to reflect your completion of the course.
Stem Cell Research Oversight (SCRO)
Please click here for the SCRO Site
The State of California has established guidelines for research involving human stem cells, including a requirement that each research project be reviewed by a Stem Cell Research Oversight panel. Stanford University has established the Stem Cell Research Oversight office to assist investigators with their stem cell research protocols. If your research involves human stem cells of any kind – including “adult” stem cells – please create and submit your research protocol in the new Stem Cell Research Oversight (SCRO) eProtocol web-based system: https://scroprotocol.stanford.edu/ Please find general information about Stem Cell Research Oversight at the SCRO Website: http://scro.stanford.edu/ The Human Embryonic Stem Cell Research Tracking (HESCRT) form – previously used for research protocol information – will now only track materials and equipment; if your laboratory conducts human embryonic stem cell research, complete this form by visiting the Office of Research Administration (ORA) website: http://ora.stanford.edu/hesc/
Sheena Bishop, IRB/ SCRO Coordination Manager: 650-725-4133, firstname.lastname@example.org