If your project is BOTH Research and Research with Human Subjects, you are required to submit a protocol to the IRB for review and approval.
Protocols are reviewed by the IRB via 3 review processes: 1. Exempt, 2. Expedite or 3. Full-board. What type of review is appropriate for your research?
Check out the Exempt and Expedite/Full-Board sections of our website for complete details on the three review methods.
If you have questions about which review criteria fits your study, please feel free to contact an IRB Coordinator.
Important Note to Researchers: Exempt applications (MS Word document) are submitted to the IRB either via email or hard copy. Expedite and Full-board review protocols must be submitted online via eProtocol. Submissions made via eProtocol that are determined by the IRB to be exempt will be returned to researchers once the Exempt determination memo has been completed.
Types of Reviews:
- Can be Submitted at any time
- Exempt determination made by IRB Administrator
- 1 Administrative reviewer
- 10-15 day turn around
- Can be submitted any time
- Expedite determination made by IRB
- 2 Reviewers
- 3-5 week review (target time)
- Due by 5:00 p.m. on the 1st Thursday of each month.
- 4-5 week turn-around; Comments to PI within 7-10 working days after full board committee meeting
eProtocol Tips & FAQs
What is eProtocol and what are the major benefits for PIs?
eProtocol is an online protocol submission-and-review system with features that make keeping track of your IRB protocols convenient for all personnel listed on the protocol. Researchers can view, create, edit, clone and submit protocols from any computer at any time. All documents associated with the protocol will be available online (including the approval letter) for all personnel listed on the protocol.
Where do I find International Research in the Code of Federal Regulations?
Please see §46.101(h) When research covered by this policy takes place in foreign countries, procedures normally followed in the foreign countries to protect human subjects may differ from those set forth in this policy. [An example is a foreign institution which complies with guidelines consistent with the World Medical Assembly Declaration (Declaration of Helsinki amended 1989) issued either by sovereign states or by an organization whose function for the protection of human research subjects is internationally recognized.] In these circumstances, if a department or agency head determines that the procedures prescribed by the institution afford protections that are at least equivalent to those provided in this policy, the department or agency head may approve the substitution of the foreign procedures in lieu of the procedural requirements provided in this policy. Except when otherwise required by statute, Executive Order, or the department or agency head, notices of these actions as they occur will be published in the FEDERAL REGISTER or will be otherwise published as provided in department or agency procedures.
How can I access eProtocol? Who can access eProtocol?
To locate eProtocol, follow the link to: https://csu.keyusa.net. Your username and password are the same as your CSU eID & password. Only those with a CSU eID will have access to the protocol; however, you can list researchers outside of CSU on the personnel listing of your protocol. These researchers will not have access to the online system. If you would like a co-investigator from outside of CSU to have viewing/editing access to your protocol, this individual will need to have CSU Associate status. Please contact RICRO for more information on the Associate-application process.
How far in advance of leaving the country should I plan to submit my protocol?
Whether you are a CSU faculty member, staff or student, your human subjects’ research study must be approved by the IRB before it can be implemented. We suggest you apply to the IRB at least two months before you leave the United States to ensure adequate time for review and approval before you leave the country. Bring your written IRB approval notification with you on your trip.
I can’t remember my CSU eID or password. Can you help?
RICRO staff have access to your user name, but cannot help you with your eID password. Please contact Academic Computing & Networking Services for assistance with your password. Information regarding your eID can be found here: https://eid.colostate.edu/About.aspx.
In addition to IRB Ethics Board review and approval, am I required to contact the consulate or ministry in country to register my research with the government abroad?
You may be. Please refer to the 2017 Edition of the International Compilation of Human Research Protections from the Office of Human Research Protections. This site provides links and information regarding regulations for research in many countries.
I am a student and will be submitting a protocol for my thesis/dissertation project. Can I be the PI on a protocol on eProtocol?
While students can log-in and create the entire protocol for their project, the student’s advisor must be listed as the Principal Investigator on the protocol. Student researchers should be listed as Co-PIs. The IRB asks that your advisor completes the Conflict of Interest and Obligations sections and (when possible) submits the protocol. The PI and Co-PI will receive the emails regarding their review process, approval and renewal.
I have a grant that is funded by NIH, and I will be collaborating with a researcher at another academic institution abroad. Are both institutions required to review the protocol?
For research that is sponsored by a U.S. Federal agency, where CSU is the prime grantee of the award, the CSU investigator is responsible for ensuring that all engaged international sites hold a federalwide assurance, and that the research is approved by the IRB or Ethics Committee of the participating sites listed on the federalwide assurance. In some circumstances, the IRB may approve an IAA (IRB Authorization Agreement) between the two institutions, but this will depend on the activities that each Investigator will perform. You can find International FWA information for specific International institutions here (select Advanced Search to find International institutions). Contact the IRB Coordinators for IAA applicability.
Is training required to use eProtocol?
eProtocol training is not required to access/use the system. eProtocol is an intuitive system that we believe you will find fairly user friendly. If you have any questions about the system or experience any problems, please don’t hesitate to contact the IRB team. RICRO staff are pleased to help you in-person, over the phone, of via email. Contact the IRB eProtocol lead coordinator with any questions regarding eProtocol or the front office staff
I am working with an international NGO, and they have agreed to assist me with my research y providing access to the community. What sort of documentation do I need to provide the RB to document this NGO’s agreement to assist me with my research?
If the organization’s role is limited to assisting you with recruitment/access to potential participants, the CSU IRB require that you obtain a letter or email from the organization to document their agreement to assist you and to outline their role in your research. If you do not have this document at the submission of your protocol, please inform the IRB that this is in process. Your protocol can be reviewed and approved with receipt of this documentation as a condition of approval. Please see “Letters of Cooperation”.
A few important points to remember when using eProtocol:
- In order for the system to work properly, you must allow pop-ups for csu.keyusa.net (allowing popups addresses nearly 80% of the problems that PIs encounter!)
- Remember to click on the IRB tab when starting your eProtocol process.
- Do not navigate from page-to-page with your web browser’s back and forward buttons. Use the navigation tools within eProtocol.
- Remember that you must click “Submit form” for the IRB to receive your protocol. When you have successfully submitted your protocol, the link on your eProtocol homepage associated with the protocol/form will say “Submitted To IRB.” If the status on your IRB homepage is “Yet to Submit to IRB,” that means that the IRB has NOT received your protocol for review.
- Be patient with the system when you are uploading your documents in the attachment section. eProtocol is on a server outside of CSU, and uploading large files can take a few extra minutes.
- If not in use for 45 minutes, you will be timed out of the system. eProtocol will save the page that you were most recently working on. Also, while creating your protocol, clicking “Previous” or “Next” will save the work you have done on your protocol.
- You can always find your approval letter by opening the approved protocol and clicking on Event History.
A staff member at an international NGO will be considered a Co-Investigator on my research (e.g., will consent participants, collect data, and co-author manuscripts). How can I establish this relationship?
Can I add this person to my eProtocol? Is this collaborator required to have human subjects’ protection training? If foreign staff will be engaged with your research and the organization does not have its own FWA, the CSU IRB may agree to extend our FWA to cover this individual investigator. The NGO staff member would need to have documented Human Subjects Protection training, and we would enter into an IIA (Individual Investigator Agreement) with this investigator. Please inform the IRB at submission that individuals at the NGO will be engaged in your research so the agreement process can be discussed by the IRB and initiated as soon as possible. For more information regarding IIAs, view Extending an FWA to Cover Collaborating Investigators. The NGO staff member can be added to eProtocol under the “Other Researcher or Key Personnel” role. Note that they will not have viewing or editing access to the protocol.
What actions can I take with my approved protocols in eProtocol?
- View protocol and associated documents (including approved letter)
- Create Protocol
- Clone Protocol (makes a complete copy)
- Renew protocol
- Amend protocol
- Close protocol
- Report Adverse Events or any protocol deviations
Should I submit translated research instruments, recruitment, and consent with my initial protocol submission or should I wait until the protocol forms have all been approved in English first?
The translated finalized research instruments, recruitment and consent are required to be submitted to the IRB to complete your eFile. Since the IRB may request that you make changes to your consent or recruitment, please wait until these documents have been approved by the IRB before submitting your translated documents. The translated files can be submitted to the IRB as a postapproval amendment via eProtocol.
Can I submit exempt, expedite and full IRB-review in eProtocol?
No – eProtocol is used only for protocols that are reviewed via the Expedite or Full-Board review process. Please visit the RICRO website to determine what review category is right for your project. Remember that the IRB makes the final determination on how your project will be reviewed. Click here for information regarding exempt review: How Will My Project Be Reviewed by the IRB
I would like to provide some compensation to my participants. What does the IRB consider to be coercive when providing participants incentives internationally?
As with any compensation or incentives, payments should reflect the degree of risk, inconvenience, or discomfort associated with participation. Compensation should not be so large as to persuade participants to consent to the research against their better judgment. Compensation is provided to participants for their time spent and inconvenience. Items such as rice, tea, t-shirts, or mugs are also considered compensation. Careful consideration should be made to the economic status of the region. While providing $10 may not seem coercive to you, this amount may be the average weekly salary for individuals in the region, thus creating undue influence.
How do I save my protocol?
eProtocol saves as you are working on your protocol. When you navigate from one page to the next, you will notice that the system takes a moment to save your work. You can also click on the “Save” icon on the top of the page to save before moving to the next page.
When recruiting and consenting participants internationally, is it always required that I ask my participants to sign a consent form? What are my consent options?
The key consideration is the cultural context. What matters is that the participant can be fully informed and understand what your research is about, and what you are asking them to do, NOT a particular form. The IRB is receptive to proposals for “non-traditional” means to convey consent. In principle, YOU and your local collaborators should know best HOW to meet the spirit of informed consent. Obtaining signed consent from human subjects may not be culturally acceptable in the country where you will be conducting your research. Using an oral script, short cover letter, picture boards, videos, or a mobile app may be appropriate for your population. View templates for oral consent and a study summary that you can customize and provide your participants.
How do I submit my protocol?
It is important to remember that you do need to click on the “Submit Form” button to submit any new form to the IRB. When submitting your responses to the IRB, you must click “Submit to IRB” when responding to the IRB’s comments. The text on your homepage will say “Submitted to IRB” or “Responses Sent.” If you have any doubts as to whether or not the IRB has received your protocol or responses, feel free to call Evelyn @ 491-1381.
Should the CSU IRB contact information be given to participants, or should I provide participants a local contact to serve as the subjects’ rights contact?
It is the IRB’s strong preference that you provide a local subjects’ rights contact as the RICRO coordinators are not able to assist in multiple languages, and it is best not to ask your participants to place international phone calls.
Will I receive the reviewer’s comments via email from RICRO staff or via eProtocol? How do I respond to the IRB?
When the reviewers have completed their review, the IRB Coordinators at RICRO will prepare the reviewer’s comments and send them to you via eProtocol. You will receive an email to let you know that you have received the reviewer’s comments, and instructing you to log into eProtocol to respond to the IRB.
Are there any issues I should be aware of regarding taking my computer with me internationally?
Please check with the Export Control Administrator regarding taking your computer with you internationally.
Does eProtocol have a form for biomedical versus social behavioral research?
Yes, we have two basic forms: Biomedical and Social Behavioral.
What are the major considerations that the IRB reviewers are focusing on when reviewing international research protocols?
CSU Researchers and the CSU IRB share the responsibilities to ensure that human participants are provided the same or equivalent protections as provided participants in any research location. In order to review the risk-to-benefits ratio, the reviewers would like to see that you have knowledge of the local laws and the cultural context, the consent process is appropriate, required local and/or International approvals are in place, and that you have developed a data management plan. As you prepare your international research protocol, please refer to the International Research Checklist.
For protocols that are 5+ years old – I have just logged in and am getting ready to do my continuation online. I notice that Molly Gutilla and/or Evelyn Swiss are listed as personnel on my protocol. Why is this and can I delete them?
In order for RICRO to input your original protocol into eProtocol, it was necessary for us to be able to create and submit the protocol. The only way for us to accomplish this was to be included in the personnel listing. It is fine for you to delete Molly or Evelyn from your protocol once you log into the system and start to work with your protocols.
What documents should be uploaded in the attachments section?
Attach all documents that the IRB will need to complete the review of your protocol. These documents could include: Collaborating Investigator’s IRB approval and approved documents; Conflict of Interest information; Debriefing Script; Grant/Sub-contract; HIPAA Authorization Form from HIPAA-covered entity; Interview/Focus Group Questions; Investigator’s Brochure; Letters of Agreement/Cooperation from organizations who will help with recruitment; Methodology section of associated Thesis or Dissertation project; Questionnaires; Radiation Control Office approval material; Recruitment Material (e.g., flyers, email text, verbal scripts); Sponsor’s Protocol; Surveys; Other files associated with the protocol (you can upload most standard file formats: xls, pdf, jpg, tif, etc.).
I would like to submit a 118 application. Can I do that on eProtocol?
No, exempt and 118 applications are not reviewed via eProtocol. You should continue to use the forms on the RICRO website.
Who are the mandatory personnel to list on a protocol in eProtocol?
There are only two mandatory personnel: the PI and the PI’s Department Head. At the time the protocol is submitted by the PI, the Department Head receives an email to let him/her know that a faculty member in their department has submitted a protocol. You no longer need to obtain signatures for your protocol to move forward. NOTE: If there is a change in the Department Head for your department, please remember to update the Department Head listing as soon as possible (this can be submitted to the IRB as an amendment via eProtocol; RICRO staff can process administratively).
I’ve created a form by mistake. Can I delete forms that were created in error?
Yes. To delete any form that has not been submitted/reviewed by the IRB, 1. Click on the “Delete Protocol” button on your IRB homepage; 2. Select the form you would like to delete by clicking on radio button next to the form; 3. Click “delete.”
NOTE: The system will not delete any protocol that has been reviewed by the IRB. You can only delete forms that have not been submitted or reviewed.
|eProtocol Homepage at a Glance||Homepage at a Glance|
|Personnel Screen||Managing Personnel|
|Basics of Creating a Protocol||Creating a Protocol|
|How to Respond to the IRB’s Comments||Respond to IRB|
|How to Create & Submit an Amendment||Amendment|
|How to Create & Submit a Continuing Review||Renewal|
|How to Create & Submit a Final Report||Final Report|
|Why don’t I see the option for the form I would like to submit?||What Forms Are Available|
|Where is my approval letter?||Approval Letter|