Some types of research do not require human subjects approval. Please review this document: When Not to Apply Document

To access the eProtocol system, you will need a username and password. Please send all requests for a new eProtocol account to: protocols@scu.edu. In your request, be sure to include the user's name and SCU email address.

To begin an application via eProtocol: (Click Here)

**Note: Protocol submission will require you to disable any pop-up blockers. 

If the project involves collaboration with other institutions and DOES involve a Government Supported Grant (NIH, NSF, DoD, VA, ED, DOE), a Single IRB is required. A Single IRB is one IRB of record (or Reviewing IRB), selected on a study-by-study basis, providing the ethical review for all sites participating in a specific multisite study. The Single IRB is responsible for reviews required by federal regulations at 45 CFR 46, and 21 CFR 50 and 56. These reviews include the initial review, continuing review, modifications, and reportable events.

You have the following two options for a Single IRB:

(1) Budget for a Commercial IRB (Commercial or independent IRBs are contracted agencies that are not affiliated with specific institutions and are paid to conduct reviews of research with human subjects). SCU has established a contract with Advarra to manage the Single IRB process. Please click here to access Advarra Budgeting Forms.

(2) A reputable, collaborating institution can take the lead and be the Reviewing IRB. SCU then becomes Relying IRB. SCU will NOT take on the role of Reviewing IRB. Also, SCU will require a reliance agreement, which is a document signed by two or more institutions that permits one or more institutions to cede to the Reviewing IRB. View a list of documents that SCU must receive from the Reviewing IRB in order to consider a reliance agreement: List of Documents from Reviewing IRB- Govt Research

Government regulations regarding a Single IRB can be found here. Any questions regarding the Single IRB process should be sent to protocols@scu.edu.

If the project involves collaboration with other institutions but does NOT involve a Government Supported Grant (NIH, NSF, DoD, VA, ED, DOE), you have the following three options:

(1) Each institution’s IRB reviews their own protocols.

(2) A reputable, collaborating institution can take the lead and be the Reviewing IRB. SCU then becomes Relying IRB. SCU will NOT take on the role of Reviewing IRB. Also, SCU will require a reliance agreement, which is a document signed by two or more institutions that permits one or more institutions to cede to the Reviewing IRB. View a list of documents that SCU must receive from the Reviewing IRB in order to consider a reliance agreement: List of Documents from Reviewing IRB- No Govt Funding

(3) Budget for a Commercial IRB (Commercial or independent IRBs are contracted agencies that are not affiliated with specific institutions and are paid to conduct reviews of research with human subjects). SCU has established a contract with Advarra to manage the Single IRB process. Please click here to access Advarra Budgeting Forms. 

Options 2 and 3 above are considered a Single IRB. A Single IRB is one IRB of record (or Reviewing IRB), selected on a study-by-study basis, providing the ethical review for all sites participating in a specific multisite study.

Any questions should be sent to protocols@scu.edu.

Researchers not affiliated with Santa Clara University who want to conduct research on campus or with Santa Clara employees or students must first secure a faculty sponsor who is willing to collaborate and spearhead the IRB engagement and approval process. Then the research should request access to the eProtocol system by emailing protocols@scu.edu. Approval must be obtained prior to data collection. Approval by the Santa Clara committee is required even if the research has been approved by an Institutional Review Board at another institution.

Every protocol submitted should have a full-time faculty member listed as a PI, co-PI, or faculty advisor. While the eProtocol system may allow you to submit the protocol without a full-time faculty member, the protocol will be declined and returned to you. Teaching Professors of all ranks are considered full-time faculty and can serve as your co-PI or faculty advisor. Quarterly and annual adjunct lecturers are not considered full-time faculty members.

The Santa Clara Human Subjects Policy divides research into three categories: Exempt from Full Review, Expedited Review, and Regular (Full Committee) Review. Definitions for each of the three categories can be found in the Human Subjects Policy. 

In general, research qualifying for Exempt Review includes activities that involve "no more than minimal risk" to human participants. To help you determine which type of exempt review is applicable to your research, here are the Human Subject Regulations Decision Charts for the 2018 HHS regulations (45 CFR
part 41) implemented on January 21, 2019. You can also use the Decision Chart links below to determine the type of exempt review:

Note that Exempt Review applications still must be reviewed and approved before data collection is started.

Research qualifying for Expedited Review includes activities that involve "no more than minimal risk" to human participants, but also involves one or more of the procedures listed in Section IV. B. 2. of the Human Subjects Policy.

Research that does not qualify for either Exempt Review or Expedited Review falls into the Regular (Full Committee) Review category. 

All researchers must complete an on-line training module on the Belmont Report before submitting an application for review. Researchers must complete the training once every three years. To access the online course, follow the instructions provided below. This CITI training requirement applies to both faculty researchers and student research assistants.

• Go to the CITI webpage.
• Select Register in the upper right corner.
• You will be promoted for Organizational Affiliation. Select Santa Clara University.
• Complete the Personal Information as requested.
• Create a username and password.
• When asked about Continuing Education credits, select "No."
• In the "Select Curriculum" screen, select the Human Subjects checkbox.
• You will be prompted for a Learner Group. Select Social & Behavioral Research Investigators. (Note: If you have already taken a Human Subjects Course through CITI, or if you took a Human Subjects Course at another institution, you may select the radio button for "I'm required to take a Human Subjects Research Refresher Course.")
• The course will now appear under "My Courses" and you can begin completing the modules.

To modify your protocol, follow these steps:

       Protocol Modification (select amendment)

1. Open in View Mode
2. Protocol Details
3. Start Amendment (changes to protocol)
4. Start Final Report Form
5. Start Report For
6. Start Protocol Deviation For

Explaining the renewal timeline requires a bit of background knowledge. The "Common Rule" is a federal policy that ensures the ethical treatment of human subjects. In 2018, the Common Rule was modified. (More details about the Common Rule and changes that were implemented can be found in this video.) Protocols submitted prior to January 21, 2019, must follow the regulations of old Common Rule. Any protocols submitted AFTER January 21, 2019, will follow the regulations set forth by the new Common Rule.

Note: All student protocols are granted approval for one year.

• EXEMPT protocols submitted prior to January 21, 2019: Renew annually
• EXEMPT protocols submitted after January 21, 2019: Renew every 5 years

• EXPEDITED protocols submitted prior to January 21, 2019: Renew annually 
• EXPEDITED protocols submitted after January 21, 2019: Renew every 3 years

The eProtocol system is designed to send a notification when your renewal date is approaching. Please look for an email notification from @keyusa.net. Additionally, the renewal date is listed on your Approval Letter.

If you have any questions about the renewal process or when your protocol is scheduled for renewal, please email protocols@scu.edu.

When it is time to renew your protocol, you will receive a reminder from the eProtocol system. Follow these steps to renew your protocol:

       Protocol Renewal (select continuing review) 

1. Open in View Mode
2. Protocol Details
3. Start Amendment
4. Start Continuing Review (for protocol renewal)
5. Start Final Report Form
6. Start Report Form
7. Start Protocol Deviation Form

Use the links below to download eProtocol guides. Alternatively, you can always send a message to protocols@scu.edu for support.

eProtocol Investigator Guide

eProtocol Reviewer Guide