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Human Subjects

Most Santa Clara University employees and students who plan to conduct research with human participants must obtain approval from the Santa Clara University Institutional Review Board (IRB) before beginning data collection. On-line training must be completed by researchers and committee members. Training requirements and access to online courses are described below. For any questions contact Office of Research Compliance & Integrity (ORCI) at protocols@scu.edu or (408) 554-4408.

If you are interested in learning more about IRBs, specifically what an institutional review board (IRB) is and how IRBs protect people who participate in research, watch this 7-minute video released by the U.S. Department of Health and Human Services.

COVID-19

In an effort to eliminate apparent immediate hazards to subjects (45 CFR 46.108(3)(iii)) and the Santa Clara University community, all IN-PERSON visits for human research activities must be in compliance with the University COVID-19 policy per provisions of SCU's Research Resumption Plan.

2021-2022 Full IRB Review Deadlines

Fall- Sept 17, 2021

Winter- Jan 14, 2022

Spring- April 22, 2022

Expedited and Exempt Reviews Are Ongoing

Expedited and Exempt Reviews can be submitted to Research Compliance for Human Subjects approval at any time. However, reviews are not immediate so please allow plenty of time for protocol review prior to the start of your research.

IRB FAQs

Some types of research do not require human subjects approval. Please review this 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 insitutions and DOES involve a Government Supported Grant (NIH, NSF, DoD, VA, ED, DOE), a Single IRB is required. Details regarding the Single IRB, which is one single institution providing oversight for a multi-site study, can be found here. 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. Details regarding a commerical IRB can be found at: https://www.wcgirb.com/

(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.

 

Any questions regarding the Single IRB process should be sent to protocols@scu.edu.

 

If the project involves collaboration with other insitutions 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. 

(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). Details regarding a commerical IRB can be found at: https://www.wcgirb.com/

Options 2 and 3 above are considered a Single IRB. Details regarding the Single IRB, which is one single institution providing oversight for a multi-site study, can be found here. 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.

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 or co-PI. 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. Assistant Professors and Senior Lecturers are considered full-time faculty and can serve as your co-PI. 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:

Exempt #1 Educational Practices
Exempt #2 Educational Tests
Exempt #3 Research Involving Benign Behavioral Interventions
Exempt #4 Secondary Research/Existing Data
Exempt #5 Public Benefit or Service Programs
Exempt #6 Food, Taste, and Acceptance Studies
Exempt #7 Storage for Secondary Research for Which Broad Consent is Required
Exempt #8Secondary Research for Which Broad Consent Is Required

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, go to the CITI site, register using your Santa Clara University email address, and select the Human Subjects Training Module. This CITI training requirement applies to both faculty researchers and student research assistants.

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


 

OHRP Videos

ORHP provides guidance and clarification in the protection of the rights, welfare, and wellbeing of human subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS).

Directory of All Videos

Video topics include:

Nov 1, 2021
Human Subject Policy Student Research Policy Model Forms Research Involving Minors Qualtrics Survey Software CITI Human Subjects Training Ethics Point