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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. Researchers not affiliated with Santa Clara University who want to conduct research on campus or with Santa Clara employees or students also must obtain approval 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. On-line training must be completed by researchers and committee members.  Training requirements and access to on-line courses are described below.

Office of Research Compliance and Integrity has implemented a web-based online application process via eProtocol .  Complete and submit application online to HS committee (IRB) for review and approve.  For any questions contact Office of Research Compliance & Integrity (ORCI) at protocols@scu.edu or (408) 554-4408.

Do I Need to Apply for Review?

Some types of research do not require human subjects approval. (Click here) - pdf

 

What Level of Review? How Do I Apply?

1. To begin application via eProtocol. (Click Here)

2. Identify the research category.  To assist you in determining which type of review you should request for your research we have developed a Flow Chart and a Text Checklist. The Santa Clara Human Subjects Policy divides research into three categories: Exempt from Full Review, Expedited Review, and Regular (Full Committee) Review. How your application is reviewed depends on which of the three types of research you plan to conduct. 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. Applicants requesting Exempt Review must indicate which of the five kinds of research eligible for Exempt Review they are conducting (see Human Subjects Policy, Section IV. B. 1.). 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. 

3. Complete the application form as fully as possible. Respond to each item on the form, even if your answer is "not applicable." Provide enough information for the committee to understand how you will deal with each of the concerns asked about in the application form. For example, it is not sufficient to simply state that you will keep data confidential. Rather, you should explain how you will ensure data remain confidential. In some cases, you may need to provide lengthy answers, such as when describing the procedures. As a rule, the committee also will want to see copies of any tests or questionnaires you will be distributing and a copy of your consent form.

4. Complete on-line training.  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 on-line course, go to the CITI site, register as a Santa Clara University member, and select the human subjects training module.

Students must complete the student training sessions offered through CITI before submitting and application. To access the on-line course, go to the CITI site, register as a Santa Clara University member, and select the student version of human subjects training modules

 

Complex Issues with Research Involving Vulnerable Populations

This video presentation on the additional protections for certain vulnerable subjects, including pregnant women, children, and prisoners starts out at the end of a panel presentation on the additional protections afforded to vulnerable populations described in the subparts B, C, and D or the HHS regulations at 45 CFR part 46. When the video starts, you will see a fictional OHRP presenter summarizing the key points of the just completed presentation to the audience. She then invites questions from the audience, where she and her colleague (also a fictional OHRP presenter) respond to some rather complex and interesting questions regarding vulnerable populations.