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Institutional Review Board (IRB)

Overview

The SAIC Institutional Review Board (IRB) is responsible for overseeing all research done at SAIC by faculty, students or staff that involves human subjects. The IRB is subject to the regulations of a federal agency: the Office of Human Research Protections (OHRP) within the Department of Health and Human Services (HHS).

If you are conducting research with people, you need to go through the IRB review process before you begin; it’s a legal requirement. 

IRB review is more than bureaucracy, it is about protecting the people you work with and acknowledging their rights as participants in your research. The goals of the IRB are to ensure that researchers understand and uphold the following two standards dictated by federal law:

1. Human subjects should not be placed at undue risk;
2. Subjects should give uncoerced, informed consent to their participation in the research.

The SAIC IRB works with you to ensure your research meets the ethical guidelines established by the OHRP. It is made up of 8 members: 7 SAIC faculty members from departments across the school, and one outside research scientist. All members serve three-year staggered and renewable terms. Efforts are made to have a balance of gender, ethnicity, and disciplinary specialties on the Board. 

  • Karen Morris (Chair of the IRB, Associate Professor, Visual & Critical Studies)

    Adam Greteman (Associate Professor, Art Education)

    Patrick Rivers (Professor, Liberal Arts)

    Oliver Shao (Assistant Professor, Liberal Arts)

    Sarah Rosengard (Assistant Professor, Liberal Arts)

    Sarah Ross (Associate Professor, Art Education)

    Sandie Yi (Assistant Professor, Art Therapy)

    Outside Research Scientist (TBA)

Process

  • It is recommended that researchers begin the IRB application process as early as possible (at least 6 weeks before the anticipated date of research). The process of completing the IRB application can take time, as it requires an online training on ethics in human subjects research, and the completion of application forms that require applicants to really think through the details of their proposed research. Many applicants find the Research Proposal Application (IRB FORM 1) can be a very useful worksheet for thinking through the nuts and bolts of their proposed research.

    Once a complete application has been submitted, the IRB review and approval process usually takes 3-4 weeks. Once an application has been submitted, the Chair of the IRB and 1-3 members of the IRB review it and make the decision to either approve it or, in most cases, request further information/revisions. Applicants can expect to receive a decision or request for revisions within 12 business days (2.5 weeks) of submitting their application. Applicants with approaching dates for beginning research are advised to complete any requested revisions as soon as possible.  Once applicants have submitted their revised application, they can expect to receive a decision from the IRB within 3-5 business days.

  • Prospective applications should first use the section “Does My Research Project Require an IRB Application?” to determine if they need to submit an IRB application.

    If you determine that you need to submit an IRB application for your proposed research, please complete the following steps in this order:

    1. Complete CITI training (see the “Training and Certification” section for details)
    2. If you are a student performing research for degree credit (such as a thesis):
      1. Inform your faculty advisor that you will be submitting an IRB application
      2. Discuss your research plan with your faculty advisor
    3. Download IRB FORM 1. Research Proposal Application and IRB FORM 2. Informed Consent Template Form and save these Word documents to your desktop, adding your last name to the title in this format:
      1. LAST NAME IRB FORM 1. Research Proposal Application
      2. LAST NAME IRB FORM 2. Informed Consent Template Form
    4. Complete these two forms. If you will be working with more than one subject population (for example, service providers and patients), you will likely need separate consent forms tailored for each population.
    5. Complete any supplemental materials required in the Research Proposal Application (such as copies of permission letters, recruitment/advertising materials, and interview questions).
    6. If you are a student, share your completed application materials (IRB FORM 1, IRB FORM 2, and supplemental materials) with your faculty advisor for feedback and approval. Your faculty advisor must indicate their approval of your IRB application by signing your completed IRB FORM 1 (Research Proposal Application) on the last page before you submit your materials to the SAIC IRB.
    7. Submit your application materials to the IRB via email to saic-irb@saic.edu. Make sure to include, as attachments:
      1. CITI Program Certificate of Completion
      2. IRB FORM 1 (with faculty advisor signature for student applicants)
      3. IRB FORM 2
      4. Supplemental Materials required in IRB Form 1 ((such as copies of permission letters, recruitment/advertising materials, and interview questions).

    If you have any questions during the application process, please contact the Chair of the IRB at saic-irb@saic.edu.
     

Training & Certification

As part of preparing an application for IRB review, researchers must complete training on ethical research practices. It is highly recommended that you complete CITI training before starting work on your IRB application.

SAIC uses the vendor CITI for this training. After the completion of the course, you will receive a certificate valid for three years. Please retain a copy for your records, you will be asked to provide it as part of your IRB application.

CITI Training Directions for student researchers can be found here.

CITI Training Directions for faculty and staff researchers can be found here.

Does My Research Project Require an IRB Application?

You are required to submit a formal application if your proposed study meets both of these conditions:

1. It constitutes research, and
2. It is conducted on human subjects.

The questions below are designed to help you determine if your study meets both criteria. If it does, an application approved by the IRB is required before research can begin. The IRB cannot approve research after it has been done.

  • According to the Code of Federal Regulations (45 CFR 46 or “Common Rule”), research means “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”

    Answer YES OR NO to the following questions:

    1. Do you expect or intend to publish or disseminate the results of your study?
    2. Do you expect or intend to present the results of your study in a public setting, such as a workshop, exhibition, conference or poster session?

    If your answer is NO to both of these questions, your study is not considered research based on the Federal definition. No application to the IRB is required, and you are free to begin your study.

    If your answer is YES for any of the questions, your study is research. Continue to Part 2.

    NOTE: The Common Rule specifically excludes certain types of investigations from the definition of “research,” including  oral history, journalism, biography, literary criticism, legal research, and historical scholarship that focuses directly on the specific individuals about whom the information is collected.

  • Answer YES or NO to the following questions:

    1. Will people themselves be the subjects of the study? (If you interview a physics professor to learn about black holes, she is not a human subject of your investigation.  If you interview her about her experiences as a physicist, however, she is a human subject.)
    2. Will the study involve interacting with living people?
    3. Will you gather information that would ordinarily be private (e.g., personal beliefs)?
    4. Will you observe behavior in a context where the subjects would reasonably expect privacy (e.g., in their home)?

    If you answered NO to all four of these questions, your study is not considered to involve human subjects. You do not need to apply for IRB approval of your research, and are free to begin your study.

    If you answered YES to question 1 AND to one or more of the other three questions, your study is considered to involve human subjects, and you must submit an application to the IRB and receive approval before beginning your research.

Still Not Certain?
If you are still not sure whether or not your study is considered “research on human subjects,” please contact the IRB Chair (saic-irb@saic.edu).

Contact

For all inquiries related to SAIC IRB and the IRB application process, please contact the Chair of the IRB at saic-irb@saic.edu