IRB Frequently Asked Questions

  • This page contains frequent questions that have been asked of the IRB Co-Chairs in the past.  If your question or the answer is not found here,  the best source is one of the IRB Co-Chairs: Dr. Ed Timmons or Dr. Irene Wolf.

     Does my research require IRB oversight?

    The IRB follows the federal guidelines and definitions with regards to research with human participants.  Two key components are research and human subjects.  According to the regulations, "research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." [45 CFR 46.102(d)].  A human subject, according to the regulations, "means a living individual about whom the investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information." [45 CFR 465.102(f)]

    How long will it take for the IRB to approve my application?

    A typical application (exempt or expedited) will take 3 weeks from the time that the IRB Co-Chairs receive it.  However, if your application requires a full committee review, you should anticipate between 4 and 8 weeks.

    Who needs to have the NIH training?

    Anyone who is engaged in research involving human participants or associated with a research project involving human participants, needs to complete research ethics training.  There is a free online course offered through the National Institues of Health - Protecting Human Research Participants.  At the end of the training, remember to save (as a pdf) or print your certificate of completion.  You will need to submit this certificate  with your IRB application.  If you have completed a Protecting Human Research Participants program at another institution within the last 3 years and you have a certificate, you are exempt from this training.  Your certificates are valid for 3 years.

    How do I know which form to use? 

    The federal regulations categorizes research based on the level of potential risk the participant may encounter.  Saint Francis University IRB uses two separate forms.

    The Exempt form should be used for studies that are of minimal risk, do not involve protected populations and falls within one of these categories

    •  If the research is conducted in established or commonly accepted educational settings.  This does not simply mean that you are collecting data from students.
    • If the research involves the use of educational tests, survey procedures, interview procedures or observation of public behavior.
    • If the research involves collection or study of existing data, documents, records, or pathological or diagnostic specimens.
    • If the research is studying, evaluating or examining public benefit or service programs.
    • If the research involves taste and food quality evaluation or consumer acceptance studies.
    All other studies should use the full application form.

    Does my adviser need to sign my application?

    If you are a student conducting research with human participants, you must have a full-time faculty member advising you on your project.  Your adviser must complete the NIH Protecting Human Research Participants program or have a certificate from another institution.  This certificate must be submitted with your application or be on file with the IRB office.