Institutional Review Board (IRB) for the Protection of Human Subjects

  • Update from IRB Chair Re: Human Subjects Research in Light of COVID-19

    In light of the ongoing closures related to the coronavirus, the IRB office wants to provide guidance on human subjects research. We ask that you read the following information carefully if you have or are supervising an on-going human subjects project or if you are considering beginning a new human subjects project. Please note that our IRB office is open and reviewing protocols/requests for change through our IRBManager system. Investigators are asked to review this letter and the help documents available on the IRBManager website before emailing our office. While we will certainly respond to your emails, there are literally thousands of you and about four of us.

    In making decisions about human subjects studies, the health and well-being of the research subjects must be our primary concern. With the coronavirus outbreak, we must re-evaluate the risk/benefit ratio. Below you will find several research scenarios along with guidance and restrictions on how to proceed.

    • If your approved study is currently recruiting or engaging participants in a NON-face-to-face mode (e.g., Qualtrics survey, Skype/Zoom/phone interviews), you are welcome to continue with your project with no further input from our office.
    • If your approved study is currently recruiting and/or interacting with subjects in a face-to-face mode (e.g., face-to-face interviews; subjects being asked to come to a lab/room on campus), your study is effectively paused until further notice.

    Please note, if possible, we encourage you to switch your mode of interaction with the research subjects to a NON-face-to-face option (e.g., Qualtrics survey, Skype/Zoom/phone interviews). Per IRB policy, investigators are required to submit any changes to their approved protocol to our office. If you do wish to switch the mode of data collection from face-to-face to non-face-to-face, here are things to consider when submitting a request for change:

    • Complete the Request for Change form using the instructions provided in the form. Provide a justification for your change; this could be as simple as stating that concern about coronavirus spread led to the change in data collection procedures. We encourage you to make this as brief as possible given the anticipated high volume of modification reviews the IRB will be conducting in the coming weeks.

    • If your original informed consent document and recruitment materials (e.g., recruitment email, post, signage) indicate that subjects will be asked to participate in a face-to-face study, you must change the language of the informed consent or recruitment document and include updated documents as part of the Request for Change.

    Note: If your approved study is grant-funded, you must adhere to the guidelines provided by the granting agency. These guidelines are changing rapidly in some cases. However, the links below provide access to the most up-to-date information available.

    National Science Foundation

    National Institute of Health

    Department of Defense

    Department of Education

    Bill and Melinda Gates Foundation

    If you plan to submit a new protocol with the idea of recruiting subjects in the near future, please read the appropriate section above for guidance. In all cases you should try to minimize contact with human subjects and look for opportunities to conduct your research in a non- face-to-face manner.

    Sincerely,
    Jennifer Roberts, PhD

    The Institutional Review Board for the Protection of the Human Subjects is the regulatory body of IUP that is responsible for the review of research that involves human participants. The purpose of IRBs nationally is to protect participants in research as well as to protect researchers conducting research involving human participants.

    The information below is designed to provide a comprehensive set of resources for investigators, so that they can conduct the best possible research that meets their academic goals while safeguarding the well-being of the people who participate in their work.

    Feel free to use the contact information provided to find more information or clarification. You should also feel free to provide feedback about the usefulness of this web page. The IRB at IUP is engaged in ongoing efforts to collaborate with investigators to enhance the responsiveness of IRB educational and consultative efforts.

    IRBManager

    IRBManager is IUP’s new electronic submission, routing, approval, and record-keeping tool for the Institutional Review Board. This system retains the same questions from the original paper forms, but presents them in an easy to use and easy to track electronic system.

    For further details, tutorials, frequently asked questions, or to log in, visit our IRBManager page.

    For additional information, contact the IRB by e-mail at irb-research@iup.edu.

  • IRB Guidelines
    Guidelines and documents for the Institutional Review Board Protection of Human Subjects process are provided.
    Narrated Overview of the IRB Process
    This narrated Powerpoint presentation gives an overview of IUP's IRB process and helps researchers prepare a protocol for IRB review.
    Model Protocols and Consent Forms
    Sample protocols to be used as reference materials for investigators
    Classroom Research
    Guidelines are provided for classroom research/student research projects.
    Gift Cards as Research Incentives
    Gift cards may be used as research incentives but must be approved by the IRB. There are several guidelines to purchase gift cards if using IUP funds.
    IRB Training
    Find information about required, free online research ethics training, the National Institutes of Health’s free course on human protection in research, and video reports on various components of the IRB.
    Who Serves on the IRB?
    Members of IUP’s Institutional Review Board for the Protection of Human Subjects in Research
    IRB Meeting Dates and Protocol Submission Deadlines for Projects Requiring Full Board Review
    The dates for protocols requiring full board review are listed. Protocols that meet the criteria for exempt or expedited review may be submitted at any time. Exempt and expedited protocols will be initially reviewed and contact will be made with investigators typically within two weeks of the submission date.
    Related Sites
    Here is a list of additional websites with IRB information.