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

  • Updated Guidelines (8/11/20) from IRB Chair for Research with Human Subjects during COVID-19

    In light of the president’s recent announcement regarding our return to campus for the fall 2020 semester, our IRB office wants to provide some updates about ongoing and new human subjects research protocols. As you know, our office, like most across the US, paused all non-essential face-to-face (f2f) research with human subjects in March 2020. Our office has been monitoring reopening plans/trends along with federal/state/local guidance to determine how to proceed.

    As of today, protocols that can recruit and collect data in a virtual manner should be submitted with recruitment and data collection methodologies that use non-f2f methods. The added risk of spread of COVID-19 outweighs the benefit of nearly all research conducted at IUP. Therefore, the overwhelming number of research projects (ongoing and new) should be conducted using non-f2f methods. Additionally, if your approved face-to-face protocol was paused, you should consider that it is still paused.

    We recognize that some faculty and students may not be able to complete their research in a non-f2f manner. The IRB will consider on a case-by-case basis new or previously paused f2f protocols for f2f interaction; but the IRB will review and/or approve these requests only if there is a compelling scientific reason for f2f and only if the researcher submits a thorough safety plan.

    As we are all busy, rather than complete a full protocol (or request for change) for f2f recruitment or data collection and then learn that the proposed approach is not viable in the current climate, we encourage these researchers to first reach out to our office at irb-research@iup.edu with a scientific rationale for their f2f project or request for change to use f2f during this pandemic. We will review the email and then provide guidance on whether researchers should proceed and submit a formal protocol or request for change to their existing protocol to permit f2f recruitment or data collection. In this inquiry email, please consider and discuss the following:

    • State the research question;
    • Briefly describe the method(s) that will be used for data collection with the human subjects;
    • Describe the human subjects (e.g., age, any known health conditions that make them more at risk for COVID-19, how selected);
    • Provide valid, scientific/methodological reasons why the research must be conducted f2f; personal reasons will not be considered by the IRB;
    • Provide an overview of the safety plan that will be used to protect the human subjects. This should include things like: screening of investigator/data collectors for COVID-19, potential physical barriers that will be in place between researcher and subject, personal protective equipment that will be required of researchers and subjects (including who will provide what), sanitation strategies for all research materials (including tables, chairs, keyboards, laboratory equipment etc.), guidance for subjects on navigating the traffic flow in a building/space, social distancing strategies during the data collection, steps researchers will take if they or a research subject becomes COVID-19 positive (e.g., how will subjects be contacted; within how many days of contact will subjects be contacted; quarantine of researcher for how many days before resuming data collection; notification to our office of COVID-19).

    If, after reviewing these emails, our office recommends that a researcher moves forward with a formal protocol or request for change to their existing protocol to permit f2f interactions, there are several things researchers should be aware of, including:

    • The safety plan mentioned above will need to be shared with all research subjects as a separate document (i.e., separate from informed consent).
    • If the research is being done off-site, researchers will need to provide a site approval letter that is dated no earlier than August 1, 2020. Like always, the letter must come to our office on the site’s letterhead, contain a statement that indicates the site understands the nature of the research and how the site will be engaged, and be signed by someone with the authority to provide access to the site. Additionally, the letter must include a statement that the site has reviewed and approved the safety plan created by the researcher for the protection of human subjects given the coronavirus pandemic.
    • New or continuing f2f research will not be reviewed in an expedited manner. The new protocol or request for change to permit f2f interactions will be reviewed at our full board meeting. These meeting dates and their protocol submission deadlines are posted on our website (iup.edu/irb).

    Please contact the IRB Office (IRB-research@iup.edu) anytime. The IRB Office is operating remotely during the fall semester and is very responsive to email.

    We thank you for your commitment to ethical research and the protection of human subjects.

    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.