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Institutional Review Board

The DeSales IRB Committee has the responsibility and full capabilities to review and monitor biomedical and socio-behavioral research that involves human subjects in which DeSales is engaged before the involvement of human subjects may begin.

The Institutional Review Board is established to provide ethical review of research, and to assure that the rights and welfare of the human subjects are adequately protected in research and federal regulations are followed. Members include researchers, non-researchers and one member of the local community.

Please Note: During the covid pandemic and until further notice, the DeSales IRB is strongly encouraging researchers to avoid any study that would require human contact. Please be aware that any study that requires physical contact with a participant will automatically be elevated to a Full Board Review.

Institutional Review Board Information

  • 2022-2023 IRB Committee Members

    Melissa Gilroy, DC, MSPAS, PA-C
    Assistant Professor, Physician Assistant Program | Chair IRB
    Division of Healthcare Professions Gambet Center 105
    x 1324

    Michael Beardsley, Ph.D., ATC
    Assistant Professor of Sports and Exercise Physiology
    Division of Healthcare Professions
    Dooling Hall 125C
    x 1829

    Tricia Bernecker, Ph.D., RN
    Professor
    Division of Nursing
    Gambet Center
    x 1846

    Katrin Blamey, Ph.D.
    Associate Professor, Education Department Chair, Director of M.Ed. Programs
    Division of Liberal Arts & Social Sciences
    Dooling Hall 120B
    x 1455

    Sean Griech, PT, DPT, Ph.D., OCS, COMT
    Associate Professor, Doctor of Physical Therapy Program
    Division of Healthcare Professions
    Wills Hall 209
    x 2784

    Carl Hammarsten, Ph.D.
    Assistant Professor of Mathematics
    Division of Sciences & Mathematics
    Dooling Hall 222E
    x 1278

    Christos Karagiannopoulos, MPT, Ph.D., ATC, CHT
    Assistant Professor, Doctor of Physical Therapy Program
    Division of Healthcare Professions
    Wills Hall 208
    x 2142

    Mr. Gary Mills
    Community member

    Jacqueline Ochsenreither, DNP, CRNP, PPCNP-BC
    Assistant Professor of Nursing, Director of Doctor of Nursing Program
    Division of Healthcare Professions
    Gambet Center 233
    x 2779

    Joshua Schulz, Ph.D.
    Associate Professor of Philosophy
    Division of Liberal Arts & Social Sciences
    Dooling Hall 271
    x 1591

  • Does my research require IRB review?

    Investigators are responsible for determining whether an activity requires IRB review. The DeSales IRB provides ethical oversight to all activities that meet the criteria of "research involving a human subject", meaning that any activity meeting both of the following definitions requires IRB review.

    If an activity does not meet the research criterion, no IRB review is required. Similarly, if an activity is research, but it does not involve human subjects as defined above, the research does not require IRB review.

    Research

    Research is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research even if they are a component of a larger non-research activity (e.g., instruction, demonstration).

    Systematic investigation involves a predetermined system, method or plan for studying a specific topic, answering a specific question, testing a specific hypothesis, or developing theory. A systematic approach includes the collection of information and/or biospecimens, and analysis, either quantitative or qualitative.

    Generalizable knowledge is information that is collected or gathered to draw general conclusions; inform policy; inform professional knowledge in a discipline; or generalize outcomes beyond the specific group, entity, or institution (i.e., to elaborate, to be an important factor in identifying or expanding truths, facts, information that are universally applicable). 

    Examples of activities that generally do NOT meet the research definition:

    • Student projects conducted for a credit class assignment where there is no intent to contribute to knowledge in the field of study or present the data outside of the classroom.  However, faculty or staff who wish to assess students and use data for publication need IRB approval.
    • Medical case studies involving no more than two patients are not considered systematic investigations and there is no intent to publish.
    • Quality improvement activities where the data will only be used internally and there is no intent to publish or present the outcome. 

    Human Subject

    A human subject is a living individual about whom an investigator conducting research obtains data through an intervention or interaction with the individual or identifiable private information.

    Intervention includes both physical procedures by which data are gathered (e.g., drawing blood) and manipulations of the subject or the subject's environment that are performed for research purposes.

    Interaction includes communication or interpersonal contact between investigator and subject, including forms such as face to face surveys, web questionnaires, etc. 

    Intervention includes both physical procedures by which data are gathered (e.g., drawing blood) and manipulations of the subject or the subject's environment that are performed for research purposes.

    Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (e.g., medical record information). Since the definition of a human subject is a "living" individual, research involving autopsy materials, cadavers, and cadaveric materials is not considered human subjects research and is not reviewed by the IRB.

    Examples of activities that generally do NOT involve human subjects:

    • Research only using data about deceased individuals; however, research using Protected Health Information about decedents does require submission of a Research with Decedents form.
    • Data that are obtained by the investigator in a completely de-identified state when the investigator will have no access to the ability to re-identify individuals.

    If still in doubt about whether an activity requires IRB review, please submit information about the activity to the DeSales IRB Committee explaining how the activity meets the definitions above.  Once you have determined that IRB review is required, the next step is to assess what type of review is required: Exempt, Expedited, or Full Board.

  • Templates and Forms

  • Steps for successful application submission

    • Download the IRB Application.
    • Complete the application in MS Word.
    • Gather all required documents listed on the IRB Application.
    • Obtain PI’s signature on the IRB Application.
    • Scan the entire application with all attachments and create ONE file in pdf format with the following filename structure: PI last name followed by 3-4 key words from the title of the research study. Ex. Starling_ReadingScrambledWords.pdf.
    • The PI must email the application to IRB@desales.edu.
      • In the email subject line write the filename. Ex. Starling_ReadingScrambledWords.
      • In the email text write the full title of the research study. Ex. Effects of Context Cues on Reading Scrambled Words.
      • Attach the application in ONE file in pdf format.

  • FAQs and Definitions of terms

  • Researcher required training

    Anyone - faculty, staff or student - working with human subjects in research projects at DeSales University will need to complete the Collaborative Institutional Training Initiative (CITI) training modules. 

    Please use the DeSales address (2755 Station Ave, Center Valley PA 18034) and main phone number (610-282-1100).  Please choose “Lehigh Valley Association of Independent Colleges” as your affiliated organization. 

    After creating your profile click “Add a Course to Update Learner Groups”. Under Question 1: Human Subjects Research. Please then select “Social & Behavioral Research Investigators” and complete all required modules in this online course. You may find that some of the optional modules are relevant to your research and if so we encourage you to complete those modules as well. Upon completion if you return to the main menu you will see your official completion date and will have the opportunity to print your completion report. 

    If you are a previous user, please change your affiliation to Lehigh Valley Association of Independent Colleges.

    The site is fairly easy to use.  If you have any questions, please don’t hesitate to call or email the IRB Chair, Dr. Joshua Schulz at Joshua.Schulz@desales.edu, 610-282-1100 x1591.

    Create your new CITI account

  • Policies & Procedures

  • Links to external resources

  • Research Requests from the External Community

    Periodically DeSales University receives requests from external researchers seeking to conduct research involving students or employees. An external researcher is defined as anyone not employed by or otherwise affiliated with the University. In order to protect the rights of all DeSales community members and to ensure that the proposed research is in line with the University’s mission and values, the following procedures are in place for all external research requests.

    1.  The proposed research must have IRB approval from the external researcher’s home institution. Applications not already approved by a home institution’s IRB will not be reviewed. In the event that a home institution does not have an IRB, then DeSales IRB will accept an application as long as all of the following requirements are met.
    2. The proposed research must have a DeSales University faculty member willing to sponsor the research as Principal Investigator or Co-Principal Investigator.
    3. The proposed research must be submitted to the DeSales IRB using the DeSales IRB application and follow all published procedures for submission and continuing review.
    4. All applications will be reviewed as exempt, expedited, or full review as appropriate.
    5. DeSales University reserves the right to grant or deny permission to external researchers to recruit subjects on campus.
    6. The University will not grant permission to access its internal email server. In addition, the University will not provide any contact information or lists of students or employees to external researchers.
    7. The University will not allow external researchers access to class time or campus facilities.
    8. Participation from students and employees must be voluntary. All participants must provide informed consent.
    9. If results are published or presented, DeSales University students, employees, and the University itself will not be identified as participants.