Institutional Review Board (IRB)

Cupola atop a building on the Molloy University campus

Institutional Review Board

Molloy University has established an Institutional Review Board to review research proposals and related activities which involve the use of human subjects. Applicants must apply in writing for approval and be prepared to explain in person all aspects of the proposal which affect human subjects. Additional information concerning the Institutional Review Board and all appropriate forms are available in the office of the Vice President for Academic Affairs.

Structure and Policies

January 2023

Molloy University Policy regarding Human subject research in the time of Coronavirus (COVID-19)


I. Molloy IRB Principles for conducting Research.

1. Protect the health and safety of researchers and human research subjects.
2. Resume research activities as public health conditions and campus resources permit.
3. Continue to ensure research compliance.

Institutional Review Board (IRB): The Molloy University Institutional Review Board reviews all research proposals that involve human subjects, whether the researcher is a member of the Molloy University community or is someone outside Molloy University wishing to use students/faculty/community members at Molloy University as subjects. Its purpose is to safeguard and respect all human subjects invited to participate in research by faculty members, students, or other users of college facilities, regardless of where the research is conducted. The decision as to whether a protocol or activity is human subjects' research rests with the IRB. Non-HSR activities are acknowledged by the IRB and require IRB submission for that acknowledgment. ALL FORMS ARE AVAILABLE FOR COMPLETION AND UPLOAD AS WORD DOC FORMAT IN IRBNet.


II. COVID-19 Guidance
All submissions will be reviewed on an individual basis for actual or potential risk vs. benefit to researcher and participant.

a. Follow the overall guidance of Molloy University Administration regarding COVID-19 : CORONAVIRUS INFORMATION AND STATUS AT Molloy University
b. Additional Resource: New York State (NYS), and the Centers for Disease Control and Prevention
c. Principal Investigators / Co-Investigators will not submit or conduct any research or engage in activity that negates the COVID-19 guidelines set forth by Molloy University, or off campus site/institution policy.
d. Even with Molloy IRB Approval of a protocol Molloy University, NYS , CDC or off campus site /institution COVID-19 policies must still be followed.

Molloy University IRB can decide NOT to approve any human subjects research where a determination is made that the potential or actual risks outweigh the potential benefits to the participants.

Research: Regulations define Research as "a systematic investigation, including development, testing, and. evaluation, designed to develop or contribute to generalizable knowledge" (45CFR46.102(d)).

Minimal Risk: Common Rule (45 CFR 46.102):Minimal Risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

COVID-19 update for submitting protocols to Molloy Institutional Review Board

III. Human Subjects Research:

1. To resume face-to-face research with human participants at Molloy Campuses, all COVID-19 policies set forth by Molloy University Administration are to be followed.
2. To promote a safe environment when conducting face-to-face human participant research:

a. Assess the potential or actual Risk vs. Benefit to the researcher(s) and participant(s) of conducting in-person activities.
b. Consider if remote options: ZOOM, FACETIME, SURVEY MONKEY, GOOGLE FORMS
etc. are the best method(s) for achieving your goals given current conditions of the COVID-19 pandemic.
c. When conducting research/data collection/surveys off campus, researchers MUST follow those institutions /locations COVID-19 policy and take into account Molloy University, NYS and CDC recommendations.

IV. Recommended Best Practices: for the health and safety of those involved when conducting face-to-face human subject research.

a. Follow Site or Institution COVID -19 policy for face-to-face contact, PPE usage and take into account NYS and CDC recommendations.
b. Schedule one-on-one appointments only.
c. Schedule appointment times to avoid overlap/contact with other participants. Holding multiple participants in waiting areas should be avoided.
d. The PI must assess the status of both the research team members and the research participants with regard to COVID-19 (e.g., have not received a positive diagnosis in the past fourteen days, do not exhibit any symptoms, to the best of their knowledge, have not come in recent close contact with a person that may have COVID-19).

 

Molloy University Institutional Review Board Guidelines for Research Involving Human Subjects

Forms and Educational Presentations that Accompany Forms

Collaborative Institutional Training Initiative (CITI)

  • How to Register for CITI

    The Collaborative Institutional Training Initiative (CITI) is a subscription service providing Molloy's research community with comprehensive on-line training in human subjects research (HSR). If you are an investigator, research team member, or student doing human subjects research, you must take the “Responsible Conduct of Research Course” AND a "Human Subjects Research Course" in order to submit to the IRB or be listed as part of the research team.

    CITI program content is organized into modules, which can be thought of as lessons. Modules of a course may be set as required; or they may be set as elective. Modules are composed of text, images, and video content which generally follows a standard format: It begins with an introduction of the topic(s) to be covered, then provides a set of learning objectives; after that comes the main material, broken up into sections, followed by a concluding summary sections. Each module may take 10-30 minutes to complete. You can leave and come back to the site using your CITI user name and password and quizzes can be retaken to achieve a higher score until a passing score is achieved.

    Modules typically include a quiz made up of multiple-choice questions. Achieving a passing score on the set of quiz questions is required to "complete" the module. When you complete a quiz, feedback is usually provided for each question, which includes guidance on why the answer selected was correct or incorrect.  Module content can be revisited and quizzes can be retaken to achieve a higher score until a passing score is achieved.

    For each set of modules that has been assembled into a course, a learner has an associated gradebook.  The gradebook shows your progress for each module of that course-not yet started, started but not completed, completed and passed, or not passed. Training is required every three years.

     

    To Register:

    1. Go to http://citiprogram.org.
    2. Once there, simply click "Create an account".
    3. You will be taken to the page "Personal Information".
    4. Enter "Molloy University".
    5. Enter your desired username and password where indicated.
    6. Select a security question.
    7. Enter your first and last name.
    8. Enter your preferred email address.
    9. Hit submit. You will be taken to Main Menu.

     

    To Enroll in a Course:

    1. Go to My learner tools for Molloy University. Click on Add a Course or Update Learner Groups.
    2. The next page is Select Curriculum-Molloy University.
    3. All investigators, IRB members, IRB chair, students, assistants on ANY IRB protocol MUST take the Responsible Conduct for Researchers course (required modules) and a Human Subjects’ Research course-either the Social & Behavioral course OR Biomedical course. Please see uploaded form “Required Citi Training at Molloy University” for required modules.

     

    For video of how to register please go to IRB Presentations tab, CITI Training Presentation on this webpage.

Committee Members 2022-2023

Joanna Alcruz, Ph.D. School of Education and Human Services
John Carpente, Ph.D. - School of Arts & Sciences
Marcia Caton, Ph.D.  - The Barbara H. Hagan School of Nursing and Health Sciences
Lorraine Emeghebo, Ed.D. - The Barbara H. Hagan School of Nursing and Health Sciences
Ann Eckardt Erlanger, Psy.D. - CBT for Military, First Responders, and their families.(Outside Community Representative)
Tricia Kress, Ph.D. - School of Education and Human Services
Robert Marmo, Ph.D.- Prisoner Representative-Chief Planner Suffolk County Probation
Ann Marie (Nancy) O'Donnell, M.A. - The Usher Syndrome Coalition (Outside Community Representative)
Maureen Sanz, Ph.D. - School of Arts & Sciences
Ethel Ulrich, DNP, Barbara H. Hagan School of Nursing & Health Sciences - **Alternate Chairperson
Audra Cerruto, Ph.D. -  School of Education and Human Services - **Alternate Chairperson
Janice Kelly, Ed.D. - School of Arts & Sciences - **Alternate Chairperson
John D. Catalano, MPA, DrPH Candidate - School of Business
Kate Scotti, M.S. CCC-SLP, TSSLD - Speech Language Pathology in Motion (Outside Community Representative)

 

 

New Policy Update: January 2023

Contact Information

Patricia Eckardt, Ph.D., R.N., FAAN, IRB Chairperson

Molloy University
1000 Hempstead Avenue
Rockville Centre, N.Y. 11571

Audrey Cohan, Ed.D., IRB Administrator

Molloy University
1000 Hempstead Avenue
Rockville Centre, N.Y. 11571