Institutional Review Board

School of Health and Natural Sciences

Mercy College's Institutional Review Board (IRB)

The Mercy College Institutional Review Board (IRB) conducts continuing review of research at intervals appropriate to the degree of risk to human participants.

We are committed to the ethical principles for the protection of human participants in research set forth in the Belmont Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The College recognizes and accepts responsibility, which it shares with its investigators and other researchers, for determining that research involving human participants fulfills these ethical principles.

The basic ethical principles as outlined in the Belmont Report guide the Institutional Review Board's deliberations and decision-making, including respect for persons, beneficence, and justice.

IRB Members

Members of the Mercy College Institutional Review Board for Research (2021-2022)

IRB Members Program or Department Represented
Marie-Louise Blount Community Member
Charis Davidson Health Science (School of Health and Natural Sciences)
Saul Fisher Office of the Provost – Liaison
Sara Hahn Behavioral Sciences (School of Social and Behavioral Sciences)
Ruth Hansen Physical Therapy (School of Health and Natural Sciences)
Kathleen Kenney-Riley  Nursing (School of Health and Natural Sciences)
David Kilpatrick English (School of Liberal Arts)
Jeong Kim Criminal Justice (School of Social and Behavioral Sciences)
Matthijs Koopmans Educational Leadership (School of Education)
Wendy Mages Childhood Education (School of Education)
Astrid Mel Exercise Science (School of Health and Natural Sciences)
Christine Riley Community Member
Francine Seruya (Chair) Occupational Therapy (School of Health and Natural Sciences)
Raquel Warley Social Work (School of Social and Behavioral Sciences)
Helge Wasmuth
Childhood Education (School of Education)
Li Yong
Finance (School of Business)

 

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CITI Program

The Collaborative Institutional Training Initiative is the online training program used at Mercy College for training all personnel conducting research involving human or animal subjects. In accordance with Mercy College’s Responsible Conduct of Research (RCR) Policy, all Mercy College research personnel, including principal investigators, co-investigators, faculty sponsors, student investigators, and any researcher who is directly involved in research including research with human or animal subjects, must complete CITI training. Further information including how to register for CITI training can be found in the CITI Training Information Guide. In addition, the CITI training program must be completed prior to receipt of IRB approval of a new or existing application.

Additional Information & Contact

Contact Information

Electronically submit applications and all supporting documents to the Chairperson of the Mercy College IRB at:

MCIRB@mercy.edu 

Faculty members sponsoring student research may electronically sign off the application if stated in the email text and sent by the faculty member.

IRB Overview and Guidelines

The IRB typically meets on the 3rd Thursday of the month.

All Category III proposals to be reviewed at each monthly meeting must be submitted during the 1st week of the month in which they will be reviewed.

Category I and II proposals may be submitted at any time. Please allow a minimum of 2 weeks for IRB review and approval. 

Submission Instructions

  • Ensure that you have completed all required CITI training reporting before you submit any new application materials.
  • The Mercy College IRB will only accept one submission per study at a time. For example, if you have an ongoing report under review, you may not submit an amendment for the same study until the first submission is approved.
  • E-mail all submissions to: MCirb@mercy.edu.  (Please do NOT submit to the IRB chair or an individual IRB staff member.)
  • Attach all submission materials in Word or PDF.  Required documents (i.e., recruitment material, surveys) should be included in the single PDF, but not in the associated sections of the application.
  • Attach the consent document in Word format only.
  • Mercy College IRB has a One Application Policy in accordance with Title 45 CFR 46.115 (Health and Human Services, IRB Records).  Studies approved by the Mercy College IRB after November of 2018 will receive stamped IRB Approved Documents, which must be submitted for all future amendments to maintain a single, active application that incorporates all IRB-approved amendments.
  • If the PI is a student, the student’s academic advisor (as listed on the application) must be copied on all e-mailed submissions.
  • Expect a holistic review of your active study. The Mercy College IRB conducts a holistic review of your active study with each submission as part of normal review procedures to ensure it remains in compliance with current federal regulations, Mercy College policies, and IRB position statements. For example, if modifying compensation on a flyer, the Mercy College IRB will review the entire flyer to confirm that it meets Mercy’s current recruitment policy.
  • Need help? Please contact IRB Chair at 914-674-7816 or MCirb@mercy.edu.

TIPS ON COMPLETING THE APPLICATION FORMs:

The applications are fillable forms in Word.  Click on the boxes to select them and enter an X. Areas/questions that require text can be filled in by clicking on the text boxes  Click or tap here to enter text. and entering text.

Some sections contain Blue Text with further guidance on the components to report.  This blue text may be removed when reporting your specific research information.

If any sections are not applicable to your research, mark that section as N/A (for not applicable)

  • Attach the following forms in addition to the full application if they apply:
    • Appendix A (Children as Subjects) if you plan to enroll children as research participants.
    • Appendix B (Prisoners as Subjects) if you plan to enroll prisoners as research participants.
    • Appendix C (Mental Health Safety Plan) when participants may experience significant emotional distress or be at risk of themselves or others.
    • Appendix D (Use of PHI in Research) if your research will collect HIPAA Protected Health Information (PHI) from medical records for recruitment and eligibility screening purposes and/or to analyze as research data.
    • Appendix E (International Research) if the proposed research is conducting human subjects research procedures outside of the United States. 

All documents should be saved with your last name first followed by IRB application (e.g., Smith-IRB-Application).

The subject of your email should contain your last name, CWID, and “IRB application.”

All emails sent to mcirb@mercy.edu related to student research must cc the student’s research/faculty mentor.

All documents submitted (instruments (surveys, questionnaires, interview guides, recruitment materials, etc.) should be in WORD or PDF format. Your consent document must be submitted in WORD format.  Please use filenames for the documents that clarify the type of document you are uploading and include your last name.

Keep an electronic copy of your protocol.  If you submit modifications to your study later, you will need to include tracked changes to all affected study documents, including the protocol.

To determine if your research requires a review by the Mercy College Institutional Review Board, please review the MCIRB Human Subjects Research Determination Form.

See the sample recruitment flyers below for content and structure when recruiting for human participants in research.  The red font on samples 1 and 2 should be replaced with your specific study content.

MCIRB Sample Recruitment Flyer 1

MCIRB Sample Recruitment Flyer 2

MCIRB Sample Recruitment Flyer 3

Please refer to the MCIRB Glossary of Terms for definitions of terms used in the application and review of research involving human subjects.

APPROVED: No changes are required.
An IRB action taken when the required determinations are made that allows research involving human subjects to proceed consistent with federal regulations, state and local laws, and College policy.

CONDITIONALLY APPROVED: Minor, specific, non-substantial changes are required.
An IRB action that specifies conditions under which research can be approved. Comments by IRB members must be directive requesting simple concurrences or specific, non-substantive changes.
Upon receipt of the required changes, the IRB Chair or another member designated by the Chair will verify that the appropriate additions/corrections were made and will either approve the study or return it to the Full Board for further review at a convened meeting.

DEFERRED: Substantial modifications and/or additional information are required.
An IRB action taken when the convened IRB cannot fully evaluate the research under review and make the determinations required for IRB approval without modifications to the Application and/or informed consent document(s), or submission of clarifications or additional materials prior to reconsideration of the research. Deferring a submission requires that the entire study with the additional information or modifications be reviewed by the Full Board at a convened meeting.

DISAPPROVED: Criteria for IRB approval are not met.
An IRB action taken when the determinations required for approval of research cannot be made, even with substantive clarifications or modifications to the Application and/or informed consent process/document(s). Only the Full Board may disapprove a study.

TABLED: Criteria for a convened Full Board meeting are not met.
An IRB action that indicates that review was not initiated or was not completed, resulting in postponement of IRB review, usually due to loss of quorum or other administrative issue. Research tabled at a convened meeting will be reviewed at the next convened meeting.

The General Data Protection Regulation (GDPR) is a European law that went into effect on May 25, 2018 and establishes protections for privacy and security of "personal data" about individuals in European Economic Area (“EEA”)-based operations and certain non-EEA organizations that process personal data of individuals in the EEA.

MCIRB Appendix E - International Research

The purpose of the Reportable Events Policy is to describe the process and requirements Investigators must follow when reporting events that meet reporting criteria to Mercy College’s Institutional Review Board (the MCIRB).

Reportable Events Form - email to the IRB at mcirb@mercy.edu.

The purpose of the Research Misconduct policy is to provide a process for the equitable resolution of formal complaints of research misconduct.  Responsibility for this purpose resides with the Research Misconduct Panel, whose composition and functions are described below. Institutions that accept research funding from federal agencies are required to have policies and procedures in place for the management of incidents of research misconduct

The Research Misconduct Panel will have jurisdiction over these matters. In developing this policy, Mercy College believes that all individuals engaged in research are responsible for fostering an environment that encourages absolute intellectual integrity with open communication and trust--the cornerstones of the academic enterprise. Incidents of research misconduct violate this trust and harm the research community itself.