Institutional Review Board

Mercy College of Health Sciences

Institutional Review Board


The Mercy College of Health Sciences Institutional Review Board (IRB) is a federally registered board whose purpose is to protect the rights and welfare of human subjects in research, in accordance with the Health and Human Services Regulations for the Protection of Human Subjects (45 Code of Federal Regulation Part 46). In addition, guidance is provided by the Office for Human Research Protections (OHRP) in the United States.

Mercy College requires all research projects and studies involving human subject participants to undergo review by the IRB prior to initiation of data collection. The Mercy College IRB reviews, and must approve, research studies/projects for all faculty, staff, students, or anyone conducting research affiliated with Mercy College to ensure compliance with federal regulations, institutional policies, and the protection of the rights and welfare of human subjects. For further information contact the IRB at IRB@mchs.edu.

The IRB Committee meets quarterly, the second Wednesday of the month from 7:00 am – 8:00 am.

Meeting Schedule | 2021 – 22
Wednesday, March 8, 2023 via MS Teams
Wednesday, June 14, 2023 via MS Teams
Wednesday, September 13, 2023 via MS Teams
Wednesday, December 13, 2023 via MS Teams
IRB Application & Checklist

IRB Application
Prior to review of a research study by the IRB, researchers will complete the form and submit to the IRB at IRB@mchs.edu.
[Download]

IRB Checklist
To ensure researchers have the application requirements complete, view the application checklist.
[Download]

IRB Forms and Templates

Annual Review/Template
Researchers will complete the form and submit to the IRB at IRB@mchs.edu.
[Download] 

Final IRB Report Template 
Researchers will complete and submit the Final IRB Report at the conclusion of the study.
[Download]

Request to Amend or Revise a Study
[Download]

Unanticipated Problem/Adverse Event Reporting Form
[Download]

The Code of Federal Regulations
Requires Additional Protections for Vulnerable Populations Involved in Research. Includes:

Subpart B, Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research https://www.ecfr.gov/cgi-bin/text-idx?SID=0123753ed5261e2e061edea93f8b3e72&mc=true&node=pt45.1.46&rgn=div5#sp45.1.46.b)

Subpart C, Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects (https://www.ecfr.gov/cgi-bin/text-idx?SID=0123753ed5261e2e061edea93f8b3e72&mc=true&node=pt45.1.46&rgn=div5#sp45.1.46.c)

Subpart D, Additional Protections for Children Involved as Subjects in Research (https://www.ecfr.gov/cgi-bin/text-idx?SID=0123753ed5261e2e061edea93f8b3e72&mc=true&node=pt45.1.46&rgn=div5#sp45.1.46.d)

Human Subjects Training

Accepted IRB Human Subjects Training courses include: OHRP, PHRP, CITI. Please contact IRB@mchs.edu with any questions.

Facilitated Review

Researchers external to Mercy College who wish to complete a research study utilizing Mercy College human subjects will need the approval of their institution’s IRB and the Mercy College administrator over the departments or programs affected. They must submit a copy of the primary IRB’s verification of the study proposal and protocol. Mercy College’s IRB will collect verification and monitor the process using the following steps:

  • Researchers requesting a Facilitated Review will complete the following steps prior to launching a study at Mercy College that includes human subjects:
  1. Email the Program Chair/Director of the area where the researcher plans the study to be administered, requesting permission.
  2. Provide the Program Chair/Director with all parts of the research study which were previously provided to the primary IRB.
  3. Send a copy of the IRB Authorization Agreement [Download] to the researcher’s primary IRB for completion.
  4. Return the IRB Authorization Agreement to the Mercy College IRB at IRB@mchs.edu prior to launching the study.
  5. The Mercy College IRB will provide a letter of approval to the researcher only after completion of these steps.
  • Upon receiving a request by a researcher external to Mercy College to complete a study utilizing Mercy College human subjects, the Program Chair/Director of the area will:
  1. Complete a Program Chair/Director’s Approval and Consent of Confidentiality form and mail to IRB@mchs.edu. [Download]
  2. Send the original request, informed consent form, and other research study material to IRB@mchs.edu.
  • The IRB Chair or designee will:
  1. Review all materials and forms submitted.
  2. Send a letter of approval to the researcher.
  3. Request final and/or annual reports from the researcher.
  • If you have questions regarding the IRB process at Mercy College, please contact the IRB at: IRB@mchs.edu.
Informed Consent Resources
  1. University of Wisconsin Milwaukee Consent Form Templates https://uwm.edu/irb/consent-form-templates/
  2. Cornell University IRB Consent Form https://researchservices.cornell.edu/forms/irb-consent-form-templates
  3. University of California San Francisco Consent and Assent Form Templates https://irb.ucsf.edu/consent-and-assent-form-templates#consent-templates
  4. University of La Verne Consent, Assent, and Information Sheet Templates (English and Spanish versions) https://laverne.edu/irb/irb-forms-and-examples/informed-consent-forms-templates/
  5. Boston University Medical Campus and Boston Medical Center IRB Templates http://www.bumc.bu.edu/irb/inspir-ii/irb-templates/
Additional Resources for Researchers
Institutional Review Board

Questions


If you have questions regarding the IRB process at Mercy College, please contact the IRB at: IRB@mchs.edu.

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Mercy College is the only private Catholic college in central Iowa and is accredited by the Higher Learning Commission (HLC), in addition to numerous programmatic accreditors.

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