Institutional Review Board

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]

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)

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

• Office for Human Research Protections (OHRP) Human Research Protection Training: hhs.gov/ohrp/education-and-outreach/online-education/human-research-protection-trainin
• Collaborative Institutional Training Initiative (CITI) Human Subjects Research: about.citiprogram.org/en/series/human-subjects-research-hsr
• Protecting Human Research Participants (PHRP) Online Training  & Certification: phrptraining.com

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 Checklist (https://www.hhs.gov/ohrp/regulations-and-policy/guidance/checklists/index.html)
• Minimal Risk Informed Consent Models: https://www.hhs.gov/ohrp/sachrp-committee/recommendations/attachment-a-minimal-risk-informed-consent-models/index.html
• Informed Consent Tips (https://www.hhs.gov/ohrp/regulations-and-policy/guidance/informed-consent-tips/index.html)
• Examples of Adult Consent Form Templates:

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/

• OHRP Guidance on Coronavirus
• Protecting Personal Health Information in Research: Understanding the HIPAA Privacy Rule
• IRB Role under the Privacy Rule
• Family Educational Rights and Privacy Act (FERPA) Guidelines [View More]
• Rights of Research Participants
• Do’s and Don’ts for Writing Research
• Methods for De-Identification of Protected Health Information with HIPAA Guidance
• Mini-Tutorials
  • “OHRP understands that everyone is busy and may not have time for an hour-long video. To meet this need, OHRP created a series of short tutorials (each around 15 minutes long) that focus on specific aspects of HHS human subjects regulations and policy. These mini-tutorials are designed to help human research protections professionals build on their knowledge.” (OHRP, 2020: OHRP’s materials are intended for public use and distribution.)
• Food and Drug Administration (FDA) Website: https://www.fda.gov/
• Office for Human Research Protections (OHRP) Website: https://www.hhs.gov/ohrp/

Quality Improvement Human Subject Involvement Determination Form