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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 4 weeks for IRB review and approval. 

 . (Please do NOT email the IRB chair or individual IRB members or staff directly – you may contact MCIRB@mercy.edu for any procedural questions.)

You may use this to prepare your longer answers as you complete the electronic application form.

• Ensure that you have completed all required CITI training reporting before you submit any new application materials.
• The �鶹���� 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.
• Any attachments associated with your application (consent forms, recruitment scripts, interview questions, etc.) must be attached to the appropriate section of the electronic form. If you are unsure where to attach any documents, there is a space included at the end of the form for miscellaneous materials.
• �鶹���� IRB has a One Application Policy in accordance with  (Health and Human Services, IRB Records).  Studies approved by the �鶹���� 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.
• The �鶹���� 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, �鶹���� policies, and IRB position statements. For example, if modifying compensation on a flyer, the �鶹���� IRB will review the entire flyer to confirm that it meets Mercy’s current recruitment policy.
• Need help? Please contact IRB Chair at MCIRB@mercy.edu.

. (Please do NOT email the IRB chair or individual IRB members or staff directly – you may contact MCIRB@mercy.edu for any procedural questions.)

TIPS ON COMPLETING THE APPLICATION FORMS:

Your progress on the application can be saved at any time using the “save button” at the bottom of each page. When you are finished drafting your application, please be sure to use the “submit” button – only submitted applications will be reviewed by the IRB.

This is the pilot year for our electronic form. We highly recommend that you copy your responses into a separate document for safekeeping in the event of a technical glitch. 

You may use this to prepare your longer answers as you complete the electronic application form.

To obtain a PDF copy of your application responses, you can contact the Research and Grants Administrator (research@mercy.edu).

See Appendices and Special Populations for additional information and forms that may be required for your protocol.

Any attached supporting documents should have file names that include your last name followed by IRB application and clarify the type of document you are providing (e.g., SMITH_IRB Application_consent form).

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

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 �鶹���� Institutional Review Board, please complete the beginning of the application form. If your research does not require IRB approval, you will be notified and will not need to complete the rest of the application. (This assessment should take approximately 5 minutes to complete.)

IMPORTANT: All consent documents must be submitted in Word format only.

 The following consent form template can be used for adults taking part in in-person studies and electronic surveys. 

Adult Consent Template

This template will ensure that the basic elements of informed consent are included in your document and mirrors the “Key Information” section required for more complex and/or greater than minimal risk research studies.

The informed consent must be written at an 8th-grade reading level and presented in lay language. You can use this to check the reading level of your consent form.

Instructions are marked in [shaded brackets]. Additional language to be used if applicable are marked in [italicized, shaded brackets].

All plain text without shading should be included in your consent document without modification.

There may be additional elements that should be included based on your study design, research population, or funding.

HOW TO USE THE CHILD ASSENT TEMPLATES:

Using the Child Assent Templates will ensure that the basic elements of informed assent are included in your document, at a reading level that is appropriate for children included in research studies.

When to use the Child Assent Templates:

1. Your study involves participants between the ages of 7-17.
2. The child is capable of providing assent (either verbal or written).

The HRPP provides two versions of the Child Assent Template:

1. Child Assent for Research Ages 7-12 (5th-grade reading level)
2. Child Assent for Research Ages 13-17 (7th-grade reading level)

This reading level of these documents can be lowered or raised but should always be written in lay language dependent on and appropriate to your child participants. You can use this to check the reading level of your consent form.

Instructions and guidance are marked in [shaded brackets]. Additional language to be used if applicable are marked in [italicized, shaded brackets]. Brackets, shading, and italics should be removed by researchers from the final versions of the assent form.

All plain text without shading should be included in your consent document without modification.

There may be additional elements that should be included based on your study design, research population, or funding.

MCIRB Assent Template

MCIRB Parental Permission Template

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

Appendices may be required to complete your application as follows:

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. 

Please complete the appropriate form(s) as needed:

• MCIRB Appendix A - Children as Subjects
• MCIRB Appendix B - Prisoners as Subjects
• MCIRB Appendix C - Mental Health Safety Plan
• MCIRB Appendix D - Use of PHI in Research
• MCIRB Appendix E - International Research

Please review the document .

MCIRB Appendix A - Children as Subjects

The (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

Please refer to the Mercy IRB 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 University policy for a term of one year.

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 purpose of the  is to describe the process and requirements Investigators must follow when reporting events that meet reporting criteria to �鶹����’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, �鶹���� 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.