Mercy IRB Application

BEFORE YOU BEGIN!
Application Guidance

Before you start your application, please review the IRB's website for guidance on IRB applications, including sample consent forms, flyers, and a glossary of relevant terms.

If you would like, you can use this template to prepare your answers to some of the more complex questions ahead of time.

If you are a student, we strongly recommend having your faculty mentor review your application draft before formally submitting it to the IRB.

If you have any questions about the application process, please don't hesitate to reach out to the IRB for help at MCirb@mercy.edu.

RESEARCH STATUS

ONLY USE THIS FORM FOR ONGOING RESEARCH REVIEW
1. Protocol Number:*
2. Please upload your original IRB approval letter.

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3. Estimated study completion date?

MonthDayYear
4. Please upload a single PDF including the current CITI Program certificate(s) for each investigator and research team member.

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5. Please indicate the current status of the research:

Open to enrollment, but no subjects have been enrolled to dateOpen to enrollment and subjects have been enrolledClosed to enrollment, but subjects are still “active” on the protocol regimen or undergoing procedures or interventions for the researchClosed to enrollment, but follow-up of subjects (or data collection) continuesClosed to enrollment, but analysis of identifiable or coded data continuesSuspended or on hold
6. Please explain why the project has been suspended or is on hold.
7. How many subjects have been enrolled in this study since inception?
8. Are there any anticipated changes in funding for this study?

YesNo
8a. Please describe the anticipated changes in funding.
Note: Changes in funding must be reported to the IRB before expending any of the new funding. Changes in funding sometimes trigger additional regulatory requirements that must be addressed before moving forward with the research. Likewise, the loss or end of funding may remove requirements.

1. General Description of Research
Research Purpose
1.1. Briefly summarize the nature, significance, and purpose of your proposed study in lay language. Include relevant background information.
1.2. Clearly outline your specific research questions and study objectives.
1.3. Are you engaging in any primary research? I.e., is your research entirely secondary?

I am engaging only in secondary researchI am engaging only in primary researchI am engaging in both primary and secondary research

Description of Primary Research
1.4. Clearly describe the methods and procedures being used in your primary research.
1.5 How many participants will be enrolled? What is the rationale for this number?
1.6. Recruitment Methods. Describe in IN DETAIL the process and/or method by which participants will be identified, approached, and recruited for the research. Include both inclusion and exclusion criteria.
1.7. Please describe IN DETAIL the compensation to be offered. If no compensation is being offered, write "N/A".
1.8. Where will the collection of information about your participants take place?
1.9 Explain how the selection and compensation (if applicable) of participants will be equitable given the purpose and setting of the research.

Description of Secondary Research
1.10 Please describe, in detail, the original source of the data/biospecimens you will be analyzing.
1.11 Describe the type(s) of data and date range(s) of the data you will use and the characteristics of the study research population (e.g., age range, sex, and any other pertinent demographic information.)
1.12. Will you obtain and/or use HIPAA and Protected Health Information (PHI) as part of your research?

YesNo
1.12a. Describe how authorization is obtained from participants to access and use their information.
1.12b.Because you will obtain/use HIPAA and/or PHI in your research, Appendix D: Use of Protected Health Information (PHI) Accessed, Used or Disclosed from a Covered Entity is required for your application.

I acknowledge that Appendix D is required.
1.13 Will you obtain and/or use student records or materials in your research?

YesNo
1.13a Please review application guidance for use of potentially FERPA protected data. According to that guidance, is the intended research data protected under FERPA?

YesNo
We strongly recommend revising your approach. If you are set on using FERPA protected data, please reach out to the IRB for discussion.
1.13b Which best describes the student data you plan to use?

Student evaluations of instructorsStudent records obtained from someone with legitimate access to that data. The data will be de-identified for researchers.
1.13c Please upload a letter of support both describing the de-identification process and attesting that the provider of student data has legitimate access to that data.

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3. CRITERIA FOR IRB APPROVAL OF RESEARCH

Even if your protocol has exempt status, Mercy's IRB still requires it to meet certain criteria to be approved.
3.1 Risk & Benefits

See See CFR 46.111(a)1-3;7
3.1 While risks associated with participation may be minimal, all research carries some risk arising from the study design and procedures. Please describe any reasonably foreseeable risks of harm or discomforts for individuals and/or groups that may result from participation in the research, and explain how the design addresses or minimizes those risks.

Information risks (e.g., loss of privacy and / or breach of confidentiality)Psychological or emotional risks (e.g., fear, stress, confusion, guilt, loss of self-esteem, depression, triggering of past emotional experiences).Social risks (e.g., social stigma, chance of being ostracized or shunned), economic risks (e.g., change in employment or insurability).Physical risks or harms (e.g., fatigue, pain or discomfort, potential for injury, illness or disease, or death, side effects and contraindications of drugs or substances used in the research)Legal risks (e.g., risk of prosecution, mandatory reporting), including genetic privacy risk (e.g., stigmatization, self-stigmatization, limits to insurance coverage or employability, misattributed paternity, etc.).
3.1a Information risks. Please explain the following: 1) Likelihood of the risk occurring. 2) Magnitude of the effects the risk would have should they occur. 3) How the risk will be minimized. NOTE: here we are concerned with information risks stemming from study design, not data security.
3.1b Psychological or emotional risks. Please explain the following: 1) Likelihood of the risk occurring. 2) Magnitude of the effects the risk would have should they occur. 3) How the risk will be minimized.
3.1c Social risks. Please explain the following: 1) Likelihood of the risk occurring. 2) Magnitude of the effects the risk would have should they occur. 3) How the risk will be minimized.
3.1d Physical risks or harms. Please explain the following: 1) Likelihood of the risk occurring. 2) Magnitude of the effects the risk would have should they occur. 3) How the risk will be minimized.
3.1e Legal risks. Please explain the following: 1) Likelihood of the risk occurring. 2) Magnitude of the effects the risk would have should they occur. 3) How the risk will be minimized.
3.2 Please describe any potential benefits that may result from the research.

3.3 Consent

Part 2: Informed Consent
Informed consent is a process, not just a form. The IRB must ensure the informed consent process clearly discloses and facilitates the understanding of all information needed to make an informed decision to participate while promoting the voluntariness of participation.

Please use the Mercy University consent / assent templates below and consult related guidance on the IRB Overview & Guidance page to develop your consent forms.

Adult Consent Template
Child Assent Template
Parental Permission Template
3.10. Describe every step of your informed consent process, including how it connects to your process of recruitment.
3.10a. Describe how you will ensure that the participants understand all aspects of their involvement in the research.
3.10b. Describe how the researcher plans to document that each participant has provided informed consent and/or assent.
3.11. Will your research involve minors (those under the age of majority) or individuals of diminished capacity as participants?

YesNo
3.11a. Describe the capacity of the participants and their ability to assent.
3.11b. Are you requesting a waiver of assent or waiver of assent documentation?

YesNo
3.11c. Describe how assent to participate will be obtained and documented.
3.11d. Are you requesting a waiver of permission or waiver of permission documentation?

YesNo
3.11e. Describe how the permission of the parent(s) or guardian(s) will be obtained and documented.
3.12. Will your research involve deception of participants?

YesNo
Please complete the Mercy University Debriefing Information Template and upload your script at the end of this page of the application.
3.12a. Describe how participants will be deceived and why it is necessary for the study.
3.12b. Deception is an alteration of informed consent; provide justification for how the use of deception meets the criteria for alteration of informed consent.
3.12c. Describe the debriefing process (and provide a script below).
3.13. Please upload the script you will use to debrief participants. If your study involves deception, this script is required. If it does not, it is only strongly encouraged, especially for studies involving sensitive topics.

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3.14. Please upload the Informed Consent Form you will provide to the study participants.

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3.3 Consent

Part 3: Broad Consent
3.15. Do you plan on using collected identifiable information for future research outside the scope of this current study? (Answer "No" if you are not collecting identifiable information)

YesNo
You must then, in addition to any study-specific informed consent, also secure broad consent from participants. For guidance on broad consent, see here.
3.15a. Please describe the broad consent process.
3.15b. Please describe how you will ensure that the participants understand all aspects of their involvement in the research.
3.15c. Please describe how you plan to document that each participant has provided broad consent.

APPENDIX A: CHILDREN AS SUBJECTS

This Appendix must be completed by the PI when a proposed study includes children as participants.
Please review the document Guidance on Children in Research
______________________________________________________________________________
Federal regulations and Mercy University policy require research involving children to be classified into one of three (3) categories for IRB approval.

Please review the three categories of research involving children that may be approved by the IRB, based on degree of risk and benefit to individual subjects, and select which category best describes your protocol. Determinations of approval are based upon language found at 45 CFR 46.404, 46.405, or 46.406.

Category 1: Research not involving greater than minimal risk. Research in this category is approvable provided adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians, as set forth in Sec. 46.408.

Category 2: Research involving greater than minimal risk but presenting the prospect of direct benefit to an individual subject. Research in this category is approvable provided adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians, as set forth in Sec. 46.408, and all of the following conditions exist:

(a) risk is justified by the anticipated benefit to the subjects; and
(b) the relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available alternative approaches.

Category 3: Research involving greater than minimal risk with no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject's disorder or condition. Research in this category is approvable provided adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians, as set forth in Sec. 46.408, and all of the following conditions exist:

(a) the risk represents a minor increase over minimal risk; and
(b) the intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational settings; and
(c) the intervention or procedure is likely to yield generalizable knowledge about the subject's disorder or condition that is of vital importance for the understanding or amelioration of the subject's disorder or condition.

DEFINITIONS

Children are persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.
Assent means a child's affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.
Permission means the agreement of parent(s) or guardian to the participation of their child or ward in research.
Parent means a child's biological or adoptive parent.
Guardian means an individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care.
1. Please select the category that best describes your research with respect to the involvement of children.

Category 1Category 2Category 3None of these categories describes my research with respect to the involvement of children.
STOP!

A fourth category of approval requires the IRB to make certain findings and refer the proposed research activity to the Secretary of HHS for further review and approval. Please contact the MCIRB if you believe your research qualifies for such review.

Research that is not approvable under 45 CFR 46.404, 46.405, or 46.406 may be conducted or funded by DHHS under 45 CFR 46.407 provided that the IRB, and the Secretary, after consultation with a panel of experts, finds that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a significant problem affecting the health and welfare of children. The panel of experts must also find that the research will be conducted in accordance with sound ethical principles.

APPENDIX E. International Research

Complete this Appendix when the proposed research is conducting human subjects research outside the United States.
Before completing this Appendix, please review the following:

International Compilation of Human Research Standards
General Data Protection Regulations
Mercy University guidance on international travel (Travel and Expense Policy)
Mercy University guidance on Faculty Development Grants
In how many countries (other than the United States) will you be conducting research? Please list the countries below.
Please contact the MCIRB if you will be conducting research in more than three countries outside the United States.
For each country, please describe the status of permissions and/or approvals using the following categories: "Received," 'Pending," and "Not Applicable."
Please upload any approval memos you have received.

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Will research activities take place in a non-public setting (including a school, hospital or clinic) for which local permission is required?

YesNo
Please upload any letters of support or permission for each institution. If more than one, please combine into a single PDF.

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Describe how you have considered any social, political, or cultural issues that may impact participants.
Please affirm: International Compilation of Human Research Standards

I have reviewed the current version of the International Compilation of Human Research Standards and agree to abide by relevant local laws, regulations, and guidelines.
Please affirm: General Data Protection Regulations

I have reviewed the General Data Protection Regulations guidance and will abide by any requirements.
Please affirm: Mercy University guidance on international travel (Travel and Expense Policy)

I have reviewed Mercy University guidance on international travel
Please affirm: Mercy University Faculty Development Grants

I have reviewed Mercy University guidance on Faculty Development Grants
Are you a student who plans to conduct in-person research in a foreign country?

YesNo
Please provide the name and contact information (organization information, address, phone number, email) of a local contact, advisor, or sponsor who will be with you at your research site.

PART VIII. Attachments

In this section, you will attach any relevant documents for the IRB's review.
Please indicate any additional documents you would like (or need) to provide in order to complete your application.

All of my necessary documents have been uploaded in previous sections of this application.1. CITI Training Certificate2. Data collection materials (questionnaires, surveys, interview scripts, etc.)3. HIPAA Authorization4. Informed consent documents / debriefing scripts5. Permissions, approval documents, and/or support letters6. Recruitment materials (emails, flyers, letters, scripts, posters, brochures, etc.)7. Request for Approval to Serve as Principal Investigator on a Human Subjects Research ApplicationOther
Please upload any CITI Certificates as a single document.

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Please upload any data collection materials (questionnaires, surveys, interview scripts, etc) as a single document.

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Please upload any HIPAA Authorizations as a single document.

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Please upload any informed consent materials or debriefing scripts as a single document.

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Please upload any permissions, approval documents, and/or support letters as a single document.

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Please upload any recruitment materials (emails, flyers, letters, scripts, posters, brochures, etc) as a single document.

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Please upload paperwork pertaining to a change of PI request as a single document.

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STUDENT IRB PROTOCOL APPLICATION
As part of your course, your instructor should have asked you to fill out an application as a word document. Please upload that document here.

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Please upload your informed consent form and debriefing form (if applicable) here.

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Please upload your recruitment materials here (if applicable)

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Please upload all your survey instruments, including demographic questionnaires, here.

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Please upload CITI certificates for all researchers attached to your project. If you are unsure what this is, please reach out to your instructor.

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PART IX. CERTIFICATION OF PRINCIPAL INVESTIGATOR RESPONSIBILITIES
A. Conduct of the Research
1. I accept responsibility for the ethical conduct of this research and protection of participants as set forth in the Belmont Report, Common Rule, and Mercy University policies.
2. I accept responsibility for ensuring this research is conducted in accordance with:
  - Sound research design and methods;
  - The parameters of the research plan and activities described in this Application;
  - The applicable terms of the grant, contract, or other signed funding agreements;
  - Applicable laws and regulations, including those protecting the rights, safety and welfare of human subjects.
3. I certify that I am, or my faculty advisor is, sufficiently qualified by education, training and experience to assume responsibility for the proper conduct of this research.
4. I accept responsibility for ensuring that all members of the research team have or will complete human subjects CITI training before any work with participants or identifiable data / biospecimens begins.
5. I accept responsibility to personally conduct and/or direct this research.
6. I certify that I have sufficient time and resources to properly conduct this research.
B. Ensuring and Maintaining Compliance
1. I will comply with relevant regulatory and institutional reporting requirements, including Mercy University’s Reportable Events Policy.
2. I understand that it is my responsibility to ensure that any research personnel, including myself, responsible for the design, conduct or reporting of the research declares any conflicts of interest related to this research.
3. I will ensure that any changes pertaining to any potential conflicts of interest shall be reported promptly to Mercy University’s IRB.
4. I will ensure that prospective agreement and/or informed consent is obtained and a copy is provided to participants, when appropriate.
5. I will promptly notify the Mercy University’s IRB in the event that any changes in the research described in this Application for Approval of Research may impact the study’s classification (as either Exempt, Expedited, or Full Board Review).
6. I will maintain approval, as applicable, with collaborative parties, including approvals from other countries or jurisdictions.
7. I will cooperate with any post-approval monitoring or auditing of study activities and/or study records as requested and/or required by the Mercy University’s IRB, funding entities, sponsors, and/or any federal or state regulatory agencies.
C. Records, Reports and Documentation
1. I will maintain all research protocol materials and consent materials for the duration of this study.
2. I will maintain research records for at least three years following the end of this research, or for a longer length of time if specified in applicable regulations or sponsor requirements. I will take measures to prevent accidental or premature destruction of these records.
3. I will ensure that the data security measures for acquisition, collection, transfer, use, and destruction of study data described in PART VI of this Application are adhered to by all members of the research team.
In lieu of a signature, please enter your full name.
Please check below to affirm your understanding of your responsibilities as PI.

I certify that I have read and agree to uphold the PI responsibilities outlined above.
Once you submit this application, Jotform will email you a confirmation that includes a link to edit your submission. Please save this link and do not delete: if the IRB's response memo indicates changes should be made to your application, you will use this link to access it to make the appropriate changes. Please check below to affirm your understanding.

I understand
Date

MonthDayYear
Should be Empty:

-Names	-Certificate or license numbers
-Fax Number	-Device identification or serial numbers
-Email address	-Universal resource locators (URLs)
-Telephone numbers	-Internet Protocol addresses (IPs)
-Account numbers	-Full face photographs and comparable images
-Biometric identifiers	-Postal address information other than city, state, and zip
-Social security number	-Vehicle identification/serial numbers, including license plate numbers
-Medical record numbers

BEFORE YOU BEGIN!

Information about You and Your Project

AMENDMENT REQUEST FORM

RESEARCH STATUS

1. General Description of Research

Research Purpose

Description of Primary Research

Description of Secondary Research

PART 2: DETERMINING REVIEW TYPE

Is Your Protocol Human Subjects Research?

EXEMPTION EXCLUSION CRITERIA

Exemption Inclusion Criteria

PART 2.4. ELIGIBILITY FOR EXPEDITED REVIEW

3. CRITERIA FOR IRB APPROVAL OF RESEARCH

3.1 Risk & Benefits

3.2 Data Security

Part 1: Privacy & Data Collection

3.2 Data Security

Part 2: Data Storage & Confidentiality

3.3 CONSENT

3.3 Consent

3.3 Consent

PART 4. APPENDICES

APPENDIX A: CHILDREN AS SUBJECTS

APPENDIX B: Prisoners as Subjects

APPENDIX C: MENTAL HEALTH SAFETY

Safety Plan Procedures

Continued Study Involvement

Resource Referral List

State when the list will be given (e.g., at time of consent, after review of the assessments).

APPENDIX D. Use of Protected Health Information (PHI) Accessed, Used or Disclosed from a Covered Entity

APPENDIX E. International Research

PART VIII. Attachments

STUDENT IRB PROTOCOL APPLICATION

PART IX. CERTIFICATION OF PRINCIPAL INVESTIGATOR RESPONSIBILITIES