Mercy IRB Application

Mercy IRB Application
Information about You and Your Project

Name(s) and Contact Information
Project Title:
The IRB term for project is "protocol," used hereafter.
Principal Investigator:
Mercy email address:
Department/Program
Applicant status: Please indicate your Mercy University status below.

AdjunctFacultyStaffStudent
Who is your Faculty Advisor?
What is your Faculty Advisor's phone number?
What is your Faculty Advisor's Mercy email address?
If you have more than one Faculty Advisor, please list additional names, phone numbers, and email addresses here. (Otherwise, enter N/A.)
Are there additional investigators? (This includes student research assistants.)

YesNo
Please list names and email addresses for any additional investigators.
Application purpose: Please indicate what kind of IRB review you are seeking.

Original application [My project has not yet been reviewed by the IRB, or it has been reviewed but not given final approval.]Project Addendum [My project has already been approved by the IRB, but there have been changes to the original protocol.]Ongoing research [I have been asked by the IRB to provide an update on the conduct of my approved research.]
As you proceed through the rest of the application, it may be helpful to refer to the Mercy University IRB Glossary.

Any project that satisfies the federal definition of Human Subjects Research (HSR) must receive IRB approval prior to initiation.

A project that involves collecting data from people does not automatically qualify as HSR; rather, you must determine whether your project meets the criteria of both Research and Human Subjects, in that order.

Note: detailed information on Human Subjects Research is available from the U.S. Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP), including the Code of Federal Regulations Title 45 Part 46 (45 CFR 46) documentation and related HHS decision charts.

Revision Request Form

Full Board and Expedited Amendments; Exempt Modifications
Protocol Title:
Name of Principal Investigator:
Your Department/Program:
Your Mercy Email address:
Who is your Faculty Advisor?
Protocol Number:*
Please upload your original IRB approval letter.

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RESEARCH STATUS REPORT

Use this form for ongoing project review.
Protocol Title:
Principal Investigator:
Mercy Email address:
Department/Program:
Who is your Faculty Advisor?
Protocol Number:*
Please upload your original IRB approval letter.

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Estimated study completion date?

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

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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
Please explain why the project has been suspended or is on hold.
How many subjects have been enrolled in this study since inception?
Are there any anticipated changes in funding for this study?

YesNo
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.

PART V. USE OF SECONDARY DATA

For research that involves the use of identifiable secondary data, including coded data from which you may be able to ascertain participant identity.
You do not need to complete Part V if your project does not involve secondary data.

Proceed to Part VI
1. From what source(s) will you acquire or access the data / biospecimens?
2. 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.)
3. Will you obtain and/or use HIPAA and Protected Health Information (PHI) as part of your research?

YesNo
3a. Describe how authorization is obtained from participants to access and use their information.
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.

APPENDIX A: CHILDREN AS SUBJECTS

This Appendix must be completed by the PI when a proposed study includes childenren 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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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

Mercy IRB Application

Information about You and Your Project

Revision Request Form

PART I. PROPOSED CHANGES

PART II. ATTACHMENTS

RESEARCH STATUS REPORT

Human Subjects Research Screening

PART I. EXEMPT ELIGIBILITY SCREENING

Exemption Categories

PART II. RISK ASSESSMENT & EXPEDITED ELIGIBILITY

Expedited Eligibility Screening

PART III. RESEARCH DESIGN & METHODS

PART IV. INFORMED CONSENT

PART V. USE OF SECONDARY DATA

PART VI. DATA SECURITY ASSESSMENT

PART VII. APPENDICES

APPENDIX A: CHILDREN AS SUBJECTS

APPENDIX B: Prisoners as Subjects

APPENDIX C: MENTAL HEALTH SAFETY

Safety Plan Procedures

Continued Study Involvment

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

PART IX. CERTIFICATION OF PRINCIPAL INVESTIGATOR RESPONSIBILITIES