• Mercy IRB Application

  • Information about You and Your Project

    Name(s) and Contact Information

  • 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
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  • PART I. PROPOSED CHANGES

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  • Personnel Changes/New Investigator(s):

    Mercy University defines the term “Investigator” as “the project director or principal investigator and any other person, regardless of title or position (e.g., full or part-time faculty member, staff member, student, trainee, collaborator, or consultant), who is responsible for the design, conduct, or reporting of sponsored research.”

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  • PART II. ATTACHMENTS

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  • RESEARCH STATUS REPORT

    Use this form for ongoing project review.
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  •  - -
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  • Human Subjects Research Screening

    In this portion of the form, you will determine whether IRB approval is required for your project.

  • Exempt studies must meet the federal definition of Human Subjects Research. 

    The following questions are designed to determine whether or not your project meets the federal definition of Research.

    Review the information below to determine if your project satisfies the criteria of (A) systematic investigation, and (B) designed to develop or contribute to generalizable knowledge.

  • (A) Systematic Investigation 

    A systematic investigation involves a logical and organized approach to data collection and analysis, developed in advance of project initiation. Qualities of a project involving systematic investigation include: 

    • one or more specific questions of interest, often framed as hypotheses, that the project will seek to answer
    • uses data collection methods that are appropriate to address the question(s)
    • data analysis plans are appropriate for the type(s) of data collected
    • an ability to use the analyzed data to answer the question(s)

    Your project should clearly demonstrate all of these qualities to satisfy this criterion.

  • (B) Designed to Develop or Contribute to Generalizable Knowledge

    A study designed to develop or contribute to generalizable knowledge intentionally links to, applies, and/or expands upon existing knowledge. The methods allow for replication and for comparisons with data collected from different samples of the same population, and the results apply to people beyond those directly studied.

    Qualities of a project designed to develop or contribute to generalizable knowledge include:

    • basis in a theoretical framework of established knowledge
    • identification of a gap in knowledge that the project plans to address
    • identification and description of one or more specific populations of interest
    • unbiased sampling methods (i.e., random or probability sampling), when feasible, that allow for the recruitment of samples representative of the population(s)
    • operationalization of variables and constructs
    • data collection plans employing measurement tools and techniques with established and satisfactory reliability and validity
    • data analysis plans using techniques consistent with those employed in the literature of the theoretical framework and considered appropriate for the type(s) of data collected
    • an ability and plan to use the collected and analyzed data to draw meaningful conclusions about the results and link these back to the theoretical framework and identified gap in knowledge.

    Your project should demonstrate most or all of these qualities to satisfy this criterion.

  • The following questions are designed to determine whether or not your project meets the federal definition of Human Subjects.

    Human subject means a living individual about whom an investigator (whether professional or student) conducting research (1) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (2) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

    Review the information below to determine if your project satisfies the criteria of (A) about whom, (B) intervention or interaction, and (C) identifiable private information or identifiable biospecimens.

  • (A) About Whom

    Obtaining data about individuals is different than obtaining data from individuals; for example, you might obtain data about individuals from a database (i.e., not directly from the individuals). In this case, you would select 'Yes'. On the other hand you might obtain data from individuals about something impersonal (e.g., the weather). In this case, select 'No'.

    Note that biological specimens of living individuals satisfies this criterion (select 'Yes').

  • (B) Intervention or Interaction

    Intervention includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.

    Interaction includes communication or interpersonal contact between investigator and subject. Typical examples include face-to-face meetings, phone conversations, and targeted physical or electronic mail correspondence.

  • (C) Identifiable Private Information or Identifiable Biospecimens

    Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record).

    Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.

    An identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.

  • STOP!
    If you answered “No” to any of the above questions, your study does not meet the definition of Human Subjects Research.
    You are not required to submit an Application for Research Approval.

    Your responses have been recorded and no further action is required.

    Exclusion from IRB oversight due to non-HSR status prohibits neither the conduction of a data collection study nor the presentation or publication of its findings; however, you must avoid claiming or insinuating that your study received IRB review or approval. You must also consider ethical principles during design and execution and we strongly encourage you to work closely with your research advisor, instructor, colleagues, and/or organizational representatives to avoid ethical and/or legal violations.

    Thank you for using the Mercy University Institutional Review Board (IRB) interactive decision tree. This tool is provided to help determine whether a data collection project involving humans satisfies the federal definition of Human Subjects Research (HSR) and by extension requires IRB approval prior to initiation. Please address any questions to MCIRB@mercy.edu.

    Thank you.

    Mercy University Institutional Review Board

  • Based on your responses it appears possible or likely that your planned project satisfies the definition of Human Subjects Research (HSR) and requires Institutional Review Board (IRB) approval prior to initiation.

    Please click next to continue your application.

  • PART I. EXEMPT ELIGIBILITY SCREENING

    In some circumstances, specific characteristics may disqualify a study for exemption. When this is the case, a study that may otherwise qualify for exemption must undergo expedited or full board review by the IRB. Please answer the following questions to determine whether your study may be ineligible for or otherwise prohibited from exemption.
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  • Your study does not qualify for an Exempt Review. Instead, you will need to continue to Full Board Review. (Please click next to continue.)

  • Based upon your answers, it is likely that your study qualifies for an exemption. 

  • Exemption Categories

    From the exemption categories described below, please select the one that is most applicable to your proposed research and complete the corresponding Exempt Category Worksheet. If none of the categories applies to your project, then select "None of the above."

  • Exemption 1: Research conducted in an established or commonly accepted educational setting that specifically involves normal educational practices

    Exemption 2: Research that ONLY includes interactions involving:

    • Educational tests (cognitive, diagnostic, aptitude, achievement); or
    • Survey procedures; or
    • Interview procedures; or
    • Observation of public behavior; or
    • Focus Groups

    Exemption 3: Research involving ONLY benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses or audiovisual recording

    Exemption 4: Secondary research using identifiable private information or identifiable biospecimens, collected for a purpose other than this study

    Exemption 5: Research and demonstration projects conducted or supported by a Federal department or agency that is designed to study, evaluate, improve, or otherwise examine public benefit or service programs

    Exemption 6: Taste and food quality evaluation and consumer acceptance studies.  Mercy University does not typically review these types of studies.

    Exemption 7: Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use for which broad consent is required.

    Exemption 8: Secondary research involving the use of identifiable private information or identifiable biospecimens for potential secondary research use for which broad consent is required.

  • PART II. RISK ASSESSMENT & EXPEDITED ELIGIBILITY

    Minimal Risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examination or tests.

  • Expedited Eligibility Screening

  • From the research categories described below, please select the one that is most applicable to your proposed research, if any.

    Category 1: Clinical studies of drugs and medical devices only when condition (a) or (b) is met:

    (a) research on drugs for which an IND application is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review);

    OR

    (b) research on medical devices for which (i) an IDE exemption application is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.

    Category 2: Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture.
    NOTE: Mercy University IRB does not typically review/approve studies in this expedited review category.

    Category 3: Prospective collection of biological specimens for research purposes by noninvasive means.
    NOTE: Mercy University IRB does not typically review/approve studies in this expedited review category.

    Category 4: Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.) Examples may include:

         (a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject's privacy;

         (b) weighing or testing sensory acuity;

         (c) magnetic resonance imaging;

         (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography;

         (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.

    Category 5: Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis).
    NOTE: Some research in this category may be Exempt. Review the categories for Exemption before selecting this option.

    Category 6: Collection of data from voice, video, digital, or image recordings made for research purposes.

    Category 7: Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
    NOTE: Some research in this category may be Exempt. Review the categories for Exemption before selecting this option.

    Category 8: Continuing review of research previously approved by the convened IRB as follows:

    (a) where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; 

    OR

    (b) where no subjects have been enrolled and no additional risks have been identified; or (c) where the remaining research activities are limited to data analysis.

    Category 9: Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.

  • PART III. RESEARCH DESIGN & METHODS

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  • PART IV. 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

    As you describe your process in Question 1, please consider the following:

    • How will the required elements of informed consent will be conveyed to participants (i.e., informed consent document, verbal script, online consent, etc.)? In certain circumstances, the IRB may approve a consent process which does not include, or which alters, some or all the elements of informed consent or waive the requirements to obtain informed consent.
    • Where and when the informed consent process will take place (i.e., in-person in a private room, by phone, online etc.).
    • Any cultural considerations (e.g., tribal or group permission requirements, age of majority, technological limitations, etc.).
    • Steps that will be taken to ensure voluntary participation and to minimize the possibility of coercion or undue influence.
    • Which research roles (e.g., PI, Research Assistant, etc.) will conduct the consent process and how those individuals will be trained (e.g., previous experience or related training, one-on-one training with PI, etc.).

    If multiple participant groups or consent procedures are to be included, these need to be clearly delineated (e.g., consent process for eligibility screening, consent process for in-person main study, etc.).

  • As you describe your process in Question 2, consider the following:

    • What special provisions, if any, will help individuals who might have trouble comprehending the consent information.  
    • If any participants do not speak English, describe: Whether or not the researcher is fluent in the language. 
    • Whether or not and how a translator will be used. 
    • Whether or not translated consent materials will be used. 
    • Whether or not there are any differences in the consent process for different populations based on the language they speak.  
    • How you will ensure ongoing consent.

  • Please complete the Mercy University Debriefing Information Template and upload your script at the end of this page of the application.

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  • 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.

  • PART VI. DATA SECURITY ASSESSMENT

  • IMPORTANT NOTES

    REDCap: Mercy University has its own REDCap access.

    Data collection: The expectation is that data collection devices will only store data during active data collection. Data must then be transitioned to more secure long-term storage solutions.

    Departmental/University managed servers: If data are collected/entered directly onto a Departmental or University managed server, you must ensure that the server meets the security standards described in the University Computing Policies.

  • PART VII. APPENDICES

    Please respond to the following questions and complete the required appendices.

  • 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.

  • 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 B: Prisoners as Subjects

    This Appendix must be completed by the PI when a proposed study includes prisoners or a study is being amended to add prisoners as participants.

  • Federal regulations and Mercy University policy require research involving prisoners to be classified into one of four (4) categories.

    Please review the three categories of research involving prisoners 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. 

    Category 1: The research involves the study of the possible causes, effects, and processes of incarceration, and of criminal behavior. The study presents no more than minimal risk and no more than inconvenience to the subjects.
    Category 2: The research involves study of prisons as institutional structures or of prisoners as incarcerated persons. The study presents no more than minimal risk and no more than inconvenience to the subjects.
    Category 3: The research involves a study on conditions particularly affecting prisoners as a class.
    Category 4: The research involves a study on practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well-being of the participants.

    DEFINITIONS

    Prisoner is any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing (45 CFR 46.303(c)). Individuals are prisoners if they are in any kind of penal institution, such as a prison, jail, or juvenile offender facility, and their ability to leave the institution is restricted. Prisoners may be convicted felons or may be untried persons who are detained pending judicial action (e.g., arraignment or trial).

    Common examples of the application of the regulatory definition of prisoner are as follows: Individuals who are detained in a residential facility for court-ordered substance abuse treatment as a form of sentencing or alternative to incarceration are prisoners; Individuals with psychiatric illnesses who have been committed involuntarily to an institution as an alternative to a criminal prosecution or incarceration are prisoners; Parolees who are detained in a treatment center as a condition of parole are prisoners.

  • The following questions are those that the IRB must consider when determining whether your use of prisoners in the proposed researcher can be approved.

    [You may need to return to your protocol application and/or consent documents to provide sufficient information in your application to justify your selections below.]

  • APPENDIX C: MENTAL HEALTH SAFETY

    This research study participant Mental Health Safety Plan (“Safety Plan”) is a set of procedures developed to ensure the well-being of research participants who may experience significant emotional distress (e.g., depression), or be at risk of harming themselves or others during a research study.

  • THANK YOU!

    You do not need to complete this Appendix.

  • 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).

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

    Complete these questions when the proposed research includes plans to access, use, or disclose Protected Health Information (PHI). The Privacy Rule permits several methods by which PHI may be used in research.

  • Refer to the “HIPAA Authorization” (Authorization to Use Protected Health Information in Research) form/template to be presented to the study participant for review and to provide permission for access to their PHI. Be sure to compete HIPAA Authorization form/template with the required information and include it with the IRB submission application.

  • An Authorization or documentation of a waiver or alteration of Authorization is not required for a Mercy University researcher to receive a Limited Data Set when the data is accompanied by a Data Use Agreement from the PHI providing institution. A limited data set must have all the identifiers listed below removed from the data. It is the responsibility of the researcher and the party releasing the PHI to have in place and maintain a copy of a data use agreement which meets HIPAA requirements. A copy of the data use agreement must be included with the IRB submission.

    -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  

     

  • STOP!

    Based upon your answers, a waiver is not applicable to this research.

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  • 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

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  • PART VIII. Attachments

    In this section, you will attach any relevant documents for the IRB's review.
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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.
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