• 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.

     

  • Information about You and Your Project

  • Applicant status: Please indicate the PI's Mercy University status below.*
  • Is this a course-based project, e.g. for PSYCH 616/617, the Research Methods course sequence?
  • Are there additional investigators? (This includes student research assistants.)

  • Jotform does not currently allow multiple researchers to edit a single jotform application before it has been submitted. If you want to give a co-PI the ability to edit your application, please email MCIRB@mercy.edu for a workaround. 

  • Application purpose: Please indicate what kind of IRB review you are seeking.

  • AMENDMENT REQUEST FORM

    Use This Form For Full Board and Expedited Amendments; Exempt Modifications
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  • 5. Have you added any new Mercy-affiliated Investigators to this project since your most recent IRB review (initial review or review of your most recent amendment/modification)?
  • 5a. How many new investigators have been added to your study?
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  • 6. Do the proposed revisions entail changes to the following documents? Select all that apply.
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  • RESEARCH STATUS

    ONLY USE THIS FORM FOR ONGOING RESEARCH REVIEW
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  • 3. Estimated study completion date?
     - -
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  • 5. Please indicate the current status of the research:
  • 8. Are there any anticipated changes in funding for this study?

  • 1. General Description of Research

  • Research Purpose

  • 1.3. Are you engaging in any primary research? I.e., is your research entirely secondary?

  • Description of Primary Research

  • Description of Secondary Research

  • 1.12. Will you obtain and/or use HIPAA and Protected Health Information (PHI) as part of your research?
  • 1.13 Will you obtain and/or use student records or materials in your research?
  • 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?

  • 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?
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  • PART 2: DETERMINING REVIEW TYPE

  • Is Your Protocol Human Subjects Research?

  • The following five questions aim to determine if your project meets the definition of Human Subjects Research (HSR). Protocols that meet this definition are within the scope of IRB Review. Please see the application guide and/or glossary if you are unsure about how to answer the following questions.

  • 2.1. Is your project a systematic investigation?
  • 2.2. Is your project designed to develop or contribute to generalizable knowledge?
  • 2.3.Does your study involve information about living individuals?
  • 2.4. Will you either (a) collect information through some type of intervention or interaction or (b) use identifiable private information (or identifiable biospecimens)?

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

    Please click "Next" to continue your application.

  • Based on your responses, it appears that your planned project does not meet the criteria for Human Subject Research.

    Nonetheless, the Mercy University IRB requires you to sumbit your protocol for IRB review. There are two reasons for this:

    1. The IRB needs to review your project to ensure that the classification as non-HSR is correct.
    2. Mercy's IRB has broader ethical responsibilities to review research projects even if they do not technically classify as HSR.

     

  • EXEMPTION EXCLUSION CRITERIA

  • Many human subject research protocols are exempt from IRB review. However, in some circumstances, e.g. when studies concern vulnerable populations, 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 is ineligible for exemption.

  • 2.5. Do you believe your research presents GREATER or NO GREATER than minimal risk? Note: research that involves greater than minimal risk is ineligible for both exemption and expedited review.
  • 2.6. Does this research propose to study prisoners as a targeted population?
  • 2.7. Is there a state, federal or other applicable law (e.g., tribal or international law) that prohibits an exemption determination for this research?
  • 2.8. Does the agency funding your research, or an agency with whom you are working, prohibit an exemption determination and require that you have IRB approval?
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  • 2.9. Are there any other study-specific requirements of which you have been informed that prohibit an exemption determination?
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  • Based on your answers, your study possess characteristics that disqualify it from exemption. As a result, it must undergo expedited or full IRB review and receive IRB approval.

  • Based on your answers, your study does not possess any characteristics that would automatically disqualify it from being exempt from review. Proceed to the next page to determine whether it meets the inclusion criteria for exemption.

  • Exemption Inclusion Criteria

  • Research protocols that are exempt from IRB review must fall under one of the exemption categories described below.

  • 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.

  • 2.10 From the list above, which exemption best describes your proposed project?
  • 2.10.2a Does your research involve children?
  • 2.10.2b Which of the following best describes your study?
  • 2.10.2c Are investigators participating in the activities being observed?
  • 2.10.3a. Does your research involve children?
  • 2.10.3b. Does your research involve deceiving subjects as to the nature of purposes of your research?
  • 2.10.3c. Do you plan to have subjects authorize the deception through prospective agreement to be unaware of or misled regarding the nature or purposes of the research?
  • 2.10.3d Will the subjects prospectively agree to the intervention and collection of information?
  • 2.10.3e Is the information obtained recorded in such a manner that human subjects can readily be identified, directly or through identifiers linked to the subjects?
  • 2.10.3f. Would any disclosure of the human subjects' responses outside the research reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation?
  • 2.10.4 Do any of the following apply to your study?

  • YOUR PROTOCOL IS EXEMPT. PLEASE CONTINUE WITH YOUR APPLICATION.

  • YOUR PROTOCOL IS NOT EXEMPT. PLEASE CONTINUE WITH YOUR APPLICATION.

  • YOUR PROTOCOL IS EXEMPT, CONTINGENT ON LIMITED IRB REVIEW. PLEASE CONTINUE WITH YOUR APPLICATION.

  • Mercy University's IRB does not typically review these kinds of studies. Please reach out to the IRB for discussion before continuing with your application. If you have already discussed this with the IRB, and the IRB has given informal approval to continue with this study, please continue with your application. 

  • PART 2.4. ELIGIBILITY FOR EXPEDITED REVIEW

  • Not all non-exempt research protocols require full board review. Some may be eligible for expedited review. There are eight categories of non-exempt research that qualify.

    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.

  • 2.11. From the list above, which category, if any, best describes your proposed project?

  • 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.

  • 3.2 Data Security

  • Part 1: Privacy & Data Collection

  • 3.3 Are you collecting data?

  • 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.

  • 3.3a. How will study data be collected?

  • You don't need to fill out this section. Proceed to the next part that concerns data storage and confidentiality.

  • 3.2 Data Security

  • Part 2: Data Storage & Confidentiality

  • 3.4 Will you be collecting identifiable data?
  • 3.4e Will participants' private information be coded (i.e. identifying information has been replaced with a number, pseudonym, etc.)?
  • 3.6 Who will have access to the study data?
  • 3.7. Are there any provisions for data and safety monitoring?
  • 3.7b. Is there a separate Data and Safety Monitoring Plan (DSMP)?
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  • 3.7d. Is there an established Data and Safety Monitoring Board / Committee (DSMB/C) to monitor the progress of the research and the safety of participants. NOTE: The frequency and operations of the DSMB/C should be covered in the DSMP.

  • 3.3 CONSENT

    Part 1: Requesting to Waive Consent

  • For nearly all protocols, the answer to these two questions will be "no". If you are thinking of requesting a waiver or alteration of consent, please reach out to the IRB for discussion ahead of time.

  • 3.8. Are you requesting a waiver or alteration of consent (i.e., such that participants are not asked to go through a full consent process)?
  • 3.8b. Does the research involve using identifiable private information or identifiable biospecimens?
  • 3.8d. Will participants be provided with additional pertinent information after participation?
  • 3.9. Are you requesting a waiver of documentation of consent (i.e., such that participants are not asked to sign a consent document)?
  • 3.9a. Which of the following applies to your research with respect to informed consent?

  • 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

  • 3.11. Will your research involve minors (those under the age of majority) or individuals of diminished capacity as participants?
  • 3.11b. Are you requesting a waiver of assent or waiver of assent documentation?
  • 3.11d. Are you requesting a waiver of permission or waiver of permission documentation?
  • 3.12. Will your research involve deception of participants?

  • 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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  • 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)

  • You must then, in addition to any study-specific informed consent, also secure broad consent from participants. For guidance on broad consent, see here.

     

  • PART 4. APPENDICES

    Please respond to the following questions and complete the required appendices.
  • 1. Does the proposed study include children (or are you amending an already approved study to include children) as participants?
  • 2. Does the proposed study include prisoners (or are you amending an already approved study to include prisoners) as participants?
  • 3. Does the proposed study involve participants who may experience significant emotional distress (e.g., depression) or who may be at risk of harming themselves or others during the research study?
  • 4. Does the proposed study include plans to access, use, or disclose Protected Health Information (PHI)?
  • 5. Does the proposed study involve conducting human subjects research procedures outside the United States of America?

  • 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.

  • 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.

  • 1. Please select the category that best describes your research with respect to the involvement of 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.]

  • 2a. Are any possible advantages accruing to the prisoner through their participation, when compared to the general living conditions, medical care, quality of food, amenities, and opportunity for earnings in the prison, of such a magnitude that their ability to weigh the risks of the research against the value of such advantages in the limited choice environment of the prison is impaired?
  • 2b. Are the risks involved in the research commensurate with risks that would be accepted by non-prisoner volunteers?
  • 2c. Are the procedures for the selection of participants within the prison fair to all prisoners and immune from arbitrary intervention by prison authorities or prisoners?
  • 2d. Are control participants selected randomly from the group of available prisoners who meet the characteristics needed for that particular research project?
  • 2e. Is the information presented in language which is understandable to the subject population?
  • 2f. Does adequate assurance exist that parole boards will not take into account a prisoner's participation in the research in making decisions regarding parole?
  • 2g. Does adequate assurance exist that each prisoner is clearly informed in advance that participation in the research will have no effect on their parole?
  • 2h. Has adequate provision been made for follow-up examination or care of participants after the end of their participation, taking into account the varying lengths of individual prisoners' sentences and informing participants of this fact?

  • 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.
  • This Safety Plan must be included in the protocol if any of the following apply:

  • THANK YOU!

    You do not need to complete this Appendix.

  • ASSESSMENTS CHECKLIST. Please indicate all the tools you will be using as part of your assessment (select Other to add any assessments that are not listed).
  • How will assessments be conducted?
  • How will assessment responses be reviewed?

  • Safety Plan Procedures

  • Please describe the make-up of your research staff who are responsible for assessments.
  • The study measures will be administered by:
  • The study’s licensed medical provider will do one of the following:
  • The research staff conducting the assessment will immediately do one of the following if a participant is at imminent risk of harm:

  • Continued Study Involvement

  • Triggering the Safety Plan may impact a participant’s continued involvement in the study. If the Safety Plan is triggered and the licensed medical provider determines there is no imminent risk of harm, then...

  • Resource Referral List

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

  • Will your study involve research activities outside of the United States of America?
  • Are there laws regarding mental health safety in these locations?
  • Please affirm the following concerning your intended research outside the United States.
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  • The country/countries has no reporting law regarding mental health. Therefore, we will...

  • 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.
  • Part 1: Select the approval method below that is most applicable to your 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  

     

  • PART 2: Request for IRB Waiver or Alteration of HIPAA Authorization. Check below to indicate which IRB action you are requesting:
  • Provide information below about the PHI accessed in the research under the waiver/alteration. Please check all that apply:
  • The research could not practicably be conducted without access to and use of the PHI noted above and the research could NOT practicably be conducted without the waiver or alteration.
  • The use and disclosure of the PHI identified above involves no more that minimal risk to the privacy of individuals based on the presence of all the following (you must check each item to confirm):
  • Please affirm: The use and disclosure of the PHI identified above involves no more that minimal risk to the privacy of individuals.

  • STOP!

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

  • Today's Date:
     - -

  • 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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  • Will research activities take place in a non-public setting (including a school, hospital or clinic) for which local permission is required?
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  • Are you a student who plans to conduct in-person research in a foreign country?

  • 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.
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  • STUDENT IRB PROTOCOL APPLICATION

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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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