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Protocol Application

Request for Research Involving Human Participants

Institutional Review Board

Part 1: Administrative Information

  1. Title of protocol
    Contact information
    Principal Investigator (PI)
    Name
    Email address College/Division
    Department/Unit
    Status     o Undergraduate Student o Graduate Student   o Faculty   o Staff

1.1 Co-PIs and members of the research team:

Name Email Address College and Department Name of Organization State and Country
  1. Funding information
    Indicate if your project is funded by an external sponsor, including a gift or a sponsored award.

    • Federal Funding Agency
    • Federal Flow   through funds
    • Student projects funded fully or in part by Federal funds received by a Faculty Advisor
    • Non Federal sponsor that requires compliance with Federal IRS regulations
    • Other Funding source
    • My research is not funded by any outside funding agency (this option should be available only if none of the above are selected)
      Name of the external funding agency:

Part 2: Study Design, Methods and Procedures

  1. Type of project/study: Please select ALL of the categories of work that apply to this proposed project
  • Active collection of data (not human biological materials or physiological data)
  • Active collection and use of human biological materials or physiological data
  • Use of physiologic or biomedical devices, or drugs, biologic, or chemical agents
  • Use of existing data (not human biological materials)
  • Use of existing human biological materials
  1. Please provide a summary of the study, including the purpose, research questions and hypothesis to be evaluated.

 

  1. Please describe briefly how this study will contribute to existing knowledge in the field.

 

Part 3: Participants, Recruitment and Compensation

  1. Please provide the estimated number of participants you plan to recruit.

 

 

  1. Please provide the age range of the participants

 

  1. Please select all the categories of participants that will be included in your study.
  • Healthy adult volunteers
  • Children under 18
  • Employees of the investigating group
  • CMSV students
  • CMSV employees
  • Cognitively impaired persons
  • Pregnant or nursing women
  • Prisoners or individuals under detention or on probation
  • People in foreign countries
  • People unable to read, speak or understand English
  • People with limited literacy
  • People with specific health conditions
  • Other (Please describe below)
  • None of the above
  1. Please select all of the tools that you plan to use to recruit your participants.
  • Flyers
  • Notices
  • Mailers (S. Post)
  • Online Advertisements
  • Email
  • Use of Internet social media or online networking sites
  • TV, radio, print advertisements
  • Web-based participant pool management software)
  • Face to face public intercept
  • Presentations at meetings
  • Other (Please describe below)
  1. Please describe each recruitment method to be used.

 

  1. Describe the inclusion or exclusion criteria for participants as applicable in this study.

 

  1. Will participants be compensated for their participation? o Yes   o No

 

  1. Please describe the tasks that the participants will be asked to perform for each phase of the study.

 

  1. Please provide an estimate of the time commitment from each participant for each phase of the study.

 

  1. Projected overall time for study completion

Part 4: Risks and Benefits

  1. From the list below, please select ALL of the potential risks that are involved in your study.
  • Use of deceptive techniques
  • Use of private records (such as educational or medical records)
  • Manipulation of psychological or social state such as sensory deprivation, social isolation, psychological stress
  • Probing for personal or sensitive information in surveys or interviews (e.g.: private behaviors, employer assessments)
  • Presentation of materials which some participants may consider sensitive, offensive, threatening or degrading
  • Possible invasion of privacy of subject or subject’s family
  • Social or economic risk (reputational, cultural, employability, etc.)
  • Identification of child, spousal, or elder abuse
  • Identification of illegal activity
  • Risk of injury or bodily harm
  • Other risks (please specify)
  • There are no risks of any kind to any participants enrolled in this study. This option is valid only if none of the risks above are selected.

 

  1. Describe the nature and degree of the risks or harms selected All of the risks/harms must be disclosed in the consent form.

 

  1. Describe the steps that will be taken to minimize risks or harms and to protect the welfare of Include a description of how you will handle an adverse or unexpected outcome that could be potentially harmful (e.g., suicidal ideation). If the study will include protected populations, identify each group and provide an explanatory paragraph for each group.

 

  1. Describe any benefits that individuals may reasonably expect from participation
    If there are none, state “None.”

 

  1. Describe the anticipated benefits of this study to society, academic knowledge or

Part 5: Privacy and Confidentiality

  1. Will you or any member of your research team collect or have access to any of the personal identifiers listed below? Select all that apply.
    • Name
      Date of birth
    • Mailing or email address
    • Phone or fax numbers
    • Social Security number
    • Medical records
    • License, certificate or Vehicle ID
    • IP address
    • Biometric identifiers
    • Photos/images/audio recording
    • Signatures, handwriting samples
    • Any unique identifier not mentioned above
    • No member of the research team will have access to any personal identifiers. This option is valid only if none of the other options in this question are selected.

Part 6: Consent Process

  1. Informed Consent:
    • 1.1 Will you use a written informed consent document?
      • Yes
      • No, I am seeking a waiver of written informed consent
      • Not applicable
  2. Written assent for individuals under 18:
    • 2.1 Will you obtain written assent for children and individuals under 18?
      • Yes
      • No, I am requesting a waiver of written assent
      • Not applicable
  3. Written parental permission:
    • 3.1 Will you obtain written parental or guardian permission for children and individuals under 18?
      • Yes
      • No, I am  requesting a waiver of written parental or guardian permission
      • Applicable

Reminder Checklist

You have now completed this form. Please review it to ensure that it is filled out completely and accurately. Please save this form and proceed to the signature page form. If you have any questions or need assistance, please contact the IRB staff. 

The following documents need to be submitted to the IRB chair, along with the IRB application:

  1. IRB application
  2. IRB consent form
  3. Debriefing form
  4. Data collection tools
  5. Demographic form
  6. PHRP or CITI certificates

Contact
irb@umsv.edu

Signature

This page is to be signed by the principal investigator. If the principal investigator is an undergraduate or graduate student, the faculty super visor must also sign in the lower box.

Principal Investigator
I certify that the information I provide in this application is correct and complete. I also pledge that I will not change any of the procedures, forms, or protocols used in this study without first seeking review and approval from  the Institutional Review  Board for  Human  Participants.

 

o Attestation of Principal Investigator

_______________________________________                              _____________________

Name / Signature of Principal Investigator                                            Date

 

_____________________________________                                   ____________________

Faculty Supervisor                                                                                      Date