Expedited Course Assignment/Project Form

Human Subject Participation - to be completed by instructor

Course Instructor

  • Course Information

  • Meet the VSU IRB definition of research (cited below)
    Involve a condition for IRB oversight (cited below)
    Neither of the above
  • Valdosta State University IRB Definition of ResearchValdosta State University defines research as a systematic investigation, including research development, testing, and evaluation designed to develop or contribute to generalizable knowledge. (45 CFR §46.102)

    Conditions for IRB Oversight: The following conditions may not meet the definition of “research” as provided above, but may require IRB review/oversight:

        • Intent to produce results that will be submitted for peer-reviewed publication or presentation
        • Include minors (e.g. those under the age of 18)
        • Target potentially vulnerable individuals
        • May place pregnant women and/or fetuses at risk of physical harm
        • Deal with a topic of sensitive nature in a way which anonymity cannot be sustained
        • Involve any activity that places the participants at more than minimal risk
  • YES
    NO
  • YES
    NO
  • YES
    NO
  • “Intervention” includes both physical procedures by which data are gathered (e.g. measurement of heart rate of venipuncture)

    “Interaction” includes communication or interpersonal contact between the investigator and participant (e.g. surveying or interviewing)

  • YES
    NO
  • Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or video recording is taking place.

    Identifiable means that the identity of the participant maybe ascertained by the investigator.

    EDUCATIONAL REQUIREMENTS: In accordance with federal regulations, the VSU IRB requires all researchers, co-investigators, and faculty advising student researchers to complete the CITI IRB Basic course modules.   

    Please visit: https://about.citiprogram.org/en/homepage/ to complete all of the following mandatory trainings:

      1. Introduction
      2. History and Ethical Principles
      3. Defining Research with Human Subjects
      4. The Regulations and the Social and Behavioral sciences
      5. Basic Institutional Review Board (IRB) Regulations and Review Process
      6. Assessing Risk in Social and Behavioral Sciences
      7. Informed Consent
      8. Privacy and Confidentiality
      9. Valdosta State University Module
  • Minors (under the age of 18)
    Public school Children
    Pregnant Women
    Prisoners
    Potentially vulnerable individuals whose ability to consent may be limited
    Individuals in foreign countries
    Individuals from different cultures and/or from a particular racial/ethnic group
    Individuals about whom data will be collected from existing records
    Individuals from or about whom Private Health Information (PHI) subject to HIPAA compliance will be collected
    Individuals from whom information will be collected via Internet
    Co-workers/Employees
  • YES
    N/A - please explain

  • File attachment size limit is 2 MB.
  • YES
    NO
  • YES
    NO

  • File attachment size limit is 2 MB.
  • Please check all categories that apply:
  • Clinical studies of drugs and medical devices only when:
  • (a) the research is on drugs for which an investigational new drug application (21 CFR 312) is not required or

    (b) the research is on medical devices for which

    (i)  an investigational device exemption application (21 CFR 812) 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.

  • Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture from:
  • (a) healthy, non-pregnant adults who weigh at least 110 pounds for whom

    (i) the amounts drawn do not exceed 550 ml in an 8 week period and

    (ii) collection does not occur more frequently than 2 times per week or

    (b) other adults and children, for whom, considering the age, weight, and health of the participants, and the collection procedures,

    (i) the amount of blood to be collected does not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and

    (ii) collection does not occur more frequently than 2 times per week.

    (NOTE: Children are defined as "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.")

  • Prospective collection of biological specimens for research purposes by noninvasive means, including:
  • (a) hair and nail clippings, in a non-disfiguring manner;

    (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction;

    (c) permanent teeth if routine patient care indicates a need for extraction;

    (d) excreta and external secretions (including sweat);

    (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue;

    (f) placenta removed at delivery;

    (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor;

    (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques;

    (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; and

    (j) sputum collected after saline mist nebulization.
  • Collection of data through non-invasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Such procedures 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 participant or an invasion of the participant'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; and

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

    (NOTE: Where medical devices are employed, they must be cleared/approved for marketing.)

  • Research involving materials that have been collected, or will be collected, solely for non-research purposes
  • Materiela such as data, documents, records, or specimens for purposes such as medical treatment or diagnosis. 
  • Collection of data from voice, video, digital, or image recordings made for the evaluation of teaching methods.
  • 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.

  • Describe (a) the participant population and any special characteristics of participants, (b) methods for selecting participants, and (c) procedures for assuring that their participation is voluntary. If utilizing data about human participants, describe the strategies you will employ to access data about the participants.
  • Describe how you will implement the informed consent process. If English is not the participants’ first language, describe how you will communicate with the participants and how you will provide an understandable written consent document. If appropriate, a Child Assent Form written at an age-appropriate level should also be developed.

  • In lay terms, describe the specific procedures that relate to the participants’ participation. What will the participants do and/or what will be done to them? Provide enough detail so that a lay reader will understand exactly what is going to occur in the study.

  • Explain if the participants will be identified and/or if their participation in the project might place them at risk for criminal or civil liability; or be damaging to their financial standing, employability, insurability, or reputation; or be stigmatizing. Describe the protections that will be implemented to reduce risks related to invasion of privacy and/or breach of confidentiality, including data collection, manipulation, and reporting methods and plans for long-term protection, including any methods to render the data anonymous/unidentifiable and/or disposal or destruction of participants’ data or records. (Note: Consent forms must be destroyed upon course completion.) 
  • Describe potential risks to project participants, including potential physical, psychological, social, and/or economic harms.

  • File attachment size limit is 2 MB.

  • File attachment size limit is 2 MB.
  • By signing this form I am aware of the following:

    Students are not permitted to continue course projects after the semester has ended without IRB approval

    This project is educational in nature. Project data will not be published or presented outside the course, or used in future research. Identifiable data generated from course projects will be destroyed upon completion of the course. 

    Students have been instructed to complete the CitiProgram Students in Research course (or IRB Basic modules).

    It is the responsibility of the course instructor to review student projects that include human participants (human participants does NOT include minors), prior to permitting students to begin the recruitment and/or data collection phase. It is expected that assigned student projects will uphold the principles of ethical treatment, respect, and safety of all individuals involved in the projects.

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