Course Assignments/Projects involving human subjects (subjects not registered for the course) are generally conducted for educational purposes or training solely to fulfill a course requirement; as such, an element of the definition of research – intent to contribute to generalizable knowledge – is missing. Therefore, many student course assignments/projects can be excluded from the requirement to submit an IRB application for review and would only need a course assignment/project form; however, there are specific parameters listed below that must be reviewed and followed to confirm exclusion from review.

If a Course Assignment/Project is a systematic investigation (research development, testing, surveying, interviewing, and evaluation) OR contributes to generalizable knowledge, it meets the definition of research and will require IRB review and approval.

Parameters for Determining a Course Assignment/Project

  1. NO MINORS or VULNERABLE POPULATIONS – the assignment/project cannot include minors or any other vulnerable populations (e.g., pregnant women, prisoners, those who lack the capacity to consent, non-English speaking individuals, etc.).
  2. NO MORE THAN MINIMAL RISK – is the probability and magnitude of harm that is normally encountered in the daily lives of healthy individuals. Data collection must be anonymously provided and never identifiable either directly or indirectly.
  3. NO DECEPTION – class project cannot include any deception. Individuals must be fully informed and provided with an opportunity to voluntarily consent to participate by giving their verbal agreement/consent.
  4. NO PUBLICATION/PRESENTATION – data from class projects approved under this exclusion cannot be shared outside the classroom, used to present at a conference, and/or for publication in a thesis/dissertation, journal, etc.
    1. Federal regulations do not permit the IRB to provide retroactive approval. Please make certain PRIOR to conducting data collection that you and your students are aware and this is applicable.
    2. Dissemination of findings to an audience is a sufficient criterion for defining a project as “research” and thus requires an IRB application and approval. Dissemination includes, but is not limited to, presentation at meetings or conferences; blogs or internet postings; submission to or publication of a paper in a journal.
  5. AUDIO OR VIDEO RECORDING cannot be shared outside of the classroom to meet the Course Assignment/Project guidelines. If audio or video recordings will be used outside the classroom the Expedited Course Assignment/Project form is required. If your Course Assignment/Project does not fall within the above parameters, please contact us at irb@valdosta.edu.

 

Faculty Responsibilities When Conducting Course Assignments/Projects

 

It is the responsibility of the faculty or course instructor to contact the IRB when in doubt as to whether the assignment/project requires a course assignment/project form.

As with any instructional activity, the faculty or course instructor assumes responsibility for the conduct and oversight of the class projects or activities. It is expected that these activities will uphold the principles of ethical treatment and respect, and ensure the safety and protection, of the student researcher and any human subjects involved in these projects. This includes:

  1. Faculty/Instructor must maintain current certification on the IRB Basic Modules in CitiProgram to confirm their full understanding of ethical treatment for human subjects/participants.
  2. Congruent with discipline or area specifications, discuss with the class the general principles of ethical treatment of human subjects/participants prior to the initiation of the assignment/project. This should be supplemented by the completion of the CitiProgram “Students in Research” or “IRB Basic” course by all the students who will conduct the course assignments/projects.
  3. Reviewing student Course Assignment/Project plans and monitoring activities to ensure that human subjects/participants are protected.
  4. Faculty/Instructor should make clear the difference between the student's task and the IRB definition of research for the purpose of instructing the student not to use IRB references/materials or to lead the participant to believe the project is research that would be generalizable or publishable.
  5. Faculty/Instructor must instruct the students conducting the assignment/project to inform the human subjects/participants of the voluntary nature of participation and employ measures to confirm no personally identifiable information is collected.
  6. Faculty/Instructor discusses with students before the Course Assignment/Project begins the above parameters so that an informed decision can be made as to whether or not IRB approval is necessary.
  7. Any concern or complaint by a human subject/participant of the Course Assignment/Project must be reported immediately in writing to the IRB at irb@valdosta.edu and a solution addressed.

 

Student Responsibilities When Conducting Course Assignments/Projects

 

All students conducting assignments/projects under this exclusion should disclose important information to the human subjects/participants.

 

  1. Students must complete the CitiProgram “Students in Research” or “IRB Basic” course (no cost).
  2. Participant identifying information may not be included in data collection. Students are required to destroy all data collected from human subjects/participants upon receipt of a final grade at the end of the course.
  3. When students communicate with human subjects the assignment/project must be referred to as a class assignment/project and not as research, nor having received IRB review/approval.
  4. In order to ensure that all required information has been provided to potential human subjects/participants the following Participant Statement for Course Assignment/Project template should be used. The participant statement must be read and/or a copy provided to each participant.

 

You are being asked to participate in a course assignment/project interview or survey entitled “<Title of Project>”, which is being conducted by <name of student conducting interview or survey>, enrolled in <course name & instructor name> at 国产AV. The purpose of the course assignment/project is to <in layman’s terms, clearly state what the assignment/project is about>. Your responses may help us learn more about <explain this in layman’s terms>. Participation should take approximately <minutes and/or hours> to complete. There are no known risks involved in participating in this assignment/project. No one, including the student, will be able to associate your responses with your identity. All collected data will be destroyed upon completion of the course. Your participation is voluntary. You may choose not to participate, to stop responding at any time, or to skip questions that you do not want to answer. You must be at least 18 years of age to participate. Your participation serves as your voluntary agreement to participate in this project and your certification that you are 18 or older. Questions regarding the purpose or procedures of this course assignment should be directed to <course instructor name at e-mail address>.

 

Future Use of Data

 

It is important that careful consideration be given to the possibility of any presentation, publication, or use of any collected data for future research studies. Federal guidelines state that retroactive approval cannot be granted for studies conducted without IRB approval. Both faculty/instructor and student need to be aware of the prohibition against use of existing data (participants and/or students) not collected under proper consent.

Please contact the IRB at irb@valdosta.edu if you have additional questions.