Academic Policy 21

Policy:

For activities conducted in association with the Penn State Fayette PTA program involving human participants that do not meet the definition of research, the PTA program will adhere to guidelines as stated in IRB Policy I–Student Class Assignments/Projects located at research.psu.edu/policies/research-protections/irb/irb-policy-1.

To insure informed consent of human participants/subjects, any demonstrator associated with the Penn State Fayette PTA program (including academic or clinical faculty member and students) must explain the nature and purpose of the demonstration or study, the length of time the subject will be used, and the procedures to be used during demonstration. Any persons anticipated to view observe, or listen to either live demonstration or its’ recording, or read published material regarding the study must be made known to the subject. Subjects must inform the demonstrator of any known or perceived contraindications or precautions for a treatment procedure or skill.

For PTA students, serving as a human subject during laboratory activities is essential for learning and evaluation of learning. Therefore, it is expected that PTA students serve as human subjects during Program-related learning activities and participation may be calculated as part of a course grade (see course syllabi). Faculty will work with PTA students to accommodate any participation limitations due to medical or protected (e.g. religious) reasons.

Students and prospective students are informed of this expectation through the Program website and PTA student Handbook.

Procedure:

  1. PTA program orientation will include education on the rights and responsibilities of serving as a human subject.
  2. Non-PTA students will receive education on the rights and responsibilities of serving as a human subject prior to the demonstration and have the right to decline participation.
  3. Subjects will be asked to sign two copies of the Informed Consent Assumption of Risk and Release form.
  4. One copy will be filed in the PTA office.
  5. The subject will keep the second copy.
  6. For each activity/demonstration in which the participant serves as a human subject:
    1. Subjects will first receive education regarding the contra-indications and precautions associated with the procedure.
    2. Subjects must inform the demonstrator of any known or perceived contraindications or precautions for a treatment procedure or skill.
    3. The demonstrator will explain the purpose of the demonstration or study the length of time the subject will be used, and the procedures to be used during demonstration.
    4. The demonstrator will provide the subject with an opportunity to ask questions.
  7. Subjects are asked to sign the Human Participant/Subject Consent Assumption of Risk and Release form. PTA students should notify the instructor of any perceived participation limitations due to medical or protected reasons.
    1. The PTA student and instructor will meet privately to discuss the student’s participation limitations and determine and document a participation plan. The Program Coordinator and/or Disability Services Liaison may participate in the meeting and determination of the plan, as appropriate.