麻豆果冻传媒

Student Activities Involving Human Subjects

The IRB has identified three categories of student activities involving human subjects:

1. Student Research
   a.  鈥淪tudent research鈥� is defined as an activity undertaken by undergraduate or graduate students which meets the DHHS definition of research: 鈥渁 systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.鈥� 鈥淪tudent research鈥� can take place in a class or as a faculty-directed independent study.
   b.  鈥淪tudent research鈥� meets the DHHS criteria for research; therefore, it is subject to IRB review at the appropriate level.
2. The Classroom Project
   a.  The 鈥渃lassroom project鈥� is a class project of significant length and scope that is included in the course syllabus. The 鈥渃lassroom project鈥� may involve systematic data collection and analysis and may be referred to as 鈥渞esearch,鈥� but does not meet the DHHS definition of 鈥渞esearch,鈥� as it is not intended to contribute to generalizable knowledge. (See I.A.1).
   b.  The purpose of the 鈥渃lassroom project鈥� is to function as a learning tool designed to facilitate the student鈥檚 mastery of research theory and practice. The purpose is NOT to 鈥渄evelop or contribute to generalizable knowledge,鈥� which places it outside of the definition of "research." Results of the 鈥渃lassroom project鈥� may not be presented outside of the department in which the activity takes place, including publication, inclusion in theses, dissertations, or presentations in public fora.
3. The Student Assignment
   a.  The "student assignment" is a required out-of-class activity involving interviews or surveys and is one component of many in a given course. The assignment is completed and submitted for a grade in the course. It is not typically a systematic investigation, and it is not designed to contribute to generalizable knowledge.
   b.  Results of the 鈥渟tudent assignment鈥� may not be presented outside of the department in which the activity takes place, including publication, inclusion in theses, dissertations, or presentations in public fora.

SUGGESTED GUIDELINES FOR STUDENT ACTIVITIES WITH HUMAN SUBJECTS

1. 鈥淪tudent Assignments鈥� and 鈥淐lassroom Projects,鈥� are activities involving human subjects that do not meet the OHRP and IRB definitions of "research." These activities, therefore, are not subject to IRB review. Such activities are identified and monitored by the Department Review Committee in the department in which the activities take place.
2. It is recommended that all faculty members and students who participate in the conduct of Student Assignments and Classroom Projects, as defined by the IRB, be familiar with the IRB definitions of these activities, and with the definition of 鈥渞esearch鈥� adopted by the OHRP and the 麻豆果冻传媒 IRB.
3. It is recommended that all faculty members and students who participate in the conduct of Student Assignments and Classroom Activities complete CITI training for activities with human subjects, at the level suggested by the IRB. (See website training page.)
4. A Determination Form for Human Subjects Activities  (DFHSA) is offered for use or adaptation at the departmental level to identify a project as belonging to the category of Student Assignment or Classroom Project. Neither the use nor the submission of this form is required by the IRB. This form may, however, be adapted for use within the department, at its discretion, and procedures for the use of the form determined by the department chair or departmental review committee.
5. Please note that any proposed student activity involving human subjects which does not meet all of the requirements and qualifications for Student Assignment or Classroom Project is considered to be 鈥渞esearch,鈥� under the OHRP definition, and 鈥淪tudent Research,鈥� as defined by the IRB. The proposal for such a project must be submitted to the IRB for approval at the appropriate level of review, prior to commencement of contact with human subjects.
6. The class instructor or project supervisor should report to Research & Economic Development any suspected adverse events or effects involving human subjects that take place during, or as a result of, the conduct of the project or assignment.
7. Unless unavoidable, we discourage the use of human subjects that are under the age of 18 or are members of 鈥渧ulnerable populations,鈥� such as pregnant women, people with mental or physical disabilities, or prisoners. Moreover, we discourage any activities that present more than minimal risk for the participants, involve participation in illegal activities, involve the collection of sensitive private information, or involve the use of deception.
8. If the class instructor or supervisor feels that the use of human subjects under the age of 18 or from a 鈥渧ulnerable鈥� population or that activities involving elevated risk for the participants, illegal behavior, collection of sensitive information, or deception are necessary to fulfill the learning objective for the classroom project or student assignment, we strongly encourage them to consult with their department chairperson and other faculty within the department or college to establish internal guidelines for overseeing the activities and ensuring the safety of the human subjects and that they are treated ethically and professionally.
9. The course instructor or supervisor is solely responsible for all aspects of classroom projects and student activities. Anyone conducting any type of non-research activities should work closely with their departmental chairpersons and departmental faculty to maintain the highest professional and ethical standards."