EIU Office of Research and Sponsored Programs

Course Certification and Course Project Research

Students may be required in particular courses to conduct projects involving human subjects. The purpose of such projects is not intended to contribute to advances in generalizable knowledge, nor are the results of such activities to be published, presented, or archived. Rather, the function of these class projects is to contribute to the students’ individual knowledge and training in a particular academic discipline.

Even though IRB review may not be required for most class projects, they are subject to faculty oversight. Course projects can be certified by the IRB either through course certification or course project research review. 

Course Certification

• are not intended to contribute to generalizable knowledge, 
• are not intended to place the subjects at more than minimal risk,
• are not intended for publication, and
• do not involve subjects who are members of a vulnerable population. 
  Vulnerable populations include, but are not limited to: children, prisoners, pregnant persons, mentally disabled persons, economically or educationally disadvantaged persons, individuals who are unable to give informed consent due to a physical or mental condition, or individuals whose circumstances may make them vulnerable to coercion (e.g., probationers).

This course approval mechanism ensures that human subjects in class projects are nevertheless protected in activities that are not under direct oversight by the IRB. 

• This form should be submitted every semester by the instructor for each course in which instruction-related research is performed.
• If more than one instructor teaches a section of the same course, each instructor should submit the Course Certification Request Form.

1. CITI Training
   Students will complete the Social/Behavioral Research course at https://about.citiprogram.org/. ORSP will verify that all students enrolled in the course have completed training - CITI completion certificates do not need to be submitted with the Course Certification Request Form.
2. Utilizing the "Protecting Human Subject in Research" document
   The course syllabus must explicitly mention the training as part of course requirements, and questions about the material should be included on at least one quiz or exam. The instructor must submit a copy of the course syllabus with the Course Certification Request Form.
   
3. A method of the instructor's choice, provided the essentials of proper protection of human subjects are conveyed.
   The course syllabus should explicitly mention the training as part of course requirements, and questions about the material should be included on at least one quiz or exam. The instructor must submit a copy of the course syllabus with the Course Certification Request Form.
   

Instructors incorporating human subject research projects in their instruction must also be trained in accordance with EIU policy. In addition, instructors should provide training to students in the ethics of conducting research with human subjects in accordance with this same section. This will ensure that students conducting class projects involving human subjects understand, and can apply, ethical principles in human research. 

The submission of this form will certify to the IRB that the instructor is fully cognizant of the policies of EIU regarding the utilization of human subjects in research. Furthermore, the instructor will hereby certify to the IRB that she/he will exercise reasonable and customary instructional supervision in an attempt to ensure that all class research projects will be conducted in compliance with these policies.  Students should conduct only the activities approved by the instructor.

Upon receipt of the Course Certification Request Form, the Office of Research and Sponsored Programs (ORSP) will training requirements have been met. Once training is verified, ORSP will send a letter of certification to the instructor. 

An instructor should not allow student research projects to begin until course certification approval has been received from the Office of Research and Sponsored Programs. 

Instructional-related research projects must communicate applicable elements of informed consent (e.g., institutional affiliation of researcher, risk, benefit, voluntary participation, permission to withdraw, etc.) and include appropriate anonymity and confidentiality protections.

Students must report to their instructor any problems that may arise regarding human subjects as a result of project activities and should cease project activities until it is determined whether or not the project may continue. The instructor must investigate reported problems, and if any harm to a subject has or may occur, the should inform the IRB immediately. 

Course Project Research Review

• The project meets the criteria for course certification but involves subjects that are members of a vulnerable population
  Vulnerable populations include, but are not limited to: children, prisoners, pregnant persons, mentally disabled persons, economically or educationally disadvantaged persons, individuals who are unable to give informed consent due to a physical or mental condition, or individuals whose circumstances may make them vulnerable to coercion (e.g., probationers).
  
• The likelihood exists (even minimal) that the assignment or project may fall under the definition of research as outlined in EIU Policy

• Research projects that meet the criteria for course project research review should not be submitted on the Application for IRB Review.

If, upon review it is determined that the project meets the criteria for research (and IRB review), the student researcher will be instructed to submit the an addendum application to provide additional information required for review.

Please note that IRB approval of a research protocol cannot be granted retroactively under any circumstances, and that research cannot begin until a letter of certification is received from the Office of Research and Sponsored Programs. 

Instructional-related research projects must communicate applicable elements of informed consent (e.g., institutional affiliation of researcher, risk, benefit, voluntary participation, permission to withdraw, etc.) and include appropriate anonymity and confidentiality protections.

Students must report to their instructor any problems that may arise regarding human subjects as a result of project activities and should cease project activities until it is determined whether or not the project may continue. The instructor must investigate reported problems, and if any harm to a subject has or may occur, the should inform the IRB immediately. 

Exceptions

• The study asks identifiable subjects about illegal activities (e.g., underage drinking), which may place the data at risk of subpoena.
• The study places identifiable subjects at risk of a breach of confidentiality that may lead to criminal or civil liability, or damage the subject’s financial standing, employability, or reputation [45 CFR 46.109(b)(3)].
• The study places subjects at more than minimal risk due to psychologically sensitive subject matter (e.g., interviews covering traumatic events).
• Subjects are members of a vulnerable population (see IRB Policy A.2.1, Definitions).
  • Vulnerable populations include - but are not limited to: children, prisoners, pregnant persons, mentally disabled persons, economically or educationally disadvantaged persons, individuals who are unable to give informed consent due to a physical or mental condition, or individuals whose circumstances may make them vulnerable to coercion (e.g., probationers).

Research projects that meet this criteria must be reviewed by the IRB. The research protocol would be submitted using the Application for IRB Review.

Instructors are advised to discuss protection of human subjects with students before the instructional assignment or project begins so that informed decisions can be made about whether IRB review is needed. Please note that IRB approval of a research protocol cannot be granted retroactively under any circumstances.