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Guidelines for Class Projects Involving Human Subjects

These guidelines are intended to assist instructors in determining when class projects meet the definition of research with human subjects and require review by the University of Maine’s Institutional Review Board for the Protection of Human Subjects (i.e., IRB).

For questions or additional guidance, contact the IRB Office at 1-1498.

For clarification, the following are NOT class projects; if they involve human subjects, they are considered research and must be reviewed and approved by the IRB:

  • Senior research projects conducted within the framework of the senior capstone experience
  • Honor’s theses
  • Master’s theses
  • Doctoral dissertations

Terms

  • Research is defined as:  “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”  [45 CFR 46.102(d)]
  • Generalizable knowledge is information which has the potential to be expanded from the isolated circumstances in which it is acquired to any broader context.
  • Dissemination of findings to a scientific, professional, or public  audience is a sufficient, but not a necessary, criterion for defining research.  Dissemination includes, but is not limited to, presentation at scientific meetings, submission for publication in a scientific journal, and Internet postings.  Dissemination of the findings also includes presentations at university, state, national, or international settings.
  • Human Subject is defined as:  “a living individual(s) about whom an investigator (whether professional or student) conducting research obtains:  1.  Data through intervention or interaction with the individual; or 2. Identifiable private information.”  [45 CFR 46.102(f)]

Review Procedures

  • Class projects that involve systematic collection of data and for which the design or objective is to develop or contribute to generalizable knowledge are considered research.  In other words, if the student (or instructor) plans to use the data outside of the class, the project is considered research and requires IRB review.
  • Class projects that are designed solely with the objective of providing students with training about and experience with research methods are not considered research.  In cases in which data will not be used outside of the classroom context and data will be destroyed upon completion of the project, these projects are not considered research and do not require IRB review.  HOWEVER, if the instructor allows a student to design a class project that involves protected populations or sensitive information (as defined at the end of this document), IRB review and approval are required.

 Training Requirements

 Instructors assigning class projects are required to complete the IRB training tutorial.

  • Instructors should require students to complete the IRB training tutorial as part of the learning experience, even in cases when the student’s project does not have to obtain IRB approval.

Instructors’ Responsibilities

  • Instructors should meet with students as soon as possible and go over these guidelines to determine if the proposed class project could be considered research.
  • If there is even a remote possibility that a class project may fall under the definition of research, instructors are advised to submit a human subjects review application with the student to the IRB. Remember, class projects that involve protected populations or sensitive information (as defined at the end of this document) require IRB review and approval.

If the class project meets the definition of research:

The instructor should meet with the student to prepare the human subjects review application.

  • If the project goes before the Full Board at its monthly meeting, the instructor must attend the IRB meeting with the student.

If the class project does not meet the definition of research:

  • It is the responsibility of the instructor to ensure that the student project does not meet the definition of research.
  • It is the responsibility of the instructor to ensure that the class project is conducted according to the ethical standards of the relevant discipline.
  • Remember that from the participant’s viewpoint, giving out personal information does not differ for a class assignment or a research project.  Personal information is personal information.  Instructors should advise students to identify the project to participants as a class assignment and be sensitive to the personal nature of the obtained information.  Labeling the class project as “research” is inaccurate and misleading to participants.
  • Students should inform participants that data will be destroyed after their assignment or class project is completed.
  • Instructors are advised to tell students that data from human subjects should not contain any personal, identifying information whenever possible.
  • All class projects must include informed consent language that closely follows the guidelines.  Information on what to include in a  consent form/script is described below.  For an on-line survey, this would be the first page of the survey or in the email post.
  • The IRB is available to give feedback on any proposed class project not meeting the definition of research, even though the IRB would not officially act on the project.

website Link to Human Subjects Information

Information on research with human subjects is found at:  http://www.umaine.edu/research/research-compliance/institutional-review-board-for-the-protection-of-human-subjects-irb/.  This includes the Policy, application form, the tutorial, and other useful information.

Any class project that meets the definition of research or involves protected populations or sensitive information must be reviewed and approved by the IRB (contact person:  Gayle Jones, 581-1498; First Class).  Approval cannot be granted retroactively under anycircumstances for any research project.

We would like to acknowledge the use of IRB guidelines on class-related projects from both Pennsylvania State University and Duke University.


Information to Include in Email Postings or Verbal Scripts for Informed Consent

When information is collected for a class project that does not meet the definition of research (as defined by the federal regulations) and does not require approval by the IRB, it is still important to “inform” the participants about the class project, whether posted as an email message or presented verbally in person.  Make sure the participant is told:

  • The identity of the student (introduce yourself!).  (This may not always be necessary, as many students enlist the help of friends or family to collect data for a class project.)
  • They must be at least 18 years of age to participate.
  • It is a class project.  (Give a little information, e.g., This is for my business class, I am trying to see if there is a relationship between X and Y.)
  • What they will be asked to do (“I would like to ask you some questions about why you chose to attend the University of Maine.  If there are any questions you don’t want to answer, it is fine to skip them.”).
  • How long the interview, survey, etc., may take to complete.
  • What will happen to the information collected (“The information will be used to write my paper for the class, and I will give a presentation in class.  All of my notes, surveys, etc., will be destroyed when the project is completed.”)
  • If they will be identified:  examples:  “I will not write your name on my notes”; “Do not write your name on the survey;” “I will not use your name in my paper.”
  • The student’s and instructor’s contact information if they have any questions (provide phone number/email).

Protected Populations/Sensitive Information

*Protected Populations – Examples include, but are not limited to:

  • Children/Minors (under the age of 18) (Exception – projects conducted in established or commonly accepted educational settings involving normal educational practices.  Contact IRB office for guidance.)
  • Prisoners (now includes non-publicly available secondary data)
  • Pregnant women
  • Fetuses and products of labor and delivery
  • People with diminished capacity to give consent
  • Mentally or physically challenged individuals

*Sensitive Information – Examples include, but are not limited to:

  • Information relating to an individual’s psychological well being or mental health
  • Information relating to sexual attitudes, preferences, or practices
  • Information relating to the use of alcohol or drugs
  • Information relating to illegal behavior
  • Information that if released could reasonably place the individual at risk of criminal or civil liability or be damaging to the individual’s financial standing, employability, or reputation
  • Information that would normally be recorded in a patient’s medical record and the disclosure could reasonably lead to discrimination, stigmatization, etc.

*Instructors/students who are unsure of whether a proposed project involves a protected population or sensitive information should contact the IRB Office at 1-1498.

Please see flow chart for assistance with the decision-making process (Word Document)


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