Office of Research and Sponsored Programs:<br /> Guidelines for Student Research Activities

Guidelines for Student Research Activities

Class assignments or exercises involving human participants may or may not require Institutional Review Board (IRB) or Exempt Review Committee (ERC) review depending on whether they meet the Federal definition of “research,” which is defined as “a systematic investigation designed to develop or contribute to generalizable knowledge,” Code of Federal Regulations: 45 CFR 46 .

Independent Studies, Theses, Dissertations, and Honors Projects

According to the federal definition, all students completing theses (undergraduate honors or graduate), independent studies, or doctoral dissertations must apply through the IRB or ERC.  Such research requires a Marywood University faculty sponsor.

Classroom Assignments, Educational Inquiry, and Practice

Research activities that are designed as part of a course requirement and involve human participants may not require IRB or ERC review and approval.  Eligible assignments or learning exercises are those that do not involve a systematic investigation designed to contribute to generalizable knowledge.  Such activities may engage students in interaction with individuals in order to teach research methods or to help students comprehend topics covered by the course.  In most instances, such activities are not intended to create new knowledge or to lead to scholarly publication or presentation.

Classroom activities may not require IRB or ERC review if all of the following conditions are true:

• The activity is a class assignment designed for learning purposes only and is not designed to develop or contribute to generalizable knowledge.  However, individuals who wish to gather data from human participants for classroom assignments, educational inquiry or practice AND intend to use the data as research data for the purpose of publishing or sharing with a research community or the public at large (e.g., research or professional forum), MUST OBTAIN IRB OR ERC APPROVAL PRIOR TO CONDUCTING THE ACTIVITY.

• Results of the research are viewed only by the course instructor for teaching purposes and discussed within the classroom for teaching and learning purposes.  In the case that data is gathered at an internship or practicum, it is acceptable to share the data with the collaborating agency.

• Results of the research are not made public through presentation (outside of the classroom) and are not published in paper or electronic format.

• Risk to participants is minimal or no greater risk than would ordinarily be encountered in daily life.

• Participants are not a vulnerable population (under 18 years of age, prisoners or court-ordered individuals, etc.).

• Participants or data collected is not identifiable.

• When an investigator obtains data through an intervention or interaction (survey, interview, observation, etc.) with living individuals, a participant letter must be provided to fully inform the individuals about the nature and expectations of their participation in the research activity.

Responsibility of the Course Instructor

The course instructor is responsible for informing students of the ethical considerations of human subject research.  Procedures for course assignments should include proper instruction regarding: informed consent, appropriate recruitment of subjects, minimizing risk to subjects, and protecting confidentiality.  Completion of the online training courses (CITI) is not required for student projects that do not require IRB/ERC review.  As an alternative, the IRB and ERC administrators are available to speak to classes about human subject’s protections and/or ethical research practices.

It is important to note that IRB approval cannot be provided retroactively.  If a classroom assignment produces interesting results, the data MAY NOT be used nor may the results be disseminated if IRB/ERC approval was not obtained prior to the implementation of the study.  If a student believes that data collected may be useful for research purposes, then IRB or ERC approval must be sought at the outset, before any research activity has begun.

In making a determination of whether or not a class research project requires IRB/ERC review, the instructor is encouraged to contact the  Director of Research Compliance, 570-340-6031 to discuss any questionable cases.