IRB Policy I - Student Course Assignments/Projects
Purpose:
The purpose of this policy is to define which course assignments/projects require submission to the Office for
Research Protections (ORP), The 330 Building, Suite 205, University Park, PA 16802 (814-865-1775), and
subsequent reviews, approvals/determinations by Pennsylvania State University’s (Penn State) Institutional
Review Board (IRB)/ORP. The submissions must be made to ORP via the Protocol, Review, Approval and
Management System - PRAMS (http://www.prams.psu.edu).
The policy also defines the responsibilities of those (i.e. students and instructors) conducting and/or overseeing
classroom activities that do not require submissions to ORP.
Applicability:
This policy is applicable at all Penn State University locations (except the Hershey Medical Center/College of
Medicine which conducts independent IRB reviews).
Definitions:
Classroom Activity: Although research involving human participants may be conducted as part of a course; for
the purpose of this policy, classroom activities are course assignments/projects conducted by an individual (i.e.
an enrolled student) to satisfy the curriculum requirements of a course, and that are typically concluded at the
end of the relevant semester. A classroom activity is not “human participant research”, and does NOT result in
research data that will be disseminated beyond the institution of Penn State and its immediate university
community.
Generalizable: Refers to being “universally or widely accepted,” (i.e. research findings become common
knowledge and formulate the scientific community’s general principles or inferences).
Data that will be
disseminated beyond the institution of Penn State and its immediate university community is considered
generalizable.
Human Participant: (1) A living individual about whom a researcher (e.g. professor or student) conducting
research obtains data through intervention or interaction with the individual or identifiable private information,
or (2) a participant in research, that is either a recipient of a test article or acting as an experimental control.
Human Participant Research: A systematic investigation designed to develop or contribute to generalizable
knowledge that involves gathering/obtaining data about living individuals through intervention or interaction
with the individual or by obtaining identifiable private information about the living individual.
Interaction: Includes communication or interpersonal contact (e.g. by telephone conversation, or through
internet use) between a researcher and participant.
Intervention: Includes both physical procedures by which data are gathered (e.g. venipuncture), and
manipulations of the participant or the participant’s environment that are performed for research purposes.
Minimal Risk: The probability and magnitude of harm or discomfort anticipated in the research are not greater in
and of themselves than those ordinarily encountered in daily life or during the performance of routine physical
or psychological examinations or tests.
Research: A systematic investigation, including research development, testing and evaluation, designed to
develop or contribute to generalizable knowledge.
Vulnerable Populations: Participants that may have compromised autonomy relating to decision making (e.g.
children, prisoners, pregnant women and fetuses, neonates, the mentally disabled, or economically, socially,
physically, or educationally disadvantaged).
Policy:
Course assignments/projects involving interactions or interventions with people, or the examination of
individuals’ private information may or may not meet the definition of human participant research.
It is the policy of Penn State’s IRB and the ORP to require submissions, subsequent review and
approval/determination for ONLY course assignments/projects meeting the definition of human participant
research. Review and approval/determination MUST occur before the course assignment/project is initiated.
The IRB/ORP will NOT review classroom activities as defined in the Definitions section.
Responsibilities:
1. If students conduct human participant research, their research must be submitted for IRB/ORP review
and approval/determination PRIOR to initiating the project. Some course assignments/projects
considered human participant research include, but are not limited to:
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Research exhibitions,
Presentations at a scientific meeting or conference,
Projects that contribute to scientific merit or scholarship, and
Written reports, abstracts, or manuscripts to be submitted for publication in, for example, a
professional journal.
2. If instructors require students to engage in course assignments/projects that involve interactions with
people, the instructor has the ultimate responsibility of ensuring course assignments/projects considered
to be human participant research are submitted for IRB/ORP review. Course assignments/projects
which place people at more than minimal risk, or involve vulnerable populations are encouraged to
contact the ORP for guidance.
Additional Guidance:
1. If course assignments/projects are considered human participant research, the instructors may contact
the ORP for guidance (ORProtections@psu.edu or 814-865-1775), and to ensure the course
assignment/project can be approved within the time constraints of the course.
2. If a course assignment/project is determined to be human participant research, then the student should
be listed as the Principal Investigator (PI) and the course instructor as the Advisor. Human participant
research involving more than minimal risk for participants must be reviewed at the full committee level
by the IRB. In a situation such as this one, the student’s research advisor or course instructor must be
listed as the PI on the IRB application. The student(s) may be listed as a co-investigator(s).
3. If a course assignment/project will be completed as a group, only one person can be listed as the PI.
Therefore, it is necessary to appoint one person to be the sole contact with the IRB/ORP.
References:
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Protection of Human Subjects, Title 45 Code of Federal Regulations, Part 46
Protection of Human Subjects, Title 21 Code of Federal Regulations, Part 50
First Approved by the IRB#1 on 02/09/2010; IRB#2 on 02/25/2010
Last Revised: 10/27/2011
Last Approved by the IRB#1 on 09/13/2011; IRB#2 on 09/22/2011