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IRB (Human and Animal Subjects)

Where appropriate, please include this statement on all printed or displayed project materials, including abstracts, posters, Power Points, etc.:

This project has been approved by Grand Valley State University’s {HRRC or IACUC}, {approval number}, {expiration date}.

If applicable, clearly state when a project is a literature review or theoretical exercise.

For assistance with the review process, please contact the Office of Research Compliance and Integrity by phone (616-331- 3197) or email (rci@gvsu.edu).

Presentations Involving Human Subjects

All research involving human subjects performed at GVSU and/or by GVSU students, staff, and/or faculty must be reviewed and approved by the Human Research Review Committee prior to beginning the research.

Submit a Change in Protocol form to add a student researcher as key personnel to any previously approved study. Please note: Exempt human subjects research must still be reviewed and approved by the HRRC.

Presentations involving Animal Research

All animal research at GVSU must be conducted in accordance with IACUC standards and comply with the Public Health Service policies and USDA animal welfare regulations. All research involving the use of animals must be approved prior to beginning research activities.


Do Classroom Research Activities Need IRB Approval?

When is review and approval needed, either by the Human Research Review Committee (HRRC) or the Institutional Animal Care and Use Committee (IACUC)?  Please consider the following:

Student class assignment definition
For the purposes of this policy student class assignments include activities that are:

  • Conducted during, or outside of class, with students enrolled in an official course (for credit or not for credit. Note this includes 399 and 499 classes)
  • Conducted in fulfillment of class assignments involving interactions with individuals other than the members of the class
  • Typically initiated and completed within a single term
  • Designed to teach research methods through student interaction with individuals or data about individuals, or designed to help students understand concepts covered by the course
  • Generally not intended to create new, generalizable knowledge or to lead to scholarly publication

Student class assignments, as a general rule, are not systematic data collection efforts intended to develop or contribute to generalizable knowledge and, thus, do not meet the federal regulatory definition of research (link is external). Therefore, as a rule, student class assignments do not fall under the jurisdiction of the HRRC and do not require HRRC application, approval, or oversight.

Most student class assignments pose little or no risk to students or others. However, instructors should take special care to ensure that students realize the potential for harm and take all possible steps to eliminate the risks to students or individuals outside the class involved in the assignment. These risks may include: physical harm, or potential psychological, social, economic, or legal harm, especially when data is collected about sexual activity, use of alcohol or illegal drugs, or involvement in illegal activities. Faculty are expected to exhibit prudence in the types of classroom activities allowed, and exercise adequate training for students to ensure subject safety.

Research vs “Not Research”
Student class assignments that are intended to collect living human (or vertebrate animal) subject information systematically, with the intent to develop or contribute to generalizable knowledge (e.g., publish or disseminate data) meet the federal regulatory definition of "research." These class assignments fall under the jurisdiction of the HRRC and require application, approval and oversight. Faculty wishing to use such assignments must apply to the appropriate committee for review and approval of these assignments before they begin. GVSU currently uses IRBnet as our documentation system.

Class assignments may become subject to this policy (and be considered regulated research) if the faculty member or the students change their plans to use the data during the data collection or after the data have been collected. If the faculty member or students wish to use data collected from class assignments for research and publication, application to the HRRC (or IACUC) for permission to use the data is required.

Independent research projects (e.g., theses, honor projects, independent studies) conducted by students that collect data through interactions with living people or access to private information fall under the jurisdiction of the HRRC. It is encouraged that the faculty member serve as a co-PI on these investigations to ensure that continuing review and other correspondence is directed to the faculty member after the student has left GVSU.

Human Research Review, Conducted by the Human Research and Review Committee (HRRC)
In reviewing an application for student research conducted in the context of a course, the HRRC may determine that the activity qualifies as:

After review by the HRRC, a declaration of exemption means that, so long as there are no major changes in the research, its conduct does not need to be overseen on a continuing basis by the HRRC. It does not mean, however, that students should act any less professionally or be any less respectful of individuals with whom they interact or about whom they collect private information. Research ethics apply to ALL activities. (See: Guidance Document, Exempt Protocol)

An expedited protocol and review means that the IRB chair or other designated reviewers may approve a project on behalf of the entire committee. If such an application is well formulated and contains all the information required by the IRB, this process may speed approval. Expediting reviewers may not disapprove a project. Please be sure to be clear in your proposal. (See: Guidance Document, Expedited Protocol)

  • Full Board- if it is determined that the proposal places the subjects above minimal risk, a review will be convened at a meeting of the full board. The Investigators will be invited to attend this meeting.

Animal Research Review, conducted by the Institutional Animal Control and Use Committee (IACUC)

In reviewing an application for student research involving animals that is conducted in the context of a course, the IACUC may determine that the activity qualifies as:

  • Exempt (see IACUC Handbook of Policies and Procedures Policy 3.3 Exemptions) 

After review by the IACUC, a declaration of exemption means that, so long as there are no major changes in the research, its conduct does not need to be overseen on a continuing basis by the IACUC.

  • Designated Member Review (see IACUC Handbook of Policies and Procedures see Policy 3.7.2 Designated Member Review)

Designated member review means that the IACUC chair or other designated reviewers may approve a project on behalf of the entire committee. If such an application is well formulated and contains all the information required by the IACUC, this process may speed approval. Designated member reviewers may not disapprove a project. Please be sure to be clear in your proposal.

  • Full Committee Review- if it is determined that the proposal places the animals above minimal risk, a review will be convened at a meeting of the full board. The investigators will be invited to attend this meeting.

Instructor Obligation
Even when a class assignment is "non-research" and, thus, not requiring HRRC or IACUC review, faculty members have an ethical obligation to ensure that students understand appropriate techniques as well as ethical treatment of human subjects, or animal subjects, when conducting their assignments. Faculty should provide guidance to students collecting information so as to minimize any unintentional harms to other students or to individuals, especially if students will interact with or collect private information. Departments are encouraged to delimit project areas within faculty areas of expertise to ensure sound instruction and guidance to students.

Faculty members may use a number of ways to educate students and encourage responsible interactions with others, including:

  • Reviewing students' plans for classroom or group projects and suggesting improvements in design and protections for confidentiality.
  • Requesting that students take the Epigeum Online Training Modules on human subject protection before collecting information from others. There is a 45 minute module as well as a longer module. Note Graduate students at GVSU MUST complete Epigeum training before beginning any research.
  • Explaining ways in which students should be attentive to the welfare of individuals in cases in which:
    • Any possibility of physical harm to the student or other individuals
    • students will pose sensitive questions including topics related to sexual activity, victimization, use of alcohol or illegal drugs, or involvement in illegal activity
  • Requiring printed instructions/information on questionnaires that explain the use of the data for coursework and include the name and contact number of the instructor
  • Requiring, whenever possible, anonymous data collection so that the data are not linked to individuals
  • Requiring that information identifying individuals be kept separately from the information collected from those individuals
  • Requiring destruction of non-research data at the end of the course or within a short time afterward
  • Instructing students about the privacy and security vulnerabilities associated with networked computers

Questions?
If you have any questions, please contact the Office of Research Compliance and Integrity by phone (616-331- 3197) or email (rci@gvsu.edu).