Skip to main

Baker University Institutional Review Board

Baker University Federal-wide Assurance (FWA00035255)

Campus_120.jpg

Table of Contents

Specific Responsibilities

The purpose of the Baker University Institutional Review Board is to ensure the ethical conduct in research involving human participants.

  1. To assure the university that human participants used in research or educational programs are not at undue risk and that the participants are informed of any risks.
  2. To advise the Office of the Chief Academic Officer of the university’s compliance with federal guidelines and inform the university policy and procedures regarding the protection of human participants, and to certify to the Office of Academic Affairs that any research project or activity involving human participants has been reviewed and approved by the IRB.

Scope

This board is to review all research involving human participants, and all other activities that even in part involve such research, regardless of sponsorship, if one or more of the following apply:

  1. The research is sponsored by this institution, or
  2. The research is conducted by or under the direction of any employee or agent of this institution in connection with his or her institutional responsibilities, or
  3. The research is conducted by or under the direction of any employee or agent of this institution using any property or facility of this institution, or
  4. The research involves the use of this institution’s nonpublic information to identify or contact human research subjects or prospective subjects.

The term “research” herein denotes a systematic investigation or testing and evaluation designed to develop or contribute to generalizable knowledge.  Activities that meet this definition may be conducted as a component of another program not usually considered research.

Certain kinds of activities that might be called “human subjects research” do not require review for the protection of human subjects.  The following kinds of activities do not require such review:

  1. accepted and established service relationships between professionals and clients where the activity is designed solely to meet the needs of the client;
  2. research using only historical documents; and
  3. research using only archaeological materials or other historical or prehistorical artifacts.

Pilot studies, pretests, and other “preliminary” investigations are considered research, and must be reviewed unless they fall into one of the excluded categories listed above.

Classroom activities may include instructing students in human research methodologies and techniques.  If the sole purpose of the activity is to teach students research techniques or methodology and not to develop or contribute to generalizable knowledge, it is not considered to be research.  However, if students will practice research methodologies on human beings, they should be instructed in the ethical conduct of such activities and should be advised to obtain informed consent from their practice subjects.

Quality improvement and quality assurance activities conducted solely for the intent of maintaining or improving quality of services provided by an institution, likewise, are not considered research activities.  However, if the data collected are generalizable and are to be shared outside of the institution through discussion, presentation, or publication, the activity qualifies as research.  Sometimes, data from a quality improvement or quality assurance activity become of interest to the external community after they have been analyzed.  In these cases, the research use of the data collected for another purpose must be reviewed.

Procedures

Proposals requiring the use of human participants will be submitted to the Office of Institutional Research, which will register the application and forward it to the chairperson of the Baker University Institutional Review Board.  The chairperson, representing the board, will determine the review category that is most appropriate for the proposed research and will advise Institutional Research of that determination.  The chairperson will consider the degree of risk the proposed research places on human participant(s), and whether or not proper safeguards are planned and/or operational.  All proposed research involving human participants, unless found by the IRB chairperson to be exempt, shall be reviewed either by the expedited review process or full board review.  For expedited review, the chairperson and two members of the committee would comprise the board.  For full review, the entire membership must participate.

Baker University’s IRB requires all researchers listed as Principal Investigators (PI) and all faculty mentors on IRB proposals to submit evidence of completion of the five U.S. Department of Health and Human Services training modules included in their Human Research Protection Foundational Training. These short training modules will help educate you about the role of the IRB in human research and the ethical conduct of human research. The training is free, easily accessible, and not overly burdensome to complete. Following completion of each module, you will complete and download a certificate of completion. These five certificates will then serve as evidence of completing the training requirement of the IRB and will be attached to the submission when you send your IRB form and related attachments to the IRB (IRBProposals@bakerU.edu).

Proposals are reviewed on a rolling basis.  The IRB will typically respond to a submission with questions or approval within a week, but please allow up to two when planning your research project.

Do not use your browser’s built-in PDF reader to fill out the proposal form. Please use Adobe Acrobat Reader: Download Acrobat Reader DC. Learn how to digitally sign PDFs.

Contact the IRB chair for further questions: irbproposals@bakerU.edu

Research Involving Animals

Any classroom or laboratory activities, on campus or in the field, that involves the capture, restraint, and use of animals, will require review by a different university review board, to be determined.