Baker University Institutional Review Board
The purpose of the Baker University Institutional Review Board is to ensure the ethical conduct in research involving human participants or animal subjects.
1a. 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.
1b. To assure the university that animal subjects used in research or educational programs are adequately cared for and used in accordance with the provisions of the federal Animal Welfare Act. The Animal Welfare Act is a federal law instituted to ensure that, among other things, animals used in research receive humane care and treatment. Certain provisions of this law regulate housing, care, handling, and treatment of animals. For the purposes of this document, an animal is considered to be any live, vertebrate organism that is being used, or is intended for use, in instruction, research, or exhibition.
2. To advise the Office of the Provost of the university’s compliance with federal guidelines and inform the university policy and procedures regarding the protection of human participants and the proper care and use of animals, and to certify to the Office of the Provost that any research project or activity involving human participants or animal subjects has been reviewed and approved by the IRB.
This board is to review all research involving human participants or animals, and all other activities that even in part involve such research, regardless of sponsorship, if one or more of the following apply:
- The research is sponsored by this institution, or
- 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
- 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
- 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:
- accepted and established service relationships between professionals and clients where the activity is designed solely to meet the needs of the client;
- research using only historical documents; and
- 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.
Any classroom or laboratory activities, on campus or in the field, that involves the capture, restraint, and use of animals, will require review.
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.
Proposals requiring the use of human participants or animal subjects 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. For proposals involving animals, the chairperson will consider whether or not proper safeguards are planned and/or operational. All proposed research involving human participants or animal subjects, 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.