Baker University Institutional Review Board

Specific Responsibilities

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 research using only historical documents; and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.