Purpose

The Institutional Review Board for Human Subjects of Samford University has been established in compliance with Federal Regulations concerning experimentation involving human subjects (45 C.F.R. Part 46, Protection of Human Subjects). The purpose of this board is to provide review of all research conducted by faculty, staff, and students to insure protection of human subjects and compliance with the federal regulations.

Scope

All research conducted by either faculty or students under the direction of a faculty adviser, and involving human subjects must receive approval from the Institutional Review Board for Human Subjects (IRB). When conducting cooperative research which involves more than one institution, each institution is responsible for safeguarding the rights and welfare of human subjects and for complying with this policy. When a member of the Samford University faculty is involved in cooperative research, that faculty member is responsible for obtaining approval through the Samford University IRB. Any research involving vulnerable populations (fetuses, pregnant women, or prisoners) may require additional approvals. Thus, all researchers are referred to the OPRR Reports Protection of Human Subjects Title 45 Code of Federal Regulations, Part 46 for additional information.

Definitions

The term human subject refers to "a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information" (45 CFR 46 Section 46.102).

Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge (45 CFR 46 Section 46.102). Activities which meet this definition constitute 'research' for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes.

IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB.

Minimal risk means that 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.

Children are persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.

Assent means a child's affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.

Permission means the agreement of parent(s) or guardian to the participation of their child or ward in research.

Guardian means an individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care.