For the word of God and the testimony of Jesus Christ

Policy and Guidelines

Introduction

The Institutional Review Board (IRB) is a faculty panel whose task is oversight and ethical review of any and all research involving human participants conducted by faculty, staff, administrators, and students under the purview of Cedarville University (CU).

Such oversight springs from our common commitment to the principles of human value and human dignity arising from God's Word (Psalm 8; Genesis 1:26-28; Psalm 139: 13-16). Our respect for human life at all stages, from conception until death, requires the implementation of careful, concise internal standards to protect individuals participating in research initiatives from intentional or unintentional harm, and to affirm their value as fellow bearers of God's image.

In the history of the United States, research on human participants has not always been conducted in an ethical manner. Certain highly publicized abuses led to the 1979 Belmont Report, which specifically outlines the principles for the treatment of human research participants. In 1981, based on this report, the Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA) established regulatory guidelines for such research, which are still in place to this day. The Cedarville IRB policy is designed to be compliant with DHHS and FDA regulations.

The ethical principles undergirding this IRB policy include human autonomy, beneficence, nonmaleficence, and justice. Autonomy requires that every person has the right to make his or her own decisions about participation in research. This requires complete disclosure of the risks and benefits of such participation. Those with diminished autonomy must be protected by the informed consent of an appropriate surrogate.

Beneficence and nonmaleficence require that no research study cause intentional or preventable injury, loss of function, or undermining of personal dignity. The potential benefits of participation for research participants must outweigh the risks. There must also be no foreseeable violation of privacy or exposure to embarrassment or legal liability. Justice (sometimes amplified by the phrase "distributive justice") requires that all participants be treated in the same manner, regardless of gender, ethnicity, socio-economic status, religion, or other non-relevant factors.

Finally, certain vulnerable special groups require extra protection and consideration. These include pregnant women, the unborn, children, prisoners, and those with physical and mental disabilities. Research involving such groups will require special scrutiny. For all research participants in the healthcare arena, strict adherence to principles of confidentiality of private information must be maintained, in accordance with HIPAA regulations (Health Insurance Portability and Accountability Act of 1996).

IRB Policy References:

1. CFR - Code of Federal Regulations Title 21. 2011; http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=312.

2. Human Subjects Research (45 CFR 46). 2012; http://www.hhs.gov/ohrp/humansubjects/guidance/.