Stephen F. Austin State University

Informed Consent

Informed Consent

A subject's informed consent must be obtained through methods that are consistent with federal law (45 CFR §§46.116-.117). An individual does not abdicate any rights by consenting to serve as a research subject. A human subject has the right to withdraw from a research project at any time or can refuse to participate; in either case, the subject must not experience any loss of benefits for withdrawing from a research project. Further, a human subject has the right to receive appropriate professional care, to enjoy privacy and confidentiality in the use of personal information, and to be free from undue embarrassment, discomfort, anxiety or harassment.

The legal age of consent for research purposes in the State of Texas is eighteen (18) years of age. For human subjects under 18, consent must be given by a legally authorized representative, an individual, judicial, or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the research procedure(s). Additionally, the human subject under 18 must assent to the research. If the subject is a minor, written consent by a legally authorized representative is required unless waived by the IRB. Such waivers will be granted by the IRB only if the Principal Investigator can provide adequate justification for the request [45 CFR §46.116(c)] and demonstrate assent of the minor, unless the IRB acknowledges the minor is incapable of giving assent.

Consent must be voluntary and must be given without coercion or undue influence. This includes provisions for payments or other incentives to participate in a research study [Payments to Human Research Subjects (SFA Policy 8.8)]. The information provided to the subject or to the subject's legally authorized representative must be in simple, easily understood language. If the human subject does not understand English, the informed consent must be presented in the appropriate language.

Informed consent cannot waive or limit a human subject's legal rights, including any release of the institution or its agents from liability for negligence. Requirements and guidelines for informed consent can be obtained from the ORGS website.