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Stephen F. Austin State University

Policy, Rules & Regulations

Introduction

Stephen F. Austin State University (SFA) seeks to protect the welfare of every person who may be a subject of a research activity. In doing so, the university complies with appropriate federal, state, and local laws, including regulations by the Department of Health and Human Services (DHHS) for the Protection of Human Subjects in Research (45 CFR Part 46, as amended). Documentation of procedures is required for all protocols that are government funded. SFA follows the ethical principles regarding all research involving humans as subjects as set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, entitled Ethical Principles and Guidelines for the Protection of Human Subjects of Research (the "Belmont Report"), and in the Code of Federal Regulations (CFR).

Institutional Policy

All research projects involving human subjects conducted by SFA faculty, staff, and/or students, on or off campus, must have prior approval of the Institutional Review Board (IRB). For purposes of this policy, the following definitions apply:

Failure to obtain written IRB clearance may result in the imposition of restrictions on the investigator's research activities at SFA. Once IRB approval is obtained, the investigator(s) must abide by several conditions:

Guiding Principles to the Ethical Use of Human Research Subjects

All research activities involving humans as subjects must provide for the safety, health and welfare of every individual. Additionally, all legal rights, including the right to privacy, must not be infringed. The direct or potential benefits to the subject or the importance of the knowledge to be gained must outweigh the potential risks to the individual. No human subject can participate in a research project until the IRB has approved the research protocol and written informed consent has been obtained from the subject.

The Principal Investigator has the obligation of safeguarding information obtained as part of a research project. Principal Investigators are responsible for the IRB application, training for the research protocol, research activities, supervision of human subjects, and reporting any changes to the IRB, as well as unanticipated consequences from the research.

Conflict of Interest

Conflict of interest is a situation in which financial or other personal considerations have the potential to compromise or bias professional judgment and objectivity. This definition applies to any IRB member or his/her immediate family member (within the second degree of affinity or third degree of consanguinity). An IRB member who has a conflict of interest, or a perceived conflict of interest, in any research application must recuse himself or herself from the vote and must disclose the conflict of interest. If a quorum is present without the recused member, a vote can proceed. Otherwise, an alternate IRB member must be present to proceed to a vote. No individual conducting and/or supervising a specific project can participate in IRB review of the proposal, except to provide information.

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.

Exempted Research

All qualifying research with human subjects, as defined in section II, must be reviewed by the IRB. A Principal Investigator cannot claim exempt status in order to bypass IRB review. The IRB is responsible for determining whether a research project falls within one of the exempted categories as defined in 45 CFR 101(b)(1)-9(b)(6).

Expedited Review

Certain research projects may be eligible for expedited review. In making this determination, the research protocol will be reviewed by the IRB chair and/or experienced IRB members selected by the chair. All members of the IRB will be advised on research proposals that have been approved under expedited review at each IRB committee meeting.

Full Review Research

Full review research protocols that include any protected populations must be reviewed by the full IRB committee. Protected populations include prisoners, children (unless the study is normal educational practice), employees, terminally ill subjects, AIDS/HIV subjects, human fetuses, and neonates. The IRB committee may reject the application, accept the application with minor revisions, or request significant changes with the request for an additional full committee review.