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Austin College affirms that human research subjects should be treated with dignity, respect, and with due regard for their welfare. To protect human research subjects, the College established the Institutional Review Board. We understand “human subjects” to include all individuals and groups from whom researchers anticipate gathering information or data necessary for the successful completion of the research design. We consider the terms “subject” and “participant” to be synonymous and these terms may be used interchangeably here or in other relevant documents. Research proposals will be assessed by the IRB in accordance with Federal requirements of IRBs outlined by Title 45 Code of Federal Regulations (CFR), Part 46, Protection of Human Subjects (June 18, 1991), known as the Common Rule. The Office of Human Research Protections (OHRP) in the Department of Health and Human Services of the federal government oversees IRB filings for federal research. OHRP defines the Criteria for IRB approval of research as follows:
- Risks to participants are minimized;
- Risks are reasonable in relation to anticipated benefits;
- Selection of participants is equitable;
- Informed consent is sought from each subject;
- Informed consent is appropriately documented.
Austin College is committed to protecting the safety, welfare, rights, and privacy of all persons who participate in research projects conducted by our faculty, staff, and students. It is also committed to ensuring that the participants of such research are fully aware of their rights and the protections available to them. In addition to following federal guidelines, the safeguards and guiding principles used by the Austin College IRB are derived from the following ethical principles, first articulated in the Belmont Report issued by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1979.
- Respect for Persons – Respect for persons incorporates the following ethical convictions. Individuals should be treated as autonomous agents and persons with diminished autonomy are entitled to greater protection (such as, including prisoners, children, those who are mentally or cognitively disabled, pregnant women, or economically or educationally disadvantaged persons). Each person should be given the respect, time, and opportunity necessary to make his or her own decisions. A core feature of respect for persons is informed, voluntary consent. Prospective participants must be given the information they will need to decide to participate in a study or not to participate. Once provide with adequate information, the decision to enter a research project or not should be completely voluntary – free from undue influence or coercion.
- Nonmaleficence and Beneficence – Persons are treated in an ethical manner by respecting their decisions and protecting them from harm. Two general rules have been formulated as complementary expressions of beneficent actions in this sense: (1) do no harm and (2) maximize possible benefits while minimizing possible harms.
- Justice – Justice is a difficult and complex ethical issue. Who ought to receive the benefits of research and bear its burdens is a question of justice in the sense of “fairness in distribution” or “what is deserved.” An injustice occurs when some burden is unduly imposed or when some benefit to which a person is entitled is denied without good reason. Attempt at all times to distribute the risks and benefits fairly and without bias.
Keep the principles of autonomy, beneficence, and justice in mind when you are selecting participants, excluding participants, obtaining consent, and conducting your study. The responsibility to protect and inform research participants is ultimately yours (all those engaged with research) and cannot be ignored or delegated. Although you may delegate various tasks to certain team members, you cannot delegate the responsibility of protecting and informing participants of their rights.