IRB prologue and general policies
The UW-Eau Claire policies and procedures for protection of human subjects have been established to protect the rights and welfare of human subjects utilized in research projects. Safeguarding of human subjects protects not only the individual subject, but also the researcher and the institution sponsoring the research project. In accordance with U. S. Department of Health and Human Services regulations (45 CFR Part 46, "Protection of Human Subjects," as amended; http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.111) as well as State and University regulations, these policies and procedures are herewith implemented by the Institutional Review Board for the Protection of Human Subjects, which sets policy and describes the protection procedures to be followed by researchers.
Any research project, either funded or unfunded, originated at or supported by the University, that involves human subjects must be reviewed and approved by the Institutional Review Board for the Protection of Human Subjects (hereafter IRB) before initiating any collection of data. The UW-Eau Claire IRB follows the federal definitions for both "research" (a systematic investigation designed to contribute to generalizable knowledge) and "human subject" (a living individual about whom an investigator obtains data through interaction or identifiable private information) which are located at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.102. This review process will assure that the rights of human subjects are protected and that appropriate methods for obtaining informed consent will be utilized.
This review shall ascertain whether subjects will be placed at risk, and, if risk is involved, whether or not:
- Risks to the subject are so outweighed by the sum of the benefit to the subject and the importance of the knowledge to be gained as to warrant approval of the research project.
- Rights and welfare of all subjects will be adequately protected.
- Legally informed consent will be obtained by adequate methods in accordance with the provisions as outlined under informed consent.
- Any exceptions are consistent with federal and university guidelines.
Obtaining the informed consent of a potential human subject for participation in an experiment, survey, interview, or demonstration is a necessary safeguard for protecting her/his well-being. The need to obtain informed consent relates to all categories of research involving human subjects, including those projects in the fields of education and the humanities that utilize research techniques such as oral history and evaluation of performance. Further, it is a safeguard of the basic ethical principle of voluntariness. Permitting the subject to make a fully informed decision about whether to participate in a research activity averts potentially inequitable or coercive conditions of human subject use and assures the voluntary nature of subject involvement. A full explanation of the procedures to be followed--their benefits, their risks, if any, and any alternative procedures, help to assure a protective safeguard for the subject's well-being. In studies involving subject deception, the reasons for the deception must be fully justified to the IRB and the subject must be given a complete explanation of the study upon completing her/his participation. The rights and welfare of the human subject must also be protected in accordance with U.S. Department of Health and Human Services regulations (45 CFR Part 46, "Protection of Human Subjects;" http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.111) and the guidelines of various professional codes of ethics. Therefore, the following additional policies are herewith implemented:
- No respondent can be identified in any way with the information/data provided to the researcher without prior consent. Subjects will be advised at the beginning of the data collection procedure that all information/data will be kept confidential, and said data will not be identified with the subject unless she/he approves, in writing, of this disclosure.
- At the outset of the data collection procedure, the subject will be advised in a general way about the purpose of the research as well as its sponsorship if a non-university organization is involved.
- For survey research projects, informed consent is obtained by providing a detailed explanation of the purpose and protocol for the research project to the potential subject/respondent. The completion of the survey instrument (i.e., questionnaire/interview schedule) may constitute informed consent.
- If questionnaires or interview schedules are used, the maximum number of follow-ups that can be reasonably employed to improve the return rate in a given research project is subject to approval, on a case-by-case basis, by the IRB. This limitation of follow-ups will avoid harassment and feelings of coercion on the part of the subjects.
- No pregnant woman may be involved as a subject in a research project unless:
- The purpose of the research activity is to meet the health needs of the mother, and the fetus will be placed at risk only to the minimum extent necessary to meet such needs; or
- The risk to the fetus is minimal.