Essential in the protection of human subjects is that potential participants first understand and then freely consent to the proposed research project.
A full explanation of the procedures to be followed—including time, benefits and risks—helps to safeguard the subject's well-being and permits the subject to make fully informed decisions. Although informed consent is often in the form of a signed and archived document, in situations where such a document might become the only identifying data, alternatives are encouraged.
Informed consent typically:
- Informs participants of all factors that might influence their choice to participate. (including purpose, procedures, possible benefits/risks, and the identity of the investigators)
- Presents that information in a comprehensible way. Important considerations include ethnicity, language, education, and socio-economic status.
- Assesses a potential participant's comprehension of the aforementioned information.
- Obtains consent without coercion or pressure.
- Continues to provide information if requested.
Specific guidelines on informed consent can be found at UW-EC's IRB Consent Form preparation page, the 45 CFR 46.116(b), and the Federal Government's Health and Human Services Informed Consent FAQ.
Students as Subjects
Recruitment of any research subjects who may be in a status relationship with the investigators raises unique ethical concerns. At UW-Eau Claire this especially pertains to students, but could also include employees and family members. The concern is that individuals may feel they cannot decline participation in a research study, because they believe that would lead to adverse consequences for their student careers or employment. Therefore, the IRB has issued the following Policy Statement – The use as research subjects of students or others who have a status relationship with the investigator(s).
UW-Eau Claire's implementation of HHS guidelines
- Confidentiality is of utmost importance. No respondent should 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, that is, not identified with the subject unless she/he approves, in writing, of any 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 starts 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) often constitutes 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 is to avoid feelings of harassment or coercion on the part of the subjects.
- All research projects that involve human subjects must obtain informed consent. This includes projects in the fields of education and the humanities that utilize research techniques such as oral history and evaluation of performance.
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