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Research Responsibility and ComplianceHuman Subjects: Institutional Review Board (IRB)IRB Letter to Researchers Human Subjects: Institutional Review Board (IRB)Dear Researcher: If you are planning to conduct a research project involving data collection from people, your project must be reviewed by the University's Institutional Review Board for Protection of Human Participants (IRB) to determine if adequate measures are being used to protect those individuals participating in your study. All research projects must be reviewed by the IRB. No research project is exempt from review. The information below will assist you in complying with policies and procedures adopted by the University of Wisconsin Oshkosh. These policies and procedures were designed to protect the rights and safety of human participants, as well as researchers, and to conform to the common federal policy for Protection of Human Subjects (FR 6/18/92). Conformance with these policies and procedures is in your best interest. Please read this entire Web site section. The IRB will make every effort to process your application in a timely manner. In order to do so, you must submit the required information on the application form and in the Project Outline Format. Assuming that your research is appropriate for an Expedited Review and that there is no need to request additional information from you, the review process typically is completed in approximately two weeks when school is in session during the academic year. An expedited review may take longer during vacation periods and the summer. If the full IRB must review your application, either because it is not eligible for an expedited review or is not approvable through an expedited review, the process may take as long as four to six weeks. In all cases the review results are sent to you promptly. If you have any questions regarding the completion of the application form or regarding these policies, please feel free to contact a member of the IRB. Sincerely, Institutional Review Board for Protection of Human Participants Frances Rauscher, Psychology--IRB Chair Submit two copies of completed project outline, application form, and supporting materials (informed consent or information sheet) to the Office of Grants and Faculty Development, located in the Old Credit Union Building. Informed Consent and Samples to be Completed by Researcher Guidelines for Long Form Written Consent The purpose of the consent process is to provide information to research participants so that they are able to make an informed decision about whether to participate in the research. Participation in research is voluntary. Therefore, participants must always be told they can choose not to participate or can withdraw at any time during the research with no penalty. When feasible and appropriate, the more desirable procedure for obtaining consent consists of having the participant sign a document that provides any and all appropriate elements of information about the project (sample consent document in PDF format and IRB Policy, section 4.1.1). Signed consent is generally required when research is nonexempt, when minors or protected/sensitive populations are involved, when participants are being videotaped/audiotaped, or when participants can be identified (directly or indirectly) and disclosure of their responses outside of the research could reasonably place the participant at risk of criminal or civil liability or be damaging to the participant's financial standing, employability, or reputation. Participants must be provided with a copy of the consent document; the researcher also keeps a copy.
Guidelines for Short Form Written Consent A short form consent may be signed by the participant or legal representative in instances where it is difficult or impossible for the participant to read or sign a long form consent document. Specific procedures for obtaining short form consent are described in the IRB Policy, section 4.1.2. Following the long form sample (above), there is a sample of a short form consent document. Notes:
Where appropriate, add statements such as the following to the consent document:
Guidelines for Information Sheet This is an example of a written summary that would be presented to the prospective research participant when the research has been determined to be exempt. It contains all of the elements of the long form consent document (refer to Sample). A copy of this document is to be given to the participant. SUMMARY OF RESEARCH PROJECT The purpose of this summary is to describe the research study, .... (TITLE)... and to explain the study's scope, aims and purpose. 1. The reasonably expected benefits of the project include:
2. The procedures that will be used involve.... (Description)... including the experimental procedures.... (Description).... 3. It is reasonably foreseeable that you will experience.... (Describe).... discomfort. The risk of harm that could result from your participation in the project is.... (level of risk) .... 4. The alternative procedures that could have been used in this study include.... (Describe).... 5. The expected duration of your participation is.... (time period) .... 6. Your participation in the study is completely voluntary--you do not have to participate and you can stop at any time. If you refuse to participate now, or withdraw from the study later, it will have no effect on any regular services or benefits available to you at the University of Wisconsin Oshkosh. 7. Any personal information used in this study will be treated confidentially. Information that identifies you as an individual will not be released, without your consent, to anyone for purposes that are not directly related to this research study. 8. If you have any question about this study, or your rights, you may call or write: (Name)…(Address)…(Phone Number)…. 9. You will be given a copy of this statement, which serves to acknowledge the fact that you have been informed about the project and that you have voluntarily agreed to participate. Notes: Where appropriate, add statements such as the following to the information sheet:
Exempt/Nonexempt Research Status All research must be approved by the IRB. No research is exempt from
review. When the term "exempt" is used, the IRB is determining
whether the proposed study is subject to the University's Protection
of Human Participants Policy and whether the research may
require either (1) a signed informed consent, or (2) an information sheet.
All research participants must be provided with information about the research in which they will participate. If the research is nonexempt, the principal investigator may be required to obtain the research participants' signatures on informed consent forms. If the research is determined to be exempt, the principal investigator provides the research participants with information about the research, including all information that is provided in the written informed consent, but does not need to obtain a signature. (Note: If the research is exempt and involves only the collection or study of existing data, documents, or records, then this requirement to provide the participant with information is not applicable.) The principal investigator, therefore, is interested in understanding the distinction between exempt and nonexempt research because that distinction determines whether the principal investigator must comply with all of the provisions in the Protection of Human Participants Policy.
Ethical Standards from the American Psychological Association REVISED ETHICAL STANDARDS The decision to undertake research rests upon a considered judgment by the individual psychologist about how best to contribute to psychological science and human welfare. Having made the decision to conduct research, the psychologist considers alternative direction in which research energies and resources might be invested. On the basis of this consideration, the psychologist carries out the investigation with respect and concern for the dignity and welfare of the people who participate and with cognizance of federal and state regulations and professional standards governing the conduct of research with human participants. A. In planning a study, the investigator has the responsibility to make a careful evaluation of its ethical acceptability. To the extent that the weighing of scientific and human values suggests a compromise of any principle, the investigator incurs a correspondingly serious obligation to seek ethical advice and to observe stringent safeguards to protect the rights of human participants. B. Considering whether a participant in a planned study will be a "participant at risk" or a "participant at minimal risk," according to recognized standards, is of primary ethical concern to the investigator. C. The investigator always retains the responsibility for ensuring ethical practice in research. The investigator is also responsible for the ethical treatment of research participants by collaborators, assistants, students, and employees, all of whom, however, incur similar obligations. D. Except in minimal-risk research, the investigator establishes a clear and fair agreement with research participants, prior to their participation, that clarifies the obligations and responsibilities of each. The investigator has the obligation to honor all promises and commitments included in that agreement. The investigator informs the participants of all aspects of the research that might reasonably be expected to influence willingness to participate and explains all other aspects of the research about which the participants inquire. Failure to make full disclosure prior to obtaining informed consent requires additional safeguard to protect the welfare and dignity of the research participants. Research with children or with participants who have impairments that would limit understanding and/or communication requires special safeguarding procedures. E. Methodological requirements of a study may make concealment or deception necessary. Before conducting such a study, the investigator has a special responsibility to: (1) determine whether the use of such techniques is justified by the study's prospective scientific, educational, or applied value; (ii) determine whether alternative procedures are available that do not use concealment or deception; and (iii) ensure that the participants are provided with sufficient explanation as soon as possible. F. The investigator respects the individual's freedom to decline to participate in or to withdraw from the research at any time. The obligation to protect this freedom requires careful thought and consideration when the investigator is in a position of authority or influence over the participant. Such positions of authority include, but are not limited to, situations in which research participation is required as part of employment or in which the participant is a student, client, or employee of the investigator. G. The investigator protects the participant from physical and mental discomfort, harm, and danger that may arise from research procedures. If risks of such consequences exist, the investigator informs the participant of that fact. Research procedures likely to cause serious or lasting harm to a participant are not used unless the failure to use these procedures might expose the participant to risk of greater harm, or unless the research has great potential benefit and fully informed and voluntary consent is obtained from each participant. The participant should be informed of procedures for contacting the investigator within a reasonable time period following participation should stress, potential harm, or related questions or concern arise. H. After the data are collected, the investigator provides the participant with information about the nature of the study and attempts to remove any misconceptions that may have arisen. Where scientific or human values justify delaying or withholding this information, the investigator incurs a special responsibility to monitor the research and to ensure that there are no damaging consequences for the participant. I. Information obtained about a research participant during the course of an investigation is confidential unless otherwise agreed upon in advance. When the possibility exists that others may obtain access to such information, this possibility, together with the plans for protecting confidentiality, is explained to the participant as part of the procedures for obtaining informed consent. |
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