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This sample is a template from which a consent form can be developed. The language does not have to be repeated verbatim. THE CONSENT FORM SHOULD BE WRITTEN IN TERMS UNDERSTANDABLE TO THE SUBJECT (avoid or define technical terminology, adjust for educational background and ages, provide translations in other languages when subjects do not understand English). Information provided in italics needs to be filled in and the italics deleted.
A detailed description of the basic elements of consent is in the Investigator's Manual. Investigators with projects involving more than minimal risk and/or those working with special populations (children, people with intellectual or developmental disabilities, prisoners, pregnant women) must consult the Manual for additional informed consent elements.
You are invited to participate in a research study conducted by [name of investigator], from the University of Oregon [departmental affiliation]. I hope to learn [state what the study is designed to discover or establish. If a student, indicate that results will contribute to thesis or dissertation]. You were selected as a possible participant in this study because [state why subject was selected].
If you decide to participate, [describe procedures, including their purpose, how long they will take, their location and frequency. If activities are to be audio or video recorded, indicate this].
The procedures [describe research activity] may [Describe risks, discomforts, inconveniences, and how these will be managed. Do not use definative statements regarding lack of risks. Describe any alternative procedures or courses of treatment, if applicable. Indicate costs of participating, if any.] [Describe benefits to subjects and humanity expected from the research]. However, I cannot guarantee that you personally will receive any benefits from this research. [If subject will receive compensation, describe amount and when payment is scheduled.] [If blood or urine samples will be collected and the samples will not be evaluated by a physician with results given to the subject, the following statement needs to be included in the consent form: "Blood (and/or urine, if applicable) samples are not being collected for diagnostic purposes. The results will not be reviewed by a physician and no action will be taken if a laboratory value falls outside of the normal range."]
[If project is more than minimal risk, the standard language regarding responsibility for medical expenses and liability must be included. See p. 18 of the Manual for this language. Other elements of informed consent may be required for a particular study. Refer to pp. 18 and 34-35 for this information.]
Any information that is obtained in connection with this study and that can be identified with you will remain confidential and will be disclosed only with your permission. Subject identities will be kept confidential by [describe coding procedures and plans to safeguard data]. [If information will be released to any other party for any reason, state the person/agency to whom the information will be furnished, the nature of the information, and the purpose of the disclosure.] [If protected health information (PHI) will be used, language referencing the authorization to access and use an individual's personal health information needs to be included in the form and an authorization form needs to be developed. Further information and a sample form may be found at HIPAA Instructions.]
The Office for Responsible Conduct of Research and/or authorized representatives of the Food and Drug Administration (FDA) [or a funding agency, if the project is funded, such as the National Institute of Health] may need to review records of individual subjects. As a result, they may see your name; but they are bound by rules of confidentiality not to review your identity to others.
Your participation is voluntary. Your decision whether or not to participate will not affect your relationship with [name of agency, school, etc. where subject was recruited]. If you decide to participate, you are free to withdraw your consent and discontinue participation at any time without penalty.
If you have any questions, please feel free to contact [provide name, phone number, and department address. If student, also provide advisor name and phone, and identify as your advisor.] If you have questions regarding your rights as a research subject, contact the Office for Protection of Human Subjects, University of Oregon, Eugene, OR 97403, (541) 346-2510. This Office oversees the review of the research to protect your rights and is not involved with this study.
Your signature indicates that you have read and understand the information provided above, that you willingly agree to participate, that you may withdraw your consent at any time and discontinue participation without penalty, that you have received a copy of this form, and that you are not waiving any legal claims, rights or remedies.
Print Name________________________________________________________
Signature ________________________________________________________ Date_________________________
(If subject is a child, indicate: Signature of Parent/Legal Guardian and include a space for name of child.)
NOTE: Language may be altered to obtain parental consent for participation of their child (e.g., "If you decide to allow you child to participate in this study, the child will be asked to..."). Children may also sign this form if they understand the information provided, or a separate assent form may be given to young children (see Manual for sample). If subjects are mentally disabled, the language should be appropriate to their understanding, and additional signatures are required (Manual - Special Subject Populations). The form should indicate that the "parent/legal guardian" is the appropriate person to sign the form.