OFFICE FOR PROTECTION OF HUMAN SUBJECTS |
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.
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].
The survey or interview [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.]
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 int he form and an authorization form needs to be developed. A sample form may be found at HIPAA Authorization.]
Your participation is voluntary. Your decision whether or not to participate will not affect your relationship with [name 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 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 your 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). The form should indicate that the "parent/legal guardian" is the appropriate person to sign the form.