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Informed Consent

Human subjects asked to contribute their time and effort to research should consent to do so freely. The consent should be given only after the subject understands what he or she is consenting to, and any risks that may be involved. Subjects should be assured that there will be no penalties for declining to participate, and that they are free to withdraw from the research at any time after they have given their initial consent. Federal regulations require that, in most cases, whenever there is more than minimal risk, consent is to be documented by a signed and dated consent form that has been approved by a Human Subjects Review Committee. However, you may be asked by the in-house exemption review committee to provide a consent form for a study that is eligible for exemption, or no risk, clearance.

As you are writing a consent form or preparing an oral script for consent, see the Federal and University of Washington elements of consent, which are available at www.washington.edu/research/hsd/policy/. Elements of consent are not optional - please include all points. Note instructions around the importance of language and readability here.

The Human Subjects Division offers some helpful hints on consent form writing at www.washington.edu/research/hsd/topics/Consent,+Assent+and+Waivers. The Human Subjects Manual offers useful and detailed information on consent.

Important:  Review the Human Subjects Division's sample consent form at www.washington.edu/research/hsd/forms/ (follow the "Sample Standard University of Washington Consent Form" link).  Copy the Researcher's Statement into your consent form. 

A sample consent form written for a fictitious research project purportedly conducted by a School of Social Work researcher can be viewed at Sample Consent Form