The UTHSC-H policies require that written informed consent be obtained from all human subjects prior to their participation in any research unless the requirement has been waived by CPHS.The language of the consent document should be in the second person style such that it conveys a dialogue with information being provided and that there is a choice to be made by the subject rather than presumption of the subject’s consent with the use of the first person style. The information provided in the consent document should be simple enough that a subject at 6th to 8th grade reading level can understand it. Technical and scientific terms should be adequately explained using simple language.
Consent documents should not contain any exculpatory language through which the subject is made to waive or appear to waive legal rights, or releases or appears to release the Investigator, the Sponsor, or the institution from liability for negligence.
Many investigators find that starting with the CPHS Consent Template is very helpful. If you need help with developing a consent document, please feel free to contact us.
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