Clinical Trials Resource Center

Consent Writing Tools and Development

Please use CPHS provided templates.

The UTHealth 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. See readability resources below:

Use Microsoft Word tools to check readability

Online Readability Tool (insert your wording for readability statistics)

PlainLanguage.gov (glossary of simplified words)

Web Based Instruction on Informed Consent (UofMinn)

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.

For additional guidance on informed consent process, please refer to CPHS policy.

If you will be using Chesapeake IRB (or CIRBI), simply provide them with the sponsor's consent template.  Chesapeake will incorporate the current required UT language and adjust the document to the appropriate reading level.

TRANSLATION

For non-English speaking participants, a translated copy of the consent form must be added; verbal translations are not acceptable. The CPHS office does not provide translation services for informed consents, however, Spanish consent forms will be reviewed and approved for content.

If you need translation assistance, please contact an outside company or use an online translation tool. Listed below are a few local translation companies.

Transperfect Translations (713) 650-0440

International Language Assoc. (713) 206-0910

ALS Translation & Interpreting (713) 227-3500

In addition, the Patient Relations Department at Memorial Hermann Hospital offers translation services. They can be contacted at 713-704-2020.

 

ILLITERATE SUBJECT

A person who speaks and understands English, but does not read and write, can be enrolled in a study by "making their mark" on the consent document.  A person who can understand and comprehend spoken English, but is physically unable to talk or write, can be entered into a study if they are competent and able to indicate approval or disapproval by other means. If (1) the person retains the ability to understand the concepts of the study and evaluate the risk and benefit of being in the study when it is explained verbally (still competent) and (2) is able to indicate approval or disapproval to study entry, they may be entered into the study. The consent form should document the method used for communication with the prospective participant and the specific means by which the prospective participant communicated agreement to participate in the study. An impartial third party should witness the entire consent process and sign the consent document.
Complete GCP Guidance