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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.

Under most circumstances, if a study participant sustains any injury or adverse event as a result of their participation in the study, UTHouston will provide treatment and care for the participant.

Industry sponsors must agree to pay for reasonable and necessary medical expenses for injuries that are a direct result of the study drug or device, or study procedures carried out in accordance with the study protocol and not due to natural course of underlying disease. For investigator initiated trials, consent documents must clearly state that no arrangements have been made to provide payment for treatment of research related injuries.

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

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.

ADDITIONAL RESOURCES

CLINICAL RESEARCH UNITS (CRU) | BERD | REDCap
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS |ANIMAL RESEARCH | ENVIRONMENTAL HEALTH & SAFETY | CORE LABORATORIES | SPONSORED PROJECTS TECHNOLOGY MANAGEMENT
OFFICE OF RESEARCH 

Center for Clinical and Translational Sciences

Clinical Trials Resource Center (CTRC)
7000 Fannin Street, Suite 795

Houston, Texas 77030
phone 713-500-3622
fax 713-500-0334
clinicaltrials@uth.tmc.edu

last modified October, 2013
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