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THE COMMITTEE ON HUMAN RESEARCH
USCF ADVERTISEMENTS, NOTICES, AND/OR MEDIA FORMAT GUIDELINES
(March 2008)
• Requirments
• LImitations
Requirements
The text of any advertisements, notices, and/or media materials must include a reference to UCSF* and should be limited to the following information:
- The name and address of the investigator or research facility.
- The condition under study.
- the purpose of the research.
- Summary of the criteria used to determine eligibility.
- Brief list of participation benefits, if any (e.g., a no-cost health examination).
- Time or other commitment required.
- Location of the research.
- Person or office to contact for further information.
* An exception may be made for national recruitment campaigns but these will be reviewed on a case-by-case basis.
Limitations
The researcher and the CHR must ensure that the advertisements, notices, and/or media do not:
- State or imply or imply a certainty of favorable outcome or other benefits beyond what was outlined in the consent document and the protocol.
- Make claims, either explicitly or implicitly, that the research procedures were safe or effective for the purposes under investigation.
- Make claims, either explicitly or implicitly, that the research procedures were known to be equivalent or superior to other drugs, biologics, or devices.
- Use terms such as “new treatment,” “new medication,” or “new drug” without explaining that the test article was investigational.
- Promise “free treatment” when the intent was only to say participants would not be charged for taking part in the investigation.
- Emphasize the payment or the amount to be paid, by such means as larger or bold type.
- Include any language that announces the investigator cannot be held liable or at fault for any research related event.
- Allow for compensation towards the investigational agent once FDA approved.
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