Updated 9th July 2010.

The following are the standards that advertisements must adhere to where there has not been approval of the advertisement by a HREC.

Where there has been approval of an advertisement by a HREC, Trialfacts will defer to that approval, except in the rare exception where a reasonable standard of patient protection has not been met.

General Guidelines

• Trialfacts follows the FDA guidance on recruitment of study subjects and International standards of Good Clinical Practice.
• It is imperative to ensure appropriate safeguards to protect the rights and welfare of research subjects.
• Patients must not be unduly coerced into participation in clinical research.
• The privacy of patients and our members must at all times be protected, at minimum to the standard of the National Privacy Principles (you can read our Privacy Policy here).

Advertising & Promotional Material Guidelines

• Promotional material should not state or imply a favourable outcome or other benefits beyond what is outlined in the consent document and/or the protocol.
• Promotional material must not explicitly or implicitly make any undue claims as to the safety of the research.
• Promotional material must not explicitly or implicitly make any undue claims as to the efficacy of the treatment.
• Promotional material must be clear at all times that the research is experimental.
• Promotional material should avoid use of the word “free”, and instead employ the phrase “at no cost” where appropriate.
• Promotional material must not emphasise any compensation for taking part in the research.

Our Service

• We will not publish any advertisements for clinical research unless the advertiser has sought and received approval from a properly constituted Human Research Ethics Committee for the advertisement in question.
  • It is the responsibility of the advertiser to seek such approval, and provide confirm such approval.
• If a HREC requires changes to a published advertisement, we will make the required changes or remove the advertisement as soon as is reasonably possible (generally within 1 business day).

Information not requiring HREC approval

• In line with FDA guidance and industry practice we will not require HREC approval for basic trial information that is collected by clinical trial registries clinicaltrials.gov and anzctr.org.au. This includes:
  • Target conditions
  • Trial site locations
  • Principal Investigator
  • Ethics Committee
  • Basic eligibility criteria
  • How to contact the site for further information
• Information that does require ethics approval:
  • Any kind of advertisement
  • Any material mentioning potential benefits of participation
  • Any material which explicitly or implicitly makes a claim as to the safety of the research
  • Any material which explicitly or implicitly makes a claim as to the efficacy of the treatment
  • Any other information

Feedback

• We’re interested in your comments and feedback. Please contact us.