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Informed Consent Document Templates

SECTION 27

Research Subject Advertising

Under Federal Regulations [21CFR 56] all announcements and advertisements including e-mail and bulletin board notices, posters, etc. for research study subjects must be reviewed and approved by the Human Assurance Committee (HAC) prior to posting. Advertising is considered to be part of the recruitment and informed consent process.  No advertisements or announcements may be utilized until the study (and advertisements) has written HAC approval.  

The proposal must describe where the advertisements will be placed. All Medical College of Georgia (MCG) printed announcements or advertisements must include the official MCG seal, or the Research Templates provided by the Office of Strategic Communications. 

The announcement or advertisement should be limited to:

• Principal investigator's (PI) name, address and telephone number
   
  

• Purpose of the study and eligibility criteria
   
  

• A truthful description of the benefits (e.g., payments, free treatment, etc.)
   
  

• Location of research and contact person
   
  

• HAC file number 

According to MCG policies, the Graphics Standards Committee in addition to the HAC must approve all announcements and advertisements involving MCG personnel or facilities. DO NOT send the advertisement directly to the MCG Graphics Standards Committee.  The HAC staff will send the advertisement to the MCG Graphics Standards Committee.

The investigator or designee will be notified of any requested revisions.  A letter of HAC approval will not be sent to the investigator until the HAC receives approval from the Graphics Standards Committee. Approved announcements or advertisements will bear a stamp of approval from the HAC.  Any bulletin board notices must use the HAC stamped approved copy of the advertisement.  Revisions to previously approved ads must be submitted to the HAC for approval prior to placement.

Written scripts for television, 800 referral lines or radio ads must be submitted to the HAC with a completed HAC Form 100, Clinical Study Document Cover Sheet, prior to the placement of such ads.

Hints for advertisements:

• Use proper grammar
   
  

• If subjects will be paid for participation or reimbursed for expenses, do not include the actual monetary amount
   

• Be certain that the advertisement is not coercive

Letters to fellow physicians providing notification of the study do not require HAC approval.  However, direct mail letters to prospective subjects do require approval.  There are special circumstances surrounding the approval of these letters. 

VAMC advertisements are approved by the HAC only; they do not require approval by the MCG Graphics Committee.
 

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February 20, 2007