Hi Anonymous,
Did you refer to the 1999 guidance on recruiting investigators and subjects
here? If the materials are approved by an IRB for patient facing use, then they may be ok, but as you can see in the guidance, they want the IRB to review/comment not only on content but on the on the "mode of its communication." See excerpts below.
When recruiting study subjects, sponsors and investigators should take the following into consideration:
1. Direct recruiting advertisements are seen as part of the informed consent and subject selection process [see 21 CFR 50.20, 50.25, 56.111(a)(3) and 812.20(b)(11)]. IRB review is necessary to ensure that the information provided is not misleading to subjects. This is especially critical when a study may involve subjects who are likely to be vulnerable to undue influence.
2. When direct advertising is used, the IRB should review the information contained in the advertisement and the mode of its communication, to determine that the procedure for recruiting subjects is not coercive and does not state or imply a certainty of favorable outcome or other benefits beyond what is outlined in the consent document and the protocol.
3. No claims should be made, either explicitly or implicitly, that the device is safe or effective for the purposes under investigation, or that the test article is known to be equivalent or superior to any device.
4. Advertising for recruitment into investigational device studies should not use the term "new treatment," without explaining that the test article is investigational. A phrase such as "receive new treatments" implies that all study subjects will be receiving newly marketed products of proven worth.
5. Advertisements should not promise "free medical treatment" when the intent is only to say subjects will not be charged for taking part in the investigation. Advertisement may state that subjects will be paid, but should not emphasize the payment or the amount to be paid.
Generally, FDA believes that any advertisement to recruit subjects should be limited to the information the prospective subjects need to determine their eligibility and interest. The following should be included in advertisements, but FDA does not require inclusion of the listed items:
1. The name and address of the clinical investigator and/or research facility;
2. The condition under study and/or the purpose of the research;
3. In summary form, the criteria that will be used to determine eligibility for the study;
4. A brief list of participation benefits, if any (e.g., a no-cost health examination);
5. The time or other commitment required of the subjects; and
6. The location of the research and the person or office to contact for further information.
Hope that helps!
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Douglas Ferguson
VP, Clinical and Regulatory
Concord MA
United States
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Original Message:
Sent: 29-Sep-2022 20:36
From: Anonymous Member
Subject: IDE study recruiting patient website
This message was posted by a user wishing to remain anonymous
Hello Experts!
I am reviewing a website intended for recruiting subjects for an IDE trial.
I have made edits to ensure balance of risks and benefits and to avoid implied claims of effectiveness. I am getting pushback, with the primary argument being that the company doesn't bear any risk because the materials are IRB approved. And that the FDA information is directed to IRBs and Investigators, not sponsors.
I kind of understand the argument that the only intent of this is to talk to the HCP to see if you might qualify and there is a robust informed consent process that follows, so full disclosure is not required. I have always understood that risks need to be disclosed as well as benefits, and that the sponsor bears responsibility even if material is approved by an IRB.
Where do others draw the line on this?