The IRB will review direct advertisements (per FDA guidance, “advertising that is intended to be seen or heard by prospective subjects to solicit their participation in a study”) for each research study to ensure that the advertisements are not unduly coercive and do not promise a certainty of cure beyond what is outlined in the ICF and the protocol. Direct advertisements include, but are not necessarily limited to: newspaper, radio, TV, bulletin boards, posters, and flyers that are intended for prospective subjects. Direct advertisements can also include the use of social media (please see the section Use of Social Media for Advertisement and Recruitment below).
The IRB must approve all direct advertising material (including any revisions and modifications to the material) prior to use. When reviewing direct advertising material, the IRB will consider the following:
The information contained in advertisements.
The mode of their communication.
The final copy of printed advertisements.
The final audio/video taped advertisements.
The content of direct advertising materials should be limited to the information that prospective subjects need to determine their eligibility and interest. When appropriately worded, the following items may be included:
The name and address of the clinical investigator and/or research facility.
The condition being studied and/or the purpose of the research.
In summary form, the criteria that will be used to determine eligibility for the study.
The time or other commitment required of the subjects.
A brief list of potential benefits, if any (e.g. no cost of health exam).
The location of the research and the person or office to contact for further information.
The content of direct advertising materials should NOT include the following (please see the section Examples of Recommended and Inappropriate Text below for examples):
Statements implying a certainty of favorable outcome or other benefits beyond what is outlined in the informed consent document and the protocol.
Claims, either explicitly or implicitly, that a drug, biologic or device is safe or effective for the purposes under investigation.
Claims, either explicitly or implicitly, that the test article is known to be equivalent or superior to any other drug, biologic or device.
Terms that may cause therapeutic misconception such as “new treatment,” “new medication,” or “new drug” without explaining that the test article is investigational. Therapeutic misconception occurs when a research subject doesn’t understand the distinction between the purpose of clinical research and of ordinary treatment, and therefore inaccurately attributes therapeutic intent to research procedures. This may lead the subject to believe that the main purpose of the research is to provide them with a benefit, which is not always the case in studies where the research is being performed to test out the effectiveness of a drug or device.
Promises of “free medical treatment” when the intent is only to say participants will not be charged for taking part in the investigation.
Emphasis on payment or the amount to be paid, such as bold type or larger font on printed media.
Promise of “coupons” good for a discount on the purchase price of the product once it has been approved for marketing.
Exculpatory language. The FDA and OHRP consider exculpatory language to be language that has the general effect of freeing or appearing to free an individual or entity from responsibility from malpractice, blame, fault or guilt. Therefore, advertisements cannot include language by which a subject waives his or her right to be compensated for injuries arising from participation in the research.
The following are not considered direct advertising material and are NOT required to be submitted to the IRB for review:
Communications intended to be seen or heard by health professionals, such as “dear doctor” letters and doctor-to-doctor newsletters (even when soliciting for study subjects)
Study-specific publicity intended for general audiences, such as news stories or financial page advertisements directed toward prospective investors.
Study-specific information posted on a website, as long as the website format limits the information provided to basic study information*, such as the title, the purpose of the study, and study locations (for example, postings to the Tufts Medical Center On-Line Clinical Trials Listing do not need to be submitted to the IRB for approval per OHRP and FDA guidelines).
*[If additional descriptive information (such as payment, risks and potential benefits, or requesting identifiable information) is added, such information is considered part of the informed consent process and therefore requires IRB review and approval.]
Communications that are educational or provide general information, such as postings or podcasts describing symptoms of an underlying disease.
Testimonials, videos, links, or other information communicated by a third party, such as a research participant’s post on an investigator’s Facebook page (unless information will be given to subjects by the Tufts’ researchers).
Use of Social Media for Advertisement and Recruitment
Advertisement and recruitment using social media falls under the same guidelines as all other advertisements discussed above; however, the IRB will allow for some flexibility when using social media that will be discussed below. “Social media” refers to Internet-based modes of communication that allow users to interact with the medium (typically a website) or other users of the medium. The term includes social networking websites (e.g. Facebook, LinkedIn, and Twitter) and social photo and video-sharing websites (e.g. Shutterfly and YouTube). Social media also can include blogs, podcasts, and text messages.
When social media is used as a recruitment tool, researchers must do the following:
Make sure that recruitment of potential subjects using a social networking site meets the criteria for equitable selection of participants and that sample selection is justified (for example, people with a specific type of condition are frequent users of a particular message board). Researchers should also be aware that in a social media or other Internet-based research settings, the respondent population may not be entirely under the researcher’s control, as the recruitment information can be forwarded or otherwise accessible to other individuals who may not be part of the intended participant pool. Researchers should, therefore, exercise caution to appropriately identify the target participant population as part of the recruitment process. This might include limiting eligibility to potential subjects located in the United States.
The IRB should review advertising and recruitment using social media including:
Communications generated by the research sponsor, the research team, or an outsourced agent for the research (such as a marketing agency or survey company).
Recruitment for a future study
Communication that could be considered to be re-initiating study activities of a study that was previously closed-out in the IRB
Paid search advertisements, in-text advertisements, and advertisements appearing on social networks such as Facebook, MySpace, and LinkedIn.
Any blog, blog post, tweet, or text that contains study-specific direct advertising must be submitted for review.
If a researcher establishes a social network page to promote a study, that page must be reviewed and approved by the IRB prior to implementation.
If a research team member on a study intends to use a social media/internet base/ public platform such as Twitter or Facebook, the use of this platform must be reviewed and approved by the IRB (prior to use). Investigators must include the plan to use the platform in the protocol or Site-Specific Appendix. Although this use would be considered advertising, each individual post does not need to be reviewed and approved by the Tufts MC / TUHS IRB (but you may choose to obtain prior IRB approval for a group of planned posts or specific post you would like to confirm is appropriate). Use of social media must be HIPAA compliant.
Any website links should be links to IRB approved advertisements, Tufts Online Clinical Trial listings, IRB approved website postings, or www.clinicaltrials.gov postings.
Examples of Recommended and Inappropriate Text
Examples of recommended text is as following:
“Should you consider a research study?”
This research study is currently recruiting at Tufts Medical Center”
“Research study to evaluate an investigational drug for (disease or condition)”
“Clinical trial testing a vaccine for (disease or condition)”
“Tufts announces new clinical trial of (drug) for (disease or condition)”
Inappropriate text is as following:
“Will this research study be the wave of the future for (disease or condition) treatment?”
“Fantastic news!: New clinical trial for (disease or condition)”