Recruitment Materials and Guidelines

Recruitment materials directed to potential subjects must be reviewed and approved by the IRB prior to use to ensure they are not unduly influential or misleading (301 FO). Recruitment materials must include information prospective subjects need to determine their eligibility and interest. Materials should be written in a language understandable to the subjects.

You will be asked to include a description of your recruitment methods in section 8 of the application.

Note: Some online platforms have limitations for the invitation being sent to potential subjects that prevent the inclusion of all the IRB-required elements. In that instance, document the limitation in writing for the IRB and, if the recruitment invitation links directly to an online consent that contains all the required information, the IRB may accept the briefer ad.

Required Elements:

• Study title and IRB study number
• The word “research.” Make it clear that this is a research study
• “Brigham Young University”
• The PI’s name
• A contact name with either a phone number or e-mail address
• Eligibility criteria, if applicable, should be noted briefly. Especially if payment depends on meeting these criteria. For example, “English speaking only,” “Women only,” etc.
• State whether subjects will be paid for their time and effort

• If your study involves a drawing, include the odds of winning.

  • Acceptable:

    • “You will be compensated for your participation.”
    • “You will receive a gift card to X for [amt.] for your participation.”
    • “Subjects will be compensated.”
    • "Subjects will be entered into a drawing for [prize], with an estimated [1 in X] chance of winning."
• The amount of payment may be included but should not be the most prominent element on the page. Compensation should not be excessive considering the nature of the project. Payment should be stated as a range of amounts or stated as “at least” or “up to” for payments dependent on the amount of participation.

Recommended Elements:

• Purpose of the study
• What is expected of the participant
• The time commitment
• The location where the research will take place
• Avoid phrases such as “help needed” or “subjects wanted.”
• The recommended wording is “You are invited” or “Subjects invited.”

Elements That Are Not Allowed*:

• Offers of compensation from the sponsor that would involve a coupon good for a discount on the purchase price of the product once it has been approved for marketing
• Claims that state or imply a certainty of a favorable outcome or other benefits beyond what is outlined in the consent document and protocol
• Claims that the drug, biologic or device is safe or effective for the purpose under investigation
• Claims, either explicitly or implicitly, about the drug, biologic, or device under investigation that are inconsistent with FDA labeling
• Use of the term “free” in reference to treatment or procedures
• Use of exculpatory language (language in the advertising whereby prospective subjects waive or appear to waive any of their legal rights)
• Use of bold or enlarged print or other means to emphasize payment or the amount to be paid

*Contact the IRB with any requests to include disallowed elements that may be appropriate within specific contexts of research.

Teaser Advertisements:

For online recruitment, projects may use teaser ads placed on social media sites where character length permits the following information:

• the teaser mentions that it is a research project;
• the teaser does not use inflammatory language or misleading statements; and
• the teaser refers the potential participant to a full flyer with all the required elements

Social media can be defined as any online and mobile resource that provides a forum for generating, sharing, or discussing ideas and content; variably grouped as online communities (e.g., patient support groups, population-specific dating services); social networking (e.g.,

Facebook; Twitter); professional networking (e.g. LinkedIn); content production and sharing (e.g., YouTube, Tumblr, blogs); location-based services (e.g. Tinder, Grindr); and others.

Ensure that proposed social media recruitment strategies respect all relevant ethical norms, including:

• Proposed recruitment does not involve deception or fabrication of online identities
• Research studies are accurately represented in recruitment overtures
• Proposed recruitment does not involve members of research team ‘lurking’ or ‘creeping’ social media sites in ways members are unaware of
• Recruitment will not involve advancements or contact that could embarrass or stigmatize potential subjects

Facebook:

• Allowable for recruitment and secondary data analysis only

What is the difference between Groups and Pages in Facebook?

Open forums are known as Pages and are created by companies, celebrities, and brands. These are public and although only administrators of Pages can post to the account, people with personal Facebook profiles can comment on any posts or pictures. The comment feature cannot be disabled, but comments can be removed/hidden by the administrator.

VS.

Groups can be more private than Pages because the administrator has an option to choose the privacy setting. The comment feature can be managed in each group, as determined by the administrator.

• In “Closed Groups,” only those who are invited to join the group can see content shared within it. Other people on Facebook can see that the Group exists and who are members, but unable to see any information.
• “Secret Groups” are more private and no one else on Facebook can see that the Group exists except its members. The Group will not appear on the personal Facebook profile.
• “Public Groups” allow anyone on Facebook to see that the group exists and view the information that is posted, but only members of the Group have the ability to post.