Recruitment Materials & Guidelines

All materials aimed at recruiting participants into a research study (including the final copy of printed advertisements, scripts, audio or video tapes, or web sites) must be reviewed and approved by the IRB prior to use.
You will be asked to include a description of your recruitment methods in the protocol on OneAegis. Certain restrictions apply to studies that will use or disclose Protected Health Information (PHI) in the identification and recruitment of participants.

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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 participants will be paid for their time and effort
- Acceptable:
  - “You will be compensated for your participation.”
  - “You will receive a gift card to X for [amt.] for your participation.”
  - “Participants will be compensated.”
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.

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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 “Participants invited.”

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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 “new treatment”, “new medication”, or “new drug” in reference to a drug or device without explaining that the test article is investigational
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.

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Types of Recruitment Materials

Teaser Advertisements:

For online recruitment, projects may use teaser ads placed on social media sites such as where character length is limited:

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:

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 participants

Facebook:

Allowable for recruitment and secondary data analysis only
Northwestern does not recognize Facebook as an approved third-party provider and the platform cannot be used to interact with participants (e.g. via interviews, surveys, or focus groups).

What is the difference between Groups and Pages in Facebook?

Pages are open forums that can be 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.

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.

Bulk E-Mail:

The IRB is responsible for the review and approval of the content of bulk e-mail intended to solicit participants for a research study. It does not oversee the sending of the bulk e-mail at BYU. Investigators should ensure they are in compliance with for the use of bulk e-mail at BYU and the steps for obtaining approval to send bulk e-mail through the bulk E-mail system.

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Recruitment Materials & Guidelines

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