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 (HRP-315).
Certain restrictions apply to studies that will use or disclose Protected Health Information (PHI) in the identification and recruitment of participants. Please review HIPAA guidance.
You will be asked to include a description of your recruitment methods in either the protocol or the local addendum to the sponsor's protocol.
Note: Some online platforms have limitations for the invitation being sent to potential participants 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 of the required information, the IRB may accept the briefer ad.
- Study title and IRB study number.
- The word "research." Make it clear that this is a research study.
- "Northwestern 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.
- "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.
- 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."
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.
For online recruitment, projects may use teaser ads placed on social media sites such as Facebook, Twitter, Tumblr, and Vimeo where character length is limited as long as
- the teaser mentions that it is a research project
- the teaser does not use inflammatory language or misleading statements
- the teaser refers the potential participant to a full flyer with all of the required elements
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 NU. Investigators should ensure they are in compliance with NUIT’s policy and procedures for the use of bulk e-mail at NU and the steps for obtaining approval to send bulk e-mail through the enterprise NU Bulk E-mail system.
NU and the FDA do not require IRB review of the following recruitment materials:
- Materials given to healthcare providers intended to solicit research participants which are not given to or seen by the potential participant (e.g. “dear doctor” letters) do not require IRB review. However, the process (e.g. contacting healthcare providers for referrals) is required to have IRB review and approval.
- Publicity intended for individuals that are not prospective participants for a particular study
- Listing of clinical trials on a website - only if limited to title, purpose, protocol summary, eligibility criteria, study sites, and contact information for the investigator.
Recruitment Strategies that are not allowed
- Finder's Fees / Recruitment Incentives: NU policy prohibits the acceptance or use of finder's fees, direct recruitment incentives, or bonuses of any type to enroll study participants.
- Cold Calling: NU policy generally restricts the use of "cold calls" to recruit participants to research studies. An introductory letter or other informational material must be sent first or given directly to participants prior to telephone contact. Exceptions may be made on a case-by-case basis; for example, if the potential participants have previously agreed to be listed on a research registry for future research studies, are currently participating in a study conducted by the same investigator, or are frequently seen by or are well known to the investigator.
- General Ads or Flyers: General advertisements are defined as recruitment materials that describe more than one research study. The IRB prohibits the use of general advertisements because it is difficult to keep the information up to date due to modifications made over the life-cycle of several studies. Advertisements must be study-specific.