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Recruitment Materials and 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 (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 Northwestern Medicine’s Research Privacy and Confidentiality Policy and Research Recruitment FAQs.

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 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
  • “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
    • 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.

For additional guidance on recruitment materials, refer to HRP-315 WORKSHEET Advertisements (Recruitment Materials)

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.”

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.

Teaser Advertisements:

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

  • 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 participants

Facebook:

  • Allowable for recruitment and secondary data analysis only

Note: 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?

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.

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 Northwestern.  Investigators should ensure they are in compliance with for the use of bulk e-mail at Northwestern and the steps for obtaining approval to send bulk e-mail through the enterprise Northwestern Bulk E-mail system.

Northwestern 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.
  • Publicly intended for individuals that are not prospective participants for a particular study.
  • Listing on a website – only if limited to title, purpose, protocol summary, eligibility criteria, study sites, and contact information for the investigator.

Recruiting Individuals Where No Treatment Relationship Exists:

NMHC Health Care Professionals or Northwestern employed Researchers who are recruiting patients where no treatment relationship exists may recruit NMHC patients as follows:

  • Prior Permission to Recruit: Researchers do not need to obtain permission from an individual’s treating provider prior to recruiting the individual.
  • Face-to-Face: Face-to-face contact is allowed within NMHC facilities. For this purpose, a Researcher may receive names of potential study participants from the EDW.  Where necessary, direct access to NMHC’s electronic medical records may also allowed where real-time data is required (e.g., checking patient schedules).
  • Cold-Calling: Researchers who do not have a treatment relationship with an individual may contact that individual (i.e. as a potential study subject) by phone, email, or letter. Contact information for such “cold-contact” activity must be obtained from the EDW to ensure that patients who have indicated that they do not want to receive recruitment emails, letters or phone calls are not contacted.

Recruitment Strategies That Are Not Allowed:

  • Finder’s Fees / Recruitment Incentives: Northwestern policy prohibits the acceptance or use of finder’s fees, direct recruitment incentives, or bonuses of any type to enroll study participants.
  • 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.