Advertising for Human Research Study Subjects

Quick Links and info
Introduction to human subject recruitment
What is an advertisement for subject recruitment?
What is NOT an advertisement for subject recruitment? 
How to develop advertising copy (text) for recruitment of human subjects:
Creation of advertising - Templates and Information:
IRB-HSR Submission and Approval Process 
How to submit advertising if the UVA IRB-HSR is not the IRB of record for your study
When can I submit subject recruitment materials?
Marketing Communications Advertising Process 
Non-Monetary Gifts and Incentives – Retention Incentives

Quick links and info:

To submit UVA HS Clinical Trials Website Advertising: 

Go to: www.uvahealth.com/clinicaltrials 

Submit all other ads:

Email to IRBHSRads@virginia.edu

Introduction to human subject recruitment

The Institutional Review Board-Health Sciences Research (IRB-HSR) must approve all materials for human subject recruitment before your recruitment efforts begin. This is a federal requirement. The Food and Drug Administration (FDA) considers advertising the first step in the informed consent process. Federal Regulations [21 CFR 50.20, 21 CFR 50.25, and 21 CFR 56.111(a)(3)] require that the IRB-HSR review and approve all advertisements seeking participants for enrollment in research. The IRB-HSR is required to review such material for informational content as well as the mode of its communication (i.e. TV, radio, newspaper and bulletin board). Generally, the FDA believes that any advertisement to recruit participants should be limited to the information the prospective subjects need to determine their eligibility and interest. 

IRB-HSR approval means regulatory requirements are met. Additional review and approval from UVA Marketing Communications and/or Public Relations may be required depending on the type of advertisement. The approval process for each type of ad is detailed below.   If the study has an outside sponsor, the advertisement may also need to be approved by the sponsor.

What is an advertisement for subject recruitment?

An advertisement to recruit subjects is any material whose purpose is to inform and invite potential subjects to participate in a research study and provides contact information for the potential subject to initiate study related communication. Typical recruitment materials include:

Indirect methods

  • bulletin boards, flyers and handouts, posters
  • classified ads (print and online)
  • general media (radio, television, online videos)
  • journal or magazine articles (print and online) soliciting participation
  • listserv emails
  • newspaper ads (print and online)
  • online ads
  • press releases that contain recruitment elements
  • social media posts
  • websites and website postings

presentations to the general public with the focus on recruitment may also be included.

Examples of the above include Daily Progress, Craigslist, Cville Weekly, Facebook, Google Adwords, StudyKIK, Vimeo, Youtube, UVA Health Clinical Trials website posts.

These lists is are not all inclusive, please contact the IRB if you have any questions.

Direct contact

  • letters
  • e-mails
  • telephone calls
  • verbal consent scripts

Any study materials given to the potential subject PRIOR to consent that might influence a potential subject’s decision to participate may also be considered recruitment material and should be submitted for IRB-HSR approval. This includes items such as study information sheets or informational videos, etc.

What is NOT an advertisement for subject recruitment? 

  • Communications focused toward health professionals, such as "Dear Doctor" letters and doctor-to-doctor letters (even when asking the physicians to refer potential subjects)
  • News stories and press releases that DO NOT contain recruitment information 
  • Publicity intended for audiences other than potential subjects, such as financial-page advertisements directed toward prospective investors 
  • Patient Education Materials to be distributed after the consent is signed. 

How to develop advertising copy (text) for recruitment of human subjects:

Recruitment materials should contain the following key elements:

  • Name of the enrolling facility. - "UVA Health" is the preferred location of reference.  This can be waived if UVA Health is already present in a logo, banner, or as part of a website. For ads where space is an issue, "UVA" is an acceptable abbreviation. 
  • Location of the study or research groupsuch as "Department or Division of..."
  • Name of condition/disease under study
  • Purpose of the research. Use lay language and aim for a sixth-grade reading level. Write in short, complete sentences. Make sure you are clear that you are recruiting for research as opposed to providing treatment. 
  • Major inclusion/exclusion criteria such as age/gender requirements. Do not copy this list from the protocol because this is too much information and too soon in the process.
  • BRIEF list of procedures required. For example: blood tests, X-rays, MRI, etc. that will be performed as part of the study. Of particular interest is information that may influence a potential subject's decision to participate such as use of placebos 
  • Time commitment for participation. For example: number of visits, length of each visit and total length of study participation.
  • Contact Information. Primary contact name and info. This should be UVA contact information, personal email or phone is not permitted. 
  • Name of Principal Investigator (PI). This is only necessary if it is not the primary contact. 
  • IRB-HSR number/UVA Study Tracking number. This information is required for almost every ad. 
  • Compensation (optional). Compensation may be mentioned but not emphasized (e.g., bold or larger font). Make clear if the amount mentioned is per visit or at study completion

Note: All elements do not have to be present in every ad.  Please refer to the templates for further guidance.

Recruitment materials should not include the following: 

  • Promise or imply treatment, cure or benefits. 
  • "Catchy" words like "free" and "exciting." Avoid all appearance of undue influence. 
  • Offer free care or free items provided as part of research procedures. For example: free exam, free medical supplies, free pedometer, etc. The statement that "Study-related medications, exams, tests, etc. are provided at no cost" is preferred. 

Creation of advertising - Templates and Information:

UVA Health Strategic Relations and Marketing provides an excellent service to assist you in the development of recruitment materials and social media promotion. Please visit https://www.uvahealthbrand.com/our-brands/uva-health for more information. The use of UVA Health brand to create print materials is strongly recommended to create professional print materials. Please contact UVA Strategic Relations and Marketing if you are interested in creating social media. 

IRB-HSR Social Media Information: 

Study team are required to use IRB templates for recruitment in the following cases: 

A UVA Health website ad is recommended for all studies engaging in recruitment. Social media ads created by UVA Health Marketing require a link to a web ad.

For other types of advertising, IRB templates are provided but their use is not mandatory. Even if not used, the templates should still be referred to as a guideline for content. 

When can I submit subject recruitment materials?

Once an IRB-HSR number has been assigned, recruitment materials may be submitted for review. Materials cannot be approved until the study is open to enrollment. 

IRB-HSR Submission and Approval Process

Electronic submission for pre-review 

To submit a UVA Health Clinical Trials Website ad: 

  1. Complete the UVA HS Clinical Trials Website template provided on this page. 
     
  2. Go to www.uvahealth.com/clinicaltrials and submit using the Submit a Trial for Advertisement link
     
  3. Be sure to choose the keywords and categories and upload the completed web ad.

Submit all other ads to IRBHSRads@virginia.edu.  Electronic submission is preferred; however, hard copy submissions will be accepted. Please be aware that revisions may be requested which will require electronic submission of an editable document. Please contact the IRB-HSR with further instructions for hard copy submission.

***A note about sponsor produced recruitment materials:

Review all documents provided by the sponsor before submitting to the IRB-HSR. Sponsor produced ads are often missing locally required elements such as HIPAA language and UVA site contact information. If the site will be using these materials, insert this information before submitting to the IRB-HSR.

For print material that is not editable, contact information can be included by affixing a sticker label (“stickie” template above) to the document at the time of distribution. 

Review and Approval

IRB-HSR will review advertising submissions within ten working days of submission. You will either receive a request for revision or notification that the advertising has been approved and is available in IRB Pro.

All ads are approved with no expiration date.

The IRB-HSR no longer issues approval stamps.  Documents approved prior to October 2019 will have approval stamps.  Stamped documents should be filed with regulatory documents; only clean versions (unstamped) should be distributed.

How to submit advertising if the UVA IRB-HSR is not the IRB of record for your study

The IRB-HSR does not review or approve recruitment material for protocols when not the IRB of record. Follow the IRB of record’s procedures to obtain approval of the advertisement.

The use of the UVA Health Clinical Trials Website Posting template is required as the website has specific fields for information to be entered.

To request an ad to be posted on the UVA Health System Clinical Trials website:

--or--

The UVA IRB-HSR will post the submitted ad and will provide documentation of receipt.

UVA Health System Strategic Relations and Marketing (Marketing.) Review

The use of UVA Health brand templates and downloadable materials (available at www.uvahealthbrand.com) is recommended to ensure the appropriate use of the UVA logo and related branding guidelines. Marketing staff also provide assistance in creating custom documents.

Marketing approval is required in addition to IRB-HSR approval for all print ads*, some online postings, radio and television ads, social media ads, and videos that use the name of UVA, UVA Health, and/or logo. This includes the use in contact information. Recruitment materials that require professional printing or result in a cost to the study team in order to produce the materials require Marketing approval.

*Ads printed in a publication, i.e. magazine, newspaper. Excludes Cville Weekly ads.

Radio/Television/Video

Radio, television and video scripts and actual recordings require approval by the IRB-HSR and Marketing. Scripts should be submitted for approval PRIOR to recording.

Final versions of recordings should be submitted for approval PRIOR to going live.

Social Media (Facebook, Twitter)

All social media postings must be approved by IRB-HSR.

Social media ads created by Marketing should be submitted to the IRB-HSR for approval. Additional Marketing approval is not required.

Social media accounts created for studies or research centers must be approved by the IRB-HSR and Marketing. Study teams should contact Marketing for assistance in developing the account. Once created, the study team should submit a Management Plan to the IRB-HSR for approval prior to going live (see template section). 

Non-Monetary Gifts and Retention Incentives

Non-Monetary Gifts and Incentives require IRB-HSR approval.

Submit the list of items  to IRBHSRads@virginia.edu. The list of items should contain a picture and/or description of the retention items (see template section). 

The IRB-HSR will review the items to verify if the use of these items appears to be exert undue influence. The Full Board may be asked to review the retention incentives to make a determination. Full Board review will always be requested for any item valued over $25.00 for items given to children and over $50.00 for adults.

If the board deems any item is inappropriate for use at UVA, the study team will be notified in writing of the board’s determination.


Version date 9-21-20