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IRB-HSR > Getting Started> Advertising for Human Research Study Subjects

 

 

 

 

 

 

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

Quick links and info:

To submit UVA HS Clinical Trials Website Advertising:

Go to:
www.medicalcenter.virginia.edu/intranet/clinical_trials

Submit all other ads (except sponsor-produced recruitment materials)

Email to IRBHSRads@virginia.edu.

Submit sponsor produced recruitment materials in hard copy format.

Please see below under Hard Copy Submission

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 only means regulatory requirements are met. There may be additional involvement and/or authorization from UVa Marketing Communications and/or Public Relations 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 need to be approved by the sponsor as well.

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 and provide contact information for the potential subject to initiate study related communication. These materials include bulletin boards, flyers and handouts, journal articles with recruitment elements (contact information). (if they contain recruitment information), press releases ONLY if they contain recruitment material, Letters and e-mails, Newspapers (paid and free classified ad and formal display ad), Posters, Presentations to general public with focus being subject recruitment, Radio (paid and public service announcement (PSA), TV and cable (paid and PSA), Websites and website postings, Telephone contact with potential subject, Google ad postings, Twitter tweets, Facebook postings, Craigslist etc.
Of note, by this definition any study information given to the potential subject PRIOR to consent that might influence a potential subjectís decision regarding study participation may be processed as recruitment material and should be submitted for IRB approval as well. 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 System" is the preferred location of reference.  Note for advertising in papers and on websites that already list UVa Health System on a marketing- approved banner page or logo etc, the name UVA Health System does not have to be repeated. For ads where space is an issue, "UVa" is an acceptable abbreviation.
  • 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 subjectís 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.
  • Compensation. Compensation should be mentioned but not emphasized. Make clear if the amount mentioned is per visit or at study completion.
  • Contact Information. Primary contact name and info.
  • Name of Primary Investigator (PI). This is only necessary if it is not the primary contact.
  • IRB-HSR number. This information is required for almost every ad.

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:

  • Do not promise treatment, cure or benefits.
  • Do not use "catchy" words like "free" and "exciting." Avoid all appearance of coerciveness.
  • Do not use words that could be insulting to a potential subject. For example, use "overweight" instead of "fat," and "lean" instead of "skinny", etc.
  • Do not use words that evoke the "YUK response" such as pus, snot, etc.) 
  • Do not offer free care. The statement that "Study-related medications, exams, tests, etc. are provided free of charge" is acceptable. Do not state "Free treatment" or "Free care."

Creation of advertising - Templates and Information:

UVa Health System Marketing and Communications provides an excellent website to assist you in the development of recruitment materials. Please visit UVABRAND.COM The use of UVa brand to create these sorts of materials is strongly recommended but not required. In addition, if the study team wishes to use any form of social media it is essential that Marketing be involved in the development.

Social Media Information:

Please contact UVA Marketing is you are interested in creating Social Media.

 

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

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.

IRB-HSR Submission and Approval Process

Electronic submission for prereview

Submit all ads(except UVA HS Clinical Trials Website ads and sponsor produced recruitment materials or Center/Department Research Center ads) to IRBHSRads@virginia.edu. All submissions MUST include either a Routing Form OR an Advertising Submission Checklist

To submit a UVA HS Clinical Trials Website ad: (Note you get 1 UVA HS Clinical Trials Website post per study)

    1. Go to:
      www.medicalcenter.virginia.edu/intranet/clinical_trials


    2. Use the UVa HS Clinical Trials Website Template provided on this page. Be sure to select the categories and keywords you wish to use.

    3. Upload the completed template when ready for prereview.
    4. To submit Sponsor produced recruitment materials:

      1. Submit in hard copy format. Please see below under Hard Copy Submission

IRB-HSR will review advertising submissions within five days of submission. You will either receive a request for revision or notification that the advertising is ready for approval.

Hard Copy Submission

Once the review is complete you may be asked to submit hard copies of the recruitment materials All hard copies should be returned to the IRB in the following manner:

  • Submit 2 copies of EACH RECRUITMENT item.
  • Label each ad with the ad TYPE (print ad, poster, flyer, etc)
  • Label each ad with the IRB number
  • Submit copies in an organized fashion. IF a recruitment type has multiple pages, staple the pages that go together. (For example if a website ad with 6 pages is being submitted, make 2 packets of 6pages stapled together and each labeled WEBSITE.
  • Sponsor-produced ads that will be distributed locally are often are missing some required elements. This can often be corrected by affixing a "stickie" to each of the ads. You may use the "stickie" template provided below.
  • Stickie
  • Include a completed Routing Form

Please note any hard copies submitted in any other manner will NOT be processed for approval but will be returned to sender

All ads are approved with no expiration date.

You will receive an Assurance/ Approval Form with the approved ads attached. The approval documents should be filed with your regulatory documents.

A website ad is recommended for all studies engaging in recruitment.

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

  • You will need to follow the procedures of the IRB of Record to obtain their approval of the advertisement.
    • If you will want the ad to be posted on the UVa Health System Clinical Trials Website you are encouraged to use the template above for the ad as this template was developed with the Clinical Trials Office and UVa Marketing.
  • If you want the UVa IRB to post your UVa HealthSystem Clinical Trials Website ad take the following steps:
    • Submit the approved ad along with the approval of the ad from the IRB of Record through www.medicalcenter.virginia.edu/intranet/clinical_trials. This will allow you to provide the IRB with the keywords and categories you desire.
    • The UVa IRB will post the submitted ad for you. You will be provided with documentation of receipt.
  • If you are paying for advertising out of your UVa budget OR if the sponsor is producing recruitment material that uses the name of UVA, you will be required to obtain Marketing Approval and submit documentation of Marketing approval to the IRB.

When can I submit subject recruitment materials?

Once your study has been assigned an IRB-HSR number you may submit advertising materials to IRB-HSR for review. An approval for recruitment materials cannot be issued until the protocol is approved and opened for enrollment.

Marketing Communications Advertising Process

All print ads*, radio, television ads and social medial ads used in human subject recruitment for research must be approved by both IRB-HSR (if UVA IRB-HSR is the IRB of record) and the UVa Marketing Communications Department (MC) before they are released for publication or broadcast if they use the name of UVA or UVA HealthSystem in the ad even if just for contact information. In addition, any recruitment materials that require professional printing or result in a cost to the study team in order to produce the materials (excluding CVille recruitment) should be approved by Marketing.

*Ads printed in a publication, i.e. magazine, newspaper. This does not include flyers and handouts.

 

Print Ad Process: 

Newspaper and magazine display ads (not C-ville etc)

Step One:  Copy Approval

  • Clinical Research Coordinator (CRC) presents copy in template form to the IRB-HSR
  • IRB-HSR reviews and approves copy and sends approval to CRC
  • CRC sends IRB-HSR -approved copy to MC ( (243-0529)

Step Two:  Media Plan Approval

  • CRC provides MC with general idea of where and when ad should run, along with a general budget
  • MC will prepare and send CRC a Media Purchase Authorization (MPA) for review and approval
  • CRC may request changes to plan or sign and add PATEO and fax to MC (3-0529)

Step Three:  Ad Production

  • MC will design ad based on MC template
  • MC sends PDF of ad to CRC for approval
    • IF IRB-HSR-approved text is altered or if pictures are added, IRB-HSR needs to re-approve at this point. CRC should send modified ad to IRB-HSR for re-approval.
  • CRC returns ad to MC via fax (3-0529) as approved or with changes

Step Four:  Media Reservations

  • MC reserves space based on the signed MPA

Step Five:  Media Placement

  • MC prepares camera-ready material for various publications
  • MC sends to various publications and confirms receipt

Step Six:  Payment

  • MC pays invoice from publications
  • MC IDTs using the PATEO provided on MPA


C-ville Ads

Step One:  Copy Approval

  • Clinical Research Coordinator (CRC) presents copy in C-ville template form to IRB-HSR
  • IRB-HSR reviews and approves copy and sends approval to CRC

Step Two:  Request Placement

  • CRC completes listing information on template
  • CRC sends completed template (approved copy and listing information) to the Clinical Trials Office

Step Three:  Ad Production

  • Clinical Trials Office sends ads to MC
  • MC formats C-ville Clinical Trials page
  • MC sends camera-ready materials to C-ville

Step Four:  Payment

  • Clinical Trials Office sends billing information to C-ville
  • C-ville invoices CRC for individual ad
  • Note: It is the responsibility of the CRC to insure payment is processed promptly.


Radio Process


Both radio script and actual recording need to be approved by IRB-HSR and MC.

Step One:  IRB-HSR Script Approval

  • CRC presents script in radio template to IRB-HSR
  • IRB-HSR reviews submission
  • Once review process is complete IRB-HSR issues Approved Pending Minor Modifications (the minor modification needed = Marketing Approval) and forwards to CRC. The ad(s) will have no stamp on them so the actual Approved Pending Minor Modifications Assurance Form must accompany the submission to MC
  • CRC sends script withApproved Pending Minor Modification to MC
  • MC reviews and approves script and forwards to CRC

Step Two:  Media Plan Option 1

  • CRC contacts radio stations for available times and prices
  • CRC decides when and where spots will run
  • CRC sends run schedule to MC for approval
  • CRC sends MC-approved audio recording to IRB-HSR for final approval
  • IRB-HSR reviews and sends final approval or the recording to CRC
  • CRC sends final approval to MC (option 2) or station (option 1)

Step Two:  Media Plan Option 2

  • CRC contacts MC with request for placement
  • MC develops schedule based on audience and budget
  • MC presents plan to CRC for approval
  • CRC sends approval to MC
  • MC reserves air time

Step Three:  IRB-HSR Recording Approval

  • CRC or MC (option 1 or 2) sends script with Pending Approval stamp to radio station for recording
  • Station sends audio recording to CRC or MC
  • CRC and MC share audio recording with each other for MC approval
  • CRC sends MC-approved audio recording to IRB-HSR for final approval
  • IRB-HSR sends final approval to CRC
  • CRC send final approval to MC (option 2) or station (option 1)

Step Four:  Payment

  • CRC provides station with billing information
  • Station invoices CRC
  • Note: it is the responsibility of the CRC to insure payment is processed promptly


Television/You Tube Process


Television and You Tube scripts and actualrecordings need to be approved by IRB-HSR and Marketing.

Step One:  IRB-HSR Script Approval

  • CRC presents script to IRB-HSR
  • IRB-HSR reviews submission
  • Once review process is complete IRB-HSR issues Approved Pending Minor Modifications (the minor modification needed = Marketing Approval) and forwards to CRC. The ad(s) will have no stamp on them so the actual Approved Pending Minor Modifications Assurance Form must accompany the submission to MC
  • CRC sends script ans approval documentation to MC
  • MC reviews and approves script and forwards to CRC

Step Two:  Media Plan Option 1 For Television

  • CRC contacts television stations for available times and prices
  • CRC decides when and where spots will run
  • CRC forwards run information to MC for approval

Step Two:  Media Plan Option 2 For Television

  • CRC contacts MC with request for placement
  • MC develops schedule based on audience and budget
  • MC presents plan to CRC for approval
  • CRC sends approved plan to MC
  • MC reserves air time

Step Three:  IRB-HSR Recording Approval

  • CRC or MC (option 1 or 2) sends script Approved Pending Minor Modification to television station for video recording OR video recording is created
  • Station sends video recording to CRC or MC or video creator provides recording to CRC or MC
  • CRC and MC share video recording with each other for MC approval
  • CRC sends the final recorded ad to IRB-HSR
  • IRB-HSR sends a final Approved Advertising to CRC
  • Final recorded ad is scheduled for airing with station OR final recorded ad is posted to YouTube

Step Four:  Payment For Television

  • CRC provides station with billing information
  • Station invoices CRC
Note: it is the responsibility of the CRC to insure payment is processed promptly.


Social Media (Facebook, Twitter , Google Ads, etc.)


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

Step One: IRB-HSR Approval

  • CRC presents submission to IRB-HSR
  • IRB-HSR reviews submission
  • Once review process is complete IRB-HSR issues Approved Pending Minor Modifications (the minor modification needed = Marketing Approval) and forwards to CRC. The ad(s) will have no stamp on them so the actual Approved Pending Minor Modifications Assurance Form must accompany the submission to MC
  • CRC sends the Approved Pending Minor Modifications document to MC
  • MC reviews and approves ad and forwards to CRC

Step Two:  Media Plan

  • CRC contacts MC with request for placement
  • MC develops schedule based on audience and budget (if applicable)
  • MC presents plan to CRC for approval
  • CRC sends approved plan to MC

Step Three:  IRB-HSR FINAL Approval

  • CRC sends final approved social media to IRB-HSR
  • IRB-HSR reviews and sends the Advertising Approval document and stamped final ads to the CRC
  • CRC works with marketing to perform the actual posting.

Step Four:  Payment

  • CRC provides station with billing information
  • Station invoices CRC
  • Note: it is the responsibility of the CRC to insure payment is processed promptly.

* Revision date 02-29-16 *