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

 

 

 

 

 

 

Advertising for Human Research Study Subjects

Submit all subject recruitment materials to:    http://www.healthsystem.virginia.edu/pub/clinical_trials

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. These materials include:

  • Bulletin boards
  • Flyers and handouts
  • Journal articles (if they contain recruitment information)
  • Letters and e-mails
  • Newspapers (paid and free classified ad and formal display ad)
  • Posters
  • Presentations to general public with focus being subject recruitment
  • Press releases
  • Radio (paid and public service announcement (PSA)
  • TV and cable (paid and PSA)
  • Website postings
  • Telephone contact with potential subject

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 or general information about the study when the focus is to inform but not to recruit

A special note about contacting potential subjects by letter or telephone:

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.

When can I submit subject recruitment materials?

Once your study (protocol/consent) has been approved by the IRB-HSR you may submit clinical trial advertising materials to IRB-HSR for review and approval. 

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

Recruitment materials should contain the following key elements: 

  • Name of facility - "UVa Health System" is the preferred location of reference.  Note for display advertising and internal publications ads: This information is included in a pre-approved page banner or logo, so does not have to be repeated in the text of the ad. Department and/or division must also be included whenever possible. For non-display 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. 
  • 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 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."

Templates are available for the following ads, text or scripts:

IRB-HSR Submission and Approval Process

As previously stated, all subject recruitment materials must be approved by the IRB-HSR. You may submit an advertising request to IRB-HSR as soon as an IRB-HSR number is assigned to your study using the following link:     http://www.healthsystem.virginia.edu/pub/clinical_trials
When you go to this website, you will complete the information requested and attach your advertising document(s) to the form. The documents will be sent to IRB-HSR via e-mail. IRB-HSR will review these documents within five days of submission and either send suggested revisions if needed.  Once the review is complete you will be asked to submit hard copies of the recruitment materials .You will receive an Assurance/ Approval Form with the approved ads attached.  The approval documents should be filed with your regulatory documents.

If you are submitting an ad for a center's services that include opportunities for research, you will not be able to submit through this website.  Please submit these sorts of ads via e-mail to IRBHSRads@virginia.edu or by hard copy to IRB-HSR. If only hard copies of recruitment materials are available, submit 2 copies of each item.
Sponsor-produced ads 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.

All ads are given a five-year approval. If you wish to renew or revise the ad, you will need to re-submit the ad. The ad will automatically be taken off the website on the expiration date or when the IRB-HSR office has been notified that the study is closed to enrollment.
A website ad is required for all studies engaging in indirect recruitment. If you do not submit one, the IRB-HSR will ask you to create this posting OR may create a website ad for you from the advertising materials you previously submitted and forward this to you for approval. Ads approved and posted through IRB-HSR database appear automatically on the following website:
www.healthsystem.virginia.edu/clinical_trials

Marketing Communications Advertising Process

All print ads*, and radio and television commercials used to support human subject recruitment for research must be approved by both IRB-HSR and the UVa Marketing Communications Department (MC) before they are released for publication or broadcast.

 

Print Process: 

Newspaper and magazine display ads (not LINK or C-ville Clinical Trials classifieds)

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 Clinical Trials Classified

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.


LINK Clinical Trials Ad


LINK inclusion is on a first come-first served basis and requires completion of response data questionnaire with Clinical Trials Office before repeated insertion will be accepted. There is a space limit of six ads per issue.

Step One:  Copy Approval

  • CRC presents copy in LINK template form to IRB-HSR
  • IRB-HSR reviews and approves and forwards to CRC

Step Two:  Request Placement

  • CRC completes listing information on template
  • CRC sends completed, IRB-HSR-approved template to linktrials@virginia.edu by the 10th of the month prior to publication

Step Three:  Ad Production


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 and issues Pending Approval and forwards to CRC
  • CRC sends script marked Pending Approval 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 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 Audio 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 Process


Both television script and actual videotape need to be approved by IRB-HSR and Marketing.

Step One:  IRB-HSR Script Approval

  • CRC presents script in television template to IRB-HSR
  • IRB-HSR reviews and issues Pending Approval and forwards to CRC
  • CRC sends script marked Pending Approval to MC
  • MC reviews and approves script and forwards to CRC

Step Two:  Media Plan Option 1

  • 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

  • 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 with Pending Approval stamp to television station for video recording
  • Station sends video recording to CRC or MC
  • CRC and MC share video recording with each other for MC approval

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 03-08-12