Institutional Review Board for Health Sciences Research (IRB-HSR)

Getting Started

Subject Selection, Recruitment and Compensation

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 subject's 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?

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

Recruitment materials should contain the following key elements:

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:

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)


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:

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

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

Step Two:  Media Plan Approval

Step Three:  Ad Production

Step Four:  Media Reservations

Step Five:  Media Placement

Step Six:  Payment


C-ville Ads

Step One:  Copy Approval

Step Two:  Request Placement

Step Three:  Ad Production

Step Four:  Payment


Radio Process


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

Step One:  IRB-HSR Script Approval

Step Two:  Media Plan Option 1

Step Two:  Media Plan Option 2

Step Three:  IRB-HSR Recording Approval

Step Four:  Payment


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

Step Two:  Media Plan Option 1 For Television

Step Two:  Media Plan Option 2 For Television

Step Three:  IRB-HSR Recording Approval

Step Four:  Payment For Television

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

Step Two:  Media Plan

Step Three:  IRB-HSR FINAL Approval

Step Four:  Payment


Last Modified: Friday, 23-Jun-2017 13:58:12 EDT