By using this site, you agree to the Privacy Policy and Terms of Use.
Accept
Health Works CollectiveHealth Works CollectiveHealth Works Collective
  • Health
    • Mental Health
    Health
    Healthcare organizations are operating on slimmer profit margins than ever. One report in August showed that they are even lower than the beginning of the…
    Show More
    Top News
    improving patient experience
    6 Ways to Improve Patient Satisfaction Within Hospitals
    December 1, 2021
    degree for healthcare job
    What Are The Health Benefits Of Having A Degree?
    March 9, 2022
    custom software development is changing healthcare
    Digital Customer Journey Mapping and its Importance for Healthcare
    July 21, 2022
    Latest News
    6 Easy Healthcare Ways to Sit Less and Move More Every Day
    September 10, 2025
    7 Most Common Healthcare Accreditation Programs: Which Should You Use?
    August 20, 2025
    Hospital Pest Control and the Fight Against Superbugs
    August 20, 2025
    Hygiene Beyond The Clinic: Attention To Overlooked Non-Clinical Spaces
    August 13, 2025
  • Policy and Law
    • Global Healthcare
    • Medical Ethics
    Policy and Law
    Get the latest updates about Insurance policies and Laws in the Healthcare industry for different geographical locations.
    Show More
    Top News
    Feinberg’s Simulation-Based Training Program Wins Innovations Challenge
    November 16, 2012
    ACA Delays
    Top 8 ACA Delays: Blatantly Illegal or Temporary Courses of Action?
    July 7, 2014
    Vegetarina Dental Concerns Marielaina Perrone DDS
    Oral Health Concerns For Vegetarians
    February 14, 2013
    Latest News
    Healthcare at a Crossroads: Why Leadership Matters More Than Ever
    September 9, 2025
    How Social Security Disability Shapes Access to Care and Everyday Health
    August 22, 2025
    How a DUI Lawyer Can Help When Your Future Health Feels Uncertain
    August 22, 2025
    How One Fall Can Lead to a Long Road of Medical Complications
    August 22, 2025
  • Medical Innovations
  • News
  • Wellness
  • Tech
Search
© 2023 HealthWorks Collective. All Rights Reserved.
Reading: Key Considerations for Clinical Trials Submitting Digital Recruitment Content for IRB Approval
Share
Notification Show More
Font ResizerAa
Health Works CollectiveHealth Works Collective
Font ResizerAa
Search
Follow US
  • About
  • Contact
  • Privacy
© 2023 HealthWorks Collective. All Rights Reserved.
Health Works Collective > Policy & Law > Key Considerations for Clinical Trials Submitting Digital Recruitment Content for IRB Approval
Policy & Law

Key Considerations for Clinical Trials Submitting Digital Recruitment Content for IRB Approval

Jonathan Catley
Jonathan Catley
Share
5 Min Read
SHARE

Clinical trial sponsors know that any direct-to-patient advertising must secure IRB approval — but what does this mean in the digital age? By now, it’s safe to assume that the vast majority of clinicians recognize the importance of digital marketing to the trial recruitment process. However, as the industry wades into these relatively untested waters, many questions pertaining to FDA guidance and Institutional Review Board (IRB) approval will undoubtedly arise. While the process of securing approval for digital campaigns is relatively similar to that for traditional advertising materials, there are a few notable exceptions and unique considerations that must be taken into account. Armed with the knowledge of what is and is not considered to be an advertisement, along with a thorough understanding of FDA guidance for digital marketing materials, sponsors can quickly secure IRB approval and ensure they maintain compliance for the duration of the enrollment period.

Contents
  • Let’s Start With the Basics
  • How to Play Within Bounds

Let’s Start With the Basics

According to the FDA, any direct advertising to prospective trial participants is considered the beginning of the informed consent process. To clarify, this means that any marketing materials posted online with the intent of soliciting patients for a trial will have to be submitted to the IRB for approval (you can find the full FDA Recruitment Information Sheet here). Bear in mind that, on the web, this isn’t limited to a banner, display, or search engine ads; web pages linked from Google AdWords or social media posts also qualify, along with any informational pages that they may link to. Always err on the side of comprehensiveness; you may decide to publish digital recruitment ads at any point during the trial (the FDA considers this an amendment), but the earlier you submit your ad content for review, the better. As a note, you aren’t required to submit online clinical trial listings for approval, nor any material that isn’t intended for a patient audience, including doctor-to-doctor briefs or referrals, press releases and/or news stories, and messages intended for investors. However, these materials may not include anything other than basic information about the trial (eg. the trial name, location, the trial purpose, a summary of protocol, basic eligibility requirements, contact information, etc.) — any additional materials or messaging must be approved by the IRB.

How to Play Within Bounds

Of course, the IRB’s primary concern is the actual contents of your online advertising materials. All ad copy and imagery will have to secure approval before it can be uploaded to the web. Fortunately, the regulatory guidelines here are relatively straightforward, and following them with intent will keep you in the clear. According to the FDA Information Sheet, clinical recruitment advertising materials cannot:

  1. Be coercive in nature
  2. State or imply the certainty of a favorable outcome or benefit
  3. State or imply that the drug/procedure/device is safe or effective (or superior to other current treatments)
  4. Emphasize patient payment for paid trials (you can simply note the reimbursement, if there is one, however)
  5. Advertise for “free medical care” if patients won’t be charged
  6. Market the clinical trial as a “new treatment” or “new medication” because, being under clinical investigation, the treatment has not yet been formally approved
  7. Generally speaking, only information that patients require to assess their interest and eligibility should be included

The FDA also notes that you may want (but aren’t required) to include the following information:

More Read

Meaningful Use Criteria and the ACO
Do We Want Income Equality?
Preventing Alzheimer’s Before Disease Onset: A Key Expert Weighs In
Social Media Policies and “Spying” by Physicians
Bed Bugs Found Carrying Drug-Resistant MRSA
  1. The name and address of the clinical investigator and/or research facility
  2. The condition under study and/or the purpose of the research
  3. In summary form, the criteria that will be used to determine eligibility for the study
  4. A brief list of participation benefits, if any (e.g., a no-cost health examination)
  5. The time or other commitment required of the subjects
  6. The location of the research and the person or office to contact for further information

In general, it’s best for digital recruitment materials to be written in clear, straightforward language that helps patients to easily discern whether the clinical study is right for them. Not only does this practice ensure swifter IRB approval — it serves as an effective pre-screener, enabling obviously unqualified patients to vet themselves.

Share This Article
Facebook Copy Link Print
Share

Stay Connected

1.5kFollowersLike
4.5kFollowersFollow
2.8kFollowersPin
136kSubscribersSubscribe

Latest News

a woman walking on the hallway
6 Easy Healthcare Ways to Sit Less and Move More Every Day
Health
September 9, 2025
Clinical Expertise
Healthcare at a Crossroads: Why Leadership Matters More Than Ever
Global Healthcare
September 9, 2025
travel nurse in north carolina
Balancing Speed and Scope: Choosing the Nursing Degree That Fits Your Goals
Nursing
September 1, 2025
intimacy
How to Keep Intimacy Comfortable as You Age
Relationship and Lifestyle Senior Care
September 1, 2025

You Might also Like

Dental Filling Options

January 25, 2013

mHealth Summit Conference 2011: Thoughts and Takeaways

December 7, 2011
Health careHospital Administration

How To Get A Medical Marijuana Card In Ohio

April 8, 2019
Health careHealth Reform

3 Important Rule Changes In Short-Term Health Insurance Plans

July 19, 2019
Subscribe
Subscribe to our newsletter to get our newest articles instantly!
Follow US
© 2008-2025 HealthWorks Collective. All Rights Reserved.
  • About
  • Contact
  • Privacy
Welcome Back!

Sign in to your account

Username or Email Address
Password

Lost your password?