University of Maryland School of Medicine Clinical Trials Advertising Policy
Last Updated: [Current Date] | Policy Owner: Office of Research Affairs
Introduction
The University of Maryland School of Medicine is committed to advancing healthcare through innovative clinical research. Our clinical trials advertising policy ensures that research opportunities are communicated transparently while maintaining the highest ethical standards and protecting the rights and safety of potential participants.
Purpose and Scope
This policy establishes guidelines for the advertisement and promotion of clinical trials conducted under the auspices of the University of Maryland School of Medicine. It applies to all faculty, staff, researchers, and affiliated personnel involved in clinical trial communications.
Core Principles
Ethical Integrity
All clinical trial advertisements must prioritize participant welfare over research objectives. Communications should not exploit vulnerable populations or create unrealistic expectations about experimental treatments.
Scientific Accuracy
Advertisements must present accurate scientific information about the trial's purpose, procedures, risks, and potential benefits. No misleading claims or premature disclosures of preliminary results are permitted.
Informed Consent Emphasis
All advertisements must clearly communicate that participation involves risks and that individuals should consult with their healthcare providers before deciding to participate.
Advertising Guidelines
Content Requirements
- Clear identification that the opportunity involves research, not standard care
- Accurate representation of the trial phase and potential experimental nature
- Prominent disclosure of known risks and side effects
- Statement that participation is voluntary with no penalty for withdrawal
- Contact information for qualified research staff only
- Disclaimer that the sponsor has reviewed and approved the advertisement when required
Prohibited Practices
- Guaranteeing treatment success or curing diseases
- Offering financial incentives beyond reimbursable expenses
- Using testimonials from trial participants
- Making comparisons to established treatments without proper context
- Targeting specific demographic groups inappropriately
- Using coercive language or pressure tactics
Review and Approval Process
All clinical trial advertisements must undergo review by the Institutional Review Board (IRB) before publication. Digital advertisements require additional approval from the Office of Communications and Public Affairs. External partnerships involving pharmaceutical companies or research sponsors require separate review by the Office of Technology and Industry Relations.
Communication Channels
Permitted methods for clinical trial advertising include:
- University website listings with IRB approval numbers
- Professional medical society publications
- Accredited medical education programs
- Community health fairs and educational events
- Referrals from healthcare providers
- Approved patient advocacy organization partnerships
Digital Advertising Standards
When utilizing digital platforms for clinical trial promotion:
- Targeted advertising must comply with HIPAA privacy requirements
- Social media posts require pre-approval from the communications office
- Search engine marketing must include appropriate medical disclaimers
- Online registration forms must link to comprehensive informed consent documents
- Cookies and tracking technologies must respect participant privacy preferences
International Considerations
For clinical trials with international components, all advertisements must comply with both U.S. regulations and the legal requirements of participating countries. Translation accuracy must be verified by certified medical interpreters, and cultural sensitivities must be considered in messaging.
Oversight and Compliance
The Office of Research Affairs conducts annual audits of clinical trial advertising practices. Violations of this policy may result in sanctions including restricted research privileges, mandatory ethics training, or disciplinary action according to university policies.
Training and Education
All research personnel involved in participant recruitment must complete annual training on ethical advertising practices. New faculty members receive orientation on these policies during their onboarding process.
Reporting Concerns
If you observe potential violations of this policy, please contact the Office of Research Integrity at research.integrity@umaryland.edu or call (410) 706-7700. All reports will be investigated confidentially and appropriately.
Policy Review
This policy is reviewed annually by the Research Affairs Committee and updated as needed to reflect changes in federal regulations, industry standards, and institutional practices. Questions regarding this policy should be directed to the Associate Dean for Research Affairs.
Approved by: Research Affairs Executive Committee
Signature: _________________________
Date: _________________________
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