Suncare Medical Center | Clinical Research Policy
At Suncare Medical Center, we are proud to participate in clinical research aimed at advancing medical knowledge and improving patient care. Our clinical research programs are conducted with the highest ethical standards and in compliance with applicable laws and regulations. This policy outlines our commitment to transparency, patient safety, and the integrity of our research practices.
1. Purpose of Clinical Research
Clinical research is an essential component of modern medicine. At Suncare Medical Center, our research aims to:
• Develop new treatments and therapies for medical conditions.
• Evaluate the safety and effectiveness of medications, devices, and interventions.
• Contribute to the advancement of healthcare for our community and beyond.
2. Participation in Clinical Research
2.1 Voluntary Participation
• Participation in any clinical trial is completely voluntary.
• Patients have the right to decline or withdraw from a study at any time without affecting their access to medical care at Suncare Medical Center.
2.2 Eligibility Criteria
• Each clinical study has specific inclusion and exclusion criteria based on factors such as age, medical history, and current health status.
• Patients will undergo a pre-screening process to determine their eligibility.
2.3 Informed Consent
• All participants will receive detailed information about the study, including its purpose, procedures, risks, benefits, and alternatives.
• Participants must sign an Informed Consent Form before enrolling in any study. This form will be provided in a language or format they understand.
3. Patient Safety and Rights
3.1 Ethical Standards
• Our clinical research follows the principles outlined in the Declaration of Helsinki and complies with Good Clinical Practice (GCP) guidelines.
• Research studies are approved and monitored by an Institutional Review Board (IRB) to ensure ethical conduct and patient safety.
3.2 Confidentiality
• All participant information is treated as confidential and is protected under HIPAA regulations.
• Data is anonymized or de-identified whenever possible to safeguard patient privacy.
3.3 Risks and Benefits
• Participants will be informed of all known risks and potential benefits associated with the study.
• Ongoing monitoring ensures that participant safety remains the top priority throughout the research process.
3.4 Communication and Support
• Participants will have access to research coordinators and medical staff to address questions or concerns at any stage of the study.
4. Financial Aspects of Clinical Research
4.1 Coverage of Costs
• Most clinical trials are sponsored by pharmaceutical companies or other organizations, which cover study-related costs such as:
• Study medications or devices.
• Diagnostic tests and laboratory services.
• Transportation for study visits (if applicable).
4.2 Patient Compensation
• In some cases, participants may receive compensation for their time and travel expenses. The amount and terms will be disclosed during the consent process.
4.3 No Additional Costs
• Participants will not incur additional charges for participating in a clinical trial. However, routine medical care unrelated to the study may be billed to the patient or their insurance provider.
5. Research Integrity and Compliance
5.1 Oversight and Monitoring
• All clinical research conducted at Suncare Medical Center is overseen by qualified investigators and research coordinators.
• External audits and inspections may be conducted by regulatory authorities, including the FDA, to ensure compliance with research standards.
5.2 Reporting Adverse Events
• Any adverse events or side effects experienced by participants will be promptly reported to the appropriate regulatory bodies.
• Participants will be notified immediately of any new findings that may affect their decision to continue in the study.
5.3 Conflict of Interest
• Suncare Medical Center is committed to transparency and discloses any potential conflicts of interest related to clinical research.
6. Patient Responsibilities in Clinical Research
To ensure the success of clinical research, participants are expected to:
• Provide accurate and complete medical information during the screening process.
• Attend all scheduled study visits and follow the research protocol as instructed.
• Inform the research team of any changes in health or medication during the study.
• Notify the research team if they decide to withdraw from the study.
7. Clinical Research Opportunities
7.1 How to Enroll
Patients interested in participating in clinical research can:
• Speak with their healthcare provider during an appointment.
• Contact our research team directly at 305-489-9090 or info@suncaremedicalcenter.com.
7.2 Current Studies
A list of ongoing clinical trials and eligibility requirements is available on our website at www.suncaremedicalcenter.com.
8. Feedback and Concerns
8.1 Reporting Concerns
If you have any concerns about a clinical study, you can:
• Speak with your study coordinator or the principal investigator.
• Contact our Research Compliance Officer at 305-489-9090.
8.2 External Reporting
Participants may also contact the following regulatory agencies:
• U.S. Food and Drug Administration (FDA): www.fda.gov.
• Office for Human Research Protections (OHRP): www.hhs.gov/ohrp.
9. Updates to this Policy
This Clinical Research Policy may be updated periodically to reflect changes in regulations or research practices. Updates will be posted on this page with the date of the most recent revision.
Contact Information
For questions or more information about clinical research at Suncare Medical Center, please contact:
• Address: 1782 West Flagler Street, Miami, FL 33135
• Phone: 305-489-9090
• Email: info@suncaremedicalcenter.com