Notice of Privacy Practices

Your Information. Your Rights. Our Responsibilities.

This notice explains how medical and research-related information about you may be used and disclosed and how you can access that information.

Please review it carefully.

This Notice applies to Cenit Clinical Research and the healthcare and research professionals who are legally included in this Notice.

Your Rights

You may have the right to:

• Inspect or obtain a paper or electronic copy of certain health records.
• Ask us to correct information you believe is inaccurate or incomplete.
• Request that we contact you in a particular way or at a particular location.
• Ask us to limit certain uses or disclosures.
• Request information about certain disclosures of your health information.
• Obtain a paper copy of this Notice.
• Choose a personal representative to act for you.
• File a complaint if you believe your privacy rights have been violated.

Some rights are subject to legal exceptions and limitations.

Obtain a Copy of Your Records

You may ask to inspect or receive an electronic or paper copy of health information maintained in a designated record set.

We will respond within the time required by law.

We may charge a reasonable, cost-based fee when permitted.

In limited circumstances, access may be denied. When applicable, you may have the right to request review of the denial.

Request a Correction

You may ask us to correct health information that you believe is incorrect or incomplete.

We may deny the request in certain circumstances. If we deny it, we will explain the reason in writing and describe any rights you may have to submit a statement of disagreement.

Request Confidential Communications

You may ask us to contact you in a particular way, such as only by mobile phone, or to send correspondence to a different address.

We will accommodate reasonable requests.

Request Restrictions

You may ask us not to use or disclose certain health information for treatment, payment, or healthcare operations.

We are not always required to agree.

When applicable, if you pay in full out of pocket for a healthcare item or service, you may ask us not to disclose information about that item or service to a health plan for payment or healthcare operations purposes unless disclosure is required by law.

Research-related restrictions may also be governed by study documents and applicable law.

Accounting of Disclosures

You may request a list of certain disclosures of your health information made during the period permitted by law.

The accounting will not include every disclosure. For example, it may exclude disclosures for treatment, payment, healthcare operations, disclosures authorized by you, and other disclosures excluded by law.

Receive a Copy of This Notice

You may request a paper copy of this Notice at any time, even if you previously agreed to receive it electronically.

Personal Representatives

If a person has legal authority to act on your behalf, that person may exercise your applicable privacy rights.

We may require documentation confirming that authority.

File a Complaint

You may file a complaint with Cenit if you believe your privacy rights have been violated.

You may also file a complaint with the U.S. Department of Health and Human Services Office for Civil Rights.

Cenit will not retaliate against you for filing a complaint.

Your Choices

In certain situations, you may tell us how you want your information shared.

These situations may include:

• Sharing information with family members, friends, or others involved in your care.
• Disaster-relief activities.
• Certain fundraising communications.

We generally require written authorization for:

• Uses or disclosures for certain marketing purposes.
• A sale of protected health information.
• Most uses or disclosures of psychotherapy notes.
• Other uses and disclosures not permitted by law without authorization.

You may revoke an authorization in writing, except to the extent that action has already been taken in reliance on it.

How We May Use and Disclose Your Information

Treatment

We may use and disclose health information to provide, coordinate, or manage healthcare services.

Example: A Cenit investigator may share relevant information with another healthcare professional involved in your care when permitted.

Healthcare Operations

We may use and disclose information to operate our organization, improve services, conduct training, perform quality reviews, manage compliance, and support administrative activities.

Payment

When applicable, we may use and disclose information to bill and receive payment for healthcare services.

Many research-related procedures are paid by the study sponsor, but standard medical care may be handled separately.

Clinical Research

We may use or disclose health information for clinical research when:

• You provide written authorization.
• An IRB or privacy board approves a waiver or alteration of authorization.
• The information is used in preparation for research as permitted by law.
• The information relates to a deceased person and legal requirements are met.
• The information has been de-identified.
• A limited data set is used under an appropriate agreement.
• Another legal permission applies.

Research studies may involve authorized representatives of sponsors, CROs, IRBs, laboratories, regulatory agencies, and other parties identified in the applicable study documents.

Signing a research authorization may permit information to be used or disclosed for the period described in that authorization.

Contact About Research Opportunities

We may contact you about research opportunities when permitted by law and consistent with our privacy practices.

You may ask not to receive future general recruitment communications.

Study-specific communications may be necessary while you are participating.

Public Health and Safety

We may disclose health information for legally authorized public-health and safety activities, including:

• Disease prevention.
• Reporting certain adverse events.
• Product recalls.
• Reporting suspected abuse or neglect.
• Preventing or reducing a serious and imminent threat.

Health Oversight

We may disclose information to authorized agencies for audits, investigations, inspections, licensure, and regulatory oversight.

Compliance With Law

We may disclose information when federal, state, or local law requires it.

Workers’ Compensation

We may disclose information as authorized for workers’ compensation or similar programs.

Law Enforcement and Government Functions

We may disclose information for certain law-enforcement requests, national-security activities, military functions, correctional institutions, or other government purposes when legally permitted.

Legal Proceedings

We may disclose information in response to a valid court order, administrative order, subpoena, discovery request, or other lawful process.

Coroners, Medical Examiners, and Funeral Directors

We may disclose information to these individuals when permitted by law.

Organ and Tissue Donation

We may disclose information to organizations involved in organ, eye, or tissue donation when applicable.

Our Responsibilities

Cenit is required to:

• Maintain the privacy and security of protected health information.
• Follow the privacy practices described in the current Notice.
• Provide a copy of this Notice.
• Notify affected individuals following certain breaches as required by law.
• Use or disclose only the information reasonably necessary for certain purposes when the minimum-necessary standard applies.
• Obtain written authorization for uses and disclosures that are not otherwise permitted.

Changes to This Notice

We may change this Notice and make the revised Notice effective for information we already maintain and information we receive in the future, as permitted by law.

The current Notice will be posted on our website and made available at our research site.

Questions and Complaints

Contact:

Cenit Clinical Research

Phone: (941) 529-1282

Email: info@cenitresearch.com

Address: 1005 Chiquita Blvd S, Cape Coral, FL 33991

To file a complaint with the U.S. Department of Health and Human Services Office for Civil Rights, use the contact information provided on the HHS website or contact HHS directly.

Cenit will not retaliate against you for exercising your privacy rights or filing a complaint.

We are dedicated to bringing carefully conducted clinical research opportunities closer to the communities we serve.