Anchor Medical Research LLC Participants’ Rights and Responsibilities Policy

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Effective Date: 12/5/2024

Last Updated: 12/5/2024

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At Anchor Medical Research LLC ("we," "us," or "our"), we recognize and respect the rights of all individuals participating in our clinical research studies. This Participants’ Rights and Responsibilities Policy outlines the rights and responsibilities of participants involved in our clinical trials to ensure that they are treated ethically, with dignity, and in compliance with applicable laws and regulations.

1. Participants’ Rights

As a participant in a clinical trial conducted by Anchor Medical Research LLC, you are entitled to the following rights:

1.1 Right to Informed Consent

  • Clear Information: You have the right to receive complete, understandable, and accurate information about the clinical trial, including its purpose, procedures, risks, benefits, and potential impact on your health.
  • Voluntary Participation: Your participation is voluntary, and you may choose not to participate or withdraw from the trial at any time without penalty or loss of any benefits to which you are otherwise entitled.

1.2 Right to Privacy and Confidentiality

  • Confidentiality of Personal Information: Your personal information and medical data will be kept confidential and protected, in accordance with Anchor Medical Research LLC’s Privacy Policy and all relevant privacy laws, including HIPAA and GDPR.
  • Data Security: Any information provided during the trial will be securely stored and used only for the purposes of the study.

1.3 Right to Quality Care and Safety

  • Participant Welfare: Your safety and well-being are our top priority. We ensure that the study procedures are designed to minimize any risks, and we provide appropriate medical supervision during the trial.
  • Access to Medical Care: If any adverse events or medical concerns arise during the study, you have the right to access medical care, and the study staff will address these concerns promptly.

1.4 Right to Clear Communication

  • Ongoing Updates: You have the right to be kept informed of any new findings or developments in the study that may affect your participation.
  • Questions and Concerns: You have the right to ask questions at any time about the study and to receive honest, clear, and timely answers.

1.5 Right to Withdraw

  • Freedom to Withdraw: You may withdraw from the study at any time without any negative consequences or loss of benefits, and you will not be penalized in any way for doing so.

2. Participants’ Responsibilities

While participating in a clinical trial, you have the following responsibilities:

2.1 Responsibility to Provide Accurate Information

  • Complete Medical History: It is your responsibility to provide accurate and complete information about your health, medical history, and any medications you are taking, as this information is crucial for your safety and the success of the trial.
  • Update Study Team: If any changes occur to your health or treatment during the trial, you are responsible for informing the study team promptly.

2.2 Responsibility to Follow Study Procedures

  • Adherence to Protocols: You must follow the instructions provided by the study team, including taking medications as directed, attending scheduled visits, and completing any required tasks or assessments.
  • Compliance with Study Schedule: You are expected to attend all scheduled appointments and inform the study team in advance if you are unable to attend.

2.3 Responsibility to Ask Questions and Seek Clarification

  • Clarify Doubts: If you have any questions about the study, its procedures, or the potential risks or benefits, you are responsible for seeking clarification from the research team.
  • Informed Decision-Making: It is important to understand your rights and the study’s requirements before you agree to participate, and you should feel comfortable asking questions until all your concerns are addressed.

2.4 Responsibility to Report Adverse Events or Side Effects

  • Report Health Concerns: You are responsible for promptly reporting any side effects, health issues, or adverse events that occur during the trial. This includes any new symptoms, discomfort, or reactions to medications.
  • Adverse Event Reporting: In case of any unexpected events or health concerns, you must inform the study staff immediately so they can provide appropriate care and adjust the study protocol if needed.

2.5 Responsibility to Maintain Confidentiality

  • Respect Study Confidentiality: You are expected to maintain confidentiality regarding the details of the study and not share information with others unless explicitly authorized by the study team.

3. Participant Protections

At Anchor Medical Research LLC, we are committed to ensuring that participants’ rights are respected throughout the study:

  • Ethics Oversight: All clinical trials are reviewed and monitored by an independent Institutional Review Board (IRB) or ethics committee to ensure that they meet ethical standards and participant safety requirements.
  • Participant Advocacy: If at any time you feel that your rights are not being respected or if you feel unsafe, you have the right to report the issue to the research team, IRB, or an appropriate regulatory body without fear of retaliation.
  • Data Security: We take all necessary precautions to protect your personal data in line with our Privacy Policy and other relevant regulations.

4. Policy Updates

This Participants’ Rights and Responsibilities Policy may be updated periodically to reflect changes in regulations or best practices. Any updates will be communicated to participants through the contact information provided at the time of enrollment.

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