Purpose
This Policy sets forth MyDx’s Code of Ethics for clinical trials.
Scope
This Code of Ethics applies globally to all MyDx clinical trial activities.
Policy
MyDx’s mission is to serve patients and its clinical trial activities are carefully designed to meet this goal. MyDx strives to maintain high ethical principles, as well as high scientific and clinical standards in all of its clinical trials regardless of where they take place. The rights, dignity, safety and well being of research participants are paramount in conducting MyDx clinical trials. To that end, all MyDx sponsored trials are designed and conducted to the same high standards that meet or exceed all applicable local laws as well as widely accepted international regulatory standards. MyDx maintains detailed internal procedures to ensure compliance with these laws. MyDx procedures cover:
Appropriateness: All MyDx research is designed to answer a legitimate scientific question or need. All MyDx research must be reviewed and approved by an appropriate review body within MyDx Research & Development. Research & Development personnel are responsible for all steps of the design, conduct, and publication of research. MyDx prospectively evaluates its research programs to ensure that the potential benefit to the patient and to society is in proportion to the inherent risk and burden to the research participants.
Selection of Investigators: MyDx selects clinical investigators based on qualifications, training, research, clinical expertise in relevant fields, the potential to recruit research participants, and the ability to conduct clinical trials consistent with this Policy. MyDx respects the independence of clinical investigators and others involved in clinical research so they can protect the best interest of research participants. MyDx does not engage any clinical investigators who have been debarred, disqualified or restricted from participating in clinical research.
Ethical Review: MyDx sponsored trials undergo an ethical review, as required, by a qualified independent committee (Institutional Review Board/ Independent Ethics Committee) prior to trial initiation.
Privacy: MyDx is committed to protecting research participant privacy, collecting minimum subject identifiers (ensuring compliance with guidelines for good clinical practice when appropriate), and to complying with all applicable privacy laws. MyDx requires that its agents are contractually obligated to do the same.
Quality of Clinical Data: MyDx ensures data are reliable and have been processed and reported correctly by using established data standards.
Informed Consent: MyDx requires voluntary informed consent from research participants, where needed, prior to carrying out any protocol specified procedures. Informed consent outlines the known benefits and risks of participating in the trial. MyDx process for obtaining informed consent will take into account local law, language and custom as well as the ability of research participants to understand the information presented. MyDx will take additional steps to ensure appropriate informed consent for vulnerable research participants, such as minors. MyDx ensures that human biological material iscollected and utilized solely for the purposes for which it was consented.
Safety Monitoring: MyDx ensures subjects are appropriately monitored throughout clinical trials, including long-term follow up as needed. MyDx ensures that adverse event information regarding its products is collected, processed, reported, analyzed and communicated. MyDx continuously monitors the safety of its investigational therapies by ensuring clinical investigators appropriately report adverse event information and appropriately update research participants and others, as appropriate, of any new risks associated with the use of the investigational drug that arise during the course of the clinical trial.
Standard of Care: MyDx sets up and monitors its clinical trials to ensure the rights and well-being of research participants are protected. The standard of care provided to control groups is, at a minimum, equivalent to well-established and commonly employed local treatment.
Access to Investigational Medicines: To serve patients, MyDx engages in clinical research with the goal of obtaining regulatory approval of its products.
Clinical trials allow MyDx to evaluate investigational new treatments in volunteers in order to generate the safety and efficacy information needed to obtain approval of those treatments and make them available to the broader patient population. Outside of a clinical trial, access to MyDx’s investigational products would be considered under limited circumstances only, and as permitted by applicable law, in the following situations:
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- MyDx may provide continued access to its investigational products to research participants once a clinical trial is complete.
- MyDx may provide physician-requested expanded access to its investigational products to patients with serious or immediately life-threatening diseases who lack other therapeutic options, cannot join an active clinical trial of the investigational product, and where the potential benefits of the investigational product are greater than the known risks in the disease indication (as described by the criteria below).
Criteria Used for Considering Requests for Expanded Access
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- The patient has a serious or immediately life threatening disease or condition.
- There is no comparable or satisfactory alternative therapy for the disease or condition.
- Sufficient clinical evidence of safety and effectiveness in the indication has been established, the potential benefit justifies the potential risks, and the potential risks are not unreasonable within the context of the disease or condition.
- Product is under active development in the indication and expanded access will not interfere with the development of the product.
- MyDx has adequate supply of investigational product.
- There is a regulatory mechanism in the country or region to support expanded access.
Process for Requesting Expanded Access
A treating physician may request information about how to apply for access to one of MyDx’s investigational products by contacting MyDx Medical Information at medinfo@mydxlife.com. All physicians who receive MyDx investigational product through expanded access are required to comply with all applicable laws and regulations, and contractual conditions, including those relating to safety reporting.
Compensation: MyDx ensures that any payments or other items provided to research participants are appropriate based on the local economy and do not unduly influence their decision to participate or continue to participate in a clinical research study. Any such arrangements are evaluated as part of the ethical review. MyDx provides locally appropriate compensation for injuries, which is disclosed to research participants as part of the informed consent process. MyDx payments to clinical investigators will be within Fair Market Value, and shall be based on the services rendered.
Transparency: MyDx posts clinical trial information to comply with all applicable laws and regulations.
MyDx Global Code of Ethics for Clinical Trials is posted on MyDx external website for potential clinical investigators and potential research participants to review prior to committing to participate in an MyDx trial.
