Global Code of Ethics for Clinical Trials
FibroGen Global Code of Ethics for Clinical Trials
FibroGen’s mission is to improve the lives of people globally by developing innovative therapies anchored in high-quality science and our passion for patients. We treat patient safety as a top priority and hold ourselves accountable to maintain high ethical principles and standards in our clinical trials wherever they are conducted, whether by ourselves or collaboratively with our partners, contract research organizations or other third parties. All FibroGen-sponsored clinical trials are conducted in accordance with the applicable regulations, Health Authority standards, and Good Clinical Practice (GCP) guidelines. FibroGen maintains internal procedures to ensure compliance with the applicable clinical trial standards as it pertains to:
Appropriateness: All research should be designed to address a legitimate scientific question or need.
Selection of Investigators: FibroGen selects clinical investigators who have the required qualifications, training, research, clinical expertise, and the potential to recruit research participants. The independence of clinical investigators and others involved in clinical research is critical to protect the best interest of research participants. FibroGen does not engage any clinical investigators who have been debarred, disqualified, or restricted from participating in clinical research.
Ethical Review: FibroGen sponsored trials undergo an ethical review by a qualified independent committee (Institutional Review Board/Independent Ethics Committee) prior to study initiation.
Privacy: FibroGen is committed to protecting patients’ privacy, collecting minimal subject identifiers, and complying with all applicable privacy laws and regulations.
Integrity of Clinical Data: FibroGen ensures data are reliable and have been processed and reported correctly by using established data integrity standards.
Informed Consent: FibroGen requires voluntary informed consent from research participants, outlining known benefits and risks of the trial, and taking additional steps to ensure the protection of minors.
Safety Monitoring: FibroGen monitors patient safety throughout trials, including long-term follow-up as needed. FibroGen ensures that adverse event information regarding its products is appropriately collected, processed, reported, analyzed and communicated. FibroGen ensures clinical investigators appropriately report adverse event information and appropriately update research participants and others, as appropriate.
Compensation: We ensure that any payments, injury compensation, and other benefits provided to research participants are appropriate and do not unduly influence their decision to participate in a clinical research study. FibroGen payments to investigators will be within Fair Market Value (FMV) and shall be based upon the services rendered.
Investigator’s Meetings: FibroGen ensures that investigator’s meetings are modest in location and cost for the purpose of training study staff on participating in a FibroGen clinical trial. FibroGen does not pay the investigators for their time but pays for modest accommodations in compliance with FibroGen’s HCP/FMV policy and local country requirements.
Transparency: FibroGen makes information about its clinical trials publicly available in compliance with the applicable regulations, Health Authority standards, and GCP guidelines. We are also committed to publishing clinical trial results regardless of clinical trial outcome or regulatory approval.
Diversity: FibroGen strives to conduct clinical trials without bias. We are committed to identifying and reducing the potential barriers to clinical trial access and participation, and continue to improve our subject recruitment, enrollment, and retention process to ensure disease-appropriate subject representation and greater inclusion of patients across racial, ethnic, gender, age and socioeconomic groups in our clinical trials.