Ethics & Compliance
At Hekma Clinical Research, ethical integrity is the foundation of our clinical research operations. We are committed to conducting studies with the highest standards of scientific rigor, regulatory compliance, and respect for human rights. Our policies align with international ethical guidelines, Good Clinical Practice (GCP), and local regulations to ensure the safety, dignity, and well-being of all research participants.
1. Protection of Human Subjects
- We strictly follow the Declaration of Helsinki, ICH-GCP E6 (R2/R3), and local regulatory requirements (e.g., FDA, EMA, MHRA, CDSCO) to safeguard participants.
- Every study undergoes independent ethical review by an Institutional Review Board (IRB) or Ethics Committee (EC) before initiation.
- We prioritize risk-benefit assessments to ensure trials are scientifically justified and participant risks are minimized.
2. Informed Consent Process
- Participation in any clinical trial is voluntary, and all subjects must provide written, informed consent before enrollment.
- Our informed consent documents are clear, culturally appropriate, and free of coercion, ensuring participants fully understand the study’s purpose, procedures, risks, and benefits.
- Special protections are in place for vulnerable populations (e.g., children, pregnant women, cognitively impaired individuals).
3. Data Integrity & Privacy
- We adhere to GDPR, HIPAA, and other data protection laws to ensure confidentiality and security of participant information.
- Clinical trial data is accurately recorded, monitored, and audited to prevent misconduct or falsification.
- Electronic data capture (EDC) systems are validated and access-controlled to prevent unauthorized use.
4. Regulatory & GCP Compliance
- Our operations comply with FDA 21 CFR Part 11, ICH-GCP, and ISO 14155 (for medical device trials, if applicable).
- We maintain complete and traceable documentation for all trial activities, ensuring audit readiness.
- Regular internal audits and sponsor inspections are conducted to verify compliance.
5. Transparency & Accountability
- We uphold trial transparency by registering studies on ClinicalTrials.gov or other required registries.
- Any conflicts of interest (financial, institutional, or personal) are disclosed and managed appropriately.
- Whistleblower protections are in place to encourage reporting of ethical concerns without fear of retaliation.
6. Fair & Ethical Conduct in Research
- We prohibit fraud, data manipulation, or unethical recruitment practices.
- Our staff undergoes mandatory ethics and GCP training to reinforce compliance awareness.
- Equitable participant selection ensures no discrimination based on gender, race, or socioeconomic status.
7. Our Pledge to Stakeholders
- For Participants: Your safety and rights are our top priority.
- For Sponsors: We deliver reliable, compliant, and ethically sound clinical trial execution.
- For the Scientific Community: We contribute to credible, reproducible, and ethically conducted research.
For further details on our Ethics & Compliance policies, please contact us.