Ethical Compliance in Global Projects

Recent developments in research ethics and regulation highlight significant changes across multiple regions… In Germany, the approval process for non-interventional studies is being streamlined with a new single country-wide Research Ethics Committee (REC) application form, and the recently approved Medical Research Act may signal upcoming procedural changes for these studies. In Hong Kong, ethics approval for government hospital studies has been centralised under the Hospital Authority Central IRB, simplifying the process for commercial and multi-cluster studies. In the EU, the QUANTUM project is developing a standardized data quality label for the European Health Data Space, enhancing dataset utility for research and innovation. The European AI Act, now in force, introduces new obligations for high-risk AI systems, including medical devices, which researchers and developers must navigate carefully. In the USA, the FDA has issued final guidance on using real-world data from electronic health records and medical claims for regulatory decisions, emphasising rigorous study design and data validation. On a global scale, revisions to the Declaration of Helsinki are ongoing, potentially impacting ethical guidelines for non-interventional studies, with final changes expected in October 2024, while the ICH has finalised a reflection paper on harmonising real-world evidence, underscoring the need to distinguish real-world research from randomized clinical trials.

Change is the only constant in AI. Here are 3 ways Chief AI Officers (CAIOs) drive responsible AI adoption by balancing ethics and regulatory concerns: 1. Adopt a Change Management Mindset 💡🤝 AI adoption is about more than tech. It’s about people. Smart CAIOs turn to change management to address the human side of AI. - Upskilling & Education 📚 Educate teams on AI’s real impact. Bust myths and address biases together. - Open Communication 🗣️ Create channels for employees to voice concerns on job changes and bias. Promote AI as a teammate, not a threat. - Example 🔍 Matt Lewis launched a program showing employees how AI enhances their roles, creating a culture of trust and collaboration. 2. Set Ethical Guardrails & Governance 🛡️🌐 Ethics in AI isn’t a “nice to have.” CAIOs are creating frameworks aligned with ethical and regulatory standards, especially in high-risk cases. - Guidelines & Transparency 📜 Clear guidelines are non-negotiable for privacy, bias, and accountability. - Human Oversight 👀 High-risk applications need a “human-in-the-loop” to make sure decisions stay accountable and transparent. - Ongoing Monitoring 🔄 This isn’t “set it and forget it”. CAIOs stress the need for continuous updates to match an evolving landscape. - Example 📊: Dr. Philipp Herzig launched an ethical review board to vet AI projects, ensuring diverse voices help avoid bias blind spots. 3. Navigate Global vs. Regional Regulations 🌍🗺️ Fragmented regulations force CAIOs to manage compliance without stifling innovation. - Global vs. Regional Flexibility 🌐 Some CAIOs push for a global baseline with regional adaptations, while others prefer ethical standards that may go beyond the minimum. - Example 🛠️ Nils o. Janus developed a core set of global standards, letting regional teams adapt to specific regulations. This enabled compliance without slowing things down too much. ____ 1. Change management 2. Ethical guardrails 3. Regulatory agility 👆 For CAIOs, these aren't guardrails. They're the backbone of successful AI deployment that benefits everyone.

It isn't standard practice to gain ethical clearance for research and evaluation done in low-income countries - #Includovate wants to change that. Why do I need an ethical review? An ethical review is essential in research, particularly in international development, gender, and social inclusion studies, to ensure that all activities are conducted with respect, fairness, and responsibility toward the individuals and communities involved. Key reasons include: - Protection of Participants: Many projects involve marginalised groups and individuals, such as women, refugees, indigenous people, and those living in poverty. Ethical review ensures that their rights, safety, privacy, and overall well-being are prioritised and protected throughout the research process. - Informed Consent: Ethical review processes confirm that all participants clearly understand the aims, risks, and benefits of the research and that they are participating voluntarily, which is crucial when working with populations that may have limited power or voice. If illiterate people are respondents then the informed consent can be read out to them, or read by a trusted nominee. - Cultural Sensitivity and Respect: As development work spans diverse cultural contexts, from Tonga to Nepal, Ethiopia and beyond, ethical review helps ensure appropriate and sensitive research methods. It helps to quality check a study and ensure it does not unintentionally harm local traditions or exacerbate existing inequalities. - Accountability and Integrity: Formal ethical oversight fosters transparency and trust with research participants and funding or partner organisations, ensuring that research processes and outcomes are credible and can be used for advocacy and policy change. - Identifying Unintended Consequences:  Research and evaluation practices are inherently imbued with power dynamics that operate through resource availability, institutional connections, and communication networks.   Ethical review, especially review by qualified, experienced reviewers, ensures that these dynamics, and their potential unintended impacts on communities,  are anticipated, identified and  and minimised. Ethical review is a foundational step that upholds the dignity, safety, and rights of all involved, making research more responsible, effective, and impactful in driving equitable development. #Includovate has an #ethical review board (#IRB) that specialises in international development research. Submit your application here: https://lnkd.in/gN32B2_n

Bribery remains one of the most pervasive financial crimes, affecting businesses, governments, and non-profits worldwide. The ISO 37001:2025 standard provides an updated framework for establishing, implementing, maintaining, and improving anti-bribery management systems. It aims to foster a culture of integrity, reduce reputational and legal risks, and enhance compliance with global regulations. Key Highlights ✅ Comprehensive Anti-Bribery Management System • Establishes preventative controls to detect and mitigate bribery risks across public, private, and non-profit sectors. • Addresses direct and indirect bribery, including cases involving third parties, financial and non-financial incentives. • Can be integrated with ISO 9001 (Quality Management) and ISO 37301 (Compliance Management) standards for holistic governance. ✅ Strengthening Organizational Integrity & Governance • Leadership accountability—executives and board members must demonstrate commitment to ethical behavior. • Transparent reporting structures—clear protocols for reporting bribery concerns within organizations. • Encourages the use of whistleblowing systems aligned with ISO 37002:2021 to protect individuals reporting misconduct. ✅ Legal & Reputational Risk Mitigation • Helps organizations meet anti-bribery laws such as the FCPA (US), UK Bribery Act, and EU Directives. • Reduces costs related to legal fines, reputational damage, and loss of business opportunities. • Supports companies in proactively managing compliance risks in high-risk jurisdictions and industries. ✅ Global Compliance & Certification • Certification is available through third-party auditors, strengthening credibility with regulators, investors, and stakeholders. • Aligns with international best practices for anti-bribery enforcement, enhancing cross-border compliance efforts. • Provides a standardized approach to managing bribery risks across multinational operations. ✅ Integration with Other Compliance Frameworks • ISO 37301: Compliance Management Systems—provides broader legal, regulatory, and ethical compliance guidance. • ISO 37002: Whistleblowing Guidelines—ensures safe and confidential channels for reporting bribery. • ISO 37009: Conflict of Interest Management—helps organizations identify and manage conflicts that may lead to bribery risks. Takeaways for Compliance Leaders 🔹 Develop a structured anti-bribery framework with clear policies, training, and reporting mechanisms. 🔹 Leverage ISO 37001 certification to demonstrate compliance with international anti-corruption regulations. 🔹 Implement strong internal controls to detect bribery risks, particularly in third-party dealings and supply chains. 🔹 Align with global #compliance trends by integrating ISO 37001 with broader risk management and governance programs. 🔹 Encourage whistleblowing and ethical reporting to build a culture of integrity and accountability. #AntiBribery #CorporateGovernance #leadership #FinancialCrime

𝗡𝗮𝘃𝗶𝗴𝗮𝘁𝗶𝗻𝗴 𝗚𝗹𝗼𝗯𝗮𝗹 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗶𝗼𝗻𝘀 𝗶𝘀𝗻’𝘁 𝗷𝘂𝘀𝘁 𝗰𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗶𝗻𝗴, it’s 𝗰𝗿𝘂𝗰𝗶𝗮𝗹. Whether it’s GDPR, SOX, or local tax laws, the stakes are high. Non-compliance can mean 𝗵𝗲𝗮𝘃𝘆 𝗳𝗶𝗻𝗲𝘀, 𝗿𝗲𝗽𝘂𝘁𝗮𝘁𝗶𝗼𝗻𝗮𝗹 𝗱𝗮𝗺𝗮𝗴𝗲, 𝗮𝗻𝗱 𝗹𝗼𝘀𝘁 𝗯𝘂𝘀𝗶𝗻𝗲𝘀𝘀. How do SAP consultants help businesses stay compliant in global projects? By delivering 𝗰𝗹𝗮𝗿𝗶𝘁𝘆 𝗮𝗻𝗱 𝗰𝗼𝗻𝘁𝗿𝗼𝗹 amidst complexity: 1/ 𝗔𝘂𝘁𝗼𝗺𝗮𝘁𝗲𝗱 𝗖𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲 𝗖𝗵𝗲𝗰𝗸𝘀: SAP solutions ensure adherence to changing regulations in real time. 2/ 𝗟𝗼𝗰𝗮𝗹-𝗟𝗲𝘃𝗲𝗹 𝗖𝗼𝗻𝗳𝗶𝗴𝘂𝗿𝗮𝘁𝗶𝗼𝗻: From tax codes to payroll, SAP experts tailor processes to meet country-specific needs. 3/ 𝗥𝗲𝗽𝗼𝗿𝘁𝗶𝗻𝗴 𝗧𝗵𝗮𝘁 𝗗𝗲𝗹𝗶𝘃𝗲𝗿𝘀: Accurate, audit-ready data at your fingertips. 4/ 𝗜𝗻𝘁𝗲𝗴𝗿𝗮𝘁𝗲𝗱 𝗥𝗶𝘀𝗸 𝗠𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁: Proactively identify and mitigate risks before they escalate. 5/ 𝗔𝗴𝗶𝗹𝗲 𝗔𝗱𝗮𝗽𝘁𝗮𝘁𝗶𝗼𝗻 𝘁𝗼 𝗖𝗵𝗮𝗻𝗴𝗲: As laws evolve, SAP consultants ensure your systems evolve with them. Without the right guidance, global projects can quickly spiral into compliance nightmares. With the right expertise, you transform risk into resilience. 𝗔𝘀𝗸 𝘆𝗼𝘂𝗿𝘀𝗲𝗹𝗳: Is your team equipped to stay ahead of ever-changing regulations? 𝗥𝗲𝗮𝗱𝘆 𝗳𝗼𝗿 𝗰𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲-𝗰𝗲𝗿𝘁𝗮𝗶𝗻𝘁𝘆?