Ethical Approval Processes

Navigating the Research Engagement Process Conducting health research is not just about designing a study and collecting data. Behind the scenes lies a critical process that ensures credibility, compliance, and trust: the research ethics and engagement pathway. As a Research Program Manager, I’ve seen firsthand that without a clear roadmap for ethics approvals and stakeholder engagement, studies risk delays, rejection, or even loss of community trust. Below, I outline the step-by-step process typically required when conducting health research in Kenya, a process that safeguards participants while strengthening research impact. 1️⃣ Obtain Research Ethics Approval Begin by submitting your protocol to a recognised research ethics body. For lab-related studies, this could be the KEMRI SERU Board. ⏳ Timeline: Allow at least 6–8 weeks for review. 2️⃣ Apply for NACOSTI Research Permit With your ethics approval letter, apply to the National Commission for Science, Technology, and Innovation (NACOSTI) for a research permit. ⏳ Timeline: ~2 weeks. 3️⃣ Secure an Institutional Introductory Letter Your institution should issue a formal letter introducing your study and confirming affiliation. 4️⃣ Notify the Ministry of Health Submit your ethics approval, NACOSTI permit, proposal summary, and introductory letter to the relevant Ministry of Health department for national-level clearance. 5️⃣ Engage County Governments Upon Ministry approval, you’ll be directed to approach the counties where your study will take place. Each county has its own research department for review and approval. 6️⃣ Seek Facility-Level Approvals At the health facility level, you may need additional clearance. For example, Kenyatta National Hospital has its own internal ethics review board. 7️⃣ Engage Participants at Facility Level Before recruitment, engage potential participants to explain the study, answer questions, and build trust. This step reinforces ethical principles of respect and informed consent. 8️⃣ Begin Recruitment Only after all approvals and engagements are complete should recruitment and data collection begin. The research engagement process may feel long and layered, but every step serves a purpose: protecting participants, ensuring compliance, and building trust with communities and institutions. It's key to remember that your success will highly depend on navigating power and trust in the engagement process. In my experience, investing time upfront in ethics and engagement leads to smoother implementation, stronger collaborations, and findings that are more likely to inform policy and practice. 👉 To fellow researchers: What’s been your biggest challenge (or lesson learned) in navigating the ethics and engagement process? #ResearchLeadership #EthicsInResearch #StakeholderEngagement #HealthResearch

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.

Please do NOT start research on human subjects unless you have taken into account the ethics part. I beg you, please! 😂 I've encountered multiple cases of my mentees who started a project without the necessary approvals, and when it came to journal publication, they were stuck! Let's see what we need to get started 👇 1. Informed consent Ensures participants fully understand the research, its potential risks and benefits, and their right to withdraw without consequence (you must include this in your submission!) 2. Privacy and confidentiality Safeguarding participant data, including anonymization, encryption, and secure storage (you'll have to describe this in your method section.) 3. Vulnerable populations If research involves children, the elderly, prisoners, or those with cognitive impairments, additional measures protect their rights and well-being. 4. Benefit-risk assessment Potential benefits or risks to participants considering not only physical harm but also psychological and social impacts. 5. Data integrity and transparency Accurate data collection, analysis, and reporting. 6. Researcher bias and conflicts of interest Addressing personal biases and financial conflicts and transparent disclosure and mitigation strategies. 7. Cultural sensitivity Respecting diverse cultural values and beliefs AND, here comes the tough one 👇 8. Institutional review board (IRB) approval An approval letter generated by an IRB is compulsory for every single submission that involves research on human subjects. ___________________ 🔔 This is Dr. Samira Hosseini. Scholars who took my training published +2,000 articles in top-tier journals. Join my inner circle not to miss even one single bit of learning: https://lnkd.in/eVNSihCM

IND Clinical Trial Application Approval Process in India (CDSCO) What is an IND Application? An IND (Investigational New Drug) application is submitted to the Central Drugs Standard Control Organization (CDSCO) for obtaining permission to initiate clinical trials of a new drug in humans. Approval Process: Step-by-Step #Step 1: Pre-submission Preparation Conduct preclinical studies and prepare: -Investigator’s Brochure -Clinical trial protocol -CMC (Chemistry, Manufacturing & Controls) data -Safety & efficacy data -Informed consent documents #Optional: Pre-submission meeting with CDSCO for guidance. #Step 2: Submission to CDSCO Submit Form CT-04 (IND) via the SUGAM portal and attach: -All scientific data -Protocol #Step 3: Scientific Review by CDSCO -CDSCO forwards it to the Subject Expert Committee (SEC). -SEC reviews safety, rationale, and protocol. -SEC sends the application to both the Technical Committee and the Apex Committee -The applicant may be asked to clarify their information. #Step 4: Ethics Committee (EC) Approval Submit the trial protocol to a registered Institutional Ethics Committee, and the EC reviews: -Risk-benefit ratio -Informed consent form -Investigator qualifications ⚠ Approval from EC is mandatory before trial initiation. #Step 5: Approval Issued -If CDSCO is satisfied, permission is granted. -This allows the initiation of the clinical trial in India. #Step 6: CTRI Registration -Register the approved trial on the Clinical Trials Registry - India (CTRI). -The trial cannot start until registration is complete. #Step 7: Trial Initiation & Oversight Conduct trial as per Good Clinical Practice (GCP) guidelines and submit: -Serious Adverse Events (SAEs) within timelines -Annual status reports -Protocol amendments (if any) for further approval #RegulatoryAffairs #MedicalWriting #ClinicalReseach #India

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

In today’s global research landscape, ethical oversight is critical to safeguarding participant rights—but current systems often hinder both protection and progress. Multi-site studies face fragmented oversight, with each institution conducting its own IRB review 🏢. There is no evidence at all that multiple ethical reviews afford better protection to participants than a single review. On the contrary, multiple reviews create costly delays, inconsistencies, and resource strain. A Global IRB Coalition could harmonize global standards with local adaptability.🎯 How a Global IRB Coalition Would Work 💡 1️⃣ Unified Standards with Local Flexibility 🧩 Coalition members would adhere to universal ethical guidelines developed by an international panel of experts. These standards ensure consistency across coalition members while allowing local committees to make necessary cultural or regulatory adjustments. 2️⃣ Centralized Digital Platform for Seamless Collaboration 💻 A web-based platform would serve as the coalition’s operational core, enabling researchers to submit a single application. With automated translations and workflows, this platform would streamline communication and eliminate duplicative reviews. 3️⃣ “Approved by One, Recognized by All” Principle ✅ Once a coalition-certified IRB approves a study, it’s automatically recognized across all coalition-affiliated sites, reducing the need for repetitive reviews. This unified approach cuts down on delays, making multi-site studies more efficient without compromising on ethical standards. 4️⃣ Internationally Recognized Certification Seal 📜 Approved studies receive a coalition certification seal, displaying the emblems of all participating countries, signifying adherence to high ethical standards. This certification not only assures participants and institutions but also builds trust globally. 5️⃣ Pooling of Resources and Expertise 🌐 Shared resources give all coalition members, including smaller institutions, access to global expertise, ensuring comprehensive reviews and high ethical standards everywhere. 6️⃣ Enhanced Accountability and Enforcement Mechanisms: The coalition would enforce standards through audits, compliance monitoring, and transparent decision-making. Members are accountable for ethical adherence, with sanctions or membership loss as consequences for non-compliance. The Path Forward 🌱 A Global IRB Coalition with harmonized standards offers a streamlined, culturally informed model for ethical oversight and could build trust, reduce delays, and protect participants across borders. For today’s global research challenges, a unified ethical review model is not just an ideal—it’s essential for research integrity and progress. Chisquares hereby commits resources to build a cutting-edge platform at no charge for the global coalition should it take off. 📢 Please, share to amplify message so it reaches key decision makers.📢 #Chisquares #ResearchOversight #Ethics