HRB National Clinical Trials Office (NCTO)’s Post

In 2024, HSE R&D made significant strides toward a nationally coordinated research ethics system, with our REC Reform Team working to streamline processes and foster a more efficient, inclusive approach to research ethics in the health and social care services. Supporting the REC community has been a central part of this effort. We’ve provided tailored training, resources, and opportunities for collaboration to promote shared learning and inclusivity. A highlight this year was the Diversity, Equality, and Inclusion Training workshop, held for REC Chairs and Deputy Chairs, emphasising the importance of diverse perspectives in research ethics. We also established the REC Managers Community of Practice (COP)—a space for REC Managers to connect, share insights, and work collaboratively. For many, this COP has improved their experience, turning what was once described as “a lonely space” into a network of support and shared learning. Given the success of the COP, this group will be widen to all publicly funded REC Managers in 2025. Mary Clare O' Hara, Programme Manager, HSE R&D, comments: "A strong research ethics system is built on collaboration, inclusivity, and shared learning. By fostering connections and embracing diverse perspectives in our REC community, we create a culture that supports progress and empowers those involved in research. When everyone’s contributions are valued, we lay the foundation for an agile research ethics system that enhances access to health research and ultimately improves health outcomes for patients, families, and communities.” Looking ahead, the REC Reform Team is committed to building on this progress in 2025, advancing our goal of a more streamlined health and social care research ethics system that enables high-quality research for all. ➡️ For more information read the HSE Roadmap for Reform of Health and Social Care Research Ethics Committees: https://lnkd.in/ejchgbxN HRCI - Health Research Charities Ireland Health Research Board (HRB) HRB National Clinical Trials Office (NCTO) HSE Library HSE Dublin and South East Health Service Executive HSE Patient and Service User Engagement HSE West North West HSE Mid West HSE Dublin and Midlands HSE Spark Innovation Programme

📝 ETHICS COMMITTEE 💬 Ethics Committee (EC) is composed of members with expertise in both scientific and nonscientific arenas which functions to ensure the protection of human rights and the well-being of research subjects based on six basic principles of autonomy, justice, beneficence, nonmaleficence, confidentiality ... #Ethics committee role :- Ethics committee plays the pivotal role in ensuring that a trial is conducted in accordance with GCP guidelines and to safeguard the safety and well-being of subjects participating in a clinical trial. #Ethics committee purpose:- Ethics committees, or similar institutional mechanisms, offer assistance in addressing ethical issues that arise in patient care and facilitate sound decision making that respects participants' values, concerns, and interests. #Type of Ethics committee:- *Independent ethics committee (IEC) *Institutional Review Board( IRB) They play essential roles in the oversight and ethical review of clinical research protocols. #Independent ethics committee:- *It is not a part of institution or hospital or Research centre *It is an independent body without having any relationships with the institute *Most important point is , at present IEC only give approvals For BA/BE or CT studies of approved Drugs. #Institutional review board:- *It is formed by an institution that is hospital or Research centre *It reviews the documents/ protocols submitted by the institution for conducting clinical trials *It also performs ongoing review of the approved study at appropriate time intervals Ethics committee follows 6 basic principles:- 1. Autonomy: respect the patient’s right to act on his/her own value and choice. 2. Justice: fair treatment of the research subjects. 3. Beneficence: work for the benefit of the patient. 4. Nonmaleficence: primum non- nocere or first do no harm to the patient. 5. Confidentiality: privacy protection. 6. Honesty: truthfulness in terms of the study. EC Composition:- Most countries in Europe, the USA, and South Korea have a requirement of at least five members whereas recommendations in China and India need a minimum of seven members and a maximum of 12–15 members. The composition may be as follows:- 1. Chairperson 2. One - two persons from basic medical scientists 3. One - two clinicians 4. One legal expert 5. One social scientist 6. One philosopher / ethicist 7. One lay person 8. Member Secretary *NOTE* * Ethics committee shall consist of atleast 50% of its members who are not affiliated with institute or Organisation *Chairperson - who is not affiliated with the institute or Organisation shall be the Chairperson *Member Secretary - Shall be affiliated with the institute or Organisation * Form CT-01:- Application for registration or renewal of EC *Form CT-02:- Grant of registration of ethics committee related to CT or BA/ BE studies. *IRB or IEC should located in the same city as the site is within a 50 km radius

REDSSA is excited to announce the publication of a landmark research article titled "cross-border data sharing through the lens of research ethics committee members in sub-Saharan Africa" authored by Nezerith Cengiz, Siti Kabanda & Keymanthri Moodley. This comprehensive study, now available in PLOS One, provides an in-depth examination of the ethical considerations and dilemmas faced by Research Ethics Committees (RECs) in sub-Saharan Africa concerning data sharing. As global health initiatives increasingly rely on international data collaboration, the study sheds light on the critical balance required between advancing scientific research and protecting participant rights and privacy. This research is pivotal for shaping policies and frameworks that support ethical data sharing practices in the region. Key findings of the study: Ethical concerns: REC members highlighted significant ethical issues related to consent, data privacy, and the potential for misuse of shared data. Ensuring participant anonymity and safeguarding sensitive information were among the top concerns. Regulatory challenges: The study identified a lack of comprehensive and harmonized regulations to govern cross-border data sharing. REC members emphasized the need for stronger regulatory frameworks that align with both local and international standards. Need for capacity building: There is a pressing need for enhanced training and resources to support REC members in navigating the complexities of cross-border data sharing. Building capacity within RECs is essential for maintaining high ethical standards. Collaborative solutions: The research underscores the importance of developing collaborative frameworks that facilitate ethical data sharing while respecting local contexts and regulations. Promoting dialogue and cooperation among stakeholders is crucial for ethical research practices. Our research highlights the urgent need to address ethical challenges in cross-border data sharing. By enhancing regulatory frameworks and investing in capacity building, we can ensure that data sharing practices are ethical and beneficial for all stakeholders involved. The REDSSA project, funded by the NIH (DSI Africa 1U01MH127704-01), aims to advance ethical data science practices in sub-Saharan Africa through research, training and policy advocacy. This publication represents a key milestone in REDSSA's mission to support ethical research and data sharing in the region. For additional details and access to the full research article, please visit https://lnkd.in/d66F2w5y

Latest paper by Nezerith Cengiz and Siti Kabanda. Have a look, it is well written.

I’m happy to share that I’ve obtained a new certification: Research Ethics from World Health Organization (WHO)! In this course, I gained a thorough understanding of research ethics, focusing on the roles and responsibilities of Research Ethics Committees (RECs), the importance of ethical oversight, and the WHO’s involvement in research ethics. I explored the historical development of research ethics, learning about key landmarks, people, events, and documents that have shaped ethical guidelines. The course introduced me to essential ethical principles like respect for persons, beneficence, and justice, along with practical guidelines, particularly in the context of developing countries. I learned how to evaluate risks and benefits in research, emphasizing the importance of balancing harm and benefit in study design. The course also covered the ethical considerations surrounding scientific validity and the use of placebos, as well as complex issues like deception in research. It highlighted the need for transparent and scientifically valid study designs, ensuring research upholds ethical standards. The course delved into vulnerabilities in research, addressing the special considerations required when working with vulnerable populations. I also explored the obligations researchers have to participants, including providing medical care, compensating for research-related harms, and offering post-trial benefits. Community engagement was another key focus, and I learned the importance of involving stakeholders and communities in the research process. Privacy and confidentiality were emphasized as crucial aspects of ethical research, along with the importance of informed consent. The course outlined the ethical guidelines for protecting participants’ rights, ensuring that informed consent is an ongoing process and that participants are fully aware of the risks and benefits. Issues like transparency, managing conflicts of interest, and handling scientific misconduct were also addressed, providing a comprehensive view of the ethical challenges researchers face. Overall, this course equipped me with the knowledge to navigate the ethical complexities of research, ensuring that I can conduct studies responsibly while safeguarding participants' rights and well-being.

I have just enjoyed a hugely informative session with the Laidlaw Foundation Deep Dive sessions about research ethics with Kelci Jacoby. A presentation from Simon Gardiner gave a great variety of examples to consider, and stimulated our group discussions both around existential research questions and the particulars of our own current research projects. For me, among the most salient was a discussion around the importance of ethical guidelines. For my research the prioritisation of children's voices has been a key consideration, and this discussion highlighted the importance of this as an institutional value. Further discussions around motivation added insight to this - our own backgrounds and reasons for researching can colour our views of research in ways we may not fully appreciate. Ethical guidelines and codes create (as far as we can hope) a neutral and protective basis from which we can all work, ensure ethics is at the heart of all we do as researchers. Within my research, particularly as a disabled researcher working with disabled children (as well as their families and wider network), the phrase "nothing about us, without us" often guides my planning. I feel it is hygely important to center their voices, giving children the opportunity to guide interviews and therefore my research to areas which are most central to them. I feel priviledged to explore the huge spectrum of experiences of the children and adults I am working with, and acknowledging my own biases and understanding gaps around experiences of disability has helped me to ensure ethics is consciously and constantly central to my research process. I'm grateful for these opportunities to connect with fellow Laidlaw scholars and hear from experts in research in an interdisciplinary and open space. These key takeaways will guide my research in the weeks (and years) to come!

Meeting with Ms. Nana Nwachukwu, an AI Ethics Researcher and Advisory Board Member of the Digital Democracy Initiative (DDI)! It was a pleasure meeting Ms. Nana Nwachukwu, an AI Ethics Researcher and Advisory Board Member of the Digital Democracy Initiative (DDI)! Ms. Nwachukwu's dedication is evident in her work at the Digital Democracy Initiative, where she brings a unique perspective and provides valuable insights and strategies to support global development through digital transformation. Her work spans non-profits, technology, and digital media, all driven by a strong mission: to utilize the potential of AI and social research for positive social impact and to innovate in program design and operations for a more equitable digital future. The Digital Democracy Initiative (DDI) is a crucial program to safeguard inclusive democracy and human rights in the digital age. The DDI's focus on supporting local civil society in the Global South, particularly in countries undergoing democratic regression and where civic space is under pressure, is of paramount importance. The digital space has emerged as a pivotal arena in expanding and protecting democratic rights. Digital technologies, with their immense potential for strengthening pluralist democracy, encouraging civic participation, and amplifying the voices of marginalized groups, are a beacon of hope. However, it's crucial to acknowledge that digitalization also exposes human rights and democratic processes to new risks, including censorship, digital surveillance, misinformation, cyber-attacks, persecution, and harassment. The Digital Democracy Initiative was launched during the 2023 Summit for Democracy by the Danish Government and the EU Commission as a Team Europe initiative. It aims to support local organizations and activists in the Global South in their fight for democracy and human rights in the digital age. The program focuses on organizations representing women, youth, and marginalized groups, as well as informal actors and social movements with limited access to funding and other resources.

💡⚕️ Dive into the complex world of medical ethics with our latest blog. Explore thought-provoking discussions, ethical dilemmas and teaching strategies to empower your students to navigate this critical subject with sensitivity and insight. Let's spark meaningful conversations in the classroom! 📚✨ 👉 https://buff.ly/3x2cKje #medicalethics #ethicalteaching #teacherresources #educationblog #bioethics #teachingethics #classroomdiscussion #healtheducation #ethicaldilemmas #teachingsensitiveissues #studentengagement #criticalthinking #medicaldecisionmaking #ethicsinclassroom #teachingmedicine

How to manage digital ethics in a company.