HSE Research and Development’s Post

NEKS, a new network of research ethics committees in the social sciences, will greatly enrich the work conducted in our project. Read below for details

Exciting News! The results of eConsent Ethics Committees and sponsors/vendors surveys, driven by the EFGCP - European Forum for Good Clinical Practice eConsent initiative, have been published! The survey reveals interesting insights into Ethics Committees' perspectives and expectations on topics such as: · Minimal signature requirements for on-site, remote with video call, or remote with phone call interactions between investigators and participants. · Personal data hosting requirements. · Important factors for approval, among many other items Interestingly, the regional differences between Ethics Committees may not be as significant as often assumed. On the sponsor and vendor side, the surveys examined drivers, barriers, usability of digital features, and other aspects. While common viewpoints were shared, there were also some notable differences between both organizational types. A huge thank you to susie song of Biogen, Stephen Walker of CSL Behring, Sam Thomas of ClinOne, Eric Delente of Medidata, Steven A. Johnson Jr., M.S., C of Takeda, Edwin Cohen of Evinova, Vinita Navadgi of IQVIA, Radu Alex Antonie of Roche, Nora Rachida Meskini of Debiopharm, Jenna McDonnell of ThermoFisher Scientific, and Valeria Orlova, and all our EFGCP eConsent database team members. Special thanks also to all participating organizations for their valuable survey contributions! Read the full article here: https://lnkd.in/ekU-gxmK Interested in shaping the future of eConsent? Explore the Glossary of eConsent Terms, Fit-for-Purpose Study Framework, and eConsent Study Recommendations on the EFGCP eConsent website. #EFGCP #eConsent #ethics  

Are you interested in learning more about research ethics in the face of pandemics? This casebook is a valuable resource for anyone involved in public health research. #ResearchEthics #Pandemics #PublicHealth #NewRelease I'm excited to see this valuable resource come out! Research ethics is a topic I'm incredibly passionate about. Ensuring ethical research practices directly impacts public trust and the success of interventions, which is why it's important to make these critical knowledge more accessible to a wider audience. This free and timely resource tackles the complex ethical considerations that arise during public health emergencies. Authored by a globally representative team, the casebook features real-world scenarios and ethical dilemmas faced by researchers across Africa, Asia, the Americas, Europe, and Oceania. The book is freely available for download at: https://lnkd.in/e6y4VvdM

NEKS, a new network of research ethics committees in the social sciences, will greatly enrich the work conducted in our project. Read below for details

We’re excited to announce a new project to address the ethical and governance challenges related to sharing #health and #medical #data. This project seeks to improve efficiency and quality in the application of requirements for sharing clinical research data among Australian researchers, human research ethics committees (HRECs), and governance offices. It also aims to bring a more consistent approach to research data governance across different institutions. This project is being established within the Health Studies Australian National Data Asset (HeSANDA) program as part of the People Research Data Commons. Dr Kristan Kang, HeSANDA Program Manager, ARDC, said, “We’re working with CT:IQ, whom we partnered with previously on the successful 'InFORMed' Project, which addressed research participant consent for data sharing. The new project builds upon this effort by providing guidance to researchers, research governance, and ethics officers regarding the legal and ethical aspects of data sharing.” One of the advocates for the new project is Martijn Oostendorp, Associate Director Trial Operations at the NHMRC Clinical Trials Centre of The University of Sydney. The NHMRC Clinical Trials Centre is a partner in the HeSANDA program and a founding member of CT:IQ. Martijn said, “Responsible and appropriate sharing of clinical research data requires consideration to complex ethical, regulatory, legal and institutional requirements. This project will enable data sharing stakeholders to confidently navigate these considerations. It will facilitate clinical research data sharing, which in turn will maximise learnings and minimise research waste in our shared mission to improve on health outcomes.”  Sara Gottliebsen is the Senior Manager, Research Governance at Health Translation Queensland, another HeSANDA program partner. She said, “The sharing and reuse of data is an important tool for Australia to be competitive and keep up with other countries in health research. Funding bodies are starting to request details on the sharing and reuse of data. We therefore need to be providing researchers with information and guidance on how to ensure their project is set up for data reuse, alongside ethical and governance arrangements that are nationally consistent.” Dr Lisa Eckstein, Director, CT:IQ, said, “CT:IQ was established to implement recommendations to improve the impact, quality, and efficiency of clinical trials in Australia. The opportunity to collaborate with HeSANDA on this project is an exciting opportunity to meet this objective by providing guidance and resources to promote trustworthy and responsible data sharing practices. This should allow for a more trustworthy, but also more efficient, data sharing ecosystem in Australia”. Read more >  https://lnkd.in/eednjBVt #datasharing #healthdata #PeopleRDC

Grateful to have completed the Understanding research ethics approval module by Epigeum, thanks to Sheffield Hallam University!✨ Some key takeaways: ✍️ Research ethics committees (RECs) play a crucial role in ensuring research integrity by reviewing proposals to identify ethical concerns, safeguarding participants, and guiding researchers on ethical conduct. Their core responsibilities include monitoring research progress, granting or withholding approval, and ensuring compliance with international and national ethical standards, such as those outlined in the Declaration of Helsinki. In the UK, RECs vary, including institutional RECs for non-NHS research, NHS RECs for healthcare studies, and specialised committees for defense or prison research. These RECs assess proposals on multiple dimensions, such as participant vulnerability, research quality, risk mitigation, and clarity in communications, ensuring transparency and accountability. ✍️ REC approval is essential for studies involving human participants, personal data, or activities with potential risks, with additional licensing required for animal research. The GDPR mandates that personal data handling be safeguarded, ensuring anonymity and confidentiality. Researchers must also adhere to national requirements for fieldwork and high-risk studies, often requiring REC approval to mitigate potential ecological or societal impacts. REC review processes emphasise quality as an ethical component, integrating protocol development with ethical scrutiny from the outset. ✍️ The REC application process involves identifying the appropriate REC, preparing a comprehensive submission, and awaiting a decision, which could be immediate approval, conditional approval, or recommendations for revisions. While requirements vary, institutions generally offer templates and guidance to aid in preparing participant-facing materials and data handling plans. Compliance with REC feedback is crucial, as failure to obtain approval before data collection can invalidate the research and lead to severe consequences. Ethics approval thus not only upholds participant protection but also validates the research’s ethical integrity. 🎁 The University has paid for an institutional subscription for access to a number of the Epigeum online courses. This content is available to all Sheffield Hallam staff and students. #EpigeumCourses #SheffieldHallamUniversity #OnlineLearning #ResearchTraining #AcademicResources #PhDCommunity #SHU #StudentSupport #AcademicSuccess #Epigeum #UnlockYourPotential

*Breaking News: Research Ethics Course On The Way! (included is a buy 1 get 1 free deal)* Picture a scenario where friends or family members are prescribed a treatment believed to be safe but could potentially pose harm. Such situations not only lead to undue distress and health complications for patients but also tarnish the public's trust in medical research. Safeguard your site's reputation and foster greater participation in clinical trials by certifying your team through Task Research Academy's Research Ethics Training. Coming soon! P.S. Great news for TASK Research Academy Alumni! This course is free for you! Additionally, if you enrol in the Foundations and Beyond- the Clinical Research Journey course, this one's on us! It's a buy one, get one FREE deal! Spread the News! #clinicalresearch #clinicaltrials #ethics #immersivelearning #TaskResearchAcademy

What is Ethics Committee in Clinical Research? In the context of clinical trials, an ethics committee, also known as an institutional review board (IRB) or research ethics board (REB), is a crucial oversight body tasked with ensuring that the rights, safety, and well-being of research participants are protected. These committees are typically composed of experts from diverse fields, including medicine, ethics, law, and the community. Their responsibilities include: 1. Protocol Review: Ethics committees review the proposed study protocol to ensure that it meets scientific and ethical standards. They assess factors such as the study's rationale, methodology, risks, potential benefits, and informed consent procedures. 2. Informed Consent: They ensure that participants are fully informed about the nature of the study, its risks and benefits, and their rights before consenting to participate. This involves reviewing the informed consent documents and procedures to ensure they are clear, understandable, and ethically sound. 3. Participant Safety: Ethics committees assess the risks associated with the study and evaluate the measures in place to protect participants' safety and well-being. They may require modifications to the study protocol to minimize risks or enhance safety monitoring. 4. Vulnerable Populations: Special attention is given to protecting the rights and welfare of vulnerable populations, such as children, pregnant women, prisoners, and individuals with impaired decision-making capacity. Ethics committees scrutinize studies involving these groups to ensure they are conducted ethically and with appropriate safeguards. 5. Ongoing Oversight: Ethics committees provide ongoing oversight throughout the duration of the study, monitoring its progress and any reported adverse events. They have the authority to suspend or terminate a study if serious ethical concerns arise. 6. Conflict of Interest: Committees also evaluate and manage any potential conflicts of interest among researchers, sponsors, and institutions involved in the study to maintain objectivity and integrity. Overall, ethics committees in clinical trials play a vital role in upholding ethical standards, safeguarding the rights and welfare of research participants, and promoting the credibility and integrity of biomedical research. Their rigorous review and oversight help ensure that clinical trials are conducted ethically, with due regard for the dignity, autonomy, and well-being of participants. #clinicalresearch #jobs #clinicaltrial #youtube #ethicscommittee #healthcare #linkedinfollowers #clinicalresearchcoordinator #clinicalresearchassociate

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

A very important document for those conducting non-interventional clinical research, giving significant clarity around the organisational and ethical relationships and plans under the new six Regional Health Areas emerging from what was the HSE.