Research Governance and Ethics – an overview

Summary

In this informative video by the Applied Research Collaboration Kent, Surrey, and Sussex, Melanie Rees-Roberts introduces research governance and ethics. She outlines its historical roots in the Declaration of Helsinki and highlights key principles for conducting ethical research. The video emphasizes the importance of obtaining necessary ethical approvals, particularly from the Health Research Authority and NHS ethics committees, depending on the nature of the research and participant involvement. Additionally, it discusses the significance of local permissions and the role of research departments in guiding researchers through the approval process, ensuring ethical compliance throughout their projects.

Takeaways

• 📚 Research governance originated from the Declaration of Helsinki (1964), which established ethical principles for human experimentation.
• 🔍 The primary goal of research governance is to protect participants' safety and rights while ensuring research reliability.
• 📝 Ethical approval is crucial for research projects and depends on the project's nature and participant involvement.
• ❓ Researchers should determine if their project constitutes research by asking if it seeks new knowledge and involves data collection beyond routine care.
• ⚖️ The Health Research Authority Decision Tool can assist researchers in determining if ethical approval is necessary for their projects.
• 👥 Projects involving NHS patients, including those lacking capacity for informed consent, typically require HRA and Research Ethics Committee (REC) approval.
• ⚠️ Certain projects, such as those involving ionizing radiation or unapproved medical devices, automatically require full HRA and ethics approval.
• 📋 After obtaining necessary approvals, researchers must seek local permissions from organizations where they plan to conduct their studies.
• 🔑 Non-NHS staff may need a research passport to access NHS sites and ensure appropriate safety checks are in place.
• 🔗 Communication with research departments and local authorities is essential for understanding the approvals and governance processes required for research projects.

Q & A

What is research governance?

Research governance refers to the framework that ensures ethical principles and regulations are followed in research involving human participants. It originated after the Declaration of Helsinki in 1964 and aims to protect the safety and rights of participants.

What are the main areas covered in this video about research governance?

The video covers three main areas: the definition and background of research governance, the approvals required for research projects, and the local permissions needed before starting a project.

Why was the Declaration of Helsinki created?

The Declaration of Helsinki was created to address ethical concerns in human experimentation, particularly in light of unethical practices that emerged during and after World War II.

What should a researcher consider to determine if their project qualifies as research?

Researchers should ask if their project seeks new knowledge, if findings will be generalizable, if it involves collecting additional data beyond routine care, and if it includes randomization.

What is the Health Research Authority Decision Tool?

The Health Research Authority Decision Tool is a resource that helps researchers determine whether their project qualifies as research and if they require ethical approval.

What types of projects automatically require Health Research Authority and Ethics Committee approval?

Projects that expose participants to ionizing radiation, involve investigational medicinal products, use non-CE marked medical devices, or include vulnerable populations, such as prisoners or individuals unable to give informed consent, require these approvals.

What is the role of a university ethics committee?

A university ethics committee reviews research projects that may not require Health Research Authority approval, ensuring ethical standards and governance procedures are maintained.

What is a research passport and when is it needed?

A research passport is a document that verifies the background checks of non-NHS staff who need access to NHS organizations for research purposes. It is required to ensure participant safety and compliance with organizational policies.

What should researchers do if they are unsure about the approvals they need?

Researchers should contact their organization's research department for guidance on necessary approvals and to ensure their project is registered appropriately.

What is the importance of obtaining local permissions for a research project?

Local permissions ensure that the organizations where research will be conducted support the project and that researchers have appropriate access to participants and data. This includes conducting a local capacity and capability assessment.