Early on in the life of a research study, researchers are required to submit details of their study to a research ethics committee for formal review. A research study may raise a number of ethical considerations with regard to safeguarding the people taking part in the research. Any research study that involves NHS patients in England must be submitted to the Health Research Authority (HRA) (formerly the National Research Ethics Service) for review. The HRA is committed to enabling and supporting ethical research in the NHS, while also protecting the rights, safety, dignity and wellbeing of research participants. The HRA follows statutory regulations based on ethical codes and principles, such as those laid down in the World Medical Association Declaration of Helsinki, which places the interest of the research participant above those of science and society. The HRA is also concerned with protecting researchers who engage in research activities, sometimes referred to as ‘fieldwork’.
Gaining ethics approval may seem time-consuming at the start of a project, when everyone is keen for the study to get underway. However, it is a necessary part of research governance, a means of ensuring and maintaining good standards in research practice in the NHS. Research governance approvals also ensure that undertaking research in the NHS is complementary to the standard delivery of care. The Integrated Research Application System (IRAS) aims to streamline the research application process, incorporating research ethics, research governance and other regulatory requirements in a single application process.
For the qualitative interview study part of this project we have submitted a series of study documents to an ethics committee, whose members will read each one carefully. The submitted documents include the plan for the study (also known as the study protocol), the letter of invitation to patients, the participant information sheet, which contains study details, and the consent form, amongst others. We have also provided to the ethics committee details about how we will gather and store research information, and how we will ensure confidentiality and anonymity for study participants. The research ethics committee will not give their approval for the study to proceed until they are satisfied that the proposed research meets ethics requirements.
An ethics committee may require the researchers to change the proposed plan for the research to meet with their requirements. For example, committee members may feel that patients need to be given more time to consider whether or not they wish to take part in a study. The research ethics service undertakes to process applications within 60 days, though in many cases it will happen more quickly, particularly through a fast track process for low risk studies known as proportionate review.
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