What is the NHS Health Research Authority?
Health Research Authority Approval is the process for research in the NHS in England. It replaces the need for research governance review by the Clinical Research Network, or each participating NHS organisation.
What type of study is a clinical audit?
Clinical (or medical) audits are part of the continuous quality improvement process that focus on specific issues or aspects of health care and clinical practice. They consist of measuring a clinical outcome or a process, against well-defined standards set on the principles of evidence-based medicine.
What does the Health Research Authority do?
Our vision is for high-quality health and social care research that improves people’s health and wellbeing, and our core purpose is to protect and promote the interests of patients and the public in health and social care research.
Can you publish an audit?
A worthwhile goal when disseminating audit results is to publish your audit in a peer-reviewed journal. Although most journals favour original research, it is not uncommon for an audit to get published in a journal and now some journals exist that publish only audits.
What is REC approval?
Not all research conducted within the UK requires review by an NHS Research Ethics Committee (REC). This decision tool: will help you to determine if your study requires a review by an NHS REC. will not tell you whether you need any other regulatory approvals and/or types of ethics review.
Does my study need ethical approval?
Decisions on the conduct of a study, including whether there is a need for ethical approval, is the responsibility of the Principal Investigator. Regardless of whether or not ethical approval is necessary, in the vast majority of cases research with human participants requires appropriate consent.
Do you need ethical approval for a retrospective study?
Receiving informed consent is based on the international guidelines and national standards, like ethics approval. However, recently published The National Code on Clinical Trials has declared that ethics approval is not necessary for real retrospective studies.
Why do we need ethical approval?
The main reasons why most pieces of research require ethical clearance is to: Ensure the research is conducted in a responsible and ethically accountable way, Minimise the risk of harm to humans (and animals), and. Ultimately ensure that the research leads to beneficial outcomes.
Do you need IRB approval for a retrospective study?
As a general matter, there is no retrospective IRB review. However, you should submit an application to the IRB for approval and include an explanation for why you did not think you needed IRB approval. Based on the information provided, the IRB will conduct an inquiry. The research may be exempt from IRB review.
Does clinical audit need ethical approval?
In principle the question “Does audit need ethical approval?” is an easy one to answer. The answer is ‘No’. Clinical audit by definition does not involve anything being done to patients beyond their normal clinical management and therefore does not require formal ethical approval.
What is ethics committee approval?
Researchers have an obligation to conduct their research with integrity and transparency. Research ethics committees will expect you to declare any actual or potential conflicts of interest that affect your research and to be honest and transparent throughout the ethical approval process and the research process.
How does the ethical review board help in the research process?
Research Ethics Boards, or Institutional Review Boards, protect the safety and welfare of human research participants. These bodies are responsible for providing an independent evaluation of proposed research studies, ultimately ensuring that the research does not proceed unless standards and regulations are met.