Search results
Good research design is vital to ethical research practice. In order to obtain ethical approval applications should: Explain the research methods. Explain the intended outcomes (what will be produced) Identify potential ethical risks of the design e.g. working. Describe how risks will be managed and minimised.
- 363KB
- 23
- project details. This section provides the Research Ethics Committee reviewers and IOE’s administrators with all the background details of your project to ensure it is considered by the right members of staff.
- research methods summary. In this section you will need to enable the reviewers to fully comprehend the scope of your research project. This should include clear information on the aims and any supporting research, the rationale and justification for the research, the study design (including data collection and methods of analysis) as well as a justification for all of the research methods to be used and the topics/questions presented to participants.
- research participants. Most research projects at IOE are likely to have human participants, but not all. For example, if a literature review is a project in its own right (rather than one component of a wider project) there may be no human participants.
- security-sensitive material. Some projects may collect or encounter security-sensitive research material. This may be more likely if your project is within any of the following categories
You should apply for Health Research Authority (HRA) Research Ethics Committee (REC) approval through the Integrated Research Application System (IRAS). These types of study would include: a Clinical Trial of an Investigational Medicinal Product (CTIMP) (with the exception of Phase 1 trials in healthy volunteers taking place outside the NHS)
- Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s).
- Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society.
- The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society.
- The available nonclinical and clinical information on an investigational product should be adequate to support the proposed clinical trial.
The 4 main ethical principles, that is beneficence, nonmaleficence, autonomy, and justice, are defined and explained. Informed consent, truth-telling, and confidentiality spring from the principle of autonomy, and each of them is discussed.
- Basil Varkey
- 2020
Summary. Applicants for ethical approval should consider the core principles above and address any that apply to their work as part of their application. Failure to address the aspects above may lead to delays to your application for ethical approval.
People also ask
How do I apply for ethical approval for research?
How do I apply for Research Ethics Committee (REC) approval?
What does the Research Ethics Committee do?
How do I complete a research ethics application form?
What is ethical research design?
What should I consider when applying for ethical approval?
Oct 16, 2009 · In this article we discuss the practicalities of preparing an application for ethical review, and the process by which decisions are made. We offer advice on how to avoid common problems when applying to a research ethics committee and provide information on the integrated research application system, launched in January 2008.
