Guide to improving ethics applications
Common mistake: Forgetting signature
Signing the signatory page is evidence that the Principal Investigator or Academic Supervisor involved has proofread the ethics submission and are happy for their names to be associated with its content. The signature page is designed to prevent poorly completed ethics application forms and ill-advised research studies being submitted for ethics review.
Common Mistake: Yes / No boxes used in consent forms
Yes / No boxes in the consent form should be restricted to items where the participant has a choice to make about individual elements of the project.
Common Mistake: Not enough detail provided in Data Protection section
Data protection is a key part of the ethics review process. Ethics committees will require applicants to provide enough information on how data will be protected through the lifecycle of a study for them to be able to make an informed ethics decision.
Even if data is fully anonymised, ethics committees will want to see how data is adequately protected.
If you are unsure how to adequately protect your research data throughout the lifecycle of your study, you should speak with your institutional Data Protection Officer.
Common Mistake: Anonymisation and pseudonymisation used interchangeably
For data protection reasons, understanding the distinction between anonymised data and pseudonymised data is very important.
Pseudonymous data still allows for some form of re-identification (even indirect and remote), while anonymous data cannot be re-identified. If you are unsure if the data you will be collecting or using as part of the study is identifiable, pseudonymous or anonymous, you should speak with your institutional Data Protection Officer.
Common Mistake: Lay summary written using complex language
Most ethics committees will have several lay and public / patient members providing an opinion on any ethics application. This is why the lay summary is particularly important.
The lay summary is a brief summary of a research project or a research proposal that has been written for members of the public, rather than researchers or professionals. It should be written in plain English, the use of jargon should be avoided and any technical terms that are necessary to include should be explained.
Common Mistake: Patient Information Leaflet written using complex or legal language, or provides too much technical details
A good Patient Information Leaflet is one that is clear and easy to understand. This means that the information is presented in a way that allows the reader to understand and act on it after a single reading. To achieve this, it is important that you adapt the content (tone, style, words and amount of information) to ensure it is easy accessible and meaningful for the target audience. Research shows that this is particularly important for older people, ethnic minorities, people for whom English is not their first language, those with literacy difficulties and those who have not completed their formal education.
Common Mistake: Details of insurance or indemnity cover not submitted with application
All studies require some form of insurance or indemnity to protect both the research participant and the research team. You should contact your institutional insurance manager or research office to confirm that your study is covered under the institutional insurance policy.
Many research projects taking place in a state-run health care setting will be covered under the Clinical Indemnity Scheme. If your study comes under the Clinical Indemnity Scheme, you will need to notify the State’s Claims Agency of your study.
All ethics committees will require evidence that your study has adequate insurance or indemnity cover.
Common Mistake: Omitting information from additional sites or collaborating institutions such as; confirmed permission, name and contact details of institutional Principal Investigators, inclusion of Data Transfer Agreements or Memorandums of Understanding
When submitting a multi-site application to a National Research Ethics Committee, you will need to confirm that permission has been sought from all sites involved in the study. The contact details for the PI at each site will need to be included.
Any cross-institutional agreements will need to be shared with a National Research Ethics Committee as part of the decision-making process. This can include Data Transfer Agreements, Memorandums of Understandings, cross-institutional contracts etc.