The online ethics system allows you to create your ethics application and complete it online. The form can be saved and revisited for editing as many times as you need to before submission to HREC.
The ethics system has a single main application form that asks a series of filter questions which will guide you to the questions that are most appropriate for your specific project.
The main application types are low risk and high risk applications. There may also be times when you need to complete a shortened version of the application form if you are applying for an ethics review prior to applying for a funding bid, a project where The Open University is not the lead university or research that requires approval from the Health Research Authority (HRA).
The initial questions you are asked will be the same for a low or high risk application. When you reach question 12.1 and 12.2 your responses will determine whether your application will be low-risk or high-risk and which questions you are subsequently asked. As shown in figure 1, there are a number of options that can be selected in 12.1 and 12.2. You should select all that apply to your research project and if none apply, select none of the above.
If you select only options in 12.1 and none of the above for 12.2, your application will be classified as low risk. If you select options from 12.2 and/or 12.1, your application will be classified as high risk.
Once you have completed your answers to 12.1 and 12.2, select next page at the bottom of the screen. The online form will now be populated with the rest of the application form. You can view this by clicking the Navigate button on the left-hand toolbar.
This will take you to the navigation page in the online ethics system. The text under ‘Questions’ are hyperlinks and can be used to view and complete each section of the form. You can save you application at any stage by clicking on the Save button which will appear on the left-hand toolbar on each section of the application form. You can go back to your form and edit it up to the point you submit it to HREC. Once you submit, your application form will remain locked for editing until it is returned by HREC.
Yes, you can. Once you have completed questions 12.1 and 12.2, if you wish to work on the questions offline, you can create a PDF of your application form by clicking on the Save as PDF button on the left-hand toolbar. This will open a PDF copy of the form that you can save to your device. The online application form allows you to copy and paste text from another document into it if you wish to prepare your answers offline and then copy them into the online form.
Below are examples of the low and high risk application forms for your reference. You may use these to view and prepare your answers instead of generating a PDF copy of the application form from the online system first if you wish. However, you should note that the questions asked on the low and high risk application are different and if you do not use the online system to generate the questions relevant to your project as described above, you may find yourself spending time on questions that you will not be required to answer in the online system, or alternatively, you may be surprised by additional questions that you did not anticipate. Please use the risk questions shown in figure 1 to help you determine whether your application will be classified as low or high risk to minimise the risk of preparing the wrong questions.
There are three shortened versions of the application form that will apply as follows:
If you are submitting a funding bid and are required to have an ethics review to do so, you can submit a provisional ethics review to HREC by answering yes to question 6.1. This will generate a shortened version of the form where you will be prompted to upload your funding application for review.
If your project is being led by another institution and they have already issued a favourable opinion from their Ethics Committee for the project, you should answer no to question 5. You will be prompted to upload the ethics application and approval from the lead institution for HREC to review and confirm they are happy with the ethical arrangements.
If you are conducting research with NHS patients and need to submit an IRAS application to a NHS REC, you should answer yes to question 10. You will be prompted to upload a copy of your IRAS application for HREC to review. As the delegated sponsor, HREC will recommend any revisions they think are needed before your IRAS application is submitted to the HRA. Once you are given an HREC favourable opinion, you will need to submit your IRAS application to the HRA for a full review by one of the NHS REC’s.
You can find further information about HRA research and useful links on our website.
HREC will only accept application forms submitted through the online ethics system. Please do not send paper application forms to HREC as these will not be accepted for review.
The online system has a dual submission feature. You will be asked to sign your online form electronically. If you are a PGR student, you will also need to obtain an online signature from your supervisor.
Once all signatures are complete you must click the Submit button on the left-hand toolbar to complete your submission to HREC. This will need to be done for all application types and when submitting revisions requested by HREC. If you do not click on the submit button, your application will lock but will not be sent. If in doubt, check the application status on the project tree (figure 2) which appears above the question navigation section. If action is required by you as an applicant, you will see yes under action required on form (as shown in figure 2).
When submission is successfully completed, you will also receive an automated email from the online ethics system confirming this. This will come from a @infonetica email address who are the suppliers for the online ethics system and not an Open University email.
A user guide for the online ethics system can be found on our website.