Ethics and Integrity

Level 1 applications cover: secondary data analysis, approved IRAS, Caldicott and R&D applications.

Additional requirements for Level 1 applications:

• Secondary data analysis: in the project summary, the applicant must specify who collected the data originally, where it was collected originally (i.e. which organisation had oversight of the data collected), when was it collected and who approved the ethics of the original data collection.
• IRAS, Caldicott and R&D applications: please attach the original application forms submitted to these bodies outlining the data you want to access, and the letter of approval from Caldicott or IRAS or R&D to show that they have approved access.  

Level 2 applications include studies involving other people (i.e. generating new data).

Additional attachments for Level 2 applications:

• Copies of  participant recruitment, such as adverts, social media, posters and email/letter templates which will be sent to potential participants to notify them of the project.
• Participant information sheets or screenshots of online recruitment platforms. Please include the person supervising the research, an independent academic who can provide external and objective advice about the research and, the complaints contact (for HiSS this person is the Head of School).
• Consent forms. In addition to the standard statements, please include a statement specifically asking permission from the participant about what type of information is being recorded and stored. A specific statement must be ticked/agreed by the participant to show that they specifically agree to the way their data is being recorded and stored. A specific statement should be ticked/agreed by the participant about what will happen to their data (i.e. storage in an online data repository). 
• Debrief information. Please include the person supervising the research, an independent academic who can provide external and objective advice about the research, the complaints contact and information about support services with appropriate signposting.
• Examples of survey questions, interview questions etc. 
• For child studies, verbal information for child assent, verbal debrief for child and information on how child assent will be recorded.  
• Anything else that the participants will see or gatekeepers will have sight of. 

Substantial amendments require you to submit a new application including:

• Changes to the design or methodology of the study, or to background information likely to have a significant impact on its scientific value
• Changes to the procedures undertaken by participants
• Changes likely to have a significant impact on the safety or physical or mental integrity of participants, or to the risk/benefit assessment for the study
• Significant changes to study documentation such as participant information sheets, consent forms, questionnaires, letters of invitation, letters to GPs or other clinicians, information sheets for relatives or carers
• A change of sponsor(s) or sponsor’s legal representative
• Appointment of a new chief investigator 
• A change to the insurance or indemnity arrangements for the study
• Inclusion of a new trial site (not listed in the original application)
• Appointment of a new principal investigator at a trial site
• Temporary halt of a study to protect participants from harm, and the planned restart of a study following a temporary halt
• A change to the definition of the end of the study
• Any other significant change to the protocol
• If a new participant group is being recruited (i.e. recruiting parents as well as children in studies), this requires an additional or new set of participant info sheets, consents and debriefs

Non-substantial amendments allow you to add changes to your initial application and resubmit:

• Minor changes to the protocol or other study documentation, e.g. correcting errors, updating contact points, minor clarifications
• Updates of the investigator’s brochure (unless there is a change to the risk/benefit assessment for the trial)
• Changes to the chief investigator’s research team if those were named (Note: it is recommended that you do not list the names of students but specify that the project will be ongoing and current students will work on the project each year)
• Changes to the research team at particular trial sites (other than the appointment of a new principal investigator in a trial site)
• Changes in funding arrangements
• Changes in the documentation used by the research team for recording study data
• Changes in the logistical arrangements for storing or transporting samples
• Inclusion of new sites and investigators in studies other than trial sites
• Adding a new self-report or other-report (i.e., standardized questionnaire) that measure similar concepts as were already approved
• Extension of the study beyond the period specified in the application form
•  Changes to contact details for the sponsor (or the sponsor’s representative), chief investigator or other study staff are minor amendments

Pre-registration is the practice of registering the hypotheses, methods, and/or analyses of a scientific study before it is conducted and involves creating a time-stamped record and analysis plan. When you preregister your research, you are specifying your research plan in advance of your study and submitting it to a registry ensuring scientific transparency.

Pre-registration of studies should be uploaded before you start any data analysis. That means that you can submit the pre-registration while you are collecting data. If anything should change, you can also update the pre-registration before starting the analyses.

Why would I want to pre-register my study?

The primary goal of pre-registration is to be transparent about your research process, and to avoid poor research practice. Others can compare your pre-registered plans to the final study and evaluate the evidential value of the research, particularly in relation to the ability of your analysis plan to falsify predictions and control for type 1 errors (in essence, incorrectly concluding that an effect exists).

Other benefits are:

• Helps you clarify the hypotheses/research questions and the planned analyses and to make sure that the whole research team is on the same page. It encourages you to formulate precise research questions and fine-tune your design prior to conducting the study.
• Helps to avoid questionable research practices such as p-hacking.
• Will help writing up the report.
• Many journals prefer studies that had been preregistered.
• Much better chances to publish the study even in case of null results.
• The university encourages pre-registration.

If you want to read up on pre-registration:

More and more scientists are preregistering their studies. Should you?

Preregistration: Definition, Advantages, Disadvantages, and How It Can Help Against Questionable Research Practices

Pre-registration: Weighing costs and benefits for researchers

Embracing Open Science and Transparency in Health Psychology

Three steps to open science for qualitative research in psychology

Where can I pre-register my study? Open Science Foundation

You can pre-register your study on OSF (Open Science Foundation), following instructions of how to create a pre-registration.

When starting a pre-registration, you can choose between different types of preregistrations depending on your preferences and what type of study you want to pre-register. The most common are: OSF preregistration and Qualitative data preregistration.

The ethics application form contains many details of your study, which will make preparing a pre-registration quick. To help this process, we mapped the forms and made suggestions regarding which sections of the form of our committee might contain the relevant information to the different sections of the pre-registration forms.

Pre-registration examples

Below you will find examples of OSF pre-registration mapped to the School Research Ethics Application Form: