INTRODUCTION

“Ethicalizer” is a tool initially developed to serve the Recon4IMD project, which is an observational study conducted across Europe and the UK.

Biomedical and health-related research has a broad spectrum. Still, the general principles, remarkably the gold-standard Declaration of Helsinki, require a study to obtain approval from the Ethics Committee(s) before it can be performed.

Among the wide range of studies in this area, current EU legislations focus on clinical trials of medicinal products and clinical investigations of medical devices with Clinical Trials and Medical Devices Regulations (Regulations (EU) No 536/2014, No 2017/745, and No 2017/746). Particularly, the common portal – Clinical Trials Information System (CTIS) – is operated to manage clinical trials so that a single application submitted to Ethics Committees will be simultaneously assessed by the competent authorities.

Recon4IMD project, an observational study, is out of the scope of those Regulations. As a multinational study, the approval process complies with national requirements in the project’s participating countries.

The requirements in each country vary, from the terminology of research, its corresponding definition and coverage, to the Ethics Committee concept (for instance: central or local, university- or hospital- or authority-based establishment). However, the common principle remains similar: an Ethics Committee approval(s) is a must. Therefore, at least one application must be submitted in each country where the study is intended to be carried out.

From that, issues have emerged: Different Ethics Committees have different requests. Besides study documents such as protocol, an application form must be filled out. This application form can be short and contain basic administrative information or a lengthy questionnaire asking for details about the study. And since each country has its official language, this application form could be written in a language other than English.

To lower the workload of preparing various applications to get ethical approvals for Recon4IMD project, the automated “Ethicalizer” tool was developed. This tool was built using Python, integrated with the OpenAI GPT model and Microsoft Azure AI Translator.

INSTRUCTIONS

Please read the below instructions carefully before using the tool.

There are 5 inputs needed for the process: 4 required and 1 optional.

1. Protocol (required):

Please upload your Protocol.

This document must be in the format of PDF/DOC/DOCX.

2. EC Application Form (required):

Please upload the Ethics Committee’s Application Form/Questionnaire that needs to be answered.

This document must be in the format of PDF/DOC/DOCX.

API Keys:

Application Programming Interface (API) is a necessary component to enable “Ethicalizer” tool to interact with GPT Model and Microsoft Azure AI Translator for processing.
API keys are unique identifiers used to authenticate requests to APIs.

3. GPT API Key (required):

Content of the Protocol and Application Form will be extracted and fed to GPT Model to generate the answers.

Our tool is using gpt-4-turbo-2024-04-09 because its long Context Window is suitable for the lengthy document as Protocol.

Please note:

Guidance to get GPT API Keys is here.
GPT-4 Models could be costly, refer to pricing here.
Ensure you have access and enough credits to use GPT-4 Models, guidance is here.

4. Azure AI Translator API Key (optional):

For Application Form written in another language than English, the tool can translate the language after receiving GPT’s responses.

The answer package will include 2 documents: 1 is translated to language of the Application Form (Form's language will be automatically detected), 1 is in English for your manual validation.

You can ignore this field if you don’t need this function (i.e., your Application Form is in English, or you want to translate by yourself).

Please note:

Guidance to get Azure AI Translator API Keys is here: please follow the guidance for “single-service resources type” and choose “West Europe” for the “Region”.

5. Ethicalizer Code (required):

This is your own code containing maximum 20 characters.

We will not store any of your inputs. However, to provide you the result, we will store the answer package generated in our database.

NOTES:

The process could take up to 15 minutes, please don’t reload the page after submitting.
We use GPT to generate answers and Microsoft Azure AI Translator to translate. Therefore, the result is not verbatim every run of the tool. Even though it could just be a matter of wording, your manual verification is necessary before final responses are placed in the application forms for submission.