ProEthos platform for ethics review of human subjects research

medical sciences

What is ProEthos?

ProEthos is a free, open-source platform that PAHO developed in collaboration with the Pontifical Catholic University of Paraná (Brazil) and the Latin American and Caribbean Center for Information in Health Sciences (BIREME - Regional Library of Medicine, originally) to facilitate the work of ethics review committees (ERCs). ProEthos was developed starting in 2012 and is now in its third version.

Objectives:

Catalyze ethical research:  

  •  Allow ERCs / institutions to securely manage their own ethics review process digitally via an efficient, secure, online platform that is easily accessible to staff, members, and researchers.
  • Center the focus of the ethics review process on the ERC’s deliberations; streamline the administrative burdens caused by the excessive paperwork and revisions of ethics review, document editing, and managing communications among investigators, ERC Members, ERC support staff, and research sponsors.
  • Promote transparency in research among ERCs, institutions, investigators, and other stakeholders through exports of data in relevant formats (.xls, .xtml.) for uploading to international clinical trials registries (WHO/ICTRP and others)

 

 

proethos logo

Visit the Proethos2 repository on GitHub to download the software and manual.

How does ProEthos work?

  1. ProEthos allows for the input, submission, and review of a digital research proposal to the ERC for ethics review. Secure user accounts and data entry fields with set parameters require investigators to submit only complete and relevant data for the ERC. Various documents (word, pdf, excel, .jpeg. etc.) can be uploaded with the submission and combined to a single PDF, creating a complete proposal.
  2. Manages the ERC’s entire ethics review process. ProEthos receives, documents, dates, and timestamps all the steps, documents, and edits received throughout the ethics review process.
    • Protocols can be assigned and sent electronically to ERC members and external reviewers.
    • Automatic email messages can be sent throughout the process to facilitate all communications between the ERC administrators, members, external consultants, and researchers.
    • Decisions can be uploaded and sent via email; investigators can easily edit a submission to fix the committee’s concerns and return a revised proposal.
  3. Supports the ethics supervision process and institutional recordkeeping. ProEthos solicits monitoring actions from investigators at set intervals, facilitates reporting of research protocols, and exports data to the formats required for clinical trial registries (.xlm,. xtml)

How does ProEthos improve the ethics review processes?

ProEthos is not meant to replace the in-person or virtual ethics deliberations carried out by an independent ERC. Rather, ProEthos aims to minimize and digitize the administrative steps of the ethics review processes so that the bulk of members’ time is spent conducting substantive reviews of research protocols. Comments from ERC members and investigator updates to the protocol are easily captured, and emails are sent to investigators automatically at each stage of the process, which supports transparent communication channels.

What is the cost to install ProEthos?

ProEthos is an open-source software package – there is no direct cost to download it or subscription fees. However, a skilled computer programmer and a dedicated server are necessary to successfully download and use ProEthos. If your institution does not have a dedicated programmer and/or server space for ProEthos, installing ProEthos implies assuming the cost to hire a programmer for the installation and/or purchase space in a server or cloud-based server.

How do we install ProEthos? What are the technical requirements?

We recommend installing ProEthos in an Ubuntu server environment for optimal functioning; it can also be installed using a Windows environment. You can review the diagram of the open-source framework here.

What does collective governance mean?

ProEthos is free because it is opensource and operates through a collective governance model. This means PAHO/BIREME does not offer direct technical support to institutions to download and use the software and is not responsible for the configuration and maintenance of the system at the local level. Other technical and administrative users of ProEthos throughout the LAC region provide technical support and advice through our online forum. This, along with the technical specifications for the platform, is located on the platform for developers titled GitHub. This also means that:

–Periodic training is offered to users; we hope users will also share their knowledge with others when possible.

– Active contributions from many users create a stronger web of knowledge (more documentation of errors/bugs and their resolutions means more resources for everyone)!  

– Periodic updates to the system are initiated by BIREME but must be proactively sought and incorporated by individual institutions to ensure its optimal functioning.

How do we get started?

Reviewing the written resources and specifications available on GitHub is the best place to start. You may also contact pahoerc@paho.org to request an additional meeting about the site.

Which countries are currently using ProEthos?

PAHO does not control which countries/institutions download and use the software, but we know it is in use at several institutions in the following countries: Argentina, El Salvador, Guatemala, Honduras, Panama, Peru, and Trinidad and Tobago.