Union College officially has a chapter of eNable! eNable is a foundation that connects people who want 3D printed prosthetic limbs to people who have the means to 3D print them. Typically this is more of a grass roots initiative, but as we started this project at Union, the possibilities for research and public relations came up, which raised many questions about legal and ethical obligations. So, we did some due diligence. Because the eNable project is mostly open source, we’d love to share our approach with others, hoping to save them some time.

At Union, we have a Human Subject Testing Review Board. Here is a copy of what was submitted and approved by that committee. The document includes participant questionnaires and parental consent forms.

We borrowed legal documents from UMass Lowell, and updated them to fit Union College’s needs. Those can be found here.

We also questioned whether the data we were collecting from people needed HIPAA classification, or was considered medical data. After consulting with our campus security team, we discovered that since our campus uses Google Cloud, and Google Cloud has special coverage for HIPAA like data, that we could use a Google Spreadsheet to store the data, with policies in place to prevent sharing. We also developed a procedure for anonymizing any patient data when necessary.

Finally, we decided it was a good idea to provide care and follow up instructions for people we make prosthetic arms for. Those can be found here.