Ethics Working Group

The Ethics Working Group (EWG) of the HCA is developing an Ethics Toolkit to help members of the HCA community understand the ethical framework of the HCA.  It provides tools that researchers can adapt to their own regulations, laws, local context and requirements (for example, consent, data sharing, etc.).

The Ethics Toolkit

The Ethics Toolkit does not intend to provide compulsory or mandatory documents or legal advice.  In all cases, HCA projects must consult with their research ethics committees and institutions to verify how these tools can be adapted to any specific requirements.

The following tools are made freely available to the HCA community:

Tips for submission to research ethics committees

• Ethics and data governance document
• Ethics submission guidance document

Consent Tools (Adult & Pediatric)

Core Consent Elements

Summary version of the Core Consent Elements detailed in the Ethics and data governance document.

HCA main consent template

Full research consent form template, can be used for sampling of tissues from healthy or diseased, capable adult participants.

HCA consent addenda

(in development) Consent form templates for additional tissue sampling scenarios.

• Template consent forms for deceased tissue/organ donors:
  • donation as a gift
  • sampling as part of a research project
• Template consent forms for developmental atlas
  • use of embryos for research
  • use of fetal tissue for research
• Template consent clauses for the use of clinical samples

HCA pediatric consent templates

• Main parental/mature minor consent form
• Assent and information form (7-11 years old)
• Consent form for use of pediatric leftover clinical tissue
• Consent form for pediatric rare disease research
• Consent for research use of newborn blood spots

Consent filter - HCA Retrospective Assessment Filter, Self-assessment tool for existing consent forms/consent forms used to collect legacy samples/data.

Recruiter training materials

If you have any issues downloading editable versions of the documents, please contact the Ethics Helpdesk at: ethics-help@humancellatlas.org

Biomedical Database Data Protection Impact Assessment Template

• Biomedical Research Database DPIA Template

Tips on sample or data sharing between sites, prior to submission to Data Portal

• Template Material and Data Transfer Agreement

Additional reading

• “Building the Human Cell Atlas: Issues With Tissues”, Michael Beauvais, Emily Kirby and Bartha Maria Knoppers
• “Children's right to Health”, Robyn McDougall, Dimitri Patrinos.
• “Children's Data Protection”, Michael J. S. Beauvais.