Emerging Technologies, Ethics, and Research Data Consulting Service

Consultations offered include

  • Regulatory requirements education services
  • Protocol review
  • Feasibility
  • Analysis planning & advice
  • Human subjects research expertise
  • Support for institution-based education and training

Eligibility

  • All researchers at Harvard University and affiliated academic healthcare centers
  • Institutions that are participating in or preparing to participate in the Harvard Catalyst Master IRB Reliance Agreement

Cost

  • Free during pilot stage

Consultation Services Available

IRB-related research data consult

  • Regulatory definitions and institutional review board (IRB) oversight requirements
  • Review of technology-based study procedures, and evaluation against regulatory criteria for human subject’s research approval
  • Overview of requirements for conducting research with emerging or novel technologies

IT-related research data consult

  • Information about regulatory framework requirements
  • Overview of requirements for conducting research with emerging or novel technologies
  • Review of technology specifications for research data collection, storage, management, and retention

Institutional connection service

  • Institution-specific policy guidance for both IRB applications and/or institutional information technology policies

Technology risk assessment

  • Identification of risks associated with technology solutions used in human subject’s research
  • Support for the appropriate evaluation of the safety and potential risks of technology being utilized to conduct research

ETech Consulting Service

The use of technologically interconnected products and services continues to revolutionize the design and conduct of human subject research. These technological innovations raise important legal, regulatory, and ethical questions for institutional review boards (IRB). To adequately address these emerging issues, ensure protection of human subjects, and accurately apply the regulatory criteria for approval, it is recommended that IRBs incorporate information technology (IT) expertise throughout their work.

Our Emerging Technologies, Ethics, and Research Data Consulting Service is composed of volunteer IT and institutional review board (IRB) experts from the Harvard academic, medical, and hospital communities. The service offers expertise, resources, and shared experiences to assist investigators at this critical intersection, and to equip IRBs in managing the need for IT expertise on their boards.

The ETech Consulting Service aims to help increase regulatory compliance and further development of innovative technology use, data (and by extension human subjects) protection, and security standards with the support of Harvard Catalyst resources. The service focuses on providing assistance to researchers during the early stages of research development. Please note that requests from eligible investigators at Harvard-affiliated academic healthcare centers will be redirected to their institution’s designated contact. Upon submission of request for consultation, the affiliated hospital IRB will be notified of the investigator’s request for consultation and the final decision regarding IRB approval is with the reviewing IRB.

In addition to the above, the service offers hands-on training for IRB members. The ETech Consulting Service can assist IRBs on finding ways to include IT expertise as follows:

1) onboarding/appointing institutional IT professionals as IRB Members, or

2) conversely, if appointing an IT professional to the IRB is not feasible, the consulting service will provide a curriculum for existing IRB members, which will enhance their understanding of IT and/or data confidentiality protections, evaluating technology-related risks, while concurrently evaluating the regulatory criteria for approval.

How do I request a consultation?

To initiate a consultation, please complete and submit the webform below. After your request is submitted, it will be reviewed by the consultation service and you will be contacted to arrange the details of the consultation. Please be advised that consultation is provided on a first-come, first-served basis. We recommend that you submit your request for a consultation as early as possible to allow for any scheduling delay.

ETech Consulting Service Form

To request a Harvard Catalyst ETech consultation, please complete and submit this webform.

To learn more, please visit the Regulatory Foundations, Ethics, and Law Program page.