Regulatory Foundations, Ethics, and Law Program

Emerging Technologies, Ethics,
and Research Data

The Emerging Technologies, Ethics, and Research Data subcommittee works to identify and develop models to aid IRB and IT collaboration, as well as to create practical tools to enhance the data security reviews and human subjects protections in research involving novel technologies (i.e. cloud platforms, apps, inter-connected smart devices, and other big data research initiatives).

Electronic Institutional Certification Survey Template

Download the Electronic Institutional Certification Survey Template for your institutional use and needs. The Harvard Catalyst ETech subcommittee has created this template  to comply with the NIH Genomic Data Sharing Policy.  The responsibility rests on institutions and IRBs to assure that the submission of study data to an NIH-designated data repository meets the below guidelines:

• The data submission is consistent, as appropriate, with applicable national, tribal, and state laws and regulations as well as relevant institutional policies;
• Any limitations on the research use of the data, as expressed in the informed consent documents, are delineated;
• The identities of research participants will not be disclosed to NIH-designated data repositories; and
• An IRB, privacy board, and/or equivalent body, as applicable,  has reviewed the investigator’s proposal for data submission and assures that
  • The protocol for the collection of genomic and phenotypic data is consistent with 45 CFR Part 46;
  • Data submission and subsequent data sharing for research purposes are consistent with the informed consent of study participants from whom the data were obtained;
  • Consideration was given to risks to individual participants and their families associated with data submitted to NIH-designated data repositories and subsequent sharing;
  • To the extent relevant and possible, consideration was given to risks to groups or populations associated with submitting data to NIH-designated data repositories and subsequent sharing; and
  • The investigator’s plan for de-identifying datasets is consistent with the standards outlined in the NIH Genomic Data Sharing Policy.

We hope the Electronic Institutional Certification Survey Template eases any burdens associated with the collection of this information.

Emerging Technologies, Ethics, and Research Data Consulting Service

Consultations offered include

• Updated NIH Data Management and Sharing Plan questions
• 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

Learn more about our Emerging Technologies, Ethics, and Research Data Consulting Service and apply for a consult.

Sample Informed Consent Language Library: Describing Technologies Used in Research

The library was developed to assist investigators in describing technologies used in research within the informed consent form. The library is a series of sample informed consent language adopted from real-world examples, examining regulatory issues specific to various technologies used in research projects and suggestions for understanding and describing them.

Additional Resources

Data Protection Privacy and Security Matrix
(Request Matrix: regulatory@catalyst.harvard.edu)
A tool to assist investigators in assessing research information practices.

To request any of the above documents be made accessible please email communications@catalyst.harvard.edu.