Helping researchers navigate clinical & translational research regulatory processes. Regulatory Foundations, Ethics, and Law Program

Novel Technologies in Research: IRB and IT Solutions

Overview

These days, more and more investigators and institutions are using novel tools and technologies in the conduct of research. As this becomes increasingly common, guidance is needed to enhance efficiencies and ensure safety. That's where the Regulatory Foundations, Ethics, and Law Program comes in. We facilitate the development and strengthening of IRB and IT relationships across Harvard Catalyst's participating institutions to enhance efficiencies in the review and conduct of research. Our program also ensures the safe and secure collection, storage, access, and sharing of research data.

The IRB-IT Task Force works to identify and develop models of IRB-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).

As part of our program, IRB and IT representatives have come together to:

  • Identify best practices, tools, and gaps in IRB and IT/data security collaboration
  • Increase knowledge about research collaboration technologies
  • Identify and share processes and standards used to vet research technologies
  • Identify data security standards and tools that facilitate multisite transfer and access of clinical data for research purposes

Contribute to our Informed Consent Library:
Share examples of language to help research subjects understand how their personal information will be used in research utilizing novel technologies.

Sample Informed Consent Language Library: Describing Technologies Used in Research

Sample Informed Consent Language: Describing Technologies Used in Research 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.

Investigators should use this resource when developing consent documents in consultation with collaborators and Institutional Review Boards (IRBs), as well as with research participants and communities.

Download the complete Harvard Catalyst Sample Informed Consent Binder [PDF] or select from the individual topics below.

Sample Informed Consent Language Library Overview

Research participants' health information and data are increasingly being collected, stored, and shared using more powerful and prolific technologies.

When designing a research study, investigators must consider and address these factors, while also finding meaningful and effective ways to describe technology-specific factors within the informed consent process and consent form.

Each section includes model statements investigators may adapt to describe the technology.

Download a PDF

Chat Technology

  • Real-time, instant messaging electronic communication between two users, connected by a network
  • Considerations:
    • Encryption and security concerns
    • Company terms of use and privacy policies
  • Model statements investigators may adapt to describe chat technology

Download a PDF

Data Collection and Privacy Considerations

  • Ensuring integrity of data during the data collection process, protecting against the risks of unauthorized use
  • Considerations:
    • Method of data collection
    • Risks of unauthorized use and users
    • Encryption and security concerns

Download a PDF

Transmission of Research Data

  • Transferring research data in motion from one machine or device to another
  • Considerations:
    • Personally-identifiable data of research participants
    • Method of data transfer
    • Encryption and security concerns

Online Tracking and Cookies

  • Tracking cookies or web beacons have the ability to track and monitor activity; these elements that may not be evident to the average user
  • Considerations:
    • Method of online tracking and cookies
    • Privacy risks/concerns with tracking technologies
    • Suitable privacy safeguards

Download a PDF

Storage and Archiving

  • Investigators should inform participants about the data storage and archiving technologies, back-ups plans, and access controls
  • Considerations:
    • Method, location, duration of data storage, and archiving
    • Encryption and security concerns
    • Storage and archiving technology company terms of use and privacy policies

Download a PDF

Research Data Destruction

  • Additional steps must be taken to sufficiently destroy data so that the data cannot be recreated, reconstructed, or extracted
  • Considerations:
    • Data collected in a federal- or state- funded project
    • Method of data destruction
    • Encryption and security concerns

Download a PDF

Email

  • Communication tool to be evaluated for use in research in reference to regulations
  • Considerations:
    • Encryption and security concerns
    • Email technology company terms of use and privacy policies

Download a PDF

Mobile Health: Devices, Apps, and Wearables

  • The method of delivering healthcare through mobile technology allowing investigators to collect data from research participants when they are not physically present
  • Considerations:
    • Passive data collection
    • Encryption and security concerns, including loss and theft
    • Mobile device and application technology company terms of use and privacy policies

Download a PDF

Online Survey Tools

  • Online survey tools or questionnaires may require different data security requirements based on the complexity of the project and the study population
  • Considerations:
    • Survey tools available at an academic institution versus a third party software company
    • Encryption and security concerns
    • Survey tool technology company terms of use and privacy policies

Download a PDF

Social Media

  • Social media used for research recruitment raises unique issues including access to personal health information and appropriate online communication while enrolled in a study
  • Considerations:
    • Encryption and security concerns
    • Social media technology company terms of use and privacy policies

Download a PDF

Video, Audio, and Photography Recordings

  • Recording the voice and/or image of a research participant creates a distinct type of record that requires unique handling and storage
  • Considerations:
    • Method of recording
    • Encryption and security concerns

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Glossary of Terms

Terms used to describe technologies used in research

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Resources

Resources we found helpful while creating the document

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Attribution, Sharing, and Adapting

We encourage you to request, share, adapt, and contribute to the Informed Consent Library

Download a PDF

Sample Informed Consent Binder
Study

Complete Harvard Catalyst Sample Consent Language Library, with sections bookmarked in one PDF

Download a PDF

Resources

For Investigators
  • Guide to Technologies Used in Research: Information Risks, IRB Strategies (coming soon)
    Researchers use both institutional and external tools and technologies to enable their research. IT and information security departments utilize institutional processes and standards to vet such technologies. This document identifies vetted (and non-vetted) tools and technologies.
  • Harvard Medical School Vetted Technologies
    Technologies that have been vetted by HMS IT or have been identified for use with certain data classification levels.
  • The Use of Social Media in Recruitment to Research: A Guide for Investigators and IRBs
    Social media is emerging as a promising tool for recruiting people into clinical trials and other important types of research. This guidance document outlines numerous concrete recommendations on the ethical and regulatory aspects of using social media as a research recruitment tool.

    If you have feedback on the guidance, please contact us.
For Institutions
  • Model Informed Consent Library (coming soon)
    May be used when developing consent documents, to help research subjects understand how their personal information will be used in research utilizing novel technologies (i.e. Google Glass, social media, mobile apps, smart devices, big data platforms, etc.)
  • Guide to Technologies Used in Research: Information Risks, IRB Strategies (coming soon)
    IRBs must review both institutional and external tools and technologies that investigators seek to use in their research. IT and information security departments utilize institutional processes and standards to vet such technologies. This document identifies vetted (and non-vetted) tools and technologies, to assist IRBs in their review processes.
  • Harvard Medical School Vetted Technologies
    Technologies that have been vetted by HMS IT or have been identified for use with certain data classification levels.
  • The Use of Social Media in Recruitment to Research: A Guide for Investigators and IRBs
    Social media is emerging as a promising tool for recruiting people into clinical trials and other important types of research. This guidance document outlines numerous concrete recommendations on the ethical and regulatory aspects of using social media as a research recruitment tool.

    If you have feedback on the guidance, please contact us.

Learn more on our How We Work page.

Contacts

Kristen Bolt
IRB-IT Taskforce Co-chair
Program Manager, Global Data Sharing
Multi-Regional Clinical Trials Center of Harvard and Brigham and Women's Hospital
Email

Joseph Zurba
IRB-IT Taskforce Co-chair
Information Security and IT Compliance Officer
Harvard Medical School
Email

Sabune Winkler, JD
Director, Regulatory Foundations, Ethics, and Law Program
Email
617-432-7811

Aaron Kirby, MSc
Associate Director, Regulatory Affairs Operations
Email
617-432-5755