COVID-19 Research Resources
A curated list of research resources around guidelines, policies, and procedures related to COVID-19, drawn from Harvard University, affiliated academic healthcare centers, and government funding agencies

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

Emerging Technologies, Ethics, and Research Data

Overview

The Emerging Technologies, Ethics, and Research 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).

Resources

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.

Download the complete Harvard Catalyst Sample Informed Consent Library [PDF].

Case Studies

A series of case studies below examine regulatory issues specific to various research data security issues and suggestions for managing them.

  • A Study Involving Multiple Institutions and CMS Data [PDF]
  • Managing Data Security with Local and International Partners [PDF]
  • Research Data Loss Incident - Multi-Stakeholders [PDF]
  • Secondary Use of Data in Studies Involving Wearable Technology [PDF]
  • Accidental Receipt of Identifiable Data [PDF]
  • Maintaining Sensitive and Non-Sensitive Data [PDF]
  • Police Body Cameras [PDF]
  • Secure Storage of Audio Recordings [PDF]
Additional Resources
  • Information Risks and IRB Strategies for Technologies Used in Research: A Guide for Researchers, IT, and IRBs [PDF]
    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.
  • Research Data Management: Guide for Investigators [PDF]
    This Guide addresses how to plan and manage research data considerations for researchers who expect to work with confidential or sensitive information involving individuals in the course of a research study. The Guide follows the research data management lifecycle, highlighting key issues to consider, and a roadmap to follow through the lifecycle of data from the beginning planning phases through design, and all the way to proper destruction and disposal of data.
  • The Use of Social Media in Recruitment to Research: A Guide for Investigators and IRBs [PDF]
    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.
  • Providing IT expertise to the IRB [PDF]
    The incorporation of Information Technology (IT) expertise onto IRBs is one way to help ensure the appropriate evaluation of the safety and potential risks of the technology being utilized to conduct research. This document serves as a short guide to onboarding IT staff onto IRBs.
  • Important IT Considerations for IRBs [PDF]
    IRBs need not be IT experts, however an awareness of potential risks posed by new technologies may be helpful. This document includes a list of questions for IRB members to consider when thinking about IT and/or data confidentiality protections, and concurrently evaluating the regulatory criteria for approval. This list is not exhaustive, but provides a baseline of questions to consider when evaluating the potential risks of the technology being utilized in the research.
  • Guide to Vetting Technologies [Excel]
    The guide is designed to be used as a supplementary resource to help investigators ascertain which commonly-used technologies have or have not already been vetted by their institution. This helps to ensure the safe and secure collection, storage, access, and sharing of research data.

Data Protection

    Research Data Education
  • Top Ten Research Data Security Tips [PDF]
    A selection of data security measures investigators can take to help prevent unauthorized uses of personally identifiable information.
  • Research Data Security Assessment
  • Research Data Security Self-Assessment Questionnaire [PDF]
    The questionnaire is designed to help researchers assess their research data protection and security of their existing studies. The questions selected for this document are intended to identify gaps, and encourage the researcher to address those gaps.
  • Researcher Data Protection and Security Awareness Tool for Education [PDF]
    An educational resource designed to help researchers become aware of the questions to ask when protecting research data.
  • Research Data Planning
  • Data Privacy and Security Planning Checklist [PDF]
    A checklist for investigators preparing an IRB application. IRBs may use the checklist to supplement data security questions on their application forms.
  • Data Protection Privacy and Security Matrix (Request Matrix)
    A tool to assist investigators in assessing research information practices.
  • Data Use Agreement [PDF]
    A template for sharing limited data sets among Harvard Catalyst institutions (for institutions that do not have an existing data use agreement).
  • Guidance
  • Investigators Guide to Research Data Management Practices [PDF]
    Mapped along a Research Data Management Lifecycle, the Guide highlights key issues to consider and offers a roadmap for researchers to follow over the course of data collection, storage and use, dissemination, and final disposition/disposal.
  • Guidance for Researchers Using Internet Cloud Computing Services and Apps [PDF]
    This document offers key points to consider when using cloud services, including how to mitigate risks and what to do in the event of data loss, breach, or unlawful or unethical use or disclosure.
  • Vendor Assessment Worksheet [PDF]
    This worksheet offers a list of data security controls that institutions may require that vendors or other third parties implement to protect confidential data.
  • Vendor Information Security Plan (VISP) [PDF]
    A template planning tool for institutions to evaluate the capacity of third-party vendors to protect personally identifiable research data or other confidential information. (Email us to request Word Doc version.)