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Clarifying Data Sharing in Informed Consent

Focus Area: Ethics, Conduct, and Oversight

Clarifying Data Sharing in Informed Consent

Informed Consent is a core requirement of ethical human subjects research. As articulated by the Nuremberg Code (1949), the Declaration of Helsinki (1964), the Belmont Report (1978), and the International Ethical Guidelines for Biomedical Research Involving Human Subjects (1982), informed consent is rooted in a triad of foundational ethical principles: respect for persons, beneficence, and justice. Together, these ethical principles underscore the theoretical objective of informed consent: to ensure that potential research participants assess sufficient information about a study to make a knowledgeable, voluntary, and value-concordant choice about whether or not to participate.

To achieve this theoretical objective, regulatory bodies often require that several key pieces of information be provided to potential research participants. Within the United States, for example, the Federal Policy for the Protection of Human Subjects (also known as the ‘Common Rule’) requires that informed consent forms contain nine basic elements and eight additional elements, when applicable.¹

While the communication of these elements to prospective research participants is integral to the ethical conduct of human subjects research, there is an emerging consensus within the research community that informed consent forms do not present vital information in a manner that promotes comprehension. Informed consent forms are steadily increasing in both length and complexity; they are teeming with confusing legal and regulatory jargon; and their readability levels consistently exceed those of the general population.

In recognition of these enduring challenges, the MRCT Center has facilitated several practical approaches to enhancing the communication and comprehension of clinical research information. From developing standardized terminology for data sharing terms, to advancing principles of health literacy and numeracy, to constructing plain-language educational tools, research participants’ needs are central to the MRCT Center’s informed consent efforts. By equipping research participants with coherent, intelligible information about clinical research, we strive to uphold the foundational ethical principles of informed consent.

Current Status: Active

Impact: The research community will have access to informed consent tools and resources that promote participant comprehension of clinical research

Objectives

  • Identify barriers to participant comprehension of clinical research
  • Define elements of an effective and ethical informed consent process
  • Develop educational tools and resources that respect health literacy principles, improve readability of informed consent forms, and enhance participant comprehension of clinical research

Key Milestones:

Project or WorkgroupRelevant DeliverablesDescription
MRCT Center's Data Sharing and Transparency Initiative: Data Sharing Governance WorkgroupMARCH 2015: Informed Consent Language for Confidentiality and Data SharingThis 5-page template (for trials with external sponsor and no external sponsor) provides language that describes how participants' data are protected and how they will be used or shared
Harmonized Governance Tools for Data SharingFEBRUARY 2018: Data Sharing Template Section for Informed Consent FormsDeveloped in Collaboration with patient and participant advocacy groups, this plain-language paragraph enables secondary use of collected information while committing to participant autonomy and privacy
Health Literacy in Clinical ResearchPRESENT: Suite of plain-language tools and resources for research participants, IRB personnel, and investigatorsAfter identifying existing barriers in participant comprehension of clinical research, this collection of resources seeks to improve communications throughout the clinical research lifecycle

Project Coordinator: Emily Statham

¹ For additional information, please visit http://about.citiprogram.org/wp-content/uploads/2018/07/Handout-3-Comprehensive-Guide-to-Informed-Consent-Changes-presentation-slides.pdf