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Effective Delivery of Informed Consent (EDICT)

  • United States
National Institute of Allergy and Infectious Diseases
2013 - 2015

Individuals who are considering participation in a research study need sufficient understanding of the research to make an informed decision about their participation. Yet, many individuals do not fully understand the research in which they are participating. One reason is the long length of consent forms, which can be confusing and contribute to a time-consuming enrollment process, unnecessarily burdening both participants and study staff. The length of consent forms has increased over time, and long forms are commonplace. 

The EDICT study uses a novel, modified Delphi data collection process for building consensus among key stakeholders on how to shorten informed consent forms. The study’s recommendations will focus on advancing the use of shortened consent forms in HIV-related research and will inform debates on the appropriate length of consent documents.

FHI 360 is partnering with Johns Hopkins University and the HIV Prevention Trials Network (HPTN), through HPTN 069, a study to assess the safety and acceptability of four different drug combination of oral pre-exposure prophylaxis (PrEP), and HPTN 073, an oral PrEP demonstration project.

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