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Reported consent processes and demographics: a substudy of the INSIGHT S trategic T iming of AntiRetroviral T reatment ( START ) trial
Author(s) -
Denning E,
Sharma S,
Smolskis M,
Touloumi G,
Walker S,
Babiker A,
Clewett M,
Emanuel E,
Florence E,
Papadopoulos A,
Sánchez A,
Tavel J,
Grady C
Publication year - 2015
Publication title -
hiv medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.53
H-Index - 79
eISSN - 1468-1293
pISSN - 1464-2662
DOI - 10.1111/hiv.12230
Subject(s) - informed consent , medicine , family medicine , demographics , institutional review board , clinical trial , randomized controlled trial , alternative medicine , psychiatry , surgery , demography , pathology , sociology
Objectives Efforts are needed to improve informed consent of participants in research. The S trategic T iming of AntiRetroviral T herapy ( START ) study provides a unique opportunity to study the effect of length and complexity of informed consent documents on understanding and satisfaction among geographically diverse participants. Methods Interested START sites were randomized to use either the standard consent form or the concise consent form for all of the site's participants. Results A total of 4473 HIV ‐positive participants at 154 sites world‐wide took part in the I nformed C onsent S ubstudy, with consent given in 11 primary languages. Most sites sent written information to potential participants in advance of clinic visits, usually including the consent form. At about half the sites, staff reported spending less than an hour per participant in the consent process. The vast majority of sites assessed participant understanding using informal nonspecific questions or clinical judgment. Conclusions These data reflect the interest of START research staff in evaluating the consent process and improving informed consent. The START I nformed C onsent S ubstudy is by far the largest study of informed consent intervention ever conducted. Its results have the potential to impact how consent forms are written around the world.