Evidence-Based Strategies for Shortening Informed Consent Forms in Clinical Research

Abstract

Long informed consent forms (ICFs) remain commonplace, yet they can negatively affect potential participants’ understanding of clinical research. We aimed to build consensus among six groups of key stakeholders on advancing the use of shorter ICFs in clinical research. Partnering with the HIV Prevention Trials Network (HPTN), we used a modified Delphi process with semi-structured interviews and online surveys. Concerns about redundancy of information were common. Respondents supported three strategies for reducing ICF length: 1) 91% agreed or strongly agreed with grouping study procedures by frequency, 2) 91% were comfortable or very comfortable with placing supplemental information into appendices, and 3) 93% agreed or strongly agreed with listing duplicate side effects only once. Implementing these strategies will facilitate adoption of the proposed changes to U.S. regulations on ICF length, should they be enacted.

What information and the extent of information research participants need in informed consent forms: a multi-country survey

“…The analysis of the respondents’ acceptable page length suggests that an approximately 6-page-long ICF seems to be acceptable to general populations in 7 countries across the Asia-Pacific region. This result is in line with other evidence promoting the use of short and concise ICFs in biomedical research [ 33 ]. As shown in a previous empirical study on the preferred length of ICFs, most participants preferred concise, rather than detailed information when they made a decision on trial participation [ 11 ].…”

“…Recently, there has been a major change in the ethical guidelines and regulations that encourages investigators and sponsors to summarize relevant and important information in a few pages [ 7 , 8 ]. An ICF used in biomedical research should no longer be an unduly long document, with key information often being hard to find [ 33 ]. Concise ICFs with complete information as required by regulations can be developed, for example, using the SIDCER ICF methodology, which has recently been validated and published [ 36 – 39 ].…”

“…Nevertheless, some groups of participants, such as the Taiwanese, might indicate a preference for a relatively longer ICF which contains more detailed and comprehensive information. Supplementary provision of detailed information could be offered to such groups in additional papers (e.g., appendices) or via websites [ 25 , 33 ].…”

Stakeholder engagement to informHIVclinical trials: a systematic review of the evidence

“…Of the 108 studies, 48 studies (44.4%) conducted stakeholder engagement in high‐income countries 5, 23, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70. In contrast, fewer studies conducted stakeholder engagement in middle‐ (30 studies; 27.8%) 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93,...…”

“…In contrast to this targeted approach in defining stakeholders, members of the general public were engaged in just 12 studies (11.1%). Thirteen studies (12%) described engagement conducted with community stakeholders or community representatives without specifying further as to what aspect of the community these stakeholders represent [29,30,56,59,70,92,98,108,112,120,122,125,128].…”