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The Evolution of Consent Forms for Research: A Quarter Century of Changes

Institutional review boards (IRBs) and researchers have struggled to ensure that subjects receive sufficient information to make knowledgeable decisions about study participation. But the quality of the consent forms that are a key component of this process has rarely been evaluated. We reviewed 215 consent forms approved by an IRB serving a major academic department from 1978–2002 and discovered two trends: greater consistency in the description of risks, and an increase in the length of consent forms. However, despite data indicating that length and comprehension are inversely related, length of consent forms increased linearly. The findings demonstrate the dilemma in attempting to provide information on consent forms that is simultaneously accurate and concise.

Key words/concepts: human subjects research, informed consent forms, disclosure, risks, length of forms.

Institutional review boards (IRBs) and researchers have struggled to ensure that subjects receive sufficient information to make knowledgeable decisions about study participation. But the quality of the consent forms that are a key component of this process has rarely been evaluated. We reviewed 215 consent forms approved by an IRB serving a major academic department from 1978–2002 and discovered two trends: greater consistency in the description of risks, and an increase in the length of consent forms. However, despite data indicating that length and comprehension are inversely related, length of consent forms increased linearly. The findings demonstrate the dilemma in attempting to provide information on consent forms that is simultaneously accurate and concise.

Key words/concepts: human subjects research, informed consent forms, disclosure, risks, length of forms.

Ilene Albala, Margaret Doyle, and Paul S. Appelbaum, "The Evolution of Consent Forms for Research: A Quarter Century of Changes," IRB: Ethics & Human Research 32, no 3 (2010): 7-11.