September 27th, 2020

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Title:
Inform and Consent: More Than Just “Sign Here”
Authors:  Jody Lynee Madeira, J.D., Ph.D., Mindy S. Christianson, M.D., Miryoung Lee, Ph.D., J. Preston Parry, M.D., Guido Pennings, Ph.D., and Steven R. Lindheim, M.D., M.M.M.
  OBJECTIVE: Assisted reproductive technology (ART) presents complex ethical and medical considerations that make informed consent difficult. We assessed patient experiences and perceptions regarding the informed consent process.

STUDY DESIGN: A quantitative online survey of patients who had undergone autologous in vitro fertilization (IVF). Survey questions evaluated consistency and perceptions regarding informed consent importance, redundancy, and protections.

RESULTS: Posters containing a link to the online survey were posted in 6 participating clinics, and messages were posted online in fertility forums such as those on resolve.org. Of the 262 responses, 249 were complete who had done at least one IVF cycle and were included in the analysis. More than 86% of respondents read the entire informed consent form (23% “somewhat carefully” and 46% “very carefully”). Nonetheless, some respondents described the consent process negatively, such as “too long” (18%), “something to get out of the way” (44%), “overwhelming” (34%), “unhelpful” (5%), and “difficult and confusing” (21%). Patients under 35 years reported discussing selective reduction more often (87%) as compared to those over 40 (69%). In an age- and income-adjusted model, age and income were not associated with reading forms carefully; reading carefully was significantly associated with the number of IVF cycles.

CONCLUSION: These findings show that, although patients report reading and understanding IVF informed consent forms, they are less likely to read forms as they complete more cycles. Classic approaches to informed consent need to be reexamined.
Keywords:  assisted reproductive technology; comprehension; decision making; disclosure; ethics, medical; female; guidelines as topic; humans; in vitro fertilization; informed consent; legal liability; medical liability; patient education as topic; patient preference; personal autonomy; physician-patient relations; policy making
   
   
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