A Review of Consent Documents From Canadian IVF Clinics, 1991 to 2014.

OBJECTIVE

We reviewed the content of IVF consent documents (i.e., consent forms and accompanying information sheets) used by Canadian IVF clinics in 1991, 2004, and 2014, paying particular attention to the inclusion of information that should be provided to patients in accordance with minimum ethical standards for disclosure.

METHODS

We contacted all Canadian IVF clinics in operation in 1991 (17 clinics), 2004 (24 clinics), and 2014 (35 clinics) by mail and requested blank copies of their IVF consent documents. Documents received were reviewed for the inclusion of information about the nature of IVF, the potential benefits of IVF, the potential harms and inconveniences of IVF, confidentiality, voluntariness, and options for the use or discarding of embryos not transferred in the original stimulated cycle (sometimes referred to as supernumerary, excess, or spare embryos).

RESULTS

We received responses from 11 of 17 clinics operating in 1991 (response rate 65%), 14 of 24 clinics operating in 2004 (response rate 58%), and 11 of 35 clinics operating in 2014 (response rate 31%). In general, comparisons of the 1991, 2004, and 2014 data sets showed a long-term decrease in documented disclosure of information that should be provided to patients in accordance with minimum ethical standards. The only cases in which this trend appeared to be reversed was with disclosure about the probability of supernumerary embryos, long-term risks of treatment, the right to revoke consent to the use or discarding of supernumerary embryos, and some of the options for the use of supernumerary embryos. In these few instances, there was a notable improvement in the disclosure of relevant information between 1991 and 2014.

CONCLUSION

The disclosure of information relevant to the interests of those undergoing IVF and those who are born as a result of IVF appears to be decreasing. Furthermore, the information that increasingly is being disclosed in consent documents appears to be directing the orientation and content of these documents away from the primary interests of the relevant women, couples, and children. These two trends are inconsistent with the goal of informed consent.