O-18: Framework of Informed Consent and Ethical Codes for Clinical Trials Especially Designed for Assisted Reproduction
Clinical trials are known as the most valid medical research. It is able to promote medical evidences on prevention, diagnosis, screening, treatment, and quality of life because in this type of study, an intervention is intentionally performed on subjects. Therefore, it encompasses ethical concerns and considerations, especially when human subjects are studied. In other words, clinical trials are considered valuable as they give the best possible response to public health problems in human societies, and do not damage to human’s health and wellbeing. The World Medical Association (WMA) (64th WMA General Assembly, Fortaleza, Brazil, October 2013) has developed the declaration of Helsinki as a statement of ethical principles for medical research involving human subjects. There were no dedicated ethical statements only for a certain type of study, especially for clinical trials, in WMA. All principles were designed as cover medical researches. At present, large clinical trials are conducting on various fields. One of the most important existing clinical trials is researches on infertility treatment and Assisted Reproductive Techniques (ARTs). The trials are distinct and different from other trials. Several reasons make such a distinction. First, trials on infertility treatments generally involve multiple participants. If the intervention succeeds, there is a pregnancy that may or may not lead to an infant. Therefore, at a minimum, a successful treatment involves three individuals, that is, a newborn, and potential mother and father. In some reproduction techniques, it is required to use gametes or fetus of others to achieve pregnancy or live birth. In the trials, it is possible to include third party. Of the participants who have the target of reproduction intervention, there is a newborn of infant does not exist at the start of the trial. Most often one is ignored as subjects who affected by such interventions. Hence, there is a gap in ethical statements of WMA, especially for trials on infertility treatments. It needs to modify WMA declaration of Helsinki. to improve the ethical statements of last version of WMA to be applicable for clinical trials regarding infertility treatments.
Materials and methods