Obtaining Informed Consents Regarding Pediatric Surgery in the Statute Law of Iran at 17 Shahrivar Hospital, Rasht

In case of failure to obtain informed consents in pediatric surgery, the four principles of medical ethics have not been observed; as a result, patients’ rights will be violated, and the physician will be held responsible both in terms of medical ethics and legally. The reason is that in the absence of the patient or his/her parents informed consents, a crime has been committed. However, if a consent is obtained, in case the patient dies or is maimed and there is no proof of fault, only civil liability will be realized. Therefore, given the importance of obtaining informed consents, this study assessed the status of obtaining informed consents in pediatric surgery through considering the relationship between the individual giving consent and the patient's age, gender, and type of surgery in terms of being emergency or non-emergency.

In this analytical descriptive cross-sectional study, the data regarding consent forms in pediatric surgery at 17 Shahrivar Hospital, Rasht was collected from April 2018 to September 2019, according to a prepared checklist including the patient’s gender and age, the type of operation, and the relationship between the individual giving consent and the patient. To analyze the research data, ANOVA test was used for quantitative variables and Fisher's exact test was used for qualitative variables. The collected data was entered into SPSS version 21 and the significance level of p<0.05 was considered.

Ethical Considerations: 

This study has been approved by the Ethics Committee. Ethical considerations such as filling out the informed consent form; voluntary participation, explaining the research objectives and ensuring data confidentiality were observed.

Based on the results obtained from 187 cases, 61.3% had emergency surgeries and the rest had non-emergency surgeries. Among the individuals giving consents, 202 were legal custodians (66.2%) and the rest included the mothers without custody of their children (31.8%), the individuals with child custody letters (0.7%) and the individuals without a legal status (other than mothers) (1.3%). According to the results of the present study, among the legal custodians, 199 (98.5%) individuals giving consents were fathers and 3 (1.5%) were both parents. In the case of the individuals without a legal status, 97 (96%) were mothers, 2 (2%) were nurses, 1 (1 percent) was a foster mother and 1 (1 percent) was a grandmother. There was 1 individual with a child custody letter (50%) and 1 grandmother (50%). Based on the obtained results, it was found that gender (p=0.894) and age (p=0.336) had no significant relationship with the individuals giving consents; however, the type of surgery had a significant relationship with the individuals giving consents (p<0.001). Most of the individuals giving consents in emergency surgeries were the patients’ legal custodians.

In many investigated cases, ethical and legal standards were observed in obtaining informed consents from the children’s legal custodians. However, in none of these procedures, there was recorded proof of obtaining consents from children, which needs attention in the health system.