Augmentation mammoplasty: how it is done, recovery and frequent questions.

Cosmetic surgery to insert silicone prosthesis may be indicated when the woman has very small breasts, is afraid of not being able to breastfeed, has noticed a reduction in their size or has lost a lot of weight. But it can also be indicated when a woman has breasts with different sizes or needed to remove the breast or part of the breast due to cancer. This surgery can be done from the age of 15 with parental permission, and is performed under general anesthesia, taking about 45 minutes, and can be with a short hospital stay of 1 or 2 days, or even in an outpatient setting, when he is discharged on the same day.

Enroller Experience and Parental Familiarity of Disease Influence Participation in a Pediatric Trial

Introduction: Acquiring parental consent is critical to pediatric clinical research, especially in interventional trials. In this study we investigated demographic, clinical, and environmental factors associated with likelihood of parental permission for enrollment in a study of therapies for diabetic ketoacidosis (DKA) in children. Methods: We analyzed data from patients and parents who were approached for enrollment in the Pediatric Emergency Care Applied Research Network (PECARN) Fluid Therapies Under Investigation in DKA (FLUID) trial at one major participating center. We determined the influence of various factors on patient enrollment, including gender, age, distance from home to hospital, insurance status, known vs new onset of diabetes, glycemic control (hemoglobin A1c), DKA severity, gender of the enroller, experience of the enroller, and time of enrollment. Patients whose parents consented to participate were compared to those who declined participation using bivariable and multivariable analyses controlling for the enroller. Results: A total of 250 patient/parent dyads were approached; 177 (71%) agreed to participate, and 73 (29%) declined. Parents of patients with previous episodes of DKA agreed to enroll more frequently than those with a first DKA episode (94.3% for patients with 1-2 previous DKA episodes, 92.3% for > 2 previous episodes, vs 64.9% for new onset diabetes and 63.2% previously diagnosed but no previous DKA). Participation was also more likely with more experienced enrollers (odds ratio [95% confidence interval] of participation for an enroller with more than two years’ experience vs less than two years: 2.46 [1.53, 3.97]). After adjusting for demographic and clinical factors, significant associations between participation and both DKA history and enroller experience remained. Patient age, gender, distance of home from hospital, glycemic control, insurance status, and measures of DKA severity were not associated with likelihood of participation. Conclusion: Familiarity with the disease process (previously diagnosed diabetes and previous experience with DKA) and experience of the enroller favorably influenced the likelihood of parental permission for enrollment in a study of DKA in children.

Whether to Waive Parental Permission in HIV Prevention Research Among Adolescents: Ethical and Legal Considerations

Critical ethical questions arise concerning whether studies among adolescents of new behavioral and biomedical HIV preventive interventions such as Pre-Exposure Prophylaxis (PrEP) should obtain parental permission. This paper examines the relevant regulations and ethical guidance concerning waivers of parental permission, and arguments for and against such waivers. Opponents of such waivers may argue that adolescent decision-making is “too immature” and that parents always have rights to decide how to protect their children. Yet requiring parental permission may put adolescents at risk, and/or limit adolescent participation, jeopardizing study findings’ validity. This paper presents recommendations on when researchers and Institutional Review Boards (IRB) should waive parental permission, and what special protections should be adopted for adolescents who consent for themselves, e.g., assuring adolescent privacy and confidentiality, screening for capacity to consent, and identifying adolescents who are at elevated risk from study participation. We also present a series of specific areas for future research to design tools to help make these assessments, and to inform researcher and IRB decisions. These recommendations can help ensure that research is conducted that can aid adolescents at risk for HIV, while minimizing risks and protecting these individuals' rights as much as possible.

Online Pediatric Research: Addressing Consent, Assent, and Parental Permission

This article provides practical guidance for researchers who wish to enroll and collect data from pediatric research participants through online and mobile platforms, with a focus on the involvement of both children and their parents in the decision to participate.

Recruitment and Parental Permission for Neonatal Clinical Trials

This chapter uses the example of a randomized clinical trial of erythropoietin in extremely premature infants to improve neurocognitive outcomes in order to highlight ethical questions related to this clinical context. One question regards whether the recruitment and permission process is more ideally conducted in the prenatal or postnatal setting. A second set of questions regards the role of the person who obtains permission and whether this should be the clinical attending or the researcher, and if it is acceptable for a clinician to hold both roles simultaneously. The normative concerns are that understanding and voluntariness can be affected by specific recruitment approaches. However, excluding some approaches has the potential to limit eligibility, which has implications for generalizability, fairness, and resource utilization. This chapter considers the normative concerns related to these recruitment approaches as well as empirical research about parental permission and parental attitudes.