**3.3 Human resources**

Building a team or improving an existing team requires that the visiting team provide individuals that are specialists in pediatric cardiac care and education. Frequently the visiting team will have volunteers including medical students, residents and fellows who are wanting to explore global health initiatives. The team leader of the visiting team must remember that the purpose of the visit is to increase the experience and capacity of the local team. Members of both the visiting and the receiving teams can all benefit from the educational opportunities, but it is incumbent upon the team leader to mentor the recipient team members particularly. A trip to an LMIC is not a place for medical students to learn the intricacies of pediatric cardiac surgery, or cardiology or anesthesia; you are there to teach the local team and they should always be the primary recipient of training [10]. Upperlevel residents and fellows should participate in all aspects of care as the children in LMIC are not the same as the infants that they care for at their home institution. The opportunity to see the ravages of chronic congenital heart disease on a child or adolescent is a lesson in natural history for them, but a daily occurrence for the local caregivers. Global cardiac surgical initiatives are first and foremost an opportunity to exchange knowledge in both directions between visitors and the local team.

However, one should not offer to provide or perform operations beyond the scope of your practice at your home institution [11]. Moreover, one must also maintain a sense of what is actually possible not just in the operating theater but, in the intensive care unit as well. Although the surgical expertise may exist to perform a complex operation flawlessly in the operating theater there must be adequate support for the recovery of these patients.

#### **3.4 Medications and materials**

Frequently the visiting team will provide donated products to carry out the surgery and care of the children. Several medical product and pharmaceutical companies in UIC support these efforts by providing product that may have a limited expiration date remaining. Additionally, hospitals in UIC often provide products which have had the external wrapping removed but remain in a secondary sterile packet and can be re-sterilized at the local site. Working in resource limited LMIC institutions one must be sure to understand the medical importation regulations before shipping nearly expired products. There are times when a nongovernmental organization (NGO) may be offered expired products and medications from hospitals and manufacturers, when is it ethical to use such products? Clearly the expiration dates for medications are arbitrarily set and publications on potency after expiration are available [12, 13]. One must ask is it ethical to use a product or medication in order to provide life-saving cardiac surgery, this is an answer that will vary by site, culture and country. Implicit in this decision is input from the local team. Consultation with the local team over this issue is both respect and autonomy for and of the local team. Moreover, the family should be involved in this decision, as patient autonomy clearly must be preserved.

Regulations for the importation of medications vary by country and similarly drugs which are registered for use vary. One must balance the good for the patient in deciding whether to adhere to local regulations but, beware of the consequences of violating such regulations [14]. A drug as beneficial as milrinone is not registered in several countries that we travel too, but we and our local colleagues know the benefits of this drug in pediatric cardiac surgery. We receive requests routinely to bring milrinone to countries where it is not registered for use and hand-carry sufficient quantities to carry-out the operative list. Clearly one must consider the ethical position of beneficence versus local regulations installed by a slowly moving bureaucracy.

#### **3.5 Patient care**

Providing safe, beneficial patient care is the first priority of the visiting team and is an excellent starting point for teaching the local team how to organize a pediatric cardiac care program [15]. We are all aware that it is not unusual for the local team to prepare a list of complex operative interventions for the visitors. Operations that the locals have never seen and certainly never performed are frequently on the list of the patient management conference. Once again it is important not to operate outside of your boundaries because you are not at home. Trust is important in developing relationships and can be eroded by an unwanted outcome as a result of operating outside normal boundaries, whether for the surgeon, perfusionist or ICU team's capabilities. Moreover, the unethical performance of an operation outside the limits of your capabilities can bring unwanted and complicating legal issues to bare as well. Teaching and reinforcing a patient-centric non-maleficence philosophy will lead to the development of a patient first approach by the locals.

**243**

**4.2 Research**

*Ethical Considerations for Global Pediatric Cardiac Surgical Assistance Programs*

Placing patient well-being above all other considerations must be balanced with your educational responsibilities to the local team. We have found that a frank conversation with the local team before the start of the surgical program is beneficial in understanding the local capabilities. A mentored program of having the local team serve as assistants first is patient-centric and provides the locals with an experience in how to perform safe surgery. The transition from assistant to primary surgeon for the local surgeon is graduated based upon the teacher's observations of progress. The principle of the placing the patient's well-being first requires that the teaching surgeon have confidence that the local can provide the operation safely. Obviously if this is not the case then the teacher must take the place of the trainee as needed. Such a switch during an operation, induction of anesthesia or care in the ICU must be done in a diplomatic fashion as not to damage the confidence of the trainee.

One issue faced by all who are involved in assistance development is the presentation of a child with either a critical defect or in heart failure from the chronicity of their defect who needs an urgent operation at the end of a visit. We must consider the issue of non-maleficence and ask ourselves if there is a team prepared to care for the child after surgery that is capable of recovering the child. Agreeing to operate on this child and then have the visiting team depart when the child still needs complex care is providing false hope to the family and ethically questionable. We have faced this problem countless times in our history and have decided that if we are operating late in the trip on critically ill children, we will leave a team of ICU caregivers behind to provide 24-hour coverage until the child is discharged from the ICU. The decision to operate on such a child must be made in concert with the local team and

Developing a truly equitable program in an LMIC requires the encouragement of a clinical database and research projects. The benefits of a database need to be clearly communicated to the local team and then they must be left to make the decision to proceed with the establishment of one or not. Again, this highlights the autonomy of the local team and provides them with the opportunity to display complete commitment to program development, rather than simply intermittent surgical mission trips by the visitors. Program growth cannot be judged, and corrective actions taken unless a clinical database of outcomes is implemented. Furthermore, the establishment of a database and routine review and presentation of results provides the Ministry of Health with a realistic view of program growth and development, thus justifying the continuation of Ministry level support. Ideally the site will enroll in an international database that serves LMIC, examples include the IQIC [16] and WSPCHS registries [17]. Databases which only enroll UIC programs can be discouraging when results are compared, and the site should seek

Research is to be encouraged when assisting a site, whether it is pure clinical or translational, few LMIC sites will have opportunities for basic science research [18]. The research project requirements for overseas programs you are assisting as the same as those of your home institution. The project should be reviewed by the

family, autonomy of decision for both is critical for all stakeholders.

**4. Database and research needs**

to compare itself to similar programs in LMIC.

**4.1 Database**

*DOI: http://dx.doi.org/10.5772/intechopen.96599*

#### *Ethical Considerations for Global Pediatric Cardiac Surgical Assistance Programs DOI: http://dx.doi.org/10.5772/intechopen.96599*

Placing patient well-being above all other considerations must be balanced with your educational responsibilities to the local team. We have found that a frank conversation with the local team before the start of the surgical program is beneficial in understanding the local capabilities. A mentored program of having the local team serve as assistants first is patient-centric and provides the locals with an experience in how to perform safe surgery. The transition from assistant to primary surgeon for the local surgeon is graduated based upon the teacher's observations of progress. The principle of the placing the patient's well-being first requires that the teaching surgeon have confidence that the local can provide the operation safely. Obviously if this is not the case then the teacher must take the place of the trainee as needed. Such a switch during an operation, induction of anesthesia or care in the ICU must be done in a diplomatic fashion as not to damage the confidence of the trainee.

One issue faced by all who are involved in assistance development is the presentation of a child with either a critical defect or in heart failure from the chronicity of their defect who needs an urgent operation at the end of a visit. We must consider the issue of non-maleficence and ask ourselves if there is a team prepared to care for the child after surgery that is capable of recovering the child. Agreeing to operate on this child and then have the visiting team depart when the child still needs complex care is providing false hope to the family and ethically questionable. We have faced this problem countless times in our history and have decided that if we are operating late in the trip on critically ill children, we will leave a team of ICU caregivers behind to provide 24-hour coverage until the child is discharged from the ICU. The decision to operate on such a child must be made in concert with the local team and family, autonomy of decision for both is critical for all stakeholders.
