9D.A. Bolnick et al. (eds.), Surgical Guide to Circumcision, DOI 10.1007/978-1-4471-2858-8_2, © Springer-Verlag London 2012

2

Introduction

The importance of informed consent cannot be overemphasized. Seeking a person’s consent shows a respect for individual autonomy and allows the patient to determine what is in his or her best interests. It also follows the primary principle of medicine, primum non nocere , or fi rst do no harm, by recognizing the physician’s responsibility to treat others justly and in the manner in which he or she would expect to be treated. Finally, it helps to establish an active alliance between the physician and the patient, improving patient compliance with care and allowing for shared decision-making and shared responsibility for the patient’s well-being. The application of these principles to the pediatric setting, especially in the case of an elective pro-cedure such as circumcision, raises unique con-siderations and concerns. The purpose of this chapter is to delineate the general principles of informed consent and to identify their application to the pediatric population generally and to the case of elective circumcision speci fi cally.

General Principles of Informed Consent

Informed consent is a process consisting of an ongoing dialogue between the physician and the patient that allows for a lasting alliance between the physician and patient based on trust. Although

Informed Consent: Principles for Elective Circumcision

Vijaya M. Vemulakonda

V. M. Vemulakonda , M.D., JD University of Colorado , Denver , CO , USA

Department of Pediatric Urology , Children’s Hospital Colorado , Aurora , CO , USA e-mail: ask@guidetocircumcision.com

Editors’ Note

Informed consent is more than a process; it is a gestalt that embraces the concept of the provider (physician or other practitioner) and the patient engaging in a two-way exchange of ideas to best determine a med-ical course of action. In pediatric cases, the parents are the decision-makers for their children and are presumed to have the best interest of the child in mind. The most important point to keep in mind is that patients (parents) come with preconceived expectations and often cultural consider-ations. It is important to be sensitive to these and at the same time present a well-balanced summary of the pros and cons of circumcision. To that “a well-crafted informed consent document outlining the procedure, goals of surgery, risks, bene fi ts, and expected outcomes of the procedure allows an opportunity to con fi rm that the patient has understood and retained the information needed to reach a mean-ingful decision.”

10 V.M. Vemulakonda

the consent form is documentation of this pro-cess, completion of the consent form is not suf fi cient to meet the requirements of informed consent. The process of consent requires a mutual understanding between the patient and physician about the procedure and its relative bene fi ts and risks and culminates in a shared responsibility for medical decision-making.

The Three Elements of Informed Consent

Informed consent is comprised of three elements, each of which builds on the other to ensure a complete consent process. The fi rst element of consent is physician disclosure . Disclosure refers to the physician’s responsibility to inform the patient about the proposed treatment during the consent process. The physician must convey ade-quate information about the patient’s condition, the options of management, including the option of nonintervention, the risks and bene fi ts of each option, the expected sequelae of the treatment, and the medical uncertainties regarding the diagnosis, management options, and outcomes. Conveyance of information should be tailored to the patient’s ability to understand and retain the information necessary to make a decision [ 1, 2 ] . It is incumbent upon the physician to clearly dis-close this information in a way that is clearly understood by the patient or proxy decision-maker and that allows for a balanced perspective of the alternatives available.

The second element of consent is patient understanding . The patient needs to be attentive to the information being provided. The physician should take note of patient anxiety and focus dur-ing the discussion and should provide the oppor-tunity for patient concerns to be addressed and questions to be answered throughout the consent process. The patient must be given suf fi cient time to process and absorb what the physician has said prior to making a decision. Finally, the physician should ensure that the patient not only understands the information being provided but also under-stands the decision he faces. The patient must

process that, by consenting, he is allowing the physician to perform the procedure described and that, without his expressed consent, further treat-ment cannot occur. Furthermore, he must under-stand not only the goals of the procedure but also the expected potential outcomes of surgery, including postoperative recovery, functional limi-tations, and cosmetic changes due to the proce-dure. The onus is on the physician to ensure that patient understanding is reached. This may require questions by the physician to ensure that the patient has absorbed and can recollect informa-tion about his condition and the alternative treat-ments he faces. Alternatively, to avoid the potential embarrassment of verbal quizzes, a well-crafted informed consent document outlining the proce-dure, goals of surgery, risks, bene fi ts, and expected outcomes of the procedure allows an opportunity to con fi rm that the patient has understood and retained the information needed to reach a mean-ingful decision. By reviewing the consent form with the patient, the physician can also gauge any confusion or uncertainty that needs to be addressed prior to obtaining consent [ 1 ] .

The fi nal element of the consent process is deci-sion-making . This process allows the patient to have as much or as little participation in the deci-sion as he desires [ 1 ] . The physician should ensure that the patient has an understanding of the basic elements of the procedure, risks, bene fi ts, and alter-natives and has a framework in which to make decisions. By aiding the patient in identifying val-ues that are important to his or her decision, the physician can ensure that the patient has an ade-quate measure by which to gauge treatment alter-natives. The physician should initially provide a balanced view of alternatives without offering rec-ommendations for treatment. Once the patient has had the opportunity to evaluate alternatives within his own value framework, the physician may then offer recommendations. By allowing the patient to independently weigh alternatives prior to providing recommendations, the physician may ensure that the patient’s decision is not unduly in fl uenced by physician bias. By discussing the best way to meet patient concerns and by offering recommendations, the physician also allows for a sense of shared deci-sion-making, where the physician and the patient

112 Informed Consent: Principles for Elective Circumcision

are acting in concert to determine the best option of treatment, allowing for improved rapport between the patient and the physician and fostering a sense of shared responsibility.

Informed Consent in the Pediatric Setting

In pediatric cases, the parents are the decision-makers for their children and are presumed to have the best interest of the child in mind. The role of the physician in these cases is to keep this focus on the child’s interest at the forefront of the discussion while respecting the parents’ decision-making process. In identifying who is ultimately responsible for the decision, the physician should ideally involve both parents in the consent pro-cess [ 2, 3 ] . However, in cases of parental dissent, the physician may be tasked with determining parental responsibility, especially where parents are unmarried or divorced. Although there are exceptions, generally, the custodial parent has decision-making capability. In cases where the parents are unmarried, the mother generally has the responsibility of providing consent [ 4 ] .

The pediatric patient should also be actively involved in the decision-making process. The role of the pediatric patient in the informed consent process is dependent upon the child’s ability to participate meaningfully in the consent process. The age at which children are suf fi ciently mature to make a meaningful decision depends upon the individual and the governing state law. Generally, 18 years is the legal age for independent consent, although exceptions to this rule do exist, espe-cially in cases regarding reproductive decision-making [ 2 ] . There has been a movement, however, to expand the pediatric patient’s autonomy in the decision-making process to earlier in adolescence. As a result, the autonomy of adolescents who are able to understand the consent process and reach a meaningful decision should be respected even in cases where they are not legally of the age of inde-pendent consent [ 2 ] .

Although not all children are capable of the understanding necessary for consent, to the extent

that the pediatric patient is able to participate in the process, he should. The ability of the child to meaningfully participate in the consent decision may be based not only on age but also on cogni-tive capacity and personal experience [ 2 ] . The goal of the physician should be to take these cir-cumstances into account when determining the extent to which the child should be involved in the decision-making process. For children who are not suf fi ciently mature to reach an informed decision, the goal of the physician should be to include the patient in the discussion of options and to provide information about the decision reached by the patient’s parents, allowing them to participate in the discussion to the extent to which they are capable [ 1, 2 ] .

In cases where the patient and parents dis-agree, the physician should act as arbitrator to allow for both the pediatric patient and his par-ents to come to a common understanding that allows for a decision that is acceptable to all involved parties. As a result, the physician’s role is to evaluate both the parents’ preferences and the child’s needs to help the family reach a com-mon understanding about which alternative is in the patient’s best interest, not to determine whose decision “wins” [ 1, 2 ] . The more dependent chil-dren are upon their parents for support, the more the physician’s focus should be on the best inter-ests of the child in discussing plans of care.

Informed Consent for Elective Circumcision

The issue of elective circumcision continues to be a controversial one. While most boys in the United States undergo circumcision, this is not the case in many parts of the world. Given the debate surrounding circumcision, informed con-sent by parents for pediatric circumcision has also been controversial. In counseling families about circumcision, the American Academy of Pediatrics has recommended detailed discussion of the risks, bene fi ts, and alternatives during informed consent but has not taken an of fi cial position for or against routine circumcision [ 5 ] .

12 V.M. Vemulakonda

The medical bene fi ts of circumcision, while present, tend to be small in magnitude and should be neither under- nor overemphasized. Further-more, circumcision, while routine, is not risk free (see Chaps. 6 and 11 on complications of circum-cision). Due to the potential risks and bene fi ts and the lack of a clear medical indication, elective cir-cumcision is often sought for cultural or social reasons rather than medical reasons [ 6 ] .

While discussion of the medical indications, risks, and bene fi ts are important, parents often do not change their decision even after being pre-sented with information about the risks and bene fi ts of the procedure [ 7 ] . It is essential that the physician also discuss the reasons behind the parents’ decision to identify and address any unspoken concerns that are driving the decision. These may include concerns about the effects of peer attitudes or the circumcision status of other family members on the child’s self-esteem. Additionally, some religious faiths, including Judaism and Islam, consider circumcision a reli-gious act that is required for integration into the religious community [ 8 ] . It is therefore incum-bent on the physician to discuss not only medical but also social and cultural concerns during the informed consent process to give parents a com-plete and balanced view of the procedure and its alternatives (see Part 8 of this book for details on rituals, cultures, and economic issues).

Given the absence of a medical indication for circumcision in most cases, the onus is on the parents to demonstrate that this is in the best interest of the child. The child’s best interest must be considered in light of the patient’s own desires, his ability to understand the proposed procedure and its alternatives and to participate in the dis-cussion and in reaching a decision, the risks to the patient of pain or other adverse effects, paren-tal desires and preferences, the social and cultural implications of proceeding or not proceeding with circumcision, and the impact of the decision on future patient choice and opportunity [ 9 ] . The physician’s role is to clearly delineate the balance of risks and bene fi ts of the procedure to the fam-ily [ 10 ] . The physician must also recognize his own biases in counseling the patient and his fam-ily; older, male physicians who are circumcised

themselves are more likely to recommend circumcision to their patients [ 11 ] .

The need for parental agreement in these cases is essential, and some medical associations have advocated required consent by both parents, either verbally or on the written consent form, to con fi rm their understanding of the procedure and their mutual agreement to proceed [ 8, 10 ] . In cases of parental disagreement brought to the courts, the decision has usually been not to cir-cumcise. This decision is independent of who has the legal right to consent [ 4, 12 ] . Furthermore, the child should participate in the decision-making process to the extent to which he is capable [ 8, 10, 12 ] . In cases of signi fi cant disagreement, the physician may consider deferring treatment until the concerns of the parents are addressed and a common understanding can be reached [ 8 ] . Ultimately, in the absence of a clear medical necessity, the goal of the physician is to ensure that a thorough, balanced discussion of the proce-dure and its alternatives has been held; that parental social, cultural, and religious concerns outweigh the risks of surgery; and that this deci-sion has been agreed upon by the physician, the parents, and, to the extent possible, the patient.

Conclusions

Informed consent for elective circumcision, like any procedure, is more than a piece of paper required by the bureaucracy of medicine. It is an ongoing process based upon the principles of mutual trust and understanding between the phy-sician, the patient, and, in the case of the pediatric patient, the parents. While the process of consent is often a dif fi cult one, it ultimately leads to a sense of shared responsibility and understanding, thereby improving patient and parent compliance and preparing the patient and parent for expected and unexpected postoperative sequelae. It is the responsibility of the physician to recognize and address not only medical concerns but also the social, cultural, and religious mores that in fl uence the decision to proceed with elective circumci-sion. Additionally, it allows the physician to identify and minimize the impact of his or her

132 Informed Consent: Principles for Elective Circumcision

own biases on the discussion. By taking the time to participate in meaningful discussion, the phy-sician is able maintain his responsibility to his patient, forge a meaningful physician-patient relationship, uphold the principles of his profes-sion, and, most importantly, allow the patient and his family to reach a well-considered decision about an elective procedure.

References

1. McCullough LB, Jones JW, Brody BA, editors. Surgical ethics. New York: Oxford University Press; 1998. p. 15.

2. De Lourdes Levy M, Larcher V, Kurz R. Informed con-sent/assent in children. Statement of the ethics working group of the confederation of European specialists in pediatrics (CESP). Eur J Pediatr. 2003;162:629.

3. Steven M, Broadis E, Carachi R, Brindley N. Sign on the dotted line: parental consent. Pediatr Surg Int. 2008;24:847.

4. Cooke RWI. Good practice in consent. Semin Fetal Neonatal Med. 2005;10:63.

5. Task Force on Circumcision, American Academy of Pediatrics. Report of the task force on circumcision. Pediatrics. 1989;84:388.

6. Lerman SE, Liao JC. Neonatal circumcision. Pediatr Clin North Am. 2001;48(6):1539.

7. Fetus and Newborn Committee, Canadian Paediatric Society. Neonatal circumcision revisited. Can Med Assoc J. 1996;154(6):769.

8. Wheeler R. Consent for non-therapeutic male circum-cision: an exception to the rule? Arch Dis Child. 2008;93(10):825.

9. British Medical Association. The law and ethics of male circumcision: guidance for doctors. J Med Ethics. 2004;30:259.

10. Singh D. BMA says non-therapeutic circumcision needs consent of both parents. Br Med J. 2003;326(7393):782.

11. Stein M, Marx M, Taggert S, Bass R. Routine neona-tal circumcision: the gap between contemporary policy and practice. J Fam Pract. 1982;83 Suppl 1:93.

12. Diekema DS. Boldt v. Boldt: a pediatric ethics per-spective. J Clin Ethics. 2009;20(3):251.