More than a document: The importance of the informed consent process

In a recent issue of JAMA Surgery, Dr. Jacqueline M. Garonzik-Wang and colleagues presented the results of an important study of missing surgical consent forms at Johns Hopkins Hospital. The authors tallied the absence of a surgical consent form in a patient’s medical record and the resulting delays and other impacts on the surgical services. The authors also surveyed nurses, surgical residents, and surgical faculty regarding their satisfaction with the informed consent process. The results of the study show that cases are often delayed and surgical residents are often pulled away from other activities (e.g., educational conferences) to have new consent forms signed in the preoperative area. In addition, both faculty and residents had concerns about residents obtaining informed consent for major elective procedures.

This is undoubtedly an important study in that it casts light upon an important source of delays and dissatisfaction in the preoperative setting. However, are there additional lessons about informed consent that might be gleaned from this type of analysis?

Moving beyond the study itself, other important issues arise. Consider a patient who comes to the office for evaluation of a symptomatic hernia. Once the surgeon decides that the operation is indicated, the consent process requires a description of the indications (benefits), risks, and alternatives for the patient. Even though the surgeon may be convinced that the benefits of the operation outweigh the risks, the patient still needs to be convinced. Depending on the patient and the procedure being recommended, the time necessary to explain the above to the patient so that he or she is adequately informed and willing to sign the consent form will vary greatly.

In contemporary surgical practice, the determination of when the patient has been adequately informed is made by the patient. At the point that he or she is comfortable enough with the recommendation to proceed to an operation, the informed consent process has reached its conclusion. Only at this point, is the informed consent form even relevant to the discussion. The patient’s signature on the informed consent form is designed to signify the conclusion of the informed consent process.

Although we often mix the signature on the form with the process itself, they are, in fact, markedly different. The informed consent process is an ethical requirement; whereas the signature on the form is a legal requirement. The fact that these two requirements are different can readily be seen from the Mayo Clinic experience. For years, no informed consent forms were even used at the Mayo Clinic! The discussion of the indications, risks, and alternatives was documented in the surgeon’s notes and the fact that the patient showed up for the elective operation could be taken as the evidence of the adequacy of the informed consent process. Although this practice was acceptable to both surgeons and patients for years, the Clinic ultimately changed its practice in response to federal regulations that require the patient’s signature on an informed consent form.

Certainly, there is nothing inherently wrong with the practice of obtaining a signature from a patient on a consent form at the conclusion of the informed consent process. However, the current emphasis on the form itself has had a tendency for the process to be short changed in favor of getting the signature. The fact that both practicing surgeons and surgeons in training often slip into the habit of referring to the process solely by the form can frequently be seen. How often have we or our colleagues talked about "consenting the patient" when we really mean "obtaining informed consent from a patient"?

The Hopkins study serves to remind us that if we really take the process of obtaining informed consent from surgical patients as ethically important, we must be sure to give it the attention it deserves in our practice. If obtaining informed consent is central to the ethical practice of surgery, then why do we so often depend on the least experienced member of the surgical team to carry out this task right before surgery? Perhaps this practice does not reflect our devaluation of the informed consent process as much as a realization that if a patient scheduled for elective surgery has discussed the operation with the surgeon and has chosen to come to the hospital for the procedure, we can assume that the patient has already had a satisfactory consent process. In this context, the problem of the missing consent form is less an ethical issue than a clerical one that might be solved by eliminating the paper form and depending on technology for a solution.

How might a technological fix help in this situation? Among the possibilities would be to have paper forms signed in the attending surgeon’s office at the time of the informed consent discussion. The form could then be scanned into the electronic medical record. Such an approach should significantly reduce the numbers of missing forms since the electronic version cannot be misplaced. This approach will not, however, solve the problem of the missing consent form if the patient is undecided about surgery when he or she leaves the outpatient visit. In such cases, the patient may not be back to the office or hospital until the day of surgery.

Alternatively, all of the information on the standard informed consent form could be made electronic and after the discussion with the attending surgeon, the electronic version could be signed if the patient is amenable, or printed for the patient to take home if he or she is undecided. If the patient then decides to proceed with surgery, the patient could sign in to a secure website and electronically acknowledge (that is, sign) the electronic consent form. This electronic version could then be reviewed by the preoperative nurse and the patient on the day of surgery. As long as the informed consent process that is dependent on the relationship between the surgeon and patient remains intact, there is no reason why technology might not help us eliminate the problem of the missing consent form.

Garonzik-Wang JM, Brat G, Salazar JH, et al. Missing consent forms in the preoperative area: A single-center assessment of the scope of the problem and its downstream effects. JAMA Surg. Published online July 10, 2013, E1-E4.

Dr. Angelos is an ACS Fellow; the Linda Kohler Anderson Professor of Surgery and Surgical Ethics; chief, endocrine surgery; and associate director of the MacLean Center for Clinical Medical Ethics at the University of Chicago.

In a recent issue of JAMA Surgery, Dr. Jacqueline M. Garonzik-Wang and colleagues presented the results of an important study of missing surgical consent forms at Johns Hopkins Hospital. The authors tallied the absence of a surgical consent form in a patient’s medical record and the resulting delays and other impacts on the surgical services. The authors also surveyed nurses, surgical residents, and surgical faculty regarding their satisfaction with the informed consent process. The results of the study show that cases are often delayed and surgical residents are often pulled away from other activities (e.g., educational conferences) to have new consent forms signed in the preoperative area. In addition, both faculty and residents had concerns about residents obtaining informed consent for major elective procedures.

This is undoubtedly an important study in that it casts light upon an important source of delays and dissatisfaction in the preoperative setting. However, are there additional lessons about informed consent that might be gleaned from this type of analysis?

Moving beyond the study itself, other important issues arise. Consider a patient who comes to the office for evaluation of a symptomatic hernia. Once the surgeon decides that the operation is indicated, the consent process requires a description of the indications (benefits), risks, and alternatives for the patient. Even though the surgeon may be convinced that the benefits of the operation outweigh the risks, the patient still needs to be convinced. Depending on the patient and the procedure being recommended, the time necessary to explain the above to the patient so that he or she is adequately informed and willing to sign the consent form will vary greatly.

In contemporary surgical practice, the determination of when the patient has been adequately informed is made by the patient. At the point that he or she is comfortable enough with the recommendation to proceed to an operation, the informed consent process has reached its conclusion. Only at this point, is the informed consent form even relevant to the discussion. The patient’s signature on the informed consent form is designed to signify the conclusion of the informed consent process.

Although we often mix the signature on the form with the process itself, they are, in fact, markedly different. The informed consent process is an ethical requirement; whereas the signature on the form is a legal requirement. The fact that these two requirements are different can readily be seen from the Mayo Clinic experience. For years, no informed consent forms were even used at the Mayo Clinic! The discussion of the indications, risks, and alternatives was documented in the surgeon’s notes and the fact that the patient showed up for the elective operation could be taken as the evidence of the adequacy of the informed consent process. Although this practice was acceptable to both surgeons and patients for years, the Clinic ultimately changed its practice in response to federal regulations that require the patient’s signature on an informed consent form.

Certainly, there is nothing inherently wrong with the practice of obtaining a signature from a patient on a consent form at the conclusion of the informed consent process. However, the current emphasis on the form itself has had a tendency for the process to be short changed in favor of getting the signature. The fact that both practicing surgeons and surgeons in training often slip into the habit of referring to the process solely by the form can frequently be seen. How often have we or our colleagues talked about "consenting the patient" when we really mean "obtaining informed consent from a patient"?

The Hopkins study serves to remind us that if we really take the process of obtaining informed consent from surgical patients as ethically important, we must be sure to give it the attention it deserves in our practice. If obtaining informed consent is central to the ethical practice of surgery, then why do we so often depend on the least experienced member of the surgical team to carry out this task right before surgery? Perhaps this practice does not reflect our devaluation of the informed consent process as much as a realization that if a patient scheduled for elective surgery has discussed the operation with the surgeon and has chosen to come to the hospital for the procedure, we can assume that the patient has already had a satisfactory consent process. In this context, the problem of the missing consent form is less an ethical issue than a clerical one that might be solved by eliminating the paper form and depending on technology for a solution.

How might a technological fix help in this situation? Among the possibilities would be to have paper forms signed in the attending surgeon’s office at the time of the informed consent discussion. The form could then be scanned into the electronic medical record. Such an approach should significantly reduce the numbers of missing forms since the electronic version cannot be misplaced. This approach will not, however, solve the problem of the missing consent form if the patient is undecided about surgery when he or she leaves the outpatient visit. In such cases, the patient may not be back to the office or hospital until the day of surgery.

Alternatively, all of the information on the standard informed consent form could be made electronic and after the discussion with the attending surgeon, the electronic version could be signed if the patient is amenable, or printed for the patient to take home if he or she is undecided. If the patient then decides to proceed with surgery, the patient could sign in to a secure website and electronically acknowledge (that is, sign) the electronic consent form. This electronic version could then be reviewed by the preoperative nurse and the patient on the day of surgery. As long as the informed consent process that is dependent on the relationship between the surgeon and patient remains intact, there is no reason why technology might not help us eliminate the problem of the missing consent form.

Garonzik-Wang JM, Brat G, Salazar JH, et al. Missing consent forms in the preoperative area: A single-center assessment of the scope of the problem and its downstream effects. JAMA Surg. Published online July 10, 2013, E1-E4.

Dr. Angelos is an ACS Fellow; the Linda Kohler Anderson Professor of Surgery and Surgical Ethics; chief, endocrine surgery; and associate director of the MacLean Center for Clinical Medical Ethics at the University of Chicago.

In a recent issue of JAMA Surgery, Dr. Jacqueline M. Garonzik-Wang and colleagues presented the results of an important study of missing surgical consent forms at Johns Hopkins Hospital. The authors tallied the absence of a surgical consent form in a patient’s medical record and the resulting delays and other impacts on the surgical services. The authors also surveyed nurses, surgical residents, and surgical faculty regarding their satisfaction with the informed consent process. The results of the study show that cases are often delayed and surgical residents are often pulled away from other activities (e.g., educational conferences) to have new consent forms signed in the preoperative area. In addition, both faculty and residents had concerns about residents obtaining informed consent for major elective procedures.

This is undoubtedly an important study in that it casts light upon an important source of delays and dissatisfaction in the preoperative setting. However, are there additional lessons about informed consent that might be gleaned from this type of analysis?

Moving beyond the study itself, other important issues arise. Consider a patient who comes to the office for evaluation of a symptomatic hernia. Once the surgeon decides that the operation is indicated, the consent process requires a description of the indications (benefits), risks, and alternatives for the patient. Even though the surgeon may be convinced that the benefits of the operation outweigh the risks, the patient still needs to be convinced. Depending on the patient and the procedure being recommended, the time necessary to explain the above to the patient so that he or she is adequately informed and willing to sign the consent form will vary greatly.

In contemporary surgical practice, the determination of when the patient has been adequately informed is made by the patient. At the point that he or she is comfortable enough with the recommendation to proceed to an operation, the informed consent process has reached its conclusion. Only at this point, is the informed consent form even relevant to the discussion. The patient’s signature on the informed consent form is designed to signify the conclusion of the informed consent process.

Although we often mix the signature on the form with the process itself, they are, in fact, markedly different. The informed consent process is an ethical requirement; whereas the signature on the form is a legal requirement. The fact that these two requirements are different can readily be seen from the Mayo Clinic experience. For years, no informed consent forms were even used at the Mayo Clinic! The discussion of the indications, risks, and alternatives was documented in the surgeon’s notes and the fact that the patient showed up for the elective operation could be taken as the evidence of the adequacy of the informed consent process. Although this practice was acceptable to both surgeons and patients for years, the Clinic ultimately changed its practice in response to federal regulations that require the patient’s signature on an informed consent form.

Certainly, there is nothing inherently wrong with the practice of obtaining a signature from a patient on a consent form at the conclusion of the informed consent process. However, the current emphasis on the form itself has had a tendency for the process to be short changed in favor of getting the signature. The fact that both practicing surgeons and surgeons in training often slip into the habit of referring to the process solely by the form can frequently be seen. How often have we or our colleagues talked about "consenting the patient" when we really mean "obtaining informed consent from a patient"?

The Hopkins study serves to remind us that if we really take the process of obtaining informed consent from surgical patients as ethically important, we must be sure to give it the attention it deserves in our practice. If obtaining informed consent is central to the ethical practice of surgery, then why do we so often depend on the least experienced member of the surgical team to carry out this task right before surgery? Perhaps this practice does not reflect our devaluation of the informed consent process as much as a realization that if a patient scheduled for elective surgery has discussed the operation with the surgeon and has chosen to come to the hospital for the procedure, we can assume that the patient has already had a satisfactory consent process. In this context, the problem of the missing consent form is less an ethical issue than a clerical one that might be solved by eliminating the paper form and depending on technology for a solution.

How might a technological fix help in this situation? Among the possibilities would be to have paper forms signed in the attending surgeon’s office at the time of the informed consent discussion. The form could then be scanned into the electronic medical record. Such an approach should significantly reduce the numbers of missing forms since the electronic version cannot be misplaced. This approach will not, however, solve the problem of the missing consent form if the patient is undecided about surgery when he or she leaves the outpatient visit. In such cases, the patient may not be back to the office or hospital until the day of surgery.

Alternatively, all of the information on the standard informed consent form could be made electronic and after the discussion with the attending surgeon, the electronic version could be signed if the patient is amenable, or printed for the patient to take home if he or she is undecided. If the patient then decides to proceed with surgery, the patient could sign in to a secure website and electronically acknowledge (that is, sign) the electronic consent form. This electronic version could then be reviewed by the preoperative nurse and the patient on the day of surgery. As long as the informed consent process that is dependent on the relationship between the surgeon and patient remains intact, there is no reason why technology might not help us eliminate the problem of the missing consent form.

Garonzik-Wang JM, Brat G, Salazar JH, et al. Missing consent forms in the preoperative area: A single-center assessment of the scope of the problem and its downstream effects. JAMA Surg. Published online July 10, 2013, E1-E4.

Dr. Angelos is an ACS Fellow; the Linda Kohler Anderson Professor of Surgery and Surgical Ethics; chief, endocrine surgery; and associate director of the MacLean Center for Clinical Medical Ethics at the University of Chicago.