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Communications to the Editor |

Informed ConsentInformed Consent FREE TO VIEW

Kenneth A. Berkowitz, MD, FCCP; Mary Beth Foglia, RN, MA; Barbara L. Chanko, RN, MBA
Author and Funding Information

Affiliations: Department of Veterans Affairs, National Center for Ethics in Health Care, Washington, DC,  Yale University School of Medicine, Bridgeport, CT

Correspondence to: Kenneth A. Berkowitz, MD, FCCP, National Center for Ethics in Health Care, VA New York Harbor Healthcare System (10E), Clinical Addition, Room 2585, 423 E 23rd St, New York, NY 10010; e-mail: Kenneth.Berkowitz@med.va.gov



Chest. 2004;125(6):2367-2368. doi:10.1378/chest.125.6.2367
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To the Editor:

The findings reported by Manthous et al (November 2003)1 are difficult to interpret because the survey instrument failed to define informed consent, and did not differentiate between oral and signature informed consent. Informed consent is a communication process that is ethically required before the initiation of any treatment or procedure. Signature informed consent is generally required for a subset of treatments or procedures that are reasonably expected to involve increased risk of discomfort, morbidity, or mortality. In the present study, if a respondent indicated that separate consent was not obtained for a procedure, did the response mean that signature consent is not required but oral informed consent was obtained, or did the response mean that no consent was obtained? This distinction is important. While signature consent is not ethically necessary for all procedures, informed consent is. The conflation of oral and signature informed consent in the present study calls into question how accurately the results reflect national practice patterns with regard to informed consent.

Manthous et al also suggest that no national standards exist to guide informed consent practices. In fact, the largest integrated health-care system in the country (the Veterans Health Administration) has had clear standards in place for many years.2 Our policy differentiates between oral and signature consent, provides guidance for deciding when each of these methods is appropriate, outlines specific procedures for each, and lists specific treatments and procedures that require signature consent. Of note, 12 of 15 procedures included in the study always require signature informed consent in Veterans Health Administration facilities. Our national informed consent policy can be found at: http://www1.va.gov/vhaethics/resources_9.cfm.

Manthous, CA, DeGirolamo, A, Haddad, C, et al (2003) Informed consent for medical procedures: local and national practices.Chest124,1978-1984. [CrossRef] [PubMed]
 
Veterans Health Administration. VHA informed consent for clinical treatments and procedures: VHA handbook 1004.1. Available at: http://www1.va.gov/vhaethics/resources_9.cfm. Accessed May 20, 2004.
 

Informed Consent

To the Editor:

We are grateful for the comments of Berkowitz and colleagues. The questionnaire that we sent to program and ICU directors did not define informed consent and therefore “failed to differentiate between oral and signature informed consent.” The implication is that respondents may have answered that they do not routinely obtain written consent (when in fact they obtain verbal consent). This is possible. However, as Berkowitz and colleagues point out, informed consent is a communication process. Since the respondents to our questionnaire were medical educators, we believe that they understand the distinction between informed consent and its documentation. Our questionnaire did not ask whether consent was documented but rather for which procedures “physicians in (their) ICU routinely obtain separate informed consent.”

We stand by the assertion that there is no uniformly accepted national standard of informed consent for many of the procedures examined in our study. The approach of the Veteran’s Administration (VA) system is comprehensive and a reasonable first draft for a national policy. However, the VA policy has at least one stipulation that is ideal in theory but problematic logistically. For example,

Treatments and procedures that do not require signature consent: Treatments and procedures that are low risk and are within broadly accepted standards of medical practice (eg, administration of most drugs or for the performance of minor procedures such as routine X-rays) do not require signature consent. However, the informed consent process must be documented in the medical record.1

Explicit documentation of consent for (each and every) administration of medications and routine radiographs is excessively onerous and not routine practice, even in the VA system. The use of the admission “blanket consent” for “routine and low-risk” diagnostic and therapeutic interventions seems reasonable. However, many routinely administered medications have potentially life-threatening side effects. Should practitioners be required to discuss risks, benefits, and alternatives of every new medication with their hospitalized patients and document each discussion? If so physicians could spend half of each day pursuing and documenting informed consent. Irrespective of its shortcomings, the VA policy has strengths that could serve as the foundation for a more uniform code of conduct in this area. We noted in casual conversations with our peers around the state and country that our local (rigid) practice of consent differed from that of many institutions. Our study simply documented this heterogeneity. The practice of informed consent, which is fundamental to patient autonomy, varies within states and even within hospitals.2 We suspect that this heterogeneity of practice resulted from lack of a single, explicit (and enforced) national standard.

References
VHA informed consent for clinical treatments and procedures. National Center for Ethics in Health Care. Available at: http://www1.va.gov/vhaethics/download/ICpolicy.doc. Accessed May 20, 2004.
 
Manthous, CA, DeGirolamo, A, Haddad, C, et al Informed consent for medical procedures: local and national practices.Chest2003;124,1978-1984. [CrossRef] [PubMed]
 

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References

Manthous, CA, DeGirolamo, A, Haddad, C, et al (2003) Informed consent for medical procedures: local and national practices.Chest124,1978-1984. [CrossRef] [PubMed]
 
Veterans Health Administration. VHA informed consent for clinical treatments and procedures: VHA handbook 1004.1. Available at: http://www1.va.gov/vhaethics/resources_9.cfm. Accessed May 20, 2004.
 
VHA informed consent for clinical treatments and procedures. National Center for Ethics in Health Care. Available at: http://www1.va.gov/vhaethics/download/ICpolicy.doc. Accessed May 20, 2004.
 
Manthous, CA, DeGirolamo, A, Haddad, C, et al Informed consent for medical procedures: local and national practices.Chest2003;124,1978-1984. [CrossRef] [PubMed]
 
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