Ethical challenges of genomics for perinatal medicine: the Budapest Declaration Zoltán Papp, MD PhD DSc; the International Academy of Perinatal Medicine T he new genomics will greatly expand the type and amount of diagnostic information about the fetus. This expanded diagnostic capacity will create ethical challenges for perinatologists. To inform clinical judgment and decision making, the International Academy of Perinatal Medicine offers the follow- ing ethical framework. Obtaining genomic information about the fetus is medically reasonable and therefore should be offered to all pregnant women, depending on availability, as a matter of fiduciary responsibility. The opportunity to obtain this information will enhance the pregnant woman’s autonomy. The disclosure of information about genomic assessment should be guided by the reasonable person standard. This standard is met when the physician provides the pregnant woman with information that a competent perinatologist would judge to be clinically important. The ethics of first-trimester risk assessment currently provides a model for decision making with and by pregnant women about genomic assessment of the fetus. It has been demonstrated that pregnant women can make sophisticated decisions, which are consistent with scientifically derived information, about the use of risk assessment information in subsequent decisions about invasive diagnosis. Pregnant women, with the support of an appropriate informed consent process, should be expected to make similarly sophisticated decisions about genomic assessment of the fetus. The policy for disclosure of the results of genomic assessment should be that information about genetic disorders and carrier status will routinely be disclosed. Information about later-onset conditions is controversial. Therefore, it is permissible but not obligatory to provide such results. Results of uncertain or un- known clinical significance should not be disclosed. There is strong ethical consensus that genomic information, like all medical information, should be protected by the pro- fessional obligation of confidentiality. Perinatologists should advocate for public policy that supports and protects the confidentiality of genomic information about the fetus. Depending on associated costs, patents on genomic tests may create significant economic barriers to fetal genomic assessment and may impede research. Perinatologists should advocate for public policy, appropriate to their national setting, that reduces or eliminates these barriers and fosters research in perinatal medicine. In conclusion, ethics is an essential component of genomic assessment of the fetus. Perinatologists have resources in medical ethics adequate to guide them in leading responsible change. These resources include the ethics of informed consent, the enhancement of patient autonomy, protection of pro- fessional integrity, fiduciary responsibility to pregnant and fetal patients, and advocacy for access to fetal genomic assessment. f From the Department of Obstetrics and Gynecology, Semmelweis University, Budapest, Hungary (Dr Papp). Reprints not available from the author. Presented at the Annual Meeting of the International Academy of Perinatal Medicine, Budapest, Hungary, Nov. 22, 2007. 0002-9378/free © 2009 Mosby, Inc. All rights reserved. doi: 10.1016/j.ajog.2009.07.007 See related article, page 351 Editorials www.AJOG.org 336 American Journal of Obstetrics & Gynecology OCTOBER 2009

Ethical challenges of genomics for perinatal medicine: the Budapest Declaration

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Editorials www.AJOG.org

thical challenges of genomics for perinataledicine: the Budapest Declaration

oltán Papp, MD PhD DSc; the International Academy of Perinatal Medicine

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he new genomics will greatly expand the type and amountof diagnostic information about the fetus. This expanded

iagnostic capacity will create ethical challenges for perinatolo-ists. To inform clinical judgment and decision making, thenternational Academy of Perinatal Medicine offers the follow-ng ethical framework.

Obtaining genomic information about the fetus is medicallyeasonable and therefore should be offered to all pregnantomen, depending on availability, as a matter of fiduciary re-

ponsibility. The opportunity to obtain this information willnhance the pregnant woman’s autonomy. The disclosure ofnformation about genomic assessment should be guided byhe reasonable person standard. This standard is met when thehysician provides the pregnant woman with information that

competent perinatologist would judge to be clinicallymportant.

The ethics of first-trimester risk assessment currently pro-ides a model for decision making with and by pregnantomen about genomic assessment of the fetus. It has beenemonstrated that pregnant women can make sophisticated

rom the Department of Obstetrics and Gynecology, Semmelweisniversity, Budapest, Hungary (Dr Papp).

eprints not available from the author.

resented at the Annual Meeting of the International Academy oferinatal Medicine, Budapest, Hungary, Nov. 22, 2007.

oi: 10.1016/j.ajog.2009.07.007

aSee related article, page 351

36 American Journal of Obstetrics & Gynecology OCTOBER 2009

ecisions, which are consistent with scientifically derived in-ormation, about the use of risk assessment information inubsequent decisions about invasive diagnosis. Pregnantomen, with the support of an appropriate informed consentrocess, should be expected to make similarly sophisticatedecisions about genomic assessment of the fetus.The policy for disclosure of the results of genomic assessment

hould be that information about genetic disorders and carriertatus will routinely be disclosed. Information about later-onsetonditions is controversial. Therefore, it is permissible but notbligatory to provide such results. Results of uncertain or un-nown clinical significance should not be disclosed.There is strong ethical consensus that genomic information,

ike all medical information, should be protected by the pro-essional obligation of confidentiality. Perinatologists shoulddvocate for public policy that supports and protects the con-dentiality of genomic information about the fetus.Depending on associated costs, patents on genomic testsay create significant economic barriers to fetal genomic as-

essment and may impede research. Perinatologists should ad-ocate for public policy, appropriate to their national setting,hat reduces or eliminates these barriers and fosters research inerinatal medicine.In conclusion, ethics is an essential component of genomic

ssessment of the fetus. Perinatologists have resources in med-cal ethics adequate to guide them in leading responsiblehange. These resources include the ethics of informed con-ent, the enhancement of patient autonomy, protection of pro-essional integrity, fiduciary responsibility to pregnant and fe-al patients, and advocacy for access to fetal genomic

ssessment. f