If a physician performs an abortion on an unemancipated minor during a medical emergency as defined by Texas Family Code Section 33.0022(a), the physician shall execute an affidavit explaining the specific medical emergency that necessitated the immediate abortion and include this affidavit in the minor patient’s file. The physician shall also maintain in the medical records a copy of the certification to DSHS, as required by Section 33.002, Texas Family Code.
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Performance of Sonogram Before an Abortion
During the Texas 82nd regular legislative session (2011), the Texas Legislature enacted House Bill 15, which amends the Woman’s Right to Know Act (Health and Safety Code, Section 171.001 et seq.). The physician who is to perform the abortion, or an agent of that physician who is also a certified sonographer, must perform a sonogram on a pregnant woman at least 24 hours before the abortion, or at least two hours before the abortion if the pregnant woman waives this requirement by certifying on the sonogram/abortion election form that she currently lives 100 miles or more from the nearest abortion provider.
The physician who is to perform the abortion may not delegate these tasks to anyone else, and under no circumstance may this information be provided by audio or video recording.
Before sedative or anesthesia is administered to the woman, a sonogram must be performed, and the physician who is to perform the abortion must make the sonogram available for viewing by the woman.34 That physician also must provide an understandable, verbal explanation of the sonogram results.35 The fetal heartbeat is made audible for the woman to hear, if present.36
Before receiving a sonogram by the abortion provider, and before any sedative or anesthesia is administered, the pregnant woman must complete the sonogram/abortion election form.37 The physician who is to perform the abortion must receive a copy of that signed form.38 The sonogram/abortion election form must be retained in the woman’s medical record at the location where the abortion was performed.
In a medical emergency, an abortion provider may perform an abortion without obtaining a sonogram and must:
- Include in the patient’s medical record a signed statement on the medical emergency form, certifying the nature of the emergency; and
- Not later than 30 days after the date of the abortion, submit a medical emergency incident report form to DSHS.39
The physician or physician’s agent is also required to:
- Provide a pregnant woman with a list of agencies that provide free sonograms,40 and such agency must not affiliate with or make referrals to abortion providers;41 and
- If a woman declines to proceed with the abortion after being provided with the information required by law, provide her with a state publication on paternity establishment and child support obligations.42
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Distribution of Abortion-Inducing Drug
In the second called session in 2013, the Texas Legislature passed a bill that prohibits a person from selling, dispensing, administering, providing, or prescribing an abortion-inducing drug to a pregnant woman unless the person is a physician, and unless the drug satisfies the Food and Drug Administration (FDA) protocol as outlined in the final printed label of the drug.43 The legislation provides that, as an alternative to satisfying an FDA protocol, the drug instead may be provided in the dosage amount prescribed by the clinical management guidelines defined in the American College of Obstetricians and Gynecologists Practice Bulletin that existed on Jan. 1, 2013.44
The Texas Medical Board is charged with enforcing this law.45 The legislation provides further that a physician must first examine the woman and document the gestational age and intrauterine location of the pregnancy before dispensing, prescribing, providing, selling, or administering an abortion-inducing drug.46 The legislation also places a duty on the physician with regard to informing the woman about the drug. The physician must provide the pregnant woman with:
- A copy of the final printed label of that abortion-inducing drug;47 and
- A telephone number by which she may reach the physician or health care personnel who are employed by the physician or by the facility where the abortion was performed and who have access to the woman’s relevant medical records 24/7.48 The purpose of the telephone number is to enable the woman to request assistance for any complications that arise from the administration or use of the drug or to ask health-related questions about the drug.49
Further information, including forms and state documents on free sonogram providers, can be found on the Texas Department of State Health Services website at the following links:
Consent for Anesthesia and/or Perioperative Pain Management (Analgesia) In 2011, the legislature added a section to the act that outlines the informed consent requirements for anesthesia and/or perioperative pain management (analgesia), including a form. The disclosure and consent form, promulgated by the panel, is available in English and Spanish.50
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Consent for Radiation Therapy
The Texas Medical Disclosure Panel adopted a rule on informed consent for radiation therapy in 1995. The disclosure and consent form, promulgated by the Texas Medical Disclosure Panel, is available in English and Spanish.51
The radiation therapy disclosure and consent form is to be used in lieu of the general disclosure and consent form adopted at Section 601.4(a) for disclosure and consent relating only to radiation therapy procedures.52 For surgical or anesthetic procedures that are required in combination with a radiation therapy procedure, both forms must be used.53
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Consent for Electroconvulsive Therapy
According to the Texas Mental Health Code, the executive commissioner of the Health and Human Services Commission is required to adopt a standard form for consent to electroconvulsive therapy.54 The Mental Health Code requires certain information to be included in the consent form (e.g., nature and purpose of the procedure, duration, side effects).55 The form also must include the information required by the Texas Medical Disclosure Panel for electroconvulsive therapy.56 The executive commissioner has adopted a form titled Disclosure and Consent for Electroconvulsive Therapy; that form is maintained by the Texas Department of State Health Services (www.dshs.texas.gov/mhsa/bhmd/ect/).57
Use of the consent form prescribed by the executive commissioner creates a rebuttable presumption (as is the case with the proper use of the panel’s disclosure and consent forms) that the physician did not neglect his or her disclosure obligations.58 The panel by rule has stated that a physician may use the DSHS form as long as that form contains the minimum information for ECT required by the panel.59 According to DSHS, a physician using the DSHS consent form for ECT is not required to use both the DSHS form for ECT and the panel’s disclosure and consent form.60 In an FAQ published on its website, DSHS states that “[a] provider may use both the DSHS consent form for ECT and the Panel’s Disclosure and Consent — Medical and Surgical Procedures form.”61
The Mental Health Code also requires a hospital, facility, or physician administering ECT to ensure that the patient and the patient’s guardian, if any, receive a written supplement containing related information that pertains to the particular patient being treated with ECT.62 This supplemental information, along with a written copy of the consent form, must be provided before each ECT treatment is administered.63 The signed consent form must be made a part of the patient’s clinical record.64 Other provisions require that the consent be voluntary and without coercion or undue influence.65 A patient or guardian may revoke a consent to ECT at any time, and the revocation is effective immediately.
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Consent to Investigational Stem Cell Treatment
The Texas Legislature in 2015 passed legislation allowing patients with certain terminal illnesses to access investigational drugs and devices that are in clinical trials. Then, in 2017, the legislature expanded upon this concept with the passage of “Charlie’s Law.” That law allows certain patients (those with a severe chronic disease or terminal illness) who obtain physician approval and who meet other criteria to access investigational stem cell treatments. Before receiving the investigational stem cell treatment, an eligible patient (or parent, guardian, or conservator as appropriate) must sign a written informed consent.66 The executive commissioner of the Health and Human Services Commission is authorized to adopt a form for informed consent.67
Charlie’s Law requires that a physician administering an investigational stem cell treatment according to its terms “shall comply with all applicable Texas Medical Board rules.”68 As of this writing, TMB has not promulgated rules specifically addressing disciplinary action for failure to obtain informed consent to investigational stem cell treatment.
Charlie’s Law also requires the executive commissioner of the Health and Human Services Commission to adopt rules designating those medical conditions that constitute a severe chronic disease or terminal illness for purposes of that law.69 The list of those medical conditions is the key to accessing the investigational stem cell treatments under Charlie’s Law, as a person must have one of those listed conditions to be considered eligible to access and use those treatments as provided by the legislation. As of this writing, no rules have been adopted by the executive commissioner.
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Consent in Emergency
Texas law makes allowance for those circumstances where the patient's condition precludes obtaining consent from the patient himself or herself. Express consent for emergency care of an individual is not required if:
- The individual is:
- Unable to communicate because of an injury, accident, or illness or is unconscious; and
- Suffering from what reasonably appears to be a life-threatening injury or illness;
- A court of record orders the treatment of an individual who is in an imminent emergency to prevent the individual's serious bodily injury or loss of life; or
- The individual is a minor who is suffering from what reasonably appears to be a life-threatening injury or illness and whose parents, managing or possessory conservator, or guardian is not present.70
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Special Note on Durable Power of Attorney
Durable powers of attorney often create confusion among the medical community. It should be noted that in Texas a statutory durable power of attorney contains the legend “This Document Does Not Authorize Anyone to Make Medical and Other Health-Care Decisions for You.”71 True to its warning, such documents are insufficient to show the person has been named an agent for medical decisionmaking unless the person is unable to make such decisions. In Texas, a medical power of attorney or advance directive permits for the designation of an agent. TMA has separate documents discussing medical powers of attorney and advance directives to physicians.
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Conclusion
A physician has a duty to inform his or her patients of the risks of any medical procedures to be performed for their benefit. Dialogue is an essential element of risk management and can only improve the delivery of health care to patients. A physician should make information on the risks of treatment available to his or her patients and document the patient’s understanding and consent. Doing so will provide legal protections and improve patient-physician relations.
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Resources
- Texas Medical Disclosure Panel
- Homepage at www.dshs.texas.gov/facilities/medical-disclosure/default.aspx.
- Consent forms (for medical and surgical procedures, radiation therapy, hysterectomy, and anesthesia and/or perioperative pain management) at www.dshs.texas.gov/facilities/medical-disclosure/forms.aspx.
- FAQs at www.dshs.texas.gov/facilities/medical-disclosure/faq.aspx.
- Abortion forms at www.dshs.texas.gov/facilities/abortion/forms.aspx. The page has links to these forms:
- Medical Emergency Abortion Form,
- Sonogram and Abortion Election Form, and
- Required Texas Medical Board disclosure form.
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TMA Board of Councilors Ethics Opinion
Abortion. [Relevant portions only] When abortion is requested by a patient, the patient should be informed of the medical nature of the procedure and of its potential consequences, and the operative consent should be obtained in writing from the patient, or when appropriate, from the parent or guardian of a minor patient. When abortion is recommended by a physician, the indications should be stated in the patient's record, and informed consent obtained. When abortion is recommended by a physician, the indication for the procedure should be approved by a consultant knowledgeable in regard to the condition thought to indicate abortion.
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TMA Policy
10.002. Abortion: The Texas Medical Association recognizes abortion as a legal medical procedure, and the performance of abortion must be based upon early and accurate diagnosis of pregnancy; informed and nonjudgmental counseling; prompt referral to skillful and understanding personnel working in a good facility; reasonable cost; and professional follow up (Remarks of Speaker, p 12, A-85; reaffirmed: Council on Public Health, p 105, I-89; Res. 28WW, p 218-D, A-92; Res. 28J, p 168, A-94; and Council on Health Facilities, p 64, A-97; reaffirmed CPH Rep. 2-A-07; amended CSPH Rep. 3-A-17).
10.003. Patient Autonomy and Accuracy of Information in Informed Consent for Abortion: The Texas Medical Association urges DSHS to distribute printed material to patients that accurately reflect current medical consensus of the potential health effects of abortion, updating the potential complications and risks of abortion so they are described in such a way that women understand the overall safety of the procedure. TMA supports the autonomy and dignity of the patient by respecting the patient’s right to decide what information she does and does not receive. TMA advocates for the Texas Legislature to relieve the penalties of refusal to admit to license exam or refusal of license issue or renewal if physicians are noncompliant with any state legislation that violates the physician's duty to act in the best interests of his or her patients (Amended Res. 306-A-12; amended CSPH Rep. 3-A-17).
280.016 Human Subject Research — A Patient’s Bill of Rights: The Texas Medical Association supports: (a) application of the highest ethical standards in the use of human subjects for clinical trials; (b) ensuring that the goals of clinical trials are to benefit patients, not just advance science and industry; (c) use of institutional review board approval and oversight of human subject research; (d) complete informed consent for participation with full disclosure of risks and possibility of non-treatment; (e) full disclosure of conflicts of interest by all participating parties; (f) protection of subjects not able to give true informed consent because of age, disability, educational level, socioeconomic level, institutionalization, incarceration, or emotional distress; and (g) protection of confidentiality of individual patient information obtained in human subject research (Council on Scientific Affairs, p 128, A-94; substituted CSA Rep. 3-A-06; reaffirmed CSPH Rep. 1-A-16).
280.029 Stem Cell Research: The Texas Medical Association (1) supports biomedical research on multipotent stem cells (including embryonic, adult, and cord blood stem cells); (2) supports the use of somatic cell nuclear transfer technology in biomedical research (therapeutic cloning); (3) opposes the use of somatic cell nuclear transfer technology for the specific purpose of producing a human child (reproductive cloning); (4) encourages strong public support of federal funding for research involving human pluripotent stem cells; and (5) will continue to monitor developments in stem cell research and the use of somatic cell nuclear transfer technology (CSA Rep. 3-A-04; reaffirmed CSPH Rep. 2-A-14).
105.009 Informed Consent: An informed patient is the best patient, ethically and legally. Disclosure techniques and information recommended by the Texas Medical Disclosure Panel, in addition to other information which physicians may provide, enable patients to give an informed consent for proposed procedures (Board of Councilors, p 58, A-94; reaffirmed BOC Rep.3-A-04; reaffirmed BOC Rep. 6-A-14).
50.003 Unorthodox Treatment of Cancer: The Texas Medical Association recognizes the dangers to the health of Texans by treatments for cancer with unorthodox methods that lack a proven scientific basis for effectiveness particularly when these treatments are offered as an alternative to proven, conventional treatments. TMA strongly advises that patients with cancer receive treatment that has withstood scientific scrutiny or is part of a science-based clinical trial (Committee on Cancer, p 132, A-94; amended CM-C Rep. 2-A-10).
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American Medical Association Council on Ethical and Judicial Affairs Opinion
2.1.1 Informed Consent
Informed consent to medical treatment is fundamental in both ethics and law. Patients have the right to receive information and ask questions about recommended treatments so that they can make well-considered decisions about care. Successful communication in the patient-physician relationship fosters trust and supports shared decision making.
The process of informed consent occurs when communication between a patient and physician results in the patient’s authorization or agreement to undergo a specific medical intervention. In seeking a patient’s informed consent (or the consent of the patient’s surrogate if the patient lacks decision-making capacity or declines to participate in making decisions), physicians should:
(a) Assess the patient’s ability to understand relevant medical information and the implications of treatment alternatives and to make an independent, voluntary decision.
(b) Present relevant information accurately and sensitively, in keeping with the patient’s preferences for receiving medical information. The physician should include information about:
(i) the diagnosis (when known);
(ii) the nature and purpose of recommended interventions;
(iii) the burdens, risks, and expected benefits of all options, including forgoing treatment.
(c) Document the informed consent conversation and the patient’s (or surrogate’s) decision in the medical record in some manner. When the patient/surrogate has provided specific written consent, the consent form should be included in the record.
In emergencies, when a decision must be made urgently, the patient is not able to participate in decision making, and the patient’s surrogate is not available, physicians may initiate treatment without prior informed consent. In such situations, the physician should inform the patient/surrogate at the earliest opportunity and obtain consent for ongoing treatment in keeping with these guidelines.72
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AMA Policy
H-140.989 Informed Consent and Decision-Making in Health Care
(1) Health care professionals should inform patients or their surrogates of their clinical impression or diagnosis; alternative treatments and consequences of treatments, including the consequence of no treatment; and recommendations for treatment. Full disclosure is appropriate in all cases, except in rare situations in which such information would, in the opinion of the health care professional, cause serious harm to the patient.
(2) Individuals should, at their own option, provide instructions regarding their wishes in the event of their incapacity. Individuals may also wish to designate a surrogate decision-maker. When a patient is incapable of making health care decisions, such decisions should be made by a surrogate acting pursuant to the previously expressed wishes of the patient, and when such wishes are not known or ascertainable, the surrogate should act in the best interests of the patient.
(3) A patient’s health record should include sufficient information for another health care professional to assess previous treatment, to ensure continuity of care, and to avoid unnecessary or inappropriate tests or therapy.
(4) Conflicts between a patient's right to privacy and a third party's need to know should be resolved in favor of patient privacy, except where that would result in serious health hazard or harm to the patient or others.
(5) Holders of health record information should be held responsible for reasonable security measures through their respective licensing laws. Third parties that are granted access to patient health care information should be held responsible for reasonable security measures and should be subject to sanctions when confidentiality is breached.
(6) A patient should have access to the information in his or her health record, except for that information which, in the opinion of the health care professional, would cause harm to the patient or to other people.
(7) Disclosures of health information about a patient to a third party may only be made upon consent by the patient or the patient's lawfully authorized nominee, except in those cases in which the third party has a legal or predetermined right to gain access to such information. (BOT Rep. NN, A-87; Reaffirmed: Sunset Report, I-97; Reaffirmed: Res. 408, A-02; Reaffirmed: BOT Rep. 19, I-06; Reaffirmation A-07; Reaffirmation A-09; Reaffirmed BOT Rep. 05, I-16)
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NOTICE: The Texas Medical Association provides this information with the express understanding that (1) no attorney-client relationship exists, (2) neither TMA nor its attorneys are engaged in providing legal advice, and (3) the information is of a general character. This is not a substitute for the advice of an attorney. While every effort is made to ensure that content is complete, accurate, and timely, TMA cannot guarantee the accuracy and totality of the information contained in this publication and assumes no legal responsibility for loss or damages resulting from the use of this content. You should not rely on this information when dealing with personal legal matters; rather legal advice from retained legal counsel should be sought. Any legal forms are only provided for the use of physicians in consultation with their attorneys. Certain links provided with this information connect to websites maintained by third parties. TMA has no control over these websites or the information, goods, or services provided by third parties. TMA shall have no liability for any use or reliance by a user on these third-party websites.
[1] Cruzan v. Director, MDH. 497 U.S. 261, 269 (1990) (citations omitted).
[2] Stephen Mawn, MD, JD. Informed Consent. Journal of Nursing Risk Management (1999).
[3] President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. Making Health Care Decisions: The Ethical and Legal Implications of Informed Consent in the Patient-Practitioner Relationship, 19 (October 1982). Available at: https://repository.library.georgetown.edu/handle/10822/559354.
[4] Id.
[5] Salgo v. Leland Stanford, Jr., University Board of Trustees. 154 Cal. App.2d 560, 317 P.2d 170 (1957).
[6] President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. Op. cit.
[7] Tex. Civ. Prac. and Rem. Code §74.101.
[8] Wilson v. Scott. 412 S.W.2d 299, 302 (Tex. 1967).
[9] Final Report of Texas Medical Professional Liability Study Commission Report to the 65th Texas Legislature. December 1976. www.lrl.state.tx.us/scanned/interim/64/R299.pdf.
[10] Tex. Civ. Prac. and Rem. Code §74.102.
[11] Id.
[12] Id.
[13] Nonetheless, physicians should be aware that on at least one occasion the Texas Medical Board has imposed discipline for the failure to obtained written consent for a surgical procedure not involving abortion or the treatment of a minor.
[14] The lists also are accessible via the Texas Medical Disclosure Panel website at www.dshs.texas.gov/facilities/medical-disclosure/laws-rules.aspx.
[15] Peterson v. Shields. 652 S.W. 2d 929, 931 (Tex. 1983).
[16] Knoll v. Neblett. 966 S.W.2d 622, 628 (Tex. App. — Houston 1998). See also, note 13.
[17] 22 TAC §165.1(a)(7).
[18] These forms as well as the specific consent forms mentioned later in this white paper also are accessible via the Texas Medical Disclosure Panel website at www.dshs.texas.gov/facilities/medical-disclosure/forms.aspx.
[19] 25 TAC §601.4.
[20] 25 TAC §601.5 (radiation therapy); 22 TAC §165.6 (abortion on an unemancipated minor); 25 TAC §601.7 (electroconvulsive therapy); 25 TAC §601.8 (hysterectomy); and 25 TAC §601.9 (anesthesia and/or perioperative pain management).
[21] Tex. Civ. Prac. and Rem. Code §74.106(a)(1).
[22] Russell G. Thornton, Informed Consent, BUMC Proceedings, April 2000; 13(2):187-190 (citing Drummond v. Hodges, 417 SW2d 740, 747 (Tex. Civ. App. — Dallas 1967).
[23] Tex. Civ. Prac. and Rem. Code §74.107.
[24] Id.
[25] 25 TAC §601.9.
[26] Thornton. Op. cit. (citing Boney v. Mother Francis Hospital, 880 S.W.2d 140 (Tex. App. — Tyler 1994, writ den’d); Gibson v. Methodist Hospital, 822 S.W.2d 95, 100-101 (Tex. App. — Houston [1st Dist.] 1991, writ den’d); Ritter v. Delany, 790 S.W.2d 29, 32 (Tex. App. — San Antonio 1990, writ den’d); Johnson v. Whitehurst, 652 S.W.2d 441,445 (Tex. App .— Houston [1st Dist.] 1983, writ ref’d n.r.e.); Ross v. Sher, 483 S.W.2d 297, 301 (Tex. Civ. App. — Houston [14th Dist.] 1972, writ ref’d n.r.e.); Weiser v. Hampton, 445 S.W.2d 224, 231 (Tex. Civ. App. — Houston[1st Dist.] 1969, writ ref’d n.r.e.).
[27] Thornton, Id at 187.
[28] Id.
[29] Tex. Health and Safety Code §171.012(a)(1)-(3).
[30] Tex. Health and Safety Code §171.005.
[31] 22 TAC §165.6(c).
[32] 22 TAC §165.6(b)(1)-(3).
[33] 22 TAC §165.6(b)(4).
[34] Tex. Health and Safety Code §171.012(a)(4)(B).
[35] Tex. Health and Safety Code §171.012(a)(4)(C).
[36] Tex. Health and Safety Code §171.012(a)(4)(D).
[37] Tex. Health and Safety Code §171.012(a)(5).
[38] Tex. Health and Safety Code §171.012(a)(6).
[39] Tex. Health and Safety Code §171.0124.
[40] Tex. Health and Safety Code §171.012(a)(3)(B)(iv).
[41] Tex. Health and Safety Code §171.012(a)(3)(C).
[42] Tex. Health and Safety Code §171.0123.
[43] Tex. Health and Safety Code §171.063(a).
[44] Tex. Health and Safety Code §171.063(b).
[45] Tex. Health and Safety Code §171.062.
[46] Tex. Health and Safety Code §171.063(c).
[47] Tex. Health and Safety Code §171.063(d)(1).
[48] Tex. Health and Safety Code §171.063(d)(2).
[49] Id.
[50] 25 Tex. Admin. Code §601.9.
[51] 25 Tex. Admin. Code §601.5.
[52] Id.
[53] Id.
[54] Tex. Health and Safety Code §578.003(a).
[55] Tex. Health and Safety Code §578.003(b).
[56] Id.
[57] 25 Tex. Admin. Code §405.117(1).
[58] Tex. Health and Safety Code §578.003(a). Also see 25 Tex. Admin. Code §601.7(a).
[59] 25 Tex. Admin. Code §601.7(c). The panel’s list of risks and hazards pertaining to ECT can be found at 25 Tex. Admin. Code §601.2(q)(1).
[60] Id.
[61] Go to: www.dshs.texas.gov/facilities/medical-disclosure/faq.aspx.
[62] Tex. Health and Safety Code §578.003(c).
[63] Id.
[64] Tex. Health and Safety Code §578.003(c)(5).
[65] A patient or guardian may revoke a consent to ECT at any time.
[66] Tex. Health and Safety Code §1003.054(a).
[67] Tex. Health and Safety Code §1003.054(c). As of this writing, the executive commissioner has not adopted a form.
[68] Tex. Health and Safety Code §1003.055(b).
[69] Tex. Health and Safety Code §1003.052.
[70] Tex. Health and Safety Code §773.008.
[71] Tex. Estates Code §752.051.
[72] American Medical Association, Opinions of the Council on Ethical and Judicial Affairs, “Chapter 2: Opinions on Consent, Communication & Decision Making” (2016), available at: www.ama-assn.org/sites/default/files/media-browser/code-of-medical-ethics-chapter-2.pdf.
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