Policy Review: CSA

House of Delegates policies in the association's Policy Compendium are reviewed periodically for relevance and appropriateness. The following policies are current, valid, and relevant. Clarification amendments are suggested for the following policies:

215.014 TDMHMR Texas State Advisory Councils for Mental Health : The Texas Medical Association supports increased physician representation by licensed psychiatrists on the

TDMHMR Medical Advisory Committee Department of State Health Services Advisory Council and the Texas Aging and Disability Services Council (Committee on Mental Health and Mental Retardation, p 105, A-95).

270.004 Electromyography : Clinical diagnostic electromyography examinations involving the selection of the muscles to be studied, modifying the examination as the data unfolds, inserting the needle electrodes, recording and interpreting the data therapy obtained, describing the findings, and rendering of a diagnostic opinion based upon an integration of the clinical history physical examination features, other pertinent clinical data, and electromyographic findings should be performed only by aunder the supervision of a physician fully licensed in Texas physician qualified by reason of education, training, and experience in these procedures . TMA supports, as a patient safety component, the active enforcement of this physician credentials requirement. (Committee on Rehabilitation, p 169, A-96).

30.021 Laser Therapy : The Texas Medical Association favors limiting the use of medically therapeutic lasers to physicians , both allopathic and osteopathic, fully licensed in Texas and appropriately trained to use laser therapy. TMA supports, as a patient safety component, the active enforcement of this physician credentials requirement. (Substitute Res. 28O, p 207, A-96).

Recommendation 1 : Approve as amended.

The following policy is outdated. The Scott and White Outcomes Studies Institute was dissolved a number of years ago.

265.006 Outcomes Research : The Texas Medical Association adopted the outcomes research recommendations of the Scott and White Outcome Studies Institute to support AMA Policy 450.973 that promotes outcomes research as an effective mechanism to improve the quality of medical care; support the nine principles for developing and evaluating quality and performance standards and measures as outlined in AMA Board of Trustees Report 35-A-94; urge that development of practice guidelines or protocols be limited with measurement of outcomes; urge physicians to stay abreast of activities in outcomes research; take an active role in any public or private sector efforts to establish a statewide health data commission to ensure validity and objectivity; and evaluate and consider participation in clinical valid outcomes measurement programs (Council on Scientific Affairs, pp 149 and 161, I-94).

Recommendation 2 :  Delete.

280.016 Radiation Experiments : The Texas Medical Association supports the American Medical Association's Council on Ethical and Judicial Affairs opinion on radiation experiments: Experiments exposing patients to dangerous levels of radiation, which were begun in the 1940s, were unethical. Many patients were not informed they were part of the experiments. Treating people as unwitting tools for promoting scientific knowledge contradicts the most basic principles of ethics. Moreover, many participants were exceptionally vulnerable-they were prisoners, poor, or institutionalized persons-and may have been sought because they were least likely to object. It is unethical for researchers to exploit any individual or group of people, no matter how lofty the goal.

Patients must have the ability to decide whether or not to participate in experiments, and they must be told of the nature and all potential risks and benefits before making such choices. Informed consent must occur before an experiment can go forward.

In the case of the radiation studies, informed consent would have been especially important because the experiments were intended to gather scientific information, not promote the welfare of patients.

It is important to affirm such an opinion so that the public is clear that what occurred 50 years ago is untenable by today's strict code of ethics for clinical studies involving humans (Council on Scientific Affairs, p 128, A-94).

The council believes the radiation experiments policy is only one aspect of human subject research and that TMA will be better served by a more global policy substitute:

"Human Subject Research - A Patients' Bill of Rights" : The Texas Medical Association supports:

• application of the highest ethical standards in the use of human subjects for clinical trials;
• ensuring that the goals of clinical trials are to benefit patients, not just advance science and industry;
• use of institutional review board approval and oversight of human subject research;
• complete informed consent for participation with full disclosure of risks and possibility of non-treatment;
• full disclosure of conflicts of interest by all participating parties;
• protection of subjects not able to give true informed consent because of age, disability, educational level, socioeconomic level, institutionalization, incarceration, or emotional distress; and
• protection of confidentiality of individual patient information obtained in human subject research.

Relevant TMA Policy

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).

Relevant AMA Policy
E-8.0315 Managing Conflicts of Interest in the Conduct of Clinical Trials; H-460.921 Support for Institutional Review Boards; D-460.991 Interim Report of the Inter-Council Task Force on Privacy and Confidentiality; E-2.071 Subject Selection for Clinical Trials; H-460.980 Ethical and Societal Considerations in Research.

Recommendation 3 : Approve substitute policy.

TMA House of Delegates: TexMed 2006