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ETHICS- I hope this helps

September 22 2004 at 2:19 PM
Archer  (no login)
from IP address 12.222.164.243

Though its for orthopaedic surgeons, most principles hold good for primary care physicians too.


Ethics in Health Research in Orthopaedic Surgery
Issue raised
What are the general ethical issues involved in the conduct of health research in orthopaedic surgery?
Applicable provisions of the Principles of Medical Ethics and Professionalism in Orthopaedic Surgery
"II. The orthopaedic surgeon should maintain a reputation for truth and honesty with patients and colleagues, and should strive to expose through the appropriate review process those physicians who are deficient in character or competence or who engage in fraud or deception."
"VI. The orthopaedic surgeon continually must strive to maintain and improve medical knowledge and to make relevant information available to patients, colleagues, and the public."
Applicable provisions of the Code of Medical Ethics and Professionalism for Orthopaedic Surgeons
"III.C. When an orthopaedic surgeon receives anything of value, including royalties, from a manufacturer, the orthopaedic surgeon must disclose this fact to the patient. It is unethical for the orthopaedic surgeon to receive compensation (excluding royalties) from a manufacturer for using a particular device or medication. Reimbursement for administrative costs in conducting or participating in a scientifically sound research trial is acceptable."
"III.D. An orthopaedic surgeon reporting on clinical research or experience with a given procedure or device must disclose any financial interest in that procedure or device if the orthopaedic surgeon or any institution with which that orthopaedic surgeon is connected has received anything of value from its inventor or manufacturer."
"IV.A. The orthopaedic surgeon continually must strive to maintain and improve medical knowledge and skill, and should make available to patients and colleagues the benefits of his or her professional attainments . . ."
"VIII.A. All research and academic activities must be conducted under the conditions of full compliance with ethical, institutional, and government guidelines. Patients participating in research programs must have given full informed consent and retain the right to withdraw from the research protocol at any time."
"VIII.B. Orthopaedic surgeons should not claim as their own intellectual property that which is not theirs. Plagiarism or the use of others' work without attribution is unethical."
"VIII.C. The principal investigator of a scientific research project or clinical research project is responsible for proposing, designing, and reporting the research. The principal investigator may delegate portions of the work to other individuals, but this does not relieve the principal investigator of the responsibility for work conducted by other individuals."
"VIII.D. The principal investigator or senior author of a scientific report is responsible for ensuring that appropriate credit is given for contributions to the research described."
Other references
American Academy of Orthopaedic Surgeons, Position Statement on Animals in Biomedical Research, October, 1994.
American Academy of Orthopaedic Surgeons, Policy on Authorship, February, 1993.
Association of American Medical Colleges, "Framework for Institutional Policies and Procedures to Deal With Fraud in Research," November, 1988.
Association of American Medical Colleges, "Beyond the Framework: Institutional Considerations in Managing Allegations of Misconduct in Research," September, 1992.
American College of Surgeons, Principles of Public Relations, E. "Biomedical Research Must Be Conducted Within Ethical and Legal Guidelines."
American Medical Association, Principles of Medical Ethics, "Article V. A physician shall continue to study, apply and advance scientific knowledge, make relevant information available to patients, colleagues, and the public, obtain consultation, and use the talents of other health professionals when indicated."
American Medical Association, Current Opinions of the Council on Ethical and Judicial Affairs,
Section 2.07 ("Clinical Investigation")
Section 8.031 ("Conflicts of Interest: Biomedical Research")
Section 9.08 ("New Medical Procedures")
Section 9.09 ("Patents for Surgical and Diagnostic Instrument")
Section 9.095 ("Patenting of Medical Procedures")
American Medical Association, Reports of the Council on Ethical and Judicial Affairs,
Report 24, "Scientific Fraud and Misrepresentation," December, 1989.
Report 25, "Conflicts of Interest in Biomedical Research," December, 1989.
J.A. Buckwalter, "Medical Researchers Must Be Ethical," AAOS Bulletin, July, 1990.
Council for International/Organizations of Medical Sciences, International Ethical Guidelines for Biomedical Research Involving Human Subjects, 1993.
Definitions
Orthopaedic surgeons conduct research in a number of areas. "Health research" is considered to be the universe of research dealing with health care-related matters. Health research encompasses various types of research, including clinical research (defined by the AMA as "a part of a systematic program competently designed, under accepted standards of scientific research, to produce data that are scientifically valid and significant"), outcome studies research, psychosocial research, and demographic and economic studies. In this Opinion on Ethics and Professionalism, unless otherwise noted, the broad term "health research" will be used.
Ethical considerations
According to the Academy's Opinion on Ethics and Professionalism regarding Continuing Medical Education, upon completion of orthopaedic residencies (or fellowships), orthopaedic surgeons assume an ethical and professional obligation to stay abreast of developing knowledge in the musculoskeletal sciences. Many orthopaedic surgeons have chosen to go beyond this basic obligation to assist in the advancement of musculoskeletal knowledge and in its dissemination.
Orthopaedic surgeons who conduct health research have special ethical responsibilities. They must accept responsibility for ethical conduct in their own scientific work and should help support high standards of ethical conduct in the scientific community. Failing to do so may impede or delay progress in learning about the musculoskeletal sciences and will damage the credibility of all health researchers, thereby harming not only the research community, but also the greater orthopaedic community and the patients whose care depends on the results of research.
The Academy believes the ethical tenets described below constitute reasonable guidelines to assist health researchers in orthopaedics. These guidelines include the following:
The purpose of health research: Health research should be designed and conducted to develop new or confirmatory knowledge that promotes health, prevents diseases and injuries and improves diagnosis and treatment of diseases and injuries. If the research involves human subjects, it is appropriate only when the potential risks to the patient are reasonable in relation to the potential benefits to the patient and the importance of the knowledge which reasonably might be gained.
Examples of unethical conduct:
Designing and conducting research with the primary purpose of discerning methods of causing injury, illness or suffering;
Designing or conducting research that is repetitious or redundant with the primary intent of advancing individuals or specific groups financially or professionally;
Designing or conducting research that is not intended to produce new or confirmatory information that is valid or significant; and
Purposefully stating, reporting or misinterpreting (by omission or commission) data to arrive at a pre-determined theory or opinion.
Support of sponsorship of research: The majority of financial support for health research comes from the federal government. Although support by industry for biomedical research has risen sharply in recent years, it still represents a small portion of the total external funding received by research universities.
For many years, health researchers perceived that commercial support of research was inappropriate because of the potentially biased results which might occur. However, this position has softened significantly since many major medical developments have resulted from research funded by private sources. Furthermore, industry support of health research, particularly biotechnology research, has become substantial in recent years.
There are three parties, with distinct interests, concerned with the corporate funding of health research: (1) the individual researcher; (2) the research institution; (3) the corporation funding the research. The interrelationships among these groups may vary substantially.
In the most frequent type of relationship, the funding corporation develops a Request for Proposal (RFP) or presents a research protocol to the researcher and funds the researcher for carrying out the protocol. This essentially creates a fee-for-service arrangement. Assuming that basic rules for scientific propriety are followed, this constitutes an appropriate remunerative relationship. In this relationship, it may be undesirable for the individual researcher to deal with or negotiate with the corporation funding the research. Consequently, research institutions often have created a structure whereby funded research arrangements can be negotiated in a manner that is satisfactory to all parties. Generally, the Office of the Vice-President for Research or the Dean for Research has experience and background information which provide for effective negotiation.
A second type of relationship involves the researcher submitting an unsolicited research proposal directly to the funding corporation.1 The researcher would benefit by obtaining funds for needed equipment and supplies and the funding corporation would benefit by the possibility of expanding its market potential for a given product. This arrangement also may be viewed as ethically appropriate and mutually beneficial, assuming the proper conduct of science ensues and full disclosure is maintained.
A third type of relationship involves truly cooperative projects.1 Often, these types of relationships are enacted in the setting of a clinical trial. Numerous advantages exist for the researcher, the research institution, and the funding corporation for the development of cooperative programs between medicine and industry. Full disclosure is essential to the success of this type of venture.
Ethical problems may arise when the researcher or the research institution have a direct financial interest in the research program. For example, researchers may hold stock or stock options in the funding corporation that manufactures the product or they may have other profit-sharing arrangements with the company. These financial interests may compromise (or give the impression of compromising) the objectivity of the researchers and cause them to downplay or suppress negative data while exaggerating favorable data. Such economic incentives may also introduce subtle biases into the way research is conducted, analyzed or reported.
The Academy believes that guidelines for circumstances in which researchers face economic conflicts of interest may be determined in reference to two ethical principles:
A researcher ethically may share the economic rewards of his or her efforts. If a drug, device, or other product becomes financially remunerative, the researcher may receive profits that reasonably resulted from his or her contribution. The Academy's Code of Medical Ethics and Professionalism for Orthopaedic Surgeons explicitly permits an orthopaedic surgeon to receive royalties. However, the researcher ethically may not ethically reap profits that are not justified by the value of his or her actual efforts.
Potential sources of bias in research should be eliminated, particularly where there is a direct relationship between a researcher's personal interests and potential outcomes of the research.
Several conclusions result by applying these two ethical principles. Once the researcher becomes involved in a research project for the funding corporation or knows that he or she might become involved in the research, he or she ethically cannot buy or sell the funding corporation's stock until the involvement ends and the results of the research are publicly disseminated. As long as the researcher is involved in research on the funding corporation's product, he or she has the potential to derive profits that stem from inside information, rather than from individual effort.
Researchers may serve as consultants or may be retained to lecture on behalf of the funding corporation. However, the researcher's remuneration ethically must be commensurate with his or her actual efforts on behalf of the funding corporation.
Safeguards may be necessary to protect against the appearance of impropriety, even when ethically permissible relationships among the researcher, research institution and the funding corporation exist. Full disclosure presents the best mechanism to address doubts about the propriety of a research arrangement. Researchers should disclose all ties to corporations whose products they are investigating. For example, the researcher's participation in educational activities supported by the corporation; participation in other research projects funded by the corporation; and consulting arrangements with corporation must be disclosed to the research institution, to the funding corporation, to audiences who hear the research results and to journals that publish the results of the research.
Example of unethical conduct:
Knowingly negotiating for more funding than is appropriate to support the project and related institutional and departmental overhead costs;
A researcher's selling or purchasing stock in a company whose orthopaedic device is being tested by that orthopaedic surgeon-researcher;
A researcher's receiving financial incentives to alter data;
A researcher's receiving excessive remuneration by the funding corporation for evaluating that corporation's products;
A failure to disclose research or consulting arrangements with the funding corporation when reporting about research on devices manufactured by that corporation.
Use of research resources: Resources allocated by governmental agencies (federal, state or local), industry or philanthropic organizations for the performance of specific research should be used only for that purpose unless the granting agency gives specific permission for reallocation of the resources.
Example of unethical conduct:
Using resources provided by any organization for the direct financial benefit or personal use of the investigators.
Use of animals in research: The Academy believes that the appropriate and humane use of animals in research is justified to enhance the quality of life of both humans and animals. Animals should be used in research only when there are no suitable alternatives. Research projects should be designed to use the minimal number of animals possible in a manner that avoids abuse of the animals and maintains appropriate standards of animal care. Researchers should conduct animal research only with the approval of the institution's Animal Care and Use Committee and in compliance with all applicable regulations and standards. [See also AAOS Position Statement on Animals in Biomedical Research.]
Examples of unethical conduct:
Using methods that cause animals unnecessary discomfort;
Failing to maintain appropriate standards of animal care;
Using excessive numbers of animals to perform experiments;
Using inappropriate animal models; and
Using animals when other methods of conducting the research would be scientifically valid, e.g., computer simulations, tissue culture or mathematical models.
Use of human subjects in research: The Statement of Principles of the American College of Surgeons provides "[t]he progress in medical care through research depends on informed partnership between patients and physicians in the development of new drugs and treatment methods. It is recognized that certain advances in the knowledge of treatment of disease can only be learned by properly conducted clinical trials during which the results of varying treatments recommended by individual doctors are carefully compared."
Human subjects should be used in health research only when there is no reasonable alternative. Human subjects should never be exposed to unnecessary risk, embarrassment or expense and should fully understand the purpose of the research and if their participation may benefit them (a therapeutic experiment) or is intended primarily to benefit future patients (a nontherapeutic experiment). The selection criteria of human subjects must be objective and reasonable.
Human subjects should provide voluntary informed consent before being included in a prospective study and should be allowed to decline to continue participation in a research program at any time without compromising of their medical care. Paragraph VIII.A. of the Academy's Code of Medical Ethics and Professionalism for Orthopaedic Surgeons provides that "[p]atients participating in research programs must have given full informed consent and retain the right to withdraw from the research protocol at any time." To ensure full informed consent, three elements must exist:
The orthopaedic surgeon must explain to the patient in terms the patient can understand the proposed treatment, its likely effect on the patient, and purpose of the research. Orthopaedic surgeons must provide at least the degree of information that is required by applicable state and federal law, which will include at a minimum information on the purpose of the research, its potential side effects, alternatives and risks of the proposed treatment as well as the method, purpose, conditions of participation and the opportunity to withdraw from the research protocol without penalty.
The patient's consent must be knowing. The orthopaedic surgeon must believe reasonably that the patient has understood the basic information and has engaged in rational decision-making in deciding to participate in the research; and
The patient's consent must be voluntary. The orthopaedic surgeon must believe that the patient's consent is free from undue or overbearing influences, e.g., fear of the loss of care or medical benefits if the patient declines to participate.
Human subjects participating in clinical research programs should receive the care and treatment that is in their best interest and be assured that the potential benefit of the research outweighs the risks. Researchers should conduct human subject research only with the approval of the research institution's Institutional Review Board (IRB) (and for other required review committees) and in compliance with all applicable regulations and standards. This review and approval mechanism ensures that there is informed consent, that the rights of patients are respected, and that patients participating in the research protocol are treated with the same concern and devotion as other patients.
Examples of unethical conduct:
Failing to disclose risks;
Exposing patients who are participating in the research protocol to unnecessary risks;
Failing to obtain voluntary, fully informed consent of adult patients or to obtain the substituted consent of the patient's legally authorized representative when the patient lacks the legal capacity to consent (e.g., is a minor);
Causing human subjects unnecessary embarrassment;
Causing human subjects unnecessary expense;
Manipulating human subject cohorts with selected medical problems or results of treatment with the intent of proving the investigator's bias or to promote a given treatment or medical device; and
Directly or indirectly coercing human subjects to participate in the research protocol.
Responsibility of the research institution: The ultimate responsibility for the ethical conduct of research resides within the institution in which the health research is conducted and/or with the Primary Investigator (PI). Research institutions should assure that rigorous scientific standards are upheld by each of their faculty, staff, and students and should extend these standards to all reports, publications, and databases produced by the institution. All medical schools and research institutions should implement guidelines for a review process for dealing with allegations of scientific misconduct, which include appropriate due process protections for those alleged to have committed scientific misconduct. In addition, the research institution must be capable of and committed to implementing effective procedures for examining allegations of scientific misconduct.
Examples of unethical conduct:
The research institution's failing to maintain guidelines for dealing with allegations of scientific misconduct or fraud;
The research institution's failing to inform and educate staff and students of institutional guidelines for dealing with allegations of scientific misconduct or fraud; and
The research institution's failing to implement and enforce institutional guidelines for dealing with allegations of scientific misconduct or fraud.
Responsibilities of the Principal Investigator (PI): The Principal Investigator (PI) of a health research project is responsible for proposing, designing and reporting the research. In addition, the PI is usually accountable for dispensing project funds. Paragraph VIII.C. of the Academy's Code of Medical Ethics and Professionalism for Orthopaedic Surgeons provides that "the Principal Investigator may delegate portions of the work to other individuals, but this does not relieve the Principal Investigator of responsibility for work conducted by other individuals."
Examples of unethical conduct:
The Principal Investigator's failing to participate in and supervise the design or conduct or a research project;
The Principal Investigator's failing to adequately supervise those conducting the project; and
The Principal Investigator's failing to critically review the results and verify the accuracy of reports.
Reporting results of research: The results of research should be described in timely, objective, accurate, complete reports and potential conflicts of interest should be identified. Specifically, Paragraph III.D. of the Academy's Code of Medical Ethics and Professionalism for Orthopaedic Surgeons provides that when reporting on clinical research or experience with a given device or procedure, orthopaedic researchers have a ethical obligation to "disclose any financial interest in that procedure or device if the researcher or any institution with which that researcher is connected has received anything of value from its inventor or manufacturer."
Examples of unethical conduct:
Failing to provide timely, accurate reports;
Failing to report unfavorable results;
Providing reports that do not contain a sufficient and accurate methodology to replicate the experiments or references to where such information might be obtained;
Falsifying reports;
Fabricating results;
Reporting results of uncertain or minimal significance unless clearly stated as such;
Preparing multiple partial reports or duplicate reports of the same work to increase apparent productivity of the investigators; and
Failing to identify potential conflicts of interest including possible financial benefits to the investigators from research reports.
Authorship and credit for scientific work: The Principal Investigator of a research study is responsible for insuring that articles describing the research include appropriate credit for individuals contributing importantly to the research. The Academy has endorsed The New England Journal of Medicine's policy on authorship. It provides that authorship of research articles should be limited to individuals who have made substantial contributions in fulfilling each of the following conditions: (1) conception and design, or analysis and interpretation of data; (2) drafting the article or revising it critically for intellectual content; and (3) final approval of the version to be published.2 Similarly, the authorship policy of The Journal of bone and Joint Surgery states that "[I]t is to be clearly understood that each author has participated in the design of the study, contributed to the collection of data, participated in the writing of the manuscript, and assumes full responsibility for the content of the manuscript."3 In addition, sources of financial and technical support and individuals who provide important materials and information should be acknowledged.
Examples of unethical conduct:
Failing to credit co-workers; individuals who have designed the project or who have interpreted the data; individuals or agencies that have provided resources to fund the project; or individuals or groups that have previously performed similar research, if such research is valid and appropriate;
Failing to credit sources of quotations;
Plagiarizing or using others' work without attribution;
Failing to review and credit relevant previous publications; and
Including as authors individuals who did not make substantial contributions to the work.
Copyrights and royalties: Most research institutions maintain an intellectual property policy which encourages controlled entrepreneurial activity by research faculty. A typical structure for managing these matters involves the research institution's Committee on Intellectual Property (or similarly named group), which serves in a capacity advisory to the administrative officer overseeing the policy. These intellectual property policies have many variations peculiar to the particular institution, but in general determine distribution of rewards for researchers for developing new products and authors for writing and publishing articles and books.
Typically, the patent to devices created and the copyright to articles written belong to the Principal Investigator or his or her research institution or funding corporations. The ownership of patents, the allocation of revenues, copyright and other intellectual property interests among Principal Investigators, the research institution and the funding corporations and other important issues should be made clear either in standing policies of the research institution or in clear contracts executed before the commercial support is received. The rewards of commercialization should be fairly allocated.
It is ethically acceptable for a Principal Investigator to receive royalties from a funding corporation for using a particular device or medication the researcher has developed. However, it is unethical for an orthopaedic surgeon-Principal Investigator to commit to always use a particular product in which he or she developed and for which the researcher receives royalties.
Examples of unethical conduct:
The Principal Investigator's agreeing to always use a device he or she developed.
Research records: Accurate and complete records of research data should be maintained until there has been sufficient time for critical review. The time will vary with the type of research, but five years after publication is sufficient for most work.
Example of unethical conduct:
Failing to maintain accurate complete records of research activity so that replication of the work or verification of the results is difficult or impossible.
Scientific errors; contradictory results and inability to replicate results: If errors in the proposal, conduct or reporting of research are identified, the Principal Investigator has an ethical obligation to report such errors. If the Principal Investigator or other investigators repeat an experiment and obtain results that contradict the initial report or they are unable to replicate the experiment, the contradictions or inability to replicate an experiment should be reported. If the long-term results of a health research project differ from the initial reported results, the differences should be reported. Scientific publications have a responsibility to publish reports of scientific errors, contradictory results, and failures to replicate previously reported research.
Examples of unethical conduct:
Failing to report any significant scientific error;
Failing to report work that contradicts previously reported data or conclusions;
Failing to report late adverse outcomes for techniques or devices which were introduced with favorable initial experience;
Failing to report difficulties in replicating or verifying previous findings; and
A scientific publication's failing to publish reports of scientific errors, contradictory results, and failure to replicate previously reported research.
Obligation to report scientific misconduct (versus differences in methods, interpretation and judgment): Orthopaedic surgeons have an ethical obligation to report scientific misconduct in research if they become aware of it. A spectrum of activities constitute scientific misconduct, ranging from duplicate publication at the lower end to fraud and plagiarism at the upper end. The U.S. Public Health Service (PHS) and the National Science Foundation (NSF) broadly define "scientific misconduct" to include research fraud (including plagiarism, deception, falsification and/or fabrication of scientific data) as well as "other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting or reporting research."
However, while it is clear that unequivocal scientific misconduct must be reported, members of the health research community have a concurrent responsibility to attempt to distinguish between honest error and scientific misconduct. Orthopaedic surgeons must also respect differences in scientific methods and analysis, interpretation and judgment about data.
Examples of unethical conduct:
Failing to identify and report unequivocal instances of scientific misconduct;
Personally attacking, verbally or in writing, other investigators, based upon differences in methods, analysis, interpretation, judgment or opinion;
Attempting to discredit or intimidate other investigators because of differences in methods, investigation or interpretation of data;
Attempting to restrict funding or research, publication or presentation of data because of differences in interpretation; and
Making accusations of scientific misconduct when honest error may be as likely.
Recommendations
The American Academy of Orthopaedic Surgeons urges orthopaedic surgeons who participate in health research to review and adopt these ethical tenets, which have been developed by the Academy's Committee on Ethics and Council on Research and Scientific Affairs. These tenets provide a flexible, ethical framework for the conduct and the publication of research result

Reporting of Suspected Abuse or Neglect of Children, Disabled Adults or the Elderly
Issues raised
What is the orthopaedic surgeon's obligation to report suspected cases of abuse or neglect of children, disabled adults or the elderly?
Applicable provision of the Principles of Medical Ethics and Professionalism in Orthopaedic Surgery
"I. The orthopaedic profession exists for the primary purpose of caring for the patient. The physician-patient relationship is the central focus of all ethical concerns. The orthopaedic surgeon should be dedicated to providing competent medical service with compassion and respect."
"III. The orthopaedic surgeon must respect the law, uphold the dignity and honor of the profession, and accept its self-imposed discipline. The orthopaedic surgeon also has a responsibility to seek changes in legal requirements that are contrary to the best interest of the patient."
Applicable provisions of the Code of Medical Ethics and Professionalism for Orthopaedic Surgeons
"I.A. The orthopaedic profession exists for the primary purpose of caring for the patient. The physician-patient relationship is the central focus of all ethical concerns."
"II.B. The orthopaedic surgeon should conduct himself or herself morally and ethically, so as to merit the confidence of patients entrusted to the orthopaedic surgeon's care, rendering to each a full measure of service and devotion."
"II.C. The orthopaedic surgeon should observe all laws, uphold the dignity and honor of the profession, and accept its self-imposed discipline . . ."
"III.A. The practice of medicine inherently presents potential conflicts of interest. Whenever a conflict of interest arises, it must be resolved in the best interest of the patient. If the conflict of interest cannot be resolved, the orthopaedic surgeon should notify the patient of his or her intention to withdraw from the relationship."
Other references
American Medical Association, Current Opinions of the Council on Ethical and Judicial Affairs,
Section 1.02 ("The Relation of Law and Ethics")
Section 2.02 ("Abuse of Children, Elderly Persons and Others at Risk"
Background
Much has been written in recent years regarding an apparent epidemic of child abuse in the United States. A 1992 study by the National Committee for Prevention of Child Abuse showed that nearly three million children in the United States were reported as suspected victims that year. However, fewer than half those reports were found to merit further investigation.l The study found poor children were at the greatest risk, but owing to insufficient public funds, only about two-thirds of the families in which abuse or neglect was confirmed received help.1
It is impossible to determine whether the number of alleged child abuse victims is inflated with false allegations or under represents activity that is often kept secret. One widely cited figure comes from a 1985 survey showing that one in four women has suffered childhood sexual abuse.l In this survey, "Childhood" was defined as any time through age 18, and "abuse" was defined to include everything from a single glimpse of a flasher to forced intercourse. Studies limited to girls under 14, defining "abuse" as sexual contact with a man at least five years older, have shown a fairly consistent, rate of sexual abuse of 10 to 12 percent since the 1940s.1
In 1989, a U.S. congressional committee investigated the abuse and neglect of the elderly in the United States and found it to be a "national tragedy."2 Elderly abuse may take forms, including physical, sexual, and psychological abuse as well as verbal abuse, financial exploitation and/or neglect by a caregiver. A 1989 congressional study indicates that one of every 25 Americans over age 65 suffers from some serious form of abuse, neglect or exploitation.2 In addition, in Illinois, an Elder Abuse Demonstration Program conducted from 1985-1987 made similar findings.2
In 1993, a national poll found that 34 percent of adults in the United States report having witnessed a man beating his wife or girlfriend and that 14 percent of women report that a husband or boyfriend has been violent with them.3 Studies suggest that as many as 30 percent of women treated in emergency departments (EDs) have injuries or symptoms related to physical abuse.4 A U.S. Public Health Service national objective for the year 2000 is for at least 90 percent of hospital EDs to have protocols for routinely identifying, treating, and referring victims of sexual assault and spouse abuse (objective 7.12). In addition, in 1992, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) started to recommend that accredited EDs have policies, procedures, and education in place to guide staff in the treatment of battered adults.
Legal considerations
In response to the U.S. Child Abuse Prevention and Treatment Act of 1974, virtually every state has adopted legislation that requires physicians and others in authority to report suspected cases of child abuse. In addition, a number of states have enacted legislation requiring or permitting, without legal penalty, the reporting of elder and other abuse. While the provisions of these state statutes vary, most provide a specific immunity from suit when physicians and other health care workers report suspected cases as required or permitted under the law, even if the information is obtained in the course of a treating relationship protected under the physician-patient privilege.
Illinois law is illustrative. In 1975, Illinois adopted the Abused and Neglected Child Reporting Act. The act requires physicians, school teachers and others to immediately report to the State Department of Children and Family Services a child known to them in their professional capacities who might be abused or neglected. In addition, a person required to report under the act and the medical examiner or coroner must contact the state if the child is suspected to have died as a result of abuse of neglect. A failure to report suspected child abuse or neglect will subject the physician to state disciplinary proceedings.
In 1988, Illinois adopted the Elder Abuse and Neglect Act. It provides for the permissive (not mandatory) reporting of alleged elder abuse to the State Department on Aging. The act provides that any person wishing to make a report of alleged or suspected abuse of a person 60 years of age or older will be immune from liability or professional disciplinary action on account of making the report, despite the laws of confidentiality in Illinois which would otherwise apply.
In most states, no specific laws exist that protect physicians or others who report cases of suspected abuse or neglect of adults who are disabled but who are unable to protect themselves under existing legal systems. The law presumes that once one has reached the age of majority (usually 18), one can make his or her own independent decisions and might file appropriate legal actions against those who abuse them. For example, an adult spouse who has been abused may notify the appropriate legal authorities to obtain a protective order or otherwise to stop the abusive acts. However, if the physician believes the disabled adult is being abused and is truly incapable of making his or her own decisions to report, the physician may obtain a court order to permit the reporting.
Most health care institutions have adopted policies implementing these or similar state statutes. As members of the medical staff, orthopaedic surgeons have an obligation to adhere to their institution's policies and procedures (and if they are inappropriate, to work to get them changed).
Ethical considerations
State statutes that require, or that permit without penalty, the reporting of cases of suspected abuse or neglect of children, disabled adults or elderly persons may create an ethical dilemma for some orthopaedic surgeons. The parties involved, both the suspected offenders and the victims, may plead with the orthopaedic surgeon to keep the matter confidential and not to disclose or report it for investigation by public authorities. The orthopaedist, by training, will often choose to maintain as strictly confidential all information, including information about alleged abuse or neglect, obtained in the course of medical treatment.
Children who have been seriously injured, allegedly by their parents, may attempt to protect their parents by saying that the injuries were caused by an accident. The reason may stem from the natural parent-child relationship or fear of further punishment. In addition, elderly patients who have been physically maltreated may be concerned that disclosure of what has occurred might lead to further (and possibly more drastic) maltreatment by those responsible.
However, despite the expressed wishes of the child, the disabled adult or elderly person not to report, the orthopaedic surgeon has both a legal and ethical obligation to comply with state mandatory reporting statutes and with institutional policies. Further, if an orthopaedic surgeon fails to comply with the state statutes and institutional policies requiring reporting of suspected cases of abuse or neglect, he or she may anticipate that the victims could receive more severe abuse that may result in permanent bodily, brain injury or even death.
The orthopaedic surgeon's ethical and legal obligations to comply with statutory reporting requirements are clearly stated in the Academy's Principles of Medical Ethics and Professionalism in Orthopaedic Surgery (Article III) and the Code of Medical Ethics and Professionalism for Orthopaedic Surgeons (Paragraph II.C). In addition, the ethical obligation of the orthopaedic surgeon to report suspected cases of abuse or neglect of children, disabled adults or the elderly may exceed the statutory legal requirement.












Advertising by Orthopaedic Surgeons
Issues raised
What parameters exist to guide orthopaedic surgeons regarding advertising?
Applicable provision of the Principles of Medical Ethics and Professionalism in Orthopaedic Surgery
"IX. The orthopaedic surgeon should not publicize himself or herself through any medium or form of public communication in an untruthful, misleading, or deceptive manner."
Applicable provisions of the Code of Medical Ethics and Professionalism for Orthopaedic Surgeons
"I.D. When obtaining informed consent for treatment, the orthopaedic surgeon is obligated to present to the patient or to the person responsible for the patient, in understandable terms, pertinent medical facts and recommendations consistent with good medical practice. Such information should include alternative modes of treatment, the objectives, risks and possible complications of such treatment, and the complications and consequences of no treatment."
II. A. The orthopaedic surgeon should maintain a reputation for truth and honesty. In all professional conduct, the orthopaedic surgeon is expected to provide competent and compassionate patient care, exercise appropriate respect for other health care professionals, and maintain the patient's best interests as paramount.
"VI.A. The orthopaedic surgeon should not publicize himself or herself through any medium or form of public communication in an untruthful, misleading, or deceptive manner. Competition between and among surgeons and other health care practitioners is ethical and acceptable."
Other references
American Medical Association, Current Opinions of the Council of Ethical and Judicial Affairs:
Section 5.01 ("Advertising and HMOs")
Section 5.02 ("Advertising and Publicity")
Legal analysis
Federal and state antitrust laws prohibit medical associations like the Academy from impeding physicians who use truthful advertising. The reason for this prohibition is to preserve and promote a free and open market by enabling physicians to disseminate information about their services to patients. Policy makers at the federal and state level believe that truthful advertising may assist patients in making better informed judgments and choices.
Although truthful advertising has substantial legal protections, physician advertising that is not truthful is not protected by federal or state antitrust laws nor is it protected from state regulation by the First Amendment. In fact, physician advertising that is false, deceptive, or misleading within the meaning of Section 5 of the Federal Trade Commission (FTC) Act is illegal. [15 U.S.C. Sect. 45]. The FTC has the authority to sue physicians who disseminate false or deceptive advertising. In addition, the FTC may enjoin them from further dissemination of misleading advertisements, and under some circumstances, may levy fines. Furthermore, physicians who violate an FTC order which prohibits the dissemination of false or deceptive advertising are subject to substantial fines.
In addition, many state consumer protection laws and medical practice acts prohibit false or deceptive physician advertising. These laws generally empower state attorneys general to sue physicians who engage in false advertising for fines or to enjoin further illegal activity. State medical licensure boards often have the authority to discipline physicians who engage in false advertising. In addition, patients who have been injured by false or misleading physician advertising may be able to sue the physician involved for damages under consumer protection statutes or common law fraud claims.
Ethical analysis
Orthopaedic surgeons, like all physicians, have an ethical obligation to present themselves and the services they provide to patients in a clear and accurate manner. This principle of ethical conduct is buttressed by its enforcement in law.
A successful physician-patient relationship is based on trust. The patient trusts that the physician has the appropriate training and skills, will listen to the patient's complaints and symptoms, and will advise the patient accurately and objectively about the alternative courses of treatment. It is essential to this relationship that the patient have confidence that the physician is honest and is not manipulating the information presented for any purpose. Because the patient is often in a relatively uninformed position, patients usually assume that the physician is telling them all they need to know and that what they are told is accurate. Consequently, patients are especially at risk for untruthful, misleading or deceptive advertising.
For this reason, false and deceptive advertising by physicians destroys the trust relationship between the physician and patient which is essential to quality medical care. A physician's misrepresentation may harm patients by making them less likely to seek out treatments they need or vulnerable to accepting treatments that are not essential.
The FTC has developed four general rules to determine whether physician advertisements are truthful and not false, deceptive or misleading. The four rules are:
Advertisements should be accurate and not contain explicit false claims or misrepresentations of material fact. Generally, a false claim or a misrepresentation of fact would be material if it would be likely to affect the behavior or actions of an ordinary and prudent person regarding a physician or physician service.
Advertisements should not contain material implied false claims or implied misrepresentations of material fact. An advertisement that does not contain direct false claims or misrepresentations should not by implication create false or unjustified expectations about the physician or physician services being publicized. An implied false claim or misrepresentation would be material if it would be likely to affect the behavior of an ordinary and prudent person towards a physician or physician service.
There should be no omissions of material fact from advertisements. In advertisements, disclosures of information are necessary where omission would make the advertisement as a whole misleading to an ordinary and prudent person or an average member of the audience to whom it is directed.
Physicians should be able to substantiate material claims and personal representations made in an advertisement.
The ultimate question of whether an advertisement is truthful can be determined by addressing whether all four of these rules of truthful advertising have been followed in the development and dissemination of the advertisement.
Specific issues
Endorsements and Pictures
Endorsements and pictures are sometimes used to represent the benefits of specific orthopaedic services, such as the degree of relief, recovery, or other benefits that may be attained if the services are used. The primary concern raised by endorsements and pictures is whether they communicate benefits of orthopaedic services that are representative of the benefits ordinarily attained by the average patient. If they communicate a degree of relief or recovery that is exceptional or otherwise not representative of the average patient, they may mislead patients into having unjustified medical expectations about the orthopaedic services advertised.
Claims: "Painless"
The degree of comfort, ease, or pain involved in the provision of an orthopaedic service is difficult to measure by objective standards. How these factors are experienced by an individual is subjective and varies from patient to patient. Therefore, claims or representations about the degree of comfort, care or lack of pain involved in an orthopaedic service may be difficult to substantiate and may be misleading if not used with care.
Statements that an orthopaedic procedure does not cause pain or is painless raise concerns if the services advertised are invasive. It is highly unlikely that an invasive orthopaedic procedure will not cause some degree of pain.
Claims: "Safe" or "Effective"
General representations about the safety or effectiveness of specific orthopaedic services should not be misleading. Such representations may cause a layperson to lack appreciation for the nature of any risks or adverse effects associated with the orthopaedic procedure, even if the likelihood that adverse effects may occur is low. More specific representations can also cause concerns. For example, a statement that an orthopaedic surgeon has cured or successfully treated a large number of cases involving a particular serious ailment is deceptive if it implies a certainty of result and creates unjustified and misleading expectations in prospective patients.
Representations about the safety or effectiveness of orthopaedic services should be substantiated with sound scientific support, such as peer reviewed publications in medical literature or other authoritative sources of scientific information. Such claims should not contradict or be inconsistent with conclusions reached by authoritative federal agencies, such as the National Institutes of Health, the Centers for Medicare and Medicaid Services, the Food and Drug Administration or others, unless such a contradiction or inconsistency can be substantiated with sound scientific evidence.
Simply using a phrase such as "safe" is likely to deceive prospective patients by implying an absolute or binary ("safe" versus "unsafe") standard, when in fact the "safety" of an orthopaedic procedure is necessarily a qualified concept. The failure to qualify the claim is particularly objectionable since a variety of phrases could easily be employed to communicate the safety/risk relationship (e.g. "relatively safe," "safe for most patients," or "among the safer types of orthopaedic surgery").
Claims: "Cure"
Use of the term "cure" with reference to a problem is often deceptive. To "cure" a condition means to alter the circumstances so that the condition no longer exists and will not recur. In order not to be misleading, the term "cure" should almost always be further explained and qualified to give the patient an accurate understanding of his/her prospects for improvement.
Claims: Physician Qualifications
Orthopaedic surgeon qualifications include education, training, and other indicators of status or achievement within the profession. The lay public does not have a good understanding about what various qualifications represent. Most patients will assume that physician qualifications in an advertisement indicate training, knowledge, expertise, and competence with respect to the services being advertised. That assumption is likely because patients will conclude that qualifications are listed in an advertisement to substantiate the orthopaedic surgeon's ability to perform the services being advertised. It is possible for patients to be misled if the qualifications listed imply a level of education or training which the orthopaedic surgeon did not receive; if they imply a degree of scrutiny of the orthopaedic surgeon's knowledge, training and competence that did not in fact occur; if they imply a qualification which the orthopaedic surgeon does not have; if the qualifications are inaccurately listed; or if the qualifications do not indicate education, training, knowledge, expertise, or competence with respect to the services being advertised.
Claims: "World Famous," "Top Surgeon," "Pioneer"
Only a small fraction of all orthopaedic surgeons can justifiably claim to be "world-famous." These may include some orthopaedic surgeons who are editors of major journals, who have authored widely used texts, or who have made major, original contributions to medical techniques. However, it is the very elusiveness of measures of "fame" which makes invoking them in trying to lure patients misleading. Merely traveling extensively, presenting addresses at professional meetings or treating patients from abroad does not mean that an orthopaedic surgeon is "world-famous." To so indicate is to use the inherent imprecision of the concept of fame to mislead patients. There can be little question that such claims are employed in order to give patients the impression that the orthopaedic surgeon meets some objective, high level of competence, skill or recognition - which probably does not exist with respect to the advertiser. The same is true of advertising oneself as a "top orthopaedic surgeon." Saying that one has "pioneered advances in orthopaedic surgery" is also deceptive. Such a phrase connotes a major breakthrough, not a minor alteration or refinement of conventional procedures. Simply being one of many "investigators" for a type of orthopaedic prosthesis, using one piece of equipment, or using a slightly refined surgical procedure does not justify use of the term "pioneer." Since all orthopaedic surgery requires some degree of innovation, an orthopaedic surgeon cannot meaningfully claim to be an originator or developer of a technique or product simply because he or she has modified what existed before in some minor way.
Claims: Fees and Costs
Orthopaedic surgeons may advertise truthful information about fees and costs. However, statements about fee information can be misleading if they do not fairly inform the public about the costs likely to be incurred when patronizing the advertised physician. For example, the description of any service for which a fee or a range of fees is advertised must not be deceptive or misleading, and the statement should also indicate whether there may be additional fees for related services that are commonly required when the advertised service is obtained.

Gifts and the Orthopaedic Surgeon's Relationship with Industry
Issue raised
Under what, if any, circumstances is it appropriate for orthopaedic surgeons to accept gifts or other financial support from industry, including pharmaceutical, biomaterial or device manufacturers?
Applicable provisions of the Principles of Medical Ethics and Professionalism in Orthopaedic Surgery
"I. The orthopaedic profession exists for the primary purpose of caring for the patient. The physician-patient relationship is the central focus of all ethical concerns. The orthopaedic surgeon should be dedicated to providing competent medical service with compassion and respect."
Applicable provisions of the Code of Medical Ethics and Professionalism for Orthopaedic Surgeons
"I.A. The orthopaedic profession exists for the primary purpose of caring for the patient. The physician-patient relationship is the central focus of all ethical concerns."
"III.C. When an orthopaedic surgeon receives anything of significant value from industry, a potential conflict exists which should be disclosed to the patient. When an orthopaedic surgeon receives inventor royalties from industry, the orthopaedic surgeon should disclose this fact to the patient if such royalties relate to the patient's treatment. It is unethical for an orthopaedic surgeon to receive compensation of any kind from industry for using a particular device or medication. Reimbursement for reasonable administrative costs in conducting or participating in a scientifically sound research clinical trial is acceptable."
"IV.A. The orthopaedic surgeon continually should strive to maintain and improve medical knowledge and skill and should make available to patients and colleagues the benefits of his or her professional attainments. Each orthopaedic surgeon should participate in continuing medical educational activities.
Other references:
American Medical Association, Section 8.061 (Gifts to Physicians from Industry) of the Current Opinions of the Council on Ethical and Judicial Affairs.
Australian Orthopaedic Association, "Orthopaedic Surgeons and Their Relationship with Industry," Australian Orthopaedic Association Bulletin, December 1997.
Discussion
Orthopaedic surgeons have long recognized the importance of continuing medical education in maintaining their professional skills. Both orthopaedists-in-training and practicing orthopaedic surgeons attend and participate in numerous continuing medical educational programs and seminars. Industry, including pharmaceutical, biomaterial and device manufacturers, has generously supported many of these beneficial programs.
For several years, there has been concern about industry making gifts to physicians. Some of these gifts that reflect customary marketing practices of industry may not be consistent with basic principles of medical ethics. The line is sometimes blurred between industry's providing funds for an actual continuing medical educational experience and providing funds to promote the use or purchase of a particular pharmaceutical, biomaterial or piece of orthopaedic equipment.
Generally, the American Academy of Orthopaedic Surgeons (AAOS) believes that it is acceptable for industry to provide financial and other support to orthopaedic surgeons if such support has significant educational value and has the purpose of improving patient care. All dealings between orthopaedic surgeons and industry should benefit the patient and be able to withstand public scrutiny.
Guidelines
To avoid acceptance of inappropriate gifts or other financial support, the AAOS recommends that orthopaedic surgeons observe the following guidelines:
Benefit to Patients.
The patient's best interest is paramount. Therefore, it is of utmost importance that any gift or other financial support accepted by an orthopaedic surgeon should primarily entail a benefit to his or her patient. A gift of any kind from industry should in no way influence the orthopaedic surgeon in determining the most appropriate treatment for his or her patient. It is only by strict adherence to this principle that the orthopaedic surgeon may maintain the patient's trust.
Gifts With Conditions Attached.
Orthopaedic surgeons should not accept gifts or other financial support with conditions attached. No gifts (including goods, meals, accommodations, meeting registrations, travel, etc. to attend educational meetings or learning new skills under the tutelage of an expert) should be accepted with the explicit or implicit requirement that the orthopaedic surgeon use the products or services provided by that particular industry.
Social Functions.
Although the AAOS is generally opposed to social events sponsored by industry, social functions supported by industry in combination with significant continuing medical education events are acceptable. However, social functions supported by industry (e.g. dinners, tickets to sporting events or theater, golf outings, etc.) where there is no educational element should not be offered to nor accepted by orthopaedic surgeons
Cash Gifts.
Cash gifts from industry to orthopaedic surgeons must not be offered nor accepted.
Continuing Medical Education (CME) Events.
Subsidies.
Subsidies by industry to underwrite the costs of educational events where CME credits are provided can contribute to the improvement of patient care and are acceptable. A corporate subsidy received by the conference's sponsor is appropriate and acceptable so long as such support is publicly acknowledged and the location, curriculum, faculty, and educational methods of the conference or meeting are determined solely by the organization sponsoring the educational course, not industry. Industry reimbursement, whether direct or indirect, for an orthopaedic surgeon to attend an educational event is not appropriate.
Faculty Expenses and Honoraria for Continuing Medical Education Activities.
It is appropriate for faculty at educational events where CME credits are provided to accept reasonable honoraria and to accept reimbursement for reasonable travel, lodging and meal expenses from the conference's sponsor.
Other Educational Events.
Educational events sponsored by industry may be of educational value and improve patient care. Orthopaedic surgeons are responsible for insuring that decisions to accept subsidies from industry are in the best interest of their patients. The AAOS believes a potential conflict of interest exists when an orthopaedic surgeon receives such subsidies.
Special circumstances may arise in which orthopaedic surgeons may be required to learn new surgical techniques demonstrated by an expert in the field in his/her institution or to review new implants or other devices on-site. On-site education provides the added benefit of educating a larger number of attendees per session and offers important insights into the function of ancillary staff and institutional protocols. In these circumstances, reimbursement for expenses may be appropriate.
Reimbursement should be limited to expenses that are strictly necessary and able to withstand public scrutiny. In no case should honoraria or reimbursement for time off to attend the course be offered or accepted. In addition, attending the course and learning the technique must not require or imply that the orthopaedic surgeon must subsequently use that technique.
Consultant Expenses and Honoraria.
It is appropriate for consultants to industry who provide genuine services to receive reasonable compensation and to accept reimbursement for reasonable travel, lodging and meal expenses. Token consulting or advisory arrangements cannot be used to justify compensating orthopaedic surgeons for their time, travel, lodging or other out-of-pocket expenses.
Scholarships for Orthopaedic Surgeons-in-Training.
Scholarships or other special funds from industry to permit orthopaedic surgeons-in-training to attend continuing medical education conferences are appropriate as long as the selection of students, residents or fellows who will receive the funds is made by the orthopaedist-in-training's program director.
Orthopaedic surgeons should never lose sight of their primary ethical responsibility to provide competent, compassionate patient care, maintaining professionalism and objectivity at all times.




Sexual Harassment and Exploitation
Issues raised
What is sexual harassment? What should an orthopaedic surgeon do to help eliminate sexual harassment and exploitation?
Applicable provisions of the Principles of Medical Ethics and Professionalism in Orthopaedic Surgery
"II. The orthopaedic surgeon should maintain a reputation for truth and honesty with patients and colleagues, and should strive to expose through the appropriate review process those physicians who are deficient in character or competence or who engage in fraud or deception."
"V. The orthopaedic surgeon should respect the rights of patients, of colleagues, and of other health professionals and must safeguard patient confidences within the constraints of the law."
"VII. Good relationships among physicians, nurses, and health care professionals are essential for good patient care. The orthopaedic surgeon should promote the development of an expert health care team that will work together harmoniously to provide optimal patient care."
"X. The orthopaedic surgeon has a responsibility not only to the individual patient, to colleagues and orthopaedic surgeons-in-training, but also to society as a whole. Activities that have the purpose of improving both the health and well-being of the individual and/or the community in a cost-effective way deserve the interest, support, and participation of the orthopaedic surgeon."
Applicable provisions of the Code of Medical Ethics and Professionalism for Orthopaedic Surgeons
"II.A. The orthopaedic surgeon should maintain a reputation for truth and honesty. In all professional conduct, the orthopaedic surgeon is expected to provide competent and compassionate patient care, exercise appropriate respect for other health care professionals, and maintain the patient's best interests as paramount."
"II.C. The orthopaedic surgeon should obey all laws, uphold the dignity and honor of the profession, and accept the profession's self-imposed discipline. Within legal and other constraints, if the orthopaedic surgeon has a reasonable basis for believing that another orthopaedic surgeon or other health care provider has been involved in any unethical or illegal activity, he or she should attempt to prevent the continuation of this activity by communicating with that person and/or identifying that person to a duly-constituted peer review authority or the appropriate regulatory agency. In addition, the orthopaedic surgeon should cooperate with peer review and other authorities in the their professional and legal efforts to prevent the continuation of unethical or illegal conduct."
"V.A. Good relationships among physicians, nurses and other health care professionals are essential for good patient care. The orthopaedic surgeon should promote the development of an expert health care team that will work together harmoniously to provide optimal patient care."
Other references
American Medical Association, Current Opinions of the Council on Ethical and Judicial Affairs, Section 3.08, "Sexual Harassment and Exploitation Between Medical Supervisors and Trainees." Updated June, 1994.
American Medical Association, Reports of the Council on Ethical and Judicial Affairs:
"Sexual Harassment and Exploitation Between Medical Supervisors and Trainees," 1989; and
"Reporting Impaired, Incompetent or Unethical Colleagues," 1992.
American Medical Association, "Guidelines for Establishing Sexual Harassment Prevention and Grievance Procedures," 1991.
Background
Sexual harassment involves two different situations: (1) unwelcome sexual advances and requests for sexual favors; and (2) the existence of a hostile or offensive work environment that may consist of verbal or physical conduct of a sexual nature (e.g., touching, vulgar humor, risqué remarks, pictures or photographs) or a general hostility towards individuals because of their gender. There need not be sexual advances to create a hostile or offensive work environment.
Examples of sexual harassment include inappropriate sexual advances; favoritism based upon gender, sexist jokes or slurs; the exchange of rewards for sexual favors; and malicious gossip or rumors. Sexual harassment also encompasses the use of sexist teaching materials, denied opportunities or poor evaluations because of gender, and punitive measures based upon the refusal of sexual advances.
In 1990, the American Medical Association sent a survey regarding sexual harassment and exploitation to the 130,000 female medical students, residents and physicians currently in practice in the United States. Nearly three-quarters of the 2,225 respondents said that they had experienced sexual harassment at some time in their career. Most encountered it during medical school and residency. More than 40% were harassed while in practice and some respondent's encountered sexual harassment in more than one setting. Colleagues and management staff were cited most often as the perpetrators of the harassment.
When asked, "If you did not report the incident, why not?" 977 (44%) of the survey respondents cited fear of negative impact and felt no action would have been taken. 760 (35%) felt no action would have been taken. Others said that no sexual harassment policy existed at their institution. Despite the low response rate in this survey, it is important to recognize that so many female physicians-in-training and physicians considered themselves to be targets of sexual harassment.
Legal considerations
During the past several years, the number of complaints of sexual harassment in the workplace has increased substantially as has the number of lawsuits alleging violations of state or federal law based on incidents of sexual harassment.
Legal claims of sexual harassment fall into two categories: "quid pro quo harassment," whereby submission to or rejection of the sexual conduct is used as the basis for employment decisions; and "hostile environment harassment," in which conduct is so pervasive that it unreasonably interferes with an individual's job performance or creates an intimidating, hostile or offensive working environment.
Perceptions of what constitutes offensive behavior sometimes differ between men and women. Men generally are less inclined than women to view sexual teasing as harassment. Recently, courts have begun to adopt the "reasonable woman" test for sexual harassment, ruling that behavior was sexual harassment if a "reasonable woman" would view it as such.
In a case of alleged hostile environment sexual harassment, a plaintiff must prove that "the employer did not respond promptly and effectively when it was apprised of (or should have discovered) the harassment." An internal investigation followed by appropriate disciplinary action, when warranted, has been held to constitute a proper response in a number of cases.
Employees, such as nurses and support staff, who are sexually harassed may also seek redress from the federal Equal Employment Opportunity Commission (EEOC) and its state counterparts. In the educational context, medical schools and medical trainees are often perceived as sharing an educational rather than an employment relationship. However, the EEOC has determined that interns and residents are sometimes considered to be employees of the medical schools that provide them with clinical training. As such, interns and residents may have the same legal standing as employees to file charges of sexual harassment and discrimination under Title VII of the Civil Rights Act of 1964. In addition, the Civil Rights Act of 1991 gives victims of sexual harassment, whether employees or physicians-in-training, the right to receive punitive damages of up to $300,000. Sexual harassment is also widely prohibited under state law.
Ethical considerations
By definition, conduct that would constitute sexual harassment is unethical. Patient care may be exposed to potential harm when orthopaedic surgeons have made unwelcome sexual advances towards other members of the health care team caring for the patient. Patient care may also be jeopardized in this circumstance by the creation of a sexually hostile or offensive work environment. Orthopaedic surgeons should ensure that their actions cannot be considered unwelcome sexual advances even by the most critical observer. They must also ensure that the nurturing and caring health care environment does not become sexually hostile or offensive by inappropriate communications, touching or sexual favoritism.
In the educational context, most ethicists believe that sexual harassment, broadly defined, occurs even in consensual sexual relationships between medical supervisors and trainees. These relationships raise ethical concerns because of inherent inequalities in the status and power that medical supervisors wield in relation to medical trainees. Whenever a sexual relationship exists between a medical trainee and a supervisor who has professional responsibility for the trainee, the potential for sexual exploitation exists, despite the voluntary nature of the relationship. The supervisory role should be eliminated if the parties involved wish to pursue their relationship.
Policies dealing with sexual harassment and exploitation
The American Academy of Orthopaedic Surgeons urges orthopaedic surgeons to comply with institutional sexual harassment policies and to develop and enforce such policies (or the concepts underlying these policies) in their own offices. To be effective, sexual harassment policies should include a grievance procedure that is sensitive to the difficulties and potential repercussions experienced by those who report alleged sexual harassment or exploitation. These policies should also acknowledge that both men and women are subject to sexual harassment or exploitation from members of the same or opposite gender and that mechanisms for resolving inappropriate sexual conduct must be equally stringent in all cases. Sexual harassment policies should also assure the rights of both the accuser and the accused and, to the extent possible, should protect the confidentiality of all involved. Generally, an effective sexual harassment policy will include:
A description of the types of conduct that constitute sexual harassment;
A strong statement that sexual harassment is unethical and unlawful and that the institution/orthopaedic surgeon will not tolerate such behavior;
A statement of an employee's right to complain about harassment without fear of retaliation;
A requirement that supervisors and employees promptly report any sexually harassing conduct;
A procedure for prompt, full and objective investigation of sexual harassment charges; and
A statement that offenders will face disciplinary action and possible discharge.
In the educational context, a number of instances of sexual harassment and exploitation have been reported. Because of this, the AMA House of Delegates in 1989 adopted three recommendations dealing with sexual harassment, developed by the AMA's Council on Ethical and Judicial Affairs. They are:
All medical training programs should develop and implement policies that address sexual harassment and exploitation between educators and medical trainees;
Such sexual harassment policies should include a discussion of consensual sexual relationships; and
Such sexual harassment policies should contain a grievance procedure, including a mechanism to assure that the rights of both trainees and educators to due process are rigorously observed.
Recommendations
The American Academy of Orthopaedic Surgeons urges orthopaedic surgeons to be aware of and sensitive to issues of sexual harassment and exploitation. Orthopaedic surgeons should conduct their activities professionally and should not jeopardize patient care through inappropriate sexual actions or comments. Policies should be implemented and followed to ensure that all members of the health care team may perform their professional duties without fear of sexual harassment or exploitation.




Sexual Misconduct in the Physician-Patient Relationship
Issue Raised
What obligations does an orthopaedic surgeon have regarding sexual misconduct in the physician-patient relationship?
Applicable Provisions of the Principles of Medical Ethics and Professionalism in Orthopaedic Surgery
"I. The orthopaedic profession exists for the primary purpose of caring for the patient. The physician-patient relationship is the central focus of all ethical concerns. The orthopaedic surgeon should be dedicated to providing competent medical service with compassion and respect."
"II. The orthopaedic surgeon should maintain a reputation for truth and honesty with patients and colleagues, and should strive to expose through the appropriate review process those physicians who are deficient in character or competence or who engage in fraud or deception."
"V. The orthopaedic surgeon should respect the rights of patients, of colleagues, and of other health professionals and must safeguard patient confidences within the constraints of the law."
Applicable Provisions of the Code of Medical Ethics and Professionalism for Orthopaedic Surgeons
"I.A. The orthopaedic profession exists for the primary purpose of caring for the patient. The physician-patient relationship is the central focus of all ethical concerns."
"I.B. The physician-patient relationship has a contractual basis and is based on confidentiality, trust, and honesty. Both the patient and the orthopaedic surgeon are free to enter or discontinue the relationship within any existing constraints of a contract with a third party. An orthopaedist has an obligation to render care only for those conditions that he or she is competent to treat. The orthopaedist shall not decline to accept a patient solely on the basis of race, color, gender, sexual orientation, religion, or national origin or on any basis that would constitute illegal discrimination."
"II.B. The orthopaedic surgeon should conduct himself or herself morally and ethically, so as to merit the confidence of patients entrusted to the orthopaedic surgeon's care, rendering to each a full measure of service and devotion."
"II.C. The orthopaedic surgeon should obey all laws, uphold the dignity and honor of the profession, and accept the profession's self-imposed discipline. Within legal and other constraints, if the orthopaedic surgeon has a reasonable basis for believing that a physician or other health care provider has been involved in any unethical or illegal activity, he or she should attempt to prevent the continuation of this activity by communicating with that person and/or identifying that person to a duly constituted peer review authority or the appropriate regulatory agency. In addition, the orthopaedic surgeon should cooperate with peer review and other authorities in their professional and legal efforts to prevent the continuation of unethical or illegal conduct."
Other references
American Medical Association, Current Opinions of the Council on Ethical and Judicial Affairs, Section 8.14, "Sexual Misconduct in the Practice of Medicine ."
American Medical Association, Reports of the Council on Ethical and Judicial Affairs, Report 29, "Sexual Misconduct in the Practice of Medicine ," January, 1991.
Johnson, SH: Judicial review of the disciplinary action for sexual misconduct in the practice of medicine, JAMA; 1993; 270: 1596-1600.
Background
Sexual contact between a physician and patient may occur in several circumstances: (1) the physician may become involved in personal relationships with patients that are concurrent with but independent of treatment; (2) some physicians may use their position to gain sexual access to their patients by representing sexual contact as part of care or treatment; (3) physicians may assault patients by engaging in sexual conduct with incompetent or unconscious patients. There seems to be little or no data indicating the prevalence of each type of sexual misconduct.
Although a number of studies have attempted to establish the incidence of physician-patient sexual contact, the actual prevalence of physician-patient contact cannot be determined with accuracy. What data exists is generally based on self-reporting by physicians.1 Because of the stigma attached to physician sexual contact with patients and the professional repercussions which may result from admitting to such contact, most researchers believe that the occurrence of patient-physician sexual contact is grossly underreported. There is a small minority of physicians who have reported having sexual contact with their patients.2 Studies of psychiatrists indicate that between 5-10 percent reported having sexual contact with patients. 1
Data for all specialties are not available, but a 1976 study suggests that this percentage may be comparable for other specialties. 2 Research also indicates that the effects of physician-patient contact are almost universally negative or damaging to the patient.
There is a long-standing consensus within the medical profession that sexual contact or sexual relations between physicians and patients are unethical. Current ethical thought uniformly condemns sexual relations between patients and physicians. In addition, the laws of many states prohibit sexual contact between physicians and their patients. The ban on physician-patient sexual contact is based on the recognition that such contact jeopardizes patients' medical care.
Legal Considerations
Physicians engaged in sexual activity with patients may be subject to legal penalties for such conduct. Sexual conduct by physicians with their patients may generate civil damage actions against the physician for malpractice. 3 In addition, criminal prosecutions, either under general sexual assault statutes or under recently enacted more specific statutes, are possible. 4 Indeed, four states currently specifically classify sexual exploitation by a psychotherapist as sex offenses under criminal statutes. It is noteworthy that the statue in a least one state - Florida - specifies that consent of the patient cannot be used as a defense by a physician against charges of sexual misconduct.
Sexual activity of physicians with patients may also trigger licensure disciplinary action against the physician. Seven states have enacted licensure statutes that specifically provide for disciplinary action for sexual activity, and others address the issue of a physician's having sexual relations with a patient under the general categories of "unprofessional conduct" or "moral turpitude." The range of sanctions available to licensure boards provide greater flexibility in adjusting the penalty to fit the degree of violation. However, the effectiveness of the disciplinary system in handling improper sexual activity by physicians with patients or former patients has been criticized for failing to protect patients. 5
Ethical Considerations
Patient consent
Several elements of the physician-patient relationship may combine to give the physician undue influence over his or her patient. Within the physician-patient relationship, the physician possesses considerable knowledge, expertise, and status. A patient is often most vulnerable, both physically and emotionally, when seeking medical care. When a physician acts in a way which is not to the patient's benefit, the relatively weak position of the patient makes it difficult for the patient to give meaningful consent on the part of the patient which has led researchers to compare physician-patient sexual contact to other sexually exploitive situations such as sexual assault and incest.
Patients who seek medical care must be able to trust in the physician's dedication to their welfare in order for the physician-patient alliance to succeed. A physician who engages in sexual contact with a patient seriously compromises the patient's welfare. The patient's trust that the physician will work only for the patient's welfare is violated. Consequently, sexual contact and sexual relationships between physicians and their patients are uniformly considered to be unethical.
The orthopaedic surgeon's professional obligation to serve the needs of the patient means that his or her own needs cannot become a consideration in decisions about the patient's medical care. This is because consideration of the physician's needs or gratifications may interfere with efforts to address the needs of the patient. The emotional factors which accompany sexual involvement affect or obscure the physician's medical judgment, thus jeopardizing the patient's diagnosis or treatment.
Termination of the physician-patient relationship
Physicians and patients may be genuinely attracted to each other. However, any relationship in which a physician might take advantage of the patient's emotional or psychological vulnerability is unethical. Therefore, before initiating a dating, romantic, or sexual relationship with a patient, a physician's minimum duty is to properly terminate his or her professional relationship with the patient. In addition, physicians are advised to consult with a colleague before initiating a relationship with the former patient. Termination of the professional relationship would also be appropriate if a sexual or romantic attraction to (as opposed to actual contact with) a patient threatens to interfere with the judgment of the physician.
Even the termination of the physician-patient relationship does not totally eliminate the possibility that sexual contact between a physician and a former patient might be unethical. Sexual contact between a physician and a patient with whom professional relations have been terminated would be unethical if the sexual contact occurred as a result of the use or exploitation of trust, knowledge, influence or emotions derived from the former professional relationship. The ethical propriety of a sexual relationship between a physician and a former patient depends substantially on the nature and context of the former relationship.
Reporting of sexual misconduct
Sexual misconduct is unlikely to be brought to the attention of the proper authorities by a patient because of the feelings of shame, humiliation, degradation, and self-blame.
The reporting of alleged sexual misconduct by one physician against other physicians is critically important in the case of sexual misconduct. Physicians are encouraged to report instances of sexual misconduct by their colleagues. Research on the reporting practices of physicians indicates that reluctance to report may involve concerns about confidentiality, either in the physician-patient relationship or among colleagues. In addition, because of the nature of sexual misconduct, most victims are rendered reluctant or unable to report the misconduct on their own. The Academy, in its Principles of Medical Ethics and Professionalism in Orthopaedic Surgery, provides that "[t]he orthopaedic surgeon should strive to expose through the appropriate review process those physicians who are deficient in character or competence or who engage in fraud or deception." Therefore, orthopaedic surgeons should be vigilant in exposing colleagues to appropriate review who allegedly have committed sexual misconduct.
The Academy and the AMA's Council on Ethical and Judicial Affairs believe that physicians who become aware of alleged sexual misconduct by a colleague should report the misconduct to the local medical society, the state licensing board or other appropriate authorities, except if the physician learns of the sexual misconduct while treating the offending physician.
AMA Council on Ethical and Judicial Affairs
In December, 1990, the AMA's Council on Ethical and Judicial Affairs released Report 29 on "Sexual Misconduct in the Practice of Medicine." The Report concluded that:
A physician's sexual contact or romantic relationship with a current patient is unethical;
A physician's sexual contact or romantic relationship with a former patient are unethical if the physician uses or exploits trust, knowledge, emotions or influence derived from the previous professional relationship;
Medical training should include education on the issue of sexual attraction to patients and sexual misconduct at all levels;
Disciplinary bodies must be structured to deal effectively with physician sexual misconduct;
Physician's who learn of sexual misconduct by a colleague must report the misconduct to the local medical society, the state licensing board or other appropriate authorities. Exceptions to reporting may be made in order to protect patient welfare of the physician-patient privilege;
Many states have legal prohibitions against relationships between physicians and current or former patients.
Recommendations
The American Academy of Orthopaedic Surgeons condemns sexual misconduct by orthopaedic surgeons and other physicians. The Academy concurs with the December, 1990, recommendations of the AMA's Council on Ethical and Judicial Affairs contained in Report 29 about "Sexual Misconduct in the Practice of Medicine." Orthopaedic surgeons who learn of the alleged sexual misconduct of a colleague have an obligation to report it to the local medical society, state licensing board or other authority. By taking this action, orthopaedic surgeons can help ensure that all patients are treated in a non-threatening, respectful manner

Second or Additional Medical Opinions in Orthopaedic Surgery
Issues raised
What are the ethical obligations involved in relationships between orthopaedic surgeons with respect to providing second or additional medical opinions? What different types of second or additional medical opinions exist?
Applicable provisions of the Code of Medical Ethics and Professionalism for the Orthopaedic Surgeon
"I. B. The physician-patient relationship has a contractual basis and is based on confidentiality, trust, and honesty. Both the patient and the orthopaedic surgeon are free to enter or discontinue the relationship within any existing constraints of a contract with a third party ...."
"I. C. The orthopaedic surgeon may choose whom he or she will serve. An orthopaedic surgeon should render services to the best of his or her ability. Having undertaken the care of a patient, the orthopaedic surgeon may not neglect that person. Unless discharged by the patient, the orthopaedic surgeon may discontinue services only after giving adequate notice to the patient so that the patient can secure alternative care."
VII. D. When a patient submits a proper request for records, the patient is entitled to a copy of such records as they pertain to that patient individually. Charges should be commensurate with the services provided to reproduce the medical records."
Other references
Principles of Medical Ethics and Professionalism in Orthopaedic Surgery, Article I. "The orthopaedic profession exists for the primary purpose of caring for the patient. The physician-patient relationship is the central focus of all ethical concerns. The orthopaedic surgeon should be dedicated to providing competent medical service with compassion and respect."
Code of Medical Ethics and Professionalism for Orthopaedic Surgeons, Article VII.A. "An orthopaedic surgeon should practice only within the scope of his or her education, training and experience."
American Medical Association, Current Opinions of the Council on Ethical and Judicial Affairs,
Section 3.04 ("Referral of Patients")
Section 7.01 ("Records of Physicians: Availability of Information to Other Physicians")
Section 7.02 ("Record of Physicians: Information and Patients")
Section 8.12 ("Patient Information")
Background
Patients ultimately control their own personal health care decisions. While some patients may choose to limit their control of choice by enrolling in managed care organizations, all patients have the option to obtain health care services from whomever they wish. The physician assumes a contractual obligation in undertaking the care of a patient; the patient, the ultimate purchaser, owns and has a right to participate in all decisions in this contract.
Many patients find medical decision-making difficult, particularly regarding advanced medical technology. For this reason and economic pressures to contain costs, the process of seeking a "second opinion" from another physician has developed. While patients have independently sought second or additional opinions to confirm medical decisions in the past, the frequency of seeking additional medical opinions has skyrocketed in the past decade. Indeed, some patients now seek the opinions of multiple physicians, a practice called "doctor shopping," as a matter of course. In today's environment, there is an undercurrent of skepticism and distrust that encourages the solicitation of additional medical opinions. To compound this, confusion exists about the medical decision-making process in the lay and health care communities. Second or additional medical opinions sometimes have produced anxiety, frustration, anger, and intimidation in patients and physicians alike.
Many questions concerning the ethics of seeking and providing second or additional medical opinions have been raised. Some actions have resulted in accusations of impropriety and unethical behavior. While unethical behavior has occasionally occurred, many times the conflict has arisen from a lack of proper communication and mutual respect between the treating physician and the physician from whom the patient has sought additional information. This conflict raises the specter of "turf," greed, and dishonesty and, when aired in the public forum, does much to discredit the profession.
Definitions
Distinct types of interactions exist involving the gathering of additional medical opinions to which different ethical rules apply. They include:
Consultations with a colleague, initiated by the treating physician, on behalf of and with the implicit consent of the patient, to gain additional diagnostic insight or confirmation in order to continue providing a comprehensive treatment plan for the patient;
Referrals to a colleague, initiated by the treating physician, on behalf of and with the consent of the patient, to share the care of the patient in the performance of a specified service. A referral might be temporary or permanent; this decision should be made between the two physicians at the time of the referral.
Transfers, initiated by the treating physician, to transfer all care of the patient to another physician. There are legal requirements for the treating physician in transferring a patient. The consent of the patient is required.
Withdrawals, initiated by the treating physician, to discharge a patient from his or her care. There are legal requirements for the treating physician who is withdrawing services from a patient. In addition, the Academy's Code of Medical Ethics and Professionalism for Orthopaedic Surgeons provides that "unless discharged by the patient, the orthopaedic surgeon may discontinue services only after giving adequate notice to the patient so that the patient can secure alternative care."
Second opinions, initiated by a third party payer or the insurance company of the insured prior to giving authorization to the physician to perform the procedure. In most health insurance contracts, patients must comply with this requirement to receive the full benefit of their contract. The choice of which provider will provide the additional opinion is the sole decision of the insurer.
The patient may seek additional medical opinions by initiating a consultation with another physician concerning his or her care plan or by dismissing the treating physician and transferring all care to another health care professional. The patient's course of action is entirely within the patient's prerogative.
Ethical considerations
The patient has the ultimate decision-making authority in seeking second or additional medical opinions and referrals. Although the patient may choose to give up a certain degree of free choice by participating in managed care plans or by accepting insurance coverage with certain limitations, the choice of the options ultimately remains with the patient.
The American Academy of Orthopaedic Surgeons recommends that orthopaedic surgeons observe the following guidelines regarding second or additional medical opinions and referrals:
Any illegal action is unethical. For example, it would be illegal as well as unethical for the orthopaedic surgeon providing the second or additional medical opinion to slander the referring physician if the slanderous information is known or can be proven to be false.
In accepting a patient for consultation, it is ethical for the consulting orthopaedic surgeon to render an opinion and return the patient to the treating physician for continuing care. The consulting orthopaedic surgeon should communicate with the patient as well as the referring physician about the opinion.
It is unethical for the consulting orthopaedic surgeon to solicit care of the patient. However, at the sole discretion of the patient, the patient ethically may choose to terminate his or her relationship with his or her treating physician and then enter into another treatment relationship with the consulting orthopaedic surgeon. It is not unethical for the consulting orthopaedic surgeon to accept the patient under these circumstances, although some orthopaedic surgeons choose not to accept the patient because of their personal view that a conflict of interest situation might be created.
When treating a patient referred by a colleague, the accepting orthopaedic surgeon ethically should return the patient to the referring physician after the index care has been rendered unless prior arrangements have been made with consent of both the referring physician and the patient to transfer the patient's care permanently. In a referral, professional courtesy dictates that some type of direct communication be given to the referring physician.
In the specific case where orthopaedic surgeons agree to render "second" medical opinions for a third party who then directs patients to them, the assumption of that patient's care may be prohibited expressly by the terms of the physician's arrangement with the insurance company. If the patient independently is seeking an additional medical opinion, the orthopaedic surgeons may render an opinion and advise the patient of a proposed treatment plan, provided the contract permits such action. The physician must be aware of the provisions of his/her agreement with the third party.
As an extension of patient autonomy, patients have an ethical right to prompt and complete access to their medical record information unless the physician is bound by a contract with the patient's third party payer. As a corollary, orthopaedic surgeons who proffer second or additional medical opinions at the treating physician's or patient's request also have the right to complete access to this information. In general, the physician (or the physician's clinic or group practice) legally "owns" the patient's medical records that he or she maintains. However, this ownership is subject to the patient's right of privacy and, in legal proceedings, the doctor-patient privilege. It is also subject to the patients' right in most states to obtain copies of those records or to have copies transferred to another person.
It is in the patient's best medical interests for orthopaedic surgeons to cooperate fully in sharing copies of a patient's medical records, including physician notes, prescriptions, charts, reports, laboratory results, technical information used to assess the patient's health condition, letters, photographs, x-rays, and diagnostic imaging. This is true whether the patient is referred by one orthopaedic surgeon to another for a consultation or if the patient elects to see another orthopaedic surgeon for continuing treatment.
The orthopaedic surgeon is bound legally and ethically to give his or her best medical opinion, regardless of whether the orthopaedist is the treating physician or the physician who is asked to render a second or additional medical opinion. The best interest of the patient should clearly remain the guiding principal. Ultimately, patients independently may choose their treating physicians, request transfers of their care, and dismiss their physician at their own discretion.

 

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