Opinions on Ethics and Professionalism

"II. Integrity.   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. Medical Knowledge.   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 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 the 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.”

"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 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 . . ."

"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 and Education, Revised June 2004.

Association of American Medical Colleges, “Beyond the Framework: Institutional Considerations in Managing Allegations of Misconduct in Research,” September, 1992.

American College of Surgeons, Statement of Principles, 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 “Patent for Surgical and Diagnostic Instrument”
Section 9.095 “Patenting of Medical Procedures”

J.A. Buckwalter, “Medical Researchers Must Be Ethical,” AAOS Bulletin, July, 1990.

Website of the NIH Office of Human Subjects Research (http://206.102.88.10/ohsrsite/index.html).

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 or to future patients 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.

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 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.

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.

Example of unethical conduct:

• Using resources provided by any organization for the direct financial benefit or personal use of the investigators.

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.

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:

1. 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.


2. The patient must understand for what they are providing consent. 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


3. 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 any other review committees required by the institution, and in compliance with all applicable regulations and standards, including the Health Information Portability and Accountability Act (HIPAA) Privacy Rule (see below). 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.

Research on populations designated by the federal government as vulnerable (including children and pregnant women) is scrutinized with special care by the IRB. For research involving minors, assent (by the minor) may be required in addition to parental or guardian consent. In addition, any review of any patient information, including retrospective chart and x-ray review, for any purpose other than care of an individual patient or quality improvement, must be approved by the IRB. In many cases, the IRB will grant a “chart review exemption,” but this must be obtained before initiating chart and x-ray review. Further information can be obtained from the National Institutes of Health website.

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.


• Failing to follow any IRB requirements regarding subject recruitment or research participation.

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.

Federal regulations under the HIPAA Privacy Rule also affect the storage and dissemination of research information. The Privacy Rule requires that personally-identifiable information designed as Protected Health Information (PHI) must be kept private. PHI includes any information which might identify an individual (social security number, address, photographs, etc.) as well as any information in a medical record, including diagnosis, treatment, and health status and test results. The Principal Investigator is responsible for following the Privacy Rule, and the IRB requires the researcher to determine the minimum amount of PHI necessary to perform the research; to obtain consent from all subjects for obtaining PHI for research, and to document how PHI for research will be stores, who will have access to PHI, and how reports including PHI will be disseminated. Additional limitations on the use of PHI for research may be imposed by the institutional IRB. Failure to adhere to the requirements of the HIPAA Privacy Rule of HIPAA may result in civil and criminal penalties.

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;


• Failure to maintain confidentiality of PHI obtained for the purposes of research by the Principal Investigator or anyone else assisting with the project; and


• The Principal Investigator’s failing to critically review the results and verify the accuracy of reports.

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.

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.

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, or to fail to disclose to interested parties, including patients, that royalties are received for the use of a device or medication.

Examples of unethical conduct:

• The Principal Investigator's agreeing to always use a device he or she developed.

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.

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.

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.

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 Ethics Committee and Council on Research and Scientific Affairs. These tenets provide a flexible, ethical framework for the conduct and the publication of research results.

1 AMA Council on Ethical and Judicial Affairs, Report 25: Conflicts of Interest in Biomedical Research, 1990; 1-20

October 1994 American Academy of Orthopaedic Surgeons.
Revised December 1995, May 2002, July 2003, September 2005.

This material may not be modified without the express written permission of the American Academy of Orthopaedic Surgeons.

Document Number: 1202