AAOS Bulletin - February, 2006

New SOPs proposed: Research and Academic Responsibilites

Fellowship will vote after 2006 Annual Meeting

By Kathleen Delaney

Standards of Professionalism (SOPs) on Research and Academic Responsibilities will be considered by the AAOS fellowship at the 2006 Annual Meeting. These new SOPs will be discussed during the Bylaws Committee Open Hearing on Thursday, March 23, at 8 a.m., and during the AAOS Business Meetings on Friday, March 24, at 10 a.m. If adopted, this will become the fourth set of SOPs under the AAOS Professional Compliance Program.

Alleged violations of these SOPs may serve as the basis for formal grievances under the procedures adopted in 2005. If a grievance is upheld, the AAOS Board of Directors may censure, suspend or expel a member from the AAOS. The actual vote to adopt the new SOPs will be taken after the Annual Meeting.

Background

In response to concerns raised by AAOS fellows, the Board of Directors appointed a Project Team on Copyrights and Intellectual Property. The Project Team was charged with reviewing existing AAOS policies and practices regarding copyrights and intellectual property, including the AAOS nonexclusive license form and assignment of rights forms for authors and presenters.

Of particular concern to some fellows was the indemnification clause, which required an individual to accept ultimate financial responsibility for claims that might arise from the Academy’s use of an author’s or presenter’s material.

In August 2005, the Project Team requested that SOPs on Research and Academic Responsibilities be developed. Following an examination of existing practices within the publishing community as well as in other medical associations, the Board of Directors, at its September meeting, approved the Project Team’s proposals:

• Continue to require the use of nonexclusive licenses for materials presented in courses or scientific presentations

• Continue to require an assignment of rights for enduring materials, with ad hoc exceptions for certain illustrations

• Eliminate the indemnification clause in AAOS licenses and assignment of rights forms and replace it with an explicit warranty statement that includes the author’s or presenter’s acknowledgment and understanding of copyright principles, and acceptance of responsibility and consequences for knowingly making false statements about materials submitted

• Create a comprehensive AAOS education plan so that all authors and presenters understand their intellectual property rights and responsibilities

• Develop Standards of Professionalism on Research and Academic Responsibilities, including a provision dealing with plagiarism, for vote by the fellowship after the 2006 Annual Meeting

To learn more about the AAOS Professional Compliance Program and the new SOPs on Research and Academic Responsibilities, stop by the freestanding exhibit in the AAOS Resource Center in Hall B of McCormick Place at the 2006 Annual Meeting. Staff will be available to answer questions and provide information on all aspects of the Professional Compliance Program.

Kathleen Delaney is the Professional Compliance Program coordinator. She can be reached at professionalcompliance@aaos.org, aaosexpertwitness@aaos.org or (847)384-4047.

SOPs: Research and Academic Responsibilities

The orthopaedic profession exists for the primary purpose of caring for the patient. As a member of this profession, an orthopaedic surgeon may often conduct or participate in research and academic endeavors that may lead to improvements in musculoskeletal services provided to patients.

Under the AAOS Professional Compliance Program as adopted in April 2005, the fellowship votes on all Standards of Professionalism. Standards of Professionalism establish the minimum standard of acceptable conduct for orthopaedic surgeons in a particular area. Standards of Professionalism are mandatory and apply to all fellows and members of the AAOS.

The Standards of Professionalism draw from the aspirational Code of Medical Ethics and Professionalism for Orthopaedic Surgeons that appears in bold italics. The statements that follow the aspirational Code establish the baseline standard of acceptable conduct for orthopaedic surgeons who engage in research or who author or present information to other orthopaedic surgeons or the public. Violations of these standards may serve as grounds for a formal complaint to and action by the AAOS as outlined in Article VIII of the AAOS Bylaws.

These Standards of Professionalism apply to all AAOS fellows and members in their capacity as researchers or authors and presenters valued for their knowledge and expertise. Only an AAOS fellow or member may file complaints of an alleged violation of these Standards of Professionalism regarding another AAOS fellow or member.

Aspirational: AAOS Code of Medical Ethics and Professionalism for Orthopaedic Surgeons, VIII. A.: All research and academic activities must be conducted under conditions of full compliance with ethical, institutional and governmental 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.

Mandatory Standards:

1. An orthopaedic surgeon shall, while caring for and treating a patient participating in a research program or protocol, regard his or her responsibility to the patient as paramount.

2. An orthopaedic surgeon, or his or her qualified designee, shall present pertinent information to and obtain informed consent from the patient participating in a research program or protocol, or from the person responsible for the patient.

3. An orthopaedic surgeon shall honor a request from the patient, or from the person responsible for the patient, to withdraw from a research program or protocol.

4. An orthopaedic surgeon shall, while conducting research and academic activities, seek appropriate peer review and comply with appropriate institutional and governmental regulations.

5. An orthopaedic surgeon shall, while conducting research and academic activities, be truthful and honest with patients and colleagues. An orthopaedic surgeon shall communicate in a manner that enhances the profession.

6. An orthopaedic surgeon shall report those who engage in fraudulent or deceptive research to the appropriate authorities.

Aspirational: AAOS Code of Medical Ethics and Professionalism for Orthopaedic Surgeons, 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.

Mandatory Standards:

7. An orthopaedic surgeon shall claim as his or her own intellectual property only research and academic articles for which he or she made substantial contributions to the design, collection of and interpretation of data, and final version of the report.

8. An orthopaedic surgeon shall not present ideas, language, data, graphics or scientific protocols created by another person without giving appropriate credit to that person.

9. An orthopaedic surgeon shall, while conducting research or academic activities, maintain the integrity of the profession by exposing through the appropriate review process those physicians who engage in fraud or deception.

Aspirational: AAOS Code of Medical Ethics and Professionalism for Orthopaedic Surgeons, 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 the other individuals.

Mandatory Standards:

10. An orthopaedic surgeon shall warrant that he or she has made significant contributions to the conception and design or analysis and interpretation of the data, drafting the manuscript or revising it critically for important intellectual content and approving the version of the manuscript to be published.

11. An orthopaedic surgeon shall disclose the existence of duplicate articles, manuscripts or other materials that report his or her scientific or clinical research.

Aspirational: AAOS Code of Medical Ethics and Professionalism for Orthopaedic Surgeons, 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.

Mandatory Standards:

12. An orthopaedic surgeon shall credit with authorship or acknowledge and not exclude those individuals who substantially contributed to the proposed research, the analysis and interpretation of the data and the drafting and revising of the final article or report.

13. An orthopaedic surgeon shall, in reporting on research, publicly acknowledge the source of all relevant funding or consulting arrangements.


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