- •Foreword
- •Contents
- •Contributor Current and Past Positions: Association for Academic Surgery
- •Contributors
- •Academic Surgeons as Bridge-Tenders
- •Types of Surgical Research
- •Going Forward
- •Selected Readings
- •Introduction
- •Preparation Phase
- •Assistant Professor
- •Job Search
- •The First Three Years
- •Career Development Awards (CDAs)
- •Contemplating a Mid-Career Move?
- •Approaching Promotion
- •Associate Professor and Transition to Full Professor
- •Conclusion
- •Selected Readings
- •Introduction
- •Reviewing the Literature
- •Developing a Hypothesis
- •Study Design
- •Selected Readings
- •Introduction
- •The Dual Loyalties of the Surgeon-Scientist
- •Human Subjects Research
- •Informed Consent
- •Surgical Innovation and Surgical Research
- •Conflict of Interest
- •Publication and Authorship
- •Conclusion
- •References
- •Sources of Error in Medical Research
- •Study Design
- •Inferential Statistics
- •Types of Variables
- •Measures of Central Tendency and Spread
- •Measures of Spread
- •Comparison of Numeric Variables
- •Comparison of Categorical Values
- •Outcomes/Health Services Research
- •Steps in Outcomes Research
- •The Basics of Advanced Statistical Analysis
- •Multivariate Analysis
- •Time-to-Event Analysis
- •Advanced Methods for Controlling for Selection Bias
- •Propensity Score Analysis
- •Instrumental Variable (IV) Analysis
- •Summary
- •Selected Readings
- •Transgenic Models
- •Xenograft Models
- •Noncancer Models
- •Alternative Vertebrate Models
- •Selected Readings
- •Overview
- •Intellectual Disciplines and Research Tools
- •Comparative Effectiveness Research
- •Patient-Centered Outcomes Research
- •Data Synthesis
- •Overview
- •Intellectual Disciplines and Research Tools
- •Disparities
- •Quality Measurement
- •Implementation Science
- •Patient Safety
- •Optimizing the Health Care Delivery System
- •Overview
- •Intellectual Disciplines and Research Tools
- •Policy Evaluation
- •Surgical Workforce
- •Conclusion
- •References
- •Introduction
- •What Is Evidence-Based Medicine?
- •Evidence-Based Educational Research
- •Forums for Surgical Education Research
- •Conducting Surgical Education Research
- •Developing Good Research Questions
- •Beginning the Study Design Process
- •Developing a Research Team
- •Pilot Testing
- •Demonstrating Reliability and Validity
- •Developing a Study Design
- •Data Collection and Analysis
- •Surveys
- •Ethics
- •Funding
- •Conclusions
- •Selected Readings
- •Genomics
- •Gene-Expression Profiling
- •Proteomics
- •Metabolomics
- •Conclusions
- •References
- •Selected Readings
- •Introduction
- •Why Write
- •Getting Started
- •Where and When to Write
- •Choosing the Journal
- •Instructions to Authors
- •Writing
- •Manuscript Writing Order
- •Figures and Tables
- •Methods
- •Results
- •Figure Legends
- •Introduction
- •Discussion
- •Acknowledgments
- •Abstract
- •Title
- •Authorship
- •Revising Before Submission
- •Responding to Reviewer Comments
- •References
- •Selected Readings
- •Introduction
- •Origins of the Term
- •Modern Definition and Primer
- •Transition from Mentee to Colleague
- •Mentoring Risks
- •Conclusion
- •References
- •Selected Readings
- •The Career Development Plan
- •Choosing the Mentor
- •Writing the Career Development Plan
- •The Candidate
- •Research Plan
- •Final Finishing Points About the Research Plan
- •Summary
- •References
- •Introduction
- •Decisions, Decisions!
- •Mission Impossible: Defining a Laboratory Mission or Vision
- •Project Planning
- •Saving Money
- •Seek Help
- •People
- •Who Should I Hire?
- •Advertising
- •References
- •Interviews
- •Conduct a Structured Interview
- •Probation Period
- •Trainees
- •Trainee Funding
- •Time Is on Your Mind
- •Research Techniques
- •Program Leadership
- •Summary
- •Selected Readings
- •Introduction
- •Direct Evidence
- •Indirect Evidence
- •Burnout
- •Prevention of and Recovery from Work–Life Imbalance
- •Action Plan for Finding Balance: Personal Level
- •Action Plan for Finding Balance: Professional Level
- •Conclusion
- •References
- •Introduction
- •Time Management Strategies
- •Planning and Prioritizing
- •Delegating and Saying “No”
- •Action Plans
- •Activity Logs
- •Scheduling Protected Time
- •Eliminating Distractions
- •Buffer Time
- •Goal Setting
- •Completing Large Tasks
- •Maximizing Efficiency
- •Get Organized
- •Multitasking
- •Think Positive
- •Summary
- •References
- •Selected Readings
- •Index
Chapter 4. Ethics in Surgical Research |
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mentees to exchange research ideas, as well as scientific standards and ethical research behavior. Mentors should also model how to perform “good” science, as only “good” science is ethical science. Careless research is unethical as it wastes societal resources, exposes subjects (e.g., humans and/or ani- mals) to unnecessary risks, and may result in erroneous find- ings that can damage future research endeavors or even injure patients.As such, researchers need to exercise caution in their research to identify and obviate “avoidable” errors. Errors in the conduct of research can be due to sloppiness, the desire to produce results quickly, or unconscious bias to demonstrate a particular result that may prevent a researcher from question- ing the premise of a given hypothesis. While some errors are honest “mistakes,” the ethical surgeon-scientist strives to avoid errors in his/her research as a means to respect the sci- entific process, as well as the resources entrusted to him/her.
Conflict of Interest
Ethical scientific research should strive to be devoid of bias.
One form of bias that has garnered much attention in the lay press has been the issue of conflict of interest.16 Conflict of interest can be defined in many ways, but should be consid- ered that set of conditions in which professional judgment concerning a primary interest may be perceived to be unduly influencing a secondary interest.17 Conflicts of interest may revolve around financial reimbursement, industry support of research, but also – as previously mentioned – publication and promotion. It is important to understand that even the perception of a conflict of interest can damage the trust that the public, patient, or subject has in the medical and research enterprise. Conflicts of interest that are handled poorly can also injure the surgeon-scientist’s reputation and career. The surgeon-scientist must therefore be aware of any and all potential conflict of interests when it comes to his/her research. In an era when surgeons frequently partner with industry in the conduct of research, it is not possible to eradi- cate all potential for conflict of interest. In fact, a conflict
54 T.M. Pawlik and M.L. Schwarze
does not necessarily imply unethical behavior, but rather the potential to have bias influence the outcome of the study.As such, the ethical ramifications are determined more by the manner in which the surgeon-scientist handles and addresses any potential conflict of interest.
Full disclosure can mitigate some conflicts of interest. Academic institutions typically have a specific policy that out- lines the rules of what and how potential conflicts of interest must be disclosed. It is each surgeon-scientist’s responsibility to familiarize themselves with their respective institution’s policy and ensure compliance with these policies. Researchers are ethically obliged to divulge connections between any third party and their research that may seem to benefit themselves or their research. Disclosure should include not only financial remuneration for the specific investigator, but in most circum- stances, any family members with financial ties. As it is often difficult for individual investigators to assess objectively the potential for conflict of interest, independent institutional review is necessary. Most institutions now review faculty dis- closures to determine whether a conflict of interest exists and if it has been appropriately managed. Some conflicts can be managed with external oversight to allow researchers to con- tinue their work. In some circumstances, however, certain conflicts cannot be managed, and researchers may need to divest from a specific area of research or the industry tie.
Publication and Authorship
Publication is the “coin” of the academic realm.Authorship – particularly primary or “first” author and “senior” author status – is important to the surgeon-scientist as it has implica- tions for career advancement and promotion. Unfortunately, issues around authorship can be ethically problematic. Junior researchers can be denied first authorship despite having contributed significantly to the study design, data collection and analysis, as well as drafting and revision of the article. Other times, authorship is “awarded” on an honorary or
Chapter 4. Ethics in Surgical Research |
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“quid pro quo”basis to individuals who have not had a mean- ingful contribution to the research project. The Vancouver Group has defined authorship based on several criteria.18 Authors should be involved in (a) the design of the experi- ment, analysis and interpretation of the data, (b) drafting or critically revising the manuscript,and (c) final approval of the product to be published. In essence, all manuscript authors need to have made substantial contributions to the work and be able to take responsibility for the work. Participation as a co-author based solely on seniority, funding, or collection of the data (e.g.,“well, I am the one who did the cases you ana- lyzed in the study”) does not constitute authorship.
Discussion about authorship is best done when the project is beginning.The principal investigator and junior researcher should have open, transparent, and frank conversations about expectations regarding the project. Specifically, the principal investigator should establish what his/her expecta- tions are regarding the amount and type of work that is expected of the junior researcher if he/she is to be the first author. The junior researcher then has a much better idea of what will be required in order to claim primary authorship. In some instances, discussions about possible contingency plans should also be explored (e.g., “if you are unable to finish the project and the next fellow does most of the work, we will need to re-examine the issue of authorship”). As with most ethical dilemmas, the key to successfully navigating the waters of authorship is good communication and a relation- ship built on mutual respect and trust.
Conclusion
Surgeon-scientists are frequently faced with ethical chal- lenges both at the bedside and in the laboratory.The research environment is enmeshed with issues around objectivity, hon- esty, and respect for persons. Seniority, hierarchy, and power imbalances can further complicate the ethical landscape of the surgeon-scientist.An environment characterized by open
56 T.M. Pawlik and M.L. Schwarze
communication, high ethical standards, and a focus on doing “what is right” should be the goal of each surgeon-scientist. To be a scientist is to engage in behavior with certain moral and ethical implications.19 Surgeons should not shrink from this responsibility. Instead, academic surgeons should actively engage in the moral issues inextricably linked to their research. It is only through this engagement that we can empower ourselves to not only be better researchers to improve the quality of scientific research, but also better phy- sicians to improve the quality of care we deliver to those who depend on us for help.
References
1. Markel H. Experiments and observations: how William Beaumont and Alexis St. Martin seized the moment of scientific progress. JAMA. 2009;302:804-806.
2. Fost N, Levine RJ. The dysregulation of human subject research. JAMA. 2007;298:2196-2198.
3. The Nuremberg Code. JAMA 1996;276:1691.
4. WorldMedicalAssociationdeclarationofHelsinki.Recommendations guiding physicians in biomedical research involving human subjects. JAMA. 1997;277:925-926.
5. McCallum JM,Arekere DM, Green BL, et al.Awareness and knowl- edge of the U.S. Public Health Service syphilis study at Tuskegee: implicationsforbiomedicalresearch.J Health Care Poor Underserved. 2006;17:716-733.
6. GoliszekA.In the Name of Science.NewYork:St.Martin’s Press;2003.
7. Services UDoHaH. Protections of human subjects, 45 CFR 46. 1991.
8. Skolnick BE. Ethical and institutional review board issues. Adv Neurol. 1998;76:253-262.
9. Weijer C, Dickens B, Meslin EM. Bioethics for clinicians: 10. Research ethics. CMAJ. 1997;156:1153-1157.
10.Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA. 2000;283:2701-2711.
11.McKneally MF, Ignagni E, Martin DK, D’Cruz J. The leap to trust: perspective of cholecystectomy patients on informed decision mak- ing and consent. J Am Coll Surg. 2004;199:51-57.
12.Biffl WL, Spain DA, Reitsma AM, et al. Responsible development and application of surgical innovations: a position statement of the Society of University Surgeons. J Am Coll Surg. 2008;206:1204-1209.
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13.Jones JW. Ethics of rapid surgical technological advancement. Ann Thorac Surg. 2000;69:676-677.
14.Resnik D. The Ethics of Science: An Introduction. New York: Routledge; 1998.
15.National Academy of Sciences NAoE, Institute of Medicine.
Responsible Science: Ensuring the Integrity of the Research Process.
Washington, D.C.: National Academy Press; 1992.
16.Morin K, Rakatansky H, Riddick FA Jr, et al. Managing conflicts of interest in the conduct of clinical trials. JAMA. 2002;287:78-84.
17.Thompson DF. Understanding financial conflicts of interest. N Engl J Med. 1993;329:573-576.
18.International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to biomedical journals. JAMA. 1993;269:2282-2286.
19.Pawlik TM, Platteborze N, Souba WW. Ethics and surgical research: what should guide our behavior? J Surg Res. 1999;87:263-269.
Chapter 5
Analyzing Your Data
Taylor S. Riall
Keywords Type I and type II error • Randomized controlled trial • Study design • Case-control study • Observational study • Multivariate analysis • Selection bias
This chapter is an introduction to data analysis for surgeonscientists beginning their academic careers. It is not meant to provide an in-depth review of all possible biostatistical meth- odologies. Rather, it is designed to assist surgeons in becom- ing informed users of biostatistics. The chapter will cover study design and analysis hand-in-hand, as the outcome of any study is critically dependent on both factors. If a study is poorly designed, no amount of statistical analysis will com- pensate. Likewise, a well-designed study can produce irrele- vant results if it is not properly analyzed. Consult with a statistician early and often throughout the course of any study to prevent critical errors in design and analysis. Formal training in basic biostatistics is also recommended, not so that you can perform your own data analysis, but so you can use your clinical knowledge to guide the statistician and interpret the results of the analyses.
T.S. Riall
Department of Surgery, University of Texas Medical Branch,
Galveston,TX, USA
H. Chen and L.S. Kao (eds.), Success in Academic Surgery, |
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DOI 10.1007/978-0-85729-313-8_5,
© Springer-Verlag London Limited 2012