Detailed Description of the Research Component of the Residency
PGY-1
1. All PGY-1 residents have access to a list of the ongoing orthopaedic research projects identified by faculty member. This list contains the titles of both basic science and clinical research projects. Residents at this level are encouraged to consider participation in ongoing research by specific faculty members, or alternatively, they may develop research projects of their own.
2. PGY-1 residents in the Orthopaedic Research Laboratory complete a one-month research rotation during their internship year. During this time, they observe ongoing research activities to become acquainted with the techniques being utilized to address both clinical and basic science research questions. Residents also have the opportunity to gain core competencies in clinical and laboratory services. Residents complete the specific activities described in the Resident Rotation Checklist during their rotation. This checklist is maintained as a part of each resident’s research file.
Goals and Objectives:
1. Learn techniques for research planning and project implementation.
2. Become familiar with ongoing research in the Department of Orthopaedic Surgery and the Orthopaedic Research Laboratory.
3. Become acquainted with the research resources available in the Orthopaedic Research Laboratory.
4. Choose a tentative area of research interest and identify a mentor.
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PGY-1 – Resident Rotation Checklist
Use of the Computer in Research
Residents work with Cindy Livingston to learn the proper method to design data forms for the efficient collection and analysis of study data. Residents also learn how to collect data using web-based data collection methods. Because computer technology is constantly evolving, Ms. Livingston provides computer instruction concerning the operation of new equipment and software as it is upgraded.
Tissue engineering
Residents shadow the physician scientists who are working on projects at the Wake Forest Institute for Regenerative Medicine to become familiar with the tissue engineering techniques.
Prosthetics/Orthotics
Residents attend two clinics with Tony Saia and/or Jim Butts to learn about the different types of prosthetics/orthotics used for diabetic foot patients, amputees, and pediatric cerebral palsy patients. They also learn how these devices are fabricated and fitted.
Electromyography Lab, Department of Neurology
Residents attend two clinics with Francis Walker, MD to learn about the use of EMG and ultrasound in the diagnosis of neurological pathophysiology.
Vascular Surgery Laboratory
Residents attend the laboratory to observe ultrasound evaluations of vascular perfusion of the extremities.
Radiology
Pediatrics: Residents spend one day with pediatric radiologists to learn about radiological techniques that are used in pediatrics (e.g. ultrasound). They learn how to order the tests and to interpret the results.
Adult: Residents spend two days with radiologists to gain more specific knowledge on the interpretation of adult imaging studies.
Physical/Occupational Therapy
Residents spend three days at CompRehab working with therapists in the sports, hand, and spine therapy units. They become familiar with the different therapy protocols that have been developed for specific diagnoses and have the opportunity to observe patients involved in various rehabilitation programs.
Residents spend one half day at the WFU Baptist Medical Center Inpatient PT/OT department to observe the therapy ordered by the Department of Orthopaedics.
Biomechanics
Because of the Wake Forest University School of Medicine collaborations with Virginia Tech, residents who are interested in pursuing studies involving biomechanical principles may be referred to faculty and students at Virginia Tech if assistance outside the scope of our departmental resources is necessary.
Casting techniques
Residents spend a day with Phillip Rock to learn how to apply casts and splints.
Microsurgery Course
Residents complete a Microsurgery course during their research rotation. The course usually takes 10-15 hours to complete but is tailored to meet each resident’s learning rate. Instruction in microsurgery techniques are taught in a microsurgical suite located within the main orthopaedic research laboratory. Michael Callahan, PhD directs this course.
Orthopaedic Extremity Laboratory
Residents spend one day in the Orthopaedic Extremity Laboratory in order to learn how to perform an isolated cold stress test with laser Doppler fluxmetry, laser Doppler perfusion imaging, and vital capillaroscopy. These non-invasive techniques allow for the quantitative analysis of extremity perfusion at the microvascular level. Residents learn how these tests are used to evaluate microvascular perfusion before and after medical or surgical intervention and how to interpret the test data. Derangements of microvascular blood flow are common in diverse conditions including Raynauds disease/phenomenon, complex regional pain syndrome, and post-traumatic disorders.
Orthopaedic Research Laboratory (Animal Model Studies)
Residents spend a day with the technicians in the laboratory observing research involving the use of animal models. Residents complete the Animal Care and Use Examination so that they can complete the microsurgery course and pursue animal studies.
Outcome Studies
Residents complete the “on-line” program required to receive a Certificate of Clinical Research Conduct. This program satisfies all Institutional Review Board and HIPAA guidelines and provides the certification necessary for residents to work with patients enrolled in study protocols. Residents spend two days assisting the departmental clinical project managers with their various clinical trials. Residents can choose to participate in the ongoing outcome study of their choice. This experience provides experience in how clinical outcomes data is collected and what happens to the data after it is collected. Residents learn how to conduct patient interviews, the strategies required to ensure that all data is collected at each visit, and the guidelines for proper adherence to study protocols and institutional and federal guidelines.
Pediatric Physiatry
Residents spend one day in the clinic with Kat Kolaski, MD. Dr. Kolaski treats pediatric patients with cerebral palsy and other musculoskeletal disorders. She works closely with the pediatric orthopedic surgeons to identify treatment plans to address each patient’s individual needs.
Participation in Ongoing Research
In addition to their own research project, residents may assist with one project that is in progress during the time of their rotation. Projects are identified from the list of current projects. Participation in such a project allows the resident to participate as an author of an abstract or manuscript.
Case Reports
In addition to the other research activities, residents are encouraged to prepare at least one case report. The topic for the case report is chosen by the resident. Faculty members also can assist with identifying potential case reports.
Anatomic Dissections
PGY-1 residents may be asked to assist with anatomic dissections scheduled during their research rotation.
Animal Care and Use Certification
Martha Holden supervises resident certification to work with research animals. This certification is required before residents can begin the Microsurgery Course.
Clinical Research Certification
In order to participate in clinical research protocols, residents are required to obtain CITI certification. Martha Holden supervises the CITI certification process.
Checklist
The progress of each resident in completing the Checklist activities is documented by noting on the checklist the date the activity was completed. All residents are expected to complete the items on the checklist by the end of their PGY-1 Research Rotation month. However, any items not completed during this one-month rotation are completed during the PGY-3 research rotation.
PGY-2
PGY-2 residents finalize the goals of their research project during this year to ensure the most efficient utilization of their time during the basic science/research rotation during their PGY-3 year. Residents submit a two-page proposal of their proposed research project to the Research Advisory Panel. The research proposal summary consists of the following elements: Name of Research Mentor, Project Title, Background and Significance, Specific Aims, Hypothesis, Methods (if it is a clinical project, include patient exclusion and inclusion criteria), Data Analysis Plan, and References. This preplanning enables residents to begin work on their project as soon as their Basic Science rotation begins during their PGY-3 year. The deadline for submission of the research proposal summary to the Research Review Panel is October l.
Meetings involving each resident and the Research Review Panel will be scheduled in the November/December time period of the PGY-2 year to clarify research goals and to discuss project implementation. These meetings provide an opportunity to finalize research plans and to identify the resources required for successful project completion.
Goals and Objectives:
1. Finalize research plans, with the goal of a publishable paper at the conclusion of the residency program.
2. Submit a research proposal summary for approval by the Research Review Panel. This proposal summary will become a part of each resident’s research file.
3. Residents= Research Day: present research plan
PGY-3
BASIC STRUCTURE
Two, two-month research rotations provide each resident with dedicated, protected time to pursue their research goals. During the Basic Science rotations, PGY-3 residents attend the weekly departmental research meetings and present progress reports on the status of their research at each meeting. Residents maintain a regular schedule to work on their research projects and document their activities during each week. A one-page summary of each resident’s research project status is submitted to the Research Review Panel at the end of the second research block.
Anatomic Dissections
PGY-3 residents assist with anatomic dissections for the Core Curriculum and various hand conferences. PGY-3 residents also are encouraged to use their free time to use the cadaveric specimens to further their understanding of commonly used surgical approaches, as their responsibility level during the PGY-4 year will be significantly increased in terms of cases on service rotations. Residents are encouraged to share their dissections with fellow residents as time allows. Cindy Livingston is the contact person within the Department for ordering cadavers for anatomic dissection.
Additional Duties
- OPD Clinic: ½ day per week
- Diabetic foot clinic: ½ day per week
- Assist with Resident Research Day
- Assist with visiting professors including hosting duties
- Verify weekly lectures with faculty and residents (email the weekly lecture schedule to the residents and faculty each Monday)
Goals and Objectives:
Significant progress should be made on the individual resident=s research project during the research rotations with the goal to complete the majority of work required to complete the project.
- A one-page progress report is due at the end of the rotation. This report will become a part of each resident’s research file.
- Resident Research Day: Provide a project progress update and any preliminary findings.
PGY-4
Residents continue work on their research project and should report any roadblocks to timely project competition to the Research Review Panel. The manuscript describing the project should be under preparation during this year.
Goals and Objectives:
1. Finalize work on research project.
2. Report progress to the Research Review Panel in September and February during a 10-minute meeting after the end of the Friday afternoon academic conference.
3. Resident Research Day: Progress report of research project.
PGY-5
Residents meet with the Research Review Panel one Friday afternoon in September. Their manuscript is submitted to the members of the Research Review Panel for their review no later than February 1st. This will allow panel members to review the paper and offer editorial comments. Resident research day presents the opportunity for each PGY-5 resident to provide a full description of their research project.
Goals and Objectives
1. Completion of project and manuscript. The manuscript will become a part of each resident’s research file.
2. Resident Research Day: Presentation of completed project
RESIDENT RESEARCH DAYS
In the fall, the Division of Surgical Sciences sponsors a Residents’ and Fellows= Research Day. Residents and fellows display posters and describe their research to a panel of judges for review. Prizes are awarded in several categories to acknowledge outstanding research efforts. Winners are announced at a dinner to honor the residents/fellows and their mentors. Our department has a history of winning prizes at this event.
Each spring, the Department of Orthopaedic Surgery sponsors a Resident Research Day. Residents (PGY-2-PGY-5) present their research during a Friday afternoon scientific session. The content of resident presentations varies according to the residency year. PGY-2 residents may present their plans for their proposed research project because they probably have not started collecting data. However, PGY-3 residents may be able to present preliminary data. If preliminary data is not available, they may present an update of the progress on their research project. PGY-4 residents present preliminary data. By PGY-5, the research project is in manuscript form ready for publication. Therefore, residents at this level present a comprehensive review of their research project.
The residents and visiting professor are honored at a dinner that follows the presentation. Since 2006, prizes have been awarded for the best clinical research presentation and the best basic science presentation.
AUTHORSHIP GUIDELINES
A. General Principles and Right Conduct
One of the missions of the medical school is to foster the discovery and application of new knowledge through basic and clinical research in the biomedical and relevant social sciences. Coupled with this mission is the responsibility to communicate truthfully this new knowledge to the rest of the scientific community. When publishing results of biomedical research, authors should adhere to certain standards that will assure the quality and integrity of the publication. Specially, authors should:
1. If possible, report results and their verification in a peer-reviewed forum;
2. Report all relevant data including conflicting data if pertinent to the hypothesis in question;
3. Acknowledge the work of others that is relevant to the context of the study and its interpretation;
4. Refrain from redundant primary publications of the same data;
5. Take ultimate responsibility for the scholarly character, accuracy, and conduct of the research performed under their supervision;
6. Present research in appropriate scientific forums before reports are released to the press; and
7. Alert editors and readers of potential conflicts of interest that may affect how the article will be interpreted.
Fabricating data, falsifying data, and/or knowingly representing the work of others as one’s own are serious violations of our mission and the public trust and constitute scientific misconduct.
B. Criteria for Authorship
Authorship refers to the listing of names of participants in all written communications of data and their interpretation to the scientific community. Authorship is the fulfillment of the responsibility to communicate scientific research to society and is the primary means for assigning credit for a scientist’s contributions to the advancement of scientific knowledge.
Authorship should be given generously, but only to those who have contributed significantly to the research, are prepared to stand behind their findings, and have reviewed the entire manuscript. All authors of a scholarly publication should meet the following four criteria:
1. Participate substantially in conception, design, and execution of the study, or in the analysis and interpretation of data;
2. Participate substantially in the drafting of the manuscript or in the substantive editing of the manuscript;
3. Give final approval of the version of the manuscript to be published; and
4. Be able to explain and defend in public or scholarly settings that portion of the study for which he or she was directly responsible, including potential conflicts of interest.
A claim of authorship by, or assignment of authorship to, persons who may have been associated in some way with a study but do not meet the four criteria above is considered highly inappropriate. The referral of patients included in a clinical study does not in and of itself warrant co-authorship status. Individuals who have made lesser contributions such as providing advice, occasional analyses, subject/patient material, space, or who may have supported the research in other ways, should be acknowledged. The practice of permitting honorary authorship is unacceptable and should be actively discouraged.
C. Responsible Author
One author, designated as the Responsible Author must assume overall responsibility for each publication (e.g., primary research report, abstract, review article, book chapter) submitted from the medical school. The Responsible Author is typically the faculty member who leads the study and who assumes the responsibility for coordinating and completing the work, drafting of the manuscript, satisfying pertinent rules for submitting the manuscript and any required revisions, and coordinating responses of the group to inquiries or challenges. The Responsible Author should exercise due diligence in assuring the validity of the entire manuscript.
The selection of the Responsible Author, inclusion of collaborators as co-authors, and the order of authorship should ideally be determined by the research team as a whole. Decisions regarding authorship and its order should, when possible, be determined before the study begins and any disputes resolved at that time. A written memo attesting to this determination is valuable documentation if a dispute subsequently arises. Changes in authorship, which take place as a study proceeds, should similarly be documented in writing. The Responsible Author should assure that all collaborators are appropriately recognized and that study collaborators listed as co-authors meet the criteria for authorship described herein. The Responsible Author does not necessarily have to be the first author.
The Responsible Author should assure that all co-authors have had the opportunity to approve the final version of a manuscript or abstract, that each co-author has reviewed the portions of the manuscript or abstract representing his or her contribution, and each is willing to support that material.
Each co-author must consent to authorship prior to submission of any manuscript bearing his or her name. In addition, each co-author should practice due diligence to assure the validity of the manuscript.
D. Students, Fellows, and Research Associates
All persons designated as authors should qualify for authorship as defined herein.
Faculty should be aware of their responsibility to ensure that students, postdoctoral fellows, and other research associates participate in the preparation of manuscripts and are recognized as authors in publications covering the results of research in which they were active participants.
E. Multi-Authorship/Multi-Center Manuscripts
These criteria are considered important because there has been a gradual diffusion of responsibility for multi-authored or collaborative studies that has led to the publication of papers for which no single author was prepared to take full responsibility. Multi-authorship, including authorship on papers from multi-center studies, raises special issues, such as the ability of an author to evaluate all aspects of a study and the sequence of listing of authors. Authors should discuss these issues openly before initiating a multi-authored project and repeatedly during the course of such work. To promote this process in multi-center studies, specially charged Publication Committees are often invaluable (see section on Disputes over Authorship). All authors should approve the final version of a manuscript and should be prepared to take public responsibility for the work. It is recognized, however, that medical studies often involve investigators from several specialties, and it may not always be possible for a single investigator to confirm each piece of data used in the written report. It is therefore the responsibility of each participating investigator to be actively involved in verifying the sections of a manuscript that discuss his or her specialty area, and to assure all co-authors that the sections are accurate and valid.
F. Disputes over Authorship
In general, authorship issues and related matters should be freely discussed and decided upon early during the research process and prior to writing of the manuscript. However, agreements relating to authorship may need to be changed during the collection of data and preparation of the manuscript. Possible disagreements include interpretation of the criteria for authorship, order of listing of authors, editorial control of content and focus of the manuscript, selection of journal or other publication media, and choice of Responsible Author.
1. A procedure for resolution of disputes over authorship is outlined along with a timetable for each step. It is recognized that extensions in the time to resolve a dispute may be necessary. When this occurs, the reason(s) for the delay in completion should be documented in the final report. All matters related to dissolution of authorship disputes should be held in a confidential manner as much as possible.
Disagreements between or among authors should be resolved in a collegial manner by the Responsible Author in consultation with the other authors, relevant research personnel, and any other individual who claims authorship. Generally, the Responsible Author has the primary responsibility for making decisions on authorship and other matters related to the publication of manuscripts.
When matters of authorship and related issues cannot be resolved in a satisfactory manner by the Responsible Author, other authors, research personnel, and other individuals who claim authorship, all should present their controversy in writing to the Department Chair. The manuscript in question should not be submitted for publication before these issues are resolved. The Department Chair should meet with the individuals involved in the dispute, collect and retain appropriate information, and make a recommendation in writing as to authorship within 60 days of receiving the complaint. When the authorship dispute involves the Chair, if the Chair has a major conflict of interest, or if the dispute involves more than one department, then a neutral mediator will be appointed by the Dean’s designee. The mediator should hold the rank of tenured professor and make a recommendation to the Chair within 60 days. Normally, the Chair will notify the Dean of an impasse, but the individuals involved also can make this notification directly.
In the event that a satisfactory resolution still cannot be achieved by the Departmental Chair or by a neutral mediator, then the Dean (or designee) will appoint three senior faculty members (one of whom will serve as Committee Chair from departments other than the involved departments) to a committee to investigate the dispute. The review group will not include individuals with personal responsibility for the research, but should include faculty members with unique qualifications relative to the dispute in question (i.e., research expertise, training of graduate students, experience with clinical trials, active peer-reviewed research, etc.). In the case of disputes involving faculty member from other schools within Wake Forest University, a member of the committee should be from the faculty of the affected school. In addition, a representative from the Office of Research will serve as Executive Secretary. Within 75 days, the committee will make a recommendation in writing to the Dean who will evaluate this recommendation and render a decision within 10 days. The decision of the Dean is final.
2. Disputes Over Authorship in Multi-Center Studies Publication, presentation, and authorship policies should be determined and accepted by all participating investigators at the beginning of any multi-center study. Specifically, it is recommended that a Publication Subcommittee representing all Investigators should be established at the beginning of any multi-center study for the purposes of expediting, coordinating, and monitoring the paper-writing processes. Inherent in these charges is the responsibility to adjudicate disputes over authorship. As with single-center studies, difficulties for a particular paper can be avoided if the identification and sequence of authors is agreed upon by all participants in advance. If a dispute between investigators from separate centers does arise, the solution to the dispute should arise from within the organizational structure of the multi-center study. If a dispute cannot be resolved, the principle of academic freedom generally indicates that an investigator has the right to present those data for which he/she is contract custodian. However, this right should be tempered by the concept of collegial collaboration. It is unacceptable for an investigator to publish or present a study’s finding before the total group of study investigators has had a reasonable opportunity to do so.
Resident Research Evaluation Form
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Resident Name: ____________________________________
Date of One Month PGY-1 Research Rotation: ______/______
month year
Dates of PGY-3 Research Rotation
1st rotation: ______/______ through ______/______
month year month year
2nd rotation: ______/______ through ______/______
month year month year
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YEARLY GOALS
PGY-1
1. Rotation checklist Completed □ Yes
□ No
2. Identify research project topic and faculty
mentor Completed □ Yes
□ No
PGY-2
1. Submission of summary of research: □ Completed
(Deadline: October 1) Date: __________
□ Not completed
2. One hour meeting with the Research
Advisory Panel: □ Completed
(November-December time period) Date: __________
□ Not completed
3. Resident research day presentation: □ Yes
□ No
PGY-3
1. Progress report submitted to Research
Advisory Panel: □ Completed
Date: __________
(Due the end of the second research rotation)
□ Not completed
2. Resident research day presentation □ Yes
□ No
PGY-4
1. September meeting with Research
Advisory Panel: □ Completed
Date: __________
□ Not completed
2. February meeting with Research
Advisory Panel: □ Completed
Date: __________
□ Not completed
3. Resident Research Day presentation: □ Yes
□ No
PGY-5
1. February meeting with Research
Advisory Panel: □ Completed
Date: __________
□ Not completed
2. Manuscript submission □ Completed
Date: __________
(Deadline: February 1) □ Not completed
3. Resident Research Day □ Yes
□ No