MS in Biomaterials: Research Requirements and Guidelines
Requirements for Participation in Research
All students must complete a series of training modules in order to start a research project in the Department of Biomaterials. Students must take lab safety training from the Environmental Services Department at NYU Dentistry or from qualified laboratory personnel at the Department of Biomaterials and Biomimetics. The student must provide documentation of this training to the Department before starting activity in the department laboratories. All students are also required to take the Laboratory Orientation session offered by the department before starting activity in the laboratories. All students, as part of their overall training, must take Lab Safety, Hazardous Waste, Biosafety/Bloodborne Pathogens, HIPAA, and the human subjects tutorial during the course of their training. However, if the student does not directly need these modules to start their research project, they may take these training sessions when available at any time during the program.
If the student’s proposed research project involves contact with any human material, patient contacted products, or patient information; before research may begin, the student will be required to take the following training and submit documentation indicating completion to the Program Administrator: Bloodborne Pathogen training; Human subjects tutorial; and HIPAA tutorial. In addition, the student must submit through the Lab Manager and the Dean of Research a copy of an approved thesis proposal and application to do research on human material to the Institutional Review Board (IRB).
Guidelines for Completing Research Requirements
The following outlines a stepwise process for completion of the Master’s Thesis research, dissertation, and defense:
The first step in this process is formulation of a preliminary proposal for a research project. This project can be based on the student’s background or interests, literature review, or consultation with potential mentors or with peers. The student should conduct a preliminary literature survey on the proposed thesis project, and then compose this preliminary proposal as a concise document (1-3 pages, single spaced, 12 pt type) containing introduction, rationale, and specific aims sections. This must be submitted to the department, Director of Graduate Studies (DGS) and, laboratory manager (LM), and Department Chair for approval.
Based on the area of interest of the preliminary proposal, the student should select a committee and a thesis mentor who heads the committee. The committee comprises the mentor and a minimum of two additional faculty mentors. Based on the preliminary proposal a mentor may be suggested by program administration. The primary mentor must be selected from department faculty. Of the committee members, one of these can be from outside the department or from another institution. Faculty from outside of the department are encouraged to be involved in the mentoring process. Students should consult the department administration, including the laboratory manager (LM) and Director of Graduate Studies (DGS) if they have questions identifying faculty appropriate for the project. Upon selection of a thesis mentor and committee the student must notify departmental administration of the selections. The selections must be approved by the program administration. The thesis mentor and committee members must approve their selections and the primary mentor must approve the preliminary proposal to the Director of Graduate Studies (DGS).
Once the preliminary proposal and thesis mentor selections have been approved by department administration, the student must prepare a formal thesis proposal. This proposal comprises a detailed plan for the student’s thesis research and, if it is composed properly, it will become the introductory and technical (Materials and Methods) basis of the thesis. This proposal is in a format similar to those used for industrial and basic science research proposals and preparation of this document is part of the training process for the degree. The thesis proposal must have the following sections and content (this is covered in detail during the Introduction to Research Course): Introduction — This section must contain the background (critical review of the literature on the research subject), significance of and rationale for the proposed research project, a summary of the specific aims, and the hypothesis (working hypothesis and null hypothesis) of the proposal.
- Materials and Methods: This section must contain the specific technical procedures, experimental plan, and statistical analysis methods to be used in the project. Whenever applicable, a statistical power analysis should be included to ensure that adequate statistical power is incorporated into the proposed work. Materials and devices that are required from corporate sponsors must be specified here.
- Expected Results: This section should contain a summary of the specific expected outcomes of the proposed research. It should also include potential problems and suggested solutions to those problems.
- Proposed Timeline: A proposed timeline for the research should be included. This will include timelines for specific experiments, expected milestones related to specimen preparation, analysis, data analysis, and thesis preparation.
- Budget: A detailed list of material, lab, outside testing costs.
Students are strongly encouraged to submit intermediate stages of this proposal to their mentors. A thesis proposal should never be submitted in its expected final form. Program administration, in particular the Laboratory Manager, must be involved with formulation of the proposal in order to ensure that all student training, laboratory safety, animal protocol, and institutional review (for human clinical studies) requirements are met. In addition, it is extremely important that the Lab Manager reviews all protocols to ensure that the proposed work can be conducted in an efficient and timely manner within the department and college facilities. The finished thesis proposal must be approved by the mentor and accepted by the department faculty at the time of presentation before further work is conducted.
The last stage in thesis proposal preparation is presentation of the proposal at one of the Biomaterials Group Meetings. This represents both a valuable training exercise for public presentation of research as well as a way to get feedback from faculty and students regarding all aspects of the project.
The student’s thesis research comprises the most technically difficult aspect of the Master’s program. There are several aspects of this work that deserve consideration:
- Clinical studies, or studies that; (a) utilize any human tissue or fluids, (b) utilize biomaterials, devices, or instrumentation that has come in contact with human patients are subject to Institutional Review Board (IRB) approval. Students conducting this type of research must have special training for Blood Borne Pathogens, HIPAA, and human subjects (see Section 2.2) and submit appropriate protocols to IRB before the research commences. Students must work closely with the Laboratory Manager and program administration to make sure these requirements are met. IRB applications must be prepared in coordination with the Lab Manager and submitted to the Associate Dean for Research for approval before being submitted to the IRB. IRB approval must be documented with the Lab Manager prior to project initiation.
- Animal studies, or studies that utilize any animal tissue or fluids, are subject to Institutional Animal Care and Use Committee (IACUC) approval. Students conducting this type of research must have special training, and submit appropriate protocols to IACUC before the research commences. Students must work closely with the Lab Manager to make sure these requirements are met.
- Use of laboratory facilities. Students are responsible for learning to properly use the laboratory facilities necessary to conduct their research. In many cases this will require special instruction from laboratory faculty and staff. Students should be prepared to arrange appointments with appropriate personnel for this training, and must be prepared to arrange and keep appointments for use of laboratory facilities. In many cases it is necessary to use a sign-in schedule or log. It must be anticipated that some facilities will be over utilized, so facilities scheduling must be arranged and strictly followed in order to optimally utilize existing facilities and available time.
When using laboratory facilities the student is responsible for the care of those facilities. This means using the facilities in a proper and safe manner, keeping the facilities clean and in working condition, and reporting any and all malfunctioning or broken equipment to the laboratory manager. The department recognizes that malfunction and breakage are a normal part of facilities use and wear. All malfunctions and breakage must be immediately reported to keep the facilities safe and working properly.
- Research materials and contract research. Many projects involve the use of components, devices, materials or parts provided by companies or entities outside of NYU. All arrangements for funding or use of materials from outside the department MUST be made through the program administration and not directly between the student and the company. In this way, the administration can make sure that contract studies are properly funded, can track the contributions of suppliers, and prevent conflict of interest problems.
- Research record keeping. Students must keep a detailed laboratory notebook of all research conducted in the laboratories. This includes thesis research as well as preliminary projects and side projects that do not become part of the thesis. The laboratory notebook(s) must be kept in the laboratory, and all observations, data, and statistical analysis must be documented here.
While conducting the thesis research project, the student should begin writing the Master’s dissertation. The thesis proposal should represent the starting document for this effort. A summary of the final format of the thesis is included in the appendix section of this document. All students are encouraged to read dissertations available in the department library as examples of proper thesis format.
Students must submit drafts of sections of the dissertations to their primary mentor for review. They are encouraged to get significant input from their mentor at every stage of thesis writing. The mentor will assist in editing the thesis and will determine when the thesis is ready for distribution to the other thesis committee members. Along with the thesis committee, the final thesis must be submitted to the Director of Graduate Studies and to the department chair. At this time the Master’s Degree Checklist must be completed (see Appendix). The committee will not sign final documentation for graduation without the completion of this checklist.
A date acceptable to the student, the mentor, and the committee will be scheduled for the thesis defense by the program administrator. This date must be at least three weeks after the semi-final thesis is submitted to the thesis committee. Announcement of the defense will be posted within the school.
The thesis defense is public and will follow this format: the student, after being introduced by the mentor or Director of Graduate Studies will present an oral presentation summarizing the thesis research. This should be conducted using the same organizational format as the dissertation, and should take approximately 40 minutes. This will be followed by a question and answer period in which the audience can participate. After this period the audience will be excused and the committee members will question the student. After this period the student will be excused and the thesis committee will consider which of the following grades should be awarded to the student: ‘pass without revisions’, ‘pass with revisions’, or ‘fail’. In the case of a ‘pass without revision’ grade, the committee will sign the final documents for submission to the Graduate School of Arts and Science for graduation. This however is rare as revision is usually required. The ‘pass with revisions’ option means the committee will sign the final documentation only when revisions acceptable to the committee are submitted. In the case of a failing grade, the committee may or may not propose an optional plan for the student to conduct additional thesis research. A student accepting the plan may be considered for thesis defense at a later date.
The student who has passed the thesis defense and completed the checklist must provide a minimum of four (4) bound copies of the thesis: one each for the department library, the school library, the mentor, and the student. Additional bound copies may be ordered at the student’s discretion. All bound copies must be identical and comprise the final form of the dissertation.