Master of Science in Clinical Research: Thesis or Substantive Research Project

Individuals pursuing the Master of Science in Clinical Research are required to complete a formal thesis or substantive research project. The project will count for up to 3 credits (see CLRES 2080: Master's Thesis Research) and must satisfy the following requirements:

  1. The final project must meet the National Institutes of Health (NIH) definition of clinical research: "Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies."
  2. It must be primarily independent work by the trainee.
  3. It must receive preliminary approval from both the trainee's academic advisor and the Institute for Clinical Research Education (ICRE) leadership.
  4. It must form the basis for a comprehensive review of competence by a formal review committee.

As described in detail below, there are three standard mechanisms that are considered appropriate for the substantive research project, subject to ICRE approval. To obtain approval, the trainee must submit a brief prospectus in the fall term of his or her second year in the program. The prospectus must provide a brief description of the intended project and must be approved by the trainee's advisor and, in turn, the ICRE leadership before the trainee may proceed. It also should identify three or four faculty members who will serve on the trainee's review committee. The following mechanisms are the standard options for the substantive project.

  • A standard thesis: A trainee may elect to write a master's thesis in his or her field of specialty. The standard thesis should follow this format. A thesis produced under this option must conform to all applicable University policies regarding theses (visit www.pitt.edu/~graduate/etd for details) and must be defended before the trainee's formal review committee (see below).
  • A grant proposal for an R01, K-award, or equivalent award: An eligible trainee may elect to write an R01 or equivalent research proposal on which he or she is the principal investigator and may submit the proposal as evidence of his or her ability to plan and conduct independent research. To satisfy requirements of the substantive project for the Master of Science in Clinical Research, the proposal must be reviewed and approved by an appropriate scientific review committee from the trainee's department and must be "submission ready." The proposal must also be reviewed and approved by the trainee's formal review committee (see below). Two members of the committee must be independent (i.e., not listed as key personnel on the grant). Note that career development awards funded through the K12 or KL2 mechanism may not be used as the substantive project.
  • Two manuscripts for publication in peer-reviewed journals: At the discretion of a trainee's ICRE advisor, the trainee may elect to write two first-authored manuscripts related to his or her research project and submit these manuscripts as evidence of independent work. The manuscripts must be original research papers organized and formatted for peer-reviewed journals; they must be "submission ready." Each manuscript must be reviewed by at least two members of the Review Committee who are not coauthors. At least one member of the committee must be independent (i.e., not a coauthor on either paper) , and only the trainee's mentor can be a coauthor on both papers. The papers must also be critiqued and approved by the trainee's formal review committee (see below).

Each of the options listed above must be reviewed and defended before a review committee, and members of the committee must be identified on the brief prospectus form. The review committee is chaired by the ICRE academic advisor (or another ICRE faculty member named by the advisor). At a minimum, the committee must include the ICRE advisor, the trainee's research mentor, and an ad hoc member who is familiar with the trainee's project. At least one member of the committee should be from the trainee's department. In addition, at least one member of the committee must be independent of the project. The ICRE advisor and ICRE leadership will determine if additional committee members with statistical or other methodological expertise are needed.

The trainee's presentation to the review committee should be scheduled at least 8 weeks prior to graduation to allow enough time for revisions and subsequent reviews. The trainee must provide the review committee members and the ICRE Degree Program Coordinator with copies of their substantive project at least 10 business days prior to the defense date. Once approval is granted by the review committee and formal documentation is submitted to the ICRE, the trainee will receive a passing grade for CLRES 2080 (Master's Thesis Research) and will be permitted to proceed with the graduation ceremonies.