StARR Curriculum

Although the cornerstone of the proposed research training will be a one-on-one mentored research experience under the supervision of an established investigator, a core curriculum of short courses and seminars addressing the fundaments of clinical and translational research is integral to the proposed research training. The coursework will focus on basic clinical and translational research approaches, research ethics, scientific leadership, team science, mentorship training, scientific and grant writing, instruction in rigor and reproducibility, sex as a biological variable, etc. Note that these courses are not offered as part of a degree program, but rather to enhance the fundamental knowledge of research approach and conduct.

These tailored short courses, seminars and workshops will provide skills in research topics including:

• Scientific and grant writing
• Training in basis statistical approach and research methodology
• Training in basic data management
• Training in basic epidemiology
• The science of team science
• Training on maximizing the mentorship relationship
• Academic survival and leadership skills

An essential component of the trainees’ development is their mentored research project experience.

• All Emory StARR trainees will be required to have an investigator initiated, hypothesis-driven, mentored clinical research project that will be carried out during the protected research training period. This project will be proposed during the initial application to enter the Emory StARR and can be updated and further revised if appropriate after acceptance.
• The mentored research project will be carried out under the guidance of the trainee’s lead mentor. Mentor selection will be made in consultation with program leadership, but often will be intuitively linked to projects already underway or through identification of a logical mentor based on trainee’s research interest. Trainees and their lead mentor will meet on a regular basis (e.g., weekly) as outlined in the trainee’s program application and in their individual development plans (IDP).
• In order to ensure that mentors devote sufficient time to the research training needs of the individual trainee, lead research mentors will only be allowed to mentor one Emory R38 RTP at a time.
• The expectation of productivity for trainee research projects is high, and we will require the submission of at least one original research manuscript at the completion of the program.
• Mentors and trainees will sign "mentorship contracts" which outline the role of the mentor and trainee and their responsibilities.
• Each trainee will also have a Research Advisory Committee that will meet every six months to review the trainee’s research training program, goals, and scientific progress. This committee will consist of the trainee’s lead research mentor, other experts involved in research related to the trainee's area of interest, and a member of the EC.

Ultimate success of the Emory StARR will be the development of a cadre of resident physicians who will go on to pursue careers in the biomedical research workforce.  The following mechanisms will provide evaluation of the success of the short coursework and of ongoing mentoring in meeting the needs of our trainees.

• Baseline data extraction. Once accepted to the program, with the help of the program coordinator, we will extract baseline data from the trainees’ applications and CVs. This includes prior research training, degree attainment, publications, presentations, and funding/awards. We will use these baseline data to measure change throughout the program and after completion.
• Individualized development plans (IDPs). At the beginning of the program, the trainees will complete an IDP to explicitly outline their areas of development during their time as a trainee. The IDPs include statements about their long-term career goals, short-term goals, strengths and weaknesses, specific action steps to attain goals, identified opportunities for career development, funding and publishing opportunities and feedback from their mentors. These plans will be used as a mechanism to communicate goals with mentors as well as monitor and adapt their training to meet individualized career benchmarks. On semi-annual basis, the IDPs will be signed by mentors and reviewed by the PIs.
• Surveys of program effectiveness from the view of the trainees will be conducted annually by the program coordinator. The survey will include questions about the quality and utility of the didactic coursework, seminars and workshops.  Trainees’ satisfaction with the performance of their mentors will be assessed on a numeric scale, and qualitative data collected in free text regarding quality of mentoring.
• PIs review meetings will be conducted twice yearly with trainees. This face-to-face interview will allow assessment of trainees’ satisfaction with the Program. The two MPIs will summarize points of discussion in a letter to be included in each trainee’s file, and with the EC.
• Trainees’ progress reports will be submitted annually via an available electronic database management tracking system. These reports gather information regarding publications, abstracts, presentations, overall progress in a project, and specifics of didactic training.
• Mentor’s assessments will be gathered annually, at the same time as the trainee progress reports. These are qualitative assessments of the performance of the trainee’s performance, potential, skills, and any problems that need to be addressed.

Trainees in the responsible conduct of research will include didactic and hands-on training in bioethics, and scientific integrity. The Emory StARR goals for responsible conduct of research include the following:

• Educate trainees on the ethical issues, Federal, State and local regulations and guidelines that support the proper conduct of clinical research in the U.S.
• Educate trainees on the role of the Institutional Review Board (IRB) in assuring the proper conduct of clinical research throughout Emory University.
• Educate trainees on the guidelines and standard operating procedures of the IRB of Emory University.
• Educate trainees on their responsibilities as defined by Federal regulations, ICH guidelines and Emory University research procedures before, during, and after completion of a clinical research study or trial.
• Provide an ongoing educational process to continue the education of trainees and ensure the continual protection of human subjects engaging in clinical research

Coursework

Trainees will participate in Instruction in the Responsible Conduct of Research, sponsored by the Emory Center for Ethics that addresses the ethical conduct of scientific research and covers the six areas of instruction mandated by the NIH for its National Research Service Award trainees, namely, data management, policies and procedures for handling misconduct, authorship and credit, conflicts of interest, the use of human subjects in research, and the use of animals in research. Topics include: informed consent considerations and pitfalls; the responsible collection, retention, sharing, and interpretation of data; research misconduct – falsification, fabrication, and plagiarism; data manipulation and torturing; responsible authorship; intellectual property; research with special populations; conflict of interest; peer review; the ethics of using animals in research. The objectives of the course are:

• To meet federal requirements for training in ethical scientific conduct
• To improve behavior outcomes related to ethical decision making
• To improve moral reasoning
• To develop core competencies in the responsible conduct of research
• To increase appreciation for ethical guidelines, standards, and etiquette
• To increase awareness of ethical guidelines, rules, and regulations related to research
• To increase the understanding of making and responding to allegations of misconduct
  

Emory Human Subjects Education

All Emory R38 RTP will also participate in the following trainings:

• Certification in human subject protection and good clinical practice (GPC) through the Collaborative Institutional Training Initiative (CITI) Program and if conducting research in U.S. Veterans, complete the VA Privacy & Information Security Awareness and Rules of Behavior and Privacy Policy Web Training
• Certification by Office of Clinical Trials – Emory University sponsored research training including key concepts in clinical research offered by the Office for Clinical Research, Emory conflict of interest training and certification, and Emory Center for Ethics lectures series on research ethics .
• Protecting Human Research Participants training offered by the NIH Office of Extramural Research and the Protecting Human Subjects Training offered by the US Department of Health and Human Services Office Health Resources and Service Administration.
• Journal Club—participate in the monthly research journal club with the MSCR class where policy articles and research ethics peer-reviewed publications are reviewed, critiqued, and discussed.
• Receive one‐on‐one mentoring from their primary mentors in the responsible conduct of research as part of the implementation of the mentee’s research project, including discussions about ethical challenges in conducting research on vulnerable populations such as HIV‐infected and pregnant or incarcerated populations, conflict of interest, responsible authorship, policies for handling misconduct, data management, and data sharing.