PhD in Clinical Research Curriculum
PROPOSED CURRICULUM DEVELOPMENT PLAN
We propose to offer a PhD program that will emphasize epidemiological, methodological, cultural, and ethical issues inherent to clinical research in order to improve the quantity and quality of community-based research in the state. With this objective in mind, we seek to refine and implement a rigorous curriculum that will train scientists to conduct clinical research in emerging areas of biomedical and behavioral science. Encouraging the integration of quantitative, physical, behavioral, social and psychological sciences with the traditional biomedical sciences will promote the creation of new interdisciplinary research areas, as well as foster trainees' development as leading investigators in the emerging field of health disparities research. Adult learning theory and problem-based learning will be used to ensure that graduates develop the skills to become self-directed learners. The three competency domains include applied biomedical ethics, cultural competence, and multidisciplinary team building. All of the required courses, which will intensify clinical research training, have been specifically designed for the proposed PhDCR. Although MSCR students obtain foundational training in bioethics and cultural competence, the PhDCR will offer in-depth analytical and theory-generating interdisciplinary experiences that are not currently available in the MSCR. The proposed required PhDCR curriculum is explained in Table 1 and followed by specific course descriptions:
Table 1: Competency-based Curriculum for the PhDCR
Competencies |
Objectives |
|---|---|
Research : Develop and implement ethically and culturally appropriate clinical research that addresses health disparities in Asian and Pacific Islander populations. |
Conduct clinical research with cultural competence.
|
Professionalism/Ethics: Conduct ethically responsible and culturally competent clinical research. |
|
Culturally competent leadership and communication: Establish community- based research networks in area of interest. |
|
Interdisciplinary collaboration : Work collaboratively, interdependently and effectively with other members of the clinical research team. |
|
Self-directed learning : Demonstrate self-directed learning skills. |
|
Foundations of Biomedical Ethics (3 credits)
This course will explore the foundations of bioethics. Traditional notions of beneficence, nonmaleficence, autonomy and distributive justice will be discussed and challenged. The nature of health and disease, the definition of death, the morality of abortion, infanticide, euthanasia, physician-assisted suicide, germline genetic engineering, and triage decisions, for example, will be addressed within an integrated consideration of bioethics. Material regarding social justice, health care reform and research ethics, particularly in ethnic minority populations, will be reviewed. Issues will be considered from a broad perspective as well as within an Asian Pacific context. International and national legal and policy issues will be discussed, particularly as relevant to genetics, genomics and end-of-life decision making, as well as a range of other topics.Applied Biomedical Ethics (3 credits)
This course will delve more deeply in biomedical ethics by using case studies to incite discussions on topics such as: gene therapy, gene enhancement, genetic counseling, informed consent, health care professional/patient and investigator/study participant communication, advanced directives and living wills, clinical research in developing countries, clinical research in ethnic minority and socio-economically disadvantaged populations, and non-discrimination in health care and research settings. This course will encourage rigorous debate of complex issues. Trainees will refine analytical skills in order to approach problems by assessing benefits, risks, and alternatives and evaluating ethically acceptable solutions.
Cultural Competence in Biomedical Research I (3 credits)
This course will teach trainees to approach multidisciplinary research from a culturally sensitive perspective. This will entail a heightened awareness of the relationship between cultural and social beliefs and behaviors, particularly in health care and research settings. Trainees will be cautioned not to establish stereotyping strategies or “cookbook practices” that are assumed to apply to all individuals based upon racial or ethnic background, but rather to empathize with the patient in his or her unique circumstances. Communication skills, consideration of socioeconomic factors, racism and bias, and broad understanding of historical, cultural and social context will be fostered .
Cultural Competence in Biomedical Research II (3 credits)
This course will explore topics in cultural competence in greater depth, encouraging trainees to address issues from a unified yet flexible conceptual framework. This course will i nvolve building knowledge, skills and action plans to address a range of learning styles and to appreciate and benefit from diversity. Trainees will integrate content from different groups and cultures (content integration), learn to use teaching and working methods that facilitate achievement for all (equity pedagogy and mutual engagement), develop democratic attitudes, values and behaviors to reduce prejudice, and understand how knowledge is created and culturally influenced (knowledge construction). Trainees will develop comfort with differences, ability to control and change false beliefs and assumptions, and respect and appreciation for values and beliefs that differ from their own. Suggested topics include: operationalizing culturally competent care; using cultural audits to assess competence level; instituting climate change; improving customer service through cultural competence; conflict transformation and cultural healing; cultural competence educational activities; community engagement in participatory research; p rimary care practice-based research networks; diversity councils; awareness of gender, sexual preference, age, ethnicity and other factors; violence prevention and sexual harassment prevention; fostering a sense of community and social capital to build trust and networks; creating a wellness culture (for health care professionals as well as patients/study participants); and linking cultural competence to eliminating health disparities.
Team Building Seminar Component (3 credits)
Enrollment in a one-credit seminar each semester during the curriculum will be required. The team building component will focus on teaching trainees to work independently and collaborate in order to accomplish specific results. Trainees will be exposed to group dynamics, communication, healthy competition, conflict resolution, and innovative means of crossing boundaries between departments, organizations, industries and disciplines. They will develop skills to create a culture of respectful interaction, build working relationships, manage authority and responsibility and focus on achieving positive results. By learning to function as a unified whole and seek a shared vision, team members will learn to overcome traditional organizational boundaries to include and benefit health care providers, investigators, patients, study participants, and the broader support system within which they interact. Suggested topics include: frameworks for integration of socio-behavioral and biomedical research teams; diverse leadership styles; self-assessment and personality type evaluation; creative brainstorming and cross-disciplinary problem-solving; mind mapping techniques; mutual empowerment and engagement; negotiation and conflict resolution skills; reducing barriers to interdisciplinary collaboration; theoretical and practical aspects of managing interdisciplinary teams; team meeting agendas; delegating tasks and responsibilities; and developing productive partnerships. To meet requirements, trainees will need to actively participate in all meetings, accept responsibility for seminar presentations, perform satisfactorily on peer and mentor evaluations, and submit self-evaluation portfolios describing learning goals and outcomes. Through the seminar, trainees will learn to focus on collective goals rather than individual performance. As a result, trainees will greatly increase their capacity to collaborate in obtaining NIH and other extramural funding for conducting interdisciplinary clinical research.
Research Component (3+ credits)
Course offerings
MSCR
MSCR courses utilize “learn by doing” (integrate concepts through experiential training) and “just in time” (as issues arise in project implementation) approaches so effectively promoted in the UCSF program. Small class sizes encourage learning by participation, and didactic tea ching is incorporated as needed into active discussion format. At least 50% of class time focuses on interactive exchange, and courses incorporate individual trainee projects. For example, each trainee analyzes his or her own clinical dataset as part of the Biostatistics course. The first semester introduces trainees to clinical research, methods in epidemiology and biostatistics, regulatory issues, and bioethics. Bioethics is introduced early in order to instill ethical principles into all aspects of trainees' work. Two first semester courses cover biostatistics: one teaches introductory statistical methods; the other, statistical methods in epidemiology. The Applied Clinical Epidemiology and Biostatistics course emphasizes observational studies and randomized trials. For their class project, each trainee in the clinical epidemiology course designs a study he or she might choose as a practicum project. By the end of the first semester, the trainees are able to grasp basic processes of building patient-oriented research studies, understand biostatistics and clinical epidemiology, and analyze bioethical issues in clinical research.
The second semester builds upon the foundations laid in the first semester. In biostatistics, trainees learn regression methods for continuous, binary, count, and time-to-event data. As their course project, trainees perform analyses of secondary datasets. “Learning by doing” is especially important in biostatistics where abstract concepts must be applied to real clinical problems. The second semester also introduces bioanalytic methods in clinical epidemiology. Trainees learn the rationale, applications, and limitations of clinically relevant methods. Topics range from an introduction to molecular genetics and gene mapping to methods for detecting gene and protein expression. In the second semester, trainees are offered their first elective course, and are encouraged to build individual strengths and pursue unique interests. By the end of the summer, trainees are able to analyze research data with limited supervision, and know how to apply bioanalytic methods in clinical research.
In the third semester, trainees learn protocol development and scientific writing. This training is “just in time” in that trainees must present protocols to their research committees by the end of the semester. Trainees write their interdisciplinary protocols as a class project. In the third semester, trainees also take one or two elective courses. Trainees can select courses in epidemiology or biostatistics, qualitative or survey methods, basic science, genetics, or other areas of interest. By the end of the third semester trainees are prepared to start their independent mentored projects.
PhDCR
The fourth semester will focus on cultural competence, clinical research and protocol implementation. The fifth semester will further develop content related to cultural competency, applied bioethics, team building and project implementation, as described above. Students will also complete their comprehensive examinations. During the final semester students wanting to meet PhD requirements will complete their dissertations.
TABLE 2: Full-time Curriculum Model
| MSCR | PhDCR | |||||||
|
Year 1 |
Credits |
Year 2 |
Credits |
Year 3 |
Credits
|
Year 4 |
Credits |
Fall
|
Introduction to Clinical Research and Informatic Applications in Research |
2 |
Research Component (Practicum or Thesis Research) |
3 |
Foundations of Biomedical Ethics |
3
|
Research Component (Practicum or Dissertation Research) |
3 |
| Legal and Regulatory Issues and Bioethics and Institutional Review Boards | 2
|
Clinical Research Seminar | 1
|
Cultural Competence I | 3
|
PhD Clinical Research Seminar | 1 |
|
| Applied Clinical Epidemiology and Biostatistics | 3
|
PhD Clinical Research Seminar | 1
|
|||||
Clinical Research Seminar |
1
|
|||||||
| This semester | 8
|
4
|
This semester | 7
|
4 |
|||
Spring
|
Bioanalytic Methods in Clinical Research I |
2
|
Research Component (Practicum or Thesis Research) |
3 |
Applied Biomedical Ethics (II) |
3
|
Research Component (Practicum or Dissertation Research) |
3 |
| Applied Biostatistics in Clinical Research | 3
|
Clinical Research Seminar | 1
|
Cultural Competence II | 3 |
PhD Clinical Research Seminar | 1 |
|
| Clinical Research Seminar | 2
|
PhD Clinical Research Seminar | 1
|
|||||
| This semester | 7
|
4 |
This semester | 7
|
4 |
|||
Summer
|
Clinical Research Protocol Development and Scientific Writing |
3 |
Research Component (Thesis Research) |
3 |
Clinical Research Component |
3 |
Research Component (Dissertation Research) |
3 |
| Clinical Research Seminar | 1
|
Clinical Research Seminar | 1 |
PhD Clinical Research Seminar | 1
|
PhD Clinical Research Seminar | 1 |
|
| This semester | 4 |
4 |
This semester | 4 |
This semester | 4 |
||
| Cumulative | 19
|
31 |
49 |
61 |
||||
Total 48 credits
MSCR Possible Electives:
Possible elective choices:
Qualitative Research Methods (3)
Survey Research Methods (2)
Medical Informatics (2)
Gender Considerations in Research (2)
Multivariate Methods (3)
Principles of Human Genetics (3)
Health Economics and Policy (3)
If necessary, some trainees may complete their research practicum over a longer period of time by reducing the number of credits acquired during a specific semester and completing the 8-credit requirement as appropriate. This option will require enrollment in a no-credit seminar. All outcome objectives for the program remain constant. Students who have completed previous curricula may request waivers in order to meet course requirements. The Department will determine on a case-by-case basis whether waivers will be granted in accordance with Graduate Division policy.
PROPOSED RESEARCH ACTIVITIES AND TRAINING EXPERIENCES
Trainees will participate in a seminar series, attend courses, and complete a multidisciplinary mentored research project. Courses will provide the scientific, ethical, cultural and methodological foundation and the practical tools that will prepare trainees to conduct ethical multidisciplinary culturally competent clinical investigations. The mentored projects will facilitate in-depth learning that will enable trainees to become leaders in their chosen fields.
The PhDCR seminar series will provide training in team building related to health disparities research in Hawai`i, as described above. The series will invite participation of leaders from diverse disciplines throughout the university and community settings. Seminar topics will include ethnic disparities in health research, Asian, Native Hawaiian and Pacific Islander health, multidisciplinary research team development, self development, social and cultural factors related to health outcomes, and ethical aspects of research. The seminar series will cover both case studies and interdisciplinary exercises. As small group discussions, seminars will offer a forum for exchange of ideas and nurturing of trainees' relationships with instructors, many of whom may also serve as mentors for trainees' individual projects.
Trainees are required to complete an interdisciplinary mentored research project of relevance to minority health and health disparities. To provide flexibility, trainees can extend this requirement to an extra semester of mentored research to complete their projects and manuscript preparations. Priority research areas for the mentored projects are obesity, cardiovascular disease, oral health, asthma, diabetes, HIV/AIDS, cancer, end-of-life decision making, genetics, genomics and preterm birth. Health disparities have been documented in these areas, and we have identified committed mentors in each area of research. Selection and secured commitment of mentors will be guided by the faculty and will require Graduate Division approval of a Research Committee (specific for each trainee). Mentors are accomplished faculty with the time, expertise and willingness to nurture trainees' development.
Preparation for interdisciplinary mentored projects begins as soon as trainees enter the MSCR. Faculty meet with trainees, identify trainees' research interests, determine whether trainees have identified a mentor, and suggest possible mentors. Faculty encourage trainees to communicate with several potential mentors as early as possible to discuss research projects and determine research focus. By the end of the second semester, all trainees are matched with mentors. In the fall semester of Year 01, trainees draft their research proposal during the Clinical Research Protocol Development and Scientific Writing course. The proposal includes a literature review, study hypotheses and objectives, a discussion of sample size (and sampling methods, if applicable), a discussion of diagnostic criteria and other measurement issues, a timeline, and an analysis plan, including control methods for confounding variables and test methods for potential interactions.
By the fall semester of Year 01, trainees also establish contact with their Research Mentoring Team. This team consists of four to five members: the trainee's mentor (committee chair), an epidemiologist or biostatistician, and 2-3 other faculty with appointments to the Graduate Division. Although each team guides trainees in finalizing study designs and implementing projects, trainees must learn self-directed study and will therefore complete their research studies independently. In this way, trainees will be exposed to invaluable experience through which they will develop the tools to become skilled clinical researchers. The nature and extent of each research project will depend upon the trainee's focus and experience. The PhD dissertation will be required to be more substantive in both design and methodology.
MENTORING OPPORTUNITIES AND ACTIVITIES
Mentors
At least 37 funded investigators from JABSOM, SONDH, CRCH, PBRC, and other faculty from related disciplines, will mentor PhDCR trainees (See Appendix II). The faculty will ensure that trainees and mentor teams are established within the first six months of enrollment. Each trainee will have at least two mentors; one research/science mentor, and one epidemiologist or biostatistician. In addition, each PhD candidate will have a program committee and dissertation committee composed of Graduate Division faculty with expertise in the core content areas of bioethics, cultural competence and team building. Mentor team/trainee pairing will require an interview and Memorandum of Agreement (MOA) to document the relationship. The MOA will detail terms of research involvement, mutual expectations, specifics related to the final product (e.g., determination of first author/second author), and procedural and financial matters. Defining and documenting roles and expectations will minimize potential conflict and pave the way for fruitful mentoring relationships. Initially, trainees will meet with research/science mentors on a weekly basis. Throughout the program, trainees will meet with their mentoring teams monthly to ensure adequate guidance and support. The PI will attend mentoring sessions during the initial stages to ensure appropriate mentor team/trainee relationships are formed. Participating mentors will receive financial support to partially offset additional time and expenses. Trainees who are also enrolled in JABSOM fellowships will already have mentors, and the PhDCR will offer additional oversight of mentoring activities.
Research experiences will vary from working in wet labs in order to learn molecular techniques relevant to translational research, participating in patient visits at the CRC, Community Health Centers, or other appropriate facilities, refining protocols, chart review, data input and analysis, and activities necessary to complete the requirements of the PhDCR, including preparation of a final manuscript. Each trainee will engage in all scheduled lab meetings and work-in-progress sessions to gain insight into the research process as well as benefit from other members of the multidisciplinary research team, i.e., post-docs, research associates, and technicians. Joint work-in-progress sessions will be held in order to encourage sharing of trainees' experiences and expansion of research horizons.
Other Learning and Development Opportunities in Health Disparities Research Programs at UH
It is important to note that biomedical research in diverse ethnic populations is a vital component of the research program at UH. Indeed, a recent review of the NIH CRISP database reveals that out of 96 UH-based biomedical research grants, 42 programs involve aspects of minority health, at least 12 of which pertain directly to health disparities research, including Project EXPORT and the Endowed Chair Award described below. In addition, the PI for this grant, Dr. Harrigan, and the collaborator Dr. Easa, are working with the Waimanalo Health Center to conduct a “Study of Oral Health Disparities in Adult Asian & Pacific Islanders” (RFA: DE-02-005). By designing culturally competent pilot studies to assess the oral health status of pregnant women, we are strengthening our relationship with WHC, whose leaders and patients are increasingly willing to participate in further studies that are based upon sound scientific principles and strong community partnerships.
Numerous programs aimed at the faculty recruitment of scientists of Asian, Native Hawaiian and Pacific Islander descent are currently in place or in the planning process. They include JABSOM-based programs such as the newly formed Department of Native Hawaiian Health and the Native Hawaiian Center of Excellence, as well as the more global effort of JABSOM to encourage the recruitment of ethnically diverse scientists. The CRC offers inexperienced investigators the opportunity and infrastructure to develop pilot studies and to pursue funding opportunities and investigator development awards. The new Community Pediatrics Fellowship enables fellows to refine research skills in the conduct a culturally competent project at a community health center. Opportunities for minority faculty development have also been increased with the new MSCR, the expansion of which will prove invaluable in providing clinical research training and education to junior and minority faculty at JABSOM.
The PhDCR will play a vital role in development of junior faculty. The relatively small number of students enrolled in the PhDCR will allow the PI and CAC to actively participate in fostering investigator development. The addition of the PhDCR to academic offerings at JABSOM will add to the arsenal of skills and create opportunities for junior and minority investigators. Since community-based participatory health disparities research is a priority theme for both the NIH and JABSOM, we expect excellent synergy with additional funding opportunities for research projects. Finally, graduating trainees will be invited to participate as mentors for incoming trainees, which will lend consistency and collegiality to the team building and investigator development aspects of the PhDCR.