Program: Clinical and Translational Research (MS)
Date: Wed Nov 07, 2012 - 12:31:48 pm
1) Below are your program's student learning outcomes (SLOs). Please update as needed.
I. Clinical and Translations Research Questions
- Identify basic and preclinical studies that are potential testable clinical research hypotheses.
- Identify research observations that could be the bases of large clinical trials.
- Define the data that formulate research hypotheses.
- Derive translational questions from clinical research data.
- Prepare the background and significance sections of a reserach proposal.
- Critique clinical and translational research questions using data-based literature searches.
- Extract information from the scientific literature that yields scientific insight for research innovation.
II. Literature Critique
- Conduct a comprehensive and systematic serach of the literature using informatics techniques.
- Summarize evidence from the literature on a clinical problem.
- Describe the mechanism of a clinical problem reviewed in a manuscript.
- Use evidence as the basis of the critique and interpretation of results of published studies.
- Identify potential sources of bias and variations in published studies.
- Interpret published literature in a causal framework.
- Identify gaps in knowledge within a research problem.
III. Study Design
- Fromulate a well-defined clinical or translational research question to be studied in human or animal models.
- Propose study designs for addressing a clinical or translational research question.
- Assess the strengths and weaknesses of possible study designs for a given clinical or translational research question.
- Design a resarch study protocol.
- Identify a target population for a clinical or translational research project.
- Identify measures to be applied to a clinical or translational research project.
- Design a research data analysis plan.
- Determine resources needed to implement a clinical or trnslational research plan.
- Prepare an application to an IRB.
IV. Research Implementation
- Compare the feasibility, efficiency, and ability to derive unbiased inferences from different clinical and translational reserach study designs.
- Assess threats to internal vailidty in any planned or completed clinical or translational study, including selection bias, misclassification, and confounding.
- Incorporate regulatory precepts into the design of any clinical or translational study.
- Integrate elements of translational research into given study designs that could provide the bases for future research, such as the collection of biological specimens nested studies and the devleopment of community-based interventions.
V. Sources of Error
- Describe the concepts and implications of reliability and validity of study measurements.
- Evaluate the reliability and validity of measures.
- Assess threats to study validity including problems with smpling, recruitment, randomization, and comparability of study groups.
- Differentiate between the analytic problems that can be addressed with stand methods and those requiring input from biostatisticians and other scientific experts.
- Implement quality assurance systems with control procedures for data intake, maanagement, and monitoring for different study designs.
- Assess data sources and data quality to answer specific clinical or translational research questions.
- Implement quality assurance and control procedures for different study designs and analysis
VI. Statistical Approaches
- Describe the role that biostatistics serves in biomedical and public health research.
- Describe the basic principles and practical importance of random variation, systematic error, sampling error, measurement error, hypothesis testing, tye I and type II errors, and confidence limits.
- Scrutinzie the assumptions behind different statistical methods and their corresponding limitations.
- Generate simple descriptive and inferential statistics that fit the study design chosen and answer research question.
- Compute the sample size, power, and precision for comparisons of two independent samples with respect to continuuous and binary outcomes.
- Describe the uses of meta-analytic methods.
- Defend the significance of data and safety monitorying plans.
- Collaborate with biostatisticians in the design, conduct, and analyses of clincial and translational research.
- Evaluate computer output containing the results of statistical procedures and graphics.
- Explain the uses, importance, and limitations of early stopping rules in clincial trials.
VII. Biomedical Informatics
- Describe trends and best practices in infomatics for the organizaiton of biomedical and health information.
- Develop protocols utilizing management of information using computer technology.
- Describe the effects of technology on medical research, education, and patient care.
- Describe the essential functions of the electronic health record (EHR) and teh barriers to its use.
- Explain the role that health information technology standards have on the interoperability of clinical systems, including health IT messaging.
- Access patient information using quality checks via electronic health record systems.
- Retrieve medical knowledge through literature seraches using advanced electronic techniques.
- Discuss the role of bioinformatics in the study design and analyses of high dimensional data in areas, such as genotypic and phenotypic genomics.
- Collaborate with bioinformatics specialists in the design, development, and implementation of reserach projects.
VIII. Responsible Conduct of Research
VIII.a. Clinical Research Ethics Competencies
- Summarize the history of research abuses and the rationale for creating codes, regualtions, and systems for protecting participants in clinical research that requires community input.
- Critique a clincial or translational research proposal for risks to human subjects.
- Explain the special issues that arise in research with vulnerable participants and the need for additional safeguards.
- Determine the need for a rish-benefit ratio that is in balance with teh outcomes in clinical and translational research.
- Describe the elements of voluntary informed consent, including incresing knowledge about research, avoiding undue influence or coercion, and assuring the decision-making capcity of participants.
- Assure the need for privicy protection throughout all phases of a study.
- Assure the need for fairness in recruiting participants and in distributing the benefits and burdens of clinical research.
- Adhere to IRB application procedures.
- Explain how the structural arrangement of science and the research industry may influence the behaivor of scientists and the proejction of scientific knowledge.
VIII.b. Responsible Conduct of Research Competencies
- Apply the main rules, guidelines, codes, and professsional standards for the conduct of clinical and translational research.
- Adhere to the proceures to report unprofessional behavior by colleagues who engage in misconduct in research.
- Implement procedures for the identification, prevention, and management of financial, intellectural, and employment conflicts of interests.
- Apply the rules and professional standards that govern the data collection, sharing, and protection throughout all phases of clinical and translational research.
- Apply elements of voluntary informed consent, of fostering understanding of information about clinical research, and for avoiding undue influence or coercion, and taking into consideration the decision-making capacity of participants.
- Explain the need for privacy protection and best practices for protecting privacy throughout all phases of a study.
- Explain the need for fairness in recruiting participants and in distribuitn the benefits and burdens of clinicial research.
- Explain the function of the IRB.
IX. Scientific Communication
- Communicate clinical and translational research findings to different groups of individuals, including colleagues, students, the lay public, and the media.
- Translate the implications of clinical and translational research findings for clinical practice, advocacy, and governmental groups.
- Write summaries of scientific information for use in the development of clinical health care policy.
- Translate clinical and translational research findings into national health strategies or guidelines for use by the general public.
- Explain the utility and mechanism of commencializaiton for clinical and translational research findings, the patent process, and technology transfer.
X. Cultural Diversity
- Differentiate between cultural competency and cultural sensitivty principles.
- Recognize the demographic, geographic, and ethnographic features within communities and populations when designing a clinical study.
- Describe the relevance of cultural and population diversity in clinical research design.
- Describe cultural and social variation in standards of research integrity.
- Critique studies for evidence of health disparities, such as disproportional health effects on select populations (e.g., gender, age, ethnicity, race).
XI. Translational Teamwork
- Build an interdisciplinary/intradisciplinary/multidisciplinary team that matches teh objectives of the research problem.
- Manage an interdisciplinary team of scientists.
- Advocate for multiple points of view.
- Clarify language differences across disciplines.
- Demonstrate group decision-making techniques.
- Manage conflict.
- Manage a clincial and/or translational research study.
- Work as a leader of a multidisciplinary research team.
- Manage a multidisciplinary team across its fiscal, personnel, regulatory compliance and problem solving requirements.
- Maintain skills as mentor and mentee.
- Validate others as a mentor.
- Foster innovation and creativity.
XIII. Cross Disciplinary Training
- Apply principles of adult learning and competency-based instruction to educational activities.
- Provide clinical and translational sceince instruction to beginning scientists.
- Incorporate adult learning principles and mentoring strategies into interactions with beginning scientists and scholars in order to engage them in clincial and translational research.
- Develop strategies for overcoming the unique curricular challenges associated with merging scholars from diverse backgrounds.
XIV. Community Engagement
- Examine the characteristics that bind people together as a community, including social ties, common perspectives or interests, and geogrphy.
- Appraise the role of community engagement as a strategy for identifying community health issues, translating health research to communities and reducing health disparities.
- Summarize the principles and practices of the spectrum of community-engaged research.
- Analyze the ethical complexities of conducting community-engaged research.
- Specifiy how cultural and linguistic competence and health literacy have an impact on the conduct of community engaged research.
2) Your program's SLOs are published as follows. Please update as needed.
Student Handbook. URL, if available online: http://www2.hawaii.edu/~mscr/
Information Sheet, Flyer, or Brochure URL, if available online: http://www2.hawaii.edu/~mscr/
UHM Catalog. Page Number: http://www.catalog.hawaii.edu/schoolscolleges/medicine/cam.htm
Course Syllabi. URL, if available online: http://www2.hawaii.edu/~mscr/
3) Select one option:
- File (03/16/2020)
4) For your program, the percentage of courses that have course SLOs explicitly stated on the syllabus, a website, or other publicly available document is as follows. Please update as needed.
5) Did your program engage in any program assessment activities between June 1, 2011 and September 30, 2012? (e.g., establishing/revising outcomes, aligning the curriculum to outcomes, collecting evidence, interpreting evidence, using results, revising the assessment plan, creating surveys or tests, etc.)
No (skip to question 14)
6) For the period June 1, 2011 to September 30, 2012: State the assessment question(s) and/or assessment goals. Include the SLOs that were targeted, if applicable.
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Table 2. CTRECD Program Graduate Competencies
The Core Competencies in Clinical and Translational Research (Based on CTSA Education Committee Statement, Nov 2011) that are expected at program completion are stated below.
Clinical And Translational Research Questions
1. Identify basic and preclinical studies that are potential testable clinical research hypotheses.
2. Identify research observations that could be the bases of large clinical trials.
3. Define the data that formulate research hypotheses.
4. Derive translational questions from clinical research data.
5. Prepare the background and significance sections of a research proposal.
6. Critique clinical and translational research questions using data-based literature searches.
7. Extract information from the scientific literature that yields scientific insight for research innovation.
1. Conduct a comprehensive and systematic search of the literature using informatics techniques.
2. Summarize evidence from the literature on a clinical problem.
3. Describe the mechanism of a clinical problem reviewed in a manuscript.
4. Use evidence as the basis of the critique and interpretation of results of published studies.
5. Identify potential sources of bias and variations in published studies.
6. Interpret published literature in a causal framework.
7. Identify gaps in knowledge within a research problem.
1. Formulate A Well-Defined Clinical Or Translational Research Question To Be Studied In Human Or Animal Models.
2. Propose Study Designs For Addressing A Clinical Or Translational Research Question.
3. Assess The Strengths And Weaknesses Of Possible Study Designs For A Given Clinical Or Translational Research Question.
4. Design A Research Study Protocol.
5. Identify A Target Population For A Clinical Or Translational Research Project.
6. Identify Measures To Be Applied To A Clinical Or Translational Research Project.
7. Design A Research Data Analysis Plan.
8. Determine Resources Needed To Implement A Clinical Or Translational Research Plan.
9. Prepare An Application To An IRB.
1. Compare The Feasibility, Efficiency, And Ability To Derive Unbiased Inferences From Different Clinical And Translational Research Study Designs.
2. Assess Threats To Internal Validity In Any Planned Or Completed Clinical Or Translational Study, Including Selection Bias, Misclassification, And Confounding.
3. Incorporate Regulatory Precepts Into The Design Of Any Clinical Or Translational Study.
4. Integrate Elements Of Translational Research Into Given Study Designs That Could Provide The Bases For Future Research, Such As The Collection Of Biological Specimens Nested Studies And The Development Of Community-Based Interventions.
Sources of Error
1. Describe The Concepts And Implications Of Reliability And Validity Of Study Measurements.
2. Evaluate The Reliability And Validity Of Measures.
3. Assess Threats To Study Validity (Bias) Including Problems With Sampling, Recruitment, Randomization, And Comparability Of Study Groups.
4. Differentiate Between The Analytic Problems That Can Be Addressed With Standard Methods And Those Requiring Input From Biostatisticians And Other Scientific Experts.
5. Implement Quality Assurance Systems With Control Procedures For Data Intake, Management, And Monitoring For Different Study Designs.
6. Assess Data Sources And Data Quality To Answer Specific Clinical Or Translational Research Questions.
7. Implement Quality Assurance And Control Procedures For Different Study Designs And Analysis.
1. Describe The Role That Biostatistics Serves In Biomedical And Public Health Research.
2. Describe The Basic Principles And Practical Importance Of Random Variation, Systematic Error, Sampling Error, Measurement Error, Hypothesis Testing, Type I And Type II Errors, And Confidence Limits.
3. Scrutinize The Assumptions Behind Different Statistical Methods And Their Corresponding Limitations.
4. Generate Simple Descriptive And Inferential Statistics That Fit The Study Design Chosen And Answer Research Question.
5. Compute Sample Size, Power, and Precision for Comparisons Of Two Independent Samples With Respect To Continuous And Binary Outcomes.
6. Describe The Uses Of Meta-Analytic Methods.
7. Defend The Significance Of Data And Safety Monitoring Plans.
8. Collaborate With Biostatisticians In The Design, Conduct, And Analyses Of Clinical And Translational Research.
9. Interpret computer output including the results of regression models, other statistical procedures, and graphics.
10. Explain The Uses, Importance, And Limitations Of Early Stopping Rules In Clinical Trials.
1. Describe Trends And Best Practices In Informatics For The Organization Of Biomedical And Health Information.
2. Develop Protocols Utilizing Management Of Information Using Computer Technology.
3. Describe The Effects Of Technology On Medical Research, Education, And Patient Care.
4. Describe The Essential Functions Of The Electronic Health Record (EHR) And The Barriers To Its Use.
5. Explain The Role That Health Information Technology Standards Have On The Interoperability Of Clinical Systems, Including Health It Messaging.
6. Access Patient Information Using Quality Checks Via Electronic Health Record Systems.
7. Retrieve Medical Knowledge Through Literature Searches Using Advanced Electronic Techniques.
8. Discuss The Role Of Bioinformatics In The Study Design And Analyses Of High Dimensional Data In Areas, Such As Genotypic And Phenotypic Genomics.
9. Collaborate With Bioinformatics Specialists In The Design, Development, And Implementation Of Research Projects.
Clinical Research Interactions
1. Regulatory Support And Knowledge Competencies
· Describe The Fundamental Principles Of The Protection Of Human Subjects, The Main Authoritative Bodies, Key Codes, And Scope Of Enforcement.
· Describe The Food And Drug Administration Requirements For Drug Biologic Products
· Prepare An Application For IRB Approval.
· Critique A Proposal For Risks To Human Subjects And Protections Of Vulnerable Populations.
· Describe The Essential Elements Of Voluntary Informed Consent.
· Describe The Principles Of Research Documentation, Validation And Audit.
2. Responsible Conduct Of Research Competencies
· Explain The Ways In Which The Principles Of Research Ethics Are Integrated Into The Design, Conduct, Oversight And Dissemination Of Research.
· Describe the Authority For and Professional Standards for the Responsible Conduct O Research.
· Explain The Procedures For Reporting And Investigating Misconduct In Research.
· Explain Conflict Of Interest Management In Research.
· Outline Criteria for Determination of Authorship.
· Describe the Role of Peer Review in Funding and Publication.
· Explain The Purpose, Policies And Procedures To Ensure Ethical Use, Care, And Animal Safety In Research.
1. Communicate Clinical And Translational Research Findings To Different Groups Of Individuals, Including Colleagues, Students, The Lay Public, And The Media.
2. Translate The Implications Of Clinical And Translational Research Findings For Clinical Practice, Advocacy, And Governmental Groups.
3. Write Summaries Of Scientific Information For Use In The Development Of Clinical Health Care Policy.
4. Translate Clinical And Translational Research Findings Into National Health Strategies Or Guidelines For Use By The General Public.
5. Explain The Utility And Mechanism Of Commercialization For Clinical And Translational Research Findings, The Patent Process, And Technology Transfer
7) State the type(s) of evidence gathered to answer the assessment question and/or meet the assessment goals that were given in Question #6.
1. Differentiate Between Cultural Competency And Cultural Sensitivity Principles.
2. Recognize The Demographic, Geographic, And Ethnographic Features Within Communities And Populations When Designing A Clinical Study.
3. Describe The Relevance Of Cultural And Population Diversity In Clinical Research Design.
4. Describe Cultural And Social Variation In Standards Of Research Integrity.
5. Critique Studies for Evidence of Health Disparities, Such As Disproportional Health Effects On Select Populations (E.G., Gender, Age, Ethnicity, Race).
1. Build An Interdisciplinary/ Interdisciplinary/ Multidisciplinary Team That Matches The Objectives Of The Research Problem.
2. Manage An Interdisciplinary Team Of Scientists.
3. Advocate for Multiple Points of View.
4. Clarify Language Differences Across Disciplines.
5. Demonstrate Group Decision-Making Techniques.
6. Manage Conflict.
7. Manage A Clinical And/Or Translational Research Study.
Cross Disciplinary Training
1. Work as a Leader of a Multidisciplinary Research Team.
2. Manage A Multidisciplinary Team Across Its Fiscal, Personnel, Regulatory Compliance And Problem Solving Requirements.
3. Maintain Skills As Mentor And Mentee.
4. Validate Others As A Mentor
5. Foster Innovation and Creativity.
1. Examine The Characteristics That Bind People Together As A Community, Including Social Ties, Common Perspectives Or Interests, And Geography.
2. Appraise The Role Of Community Engagement As A Strategy For Identifying Community Health Issues, Translating Health Research To Communities And Reducing Health Disparities.
3. Summarize The Principles And Practices Of The Spectrum Of Community-Engaged Research.
4. Analyze The Ethical Complexities Of Conducting Community-Engaged Research.
5. Specify How Cultural And Linguistic Competence And Health Literacy Have An Impact On The Conduct Of Community Engaged Research
Disciplinary Content Competence
1. Demonstrate Mastery Of The Disciplinary Mastery of Content Associated With A Selected Area Of Health Disparity In Native Hawaiian And Pacific Peoples, For Example Neurological Health And Consequence Of Methamphetamine And Marijuana Exposure Or Cardio-metabolic Health.
2. Prepare and Submit A State Of The Science Article For Publication Related To The Area Of Disciplinary Science
8) State how many persons submitted evidence that was evaluated. If applicable, please include the sampling technique used.
All students and faculty
We did not sample
9) Who interpreted or analyzed the evidence that was collected? (Check all that apply.)
Ad hoc faculty group
Persons or organization outside the university
Advisors (in student support services)
Students (graduate or undergraduate)
10) How did they evaluate, analyze, or interpret the evidence? (Check all that apply.)
Used professional judgment (no rubric or scoring guide used)
Compiled survey results
Used qualitative methods on interview, focus group, open-ended response data
External organization/person analyzed data (e.g., external organization administered and scored the nursing licensing exam)
11) For the assessment question(s) and/or assessment goal(s) stated in Question #6:
Summarize the actual results.
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Table 1. MSCR Program
# study sections
12) State how the program used the results or plans to use the results. Please be specific.
We used them to document the succes ofthe curriculum and submit a grant to fund the program Curriculum Education
A. Proposed Research Education Program
This application “Clinical and Translational Research Education and Career Development (CTRECD)” program is to support qualified candidates to advance their careers and become part of the national cadre of clinical and translational researchers needed to help eliminate health disparities. The goal of the CTRECD program is to expand the scope of and access to clinical and translational research education and career development opportunities across the island of Hawaii. This program will help UHM address a long term goal of reducing heath disparities in Asian, Native Hawaiian and Pacific Islander populations (NAHPI) populations through the development of a critical mass of health disparities investigators who can advance our knowledge objectively, guide health services delivery, and propose health policy to address this goal.
13) Beyond the results, were there additional conclusions or discoveries?
This can include insights about assessment procedures, teaching and learning, program aspects and so on.
Not really we are moving in the direction we intended
14) If the program did not engage in assessment activities, please explain.
Or, if the program did engage in assessment activities, please add any other important information here.
All student evaluatiins using our on-line system were positive