XIII. Research Methods


A. Institutional review board and informed consent


1. Informed consent


Know the required components of an informed consent document

Know the ethical issues that complicate obtaining informed consent in young
children

Know the ethical issues affecting informed consent in older children and adolescents (also see here) and how these may be addressed

Know the issues raised by the Health Insurance Portability and Accountability
Act (HIPAA) in the informed consent process

2. Waiver of consent


Know the requirements for waiver of consent in emergency research

3. Institutional review board


Know the role of the institutional review board in approving research projects
involving human subjects`

B. Subjects and human rights


1. Human rights


Know the basic rights of humans participating in research

Know the role of the investigator in monitoring of human subjects during a
clinical trial

2. Animal rights


Know the rights of animals used in research

C. Experimental design and statistics


1. Study design


Know study designs commonly used in epidemiologic research

Know the differences in the implications of a case control, cohort, and
randomized controlled study

Know the rationale behind randomized trials

Know the implications of prospective versus retrospective data collection in
clinical research

Know the importance of sample size determinations in research

Know the concept of meta-analysis and its limitations

Know the definition and purpose of "intention to treat" analysis

Know the issues raised by HIPAA in clinical research

Know the role of power calculations in research planning

Know the definition and methods of calculation of absolute reduction in risk
(ARR) and number needed to treat (NNT)

2. Definitions


Know the definition of the "null hypothesis"

Know the definition and method of calculation of sensitivity

Know the definition and method of calculation of specificity

Know the definition and method of calculation of positive predictive value

Know the definition and method of calculation of negative predictive value

Know the definition of categorical, ordinal, and continuous variables

Know the limitations of positive and negative predictive values in relationship to
disease prevalence when comparing diagnostic tests

Know the meaning of the clinical "likelihood ratio" (LR) and its effect on
post-test odds of disease

3. Analysis and interpretation of results


Know the assumptions necessary to use parametric statistics (eg, t test)

Know the advantages and disadvantages of nonparametric tests (eg, Wilcoxon
test)

Understand the normal distribution and the use of normal approximation in
statistical analysis

Know the advantages of confidence interval in the interpretation of results

Know the difference between standard deviation (SD) and standard error of the mean (SEM)

Know the use of odds ratios in the interpretation of results

Know the difference between "statistically significant" and "biologically
meaningful"

Know the concept of "confounding" as it applies to statistical analysis

Know the assumptions in choosing the proper statistical test for data analysis

Know methods to correct for the limitations of multiple comparisons

Understand the use of the central limit theorem in justifying the use of the
normal approximation in choosing a statistical test

Know the factors that contribute to type I and type II errors

Know the interpretation and application of receiver-operating characteristic curves (ROC)

4. Conduct of research


Know the common forms of scientific misconduct

Know what constitutes an investigator conflict of interest during the course of a
study

Know the responsibilities of an investigator or co-investigator in the proper
conduct of research

Know the responsibilities required of a valid author in scientific publications

Know some common sources of bias in research (eg, ascertainment bias,
recruitment bias, recall bias)

Know the techniques of evidence-based medicine used to extract information
from published research that is applicable to one's own patients

Know the advantages and disadvantages of paired or matched research designs

Know when a matched-pairs statistical test is appropriate

Know the strengths and limitations of regression analysis (eg, what hypothesis is
tested by regression analysis, the limitations of the R and R-squared statistics,
and the use of "fit" versus "prediction" confidence intervals