Research Design, Biostatistics, and Literature Evaluation
of unethical research misconduct, such as the Tuskegee syphilis study. This rule defined human participant
research, developed the process of informed consent, and established the requirement of institutional review
The Common Rule has undergone major changes, with most implementation occurring in 2019 (Chest
2019;155:272-8). These included the following:
New categories and definitions of exempt or excluded research studies
Allowance of a single IRB for multi-institutional studies
Exclusion of public health surveillance as research
| d. | Requirement of concise, focused consent forms and online posting of consent as applicable |
|---|
Allowance of broad consent for identifiable biospecimens in future unspecified research studies
IRB of record versus institutional versus independent versus relying IRB
Differences: Processes, time, cost, forms, etc.
Central IRB
in a clinical trial should be representative of the general population of patients with the disease or syndrome.
Critical care is exemplified by the provision of supportive care for the treatment of diseases and
syndromes.
Diseases are characterized by the specific test used to identify the pathophysiologic process.
Syndromes are often identified by the presence of a constellation of signs and symptoms that suggest
the presence of a disease that exists across a spectrum of severity.
subject recruitment.
Heterogeneity in syndromes challenges the ability to identify subjects with similar severity or
probability for similar clinical outcomes for participation in clinical research.
In addition, heterogeneity challenges the ability to interpret the results from dissimilar populations,
even though they may have a single syndrome in common.
Discrepancies between results from basic and early clinical studies versus adequately powered
controlled trials show that surrogate outcome measures (e.g., organ function) or biomarkers may not
Unique to critical care clinical research is the need to enroll subjects similar in acuity or at a similar
stage in the process of their syndrome to allow meaningful comparisons.
Use of non-standardized definitions and lack of power complicate data synthesis and meta-analysis (Am
Selection of end points should be based, in part, on the ethical values outlined previously. End points
should provide social value and have scientific validity. A growing area of emphasis in research is on
neurological outcome, rather than mean change in modified Rankin Score.)