Research Design, Biostatistics, and Literature Evaluation

Study was classified as exempt from IRB review and informed consent because of the study’s

QI nature.

ii.

After a complaint, the Office for Human Research Protections of the Department of Health

and Human Services originally faulted the investigators for not obtaining informed consent.

Subsequently, the Office for Human Research Protections reversed course and classified the

project as a “non-research” activity.

Inconsistent interpretation by local IRBs, in the absence of clear guidance from the Office for

Human Research Protections, contributes to confusion regarding the necessity of informed consent

in QI initiatives (Jt Comm J Qual Patient Saf 2008;34:349-53).

Occasionally, critical care research will need to be conducted in the general community. Obtaining

consent in this scenario would be impossible, given the medical condition of the research subject.

Example: intramuscular therapy compared with intravenous therapy for prehospital status epilepticus (N

Engl J Med 2012;366:591-600). In this study of prehospital emergency care, informed consent would be

impossible to obtain in the field. Therefore, IRBs engaged local community consultation, according to

regulations, and provided approval.

the research endeavor.

Approval for this type of research is required from local IRBs.

This type of approval falls under Exception from Informed Consent

Not to be confused with Waiver of Informed Consent (Prehosp Disaster Med 2019;34:111-3)

Consider the affected community (e.g., culture, vulnerabilities, etc.) (Prehosp Disaster Med

2018;33:457-8)

Social Determinants of Health

The conditions in which people are born, grow, live, work, and age

Education level/income/occupation/recreational opportunities

Physical environment (e.g., housing, utilities availability, neighborhood, safe drinking water, clean

air, transportation, etc.)

Gender inequity

Food insecurity/nutritious choices

Early childhood experiences/development

Crime or violent behavior exposure

Global, national, local stratifications and inequities

Complex interplay (poor health/education↔employment↔income↔healthcare/nutrition↔stress↔

substance abuse/unhealthy habits)

May have a higher impact on health than healthcare