Research Design, Biostatistics, and Literature Evaluation

Necessity depends on many factors (e.g., IRB or trial design)

Because of the acute nature of critical illness, it may be singularly difficult to obtain informed consent

within a short time.

Obtaining informed consent is particularly challenging for critically ill patients, primarily because many

critically ill patients lack decisional capacity because of the acute nature of their illness and/or the effect

of medications.

Research that involves subjects with impaired consent within the ICU should include plans for assessment

of capacity. The University of California, San Diego Brief Assessment of Capacity to Consent (UBACC)

is a 10-item scale that assesses capacity for enrollment into clinical research (Arch Gen Psychiatry

2007;64:966-74).

Surrogates and family members are recognized as having authority to provide consent on the behalf of

patients, often termed “legally authorized representative,” despite the ambiguous legal standing on this

issue in several states.

It is important to realize that underlying motives for proxy consent may include the belief that

participating in the research protocol will lead to improved care.

Important to acknowledge that patients and surrogates entrust clinical researchers to act in their

best interests

Research supports that surrogate consent and patient preferences agree most of the time, but

2012;40:2590-4).

One area of growing utilization is digital consent (even video consent). Digitalized consent has the

ability to increase comprehension, particularly in those with poor literacy or a lower socioeconomic

In select circumstances, informed consent may be waived by the IRB.

the U.S. Food and Drug Administration (FDA) for waiver of informed consent. In many circumstances,

local IRBs will follow the Common Rule as the minimum standard. Further, restrictions regarding the

use of a waiver of informed consent vary by country and culture (Theor Med Bioeth 2016;37:441-6).

Waiver of informed consent is typically granted for any of the following circumstances:

Research that is deemed of minimal risk to the participant, does not adversely affect the welfare of

the subject, and could not otherwise be practicably carried out

Research that is carried out to evaluate public benefits or service programs

Research in emergencies when consent is not possible, delays lifesaving intervention, or involves

standard-of-care therapy.

An example is a study testing the hypothesis of whether drug A is noninferior to drug B for

status epilepticus (N Engl J Med 2012;366:591-600).

ii.

A trial conducted in France that investigated the timing of initiation of renal replacement

therapy did not require written informed consent because the standard of care was included in

both treatment arms (N Engl J Med 2016;375:122-33).

Controversy exists regarding waiver of consent for quality improvement (QI) research. Currently,

QI research is subject to the interpretation of local IRBs, as mentioned previously (N Engl J Med

2015;372:855-62).

Keystone ICU project was a joint collaboration between investigators at Johns Hopkins University

and the state of Michigan to reduce central line -associated bloodstream infections in ICU patients

using a checklist (N Engl J Med 2006;355:2725-32).