Chlan, Linda L. http://orcid.org/0000-0001-6922-7551
Weinert, Craig R.
Tracy, Mary Fran
Skaar, Debra J.
Gajic, Ognjen
Ask, Jessica
Mandrekar, Jay
Funding for this research was provided by:
national heart, lung, and blood institute (5R01 HL130881)
Article History
Received: 24 June 2021
Accepted: 10 May 2022
First Online: 16 May 2022
Declarations
:
: The Mayo Clinic Institutional Review Board (IRB-C) approved the study (IRB# 16-000417) with all requirements met for research approval (21CFR56.111 and 45CFR46.111). Mayo Clinic is the coordinating centre for this two-centre research study and is responsible for the study’s conduct, administration, and coordinating activities. The University of Minnesota’s principal investigator (CRW) communicates with the University of Minnesota IRB #1605M88241. IRBs from both sites approved all protocol documents and consent forms. Dissemination of protocol information and modifications are communicated through the electronic Mayo Clinic IRB (IRBe) tracking system and transmitted to prospective teams. At the University of Minnesota site, information and modifications are communicated electronically through the ETHOS system.Under the guidance of the Midwest Area Research Consortium for Health (MARCH) Data and Safety Monitoring Board (DSMB), a data safety monitoring plan is established with oversight on patient safety considerations, study data integrity, and efficacy of the clinical trial. Along with patient safety recommendations from the DSMB, there is routine medical monitoring by critical care physicians independent from research investigators. Patients are closely supervised throughout protocol completion. In addition, a blinded adverse event attribution adjudication committee was constituted comprising physicians independent from the study team. The adjudication committee reviews all adverse events (AEs) and serious adverse events (SAEs) to determine the relation of the event to the study protocol. A written report is completed and returned to the study team PI.All research personnel have undergone human subjects training before addition to the IRB protocol, including periodic re-certification for faculty and staff involved in human subjects’ research. Conflict of interest is assessed before IRB approval.The trained research staff obtain informed consent from either the patient or his/her legally authorized representative (LAR). Subjects are screened and assessed by the trained research staff for motor ability and hand-grip strength via a pen click test simulating the patient-controlled sedation button device, alertness, and presence/absence of delirium. Pre-screening assessments are reviewed with the attending consultant physician and the designated study physician to meet patient safety measures. Knowing delirium can be a transient syndrome, patients who are CAM-ICU-positive (delirium present), who are alert, following commands, and are willing and able to participate are considered for LAR proxy enrolment. Patients provide an affirmative head nod “yes” as verbal assent when obtaining LAR consent. All subjects for this study are provided with a consent form describing the research and providing sufficient information for subjects’ and his/her LAR to make an informed decision about their participation in the study. The study staff provide ample opportunity for questions. Subjects are reminded that participation is entirely voluntary; they are free to change their mind at any time without penalty of access to care or benefits. The consenting process and signatures by the research staff, subject, and/or his/her LAR are completed before study activities begin. Confidentiality is managed according to the requirements of the US Health Insurance Portability and Accountability Act of 1996 (HIPAA). All consent and HIPAA documents containing personally identifiable data are secured in a locked file cabinet with access only to the study staff with IRB approval, Data and Safety Monitoring Board, study monitors, the FDA, and the NIH. These entities have access to these signed documents and data files if requested during monitoring visits or audit inspections.
: The authors are willing to provide a consent form on request. There are no individual subject details, images, or videos included for publication.
: The authors declare that they have no competing interests.