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Volume 41 Number 2, March/April 2004
    Pages 155  — 174


Abstract - Unresolved legal and ethical issues in research of adults with severe traumatic brain injury: Analysis of an ongoing protocol

Theresa Louise-Bender Pape, DrPH, MA, CCC-SLP/L; Nancy Oddi Jaffe, JD, MSPH; Teresa Savage, RN, PhD; Eileen Collins, RN, PhD; Deborah Warden, MD

Department of Veterans Affairs (VA), Edward Hines Jr., VA Hospital, Research Service, Hines, IL; Rehabilitation
Institute of Chicago, Center for Rehabilitation Outcomes Research, and Northwestern University Medical School, Department of Physical Medicine and Rehabilitation, Office of Medical Education, Chicago, IL; Rush North Shore Medical Center, Office of Legal Affairs, Assistant General Counsel, Skokie, IL; Walter Reed Army Medical Center, Defense and Veterans Head Injury Program, Washington, DC; University of Illinois at Chicago, College of Nursing,
Departments of Medical-Surgical Nursing and of Maternal-Child Nursing, Chicago, IL; Uniformed Services
University of the Health Sciences, Bethesda, MD
Abstract — This paper synthesizes federal and state laws and bioethics literature with observations from an ongoing research protocol to identify, define, and clarify the unresolved legal and ethical issues regarding research involving adults with traumatic brain injury (TBI). Solutions that protect rights and minimize unnecessary impediments to valuable clinical and scientific inquiry are also illustrated using the same protocol. Research was performed at intensive care, inpatient rehabilitation, and long-term acute chronic hospitals. Our research protocol identified five areas of law impacting adults with TBI: advanced directives, healthcare surrogacy acts, probate acts, power of attorney acts, and the Health Insurance Portability and Accountability Act. The published bioethics literature and responses from local human subject institutional review boards (IRBs) suggest that some of the unresolved ethical issues in research include defining vulnerability, defining informed voluntary consent, determining competency and/or decision-making capacity, using caregivers as subjects, and conducting multisite cooperative studies. Collaboration with IRB members and administrators as well as legal and research ethic scholars developed procedures that protect rights while avoiding unnecessary impediments to research. Investigations of persons with TBI and other cognitive impairments are governed by complicated and inconsistent regulations within the Common Rule and federal and state statues. A need for clear and consistent regulatory guidance regarding multisite studies of TBI persists. In lieu of regulatory guidance, carefully researched solutions for critical peer review are needed to guide future multisite investigations of TBI.
Key words: altered consciousness, bioethics, regulations, statutes, traumatic brain injury.

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