title: Interventional spine research: the evolution of informed consent.
abstract: The future success of the field of interventional pain medicine depends on proof of positive outcomes. Evidence based medicine has an increasing relationship to insurance reimbursement. This makes new modes of pain management dependent upon human subject research. To succeed physicians must fulfill the ethical and regulatory requirements of research, specifically informed consent. History makes clear the importance of these ethical principles. Reliance on the beneficence and ethics of investigators has failed to protect subjects. This has led to ethical codes and governmental intervention. The basis of human research regulation is the Nuremberg Code and its underlying ethical principles. This code elucidates the requirements of Understanding and Voluntariness in informed consent for research. An analysis of these principles helps researchers fulfill the spirit of the governmental regulations and highlights the importance of protecting individual's rights. The current system of federal oversight of human research is cumbersome and inadequate. It leaves large groups of subjects unprotected and its lumbering pace often impedes investigators progress in spite of their compliance with ethical principles. Reform of these systems, is long overdue and physicians must play a role if we are to have efficient ethical human subject research in the future.
authors.affiliation: Department of Rehabilitation Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA. dlenrow@mail.med.upenn.edu
authors.forename: David A
authors.initials: DA
authors.lastname: Lenrow
authors.forename: Larry H
authors.initials: LH
authors.lastname: Chou