ABSTRACT
To conduct ethically sound research, investigators must take appropriate steps to ensure that human research participants, including their families and communities, will not suffer undue medical, social, and psychological harm in the name of research. In human participant research, 'Vulnerable populations" traditionally have been identified as persons or groups with limited or diminished autonomy. In fact, vulnerable populations may possess adequate autonomy, but lack the capacity to understand or communicate opinions regarding participation in research protocols. This may lead to a corruption of the informed-consent process. In the past, federal regulations defined vulnerable populations to include children, prisoners, the mentally or cognitively impaired, pregnant women, fetuses, and those who are economically and educationally disadvantaged.1 The concept and definition of vulnerable populations in research are in evolution. The Report and Recommendations of the 2001 National Bioethics Advisory Commission (NBAC) on Ethical and Policy Issues in Research Involving Human Participants has stated vulnerability to be "a condition, intrinsic or situational, of some individuals that put them at greater risk of being using in ethically inappropriate ways in
research/ Based on situation, any individual, regardless of competency and apparent ability to give informed consent, may be considered vulnerable to unethical research. All research investigators must consider the vulnerabilities that might exist among human participant research recruits and make appropriate accommodations. The purpose of identifying vulnerable populations is not to exclude those persons from research protocols, but to ensure that consideration is given to the ability of the participant to fulfill the requirements of the ethical research for human participants.
