Examining the Use
of Biomarkers in
Establishing the
Presence and Severity
of Impairments
PROCEEDINGS OF A WORKSHOP
Megan Snair, Tracy A. Lustig, and Cyndi Trang, Rapporteurs
Board on Health Care Services
Health and Medicine Division
THE NATIONAL ACADEMIES PRESS
Washington, DC
www.nap.edu
THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001
This activity was supported by a contract between the National Academy of Sciences and the Social Security Administration. Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project.
International Standard Book Number-13: 978-0-309-68263-3
International Standard Book Number-10: 0-309-68263-0
Digital Object Identifier: https://doi.org/10.17226/25926
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Printed in the United States of America
Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2020. Examining the use of biomarkers in establishing the presence and severity of impairments: Proceedings of a workshop. Washington, DC: The National Academies Press. https://doi.org/10.17226/25926.
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PLANNING COMMITTEE ON THE STATE OF THE SCIENCE OF THE USE OF BIOMARKERS TO ESTABLISH THE PRESENCE AND SEVERITY OF IMPAIRMENTS1
SARA ROSENBAUM (Chair), Harold and Jane Hirsh Professor, Health Law and Policy, Milken Institute School of Public Health, The George Washington University
LINDA S. BRADY, Director, Division of Neuroscience and Basic Behavioral Science, National Institute of Mental Health, National Institutes of Health
BETTY DIAMOND, Chief, Autoimmune Disease Center, Feinstein Institutes for Medical Research
SARAH E. MORRIS, Chief, Adult Psychopathology and Psychosocial Intervention Development Branch; Program Officer, Schizophrenia Spectrum Disorders Program, National Institute of Mental Health, National Institutes of Health
RALPH NITKIN, Deputy Director, National Center for Medical Rehabilitation Research; Director, Biological Sciences and Career Development Program, National Institute of Child Health and Human Development, National Institutes of Health
PATRICIA M. OWENS, Consultant, Health and Disability Policy and Programs
SARAH RUIZ, Associate Director, Office of Research Sciences, National Institute on Disability, Independent Living, and Rehabilitation Research
IRA SHOULSON, Professor of Neurology, University of Rochester; Adjunct Professor of Neurology, Georgetown University
ROBERT B. WALLACE, Irene Ensminger Stecher Professor, Cancer Research, The University of Iowa
Health and Medicine Division Staff
TRACY A. LUSTIG, Senior Program Officer
CYNDI TRANG, Research Associate
JOE GOODMAN, Senior Program Assistant
SHARYL NASS, Senior Director, Board on Health Care Services
___________________
1 The National Academies of Sciences, Engineering, and Medicine’s planning committees are solely responsible for organizing the workshop, identifying topics, and choosing speakers. The responsibility for the published Proceedings of a Workshop rests with the workshop rapporteurs and the institution.
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Reviewers
This Proceedings of a Workshop was reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the National Academies of Sciences, Engineering, and Medicine in making each published proceedings as sound as possible and to ensure that it meets the institutional standards for quality, objectivity, evidence, and responsiveness to the charge. The review comments and draft manuscript remain confidential to protect the integrity of the process.
We thank the following individuals for their review of this proceedings:
Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the content of the proceedings nor did they see the final draft before its release. The review of this proceedings was overseen by WALTER R. FRONTERA, University of Puerto Rico School of Medicine. He was responsible for
making certain that an independent examination of this proceedings was carried out in accordance with standards of the National Academies and that all review comments were carefully considered. Responsibility for the final content rests entirely with the rapporteurs and the National Academies.
4 LEGAL AND ETHICAL IMPLICATIONS
Concerns for the Use of Biomarkers in Disability
Considerations for Decision Making in Defining Disability
Examining Positive Findings and Potential Challenges
Suggestions for the Use of Biomarkers in the Social Security Administration
C Biographical Sketches of Workshop Speakers and Planning Committee Members
Acronyms and Abbreviations
| ACPA | anti-citrullinated peptide antibody |
| BEST | Biomarkers, EndpointS, and other Tools glossary |
| CNS | central nervous system |
| COA | clinical outcome assessment |
| COU | context of use |
| EEG | electroencephalogram |
| FDA | Food and Drug Administration |
| FNIH | Foundation for the National Institutes of Health |
| GABA | gamma aminobutyric acid |
| GPS | global positioning system |
| HAQ | health assessment questionnaire |
| ICF | International Classification of Functioning, Disability and Health |
| MRI | magnetic resonance imaging |
| MVP | Million Veteran Program |
| NIH | National Institutes of Health |
| OA | osteoarthritis |
| PTSD | post-traumatic stress disorder |
| RA | rheumatoid arthritis |
| RANTES | regulated on activation, normal T-cell expressed and secreted |
| SSA | Social Security Administration |
| SSRI | selective serotonin reuptake inhibitor |
| VA | Department of Veterans Affairs |
| WHO | World Health Organization |
