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Detection and Disclosure of Incidental Findings in Neuroimaging Research


January 6-7, 2005
Bethesda Hyatt Hotel
Bethesda, Maryland

Sponsored by the National Institutes of Health:
NINDS, NIDA, NIBIB, NIMH, NIA and Stanford University

  1. Introduction

    With rapidly increasing use of imaging in brain research, especially magnetic resonance (MR) technology, and expanding new applications for these tools within and outside the traditional boundaries of medicine, significant questions have been raised about the standards for detecting and disclosing incidental findings (IFs) in research subjects. To address these issues, the National Institutes of Health (NINDS, NIDA, NIBIB, NIMH, NIA) and Stanford University co-sponsored a workshop that focused on five key areas related to brain incidental findings: (I) Detection, (II) IRB Involvement, (III) Communicating with subjects, (IV) Research protocols, scanning environment & training, and (V) Subject Selection. The participants of the workshop represented a consortium of neuroscientists and medical imagers using MRI and other functional neuroimaging modalities, in partnership with bioethics scholars, health care providers and legal experts. They assembled to create an initial set of recommendations on standards for detecting and reporting unexpected findings that can be implemented rapidly and inform future policy making.

    The planning group for this meeting was comprised of Dr. Emmeline Edwards (NINDS), Dr. Laurence Stanford (NIDA), Dr. Peter Bandettini (NIMH), in collaboration with Dr. Judy Illes (Workshop Chair, Stanford Center for Biomedical Ethics and Department of Radiology), Dr. Mildred Cho, Associate Director of the Stanford Center for Biomedical Ethics, Dr. Gary H. Glover, Professor of Radiology and Director of the Radiological Sciences Laboratory, and MD/PhD student Matthew P. Kirschen (Stanford University). Dr. Ruth Macklin, Albert Einstein School of Medicine, Dr. Susan Wolf, University of Minnesota School of Law, Dr. Jennifer Kulynych, Law Offices Ropes and Gray, Dr. Paul Ford, Cleveland Clinic Foundation and Dr. Daniel Michael, Detroit Receiving Hospital, completed the roster of the planning group. At the January 6-7, 2005 meeting the planning committee partnered with an interdisciplinary group of approximately 40 distinguished scientists and scholars from around the United States and Canada specifically to:

    1. examine and debate the issues surrounding IFs in neuroimaging research,
    2. weigh trade-offs, such as medical and legal risk versus cost of routine neuroradiological involvement for managing IFs, and
    3. deliver recommendations for minimum and optimum standards that can be adopted fairly and evenly across universities, laboratories, IRBs, research sponsors of relevant research.

    The meeting was divided into three sessions over two days as follows:

    • In Session I, Dr. Peter Bandettini, Dr. Judy Illes, and Dr. Susan Wolf provided an overview of existing data, a presentation of the legal and ethical issues pertaining to the formation of guidelines, and a review of precedent and policies that could serve as a guide for the present charge to participants.
    • In Session II, breakout groups focused on the five key areas were convened to carry out discussions, debate and draft recommendations.
    • In Session III, the chairs of the breakout groups provided a synopsis of their discussions to all attendees, engaged the participants in vetting the group's recommendations, solicited general recommendations, and discussed majority and minority opinions, cautions, and next steps. A final overview and summary session allowed for full discussion of the presentations by all meeting participants and feedback to the planning committee, transforming the questions posed into solutions.

  2. Background

    Considerable enthusiasm for the growing knowledge about human brain function being gained from neuroimaging is paralleled by growing concern over findings of individual brain pathology that are unexpected and accidentally discovered ("Incidental findings") during such studies. Incidental findings have implications for research participants and researchers alike. Variations from expected brain morphology have been reported to occur in as many as 20% of research participants with clinically significant findings occurring in 2-8% of children and adults. In light of such findings, and given the rapidly increasing number of research MRIs conducted each year, significant ethical questions about responsibilities and procedures for detecting and disclosing incidental findings have been raised. For example, what is the overall burden on a researcher who discovers an abnormality in a volunteer? Should all studies involving brain MRIs or other forms of neuroimaging involve a physician qualified to review images for abnormal findings and provide clinical referral? What standardized procedures are needed for facilitating the transfer of information from the laboratory into a clinical care setting? What is the obligation of an investigator in reporting findings that may have implications for a third party, such as non-accidental head trauma or a neurogenetic disorder?

    Despite the high degree of variability observed, current procedures for handling incidental findings may, on the one hand, be adequate. To the knowledge of the workshop's organizers, neither the legal nor medical literature has yet documented an adverse outcome due to a missed finding, and while brain MRI may represent an ideal case for neurological and neuroradiologic screening prior to subject enrollment, this would be difficult to implement from the points of view of practicality and cost. However, with the number of research participants scanned no doubt in the tens of thousands per year, preliminary data suggest that it is imprudent to wait for a catastrophic event or significant legal action before taking steps to recognize the importance of managing any abnormalities that may be discovered.

    This workshop was designed to proactively formulate recommendations for standards of practice and assure an evenness in the way that guidelines are adopted by laboratories, IRBs, journals and research sponsors. The planning committee and workshop participants believe that such recommendations will have far greater acceptability and relevance than those imposed through a later reactive regulatory process. In the context of the technological advancements in brain imaging that have already characterized 21st century medical research and the pace of innovation, a set of guidelines for incidental findings on structural MRIs will also provide a model for neuroethical issues of broader concern on the horizon. These issues include management of incidental findings of potential functional significance, protection of the privacy of human thought, and the potential for misuse or abuse of such information, especially as "non research-based" uses surface in the setting of public safety, employment, education, and in the criminal justice system.

  3. Breakout Discussions

    III A. Detection of Incidental Findings (Group I)
    Chairs: Peter Bandettini, Ph.D. and Ruth Macklin, Ph.D.

    Group I convened to discuss the issues surrounding the detection of incidental findings. This breakout group reached consensus on the following points:

    • That the scanning protocols performed in a research project should be the minimum required to address the aims of the research (i.e., additional protocols for diagnostic purposes should not be performed).
    • All scans should be examined by a qualified and experienced member of the research team.
    • All studies should have a pathway for consultation and/or referral to a radiologist to perform a clinical evaluation of the acquired scans.
    • Both the member of the research team with responsibility for examination of the scans for incidental findings and the radiologist (if consultation is deemed necessary) should read the scans in a timely manner.
    • Researchers should obtain contact information for the primary medical care provider of the research participant.
    • The consultant radiologist should provide information to the Principal Investigator about incidental findings and should inform the Principal Investigator about what information should be conveyed to the participant's primary medical care provider.
    • Responsibility for the assessment of the significance of the findings and the need for follow-up tests with the participant's primary medical care provider.
    • In those cases where the participant does not have a primary medical care provider, the consultant radiologist should communicate with the subject to advise them to seek a provider to whom the IF findings would be sent.

    Group I did not reach consensus on the necessity of having a board-certified radiologist provide a clinical evaluation of all research scans (as opposed to the establishing a pathway for clinical evaluation as described above). The majority of the members of Group I did not favor this requirement.

    III B. IRB Involvement (Group II)
    Chairs: Laurence Stanford, Ph.D. and Susan Wolf, J.D.

    This group convened to discuss the issues that surround the possibility of incidental findings in neuroimaging research that are relevant to the Institutional Review Board (IRB). It was acknowledged that, from the standpoint of the design of research protocols, a range of approaches might be adopted, from protocols in which a complete clinical diagnostic study is performed as a routine part of the study design to protocols in which images are analyzed only for the purposes of addressing the specific research objectives. The cost/benefit ratio will vary with the specific approach chosen and the specific approach chosen will be influenced by a complex set of conditions including the setting in which the research is performed and the diagnostic utility of the images acquired.

    Two elements were considered to be common to all acceptable research designs. The first is that the IRB require that the way in which incidental findings will be handled is made explicit in the study design and that this be considered in the approval process. The second is that the way in which incidental findings will be handled is made explicit to any potential research subject through the informed consent process.

    III C. Communicating with Subjects (Group III)
    Chairs: Mildred Cho, Ph.D. and Emmeline Edwards, Ph.D.

    Group III focused their discussion on the protocol that should be followed once an incidental finding is identified by a research team. The following questions guided the discussions of this breakout group:

    • Who should communicate the discovery of an Incidental Finding to the subject?
    • What should the nature of the communication be (verbal? written? or both?)
    • What should be the time frame of this communication?
    • Are there HIPAA and subject confidentiality issues associated with communicating the discovery of an incidental finding?

    Group III first considered whether clinical expertise was required for all imaging studies regardless of the research setting. The group contrasted three research settings: 1) the NIH clinical center, where every subject is a patient; 2) a neuroimaging laboratory within a medical research setting where neuroimaging researchers have ready access to clinical expertise; and 3) a cognitive neuroscience laboratory in an academic center where basic science goals guide the research. The group looked at the balance between adding an additional burden on basic scientists by mandatory inclusion of medically trained personnel in imaging studies and imposing different obligations for medically - and non-medically trained investigators towards the subjects participating in neuroimaging studies. Group III reached consensus that in neuroimaging research, there should be no requirement to have every research scan read by a neuroradiologist. In the event that an incidental finding is discovered, the group concluded that the information should be communicated to the subject by the PI of the study or another qualified member of the research team. An incidental finding can also be communicated to the subject by a neuroradiologist or the family physician if the subject gave prior consent that such finding could be disclosed to these individuals. The group agreed that communication to the subject should be first made verbally, in a timely fashion, allowing subjects to have questions answered in real time. A follow up a letter should be sent to the subject. Group III concluded that all subjects enrolled in a neuroimaging study have the right to an informed consent process that allow them to know of and to evaluate the potential for obtaining information about incidental findings including the strengths and limitations of the research team in identifying, interpreting and/or communicating incidental findings.

    III D. Research Protocols, Scanning Environment and Training (Group IV)
    Chairs: Gary Glover, Ph.D. and Jennifer Kulynych, Ph.D., J.D.

    This group reached consensus on the need to have consistent procedures in neuroimaging experiments related to safety, operation of the scanner, screening and handling of subjects, an informed consent process that explicitly address the potential of incidental findings and a pathway for follow-up. Group IV also reached consensus that written guidelines within a neuroimaging protocol would not require that research personnel receive training in the detection of incidental findings. The group decided that each research site would determine the appropriateness of offering the subjects scans of their own imaging data as an incentive. Alternative approaches were discussed. These include: sharing highly processed images (e.g., 3D renderings of anatomical scans), offering generic or anonymous brain images instead of subject's own scan. Group IV recognized that neuroimaging studies include HIPAA authorization language through which subjects grant permission for the research team to disclose patient health information to, and receive PHI from, a neuroradiologist and the subject's clinical caregivers in the event that a suspected incidental finding is identified. Group IV also indicated that IRB's should review the neuroimaging protocol and ensure that a procedure and pathway for reporting incidental findings.

    III E. Subject Selection (Group V)
    Chairs: Paul Ford, Ph.D. and Daniel Michael, M.D.

    The task of this group was to discuss the issues surrounding the selection of subjects for neuroimaging research studies and, especially, how the possibility of incidental findings should or should not influence subject selection. It was agreed that, as a general principle, the selection of subjects for neuroimaging studies should conform to the same guidelines and requirements for ensuring gender, race, ethnicity, and age representation as other clinical research. Concomitant with the desire to achieve generalizability of the results obtained from neuroimaging studies, the group agreed that the following factors must also be considered:

    • Subject selection must be based on a sound scientific rationale dictated by the aims of the research.
    • Subjects should not be excluded from a study based on the likelihood that an incidental finding might be detected.
    • Clinical scans and clinical evaluation of images should not be required.
    • The procedure for handling an incidental finding must be made explicit to all participants in the research project.
    • The study design should include a mechanism for ensuring that a participant can be contacted during the time frame in which incidental findings would be detected. 77

    Further, this group recommended that a database of incidental findings should be developed.

  4. Discussions and Recommendations

    A primary outcome of the January 2005 Trans-NIH/ Stanford University meeting on Incidental Findings is the establishment of a consortium among meeting participants that will generate a summary publication with recommendations for detection, handling and disclosure of incidental findings. This document, along with supplementary materials (e.g., sample IF text to be included in an informed consent, IF documentation and referral forms) will be delivered to the NIH as a white paper, published as a scientific journal article and disseminated in the peer-reviewed literature. The paper will highlight the consortium's resolution on the issues, and provide an agenda for how to manage these findings and others in the future. In addition, it is expected that the discussion stimulated at the workshop will lead to new research and other publications in major scientific, clinical, and bioethics journals.

    The following recommendations were agreed upon by the meeting participants:

    1. In neuroimaging research, scientists and clinicians should anticipate the potential for Incidental Findings (IFs) in experimental design and establish a process to handle the discovery of an incidental finding.
    2. The IF process should allow for the inclusion of a professional competent to interpret a neuroimaging scan for clinically significant findings. There was varying opinion as to whether this individual must be a medical professional with a specialty in neuroradiology or radiology or a physician competent to interpret a neuroimaging scan.
    3. In a neuroimaging research protocol, the subject or surrogate is first in line for disclosure of an incidental finding. Communication with the subject or surrogate should be done by a qualified member of the research team: the Principal Investigator (PI), a neuroradiologist or physician.
    4. Verbal communication of an incidental finding should be done in a timely fashion, and documented in writing by a letter that draws on the informed consent language.
    5. Incidental Findings should be addressed specifically in consent forms with disclosure of a pathway for follow up and cost of handling this finding.
    6. Institutional Review Boards (IRBs) should require that a pathway for managing IFs be fully transparent and should be addressed in the IRB review. Investigators should develop and provide templates for IF language in the consent forms for the study.
    7. IF considerations may not be relevant for some neuroimaging modalities that, by nature of the protocol, do not generate images that are clinically interpretable. These include imaging protocols that are not designed to acquire clinically useful morphological data such as functional magnetic resonance imaging (fMRI) and other non-morphologic data (PET, SPECT, MRS).
    8. Guidelines for detection and disclosure of incidental findings should highlight the responsibility of the research team but should not stand in the way of neuroimaging research.
    9. The development of a database of incidental findings and an atlas of different types of incidental findings would be a valuable scientific resource.

    Participants

    William Ball, M.D.
    Professor and Chair
    Department of Biomedical Engineering
    University of Cincinnati
    884 Engineering Research Center
    P.O. Box 210048
    Cincinnati, OH 45221-0048

    Peter Bandettini, Ph.D.
    Director
    Functional ImagingFacility
    National Institute of Mental Health
    Building 10, Roo 1D80
    10 Center Dr., MSC 1148
    Bethesda, MD 20892-1148
    Phone: 301-402-1333
    Fax: 301-402-1370
    Email: bandettp@mail.nih.gov

    Tsuri Bernstein, Ph.D.
    Global IP Manager
    Global Technology Operations
    GE Healthcare - Technologies
    3000 Grandview Boulevard, W-706
    Waukesha, WI 53188

    Kelly Botteron, M.D.
    Associate Professor of Psychiatry and Radiology
    Department of Psychiatry
    Washington University
    School of Medicine
    660 South Euclid Avenue
    Campus Box 8134
    St. Louis, MO 63110

    Neil Buckholtz, Ph.D.
    Chief, Dementias of Aging Branch
    Neuroscience and Neuropsychology
    Aging Branch
    National Institute on Aging
    7201 Wisconsin Avenue, Suite 350
    Bethesda, MD 20892-9205
    Phone: 301-496-9350
    Fax: 301-496-1494
    E-mail: buckholn@nia.nih.gov

    Joseph Callicott, M.D.
    Chief, Unit on Functional MRI
    Clinical Brain Disorders Branch
    Genes, Cognition, and Psychosis Program
    National Institute of Mental Health, IRP
    National Institutes of Health
    10 Center Drive, Room 4C-216, Bethesda, MD 20892-1364
    Phone: 301-402-3081
    Fax: 301-480-7795
    E-mail: calliottj@mail.nih.gov

    Betty (B.J.) Casey, Ph.D.
    Sackler Professor
    Department of Psychiatry
    Weill Medical College of Cornell
    1300 York Avenue, Box 140
    New York, NY 10021

    Mildred Cho, Ph.D.
    Associate Director
    Stanford Center for Biomedical Ethics
    Stanford University
    701A Welch Road, Suite 1105
    Palo Alto, CA 94304

    Carlo Contoreggi, M.D.
    Clinical Director
    National Institute on Drug Abuse
    National Institutes of Health
    5500 Nathan Shock Drive
    Baltimore, MD 21224
    Phone: 410-550-1477
    Fax: 410-550-1479
    E-mail: ccontore@intra.nida.nih.gov

    Emmeline Edwards, Ph.D.
    Acting Deputy Director Extramural Research & Program Director
    for Systems and Cognitive Neuroscience
    National Institute of Neurological Disorders and Stroke
    6001 Executive Boulevard, Room 3305
    Bethesda, MD 20892-9531
    Phone: 301-496-3562
    Fax: 301-402-2060
    E-mail: ee48r@nih.gov

    Alan C. Evans, Ph.D.
    Professor
    Department of Neurology
    Montreal Neurological Institute
    McGill University
    3801 University Street
    Montreal, Canada H3A 2BA

    Paul Ford, Ph.D.
    Professional Staff Bioethicist
    Clinical Research
    Department of Bioethics
    Cleveland Clinic Foundation
    9500 Euclid - NAIO
    Cleveland, OH 44195

    Joseph Frascella, Ph.D.
    Director
    Division of Clinical Neuroscience,
    Development, and Behavioral Treatment
    National Institute on Drug Abuse/NIH
    Neuroscience Center
    6001 Executive Boulevard
    Room 4237, MSC 9593
    Bethesda, MD 20892-9593
    Phone: 301-443-4877
    Fax: 301-443-6814
    E-mail: jf80t@nih.gov

    Lisa Freund, Ph.D.
    Program Director,
    Child Development and Behavior Branch
    National Institute of Child Health and Human Development
    National Institutes of Health
    6100 Executive Boulevard, Room 4B05C, Bethesda, MD 20892-7510
    Phone: 301-435-6879
    Fax: 301-480-0230
    E-mail: freundl@mail.nih.gov

    Lawrence Friedman, M.D.
    Assistant Director for Ethics and Clinical Research
    National Heart, Lung and Blood Institute
    Building 31, Room 5A20
    Bethesda, MD 20852-2482
    Phone: 301-496-9899
    Fax: 301-402-1056
    E-mail: Lawrence_Friedman@nih.gov

    Gary Glover, Ph.D.
    Professor of Radiology
    Department of Radiology, Radiological
    Sciences Laboratory
    Stanford University
    1201 Welch Road, Room P262
    Mail Code 5488
    Stanford, CA 94305-5488

    Thomas Grabowski, M.D.
    Associate Professor of Neurology
    And Radiology
    University of Iowa College of Medicine
    2RCP UIHC
    Iowa City, IA 52242

    Steven Grant, Ph.D.
    Acting Chief,
    Clinical Neuroscience Branch
    Division of Clinical Neuroscience,
    Development, and Behavioral Treatment
    National Institute on Drug Abuse
    6001 Executive Boulevard
    Bethesda, MD 20892
    Phone: 301-443-4877
    Fax: 301-443-6819
    E-mail: sgrant@nida.nih.gov

    Katrina Gwinn-Hardy, M.D.
    Program Director
    Neurogenetics
    National Institute of Neurological Disorders and Stroke
    Neuroscience Center
    6001 Executive Boulevard, Room 2124
    Bethesda, MD 20892
    Phone: 301-496-5746
    Fax: 301-402-1501
    E-mail: gwinnk@ninds.nih.gov

    John W. Haller, Ph.D.
    Acting Division Director
    Division of Applied
    Science and Technology
    National Institute of Biomedical Imaging
    And Bioengineering
    National Institutes of Health
    Democracy Plaza II
    6707 Democracy Boulevard
    Bethesda, MD 20892
    Phone: 301-451-4780
    E-mail: hallerj@mail.nih.gov

    Lynn D. Hudson, Ph.D.
    Deputy Director
    Office of Science Policy and Planning
    Building 1, Room 218
    1 Center Drive
    Bethesda, MD 20892
    Phone: 301-496-0786
    Fax: 301-402-0280
    E-mail: hudsonl1@od.nih.gov

    Judy Illes, Ph.D.
    Director, Program in Neuroethics
    Stanford Center for Biomedical Ethics and
    Department of Radiology
    Stanford University
    701 Welch Road
    Palo Alto, CA 94304-5748

    Matthew Kirschen, B.S.
    Graduate Student
    Department of Radiology
    Stanford University
    Lucas MRS Center, MC #5488
    1201 Welch Road
    Stanford, CA 94305-5488

    Jennifer Kulynych, J.D., Ph.D.
    Attorney
    Health Care Group
    Ropse & Gray LLP
    One Metro Center
    Washington, DC 20005

    Story Landis, Ph.D.
    Director
    National Institute of Neurological Disorders & Stroke
    Building 31, Room 8A52
    31 Center Drive MSC 2540
    Bethesda, MD 20892-2540
    Phone: 301-496-4697
    E-mail: landiss@ninds.nih.gov

    Ruth Macklin, Ph.D.
    Professor of Bioethics
    Department of Epidemiology
    And Population Health
    Albert Einstein College of Medicine
    1300 Morris Park Avenue
    Bronx, NY 10461

    Sean Marrett, Ph.D.
    Staff Scientist
    FMRIF/National Institute of Mental Health
    National Institutes of Health
    110 Center Drive, Room 1080
    Bethesda, MD 20892-1148
    Phone: 301-402-1378
    Fax: 301-402-1370
    E-mail: marrett@nih.gov

    Venkata S. Mattay, M.D.
    Staff Clinician, Unit on Functional MRI
    Clinical Brain Disorders Branch
    National Institute of Mental Health, IRP
    National Institutes of Health
    10 Center Drive, Room 4S-227, Bethesda, MD 20892-1364
    Phone: 301-435-4594
    Fax: 301-480-7795
    E-mail: vm5h@nih.gov

    Robert McKinstry, M.D., Ph.D.
    Assistant Professor
    Department of Neuroradiology
    Mallinckrodt Institute of Radiology
    Washington University in St. Louis
    5120 Kingshighway, Box 8131,
    St. Louis, MO 63110

    Daniel B. Michael, M.D., Ph.D.
    University Neurosurgical Associates, PC
    29275 Northwestern Highway
    Southfield, MI 48034

    Jonathan Moreno, Ph.D.
    Kornfeld Professor and Director
    Center for Biomedical Ethics
    University of Virginia
    P.O. Box 800758 UVA Health System
    Charlottesville, VA 22908

    Lawrence Muhlbaier, Ph.D.
    Assistant Research Professor
    Department of Biostatistics and Bioinformatics
    Duke University Medical Center
    DUMC 3865
    Durham, NC 27710-7510

    Alda Ottley, B.S.
    MRI Technologist
    National Institute of Mental Health
    Kelly Services
    National Institutes of Health
    610 Quintana Place, N.W.
    Washington, DC 20011
    Phone: 301-435-5833
    E-mail: aldaottley@mail.nih.gov

    Sarah Putney
    Director
    Human Subjects Administration
    Harvard School of Public Health
    1552 Tremont Street
    Boston, MA 12120

    Michael J. Rivkin, M.D.
    Department of Neurology
    Children's Hospital Boston
    Harvard Medical School
    300 Longwood Avenue, PV-154
    Boston, MA 2115

    Judith Rumsey, Ph.D.
    Program Director
    Neurodevelopmental Disorders Branch
    National Institute of Mental Health
    6001 Executive Boulevard, Room 7175
    Bethesda, MD 20892-9639
    Phone: 301-443-9264
    E-mail: jrumsey@mail.nih.gov

    Betty Jo Salmeron, M.D
    . Staff Clinician
    Neuroimaging Branch
    National Institute on Drug Abuse
    5500 Nathan Shock Drive
    Baltimore, MD 21224
    Phone: 410-550-1440, ext. 325
    Fax: 410-550-1441
    E-mail: bsalmeron@intra.nida.nih.gov

    Walter Schneider, Ph.D.
    Professor of Psychology
    Psychology, Center Neural Basis Cognition,
    Learning Research & Development Center
    University of Pittsburgh
    3939 O'Hara Street
    Pittsburgh, PA 15221

    Bernard Schwetz, D.V.M., Ph.D.
    Director
    Office for Human Research Protection
    1101 Wooton Parkway, Suite 200
    Rockville, MD 20852
    Phone: 301-402-5299

    Belinda Seto, Ph.D.
    Deputy Director
    National Institutes of Biomedical Imaging and Bioengineering
    National Institutes of Health
    6707 Democracy Boulevard, Suite 202
    Bethesda, MD 20892-5477
    Phone: 301-451-6768
    Fax: 301-480-4515
    E-mail: setob@mail.nih.gov
    cc: kennedyst@mail.nih.gov

    Laurence Stanford, Ph.D.
    Program Director
    Developmental Neurobiology Program
    Behavioral and Brain Development Branch
    Division of Clinical Neuroscience,
    Development and Behavioral Treatment
    National Institute on Drug Abuse
    6001 Executive Boulevard
    Room 4232, MSC 9593
    Bethesda, MD 20892-9593
    Phone: 301-402-3869
    Fax: 301-443-6814
    E-mail: lstanfor@nida.nih.gov

    Elliott A. Stein, Ph.D.
    Chief, Neuroimaging Research Branch
    National Institute on Drug Abuse
    5500 Nathan Shock Drive
    Baltimore, MD 21224
    Phone: 410-550-1440, ext. 338
    Fax: 410-550-1441
    E-mail: estein@intra.nida.nih.gov

    Chantal Stern, D.Phil.
    Associate Professor
    Center for Memory and Brain
    Department of Psychology
    Boston University
    2 Cummington Street, Room 109
    Boston, MA 2215

    Elizabeth Thomson, M.S., R.N., C.G.C., F.A.A.N.
    Program Director of Ethical, Legal, and SocialImplications (ELSI) Research
    National Human Genome Research Institute
    5635 Fishers Lane, Suite 4076
    Bethesda, MD 20892-9305
    Phone: 301-402-4997
    Fax: 301-402-1950
    E-mail: et22s@nih.gov

    Stuart Youngner, M.D.
    Susan E. Watson Professor and Chair
    Department of Bioethics
    Case University
    10900 Euclid Avenue
    Cleveland, OH 44106-4976

    David Yousem, M.D., M.B.A.
    Director of Neuroradiology
    Department of Radiology
    Johns Hopkins Medical Institution
    12 Westspring Way
    Lutherville, MD 21093

    Vivian Ota Wang, Ph.D.
    Program Director
    Ethical, Legal, and Social Implications Program
    National Human Genome Research Institute
    National Institutes of Health
    5635 Fishers Lane Suite 4076
    Bethesda, Maryland 20892-9305
    Phone: 301- 496.7531
    Fax: 301- 480.2770
    E-mail: otawangv@mail.nih.gov

    Susan M. Wolf, J.D.
    Faegre & Benson Professor of Law
    Professor of Medicine
    Director, Joint Degree Program in Law
    Health & the Life Sciences
    Chair, Consortium on Law and Values in Health,
    Environment & the Life Sciences
    University of Minnesota Law School
    229 19th Avenue South
    Minneapolis, MN 55455

Last updated May 4, 2009