Detection and Disclosure of Incidental Findings in Neuroimaging Research
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NINDS is part of the
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January 6-7, 2005
Bethesda Hyatt Hotel
Bethesda, Maryland
Sponsored by the National Institutes of Health:
NINDS, NIDA, NIBIB, NIMH, NIA and Stanford University
- 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:
- examine and debate the issues surrounding IFs in neuroimaging research,
- weigh trade-offs, such as medical and legal risk versus cost of routine neuroradiological involvement for managing IFs, and
- 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.
- 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.
- 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.
- 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:
- 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.
- 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.
- 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.
- 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.
- Incidental Findings should be addressed specifically in consent forms with disclosure of a pathway for follow up and cost of handling this finding.
- 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.
- 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).
- 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.
- 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
Phone: 513-556-4131
Fax: 513-556-4162
Email: ballws@UCMAIL.UC.eduPeter 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.govTsuri Bernstein, Ph.D.
Global IP Manager
Global Technology Operations
GE Healthcare - Technologies
3000 Grandview Boulevard, W-706
Waukesha, WI 53188
Phone: 262-544-3799
Fax: 262-513-3039
E-mail: tsur.bernstein@med.ge.comKelly 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
Phone: 314-747-67689
Fax: 314-747-6777
E-mail: botteronk@mir.wustl.eduNeil 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.govJoseph 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.govBetty (B.J.) Casey, Ph.D.
Sackler Professor
Department of Psychiatry
Weill Medical College of Cornell
1300 York Avenue, Box 140
New York, NY 10021
Phone: 212-746-5832
Fax: 212-746-5755
E-mail: bjc@med.cornell.eduMildred Cho, Ph.D.
Associate Director
Stanford Center for Biomedical Ethics
Stanford University
701A Welch Road, Suite 1105
Palo Alto, CA 94304
Phone: 650-725-7993
Fax: 650-725-6131
E-mail: micho@stanford.eduCarlo 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.govEmmeline 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.govAlan C. Evans, Ph.D.
Professor
Department of Neurology
Montreal Neurological Institute
McGill University
3801 University Street
Montreal, Canada H3A 2BA
Phone: 514-398-8926
Fax: 514-398-8948
Email: alan@bic.mni.mcgill.caPaul Ford, Ph.D.
Professional Staff Bioethicist
Clinical Research
Department of Bioethics
Cleveland Clinic Foundation
9500 Euclid - NAIO
Cleveland, OH 44195
Phone: 216-444-8723
Fax: 216-444-9275
E-mail: fordp@ccf.orgJoseph 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.govLisa 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.govLawrence 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.govGary 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
Phone: 650-723-7577
Fax: 650-723-5795
E-mail: garyg@stanford.eduThomas Grabowski, M.D.
Associate Professor of Neurology
And Radiology
University of Iowa College of Medicine
2RCP UIHC
Iowa City, IA 52242
Phone: 319-356-8753
Fax: 319-356-4505
E-mail: thomas_grabowski@uiowa.eduSteven 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.govKatrina 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.govJohn 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.govLynn 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.govJudy 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
Phone: 650-724-6393
Fax: 650-726-6131
Email: illes@stanford.eduMatthew Kirschen, B.S.
Graduate Student
Department of Radiology
Stanford University
Lucas MRS Center, MC #5488
1201 Welch Road
Stanford, CA 94305-5488
Phone: 650-724-8029
Fax: 650-723-5795
E-mail: kirschen@stanford.eduJennifer Kulynych, J.D., Ph.D.
Attorney
Health Care Group
Ropse & Gray LLP
One Metro Center
Washington, DC 20005
Phone: 202-508-4655
E-mail: jkulynych@ropesgray.comStory 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.govRuth Macklin, Ph.D.
Professor of Bioethics
Department of Epidemiology
And Population Health
Albert Einstein College of Medicine
1300 Morris Park Avenue
Bronx, NY 10461
Phone: 718-430-3574
Fax: 718-430-3076
Email: macklin@aecom.yu.eduSean 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.govVenkata 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.govRobert 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
Phone: 314-362-5949
Fax: 314-362-4886
E-mail: mckinstryb@mir.wustl.eduDaniel B. Michael, M.D., Ph.D.
University Neurosurgical Associates, PC
29275 Northwestern Highway
Southfield, MI 48034
Phone: 248-784-3718
E-mail: dmichael@voyager.netJonathan Moreno, Ph.D.
Kornfeld Professor and Director
Center for Biomedical Ethics
University of Virginia
P.O. Box 800758 UVA Health System
Charlottesville, VA 22908
Phone: 434-924-8274
Fax: 434-982-3971
E-mail: jdm8n@virginia.eduLawrence Muhlbaier, Ph.D.
Assistant Research Professor
Department of Biostatistics and Bioinformatics
Duke University Medical Center
DUMC 3865
Durham, NC 27710-7510
Phone: 919-668-8774
Fax: 919-668-7057
E-mail: lawrence.muhlbaier@duke.eduAlda 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.govSarah Putney
Director
Human Subjects Administration
Harvard School of Public Health
1552 Tremont Street
Boston, MA 12120
Phone: 617-384-5482
Fax: 617-384-5484
E-mail: sputney@hsph.harvard.eduMichael J. Rivkin, M.D.
Department of Neurology
Children's Hospital Boston
Harvard Medical School
300 Longwood Avenue, PV-154
Boston, MA 2115
Phone: 617-355-4740
Fax: 617-730-0618
E-mail: michael.rivkin@childrens.harvard.eduJudith 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.govBetty 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.govWalter 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
Phone: 412-901-4176
E-mail: wws@pitt.eduBernard Schwetz, D.V.M., Ph.D.
Director
Office for Human Research Protection
1101 Wooton Parkway, Suite 200
Rockville, MD 20852
Phone: 301-402-5299
Fax: 301-402-2071
E-mail: bschwetz@osophs.dhhs.govBelinda 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.govLaurence 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.govElliott 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.govChantal Stern, D.Phil.
Associate Professor
Center for Memory and Brain
Department of Psychology
Boston University
2 Cummington Street, Room 109
Boston, MA 2215
Phone: 617-353-1396
Fax: 617-358-3296
E-mail: chantal@bu.eduElizabeth 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.govStuart Youngner, M.D.
Susan E. Watson Professor and Chair
Department of Bioethics
Case University
10900 Euclid Avenue
Cleveland, OH 44106-4976
Phone: 216-368-6196
Fax: 216-368-8713
Email: sxy2@po.wru.eduDavid Yousem, M.D., M.B.A.
Director of Neuroradiology
Department of Radiology
Johns Hopkins Medical Institution
12 Westspring Way
Lutherville, MD 21093
Phone: 410-955-2685
Fax: 410-955-0962
E-mail: dyousem1@jhu.eduVivian 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.govSusan 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
Phone: 612-625-3406
Fax: 612-624-9143
Email: wolfx009@umn.edu
Last updated January 26, 2006
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