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Project Information

Project Information


Return of Individual-Specific Research Results Generated in Research Laboratories


Project Scope:

The Health and Medicine Division of the National Academies will undertake a study that will review and evaluate the return of individual-specific research results from research laboratories, which are required to be returned in accordance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Currently, any research laboratory that returns individual-specific research results is regulated by CLIA.  Research laboratories that do not report patient specific results are excepted from the CLIA regulations. The committee will:

 

  • Review the current evidence concerning the return of individual-specific research results to individuals, including the value to the individual participating in the research and society and the quality challenges particular to research results.
  • Review the current regulatory environment, including CLIA and any other applicable laws, for conducting tests and returning individual-specific research results, including the potential regulatory considerations associated with returning such results. In doing so, the committee will assess how the current regulations ensure or fail to ensure minimization of risks (e.g., erroneous or unreliable results) and maximization of the benefits that accrue to individuals and society. 
  • Review current practices in returning research results and identify what are considered to be best practices, if any, for doing so.
  • Identify and assess available evidence of benefits and harm to individuals and society regarding the return of research results generated in research laboratories.
  • Make recommendations on the issue of returning individual-specific research results generated in research laboratories that are regulated by CLIA, and also taking into consideration any other applicable laws or regulations. In making recommendations, the committee will take into account the desires of individuals regarding access to the information, the benefits and harms of returning research results to both the individuals themselves and to individual participation and trust in the research enterprise, the operational requirements and potential vulnerabilities associated with the return of results by research laboratories to the laboratory itself or the parent institution of the laboratory, as well as the need to protect both individuals and public health. In making the recommendations, the committee will consider and address, as appropriate:
    • The adequacy of the current CLIA regulations as applied to research laboratories (or subcategories of research testing by such laboratories) that currently return individual-specific results in accordance with CLIA. 
    • Barriers or perceived barriers that lead research laboratories to refrain from taking the steps necessary to become certified under CLIA.
    • Whether there are any operational or other requirements, including regulatory requirements, for research labs that may be developed or modified and implemented under CLIA or any other applicable laws to more adequately address the return of individual-specific research results. Additionally, whether there are or may be specific considerations for research laboratories (including any obligations or desires on the part of researchers to fulfill requests for access to research test results and whether they have the appropriate personnel or resources to explain the research results) or for individuals (including protections and ability to receive, store, and understand research results) regarding the return of such results. Also, whether, from a policy perspective, there are specific circumstances under which research results generated in research laboratories should be or should not be returned.
    • Whether there are any baseline test characteristics that should be met if individual-specific research results generated in research laboratories were to be returned in accordance with CLIA and any other applicable laws, such as the purpose or potential indication, analytic and clinical validity and potential clinical relevance of the test.
    • Whether the current regulatory requirements and policies are adequate to address returning research results in an appropriate manner and, if not, what new, revised, or alternative policies or regulatory requirements might better address the appropriate return of individual-specific research results generated in research laboratories. Also whether any such new or revised policies would have implications for the continuation of the current regulatory framework.

 

The committee will not undertake any examination of or deliberation on specific research results to be returned. The committee will also not make recommendations on the return of non-individual specific results (e.g., results in aggregate form). The committee will also not provide any legal interpretation or analysis regarding the scope or applicability of CLIA.

Status: Current

PIN: HMD-HSP-17-05

Project Duration (months): 14 month(s)

RSO: Mancher, Michelle

Board(s)/Committee(s):

Board on Health Sciences Policy

Topic(s):

Health and Medicine
Policy for Science and Technology


Committee Membership

Committee Post Date: 07/31/2017



Dr. Brian Zikmund-Fisher


Brian J. Zikmund-Fisher is an Associate Professor in the Department of Health Behavior and Health Education, University of Michigan School of Public Health, as well as a Research Associate Professor in the Division of General Internal Medicine, University of Michigan Medical School and an Associate Director of the UM Center for Bioethics and Social Sciences in Medicine. Dr. Zikmund-Fisher uses his interdisciplinary background in decision psychology and behavioral economics to study factors that affect individual decision making about a variety of health and medical issues. His research in health communications focuses on making risk statistics, test results, and other types of quantitative health information intuitively meaningful and useful for decision making by patients and the public. Dr. Zikmund-Fisher also studies the effects of poor numeracy on people's ability to use numbers to inform their health decisions and the role of narratives in health communications. He serves as an Associate Editor for the journals Medical Decision Making and Medical Decision Making: Policy and Practice.
Dr. Rhonda G. Kost


Dr. Kost has expertise in several content areas relevant to Return of Individual-Specific Research Results. First, and perhaps most importantly, as the Clinical Research Officer for The Rockefeller University Center for Clinical Translational Science, she has spent more than a decade studying participant-centered research outcomes, specifically developing validated tools and using them to assess what research participants think of, and want from, their research experiences. She has been a member of The Rockefeller University Institutional Review Board since 1997, and has directed the Clinical Research Support office as the lead in human subject protections, research ethics, regulatory compliance, engaging stakeholders, and participant advocacy, for more than a decade. In another role, as Co-Director of the Community Engagement Core, she is experienced and attuned to addressing the priorities of communities and patients. Trained in Internal Medicine and Infectious Diseases, Dr. Kost served as a Medical Staff Fellow at the National Institutes of Health, NIAID, and as an HIV Clinical Trialist at the Aaron Diamond AIDS Research Center prior to her current position at Rockefeller. She has served on and led national CTSA committees, and is respected as an active and innovative contributor to the national CTSA Consortium.
Mrs. Bray Patrick-Lake


As the Director of Stakeholder Engagement for Duke Clinical Research Institute, Bray Patrick-Lake supports efforts to actively engage patients, health advocacy organizations, and other stakeholders in local and national research programs. She has led extensive efforts through the Clinical Trials Transformation Initiative to incorporate patient voice into clinical trial design, conduct, oversight, and regulatory frameworks, as well as improvement of the clinical trial enterprise. She co-chaired the Advisory Committee to the NIH Director’s Working Group responsible for authoring the vision and roadmap to launch the Precision Medicine Initiative Cohort Program. She served as the Interim Director of Engagement for several months the after program launched and became the All of Research Program, for which she currently serves on the National Advisory Panel. She also leads engagement work at Duke’s Coordinating Center for the NIH Environmental Influences on Child Health Outcomes (ECHO) program and serves on the National Academies of Sciences, Engineering, and Medicine Health Sciences Policy Board. Ms. Patrick-Lake founded a nonprofit disease advocacy organization for cardiac patients and served as a patient representative at the FDA on a variety of advisory committees and panels, in workgroups for EMA, IMI, NIH, and NAM/IOM, and as a patient stakeholder or co-investigator for AHRQ and PCORI research projects. She’s been a member of the PCORnet Coordinating Center's Executive Leadership Committee where she developed patient engagement strategies. She is member of the America Cancer Society’s Clinical Trials Steering Committee and has served on the MDEpiNet’s National Medical Device Registry Task Force, the Medical Device Innovation Consortium’s Patient-centered Benefit-Risk Steering Committee, American College of Cardiology (ACC) Foundation's Patient-centered Care Shared Decision Making and Patient-generated Health Data working groups, and the ACC Transcatheter Valve Therapy Registry Stakeholder Advisory Committee. She currently also serves as a PCORI reviewer and ambassador.
Dr. Jeffrey R. Botkin - (Chair)


Jeff Botkin is a Professor of Pediatrics at the University of Utah and an Adjunct Professor of Human Genetics. He is Chief of the Division of Medical Ethics and Humanities in the Department of Internal Medicine. He obtained his B.A. from Princeton University, M.D. from the University of Pittsburgh, and M.P.H. from Johns Hopkins. Dr. Botkin is the Associate Vice President for Research Integrity at the University of Utah with oversight responsibilities for the IRB, conflict of interest, responsible conduct of research, biosafety, and research ethics education. His research and publications are focused on the ethical, legal, and social implications of genetic technology with a particular emphasis on research ethics, genetic testing for cancer susceptibility, newborn screening, and prenatal diagnosis. Dr. Botkin was formerly Chair of the Committee on Bioethics for the American Academy of Pediatrics and is a former member of the Secretary’s Advisory Committee on Human Research Protections at DHHS. Dr. Botkin was formerly a member of the Secretary’s Advisory Committee on Heritable Diseases in Newborns and Children. He Chairs the NIH’s Embryonic Stem Cell Working Group and is a member of the FDA’s Pediatric Ethics Advisory Committee. Dr. Botkin is an elected fellow of the Hastings Center.
Dr. Paul S. Appelbaum


Paul S. Appelbaum is the Elizabeth K. Dollard Professor of Psychiatry, Medicine, and Law, and Director, Division of Psychiatry, Law, and Ethics, Department of Psychiatry, College of Physicians and Surgeons of Columbia University; a Research Psychiatrist at the NY State Psychiatric Institute; and an affiliated faculty member, Columbia Law School. He directs Columbia’s Center for Research on Ethical, Legal, and Social Implications of Psychiatric, Neurologic, and Behavioral Genetics, and heads the Clinical Research Ethics Core for Columbia’s Clinical and Translational Science Award program. Dr. Appelbaum is the author of many articles and books on law and ethics in clinical practice. His current research focuses on the implications of new genetic technologies. Dr. Appelbaum is Past President of the American Psychiatric Association and the American Academy of Psychiatry and the Law, and has twice served as Chair of the Council on Psychiatry and Law and of the Committee on Judicial Action for the American Psychiatric Association (APA). Dr. Appelbaum is currently Chair of the DSM Steering Committee for APA, and of the Standing Committee on Ethics of the World Psychiatric Association. He has received the Isaac Ray Award of the American Psychiatric Association for "outstanding contributions to forensic psychiatry and the psychiatric aspects of jurisprudence," was the Fritz Redlich Fellow at the Center for Advanced Study in the Behavioral Sciences, and has been elected to the National Academy of Medicine.


Dr. Suzanne Bakken


Suzanne Bakken, R.N., Ph.D., FAAN, FACMI, is the Alumni Professor of Nursing and Professor of Biomedical Informatics at Columbia University. Following doctoral study in nursing at the University of California, San Francisco, she completed a National Library of Medicine postdoctoral fellowship in Medical Informatics at Stanford University. The goal of Dr. Bakken’s program of research is to promote health and reduce health disparities in underserved populations through application of innovative informatics and data science methods. A major focus of her current grant portfolio is visualization of healthcare data for community members, patients, clinicians, and community-based organizations. Dr. Bakken currently directs the Precision in Symptom Self-Management (PriSSM) Center and the Reducing Health Disparities Through Informatics (RHeaDI) pre-doctoral and postdoctoral training program; both funded by the National Institute of Nursing Research (NINR). She also served as Principal Investigator of the AHRQ-funded Washington Heights Inwood Informatics Infrastructure for Comparative Effectiveness Research (WICER) and its follow-up study, WICER 4 U, which is focused on promoting the use of WICER infrastructure through stakeholder engagement including return of individual research results. She has also received funding from the National Cancer Institute, National Library of Medicine, National Institute of Mental Health, and the Health Resources and Services Administration. Dr. Bakken has published more than 200 peer-reviewed papers. In 2010, she received the Pathfinder Award from the Friends of the National Institute of Nursing Research. In 2015-16, Dr. Bakken served as the AAN/ANA/ANF Distinguished Nurse Scholar-in-Residence at the National Academy of Medicine and is a member of the Roundtable on Health Literacy. She is a fellow of the New York Academy of Medicine, American Academy of Nursing, and American College of Medical Informatics, and a member of the National Academy of Medicine.
Dr. Chester W. Brown


Dr. Brown is the St. Jude Chair of Excellence in Genetics, and Professor and Division Chief of Genetics at the University of Tennessee Health Science Center, Le Bonheur Children’s Hospital and St. Jude Children’s Research Hospital where he was recruited to help develop precision medicine initiatives in Memphis, TN, including the development of DNA and tissue repositories and large-scale –omics technologies to aid in population-based genomic research, considering also the ethical, legal and social implications of such efforts in underserved communities. His clinical interests include a variety of rare genetic syndromes in children and adults with a research emphasis on rare genetic disorders that have severe, early onset obesity as a feature. He completed his undergraduate degree at Howard University followed by MD/PhD training at the University of Cincinnati College of Medicine. His postdoctoral and subsequent faculty roles were in Pediatrics and Medical Genetics at Baylor College of Medicine. He has more than 20 years’ clinical experience with Medical Genetics patients representing a broad spectrum of conditions. He is an active member of the Society for Pediatric Research, a member of an NIH study section, and recently completed service as a committee member for the National Academies of Sciences, Engineering and Medicine to develop a framework to inform decision-making related to genetic testing. He also directs a basic science research laboratory supported by grants from the NICHD, NIDDK, industry and a variety of foundations. He works collaboratively to better understand the host genomic factors that contribute to HIV and TB progression in African children, funded by the NIH/NIAID H3Africa initiative. He has continued clinical practice throughout his career and has never lost sight of the fundamental importance of careful observation and listening carefully to patients.
Dr. Wylie Burke


Wylie Burke, M.D., Ph.D. is Professor Emeritus and former Chair of the Department of Bioethics and Humanities at the University of Washington. Her work focuses on the ethical and policy implications of genetic information in research, public health and clinical care. She founded the University of Washington Center for Genomics and Healthcare Equality, an NHGRI-funded center of excellence in ethical, legal and social implications research addressing the implications of genomic research for underserved communities; and co-directs the Northwest-Alaska Pharmacogenomics Research Network, a research partnership involving universities and tribal communities in Alaska, Montana and Washington. Dr. Burke received a Ph.D. in Genetics and an M.D. from the University of Washington, and completed Internal Medicine residency training at the University of Washington, where she was also a Medical Genetics fellow. She is a member of the National Academy of Medicine and past President of the American Society of Human Genetics.
Dr. Richard Fabsitz


Dr. Richard Fabsitz joined the Department of Global and Community Health as Adjunct Faculty teaching Applied Health Statistics after a long-term career with the National Institutes of Health. His NIH career began with the National Institute of Mental Health but was primarily spent at the National Heart, Lung and Blood Institute where he last served in the position of Deputy Chief, Epidemiology Branch. He has extensive experience in research team management, program administration, and the conduct of cardiovascular epidemiology research in large population-based studies focused on longitudinal cohort studies, Native Americans, families, twins, and genetics. Additional research interests include the use of metrics in the management of scientific research, methods to promote collaboration and innovation in research projects, research translation, and the ethical and practical issues surrounding the return of genetic research results to study participants. He has authored or co-authored a wide range of journal articles related to cardiovascular epidemiology.
Dr. Vanessa Northington Gamble


Vanessa Northington Gamble, a physician and medical historian, is University Professor of Medical Humanities and Professor of Health Policy and American Studies at the George Washington University. Before coming to GWU, she was director of Tuskegee University’s National Center for Bioethics and Health Care. She is an internationally recognized expert on the history of race and American medicine, racial and ethnic inequities in health and health care, and bioethics. Dr. Gamble is a member of the National Academy of Medicine and Fellow of the Hastings Center.
Dr. Gregg Gonsalves


Gregg Gonsalves is an Assistant Professor of Epidemiology of Microbial Diseases at Yale School of Public Health. His research focuses on the use of quantitative models for improving the response to epidemic diseases. Gonsalves is also an Associate Professor (Adjunct) and Research Scholar in Law at Yale Law School, a co-director of the Yale Collaboration for Research Integrity and Transparency, and a leading HIV/AIDS activist. For more than 20 years, he worked on HIV/AIDS and other global health issues with several organizations, including the AIDS Coalition to Unleash Power, the Treatment Action Group, Gay Men’s Health Crisis, and the AIDS and Rights Alliance for Southern Africa. He was also a fellow at the Open Society Foundations and in the Department of Global Health and Social Medicine at Harvard Medical School from 2011-2012. He is a 2011 graduate of Yale College and received his PhD from Yale Graduate School of Arts and Sciences/School of Public Health in 2017.
Dr. Debra Leonard


Debra Leonard, M.D., Ph.D., received her M.D. and Ph.D. from the New York University School of Medicine, and is currently Professor and Chair of the Department of Pathology and Laboratory Medicine at the Robert Larner, M.D. College of Medicine at the University of Vermont and at the University of Vermont Health Network. She was previously Vice Chair for Laboratory Medicine in the Department of Pathology and Laboratory Medicine, and Director of the Clinical Laboratories for New York-Presbyterian Hospital’s Cornell campus (NYPH-WCMC), where she also served as Director of the Pathology Residency Training Program. Dr. Leonard is a nationally recognized expert in Molecular Pathology. She has served on several national committees that develop policy for the use of genetic and genomic technologies and information, including most recently the Secretary’s Advisory Committee on Genetics, Health and Society that advised the Secretary of Health and Human Services. Dr. Leonard is editor of two molecular pathology textbooks and has spoken widely on various molecular pathology test services, the future of molecular pathology, and the impact of gene patents on molecular pathology practice. Dr. Leonard is interested in the use of genomic technologies in the practice of medicine to improve patient outcomes.
Dr. Amy McGuire


Amy McGuire, J.D., Ph.D., is the Leon Jaworski Professor of Biomedical Ethics and Director of the Center for Medical Ethics and Health Policy at Baylor College of Medicine. Dr. McGuire’s research focuses on clinical integration of emerging technologies, with a particular focus on ethical and policy issues in human genetics and genomic research. Her research is funded by the National Institutes of Health. Dr. McGuire served as a member of the National Advisory Council for Human Genome Research from 2011-2015. Currently, she on the program committee for the Greenwall Foundation Faculty Scholars Program in Bioethics and is president of the Association of Bioethics Program Directors.
Dr. James H. Nichols


James H. Nichols, PhD, DABCC, FACB, is a Professor of Pathology, Microbiology, and Immunology; Medical Director of Clinical Chemistry and Point-of-Care Testing at Vanderbilt University School of Medicine in Nashville, Tennessee. Dr. Nichols received his BA in General Biology/Premedicine from Revelle College, University of California at San Diego. He went on to complete an MS and a PhD in Biochemistry from the University of Illinois, Urbana-Champaign. Dr. Nichols was a fellow in the Postdoctoral Training Program in Clinical Chemistry at the Mayo Clinic, Rochester, Minnesota. He is board certified in both Clinical Chemistry and Toxicological Chemistry by the American Board of Clinical Chemistry. Dr. Nichols spent several years as Associate Director of Clinical Chemistry, Director of Point-of-Care Testing, and an Associate Professor of Pathology at Johns Hopkins Medical Institutions. He later served as Medical Director of Clinical Chemistry for Baystate Health in Springfield, Massachusetts, and was a Professor of Pathology at Tufts University School of Medicine. Dr. Nichols’ research interests span evidence-based medicine, information management, laboratory automation, point-of-care testing, and toxicology. Dr. Nichols has served on CLIAC – The Clinical Laboratory Improvement Amendments Advisory Committee and has been involved with CLSI in a number of roles. He was a member of the Subcommittee on Point-of-Care Testing, as well as Vice-Chairholder and Chairholder of the Consensus Committee on Point-of-Care Testing. Dr. Nichols served on the Chairholders Council; participated as a member of the Consensus Committee on Evaluation Protocols; and was an advisor, member, Chairholder, and Co-Chairholder of several document development committees.
Dr. Consuelo Wilkins


Consuelo H. Wilkins, MD, MSCI is the Executive Director of the Meharry-Vanderbilt Alliance and Associate Professor of Medicine at both Vanderbilt University Medical Center and Meharry Medical College. As Associate Director of the Vanderbilt Institute for Clinical and Translational Science, she oversees programs in team science and community engagement. Dr. Wilkins is currently a Principal Investigator of the Vanderbilt-Miami-Meharry Center of Excellence in Precision Medicine and Population Health, which focuses on decreasing disparities among African Americans and Latinos using precision medicine, and the Vanderbilt Recruitment Innovation Center, national center dedicated to enhancing recruitment and retention in clinical trials. She has pioneered methods of stakeholder engagement that involve community members and patients in research across the translational spectrum. One approach, the Community Engagement Studio, was recently scaled to engage more than 650 community members across 12 states in 77 face-to-face consultations for the Precision Medicine Initiative Pilot. This work included eliciting perspectives from diverse communities on returning individual research results. With colleagues at Vanderbilt, Dr. Wilkins has developed a framework that extends the concept of return of results to “return of value”, which integrates influencers of participants’ perspectives of value and considers clinical and personal utility. Prior to joining the faculty at Vanderbilt University Medical Center in 2012, Dr. Wilkins was an Associate Professor in the Department of Medicine, Division of Geriatrics, with secondary appointments in Psychiatry and Surgery (Public Health Sciences) at Washington University School of Medicine in St. Louis. She served as Founding Director of the Center for Community Health and Partnerships in the Institute for Public Health, co-director of the Center for Community Engaged Research in the CTSA, and director of "Our Community, Our Health"- a collaborative program with Saint Louis University to disseminate culturally relevant health information and facilitate community-academic partnerships to address health disparities. Dr. Wilkins earned a Bachelor of Science in microbiology (magna cum laude, Phi Beta Kappa) and a Doctor of Medicine from Howard University. She completed residency training in Internal Medicine at Duke University Medical Center and a Geriatric Medicine fellowship at Washington University School of Medicine/Barnes-Jewish Hospital. Following her medical training, Dr. Wilkins earned a Master of Science in Clinical Investigation from Washington University School of Medicine.

Events


Event Type :  
-

Description :   
<p>The fifth meeting of the Committee on the Return of Individual-Specific Research Results Generated in Research Laboratories.&nbsp;</p><p>&nbsp;</p><p>Agenda:&nbsp;</p><p>February 20, 2018:&nbsp;<br /> Closed Session 8:30am-5:45pm</p><p>February 21, 2018:&nbsp;<br /> Closed Session: 8:30am-3:30pm</p>

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  -
Contact Email:  -
Contact Phone:  -

Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Paul Appelbaum
Suzanne Bakken
Jeffrey Botkin
Chester Brown
Wylie Burke
Richard Fabsitz
Gregg Gonsalves
Rhonda Kost
Debra Leonard
Amy McGuire
James Nichols
Vanessa Northington Gamble
Bray Patrick-Lake
Consuelo Wilkins
Brian Zikmund-Fisher

The following topics were discussed in the closed sessions:

The committee discussed the report findings, recommendations, and conclusions during the closed session.

The following materials (written documents) were made available to the committee in the closed sessions:

Briefing book including draft report language.

Date of posting of Closed Session Summary:
July 16, 2018


Location:

Arnold and Mabel Beckman Center
100 Academy Dr.
Irvine, California
Event Type :  
-

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Caroline Cilio
Contact Email:  ccilio@nas.edu
Contact Phone:  -

Agenda

Community and Participant Perspectives – Public Webinar
December 11, 2017
Time 3:30-6:30 pm PT

The National Academies’ Committee on the Return of Individual-Specific Research Results Generated in Research Laboratories is examining the preferences of research participants on issues relevant to the return of individual research results through brief discussions with research participants and community representatives. The objective of the discussions is to:
• Explore participant preferences for receiving individual research results generated during research participation;
• Consider whether receiving results would affect participation or trust in the research enterprise;
• Explore the kinds of individual research results participants expect to receive, how they want results returned, and how they would utilize results; and
• Identify any concerns or uncertainties around the return of or the nature of individual research results.

Participants:
• John Molina, Native Health, Pheonix
• Sonja Fuqua, JHS Participant and Community Health Advisor
• Crispin Goytia-Vaquez, Mount Sinai
• Matthew Rose, NMAC
• Lisa Schlager, FORCE
• Stephen Mikita, ASPREE
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Paul Appelbaum
Suzanne Bakken
Jeffrey Botkin
Chester Brown
Wylie Burke
Richard Fabsitz
Gregg Gonsalves
Rhonda Kost
Debra Leonard
Amy McGuire
James Nichols
Vanessa Northington Gamble
Bray Patrikc-Lake
Consuelo Wilkins
Brian Zikmund-Fisher

The following topics were discussed in the closed sessions:


The committee utilized the closed session to discuss comments submitted by the public, to review remarks provided during the Participant Perspectives interviews, and to deliberate on study recommendations.

Date of posting of Closed Session Summary:
December 14, 2017


Location:

Webinar
Event Type :  
-

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Caroline Cilio
Contact Email:  ccilio@nas.edu
Contact Phone:  -

Agenda

Public Webinar -- DRAFT AGENDA

December 7, 2017
2:00–3:30PM ET
90 Minute Webinar

QUALITY STANDARDS FOR REGULATED AND NON-REGULATED BIOMEDICAL RESEARCH LABORATORIES

Session Objectives:
• Explore current standards used in research laboratories to assure the reproducibility of research results or to ensure tests are analytically or clinically valid.
o Identify challenges researchers may encounter when determining whether or how to return results if certain standards are not met (e.g. challenges of interpretation and translation, contextualization, or communication).
• Consider how the innovative culture of a research laboratory does or does not align with the required practices of clinical laboratories to ensure specimen control, assay validity, and reproducibility.
• Discuss the process of CLIA accreditation and explore the barriers or perceived barriers that lead research laboratories to refrain from taking the steps necessary to become certified under CLIA
o Examine the technical and operational requirements and costs (including opportunity costs) of asking research labs to produce at clinical or near clinical laboratory level results (for example, obtaining CLIA certification or getting results confirmed in a CLIA laboratory).
• Discuss the potential utility of more codified guidelines for quality standards that could be used in non-regulated biomedical research laboratories and identify what should be included in such guidelines if they were to be produced.

Moderator: Debra Leonard, University of Vermont

Speakers: (10 minute opening remarks followed by discussion and Q&A)
• Rebecca Davies, University of Minnesota
• Randy Querry, American Association for Laboratory Accredidation

Is it a Closed Session Event?
No



Location:

Keck Center
500 5th Street, NW
Washington D.C. 20001

Event Type :  
-

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Caroline Cilio
Contact Email:  returnofresults@nas.edu
Contact Phone:  202-334-2651

Agenda

October 24, 2017

Basic and Translational Researcher Panel (non-genetic genomics)
1:00pm-2:30pm

Public Comment Session
4:30pm-5:30pm
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Paul Appelbaum
Suzanne Bakken
Jeffrey Botkin
Chester Brown
Richard Fabsitz
Vanessa Northington Gamble
Gregg Gonsalves
Rhonda Kost
Debra Leonard
Amy McGuire
James Nichols
Bray Patrick Lake
Consuelo Wilkins
Brian Zikmund-Fisher

The following topics were discussed in the closed sessions:

The committee utilized the closed session to discuss comments submitted by the public, to review remarks provided during the Basic and Translational Researcher Panel Discussion, and to deliberate on potential study conclusions and recommendations.

Date of posting of Closed Session Summary:
November 06, 2017


Location:

National Academy of Sciences Building
2100 C St. NW
Washington D.C.
Event Type :  
-

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Caroline Cilio
Contact Email:  ccilio@nas.edu
Contact Phone:  202-334-2651

Agenda

Day 1: September 6, 2017

8:30 a.m. – 8:45 a.m. Welcome and opening remarks
Jeffrey Botkin, Associate Vice President for Research, Professor of Pediatrics, University of Utah School of Medicine, Committee chair

8:45 a.m. –10:15 a.m. Session 1: Participant and community perspectives
Moderator: Gregg Gonsalves, Assistant Professor, Yale School of Public Health, Committee member
Panelists:
• Fran Visco, President, National Breast Cancer Coalition
• Ellen Wagner, Board of Directors, Parent Project Muscular Dystrophy
• Chioma Nnaji, Program Director, Multicultural AIDS Coalition

10:15 a.m. – 10:30 a.m. BREAK

10:30 a.m. – 12:00 p.m. Session 2a: Perspectives of researchers and laboratorians
Moderator: Debra Leonard, Professor and Chair of Pathology and Laboratory Medicine, University of Vermont, Committee member
Panelists:
• Wendy Chung, Kennedy Family Professor of Pediatrics and Medicine, Columbia University
• Carolyn Compton, Professor of Life Sciences, Arizona State University
• Jessica B. Langbaum, Principal Scientist, Banner Alzheimer's Institute
• Lea C. Harty, BioBank Biological Materials Custodian, Pfizer, Inc ., Representative of The Industry Pharmacogenomics Working Group (I-PWG)

12:00 p.m. – 12:30 p.m. LUNCH

12:30 p.m. – 1:15 p.m. Session 2b: Lunch keynote: Successes and challenges – CSER and eMERGE
Moderator: Steven Joffe, Vice Chair of Medical Ethics, Emanuel and Robert Hart Professor of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine, Committee member
Panelists:
• Rex Chisholm, Vice Dean for Scientific Affairs and Graduate Education, Adam and Richard T. Lind Professor of Medical Genetics, Feinberg School of Medicine, Northwestern University, eMERGE
• Gail Jarvik, Head, Division of Medical Genetics, University of Washington, CSER/eMERGE

1:15 p.m. – 2:45 p.m. Session 2c – Experiences to date of returning results from different healthcare institutions
Moderator: Chester Brown, Professor, St. Jude Chair of Excellence in Genetics, Department of Pediatrics, University of Tennessee Health Science Center, Committee Member
Panelists:
• Febe Wallace, Director of Primary Care, Cherokee Health Systems
• Ronald Przygodzki, Director, Genomic Medicine Implementation, U.S. Department of Veterans Affairs, Office of Research & Development
• Joanne Murabito, Research Center Director, Framingham Heart Study
• Adam Buchanan, Clinical Investigator I, Geisinger Health System

2:45p.m. – 3:00p.m. Break

3:00 p.m. – 4:30 p.m. Session 3: Laws and regulations governing the return of results
Moderator: Jeffrey Botkin, Associate Vice President for Research, Professor of Pediatrics, University of Utah School of Medicine, Committee chair
Panelists:
• Susan M. Wolf, McKnight Presidential Professor of Law, Medicine & Public Policy; Faegre Baker Daniels Professor of Law; Professor of Medicine; University of Minnesota Law School, Medical School, and Consortium on Law and Values in Health, Environment & the Life Sciences
• David J. Peloquin, Associate, Ropes & Gray LLP
• Sally Howard, Head of Regulatory Affairs and Policy and Chief Privacy Officer, Human Longevity, Inc.

4:30 p.m. – 6:00 p.m. Session 4: Institutional management and oversight
Moderator: Rhonda Kost, Clinical Research Officer, The Rockefeller University Center for Clinical Translational Science, Committee member
Panelists:
• Leslie G. Biesecker, Chief, Medical Genomics and Metabolic Genetics Branch, National Institutes of Health, National Human Genome Research Institute
• Alexis Carter, Physician Informaticist, Children’s Healthcare of Atlanta, Representative from College of American Pathologists (CAP)
• Mark Sobel, Executive Officer, American Society for Investigative Pathology (ASIP)
• Heather Pierce, Senior Director, Science Policy and Regulatory Counsel Association of American Medical Colleges

6:00 p.m. ADJOURN



DAY 2: September 7, 2017


8:00 a.m. – 8:15 a.m. Welcome and opening remarks
• Jeffrey Botkin, Associate Vice President for Research, Professor of Pediatrics, University of Utah School of Medicine, Committee chair

8:15 a.m. – 9:45 a.m. Session 5: Communicating Results to Meet User Needs
Moderator: Consuelo Wilkins, Executive Director, Meharry-Vanderbilt Alliance and Associate Professor of Medicine, Vanderbilt University Medical Center, Committee member
Panelists:
• Sally Okun, Vice President for Policy and Ethics, PatientsLikeMe
• Julia Wynn, Senior Genetic Counselor and Clinical Research Manager, Columbia University Medical Center
• Sara Czaja, Leonard M. Miller Professor in the Departments of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine (participating via WebEx)
• John Wilbanks, Chief Commons Officer, Sage Bionetworks

9:45 a.m. – 10:00 a.m. BREAK

10:00 a.m. – 11:00 a.m. Session 6: A discussion with workshop panelists
Moderator: Jeffrey Botkin, Associate Vice President for Research, Professor of Pediatrics, University of Utah School of Medicine, Committee chair
Panelists:
• Gail Javitt, Member of the Firm in the Health Care and Life Sciences practice, Office of Epstein Becker Green (participating vie WebEx)
• Leslie G. Biesecker, Chief, Medical Genomics and Metabolic Genetics Branch, National Institutes of Health, National Human Genome Research Institute
• Ellen Wagner, Board of Directors, Parent Project Muscular Dystrophy

11:00 a.m. – 11:30 a.m. Public Comment
Moderator: Jeffrey Botkin, Associate Vice President for Research, Professor of Pediatrics, University of Utah School of Medicine, Committee chair

11:30 a.m. ADJOURN public workshop
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Paul Appelbaum
Suzanne Bakken
Jeffrey Botkin
Chester Brown
Wylie Burke
Richard Fabsitz
Vanessa Northington Gamble
Gregg Gonsalves
Steven Joffe
Rhonda Kost
Debra Leonard
Amy McGuire (participating via WebEx)
James Nichols (participating via WebEx)
Consuelo Wilkins
Brian Zikmund-Fisher (participating via WebEx)

The following topics were discussed in the closed sessions:

The committee used the closed session to deliberate upon findings from the public workshop and recommendations for the return of results.

Date of posting of Closed Session Summary:
September 13, 2017


Location:

Keck Center
500 5th Street, NW
Washington D.C. 20001

Event Type :  
-

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Caroline Cilio
Contact Email:  ccilio@nas.edu
Contact Phone:  2020334-2651

Agenda

DAY 1:
July 19, 2017—Room 208
Meeting Objectives:
• Receive study background and charge from NIH, CMS and FDA.
• Clarify Committee questions on the statement of task via open discussion with the sponsors.
• Discuss report audience and expected products.


OPEN SESSION
1:00 p.m.–2:45 p.m.

1:00–1:15 p.m. Opening Remarks to Public Audience
Jeffrey Botkin, Committee Chair
1:15–2:00 p.m. Presentation by Sponsors Panelists:
Representatives from CMS, FDA, and NIH (TBD)
2:00–2:45 p.m. Sponsor Q&A with Committee
Time to ask clarifying questions to understand scope and charge
Moderator: Jeffrey Botkin, Committee Chair
2:45 p.m. ADJOURN open session
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Paul Appelbaum
Suzanne Bakken
Jeffrey Botkin
Wylie Burke
Gregg Gonsalves
Rhonda Kost
Debra Leonard
Amy McGuire
James Nichols (unpaid consultant)
Bray Patrick-Lake
Consuelo Wilkins
Brian Zikmund-Fisher

The following topics were discussed in the closed sessions:

Bias and conflict of interest discussion; overview of study process; discussion of study charge, background discussion, and upcoming meetings were discussed during the closed session.

The following materials (written documents) were made available to the committee in the closed sessions:

Briefing book

Date of posting of Closed Session Summary:
July 24, 2017

Publications

  • Publications having no URL can be seen at the Public Access Records Office