ENRICH Forum: Ethical aNd Regulatory Issues in Cancer ResearcH
Ethical dilemmas and regulatory concerns are highly significant in today's cancer research environment. Deep sequencing and bioinformatics technologies that enable identification of molecular signatures of cancer create novel ethical and regulatory challenges, including protecting research participant autonomy and privacy as increasing amounts of data are accumulated. As cancer research becomes more focused on a vision of genetically informed clinical care and precision medicine, decision-making becomes both more complex and more critical.
- Engaging and interacting with research participants,
- Disclosing information to research participants through the consent process or the return of research results and incidental findings,
- Determining who can access human tissue and data for research, and
- Defining the evolving scope of individually identifiable information, and gauging the ability to re-identify individuals from tissue and pooled data sources.
NCI's ENRICH Forum is designed to stimulate dialogue on ethical and regulatory issues in cancer research and promote awareness of developing policies and best practices. The Forum, sponsored by the Division of Cancer Control and Population Sciences (DCCPS) and the Division of Cancer Treatment and Diagnosis (DCTD), presents educational programs and occasional deliberative sessions focused on specific ethical, legal and social issues involving cancer research.
Upcoming Topics and Speakers
October 31, 2017 1:00 p.m. - 2:00 p.m.
Inserting the Patient Voice in Today's Health Innovation Ecosystem
Marc M. Boutin, J.D.
Chief Executive Officer, National Health Council
Patient-centricity is more than a buzz word – it requires being respectful of and responsive to patient preferences, needs, and values in the context of people's social circumstances. That often means integrating considerations beyond clinical outcomes such as a treatment's ability to help patients achieve personal goals. Patient-centricity is created by engaging, informing, and actively listening to people with chronic conditions throughout the research process and beyond. This session will explore the recent rise and evolution of patient-centricity, discuss frameworks on when and how to engage patients in research, and present rubrics on good practices for engagement and representativeness. By collectively embracing the voice of the patient, we will maximize the value and impact of research.
Note: NIH staff are welcome to attend this ENRICH Forum in-person at the NCI Shady Grove Campus, Conference Room 3W032/34.
Past Topics and Speakers
September 11, 2017 2:30 p.m. - 3:30 p.m.
Tribal Perspectives on Data Sharing
Wylie Burke, M.D., Ph.D.
Professor, University of Washington School of Medicine
Denise Dillard, Ph.D.
Director of Research, Southcentral Foundation
The aim of broad data sharing is to maximize the public benefit derived from genetic and genomic studies. However, tribal leaders have a fiduciary responsibility to assure that uses of tribal data are responsible, particularly in light of past mis-uses of research data. The sovereign status of tribal governments has implications for research agreements and data-sharing negotiations. Recognizing the unique concerns raised by tribal entities, an NIH-funded research center involving a partnership among three tribal organizations and three universities convened a meeting to consider data sharing and related research issues. The speakers discussed the tribal perspectives that arose from the meeting, and from their experience participating in tribal partnerships. While there is strong tribal support for efficient research processes that expedite the benefits from collaborative research, there is also a need for data-sharing procedures that take into account tribal sovereignty and appropriate oversight of research, and move beyond existing models of individual consent and community engagement.
July 27, 2017 3:00 p.m. - 4:00 p.m.
Diverse Patient Values About a "Library of Medical Information": Electronic Health Records (EHRs) and Biospecimens in Research
Sandra Soo-Jin Lee, Ph.D.
Senior Research Scholar, Center for Biomedical Ethics and School of Medicine, Stanford University
Mildred Cho, Ph.D.
Professor of Pediatrics, Center for Biomedical Ethics, Stanford University
Stephanie Alessi Kraft, J.D.
Senior Fellow and Acting Instructor, Seattle Children's Hospital and Research Institute
Linking EHRs with biospecimens to conduct systematic, population-based research provides unprecedented opportunities to improve health care. However, this practice poses significant challenges to traditional ethical and regulatory frameworks for data access, use, sharing, and oversight. Further, little research investigates how patients of diverse racial and ethnic backgrounds assess the risks and benefits of volunteering their EHR data and biospecimens for research.
This panel discussed an NIH-funded study of patient preferences and attitudes on the collection and use of EHRs and biospecimens in a large community-based healthcare system that is actively planning to create its own biobank. Study questions included: To what extent do patients perceive benefits of data sharing and analysis? What do they believe are acceptable tradeoffs between risks and benefits? What are the most important features of and preferred processes for governance and oversight? This panel discussed results from 20 focus groups of African American, Chinese, Hispanic, non-Hispanic White, and South Asian patients in a community-based healthcare system. It also discussed lessons learned from the development of novel multilingual videos as methodological tools.
July 26, 2017 1:00 p.m. - 2:00 p.m.
Broad Consent for Research on Biospecimens: The Views and Experiences of Actual Donors
Christopher D. Andry, M.Phil, Ph.D.
Vice Chair for Operations and Management, Department of Pathology and Laboratory Medicine, Boston University School of Medicine, and Scientific Director of Experimental Pathology Laboratory Services Core, Boston University Medical Center
Significant debate has occurred over the acceptability of broad consent approaches for collecting biospecimens to use in future unspecified research. Our speaker discussed his participation in an NCI-funded study eliciting the views of actual broad consent cancer tissue donors at four academic medical centers regarding the use of their biospecimens in future medical research.
June 8, 2017 10:00 a.m. - 11:00 a.m.
Compensating Research Tissue Donors: Henrietta Lacks and the Ethics of Paying for Biological Specimens
Debra Mathews, Ph.D., M.A.
Assistant Director for Science Programs, Berman Institute of Bioethics and Associate Professor, Department of Pediatrics, Johns Hopkins University
Henrietta Lacks, foremother of the rapidly reproducing and scientifically invaluable HeLa cell lines, was a cancer patient at Johns Hopkins in 1951 when her tissue was (in accordance with standard practice at the time) collected and stored for future research without her knowledge or consent. In this presentation, Dr. Debra Matthews explored the ethical issues surrounding compensation for tissue donation as well as continued research uses of HeLa tissue, including the HeLa genome, and discussed the different and sometimes contradictory views of Lacks family members regarding these uses.
October 6, 2016 10:00 a.m. - 11:00 a.m.
Barriers to Clinical Trial Participation and Biospecimen Donation: Community Views and Ethical Considerations
Claudia Baquet, M.D., M.P.H.
Former Deputy Assistant Secretary for Minority Health, U.S. Department of Health and Human Services (HHS) and Associate Director of Cancer Control Science at NCI
Dr. Baquet has been a pioneer in advancing cancer disparities research and bringing national attention to the field of health disparities. Diversity in clinical trial participation and biospecimen donation remain significant barriers to equity in access to emerging prevention and therapeutic modalities. Dr. Baquet described an FDA-funded study in Maryland which examined in rural and urban communities the barriers, challenges, and supportive factors that impact a person's willingness to consider participating in clinical trials, factors associated with promoting biospecimen donation, and suggestions on how to increase public trust and research participation.
April 14, 2016 10:00 a.m. - 11:00 a.m.
A Life Everlasting: The Story Behind Thomas Gray's Biospecimen Donations
Sarah Gray, M.A.
Director of Marketing and Public Affairs
The American Association of Tissue Banks
While struggling to cope with the loss of her anencephalic 6-day old son, Sarah navigated the complicated but ultimately rewarding path of donating Thomas's biospecimens to medical research. Thomas's retina and corneas were matched with research programs through the National Disease Research Interchange with the help of the Washington Regional Transplant Community. Sarah spoke about her experience as a research donor's parent, including her family's meetings with the PIs who received Thomas' corneas, retina, liver, and cord blood donations.
March 2, 2016 12:30 p.m. - 1:30 p.m.
Redux and Remix: What Race and Genomics Are and Aren't in Meaning and Measurement
Vivian Ota Wang, Ph.D., M.Phil., M.S., F.A.C.M.G.
Program Director, Data Access and Sharing
National Human Genome Research Institute
The Human Genome Project raised researchers, policymakers, and the general public's expectations that genomics would provide a scientific foundation to improve the understanding of diseases, and population and racial differences. Despite the tumultuous history that race and genetics share, research and commercial efforts have been harnessing and increasing the availability and use of genomic and self-inferred "ancestry" information to researchers, clinicians, and the general public. The speaker discussed how a conversation beyond whether genomics is relevant to the salience of racial and cultural realities is needed to better understand how understandings of race are informing genomics, identity, and health disparities science and policy issues.
November 17, 2015
Perceptions and Management of Uncertainty in Genome Sequencing
Barbara B. Biesecker, Ph.D.
Head, Genetic Services Unit
Director, Genetic Counseling Training Program
National Human Genome Research Institute
Dr. Biesecker presented her research data assessing perceived uncertainty in genomic sequencing. She discussed interventions her research team is developing to assess their effectiveness in helping participants navigate responses.
October 20, 2015
NCI's ClinOmics Protocol
Javid Khan, M.D.
Deputy Chief, Genetics Branch
Head, Oncogenomics Section
Center for Cancer Research, NCI
Kathleen Calzone, Ph.D, R.N., A.P.N.G., F.A.A.N.
Senior Nurse Specialist, Genetics Branch
Center for Cancer Research, NCI
The primary purpose of the ClinOmics protocol is to take advantage of high throughput techniques to discover somatic alterations in cancer to identify novel biomarkers and biologically relevant targets for therapy to allow for the development of new treatment strategies for patients with high-risk malignancies. The ClinOmics investigators will perform genomics, proteomics, metabolomics and other high throughput methods to perform a comprehensive Omics analysis of tumor and normal tissues. Exome and cancer panel sequencing will be performed on tumor and germ line DNA in a Clinical Laboratory Improvement Act (CLIA) setting through the ClinOmics core, a newly established resource established by the CCR. High confidence somatic mutations and germ line mutations with established clinical validity and utility will be reported to CRIS, the NIH's electronic medical records system and reported to the treating physician and the patient.
September 1, 2015
Precision Medicine Research, Race and Ethnicity: Regulatory and Contractual Influences
Shawneequa Callier, J.D., M.S.
Assistant Professor of Clinical Research and Leadership
George Washington University
Genomic technology has the potential to transform the delivery of healthcare while improving the cost and efficacy of medical interventions. Historical population sampling approaches for investigating the genetic variations that influence patients. responses to drug therapy, however, are not representative of the complex ancestral backgrounds of individual patients. In this talk, the speaker discussed the regulatory challenges and opportunities related to addressing the ethnic and racial diversity among patients in the era of precision medicine, lawsuits filed against drug manufacturers for allegedly failing to appropriately disclose knowledge about poor drug response in specific populations, and strategies that ethics committees are implementing in low and middle income countries to advance genomic research in diverse populations.
January 8, 2015
Patient-Centered Outcomes Research in Cancer
Jason Gerson, Ph.D.
Associate Director, Comparative Effectiveness Research Methods and Infrastructure, Patient-Centered Outcomes Research Institute (PCORI)
Dr. Gerson from the Patient-Centered Outcomes Research Institute (PCORI) presented on the significant regulatory and ethical issues PCORI encounters in its mission to fund comparative clinical effectiveness research while engaging patients and other stakeholders throughout the research process. PCORI sponsors research on issues related to human subjects protections, including Institutional Review Board (IRB) review and novel approaches to informed consent. Ethical issues arise in the context of study designs (e.g., cluster randomized trials, pragmatic randomized trials) or the use of particular data sources for comparative effective research (e.g., electronic clinical data).
May 20, 2015
Getting Personal: Ethical Issues in How We Talk About Genomics and Personalized Medicine
Rebecca D. Pentz, Ph.D.
Professor of Research Ethics, Emory School of Medicine and Winship Cancer Center
Dr. Rebecca Pentz, Professor of Research Ethics at the Emory School of Medicine and the Winship Cancer Center, spoke of the misleading nature of media hyperbole about personalized medicine and its potential negative impact on cancer patients and the general public. Television and radio advertisements, newspaper articles, and even science journals tend to exaggerate the progress of targeted therapies and the successful translation of genomic research to clinical oncology. Beyond toning down the rhetoric, better efforts at community engagement in medical research can hopefully counter some of these ill effects.
July 22, 2015
Mobile Consent Technologies: Ethical Considerations
Chief Commons Officer, Sage Bionetworks
Dave Wendler, Ph.D.
Head, Unit on Vulnerable Populations, Department of Bioethics, NIH Clinical Center
Mr. John Wilbanks, Chief Commons Office at Sage Bionetworks, and Dr. Dave Wendler, Head of the Section on Research Ethics in the Department of Bioethics at the NIH Clinical Center, presented on operational and ethical aspects of mobile consent technologies. Mr. Wilbanks provided an overview of the rapidly developing field of mobile and connected health technologies, culminating in Apple's recent internationally publicized ResearchKit app. Dr. Wendler highlighted some of the many ethical issues that mobile consent technologies pose, including expansive recruitment opportunities, ability to comprehend and utilize technology, and diversifying participant populations.
January 28, 2014
Engaging Communities in Biobanking Governance
Kyle Brothers, M.D.
Assistant Professor, Department of Pediatrics, University of Louisville School of Medicine
Barbara A. Koenig, Ph.D.
Professor of Medical Anthropology and Bioethics, University of California, San Francisco
The speakers discussed ethical issues and presented case studies of different models for engaging communities to inform the creation and governance of biobanks. Dr. Brothers' presentation, "Different Headaches: The Human Non-Subjects Approach to Biobanking," provided background on governance and discussed the creation of Vanderbilt University's BioVU. Dr. Koenig's presentation, "Using Deliberative Community Engagement to Help Craft Biobanking Policy," focused on a model of engagement grounded in deliberative democracy and used at the Mayo Clinic as well as other biomedical and health research sites.
March 13, 2014
Informed Consent in the Age of the Genome
Christine Grady, Ph.D.
Chief, Department of Bioethics, Clinical Center, National Institutes of Health (NIH), and Head of the Department's Section on Human Subjects Research; Member, President's Commission for the Study of Bioethical Issues
Dr. Grady's presentation focused on communicating with research participants through the consenting process, with a focus on the recommendations set forth in two Bioethics Commission reports on Privacy and Progress in Whole Genome Sequencing (October 2012) and Ethical Management of Incidental and Secondary Findings (December 2013).
May 29, 2014
Consent and Data Sharing in the Genomics Context
Laura Lyman Rodriguez, Ph.D.
Director, Division of Policy, Communications, and Education; and Acting Chief, Genomic Healthcare Branch, National Human Genome Research Institute
Dr. Rodriguez described the challenge of balancing competing ethical and policy priorities in genomics research, including calculating the risks of identifiability, public tolerance for loss of privacy, and promoting medical advances while ensuring transparency and appropriate stewardship of the public trust.
June 3, 2014
Working With Community Advisory Boards to Enhance Health Care Research
Maghboeba Mosavel, Ph.D.
Associate Professor, Department of Social and Behavioral Health, Virginia Commonwealth University School of Medicine
Laura Siminoff, Ph.D.
Dean, College of Health Professions and Social Work, Temple University
Drs. Mosavel and Siminoff are primary investigators in a survey study to examine the attitudes of family decision-makers of participants in the Genotype Tissue Expression Project (GTEx). GTEx compares gene expression in multiple types of normal tissue taken from deceased participants and works with multiple community advisory boards (CABs). The presenters described how CABs are used in medical research, including in biobanking and cancer prevention and control studies. CAB activities include recruiting participants, reviewing consent documentation, and assisting with study design and/or implementation.
June 25, 2014
Is Broad Consent Acceptable? Individuals' Perspectives From a Systematic Literature Review of U.S. Biobanks
Náníbaa' Garrison, Ph.D.
Assistant Professor of Pediatrics, Center for Biomedical Ethics and Society, Vanderbilt University
Although research on de-identified human data currently does not require informed consent from participants, the Advanced Notice of Proposed Rulemaking (ANPRM) for Revision to the Common Rule proposes that consent be required for research using de-identified data/specimens in biobank research. In anticipation of this change, the Electronic Medical Records and Genomics (eMERGE) Network is developing a survey instrument to elicit perspectives from a wide cross-section of patients on broad consent, sample and data sharing for future research, biobank governance, data protection, and return of research results. This talk highlighted key findings from a systematic literature review on individuals' willingness to provide broad consent for biobank research and data sharing, conducted for the eMERGE project.
November 18, 2014
Human Subject Protection Rules for Using Stored Tissue in Genomic Research
Deputy Director, Office of Human Research Protections, U.S. Department of Health and Human Services
Ms. Kaneshiro presented on the human subject regulatory implications of using stored tissue for genomic research. She described requirements under the current regulatory scheme at 45 CFR part 46 (the Common Rule), as well as proposed amendments to the current regulations published in the Advanced Notice of Proposed Rulemaking in 2011. Under current rules and Office for Human Research Protections (OHRP) guidance, genomic data is not considered inherently identifiable and research involving only coded data and biospecimens is not considered to be human subject research. Revisions proposed to the Common Rule may alter some of these research guidelines in the future.
July 25, 2013
Bio-Pin: A Novel Biobanking Concept
Jeremy Sugarman, M.D., M.P.H.
Professor of Bioethics and Medicine, Professor of Health Policy and Management, and Deputy Director for Medicine, Johns Hopkins Berman Institute of Bioethics; and Marianna Bledsoe, M.A., Private Consultant, formerly worked in biobanking policy at NIH and the U.S. Department of Veterans Affairs
Bio-PIN is a novel concept that recently was proposed to address ethical, legal, and social issues related to biobanking, such as privacy, informed consent, autonomy, data security, and public trust. This concept involves the anonymous deposition of samples and associated data into a biobank in which the samples and data are labeled using a code generated from an individual's biological characteristics. This session discussed the bioethical considerations of this system, as well as practical issues and challenges associated with its implementation.
September 4, 2013
Governing Clinically Relevant Data From Non-Clinical Sources: How to Access Good Data From Real People
Chief Commons Officer, Sage Bionetworks
Sharon Terry, M.A.
President and Chief Executive Officer, Genetic Alliance
The speakers described two paradigms that enable patients and prospective research participants to learn about and share health information. Mr. Wilbanks spoke about Portable Legal Consent, a web-based consent protocol that enables individuals to understand the implications of broad data sharing, and grants medical researchers unparalleled access to eligible and interested participants. Ms. Terry discussed "Reg4All," a patient-centric registry that offers clinical trial participants the ability to fine-tune how their data are used for research and with whom the data are shared.
November 25, 2013
The Myriad Mire: Patents and Trade Secrets in the Age of the Genome
Eleonore Pauwels, M.A.
Public Policy Scholar, Woodrow Wilson International Center for Scholars
Mark Rohrbaugh, Ph.D.
Director, Office of Technology Transfer, NIH
The presenters discussed the impact of the U.S. Supreme Court's recent Myriad Genetics patent decision and how, in the wake of that decision, companies may look to the trade secret doctrine to withhold genetic information.
December 11, 2013
Ethical Obligations to Disclose Incidental Findings and Individual Research Results in Cancer Genomics Research
Henry Richardson, Ph.D., J.D., M.P.P.
Professor and Senior Research Scholar, Kennedy Institute of Ethics, Georgetown University
Stephen Chanock, M.D.
Director, Division of Cancer Epidemiology & Genetics, NCI
The presenters discussed potential ethical obligations to disclose incidental findings and individual research results to people who participate in genomics studies.
- NCI's Extramural Data Access Committee for Genomic Datasets
- NIH Genomic Data Sharing Website
- U.S. Department of Health and Human Services Office for Human Research Protections
- Presidential Commission for the Study of Bioethical Issues
Related Funding Opportunity Funding Announcements
NCI currently is cosponsoring the following Funding Opportunity Announcements (FOAs) to support the study of the ethical, legal, and social implications (ELSI) of human research.
- Ethical, Legal, and Social Implications of Genomic Research—expires September 8, 2017, unless reissued
EGRP joins with other NCI Divisions, Offices, and Centers and other NIH Institutes and Centers to fund grant applications submitted in response to FOAs. EGRP also encourages investigator-initiated grant applications on environmental health topics.
- Trans-NIH Workshop to Explore the Ethical, Legal and Social Implications (ELSI) of Citizen Science (January 2015)
- Think Tank on Identifiability of Biospecimens and "-Omic" Data (June 2012)
- Carol Weil, J.D., Program Director, Office of the Associate Director, Cancer Diagnosis Program, DCTD
- Charlisse Caga-anan, J.D., Program Director, Genomic Epidemiology Branch, EGRP, DCCPS