Bioethics and Cancer Research


Overview

Bioethics is critical to the mission of the National Cancer Institute (NCI) and the National Institutes of Health (NIH). Ethical questions and challenges are inherent in science, medicine, and healthcare. Addressing these questions and challenges is vital to the public trust upon which NIH depends. The NCI, as an NIH institute, has led important initiatives for the ethical conduct of cancer research, hosted meetings focused on ethical issues that have arisen in different aspects of cancer research, and funded bioethics research projects that have led to high-impact discoveries for cancer research and clinical practice. These activities demonstrate interest within NCI in addressing the ethical issues in different types of cancer research and throughout the cancer control continuum.

Request for Information

NCI is seeking input from community members, patients, cancer researchers, physicians, other health practitioners, bioethicists, advocates, and others to help identify bioethics areas clearly relevant to cancer but in need of further development, as well as bioethics areas which are ready for translation in a cancer context. Examples of broad issues/areas include, but are not limited to: ethical issues raised by new research designs, cancer disparities, weighing the cost of cancer drugs vs. benefit gained, participant engagement in cancer research, dynamic consent models for research, etc. A more detailed list of bioethics issues for consideration is available below.

Types of Cancer Research * Research domains that raise potential ethical issues, or have ethical implications/dimensions

Basic Research

  • Molecular studies
  • In vitro studies
  • In vivo studies

Data management

  • Data stewardship, data sharing, data ownership
  • Reproducibility

Animal research

  • Research ethics (e.g. IUCUCs)

Biospecimen research

  • Sample source issues, e.g. cell lines, whether research is on "human subjects," what kind of participant engagement and protections are needed?
  • Type of review required
  • Governance of biobanks

Clinical Research

  • Clinical trials
  • Drugs safety/effectiveness
  • Medical devices
  • Screening test for prevention
  • Lifestyle change intervention for increase survival

Clinical trials

  • Enrollment/participation
  • Fair subject selection; reducing bias in recruitment
  • Multi-site trials – Central IRB, PI responsibilities
  • Adverse event reporting and communication
  • Therapeutic costs versus benefits (i.e. cost of drugs chosen for development vs. benefit gained?)
  • Safety issues

Genomics research within clinical trials

  • Secondary collection of biospecimens
  • Secondary/ancillary genomics research

Research design

  • Cluster-randomization
  • Adaptive design clinical trials

Research vs. clinical goals of care

  • Therapeutic misconception
  • Conflicts of interest

Population-based Research

  • Family history, genetics
  • Health behaviors, health history
  • Environmental exposures
  • Cancer registries and databases
  • Observational case-control and cohort studies
  • Population-based surveys

Justice Issues

  • Cancer disparities
  • Environmental justice
  • Social determinants of health

Partnering with key stakeholders

  • Community engagement
  • Returning aggregate/individual results in forms that are meaningful to community (see also "engagement") below
  • Research translation with regulators, policy makers, public health workers and departments, clinicians, families

"Big data"

  • Use of social network data (used in e.g. observational studies)

Consent

  • Scalable for large studies, prospective cohorts, retrospective cohorts

Translational Research

  • Testing results of basic and clinical research to determine whether they improve health outcomes
  • Use outside of controlled study
  • Test ways to overcome barriers to use in everyday clinical practice
  • Implementation research
  • Policy impact

Improving quality of life versus length of life

Patient reported outcomes

Research design

  • Pragmatic trials
  • Comparative Effectiveness Research
  • Learning healthcare systems

Precision medicine

  • What do patients understand, want, how to give it back to them, what is practical to provide/what can be done.
* Based on NCI's description on https://www.cancer.gov/research/nci-role and https://www.cancer.gov/research/nci-role/cancer-research-types-infographic
Issues across multiple phases of research
  • New changes to the Common Rule
    • Identifiability/de-identifiability
    • Changes to informed consent requirements
      • "Reasonable person" standard
      • Additional requirements for Biospecimen consent
    • New definition of "clinical trial" at 45 CFR 46.102(b)
  • Engagement (Patient, participant, community, public)
    • Community engagement
    • Participant engagement
    • Community-based participatory research
    • Citizen Science
    • Participant involvement in all aspects of research from design, implementation, interpretation, dissemination
    • Communicating discoveries to participants
    • Broadening dissemination practices, beyond individual results and specific project findings
    • Public education and engagement on all dimensions of research (from biobanking to pragmatic trials)
    • Cultural perception and attitudes toward research
    • Diverse perspectives regarding research (based on e.g. racial, social, and ethnic backgrounds; age [e.g. children and elderly persons; disability)
  • Ethics of collaboration and interdisciplinary team work (which includes participants and across stakeholders)
  • Data Sharing, data ownership
  • Priority-setting
    • Social justice frameworks for setting priorities in research and implementation
  • Defining the type of research and regulatory implications<
    • Behavioral interventions – Not observational, but not clinical intervention
      • Different risk and benefit profiles
    • Definition of "clinical research" and "clinical trial"
    • Prevention vs. therapeutic trials
  • Ancillary care provided to research participants
  • Genetics/genomics in research
    • Incidental findings
    • Return of results
    • Future use of biological samples/data
      • Broad consent
      • Issues raised when research consent adhere to past (outdated) standards
    • Genomic data sharing
    • Cultural considerations
  • Ethics of biobank governance and practice
    • Including consent, data sharing, and return of results specific to biobanks
Issues in cancer care and public health practice
  • Clinical Genetics
    • Somatic genetics vs. germline genetics: patient understanding
    • Managing variants of unknown significance, testing and screening guidelines
    • Psycho-social and behavioral impact of genetic/genomic information on individuals affected/impacted by cancer
  • End of Life
    • Withdrawal of treatment
    • Palliative care
  • Registries and clinical data/specimen use

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