(Press-News.org) Contact information: Hillary Wicai Viers
Hillary.Viers@bioethics.gov
202-233-3960
Presidential Commission for the Study of Bioethical Issues
Bioethics Commission on incidental findings: Anticipate and communicate
Bioethics Commission releases ethical analysis and recommendations for clinicians, researchers, and direct-to-consumer testing companies on how to manage the increasingly common issue of incidental and secondary findings
Washington, DC—Researchers conduct a memory study, scan a participant's brain, and find more than they bargain for: a tumor. What do the researchers owe the participant? What does the participant want to know? This is an increasingly common scenario for practitioners across contexts and for recipients of unexpected results that can be discovered through a variety of procedures and tests. Today the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) offered analysis and guidance on this issue and released its report Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts.
"How clinicians, researchers and direct-to-consumer companies manage incidental and secondary findings will likely touch all of us who seek medical care, participate in research, or send a cheek swab to a company for a peek at our own genetic make-up," said Amy Gutmann, Ph.D., Commission Chair. "The reality is that we might find out more than we bargained for. Yet practitioners are getting conflicting advice about how to manage such findings across contexts and modalities such as genetics, imaging, and biological specimen testing. We all need to know how to better manage health information we did not expect."
Incidental findings – whether or not we can anticipate them – give rise to a wide range of practical and ethical challenges for recipients and practitioners. Emerging medical technologies, changing cost structures, and evolving medical practice have increased remarkably the likelihood of discovering incidental findings in the clinic, research, and commercial direct-to-consumer contexts. Such findings can be lifesaving, but also can lead to uncertainty and distress if they are unexpected or identify conditions for which no effective treatment is available.
"For every setting and type of test or procedure, when it comes to incidental findings, the Bioethics Commission recommends anticipating and communicating," Gutmann said. "All practitioners should anticipate and plan for incidental findings so that patients, research participants, and consumers are informed ahead of time about what to expect and so that incidental findings are aptly communicated if they are found. The best way forward is shared decision-making between practitioners and potential recipients."
Incidental findings typically include findings that lie outside the aim of a test or procedure. However, sensitive and unexpected results in the direct-to-consumer context merit many of the same ethical considerations. Secondary findings raise related issues: these discoveries are also not the primary target of the testing but, unlike incidental findings, they are actively sought.
Currently, there are no consistent guidelines for how we best manage these discoveries. Recent reports show how unsettled the issue of incidental findings is: for example, one report recommended scans for early cancer screening; another report, released the next month, suggested early scans can cause more harm than good by detecting too many problems, thus leading to overtreatment.
"More information is not always better. Incidental findings might, but do not always, have important, actionable implications for our health and emotional as well as physical wellbeing. It would be rash—both ethically and practically speaking—to conclude that everything that can be sought should be sought, and reported, in all contexts," Gutmann said.
Recommendations:
The Bioethics Commission offered specific recommendations for handling incidental and secondary findings in clinical, research and direct-to-consumer settings. There are, however, some ethical principles and duties that span all three contexts for which the Bioethics Commission made five broad recommendations.
Practitioners should inform potential recipients, in any setting, about the possibility of incidental or secondary findings, and if and how those findings will be disclosed, before the start of a test or procedure. Informed consent and open communication between providers and potential recipients is essential.
Professional representative groups should develop guidelines that categorize findings likely to arise from each diagnostic modality, and develop best practices for managing them.
Federal agencies and other interested parties should fund research to keep abreast of the rapidly evolving types and frequency of findings; potential costs, benefits, and harms; and recipient and practitioner preferences about incidental and secondary findings.
Public and private entities should prepare materials and enhance education of all stakeholders, including practitioners, institutional review boards, and potential recipients about the ethical, practical, and legal considerations raised by incidental and secondary findings.
There is a need – based on justice and fairness – not just for a privileged few but for all individuals to have access to information and the guidance needed to make informed choices about what tests to undergo, what kind of information to seek, and what to do with information once received. Affordable access to care and quality information about incidental and secondary findings, before and after testing, can be potentially lifesaving.
Anticipate and Communicate is the Bioethics Commission's sixth major report. The Bioethics Commission seeks to identify and promote policies and practices that ensure that scientific research, health care delivery, and technological innovation are conducted by the U.S. in a socially and ethically responsible manner. The Bioethics Commission is an independent, deliberative panel of thoughtful experts that advises the President and the Administration, and, in so doing, educates the nation on bioethical issues. To date the Bioethics Commission has:
Advised the White House on the benefits and risks of synthetic biology;
Completed an independent historical overview and ethical analysis of the U.S. Public Health Service STD experiments in Guatemala in the 1940s;
Assessed the rules that currently protect human participants in research;
Examined the pressing privacy concerns raised by the emergence and increasing use of whole genome sequencing;
And conducted a thorough review of the ethical considerations of conducting clinical trials of medical countermeasures with children, including the ethical considerations involved in conducting a pre-and post-event study of anthrax vaccine adsorbed for post-exposure prophylaxis with children.
###
The report Anticipate and Communicate will be available at http://bioethics.gov/node/3183.
Read more on our website http://www.bioethics.gov, follow us on Twitter @bioethicsgov, and watch our videos on YouTube.
Bioethics Commission on incidental findings: Anticipate and communicate
Bioethics Commission releases ethical analysis and recommendations for clinicians, researchers, and direct-to-consumer testing companies on how to manage the increasingly common issue of incidental and secondary findings
2013-12-13
ELSE PRESS RELEASES FROM THIS DATE:
Bonefish spawning behavior in the Bahamas surprises researchers, should aid conservation
2013-12-13
Bonefish spawning behavior in the Bahamas surprises researchers, should aid conservation
A report to the Bahamas Ministry of Environment this week documents rarely seen pre-spawning behavior in bonefish, which should aid future conservation efforts
AMHERST, ...
Keeping the lights on
2013-12-13
Keeping the lights on
UCSB mechanical engineer Igor Mezic finds a way to predict cascading power outages
(Santa Barbara, Calif.) — A method of assessing the stability of large-scale power grids in real time could bring the world closer ...
Low-power tunneling transistor for high-performance devices at low voltage
2013-12-13
Low-power tunneling transistor for high-performance devices at low voltage
A new type of transistor that could make possible fast and low-power computing devices for energy-constrained applications such as smart sensor networks, implantable medical electronics and ultra-mobile ...
Wayne State discovers potential treatment for skin and corneal wound healing in diabetics
2013-12-13
Wayne State discovers potential treatment for skin and corneal wound healing in diabetics
DETROIT — Diabetes Mellitus (DM), a metabolic disorder that affects nearly 170 million people worldwide, is characterized by ...
Study shows symptoms linked to poor quality of life in long-term childhood
2013-12-13
Study shows symptoms linked to poor quality of life in long-term childhood
GAINESVILLE, Fla. — Due to improved treatments and technologies, more children than ever are surviving cancer. Unfortunately, about 70 percent of these children experience late effects from their ...
Civilians trained by American mental health professionals bring healing to traumatized victims of Libya's civil war, Baylor study finds
2013-12-13
Civilians trained by American mental health professionals bring healing to traumatized victims of Libya's civil war, Baylor study finds
Civilians traumatized by Libya's civil war in 2011 — which left many homeless, poor and grieving — have virtually no access ...
Medical mystery solved
2013-12-13
Medical mystery solved
A variant of NKH is uncovered
AURORA, Colorado (December 12, 13) – People from around the country and the world turn to Johan Van Hove, MD, PhD, for advice on a rare metabolic disease known as NKH, which can disrupt the body in devastating and ...
Programming smart molecules
2013-12-13
Programming smart molecules
Harvard machine-learning algorithms could make chemical reactions intelligent
Cambridge, Mass. – December 12, 2013 – Computer scientists at the Harvard School of Engineering and Applied Sciences (SEAS) and the Wyss Institute for Biologically ...
New models of drug-resistant breast cancer point to better treatments
2013-12-13
New models of drug-resistant breast cancer point to better treatments
Human breast tumors transplanted into mice are excellent models of metastatic cancer and are providing insights into how to attack breast cancers that no longer respond ...
Health spending is more efficient for men than for women
2013-12-13
Health spending is more efficient for men than for women
Health expenditures show stronger association with gains in life expectancy for males than for females throughout the industrialized countries of the world
Health care spending is a large – and ever increasing - ...
LAST 30 PRESS RELEASES:
Freeze-framing the cellular world to capture a fleeting moment of cellular activity
Computer hardware advance solves complex optimization problems
SOX2: a key player in prostate cancer progression and treatment resistance
Unlocking the potential of the non-coding genome for precision medicine
Chitinase-3-like protein 1: a novel biomarker for liver disease diagnosis and management
The Journal of Nuclear Medicine Ahead-of-Print Tip Sheet: August 22, 2025
Charisma Virtual Social Coaching named a finalist for Global Innovation Award
From the atmosphere to the abyss: Iron's role in Earth's climate history
US oil and gas air pollution causes unequal health impacts
Scientists reveal how microbes collaborate to consume potent greenhouse gas
UMass Amherst kinesiologist receives $2 million ‘outstanding researcher’ award from NIH
Wildfire peer review report for land Brandenburg, Germany, is now online
Wired by nature: Precision molecules for tomorrow's electronics
New study finds hidden body fat is linked to faster heart ageing
How a gift card could help speed up Alzheimer’s clinical research
Depression and anxiety symptoms in adults displaced by natural disasters
Cardiovascular health at the intersection of race and gender in Medicare fee for service
World’s first observation of the transverse Thomson effect
Powerful nodes for quantum networks
Mapping fat: How microfluidics and mass spectrometry reveal lipid landscapes in tiny worms
ATOX1 promotes hepatocellular carcinoma carcinogenesis via activation of the c-Myb/PI3K/AKT signaling pathway
Colibactin-producing E. coli linked to higher colorectal cancer risk in FAP patients
Animal protein not linked to higher mortality risk, study finds
Satellite insights into eutrophication trends on the Qinghai–Tibet plateau
Researchers develop an innovative method for large-scale analysis of metabolites in biological samples
Asteroid Bennu is a time capsule of materials bearing witness to its origin and transformation over billions of years
New AI model can help extend life and increase safety of electric vehicle batteries
Wildfires can raise local death rate by 67%, shows study on 2023 Hawaiʻi fires
Yogurt and hot spring bathing show a promising combination for gut health
Study explains how lymphoma rewires human genome
[Press-News.org] Bioethics Commission on incidental findings: Anticipate and communicateBioethics Commission releases ethical analysis and recommendations for clinicians, researchers, and direct-to-consumer testing companies on how to manage the increasingly common issue of incidental and secondary findings