U of M leads research to manage incidental findings in human subjects research

June 30, 2008

Susan Wolf, J.D., professor and chair of the University of Minnesota's Consortium on Law and Values in Health, Environment, & the Life Sciences, led a multidisciplinary team of national experts to develop the first major guidelines on managing incidental findings (IF) in human subjects research which have just been published. The two-year project, supported by the National Human Genome Research Institute at National Institutes of Health, has now issued groundbreaking recommendations for how to anticipate and manage IFs in genetic, genomic, and imaging research, suggesting broader application to other research domains. The project has produced a 17-article symposium including the consensus paper, which appears in the Summer 2008 issue of the Journal of Law, Medicine & Ethics.

An incidental finding (IF) is an unexpected finding concerning an individual research participant that has potential health or reproductive importance, is discovered in the course of conducting research, but is beyond the aims of the study. They are an increasingly common byproduct of research using powerful technologies that generate "extra" data. Because IFs can potentially save lives but also cause alarm, the decision on whether or not to disclose them to research participants has been a major dilemma. "Researchers often stumble upon unexpected findings but have no idea whether to share this information with research participants," said Wolf. "The information may prove highly significant or a false alarm. And researchers have traditionally drawn a bright line between their research activity and the clinical care of patients;incidental findings challenge that line."

The project members concluded that it is essential to address the possibility of IFs in the consent process. Researchers should set up a process for recognizing IFs and verifying whether there is indeed a suspicious finding of concern, and they should take steps to validate an IF and confirm its health or reproductive importance before offering the finding to a research participant. Additionally, a researcher who lacks the expertise to make this assessment may need to consult a clinical colleague. The consensus paper also addresses the vexing problem of IFs discovered in reanalysis of archived data.

The consensus article distinguishes among three categories of IFs to determine when they should be disclosed. IFs with strong net benefits--ones revealing a condition likely to be life-threatening or revealing a condition likely to be grave that can be avoided--should be offered to research participants. An IF that offers possible net benefit-one that may offer more benefit than burden to the research participant--may be disclosed at the researcher's discretion. An IF that has unlikely net benefit or whose net benefit cannot be determined should not be offered to the research participant, because disclosure may well present more burden than benefit.

"These guidelines should have an enormous impact," Wolf said. "They should prompt federal authorities, universities, institutional review boards, and researchers to develop strategies for dealing with incidental findings and to discuss the plan with people signing up to participate in research."
-end-
The University of Minnesota's Consortium on Law and Values in Health, Environment & the Life Sciences links 17 top centers at the University to address the societal implications of the life sciences and biomedicine. For more information, visit www.lifesci.consortium.edu or call 612-625-0055.

University of Minnesota

Related Health Articles from Brightsurf:

The mental health impact of pandemics for front line health care staff
New research shows the impact that pandemics have on the mental health of front-line health care staff.

Modifiable health risks linked to more than $730 billion in US health care costs
Modifiable health risks, such as obesity, high blood pressure, and smoking, were linked to over $730 billion in health care spending in the US in 2016, according to a study published in The Lancet Public Health.

New measure of social determinants of health may improve cardiovascular health assessment
The authors of this study developed a single risk score derived from multiple social determinants of health that predicts county-level cardiovascular disease mortality.

BU study: High deductible health plans are widening racial health gaps
The growing Black Lives Matter movement has brought more attention to the myriad structures that reinforce racial inequities, in everything from policing to hiring to maternal mortality.

Electronic health information exchange improves public health disease reporting
Disease tracking is an important area of focus for health departments in the midst of the COVID-19 pandemic.

E-health resource improves men's health behaviours with or without fitness facilities
Men who regularly used a free web resource made significantly more health changes than men who did not, finds a new study from the University of British Columbia and Intensions Consulting.

Mental health outcomes among health care workers during COVID-19 pandemic in Italy
Symptoms of posttraumatic stress disorder, depression, anxiety and insomnia among health care workers in Italy during the COVID-19 pandemic are reported in this observational study.

Mental health of health care workers in china in hospitals with patients with COVID-19
This survey study of almost 1,300 health care workers in China at 34 hospitals equipped with fever clinics or wards for patients with COVID-19 reports on their mental health outcomes, including symptoms of depression, anxiety, insomnia and distress.

Health records pin broad set of health risks on genetic premutation
Researchers from the University of Wisconsin-Madison and Marshfield Clinic have found that there may be a much broader health risk to carriers of the FMR1 premutation, with potentially dozens of clinical conditions that can be ascribed directly to carrying it.

Attitudes about health affect how older adults engage with negative health news
To get older adults to pay attention to important health information, preface it with the good news about their health.

Read More: Health News and Health Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.