Update on the Return of Research Results and Incidental Findings
By Rick Michels, ISBER News Editor
Mariana Bledsoe, Co-chair, Science Policy Committee
Nicole J. Sieffert, Co-chair, Science Policy Committee
Editor’s Note: This is a reprint as well as an update from our July 2013 issue, and the second of our top ten stories we’ve run over the past two years. We offer it again, perhaps as a place to have a discussion on what, if anything, may have changed regarding this issue over the past couple of years. This issue has ramifications with regard to sustainability of many of the biobanks of our membership.
Since the original article below was published on return of research results and incidental findings, there have been a number of policy developments and interesting papers published in the literature.
The US Presidential Commission for the Study of Bioethical Issues (PCBI) published a report, Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts in December of 2013 available for download at http://bioethics.gov/node/3183. This report included a series of recommendations regarding return of incidental and secondary findings in the clinical, research and direct-to-consumer contexts.
With regard to biobanking, the report recognized the complexity of the issues regarding the return of research results. On page 80, the report cited the comments that ISBER submitted to the PCBI. These comments, available for download at https://isber.site-ym.com/?page=SciPolComm, were developed by the ISBER Science Policy Committee. This demonstrates the importance of ISBER engaging in the public comment process when reports, regulations, or policies are released for public comment.
The issue of return of research results and incidental findings continues to be a topic of considerable debate and discussion in the peer-reviewed literature. A number of interesting articles have recently been published. A selected sampling of these follows. Of particular note, is the paper by Evans et. al. (2014) in which they describe some regulatory challenges in the US resulting from recent changes in the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule and the Clinical Laboratory Improvements Amendments of 1988 (CLIA) that will require some HIPAA-covered, non-CLIA-regulated research laboratories to make their data available to patients upon request if certain conditions are met under HIPAA.
These and other issues will be discussed at an upcoming workshop at the ISBER Annual Meeting in Phoenix, Arizona: “Return of Individual Research Results from Biobanks to Participants: Policy Development, Implementation Issues, Practical Experiences, and Lessons Learned.” The workshop will be held on Saturday, May 9, 2015 from 8:30 – 9:30 a.m.
Selected Articles on Return of Research Results and Incidental Findings:
Thorogood, Adrian, et al. “An implementation framework for the feedback of individual research results and incidental findings in research.” BMC medical ethics 15.1 (2014): 88.
Jarvik, G. P., Amendola, L. M., Berg, J. S., Brothers, K., Clayton, E. W., Chung, W., … & CSER Act-ROR Working Group. (2014). Return of genomic results to research participants: the floor, the ceiling, and the choices in between. The American Journal of Human Genetics, 94(6), 818-826.
Burke, W., Evans, B. J., & Jarvik, G. P. (2014, March). Return of results: Ethical and legal distinctions between research and clinical care. In American Journal of Medical Genetics Part C: Seminars in Medical Genetics (Vol. 166, No. 1, pp. 105-111).
Evans, B. J., Dorschner, M. O., Burke, W., & Jarvik, G. P. (2014). Regulatory changes raise troubling questions for genomic testing. Genetics in Medicine.
Hot Topic: The Return of Incidental Findings
(originally published in August 2013)
This topic has generated a great deal of discussion in past ISBER meetings – should a biorepository that conducts tests on banked samples (most likely de-identified) and identifies findings that may be of vital interest to the donor of the sample be required to report that finding to the donor and/or personal physician? The incidental findings are most likely a result of research, not clinical tests. As such, they are subjected to different standards, since the work being done is for research and not therapeutic reasons.
This raises an ethical question: If a researcher uncovers a finding that can have a significant impact on the health of a participant who donated his specimen for research, does this donor and his care giver have a right to be made aware of such a finding?
With issues like this come to the forefront through novel and emerging research, the U.S. Federal Government is taking an active interest. In 2009, President Barack Obama established the Presidential Commission for the Study of Bioethical Issues to help shape Federal policy in these matters. It is the role of the commission to identify and promote policies and practices that ensure ethically responsible conduct of scientific research and healthcare delivery. According to Lisa M. Lee, Executive Director of the commission, “Emerging medical technologies, changing cost structures, and evolving medical practice make the likelihood of discovering incidental findings in the clinical, research, and direct-to- consumer contexts a growing certainty.”
The commission this year requested public comment on the issue, and ISBER has weighed in. In a letter co-signed by both current President Fay Betsou and President-Elect Andy Zaayenga, the society has raised strong objections to any potential mandate to return incidental findings. You can read the letter here.
The letter, largely crafted by the ISBER Science and Policy committee and reviewed by the Isber Publications committee, focused on these major reasons for the objection:
Research findings require validation, and unless adequately reproduced, may cause more harm than good by offering unvalidated results to the therapeutic decision makers.
ISBER believes test results used in patient care should come from CLIA certified laboratories. Most research laboratories are not CLIA certified, do not have the infrastructure for CLIA certification, and may not have the resources (or remaining tissue) to run a diagnostic test along with its research tests.
Meeting the infrastructure requirements of CLIA certification, along with other necessary infrastructure changes in returning incidental findings (to a de-identified donor no less), and the potential for liability should incidental findings be wrong and cause harm would drive up the cost of research, as well as disrupt it. Research will suffer as a consequence of such a mandate.
In sum, the letter states such a requirement would actually cause more harm than good to the goal of improving health care, in both the specific and general sense:
The return of incidental findings from research to participants by biorepositories represents a fundamental change in the underlying principles of biomedical research which could potentially inhibit the primary goals of discovering new knowledge and finding ways to implement this. That is, the obligation to accomplish a therapeutic responsibility by those neither qualified to do so, nor properly resourced, could actually produce unintended and undesired outcomes, causing immediate harm to patients, and long term harm to society through a very likely reduction in research productivity… the return of incidental research findings to participants would be a large and costly undertaking by biorepositories that would detrimentally affect their support of research on human diseases.
The additional cost burdens such a requirement would place on research are of particular interest to this writer. I recently attended a panel discussion at a biomedical Innovation workshop in Seattle. The panel was made up of angel investors, venture capitalists, and representatives from philanthropic institutions, all of whom provide money for startup companies discovering new treatments in healthcare through research. One thing was made clear by those panelists looking to invest in new health care innovations, who were addressing a roomful of entrepreneurial minded researchers looking for funding for tomorrow’s big breakthrough drugs and therapies. Investors are acutely aware of the rising costs of healthcare and most interested in those innovations that have the potential of bringing down those costs. In this, both the ISBER community and the private investor appear to be in agreement.