Tag: incidental findings

Bioethics Blogs

Modernizing Human Subjects Research Protections: A Plan for Return of Results

The notice of proposed rulemaking (NPRM), issued in the Federal Register on September 8, 2015, proposes revisions to the Common Rule—federal regulations that govern the protection of human subjects in research—including changes to the criteria for institutional review board (IRB) approval of research. This is the next installment in a blog series about those changes and their relationship to the Bioethics Commission’s work on incidental and secondary findings.

Currently, the Common Rule requires IRBs to find that certain criteria have been met in order to approve research. The NPRM proposes an addition that IRBs should evaluate the appropriateness of a plan for returning individual findings discovered during research, when that plan is submitted as part of the protocol. The proposed rulemaking also addresses the potential challenges of returning individual research findings when it is unclear if the findings are clinically valid or actionable, or when the findings might have psychological or social ramifications.

The Bioethics Commission addressed return of individual research results in its December 2013 report, Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts. The Bioethics Commission recommended that IRBs review and approve plans for the disclosure and management of incidental findings—a recommendation echoed in the proposed changes to the Common Rule. The Bioethics Commission stressed the importance of this plan, recommending both that researchers develop a plan for managing incidental and secondary findings and that, during the informed consent process, researchers clearly communicate their plan to participants.

The NPRM cites to the Bioethics Commission’s report, recognizing the importance of the issue of return of individual research results, and the challenges highlighted by Anticipate and Communicate.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Modernizing Human Subjects Research Protections: A Blog Series on Recent Proposed Revisions to the Common Rule

Last week, 16 federal departments and agencies released a notice of proposed rulemaking (NPRM) to revise the Common Rule – the regulations that govern the ethical conduct of federally supported human subjects research. This highly anticipated NPRM arrived more than four years after the July 2011 release of an advanced notice of proposed rulemaking (ANPRM) that sparked substantial commentary and debate.

In its 2011 report, Moral Science: Protecting Participants in Human Subjects Research, the Bioethics Commission analyzed current protections for research participants, concluding that the regulations generally appear to protect people from avoidable harm or unethical treatment, but also offering recommendations for improvement. Indeed, the Bioethics Commission commented directly on the ANPRM in Moral Science (Recommendation 13).

The Bioethics Commission later addressed genetic research in Privacy and Progress in Whole Genome Sequencing; pediatric research in Safeguarding Children: Pediatric Medical Countermeasure Research; incidental findings in research in Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts; and research with participants with potentially impaired consent capacity in Gray Matters: Topics at the Intersection of Neuroscience, Ethics, and Society. Analysis and recommendations relevant to research ethics exist throughout the Bioethics Commission’s work.

The NPRM cites several of the Bioethics Commission’s reports, and acknowledges that “in preparing the NPRM, the deliberations of the [Bioethics Commission] were taken into account.” (NPRM, p. 397) Moreover, the NPRM’s ethical rationale in support of proposed regulatory changes often closely parallels the Bioethics Commission’s analyses of similar issues. Over the next several weeks, we will be highlighting the impact of the Bioethics Commission’s work on the NPRM, and the relationship between the Bioethics Commission’s recommendations and the proposed revisions to the Common Rule in a series on this blog called “Modernizing Human Subjects Research Protections.”

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Openness as an ethical ritual

Barbara A. Koenig wrote last year about how informed consent has acquired a “liturgical feel” in biomedical research ethics. Each time the protection of research participants is challenged by new forms of research, the answer is: more consent!

The procedure of informing and asking for consent may feel like assuming a priestly guise and performing an ethical ritual with the research participant.

The ritual is moreover sometimes practically impossible to implement. For example, if one is to inform participants in genetic research about incidental findings that might be made about them, so that they can decide whether they want to be re-contacted if researchers happen to discover “something” about them.

If it takes one hour to inform a patient about his or her actual genetic disease, how long would it take to inform a research participant of all possible kinds of genetic disease risks that might be discovered? Sorry, not just one participant, but hundreds of thousands.

How then can research participants be respected as humans, if informed consent has become like an empty ritual with the poor participant? (A ritual that in genetic research sometimes is impracticable.)

In the August issue of Nature, Misha Angrist suggests a solution: we treat participants as partners in the research process, by being open to them. How are we open to them? By offering them the researchers’ genetic raw data, which can be handed over to them as an electronic file.

Here we are not talking about interpreted genetic disease risks, but of heaps of genetic raw data that are utterly meaningless for research participants.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics News

New Guidelines to Protect Research Participants

June 24, 2015

(Today Online) – When researchers in a human biomedical research project unintentionally come across a finding that suggests potential health risks, they sometimes face a dilemma on whether they should inform the participant about it. This issue of incidental findings from such research was among several that the Bioethics Advisory Committee (BAC) was trying to address when it was revising its ethics guidelines released today (June 23).

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

What should Investigators be Doing with Unexpected Findings in Brain Imaging Research?

Guest Post by Caitlin Cole

Incidental findings in brain imaging research are common. Investigators can discover these unexpected findings of potential medical significance in up to 70% of their research scans. However, there are no standards to guide investigators as to whether they should actively search for these findings or which, if any, they should return to research participants.

This complex ethical issue impacts many groups in brain imaging: participants and parents of child participants who may desire relevant health information, but alternatively may suffer from anxiety and financial burden; investigators who must ethically grant their participants autonomy, but who also may suffer from budget and personnel restrictions to manage the review and report of these findings; Institutional Review Board (IRB) members who must provide ethical oversight to imaging research and help mandate institutional standards; and health providers who must interface with their patients and assist with follow up care when necessary.

Our research study shows these groups share some ideas on the ethics of returning incidental findings – the researcher has an ethical responsibility or obligation to tell a subject that there’s something there, however they do it, but just inform the subject, even though it’s not part of the research” – yet also acknowledge the inherent risk in reporting medical research information. As one of our IRB members commented, I mean [in regards to withholding findings] one reason would be to protect the patient from doing something stupid about them.”

When participants are asked about incidental findings, they consistently state that they want to receive all information pertinent to their health.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Second issue of our newsletter about biobanks

Now you can read the second newsletter this year from CRB and BBMRI.se:

The newsletter contains four news items:

1. Anna-Sara Lind presents a new book, Information and Law in Transition, and the contributions to the book by CRB researchers.

2. Anna-Sara Lind describes the situation for the temporary Swedish law on research registries.

3. Mats G. Hansson reports on a modified version of broad consent for future research.

4. Josepine Fernow presents a new article by Jennifer Viberg on the proposal to give research participants freedom of choice about incidental findings.

(Link to PDF version of the newsletter)

Pär Segerdahl

We recommend readings - the Ethics Blog

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Letting people choose isn’t always the same as respecting them

Sequencing the entire genome is cheaper and faster than ever. But when researchers look at people’s genetic code, they also find unexpected information in the process. Shouldn’t research participants have access to this incidental information? Especially if it is important information that could save a life if there is treatment to offer?

The personal benefits of knowing genetic information can vary from individual to individual. For one person, knowledge might just cause anxiety. For another, genetic risk information could create a sense of control in life. Since different people have different experiences, it could seem tempting to leave it for them to decide for themselves whether they want the information or not.

Offering participants in genetic research a choice to know or not to know is becoming more common. Another reason for giving a “freedom of choice” has to do with respecting people by allowing them to make choices in matters that concern them. By letting the participant choose, you acknowledge that he or she is a person with an ability to make his or her own choices.

But when researchers hand over the decision to participants they also transfer responsibility: A responsibility that could have consequences that we cannot determine today. I recently wrote an article together with colleagues at CRB about this in Bioethics. We argue that this freedom of choice could be problematic.

Looking at previous psychological research on how people respond to probabilities, it becomes clear that what they choose depends on how the choice situation is presented. People choose the “safe” outcome before taking a risk in cases where the outcome is phrased in a positive way.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

A Dramatic Narrative Drama Reinforces AER14’s Lessons

by Jim Gearhart, BA, Member of the Board of Directors for Quorum Review IRB

If you attended PRIM&R’s 2014 Advancing Ethical Research (AER14) Conference in December, there’s a good chance you attended the performance of “The Drama of DNA: Implications of Genomic Protocols that Reconceptualize the Boundaries of ‘Normalcy.'” I’m saying the chances were good because the venue for “The Drama of DNA” was a large conference room filled to standing-room only capacity. In the time since the AER14, I have recalled more than once the themes that “The Drama of DNA” shared with us.

The “Drama of DNA” sprang from the collaborating minds of bioethicists Karen Rosenberg and Lynn Wein Bush. The play portrayed two committee meetings during which the members explored the ethical questions of genome wide sequencing. The topic under discussion was a fictitious study protocol that would test and map the genomes of autistic children, their parents, and at least one sibling. The goal of the play was to highlight the difficult questions associated with genomics research by acting out the conflicts occurring in both meetings.

For me, the play’s approach worked. The issues that the players introduced reinforced key topics from AER14’s daytime sessions. The actors’ lines echoed some of the conference’s key themes: biobanking; how to manage incidental findings; risks of research versus the benefits; and conducting research with vulnerable populations. Seeing a group argue those key points, even according to a script (with some improvisation), helped cement the main ideas in memory. And the lessons echo now, too, for anyone who is following events in the field of genomics this year whether it’s the progress of 23andMe’s business model; the Obama Administration’s ambitious proposal for more biomarking research; or the latest protocol to come your way with a biobanking or genome-mapping component.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics News

The bioethics of precision medicine

The idea of ‘precision medicine’ has become the subject of much discussion, following US President Barak Obama’s 2015 State of the Union address. In his speech, President Obama promised to invest $215 million in a ground-breaking ‘precision medicine’ initiative, with the short-term aim of running drug trials for targeted cancer treatments.

Precision medicine sounds great in theory – it gives clinicians tools to identify the specific molecular/genetic profile underlying a patient’s health, disease, or condition, and thus offer more effective, targeted treatments.

But are there any attendant bioethical concerns?

De Paul University bioethicist Craig Klugeman has raised questions about privacy controls on genetic information:

“Privacy is the main bioethical issue raised by the framers of this initiative. Given the record of companies and institutions with maintaining online privacy, I’m not sure we should yet be confident that privacy could be assured. And then consider that health information will be collected via mobile devices and transmitted wirelessly presenting additional opportunities for privacy breaches.”

A similar concern has been raised by the Duke Center for Personalised and Precision Medicine. As the center’s website points out, studies of publically-available sequence data have shown that patients in research studies can be identified by their genome sequences. 

There are also ethical concerns about the release of incidental findings. With such a massive increase in the amount of genetic information being collected – Obama’s program envisages a genetic database of over 1 million participants – ethical dilemmas involving significant incidental discoveries will be more common. Who should decide which findings get relayed back to patients?

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

The Bioethics Commission’s Meeting 20 Milestone

This February will mark an important milestone for the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission); the Bioethics Commission will hold its 20th public meeting. The 2-day meeting will be held February 5-6, 2015, in Washington, D.C. Since President Obama issued the Executive Order establishing the Commission on November 24, 2009, it has convened quarterly each year in order to publically discuss and deliberate various bioethical topics. As a Federal Advisory Committee, the Commission conducts all meetings and deliberations in public.

The Bioethics Commission held its first public meeting July 8-9, 2010 in Washington, D.C. to discuss its first topic, synthetic biology and the ethics of new technologies. The Commission has since covered a wide breadth of topics including privacy and genomic sequencing, ethical treatment of research participants, ethical duties of returning incidental findings, and the ethical conduct of neuroscience research. This year Commission meetings have focused on neuroscience; bioethics education and deliberation; and public health emergency response, with a focus on the current Ebola virus disease (EVD) epidemic.

During its quarterly meetings, Commission members hear from experts relevant to the topic being deliberated. After meeting 20, the Commission will have heard from more than 200 speakers. These speakers have come from across the U.S. and the world, and represent a variety of disciplines and interests including science, technology, law, medicine, and affected communities. Presentations from these experts provide Commission members with background information and lay the foundation for their deliberations. The roundtable discussions that occur during the public meetings serve to inform the recommendations published in each report.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.