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There are no industry standards for handling incidental findings (IFs) in research. To help give IRBs and researchers guidance for IFs, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) released its report, Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts, in December 2013. The comprehensive report looks at the ways in which IFs are encountered and managed in the clinical, research, and direct-to-consumer settings, and can be read at http://bioethics.gov/sites/default/files/FINALAnticipateCommunicate_PCSBI_0.pdf.
"This report came to light because incidental findings are something that are likely to be faced by most of us, and eventually all of us," says Lisa M. Lee, PhD, MS, executive director of the Bioethics Commission in Washington, DC. "Many different scholars have looked at them [IFs] in one modality or one setting. This report did two things by looking over different modalities and settings: The commission came up with some overarching recommendations that apply in any setting, and some recommendations for each specific setting."
The main recommendation, she says, is to "anticipate and communicate" any IFs that could occur. "It is important for IRBs to know that the commission recommended that researchers anticipate what incidental or secondary findings might arise, and plan what to do with those," Lee says. "Once they anticipate, they must communicate that to the potential recipient. Those two things — anticipating and communicating the potential findings — are the key pieces for any researcher or practitioner."
The overarching recommendations apply to all situations that involve discovery of IFs. These recommendations include the following:
• Clinicians, researchers, and direct-to-consumer providers should describe to participants the types of IFs that could occur, and discuss the plan for disclosure and what may or may not be returned.
• Professional groups and institutional leadership should develop guidelines to categorize findings, best practices for managing findings, and train practitioners on these guidelines.
• Federal agencies and other parties should continue to fund research to examine issues with incidental and secondary findings, including the ethics, costs, benefits, and harms of disclosure, and ways in which practitioners divulge these findings to participants.
• Public and private entities should prepare educational materials to inform all stakeholders — including practitioners, institutional review boards, and potential recipients — about the ethical, practical, and legal considerations raised by incidental and secondary findings.
• The principle of justice and fairness requires that all participants have adequate knowledge, guidance, and support for making informed decisions about what tests to undergo, information to seek, and what to do with the information.
These guidelines can be used by all who encounter incidental findings across the clinical, research, and direct-to-consumer contexts. The commission also offered recommendations specific to researchers — recommendations about which IRBs should be aware.
The commission’s recommendations for researchers include the following:
• Explain IFs to subjects during the informed consent process. This key piece, Lee says, is whether the IF plan is adequately communicated to the research participant. "Is it clear what the incidental finding might be? Is it clearly communicated? Whatever the plan is, they must communicate it," she says. "Subjects can consent to participate or not based on that."
• Communicate to subjects what incidental findings are, what might be found, whether they will be disclosed, and how the subject can opt out of receiving the findings if he or she chooses. The informed consent document should thoroughly detail this process, along with an expected timeframe of results to be returned. If the researchers have an ethical objection to a subject opting out of receiving results, that subject does not have to be enrolled, the report states.
• Create a plan to manage the anticipatable incidental findings. Researchers should determine what IFs can reasonably be expected to be found during the course of the research study. The plan should also include who will be responsible for returning the results and discussing them with subjects. "An IRB will really need to be thinking whether incidental or secondary findings are possible given the protocol, and whether the research team has adequately planned to manage them," Lee says.
• Researchers should also decide on a process for evaluating unanticipatable findings. Despite best efforts to anticipate every IF that could arise, there may also be those that no one expected. "What is the plan for the things they can’t anticipate? You can’t know everything, but there must be a plan," Lee says. "There must be a way to handle the unexpected. Have a plan, resources, and support in place to deal with the unanticipated."
• Carefully consider whether to actively seek IFs. A secondary finding is a finding that is actively sought by a practitioner that is not the primary target. Practitioners might actively seek secondary findings when doing so is recommended by an expert body, or by a consensus of practitioners. However, researchers do not have an obligation to seek out secondary findings, the report says. A research study may not have adequate funds to put toward the time and resources it would take to search for the findings, or it could be decided that seeking them would not advance the goals of the study. But even if researchers decide not to seek those findings, it is still important to develop a plan to manage IFs that do come up, the report says.
"It could be that they [researchers] will not look for secondary findings — they don’t have an ethical obligation to seek them, so they might decide not to," Lee says. "If they happen to seek secondary findings, they must have a plan about how they will be managed and, based on that plan, informed participants can decide if it is research to which they want to consent."
Training all involved personnel in the handling of IFs is also a key piece of the puzzle for IRBs, Lee says. The commission is currently working on a primer for IRBs to address and offer guidance on all issues pertaining to IFs. The primer will include how and when incidental findings arise, how to deal and cope when they are found, and how to develop and execute a plan. The release date for the primer is set for late April 2014 and will be available at Bioethics.gov/education, says Lee.
"We’re really excited about the possibility of helping researchers and the IRBs who review their protocols deal with incidental findings," Lee says. "We hope that this report and accompanying primer can really help move IRB members along and help them gain a greater understanding of what the ethics are of the growing issue of incidental findings."
[Editor’s note: This is the first in a series of articles on IRBs and incidental findings. Watch for more articles in coming months, including IRB plans for handling IFs, and considerations for biobanks.]