Institutional review board approaches to the incidental findings problem

Institutional Review Boards (IRBs) are confronted with new challenges in the face of expanding technologies while fulfilling their existing regulatory mandate to ensure that plans are in place to protect subjects and to inform them of risks and benefits of research participation. Existing regulations and guidance do not address the issue of incidental findings (IFs), thus leaving awareness of the issue and the application of ethical principles to IRB judgment alone. In order to assure that researchers are aware of the potential for IFs, IRBs must identify which studies are likely to identify IFs and establish what plans should be put into place prior to study initiation to assure the subjects are appropriately informed of the likelihood of IFs, how IFs will be communicated to subjects, and whether the burden of follow-up falls on the researchers or is the subject's responsibility.     

Genomic research and incidental findings.

The Human Genome Project showed that there is significant genetic variation within the population. Current research is accumulating large databases that may reveal genetic variations associated with disease or health risks, even if not intended as part of the study design. These incidental findings create legal, ethical, and financial challenges for researchers. Current federal and international guidelines are not adequate. Plans for dealing with incidental findings need to be established in the study design and reviewed and approved by the Institutional Review Board.     

Managing incidental findings in human subjects research: analysis and recommendations.

No consensus yet exists on how to handle incidental findings (IFs) in human subjects research. Yet empirical studies document IFs in a wide range of research studies, where IFs are findings beyond the aims of the study that are of potential health or reproductive importance to the individual research participant. This paper reports recommendations of a two-year project group funded by NIH to study how to manage IFs in genetic and genomic research, as well as imaging research. We conclude that researchers have an obligation to address the possibility of discovering IFs in their protocol and communications with the IRB, and in their consent forms and communications with research participants. Researchers should establish a pathway for handling IFs and communicate that to the IRB and research participants. We recommend a pathway and categorize IFs into those that must be disclosed to research participants, those that may be disclosed, and those that should not be disclosed.     

Research malpractice and the issue of incidental findings.

Human subject research involving brain imaging is likely to reveal significant incidental findings of abnormal brain morphology. Because of this fact and because of the fiduciary relationship between researcher and subject, board-certified or board-eligible radiologists should review the scans to look for any abnormality, the scans should be conducted in accordance with standard medical practice for reviewing the clinical status of the whole brain, and the informed consent process should disclose the possibility that incidental findings may be revealed and what consequences will follow. In the event such findings are revealed, qualified physicians should explain to the subject the significance of the findings and the alternatives available.     

Understanding incidental findings in the context of genetics and genomics.

Human genetic and genomic research can yield information that may be of clinical relevance to the individuals who participate as subjects of the research. It has been common practice among researchers to notify participants during the informed consent process that no individual results will be disclosed, "incidental" or otherwise. However, as genetic information obtained in research becomes orders of magnitude more voluminous, increasingly accessible online, and more informative, this precedent may no longer be appropriate. There is not yet consensus on the responsibilities of researchers to disclose individual research results to research participants. Empirical research suggests that participants want to know individual research results. On the other hand, the increased resolution and power afforded by new genomic analyses may lead to findings of statistical, but not necessarily clinical, significance. This paper addresses the issues to be considered in deciding whether and how to disclose "incidental" findings or other findings of clinical significance that arise in the course of human genomic and genetic research. What research results should be offered, and what should not be offered? For which research should individual results be offered to research participants, when should they be offered, how, and to whom?     

Bridging philosophical and practical implications of incidental findings in brain research

Empirical studies and ethical-legal analyses have demonstrated that incidental findings in the brain, most commonly vascular in origin, must be addressed in the current era of imaging research. The challenges, however, are substantial. The discovery and management of incidental findings vary, at minimum, by institutional setting, professional background of investigators, and the inherent differences between research and clinical protocols. In the context of human subjects protections, the challenges of disclosure of unexpected and potentially meaningful clinical information concern privacy and confidentiality, communication, and responsibility for follow-up. Risks, including a blurring of boundaries between research and clinical practice, must be weighed against the possible benefit to subjects and a moral duty to inform. Identification and examination of these challenges have been met by scientific interest and a robust, interdisciplinary response resulting in the pragmatic recommendations discussed here.     

The law of incidental findings in human subjects research: establishing researchers' duties

Research technologies can now produce so much information that there is significant potential for incidental findings (IFs). These are findings generated in research that are beyond the aims of the study. Current law and federal regulations offer no direct guidance on how to deal with IFs in research, nor is there adequate professional or institutional guidance. We advocate a defined set of researcher duties based on law and ethics and recommend a pathway to be followed in handling IFs in research. This article traces the underlying ethical and legal theories supporting researcher duties to manage IFs, including duties to develop a plan for management in the research protocol, to discuss the possibility of and management plan for IFs in the informed consent process, and to address, evaluate, and ultimately offer to disclose IFs of potential clinical or reproductive significance to research participants when they arise.     

Legal liability and research ethics boards: the case of neuroimaging and incidental findings

Neuroimaging research covers a wide range of intriguing issues from revealing brain structures to investigating what happens in our brain when we lie. The field appears to be thriving, but skepticism and alertness to the various ethical, scientific, policy and philosophical challenges associated with it also appear to be on the rise. One particularly complex issue concerns what to do with incidental findings that emerge during the course of neuroimaging research. Research ethics boards (REBs) play a central role in research oversight. In this paper, we will consider some of the potential issues associated with REB liability in negligence in the context of incidental findings in neuroimaging research.     

The risks and benefits of searching for incidental findings in MRI research scans.

We weigh the presumed benefits of routinely searching all research scans for incidental findings (IFs) against its substantial risks, including false-positive and false-negative findings, and the possibility of triggering unnecessary, costly evaluations and perhaps harmful treatments. We argue that routinely searching for IFs may not maximize benefits and minimize risks to participants.     

Current approaches to analysis of narcotic drugs in biological substances

A method of analysis of basic narcotic drugs in urine is described. It consists in isolation by solid phase extraction, derivation and identification by gas chromatography with mass-selective detector. The approaches applied in the above method can be used for analysis of narcotic drugs undetectable by preliminary investigations as well as for urine examination for pharmacological or other biologically active substances.     

Changing approaches to corrections

A new training program was developed for correctional officers and other new employees. The training was designed to focus on a positive philosophy toward rehabilitation rather than emphasizing techniques for managing inmates. Attitude questionnaires were developed to test attitudes on treatment and security. The questionnaire was administered before and after the training to determine changes in attitude. The trainees' attitudes were compared to those of college students who had completed an internship. There was a significant difference in the attitudes of employees before training and after training. There was also a significant difference in attitudes of interns and employees before training but not after the employees had been trained.     

World formation or world mode of production? Alternative approaches to world system analysis

Conclusion Bergesen has identified the right problem but the wrong analogy. If we can make the analogy from a social formation to a world perspective then what were are analyzing is the world formation and not a world market or a world production. The capitalist world formation is the ensemble of economic relations (both the determinant production relations and the dominant world system), political relations, and ideological relations which are manifested at the world level. A world formation, as opposed to a world mode of production approach, avoids the confusion between the capitalist mode of production and participation in the capitalist world system, which Laclau pointed to as a necessary step in clarifying theories which utilize a world perspective. Furthermore, it allows us to establish the determinant effects of production in the world formation and the structuring of production by class struggle which Brenner argues is essential for the theory. And in the process it avoids economic reductionism by including the relative autonomy of the state and ideological structures.Finally, a world formation approach does not reduce the efficacy of the world perspective. This is especially true since the capitalist world formation did not arise from dust, but was a result of transformation of the feudal world formation. In this sense, the world formation has an a priori relation to social formations, which is the key insight of the world perspective.     

Forensic analysis of smart TV: A current issue and call to arms

A number of new entertainment systems have appeared on the market that have embedded computing capabilities. Smart Televisions have the ability to connect to networks, browse the web, purchase applications and play games. Early versions were based on proprietary operating systems; newer versions released from 2012 are based on existing operating systems such as Linux and Android. The question arises as to what sort of challenges and opportunities they present to the forensics examiner. Are these new platforms or simply new varieties of existing forms of devices? What data do they retain and how easy is it to access this data? This paper explores this as a future forensic need and asks if we are missing potential sources of forensic data and to what degree we are ready to process these systems as part of an investigation.     

Incidental findings in CT colonography: literature review and survey of current research practice

Incidental findings (IFs) of potential medical significance are seen in approximately 5-8 percent of asymptomatic subjects and 16 percent of symptomatic subjects participating in large computed tomography (CT) colonography (CTC) studies, with the incidence varying further by CT acquisition technique. While most CTC research programs have a well-defined plan to detect and disclose IFs, such plans are largely communicated only verbally. Written consent documents should also inform subjects of how IFs of potential medical significance will be detected and reported in CTC research studies.