Ethical, legal, and policy challenges in field-based neuroimaging research using emerging portable MRI technologies: guidance for investigators and for oversight.

Researchers are rapidly developing and deploying highly portable MRI technology to conduct field-based research. The new technology will widen access to include new investigators in remote and unconventional settings and will facilitate greater inclusion of rural, economically disadvantaged, and historically underrepresented populations. To address the ethical, legal, and societal issues raised by highly accessible and portable MRI, an interdisciplinary Working Group (WG) engaged in a multi-year structured process of analysis and consensus building, informed by empirical research on the perspectives of experts and the general public. This article presents the WG's consensus recommendations. These recommendations address technology quality control, design and oversight of research, including safety of research participants and others in the scanning environment, engagement of diverse participants, therapeutic misconception, use of artificial intelligence algorithms to acquire and analyze MRI data, data privacy and security, return of results and managing incidental findings, and research participant data access and control.

Key Expert Stakeholder Perceptions of the Law of Genomics: Identified Problems and Potential Solutions.

The law applicable to genomics in the United States is currently in transition and under debate. The rapid evolution of the science, burgeoning clinical research, and growing clinical application pose serious challenges for federal and state law. Although there has been some empirical work in this area, this is the first paper to survey and interview key scientific and legal stakeholders in the field of genomics to help ground identification of the most important legal problems that must be solved to successfully integrate genomics into clinical care. The respondents in this study identified a wide range of interconnected issues, focusing specifically on the need for clear guidelines about how to use these data, fear of liability for those who use these data, and the need to protect patients from use of this information particularly by insurers, while endorsing data sharing. Developing legal strategies to support appropriate use of genomics now and in the future clearly will require making trade-offs, taking into account the full complexity of this legal ecosystem.

Promoting evaluation capacity building in a complex adaptive system.

This study provides results from an NSF funded, four year, case study about evaluation capacity building in a complex adaptive system, the Nanoscale Informal Science Education Network (NISE Net). The results of the Complex Adaptive Systems as a Model for Network Evaluations (CASNET) project indicate that complex adaptive system concepts help to explain evaluation capacity building in a network. The NISE Network was found to be a complex learning system that was supportive of evaluation capacity building through feedback loops that provided for information sharing and interaction. Participants in the system had different levels of and sources of evaluation knowledge. To be successful at building capacity, the system needed to have a balance between both centralized and decentralized control, coherence, redundancy, and diversity. Embeddedness of individuals within the system also provided support and moved the capacity of the system forward. Finally, success depended on attention being paid to the control of resources. Implications of these findings are discussed.

Examining mixing methods in an evaluation of a smoking cessation program.

Three different methods were used in an evaluation of a smoking cessation study: surveys, focus groups, and phenomenological interviews. The results of each method were analyzed separately and then combined using both a pragmatic and dialectic stance to examine the effects of different approaches to mixing methods. Results show that the further apart the methods are philosophically, the more diverse the findings. Comparisons of decision maker opinions and costs of the different methods are provided along with recommendations for evaluators' uses of different methods.

The relationship between involvement in and use of evaluation in multi-site evaluations.

This research explores the relationship between participation in evaluation and the use of evaluation findings and processes within three large-scale multi-site evaluations. Using canonical correlation analysis and a collection of 20 interviews, this study describes and tests the relationship between these two critical conceptual powerhouses in evaluation. Using data that were collected as a part of the NSF-funded research Beyond Evaluation Use (Lawrenz & King, 2009), this study found that some theories and beliefs about participatory evaluation contribute to use and influence in similar ways as in single-site evaluations. The differences identified in this research highlight potential planning and implementation considerations that might allow multi-site evaluators and funders of multi-site evaluation to enhance use and influence of multi-site evaluations.

Relationships among affective factors and preferred engagement in science-related activities.

This study investigated how affective factors impact participation in science learning using structural equation modeling. Using a dataset from Taiwan, a model was obtained that showed the relationships among science-related interest, enjoyment, self-efficacy, self-concept, competency, leisure time engagement, and future interest in science. The paths relating to engagement and future interest were much stronger for interest and enjoyment than for self-efficacy and self-concept. There was no significant path between science competency and future science interest or engagement. The results suggest that the affective and cognitive pathways to scientific competency are divergent and that they might be differentially activated by different contexts and activities. This indicates that school science educators might wish to reconsider the merit of overemphasizing achievement in comparison to interest. Finally, the results suggest that the development of science competency per se may not be the best way to ensure public engagement and understanding of science.

Managing incidental findings and research results in genomic research involving biobanks and archived data sets.

Biobanks and archived data sets collecting samples and data have become crucial engines of genetic and genomic research. Unresolved, however, is what responsibilities biobanks should shoulder to manage incidental findings and individual research results of potential health, reproductive, or personal importance to individual contributors (using "biobank" here to refer both to collections of samples and collections of data). This article reports recommendations from a 2-year project funded by the National Institutes of Health. We analyze the responsibilities involved in managing the return of incidental findings and individual research results in a biobank research system (primary research or collection sites, the biobank itself, and secondary research sites). We suggest that biobanks shoulder significant responsibility for seeing that the biobank research system addresses the return question explicitly. When reidentification of individual contributors is possible, the biobank should work to enable the biobank research system to discharge four core responsibilities to (1) clarify the criteria for evaluating findings and the roster of returnable findings, (2) analyze a particular finding in relation to this, (3) reidentify the individual contributor, and (4) recontact the contributor to offer the finding. We suggest that findings that are analytically valid, reveal an established and substantial risk of a serious health condition, and are clinically actionable should generally be offered to consenting contributors. This article specifies 10 concrete recommendations, addressing new biobanks as well as those already in existence.

Expert panel reviews of research centers: the site visit process.

Site visits are used extensively in a variety of settings within the evaluation community. They are especially common in making summative value decisions about the quality and worth of research programs/centers. However, there has been little empirical research and guidance about how to appropriately conduct evaluative site visits of research centers. We review the processes of two site visit examples using an expert panel review: (1) a process to evaluate four university research centers and (2) a process to review a federally sponsored research center. A set of 14 categories describing the expert panel review process was obtained through content analysis and participant observation. Most categories were addressed differently through the two processes highlighting the need for more research about the most effective processes to use within different contexts. Decisions about how to structure site visits appear to depend on the research context, practical considerations, the level at which the review is being conducted and the intended impact of the report. Future research pertaining to the selection of site visitors, the autonomy of the visitors in data collection and report writing, and the amount and type of information provided would be particularly valuable.

An empirical examination of the management of return of individual research results and incidental findings in genomic biobanks.

PURPOSE: The purpose of this study was to examine and document the management and return of individual research results and incidental findings to research participants among biobanks. METHODS: A comprehensive Internet search was completed to identify biobanks and collect available documents about biobanks and their procedures and policies regarding the return of results. The Internet search was supplemented by an e-mail request to gather further such documents. A total of 2,366 documents were collected for analysis from a sample of 85 biobanks. RESULTS: The major finding of this empirical work is that the majority of the biobanks in the sample do not address the return of individual research results and incidental findings in their publicly available documents. CONCLUSION: The results suggest that there is a need for more discussion and guidance about the most appropriate ways for biobanks to consider the return of individual research results and incidental findings and generate policies and procedures that address this issue.

An empirical examination of the current state of publically available nanotechnology guidance materials.

As part of "Nanodiagnostics and Nanotherapeutics: Building Research Ethics and Oversight," an empirical search was conducted to identify publicly available resources that guided understanding about human subjects issues in nanomedicine or nanotechnology including policy statements, guidance documents, or consent forms. The authors conducted 5,083 internet searches and analyzed 175 documents. Results show that very little guidance is publicly available and most documents focused on occupational and environmental concerns.

Recommendations for nanomedicine human subjects research oversight: an evolutionary approach for an emerging field.

The nanomedicine field is fast evolving toward complex, "active," and interactive formulations. Like many emerging technologies, nanomedicine raises questions of how human subjects research (HSR) should be conducted and the adequacy of current oversight, as well as how to integrate concerns over occupational, bystander, and environmental exposures. The history of oversight for HSR investigating emerging technologies is a patchwork quilt without systematic justification of when ordinary oversight for HSR is enough versus when added oversight is warranted. Nanomedicine HSR provides an occasion to think systematically about appropriate oversight, especially early in the evolution of a technology, when hazard and risk information may remain incomplete. This paper presents the consensus recommendations of a multidisciplinary, NIH-funded project group, to ensure a science-based and ethically informed approach to HSR issues in nanomedicine, and to integrate HSR analysis with analysis of occupational, bystander, and environmental concerns. We recommend creating two bodies, an interagency Human Subjects Research in Nanomedicine (HSR/N) Working Group and a Secretary's Advisory Committee on Nanomedicine (SAC/N). HSR/N and SAC/N should perform 3 primary functions: (1) analysis of the attributes and subsets of nanomedicine interventions that raise HSR challenges and current gaps in oversight; (2) providing advice to relevant agencies and institutional bodies on the HSR issues, as well as federal and federal-institutional coordination; and (3) gathering and analyzing information on HSR issues as they emerge in nanomedicine. HSR/N and SAC/N will create a home for HSR analysis and coordination in DHHS (the key agency for relevant HSR oversight), optimize federal and institutional approaches, and allow HSR review to evolve with greater knowledge about nanomedicine interventions and greater clarity about attributes of concern.

A unified approach to validation, reliability, and education study design for surgical technical skills training.

OBJECTIVE: To present modern educational psychology theory and apply these concepts to validity and reliability of surgical skills training and assessment. DESIGN: In a series of cross-disciplinary meetings, we applied a unified approach of behavioral science principles and theory to medical technical skills education given the recent advances in the theories in the field of behavioral psychology and statistics. CONCLUSIONS: While validation of the individual simulation tools is important, it is only one piece of a multimodal curriculum that in and of itself deserves examination and study. We propose concurrent validation throughout the design of simulation-based curriculum rather than once it is complete. We embrace the concept that validity and curriculum development are interdependent, ongoing processes that are never truly complete. Individual predictive, construct, content, and face validity aspects should not be considered separately but as interdependent and complementary toward an end application. Such an approach could help guide our acceptance and appropriate application of these exciting new training and assessment tools for technical skills training in medicine.

The unique character of involvement in multi-site evaluation settings.

As the number of large federal programs increases, so, too, does the need for a more complete understanding of how to conduct evaluations of such complex programs. The research literature has documented the benefits of stakeholder participation in smaller-scale program evaluations. However, given the scope and diversity of projects in multi-site program evaluations, traditional notions of participatory evaluation do not apply. The purpose of this research is to determine the ways in which stakeholders are involved in large-scale, multi-site STEM evaluations. This article describes the findings from a survey of 313 program leaders and evaluators and from follow-up interviews with 12 of these individuals. Findings from this study indicate that attendance at meetings and conferences, planning discussions within the project related to use of the program evaluation, and participation in data collection should be added to the list of activities that foster feelings of evaluation involvement among stakeholders. In addition, perceptions of involvement may vary according to breadth or depth of evaluation activities, but not always both. Overall, this study suggests that despite the contextual challenges of large, multi-site evaluations, it is feasible to build feelings of involvement among stakeholders.

A new evaluation tool to obtain practice-based evidence of worksite health promotion programs.

INTRODUCTION: The Centers for Disease Control and Prevention developed the Swift Worksite Assessment and Translation (SWAT) evaluation method to identify promising practices in worksite health promotion programs. The new method complements research studies and evaluation studies of evidence-based practices that promote healthy weight in working adults. METHODS: We used nationally recognized program evaluation standards of utility, feasibility, accuracy, and propriety as the foundation for our 5-step method: 1) site identification and selection, 2) site visit, 3) post-visit evaluation of promising practices, 4) evaluation capacity building, and 5) translation and dissemination. An independent, outside evaluation team conducted process and summative evaluations of SWAT to determine its efficacy in providing accurate, useful information and its compliance with evaluation standards. RESULTS: The SWAT evaluation approach is feasible in small and medium-sized workplace settings. The independent evaluation team judged SWAT favorably as an evaluation method, noting among its strengths its systematic and detailed procedures and service orientation. Experts in worksite health promotion evaluation concluded that the data obtained by using this evaluation method were sufficient to allow them to make judgments about promising practices. CONCLUSION: SWAT is a useful, business-friendly approach to systematic, yet rapid, evaluation that comports with program evaluation standards. The method provides a new tool to obtain practice-based evidence of worksite health promotion programs that help prevent obesity and, more broadly, may advance public health goals for chronic disease prevention and health promotion.

Empirical analysis of current approaches to incidental findings.

This paper presents results found through searching publicly available U.S. data sources for information about how to handle incidental findings (IF) in human subjects research, especially in genetics and genomics research, neuroimaging research, and CT colonography research. We searched the Web sites of 14 federal agencies, 22 professional societies, and 100 universities, as well as used the search engine Google for actual consent forms that had been posted on the Internet. Our analysis of these documents showed that there is very little public guidance available for researchers as to how to deal with incidental findings. Moreover, the guidance available is not consistent.

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.