Frances Lawrenz

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.

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.Genet Med 2012:14(4):361–384

Research on Evaluation Use A Review of the Empirical Literature From 1986 to 2005

This paper reviews empirical research on the use of evaluation from 1986 to 2005 using Cousins and Leithwood’s 1986 framework for categorizing empirical studies of evaluation use conducted since that time. The literature review located 41 empirical studies of evaluation use conducted between 1986 and 2005 that met minimum quality standards. The Cousins and Leithwood framework allowed a comparison over time. After initially grouping these studies according to Cousins and Leithwood’s two categories and twelve characteristics, one additional category and one new characteristic were added to their framework. The new category is stakeholder involvement, and the new characteristic is evaluator competence (under the category of evaluation implementation). Findings point to the importance of stakeholder involvement in facilitating evaluation use and suggest that engagement, interaction, and communication between evaluation clients and evaluators is critical to the meaningful use of evaluations.

Time series analysis of the effect of a domestic violence directive on the number of arrests per day

Domestic violence is a serious and continuing problem in the United States today. The results of the domestic violence experiment conducted in Minneapolis suggested that arrests were an effective deterrent; however, other data have indicated that the attending officers decision to arrest is dependent on several variables. In an attempt to implement the Minneapolis findings to combat repetitive and increasingly dangerous incidents of domestic violence, a southwestern citys police department issued a directive requiring police officers to arrest one or all of the participants involved in a domestic violence incidence. This study used time series analysis to investigate the effect of that directive on the number of arrests per day. The time series results showed a slight increase in the number of arrests per day and indicated that the directive may have contributed to consistency in the number of arrests. Apparently, determining how to increase arrests in domestic violence situations is a complex issue.

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.

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.

A Collaborative Immersio Approach to Evaluation Capacity Building

The purpose of this article is to describe a new collaborative immersion approach for developing evaluation capacity that was used in kindergarten through Grade 12 (K-12) schools and to place this new approach on a continuum of existing capacity-building methods. The continuum extends from individualistic training-oriented methods to collaborative real-world methods of building evaluation capacity. The strengths and weaknesses of various evaluation capacity building methods are analyzed and critiqued. Included are examples of capacity building focused on technical assistance, workshops, fellowships, and collaborative immersion. The authors make the case for considering a collaborative immersion approach to evaluation capacity building.

Dissemination Handmaiden to Evaluation Use

Use of evaluation findings is a valued outcome for most evaluators. However, to optimize use, the findings need to be disseminated to potential users in formats that facilitate use of the information. This reflective case narrative uses a national evaluation of a multisite National Science Foundation (NSF) program as the setting for describing the evolution of, and strategic planning for, effectively disseminating evaluation findings and recommendations. The program being evaluated is NSFs Advanced Technological Education (ATE) program. The dissemination to more than 200 active ATE projects and other audiences forced the evaluation project to be creative in its approaches. The dissemination strategies are related to two very common types of evaluation information: surveys and site visits. Approaches used include Web postings of various reports, brochures, interactive data displays, guidebooks, and videoconferencing. Advantages and disadvantages in terms of use of the techniques by various audiences are discussed.Use of evaluation findings is a valued outcome for most evaluators. However, to optimize use, the findings need to be disseminated to potential users in formats that facilitate use of the informati...

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.Genet Med 2012:14(4):444–450

Relationships among student, teacher and observer perceptions of science classrooms and student achievement

This study was designed to examine relationships among observer, teacher and student perceptions of what was occurring in US ninth grade science classrooms to better understand the inter-relationships among the different perspectives. Classes were observed by trained observers, and teachers and students were asked to rate how often various activities occurred on a self-report questionnaire. The questionnaire items were factor analysed to determine the underlying factor structure. These measures were then used as independent variables to predict student achievement on a US science standards-based multiple choice test and a US standards-based hands-on laboratory skills test. The findings show that students and teachers view their classes differently although the factor structures had some similarity and that classroom observations conducted by trained observers are the best predictors of student achievement.