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.     

The Future of Incidental Findings: Should They be Viewed as Benefits?

This paper argues against considering incidental fndings (IFs) as potential benefts of research when assessing the social value of proposed research, determining the appropriateness of a study's risk/beneft ratio, and identifying and disclosing the risks and benefts of participation during informed consent. The possibility of generating IFs should be disclosed during informed consent as neither a risk nor beneft, but as a possible outcome collateral to participation. Whether specifc IFs will be disclosed when identifed is a separate question whose answer is material to determining whether IFs constitute a risk or a potential indirect beneft of participation. Finally, three types of IF should be distinguished and treated diferently during informed consent: those that will be routinely generated (e.g., results of testing to determine study eligibility), those that can reasonably be characterized in terms of their nature and frequency of generation (e.g., misattributed parentage), and those of unpredictable nature and frequency that can be characterized only in general terms. Research protocols should provide a rationale for sharing or not sharing IFs of these three types with participants. Regulatory review of such plans should not, however, be confused with regarding IFs as potential benefts when assessing the study's risk/beneft ratio or merit.     

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.     

The Management of Incidental Findings in Neuro-Imaging Research: Framework and Recommendations

This paper addresses the question of how incidental findings (IFs) in clinical research should be managed by researchers, focusing in detail on IFs discovered in neuroimaging research. It begins by engaging the larger research ethics issue of whether researchers have any obligations of clinical care to participants, and assesses the content and merits of one particular framework for answering this question, Richardson and Belsky's ancillary care model. From here the paper develops an organizational structure for integrating the ancillary care model with existing research ethics standards, with the aim of better understanding their respective domains. It makes a distinction between incidental findings that are anticipated by informed consent documents, and those that are unanticipated, arguing that this distinction is critical for evaluating researcher obligations. Finally, it takes on the issue of incidental findings in neuroimaging research, translating the standards discussed into recommendations for both unanticipated and anticipated findings.     

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.     

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.     

Disclosing Conflicts of Interest in Clinical Research: Views of Institutional Review Boards, Conflict of Interest Committees, and Investigators

Strategies for disclosing investigators' financial interests to potential research participants have been adopted by many research institutions. However, little is known about how decisions are made regarding disclosures of financial interests to potential research participants, including what is disclosed and the rationale for making these determinations. We sought to understand the attitudes, beliefs, and practices of institutional review board chairs, conflict of interest committee chairs, and investigators regarding disclosure of financial interests to potential research participants. Several themes emerged, including general attitudes toward conflicts of interest, circumstances in which financial interests should be disclosed, rationales and benefits of disclosure, what should be disclosed, negative effects of and barriers to disclosure, and timing and presentation of disclosure. Respondents cited several rationales for disclosure, including enabling informed decision making, promoting trust in researchers and research institutions, and reducing legal liability. There was general agreement that disclosure should happen early in the consent process. Respondents disagreed about whether to disclose the amounts of particular financial interests. Clarifying the goals of disclosure and understanding how potential research participants use the information will be critical in efforts to ensure the integrity of clinical research and to protect the rights and interests of participants.     

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?     

Incidental findings in pediatric research

The approach to incidental research findings in children emerges by considering the child-parent relationship and balancing divergent interests and preferences. Incidental findings with clear and proximate clinical importance should be disclosed to both. We recommend that particularly sensitive or private information (e.g., pregnancy or drug use) should be disclosed to the adolescent first, while particularly serious information (e.g., cancer) should first be disclosed to the parent. These approaches allow the researcher to form an alliance with one party prior to engaging the other. However, unlike clinical settings, where there may be presumptive expectations of confidentiality about sharing information within the family, in most research settings it is reasonable to plan to disclose such information to both parties. It is important to communicate this plan during the informed consent process separately to adolescents to avoid enrolling adolescents when sensitive incidental findings such as pregnancy and drug use may be detected. The approach to incidental findings without clear and proximate benefit is challenging. Researchers should plan more limited disclosure of such incidental findings for pediatric participants than for adult participants.     

Factors associated with escalation and problematic approaches toward public figures

Detailed comparison of factors associated with abnormal approach to the prominent and with escalation from communication to approach has not hitherto been undertaken. This partially reflects the failure of individual studies to adopt compatible terminologies. This study involves a careful dissection of six public figure studies, three involving U.S. politicians, two Hollywood celebrities, and one the British Royal Family. Common findings were unearthed across six headings. Approachers were significantly more likely to exhibit serious mental illness, engage in multiple means of communication, involve multiple contacts/targets, and to incorporate into their communication requests for help. They were significantly less likely to use threatening or antagonistic language in their communications, except in those cases involving security breaches. These results emphasize the importance of integrating mental health findings and preventive measures into risk management. Approach should not be regarded as a single behavioral category and has multiple motivations. Future studies should adopt standard terminology, preferably taken from the general stalking research.     

Incidental findings in human subjects research: what do investigators owe research participants?

The use of brain imaging technology as a common tool of research has spawned concern and debate over how investigators should respond to incidental findings discovered in the course of research. In this article, we argue that investigators have an obligation to respond to incidental findings in view of their entering into a professional relationship with research participants in which they are granted privileged access to private information with potential relevance to participants' health. We discuss the scope and limits of this professional obligation to respond to incidental findings, bearing in mind that the relationship between investigators and research participants differs fundamentally from the doctor-patient relationship.     

Reactions to participating in dating violence research: are our questions distressing participants?

In recent years, there has been increased research focus on dating violence, producing important information for reducing these violent relationships. Yet Institutional Review Boards (IRBs) are often hesitant to approve research on dating violence, citing emotional distress of participants as a possible risk of participation. However, no known research has examined the reactions of research participants to questions about dating violence. The current study examined the reactions among college students to completing a self-report measure on dating violence. Results showed that participants reported numerous positive experiences as a result of their research participation, with only mildly increased negative emotional reactions evident for some. Findings are discussed in relation to IRB proposals and appropriate informed consent for research participants.     

Predicting differences in the perceived relevance of crime's costs and benefits in a test of rational choice theory

Previous hypothetical scenario tests of rational choice theory have presented all participants with the same set of consequences, implicitly assuming that these consequences would be relevant for each individual. Recent research demonstrates that those researcher-presented consequences do not accurately reflect those considered by study participants and that there is individual variation in the relevance of various consequences. Despite this and some theoretical propositions that such differences should exist, little empirical research has explored the possibility of predicting such variation. This study allows participants to develop their own set of relevant consequences for three hypothetical offenses and examines how several demographic and theoretical variables impact those consequences' relevance. Exploratory results suggest individual factors impact the perceived relevance of several cost and benefit types, even among a relatively homogenous sample of college students. Implications for future tests of rational choice theory, as well as policy implications are discussed.     

Microcredit and Marital Violence: Moderating Effects of Husbands’ Gender Ideology

Evidence on the relation between women’s microcredit participation and their exposure to marital violence has been inconsistent across studies. This study examined how women’s various levels of microcredit participation are associated with marital violence against women (MVW), while also taking into account the husbands’ gender ideology. The study included 243 wife-abusive men in rural Bangladesh. Multiple regressions were performed to predict the frequency of MVW in the preceding year. Of the married women, 52.3 % were microcredit participants, 11.1 % of whom were active participants and 41.2 % nominal participants. The study showed that women’s active microcredit participation was negatively associated with MVW, and nominal participation was positively associated with MVW among the husbands who held a more conservative gender ideology. The findings suggest that women-focused microcredit interventions should also take into account men’s gender ideologies.     

Consent forms in genomics: the difference between law and practice

Consent forms are the principal method for obtaining informed consent from biomedical research participants. The significance of these forms is increasing as more secondary research is undertaken on existing research samples and information, and samples are deposited in biobanks accessible to many researchers. We reviewed a selection of consent forms used in European Genome-Wide Association Studies (GWAS) and identified four common elements that were found in every consent form. Our analysis showed that only two of the four most commonly found elements in our sample of informed consent forms were required in UK law. This raises questions about what should be put in informed consent forms for research participants. These findings could be beneficial for the formulation of participant information and consent documentation in the future studies.     

Students’ self‐assessment in law

Abstract

THIS STUDY is about second‐year students’ self‐assessment in law. Its aims were to test how closely the assessment by the students of their own work matched that of their tutor, to give the students an insight into the “marking process” (which research has shown improves learning), to help the students excel in their examination, to find out whether the male students did better than the female students in their assignment and subsequent examination, and to see how far staff time could be saved. The following were found: there was a high level of agreement between the students’ own marks and those of the tutor, there was generally no significant over‐estimation of assignment marks by the students, the participants did better than the non‐participants in the subsequent examination, the female students did much better than the male students in the assignments as well as the examination (although the participants in general did not do better in their examination than they did in their assignment) and considerable staff time was saved. The findings are discussed in the light of previous research.     

On Justice Knowledge Activation: Evidence for Spontaneous Activation of Social Justice Inferences

This article focuses on how people infer the justness of events they encounter. Earlier justice research typically asked participants explicitly for their justice judgments. More recent research provided evidence for the possibility of spontaneous judgment inferences. The present research extends this study in three important ways: it provides strong evidence that (1) spontaneous social justice inferences can occur in multiple research paradigms, (2) these inferences constitute a process separate from spontaneous general evaluation of valence, and (3) spontaneous justice inferences covary with individual differences in sensitivity to justice. We provide evidence for these three conclusions by means of important implicit measurement research paradigms that we specifically tailored to study justice inferences: the probe recognition paradigm and the grid-relearning paradigm. We discuss the implications of our findings for both the literatures on justice and spontaneous inferences.     

Researcher liability for negligence in human subject research: informed consent and researcher malpractice actions

Two sets of federal regulations, the "Common Rule" and Food and Drug Administration (FDA) regulations, govern human subject research that is either federally-funded or involves FDA regulated products. These regulations require, inter alia, that: (1) researchers obtain informed consent from human subjects, and (2) that an Institutional Review Board (IRB) independently review and approve the research protocol. Although the federal regulations do not provide an express cause of action against researchers, research subjects should be able to bring informed consent and malpractice actions against researchers by establishing a duty of care and standard of care. Researchers owe human subjects a duty of care analogous to the special relationship between physicians and patients. The federal regulations should provide the minimum standard of care for informed consent in human subject research, and complying with them should be a partial defense. In contrast, expert testimony should establish the standard of care for researcher malpractice, and IRB approval should be a partial defense.     

Social Support and Disclosure of Abuse: Comparing South Asian, African American, and Hispanic Battered Women

Sixty-two battered women who had accessed domestic violence services were asked to whom they disclosed the partner abuse, the responses they received, and how supported they felt by kin and nonkin network members. The findings showed that older women and those who had resided in the United States longer were more likely to make disclosures to kin members. Older women, those who had higher levels of perceived social support, and those who reported lower frequency of physical violence were more likely to disclose to nonkin members. The findings suggest that those women experiencing more severe abuse may be the least likely to disclose to others. As a group, the South Asian women were older and more educated, and greater proportions were or had been married to the abuser. In contrast to the other groups, a greater proportion reported having been burned or scalded and fewer reported being sexually coerced. In greater proportions, they disclosed the abuse to brothers and fathers and were advised to stay in their marriages. Service providers working with minority battered women must be knowledgeable of cross-cultural differences in the experience of abuse and disclosure patterns. Culturally appropriate and aggressive outreach within specific ethnic communities may be required to reach battered women in the community. Service providers must consider working with members of women's informal support network to provide both emotional and instrumental support.     

Intimate Partner Violence and Female Nurses’ Employment: Disclosure and Consequences

The study examined the relationship between women’s disclosure of intimate partner violence and their experience of employment interference, work-related consequences, and work participation in 140 nurses. Participants reported experiencing at least one employment interference tactic and 40 % of them disclosed their experience. Employment interference, work-related consequences, and work participation did not differ between nurses who disclosed violence/employment interference and those who did not. Further, our participants may have chosen to disclose employment interference in order to express their discomfort rather than to seek assistance or advice. Distribution of power governed by gender is an obstacle facing women in Jordan, limiting the extent to which they can be protected from experiencing IPV in the workplace.