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The Society for Behavioral Medicine (SBM) urges restoration of Centers for Disease Control and Prevention (CDC) funding for firearms and gun violence prevention research. Gun violence in the United States is an important and costly public health issue in need of research attention. Unfortunately, there have been no concerted CDC-funded research efforts in this area since 1996, due to the passage of the Dickey Amendment. To remedy the information-gathering restrictions caused by the Dickey Amendment bans, it is recommended that Congress remove 'policy riders' on federal appropriations bills that limit firearms research at the CDC; expand NVDRS firearms-related data collection efforts to include all fifty states; fund CDC research on the risk and protective factors of gun use and gun violence prevention; fund research on evidence-based primary, secondary, and tertiary prevention and treatment initiatives for communities that are seriously impacted by the effects of gun violence; and support the development of evidence-based policy and prevention recommendations for gun use and ownership.

The parallel rise of pervasive data collection platforms and computational methods for collecting, analyzing, and drawing inferences from large quantities of user data has advanced social computing research, investigating digital traces to understand mediated behaviors of individuals, groups, and societies. At the same time, methods employed to access these data have raised questions about ethical research practices. This article provides insights into U.S. institutional review boards' (IRBs) attitudes and practices regulating social computing research. Through descriptive and inferential analysis of survey data from staff at 59 IRBs at research universities, we examine how IRBs evaluate the growing variety of studies using pervasive digital data. Findings unpack the difficulties IRB staff face evaluating increasingly technical research proposals while highlighting the belief in their ability to surmount these difficulties. They also indicate a lack of consensus among IRB staff about what should be reviewed and a willingness to work closely with researchers.

Recent revisions to international legislation and guidelines on the care and use of animals in research and testing emphasise the importance of minimising suffering and improving welfare. Achieving this requires effective systems for recognising, recording, analysing and assessing animal behaviour, in order to identify relevant indicators of pain, suffering, distress or lasting harm so that any suffering can be rapidly recognised and ameliorated. Behavioural researchers can assist by disseminating information on developments in techniques and approaches for recognising, observing, monitoring, analysing and interpreting behaviour, both within their own facilities and more widely. They can also help to facilitate better welfare assessment by continuing to develop systems for measuring behaviours - including indicators of positive welfare - while also ensuring that harms within behavioural research are minimised., (Copyright © 2014 Elsevier B.V. All rights reserved.)

Social media Websites (SMWs) are increasingly popular research tools. These sites provide new opportunities for researchers, but raise new challenges for Institutional Review Boards (IRBs) that review these research protocols. As of yet, there is little-to-no guidance regarding how an IRB should review the studies involving SMWs. The purpose of this article was to review the common risks inherent in social media research and consider how researchers can consider these risks when writing research protocols. We focused this article on three common research approaches: observational research, interactive research, and survey/interview research. Concomitant with these research approaches, we gave particular attention to the issues pertinent to SMW research, including privacy, consent, and confidentiality. After considering these challenges, we outlined key considerations for both researchers and reviewers when creating or reviewing SMW IRB protocols. Our goal in this article was to provide a detailed examination of relevant ethics and regulatory issues for both researchers and those who review their protocols.

Debriefing is a standard ethical requirement for human research involving the use of deception. Little systematic attention, however, has been devoted to explaining the ethical significance of debriefing and the specific ethical functions that it serves. In this article, we develop an account of debriefing as a tool of moral accountability for the prima facie wrong of deception. Specifically, we contend that debriefing should include a responsibility to promote transparency by explaining the deception and its rationale, to provide an apology to subjects for infringing the principle of respect for persons, and to offer subjects an opportunity to withdraw their data. We also present recommendations concerning the discussion of deception in scientific articles reporting the results of research using deception.

Purpose/objectives: To describe a process for, response rates of, and indicated interest in recruiting patients with breast cancer and their spouses and family members from a clinical setting into behavioral and psychiatric research studies since the Health Insurance Portability and Accountability Act (HIPAA) regulations have taken effect., Data Sources: Published articles, books and book chapters, MEDLINE, government agency information and HIPAA regulatory Web sites, and survey data., Data Synthesis: Response rates among the three target groups--patients, spouses and partners, and female first-degree relatives--were 77%, 95%, and 88%, respectively. Interest was high in the three target groups, with 77%, 87%, and 65% of responding patients, spouses and partners, and female first-degree relatives, respectively., Conclusions: Taken together, these data indicate that high participation rates can be expected from patients with breast cancer and their families in clinical settings., Implications for Nursing: Regulations pose barriers to patient and family recruitment, but thoughtful systems actually can improve rates of recruitment.

Participants in substance abuse research may be vulnerable for multiple reasons. International research ethics guidelines and policy statements require that researchers provide extra protections when conducting research with vulnerable subjects, but it is uncertain which measures best protect vulnerable individuals. Concerns about vulnerability have been translated into only the vaguest regulatory requirements, and very little empirical data exist to guide researchers and ethics review committee members who want to protect participants. This article reviews two bodies of substance abuse research ethics literature. First, "normative" articles, that is, articles that discuss ethical issues that may arise in substance abuse research, are discussed. The resulting taxonomy of ethical issues then guides a review of empirical studies on issues like the informed consent process and the use of financial incentives in substance abuse research. While the ethical issues in substance abuse research are numerous and well-documented, the evidentiary base for addressing these issues is inadequate. If any one major theme emerged from the existing studies, it is that many well-intentioned, protectionist concerns--about recruitment incentives, consent comprehension, and drug administration studies--are not supported by empirical data. While these findings are at best tentative, they suggest how research on research ethics might ultimately benefit participants.

This paper argues that recent ethics research guidelines fit poorly onto the kinds of research undertaken in the humanities, where a research conversation often forms a distinctive method of investigation that has no scientific equivalent. The NH&MRC ethics guidelines pay little attention to the issues raised in humanities and social science research. Also, ethics committees are constituted primarily to look at ethical issues that arise from medical and scientific research, causing extra problems for those in the humanities and social sciences.

Evidence exists that behavioral and social science researchers have been frustrated with regulations and institutional review boards (IRBs) from the 1970s through today. Making matters worse, many human participants protection instruction programs--now mandated by IRBs--offer inadequate reasons why researchers should comply with regulations and IRBs. Promoting compliance either for its own sake or to avoid penalties is contrary to the developmental aims of moral education and may be ineffective in fostering the responsible conduct of research. This article explores the concept of professional virtue and argues that compliance is capable of becoming a professional virtue like scientific honesty. This requires, however, that regulatory and IRB demands contribute to human well-being and to the aims of research as a profession and that researchers, therefore, internalize the norms that underlie regulatory and IRB demands. This, in turn, requires a series of changes in the way society develops, promulgates, and enforces regulatory and IRB rules. The challenge is, simply put, to embed compliance into the world of living morality.

The federal regulations of human research were written to permit the use of discretion so that research can fit the circumstances under which it is conducted. For example, the researcher and institutional review board (IRB) could waive or alter some informed consent elements if they deem this the morally and scientifically best way to conduct the research. To do so, however, researchers and IRBs would first have to use mature moral and scientific judgment. They might also have to rely on empirical research to discover the most effective way to act on their moral sense (e.g., to discover how best to approach potential research participants and explain the nature and purpose of the research participation for which they are being recruited, to ensure comprehension and competent decision making). On discovering the most ethical way to proceed, they would then need to look to the federal regulations of human research to discover how to document their decision and justify it within that somewhat flexible regulatory structure. Unfortunately, many IRBs and researchers fail to take these sensible steps to solve ethical problems and proceed immediately to a default requirement of the regulations that places science at odds with the regulations and, ostensibly, with ethics. The following articles in this special issue are about the process of learning to engage in ethical problem solving and using the flexibility permitted by the federal regulations. These articles extricate researchers from the mindset that has gotten them into trouble, and, ideally, provoke them to use mature common sense and moral judgment.

Without any systematic data or evidence of a problem, or even a thoughtful analysis of costs and benefits, the application of the human participant review system within universities is overreaching at the same time that some risky experimentation on humans outside of universities is unregulated. This article questions the purpose, feasibility, and effectiveness of current IRB approaches to most "2 people talking" situations and proposes scaling back the regulatory system to increase respect accorded it by researchers and its ability to protect human participants of research from real versus imagined harms. In too many cases, the focus is on form over ethical substance: counting what can be counted, rather than focusing instead on what counts. Some disciplines--oral history and journalism, for example--simply do not belong within the scope of institutional review board jurisdiction. Others, such as survey research, informational interviews, and informal interactions, call for a shift from centralized review to more departmentally based (i.e., rooted in disciplinary ethics) oversight, and clearer guidelines on what requires advance review as opposed to provision of post hoc complaint systems.

Ethics is normative; ethics indicates, in broad terms, what researchers should do. For example, researchers should respect human participants. Empirical study tells us what actually happens. Empirical research is often needed to fine-tune the best ways to achieve normative objectives, for example, to discover how best to achieve the dual aims of gaining important knowledge and respecting participants. Ethical decision making by scientists and institutional review boards should not be based on hunches and anecdotes (e.g., about such matters as what information potential research participants would want to know and what they understand, or what they consider to be acceptable risks). These questions should be answered through empirical research. Some of the preceding articles in this special issue illustrate uses of empirical research on research ethics. This article places empirical research on research ethics into broader perspective and challenges investigators to use the tools of their disciplines to proactively solve ethical problems for which there currently exist no empirically proven solutions.

Recruiting adolescents into smoking cessation studies is challenging, particularly given institutional review board (IRB) requirements for research conducted with adolescents. This article provides a brief review of the federal regulations that apply to research conducted with adolescents, and describes researchers' experiences of seeking IRB approval for youth cessation research. Twenty-one researchers provided information. The most frequently reported difficulty involved obtaining parental consent. Solutions to commonly reported problems with obtaining IRB approval are also identified. Waivers of parental consent can facilitate recruitment of youths into studies; however, researchers must ensure that their protocols comply with federal regulations when requesting a waiver.

Many critics of U.S. regulation to protect human subjects of biomedical and behavioral research deem the system inherently unworkable and variously inadequate or unnecessary. Many deem its rationale, the Belmont Report, outdated and philosophically deficient. Some would scrap or revamp the system. These criticisms and prescriptions are challenging factually, legally, and ethically. Similar minimalist, audited self-regulation operates smoothly elsewhere in life science. Events suggest Belmont's continuing validity in its administrative-law role as interpretive touchstone for human subjects protection regulations. U.S. human subjects protection and related regulations are constitutionally grounded and consistent with U.S. obligations under human rights law. Criticisms that the system is inconvenient do not respond to ethical and legal duties--to acknowledge the innate dignity of human subjects of research, to recognize and squarely face ethical issues in human subjects research, to heed applicable domestic and international law, to say no to projects when no is warranted, to foster researcher involvement in the system, to focus on substance rather than form, and to resist automaticity. If the system is to function protectively and reasonably efficiently, then the legitimacy of the pertinent law and Belmont's legal role should be recognized as the primary resource for interpreting the human subjects regulations; the system and proposed changes should be viewed critically for efficacy rather than convenience; and policy and practice should emphasize (a) predictability, stability, and clarity of the regulatory system, and (b) resources and will to comply and enforce.

Biobehavioral research, especially that which is conducted with prisoners, has become much more closely regulated in the last 30 years. State and federal law, as well as professional standards, regulate the conduct of many types of research; in the case of prisoners, this regulation is even more stringent. However, currently no mandatory, uniform, national regulatory or oversight process exists, and many privately funded research endeavors are operating in a regulatory void. In response to this, the National Bioethics Advisory Commission has argued for the creation of a single, national, independent regulatory body to oversee all human participant research, regardless of funding source. As ethicolegal research standards evolve alongside advances in science and technology, an appreciation of the history of prisoner research and an awareness of current standards is critical to conducting ethical prison research., (Copyright 2003 John Wiley & Sons, Ltd.)

Every state and the federal government collects DNA from convicted individuals for certain crimes. Furthermore, most states participate in the Federal Bureau of Investigation's Combined DNA Identification System, which allows states to share criminal DNA records for solving crimes. Some commentators claim that the statues that authorize this practice also would allow the government to use criminal DNA samples or records in medical or behavioral research. A careful reading of the statutes reveals that these assertions are either wrong or exaggerated. Only one state allows for medical research with records, and no state allows medical or behavioral research with DNA samples. This note explains that the DNA samples, not the DNA records, are needed in order to conduct medical or behavioral research. Moreover, this note shows that the statutory phrases "law enforcement purposes," "other humanitarian purposes," and "research" into quality control or protocol probably do not authorize medical or behavioral research.

This study explored children's understanding of their research rights in the context of an investigation of how children cope with peer provocation. Participants were 178 children (97 girls and 81 boys) who had finished the second, fourth, and sixth grades (average ages: 8, 10, and 12, respectively). After children agreed to take part in research on "how kids get along together," as well as after debriefing, their perceptions of free assent, their understanding of what they would be doing and why, their belief in voluntary participation and freedom to withdraw, and their comprehension of confidentiality were assessed. The vast majority of participants gave assent freely and reported no undue pressure from their families or the experimenters to participate. Older children knew before participating in the research what their participation would involve, comprehended confidentiality, and understood the study's purpose after their participation, but second graders were less likely to understand these issues than fourth and sixth graders were. Following debriefing, children's understanding of their research rights was largely unchanged; most children still had difficulty describing the research goals.

As Internet resources are used more frequently for research on social and psychological behavior, concerns grow about whether characteristics of such research affect human subjects protections. Early efforts to address such concerns have done more to identify potential problems than to evaluate them or to seek solutions, leaving bodies charged with human subjects oversight in a quagmire. This article critiques some of these issues in light of the US Code of Federal Regulations' policies for the Protection of Human Subjects, and argues that some of the issues have no pertinence when examined in the context of common methodological approaches that previous commentators failed to consider. By separating applicable contexts from those that are not, and by identifying cases where subjects' characteristics are irrelevant and/or impossible to provide, oversight committees may be able to consider research applications more appropriately, and investigators may be less ethically bound to ascertain and demonstrate those characteristics.