Suchergebnisse

Research misconduct involving noncompliance in human subjects research supported by the Public Health Service : reconciling separate regulatory systems / Barbara E. Bierer and Mark Barnes, on behalf of the IRB/RIO/IO Working Group -- Why guidance comes from the research community / David E. Wright -- The irregular terrain of human subjects research regulations / David Forster, Daniel K. Nelson, David Borasky, and Jeffrey R. Botkin -- The third-party notification dilemma / Ann K. Adams -- Parallel processes at the NIH / Sally J. Rockey and Amy P. Patterson -- Public trust and institutional culture / Alexander M. Capron, Elisa A. Hurley, and Amy L. Davis

"Online surveys and interviews, the observations of chat rooms or online games, data mining, knowledge discovery in databases (KDD), collecting biomarkers, employing biometrics, using RFID technology -even as implants in the human body- and other related processes all seem to be more promising, cheaper, faster, and comprehensive than conventional methods of human subjects research. But at the same time these new means of gathering information may pose powerful threats to privacy, autonomy, and informed consent. Online research, particularly involving children and minors but also other vulnerable groups such as ethnic or religious minorities, is in urgent need of an adequate research ethics that can provide reasonable and morally justified constraints for human subjects research. The paper at hand seeks to provide some clarification of these new means of information gathering and the challenges they present to moral concepts like privacy, autonomy, informed consent, beneficence, and justice. Some existing codes of conduct and ethical guidelines are examined to determine whether they provide answers to those challenges and/or whether they can be helpful in the development of principles and regulations governing human subjects research. Finally, some conclusions and recommendations are presented that can help in the task of formulating an adequate research ethics for human subjects research." [author's abstract]

Testimony issued by the General Accounting Office with an abstract that begins "At the federal level the Department of Health and Human Services (HHS) is seeking to better protect human subjects in biomedical research by enhancing the visibility of its human subjects protection activities, improving its monitoring of compliance with relevant regulations by institutions and investigators, and strengthening enforcement of those regulations. HHS has also issued new guidance and is collecting information to improve oversight and monitoring at the institutional level. HHS activities directed at the investigator level consist largely of educational efforts to heighten investigators' awareness of and compliance with ethical policies and practices in conducting research. Overall, HHS' actions appear promising, but GAO has some concerns about the pace and scope of HHS' efforts to ensure the safety and protection of participants in clinical trials."

The outsourcing and offshoring of clinical trials has generated an unprecedented global field of experimental activity. The geography of drug development and clinical trial participation is changing, but estimates of trials being carried out worldwide remain tentative at best. This essay charts the mobility of the clinical trials industry and its move into low‐ and middle‐income countries. It explores how subcontracted scientists and entrepreneurs who make up this industry interact with regulatory bodies in the United States and abroad, particularly in eastern Europe, where I carried out ethnographic research. The essay illuminates the scientific, economic, and regulatory mechanisms by which this experimentality takes form. It shows the transparency of this experimental enterprise and how it molds itself to international norms and national politics. There is a public policy vacuum with regard to how benefits and risks are being assessed in this new enterprise.

Researchers often require and collect sensitive information about individuals to answer important scientific questions that impact individual health and well-being and the public health. Researchers recognize they have a duty to maintain the confidentiality of the data they collect and typically make promises, which are documented in the consent form. The legal interests of others, however, can threaten researchers' promises of confidentiality, if they seek access to the data through subpoena. Certificates of Confidentiality (Certificates), authorized by federal statute, are an important tool for protecting individually identifiable sensitive research data from compelled disclosure. However, questions persist in the research community about the strength of Certificate protections, and the evidence on which to judge the strength is scant. In this article, we address those questions through a careful examination of the legislation and regulations concerning Certificates and the reported and unreported cases we have identified through our legal research and interviews with legal counsel about their experiences with Certificates. We also analyze other statutes that protect research data to compare them to the Certificate's protections, and we review other legal strategies available for protecting research data. Based on our analysis, we conclude with recommendations for how to strengthen protection of sensitive research data.

Informed consent is a basic requirement for the conduct of ethical research involving human subjects. Currently, the Helsinki Declaration of the World Medical Association and the International Ethical Guidelines for Biomedical Research of the Council for International Organizations of Medical Sciences (CIOMS) are widely accepted as international codes regulating human subject research and the informed consent sections of these documents are quite important. Debates on the applicability of these guidelines in different socio-cultural settings are ongoing and many workers have advocated the need for national or regional guidelines. Nigeria, a developing country, has recently adopted its national guideline regulating human subject research: The National Health Research Ethics Committee (NHREC) code. A content analysis of the three guidelines was done to see if the Nigerian guidelines confer any additional protection for research subjects. The concept of a Community Advisory Committee in the Nigerian guideline is a novel one that emphasizes research as a community burden and should promote a form of "research friendship" to foster the welfare of research participants. There is also the need for a regular update of the NHREC code so as to address some issues that were not considered in its current version.

An estimated 2.5 million Americans participate in clinical research annually. Participation exposes human subjects to significant physical risks including death, as it often involves ingesting or introducing drugs and devices to the body that have not yet been proven safe or effective. In the US, a set of policies around the regulation of biomedical research emerged as a politically and contextually contingent result in the post-war years. The centerpiece for oversight of human subjects research was the local, hospital- or university-based IRB. It emerged at the height of organized medicine's political and social power and derived from a logic of professional autonomy.Much has changed. Today, 80% of clinical research in the US occurs outside the academic medical context, in community settings such as physicians' offices and freestanding research clinics. These research studies are overseen by thousands of IRBs registered with the federal government, some of which are for-profit businesses. The world for which the oversight regime was built – trained clinical researchers submitting their proposed research to the scrutiny of their trained colleagues in a university setting – no longer exists. In spite of the dramatic changes in who is carrying out research and the associated changes in their motivations for doing so, the regulations governing IRBs and clinical research oversight remain stable. Little empirical scholarship exists regarding how the IRB oversight mechanism is operating now that the research landscape has changed so substantially. Little scholarship empirically charts the entire ecology of IRBs, which now include IRBs in diverse settings such as non-teaching community hospitals, health systems, government facilities, universities and teaching hospitals, as well as independent, central, and commercial IRBs. There exists no full accounting of how many IRBs there are, of which types, in which locations – and few analytical accounts of variations between IRBs based on organizational or environmental factors. This dissertation reports on the results of an original qualitative research study that involved interviews with IRB members and administrative professionals from commercial IRBs, nonprofit healthcare organization IRBs, academic and government IRBs in the US and Canada. The chapters explore various aspects of the current IRB ecology, in light of drastic changes to the institutional and economic environments in which clinical research occurs over recent decades. After a brief introduction, the second chapter explores IRB professionals' experiences with, and responses to, the legal and regulatory environment in which these professionals and their organizations operate. The third chapter explores variation between types of IRBs, identifying governance gaps and best practices. The fourth chapter explores the attitudes of IRB professionals toward the commercialization of research ethics review in the United States and Canada. The fifth chapter provides some conclusions and steps for future research.