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Background: Laboratory data can provide a wide range of information to estimate adherence to guidelines and proper utilization of genetic testing. The methylene tetrahydrofolate reductase (MTHFR) C677T variant has been demonstrated to have negligible utility in patient management. However, the testing of this variant remains pervasive. The purpose of this study was to develop methods to analyze concordance of clinician ordering practices with national guidelines. Methods: We used laboratory data to extract specific data elements including patient demographics, timestamps, physician ordering logs and temporal relationship to chemistry requests to examine 245 consecutive MTHFR tests ordered in 2011 at an academic tertiary center. A comprehensive chart review was used to identify indications for testing. These results were correlated with a retrospective analysis of 4,226 tests drawn at a range of hospitals requesting testing from a national reference laboratory over a 2 year period. MTHFR ordering practices drawn from 17 institutions were examined longitudinally from 2002 to 2011. Results: Indications for testing included cerebrovascular events (40.0%) and venous thrombosis (39.1%). Family history prompted testing in eight cases. Based on acceptable hypercoagulability guidelines recommending MTHFR C677T testing only in the presence of elevated serum homocysteine, 10.6% (22/207) of adult patients met an indicated threshold at an academic tertiary center. Among 77 institutions, 14.5% (613/4226) of MTHFR testing met recommendations. Conclusion: We demonstrate an effective method to examine discreet elements of a molecular diagnostics laboratory information system at a tertiary care institution and to correlate these findings at a national level. Retrospective examination of clinicians' request of MTHFR C677T genetic testing strongly suggests that clinicians have failed to adjust their ordering practices in light of evolving scientific and professional organization recommendations. [ABSTRACT FROM AUTHOR]

Based on the beliefs that human life and pregnancy begin at conception, that human life has equal moral value regardless of its development stage or form, and that emergency contraception (EC) has mechanisms of action that may induce abortion, Catholic health care facilities are not permitted to provide EC to rape victims if any possibility exists that a woman may have conceived due to her rape, even if that possibility is unverifiable. The Catholic Church claims that the mechanism of action of EC is uncertain and that some studies have concluded that disruption of implantation, which the Church considers to be abortion, may occur. Drawing on insights from feminist epistemology (e.g. work by Helen Longino) and arguments at the intersection of bioethics and philosophy of science (including work by Robert Veatch and Grant Gillett), we argue that the Church's position on this matter is based on uncertain (and misinterpreted) scientific claims and that particular normative (moral and theological) commitments on the part of those wielding power over Church Law lead to a weighing of probabilities in a manner consonant with the preservation of that power. In this paper, we examine how normative commitments infuse or infect the assessment of probability and influence ethical policy. We also examine how probabilism, a moral method that operates within the constraints of Catholic normative commitments, offers an alternative approach which respects, acknowledges, and maximizes an individual's ability to determine probable reason for moral action in the face of irreducible uncertainty. [ABSTRACT FROM PUBLISHER]

Conflict of interest (COl) in dentistry is typically thought to arise when a dentist's exercise of professional judgment for the sake of a patient's interest is compromised by a secondary interest such as increase of reputation or financial gain. Disclosure of conflict of interest is often recommended as a remedy to prevent the erosion of the fiduciary relationship and to permit patients to take steps to protect their own interests. Borrowing the concept of a reasonable patient from discussions of disclosure standards for informed consent, this paper offers a patient-centered defini- tion of COl: a CDI exists when the presence of a dentist's secondary interest undermines the reasonableness of a reasonable patient's reliance on his or her dentist's professional judgment. It then argues that disclosure of CDI (modeled on other disclosures during informed consent) is an inadequate remedy for the breach of ethics presented by CDI and an inadequate strategy to prevent harms associated with CDI. It also examines research indicating that disclosure of CDI has perverse effects on the informed consent process and patient decision-making, so that disclosure of CDI actually inhibits patients from taking steps to protect their own welfare. [ABSTRACT FROM AUTHOR]

Focusing on bipolar disorders research, this article considers ethical issues of informed consent and privacy arising in genetic pedigree research at two stages: the construction of tentative pedigrees to determine family eligibility for study and, subsequently, the enrollment of subjects in and conduct of the family study. Increasing concern to protect the privacy of family members of primary subjects or probands, following ethical controversy over a survey study at Virginia Commonwealth University, has led some researchers and Institutional Review Boards (IRBs) to apply informed consent requirements to those represented on a tentative pedigree at the initial stage of research. This article analyzes the possible benefits, risks, and burdens to prospective subjects of seeking prospective consent for pedigree construction at this initial stage. It argues that the likely risk–benefit ratio favors granting a waiver of consent requirements for this stage of pedigree research and presents grounds for IRBs to grant such a waiver. The article closes by considering particular ethical concerns that should be addressed in the informed consent discussion when enrolling subjects in pedigree studies of bipolar disorder, including concerns about subjects' competence to consent, management of interim and incidental findings, and issues particular to psychiatric research. [ABSTRACT FROM AUTHOR]

Focusing on bipolar disorders research, this article considers ethical issues of informed consent and privacy arising in genetic pedigree research at two stages: the construction of tentative pedigrees to determine family eligibility for study and, subsequently, the enrollment of subjects in and conduct of the family study. Increasing concern to protect the privacy of family members of primary subjects or probands, following ethical controversy over a survey study at Virginia Commonwealth University, has led some researchers and Institutional Review Boards (IRBs) to apply informed consent requirements to those represented on a tentative pedigree at the initial stage of research. This article analyzes the possible benefits, risks, and burdens to prospective subjects of seeking prospective consent for pedigree construction at this initial stage. It argues that the likely risk–benefit ratio favors granting a waiver of consent requirements for this stage of pedigree research and presents grounds for IRBs to grant such a waiver. The article closes by considering particular ethical concerns that should be addressed in the informed consent discussion when enrolling subjects in pedigree studies of bipolar disorder, including concerns about subjects' competence to consent, management of interim and incidental findings, and issues particular to psychiatric research. [ABSTRACT FROM AUTHOR]

The use of treatment as usual (TAU) as a control condition may pose the considerable challenge of maintaining both scientific rigor and meeting high ethical standards in experiments on human subjects. The authors illustrate the tension and explore the relationship between research design and ethics, especially the interaction between the two, in the NIMH-funded PROSPECT study (Prevention of Suicide in Primary Care Elderly – Collaborative Trial). The goal of PROSPECT is to determine whether placement of a depression health specialist in primary care practices will have a favorable impact on rates of depression, hopelessness and suicidal ideation in elderly primary care patients with major or persistent minor depression. PROSPECT randomly assigns practices either to an intervention arm (which includes the provision of depression health specialists) or to an enhanced care arm (TAU, with the addition of screening and assessment services). TAU, enhanced by the provision of screening and assessment services, is to be used as a benchmark for measuring the effectiveness of PROSPECT's intervention. However, TAU in the epidemiological and clinical literature has also been linked to high rates of suicide in the elderly related to unrecognized and untreated or under-treated depression. The authors present their approach to managing the tension, or interaction, between the use of TAU for scientific and public health purposes and the requirement for beneficence, that is, the duty to assure the safety of human subjects in research and to do no harm. Through enhancements of TAU, by the provision of information to primary care physicians concerning the psychiatric status of their patients, the investigators attempt to meet the challenge of maintaining rigor and meeting high ethical standards. Copyright © 2001 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Right to privacy of health-related information is a foundational bioethical principle. In India, the importance of protecting privacy is included in law and ethical guidelines. Institutional Ethics Committees (IECs) are entrusted with the responsibility of protecting fundamental ethical principles, including privacy and confidentiality. The present qualitative study was designed to understand IECs' privacy-related obligations and the members' experience in implementing ethical guidelines and privacy protections in their institutions. An interview guide was prepared regarding knowledge of ethical guidelines. Interviews of nineteen IEC members were recorded, transcribed, and translated. Interviews were analysed using thematic analysis. Themes related to these issues were extracted after analysis: awareness, understanding, and implementation of ethical guidelines; understanding of privacy-related obligations and their implementation; and juridical risks to privacy of patients and research participants. The results suggest that training programmes and awareness workshops should be organised for IEC members to protect the rights of research participants, especially in confidentiality issues.

Background: All health professionals are morally bound to recognize and address ethical issues in their daily practice. Understanding basics of bioethics can help professionals promote autonomy and protect the welfare of both patients and research participants. As part of the Fogarty International Center, NIH, USA, funded "Training Program for Psychiatric Genetics in India," NNM was trained in bioethics at University of Pittsburgh under the mentorship of Lisa S Parker, PhD., Objectives: The overall goal of this Tutorial project was to translate NNM's Ethics training for hospital-based Indian health professionals to sensitize them to the ethical issues arising in psychiatric research and practice., Methodology: After receiving official permission from the medical superintendent of PGIMER-Dr. R.M.L. Hospital, New Delhi, the program was announced. Candidates with a degree in one of the Health Care Sciences were enrolled. Five two-hour interactive sessions were held weekly on five topics. An evaluation of the effectiveness of the interactive tutorial program was conducted., Results: A total of 16 participants enrolled in these tutorials. The post-program evaluation of satisfaction for all topics of the program by participants indicated high mean score. The main need identified was for continued refreshing of bioethical knowledge and skills through academic activities.

Privacy is a key component of individual autonomy, and a voluminous literature has established both its practical value in healthcare contexts and its status as a fundamental, but not absolute ethical right. Because the Right to Information Act (2005) permits citizens to gain information under government control, it might be thought to threaten the privacy of patients and research subjects, especially those in government institutions. It is important for clinicians, administrators, information officers, patients, and research subjects to understand that the RTI Act generally does not require or permit disclosure of personal health information to third parties. Only under unusual circumstances when the larger public interest is properly certified to warrant it, would information shared or created within the fiduciary relationships of clinical care or research be required to be disclosed. Against this background concerning the right to privacy and the RTI Act, we consider a 2007 legal case that used the RTI Act to expose patient information of a public official and argue that the "public interest" claimed in this case did not justify disclosure of the official's private health information. We conclude that the provisions of the RTI Act, when properly interpreted, are compatible with the important value of safeguarding patient privacy.

Conflict of interest (COI) in dentistry is typically thought to arise when a dentist's exercise of professional judgment for the sake of a patient's interest is compromised by a secondary interest such as increase of reputation or financial gain. Disclosure of conflict of interest is often recommended as a remedy to prevent the erosion of the fiduciary relationship and to permit patients to take steps to protect their own interests. Borrowing the concept of a reasonable patient from discussions of disclosure standards for informed consent, this paper offers a patient-centered definition of COI: a COI exists when the presence of a dentist's secondary interest undermines the reasonableness of a reasonable patient's reliance on his or her dentist's professional judgment. It then argues that disclosure of COI (modeled on other disclosures during informed consent) is an inadequate remedy for the breach of ethics presented by COI and an inadequate strategy to prevent harms associated with COI. It also examines research indicating that disclosure of COI has perverse effects on the informed consent process and patient decision-making, so that disclosure of COI actually inhibits patients from taking steps to protect their own welfare.