Barriers to the release of human tissue for clinical trials research in the UK: a national survey of cellular pathology laboratories on behalf of the National Cancer Research Institute's Cellular Molecular Pathology (CM-Path) initiative.

AIM: To survey UK cellular pathology departments regarding their attitudes and practices relating to release of human tissue from their diagnostic archives for use in clinical trial research. METHODS: A 30-item questionnaire was circulated to the National Cancer Research Institute's Cellular Molecular Pathology initiative and Confederation of Cancer Biobanks mailing lists. Responses were collected over a 10-month period from November 2016 to August 2017. RESULTS: 38 departments responded to the survey, the majority of which regularly receive requests for tissue for research purposes. Most requests come from academia and financial support to facilitate tissue release comes from a variety of sources. A range of practices were reported in relation to selection of the most appropriate sample to release, consent checking, costing and governance frameworks. CONCLUSIONS: This survey demonstrates wide variation in practice across the UK and identifies barriers to release of human tissue for clinical trial research. Until we can overcome these obstacles, patient samples will remain inaccessible to research. Therefore, this study highlights the urgent need for clear and coordinated national guidance on this issue.

I Might Have Some Bad News: Disclosing Preliminary Pathology Results.

Cytopathology is a subspecialty of pathology in which pathologists frequently interact directly with patients. Often this interaction is in the context of fine needle aspiration (FNA) procedures performed at the bedside by the cytopathologist or by another clinician with the cytopathologist present. Patient requests for preliminary results in such settings raise fundamental questions about professional scope of practice and communication of uncertainty that apply not merely to pathologists but to all clinicians. In certain settings, cytopathologists may share preliminary diagnostic impressions directly with patients. Essential to these conversations is the need to articulate potential uncertainty about both the diagnosis and next steps. In addition, the involvement and notification of the referring physician is obligatory, both for care coordination and to ensure that patients receive a consistent message.

Requests for VIP Treatment in Pathology: Implications for Social Justice and Systems-Based Practice.

Preferential treatment of patients whom we deem "very important" is a practice that is common in our health care system. The impact of this designation and the care that results is rarely studied or scrutinized. Although we assume that this type of treatment results in superior outcomes, this assumption can be wrong for a variety of reasons, which we discuss here. In addition to expressing unjust preferential treatment for some patients and not others, VIP medicine could compromise patient safety.

Ordering Stains That Aren't Indicated.

The pathologist rarely interacts with patients face-to-face, but he or she nonetheless maintains a crucial relationship with the patient (i.e., the patient-pathologist relationship). A more tangible relationship, the pathologist-clinician relationship, is typically augmented by the patient-pathologist relationship, but at times the two distinct relationships are at odds, creating ethical dilemmas for the pathologist. This case study and discussion highlight some of these potential ethical questions and underscore the need for pathologists and clinicians to have cooperative, collaborative, and professional relationships. Pathologists should feel empowered to guide the clinician's use of appropriate clinical testing to ensure proper management of the patient and responsible use of health care resources.

Error Disclosure in Pathology and Laboratory Medicine: A Review of the Literature.

Since the 1990s, the fields of anatomic and clinical pathology have made strong commitments to improving patient safety, including the creation of formal and informal guidelines for assessing and reporting quality lapses. Unfortunately, some medical errors are inevitable. Patient safety experts advocate full and complete disclosure of all serious medical errors in an effort to preserve the patient-physician relationship and minimize the risk of harm to patients. While evidence suggests that most pathologists disclose serious medical errors, many do not disclose such errors to patients. A literature review of articles published on diagnostic error disclosure in pathology and laboratory medicine suggests that there are in fact persistent barriers to the disclosure of diagnostic errors that are specific to pathology. A number of these barriers are considered here, followed by recommendations for improving patient safety in pathology.

Ethical Considerations about EHR-Mediated Results Disclosure and Pathology Information Presented via Patient Portals.

Electronic health records (EHR) now include patient portals where patients can obtain clinical reports, including notes, radiology reports, and laboratory/anatomic pathology results. Although portals increase patient access to information, no guidelines have been developed for hospitals about appropriate delays in posting different types of pathology reports to the EHR. Delays exist as a matter of policy to allow physicians time to answer questions and provide emotional support when discussing sensitive results with patients. Some types of results are more sensitive than others, however, including results of cancer, genetic, and HIV testing. Ethical questions about patient access to test results online are discussed.

[Management of Ethical Problems in the Japanese Society of Laboratory Medicine].

The Ethics Committee of the Japanese Society of Laboratory Medicine published "Opinions of Japanese Society of Laboratory Medicine about utilization of specimens after laboratory examinations for laboratory work, education and clinical studies" in 2002, and amended it in 2008. The Ethics Committee, Committee for Conflict of Interest, Compliance Committee, and Editorial Committee for Rinsho Byori, the official journal of the Japanese Society of Laboratory Medicine, cooperate to solve ethical problems in laboratory medicine. The management of ethical problems in the Japanese Society of Laboratory Medicine is discussed.

Who owns these tissues? General principles on the use of material submitted to pathology departments for healthcare, education and research purposes.

The study of human tissues procured through invasive procedures for diagnostic and treatment purposes constitutes one of the most important functions of pathology departments worldwide. The final diagnosis, determination of appropriate therapy and detailed insight on many diseases are possible only through the analysis of these tissues with the use of modern analytical techniques. While these statements present no controversy, the laws and regulations on how to use these tissues for diagnostic, educational and research purposes are woefully insufficient and cause significant debate. In addition to the lack of principles that define the possession and use of these tissues, there are a number of prejudices in our country that are not consistent with the scientific and medical facts. This study aims to frame the problems arising in this matter and provides a review of the rules, experience and legislation in various countries with a discussion of some examples. We aim to provide ideas on the general fundamental principles that should be incorporated in future legislation in our country. We also hope that our study initiates a healthy discussion of this critical topic.

Status of pathology professionals.

BACKGROUND: The status of basic, general and specialist workforces in pathology services in Nepal needs to be defined and explored for better pathology services. The objective of the study was to find out the status of laboratory medicine professionals (pathology workforces) and the regulation of ethics and limitations of the different level of workforces. METHODS: A cross-sectional descriptive study was conducted by observing and taking interview with the head of the clinical private institutions from August 2008 to January 2009. A total of 373 private pathology laboratories and the workforces working over there were included in the study. RESULTS: The workforces heading private pathology services showed that 153 (41%) of laboratories were headed by laboratory assistant, 79 (21%) by laboratory technician, 90 (24%) by (medical technologist) pathology officer, 30 (8%) by histocytopathologist and 21 (6%) by non pathology professionals. Officer level Pathology workforce (eligible to work independently) was 113 (30%) whereas 260 (70%) of laboratories had no such workforces. Intermediate level Pathology workforce (eligible to work dependently and for some investigation independently) was 34% (127/373) where as 66% (246/373) of laboratories were lacking such workforces. Specialist level (MD/M. Sc) workforces in histocytopathology, clinical microbiology and cytopatholgy & hematology were 43 (11%), 10 (3%) and 3 (1%) respectively. CONCLUSIONS: The workforces heading the private laboratories were not according to the norms of good laboratory practices. The workforces had crossed their limitations and ethical barrier in performing pathological investigations which did not abide by the rules and regulations made by respective councils of Nepal by pathology workforces. There was intervention of non medical/clinical workforce in laboratory services especially in microbiology and biochemistry.

Intersection of biobanking and clinical care: should discrepant diagnoses and pathological findings be returned to research participants?

Diagnostic discrepancies occur when the diagnosis made on a biospecimen during the course of review at a biobank differs from the original clinical diagnosis. These diagnostic discrepancies detected during biobanking present unique challenges that are distinct from other types of research results or incidental findings. The proposed process for reporting diagnostic discrepancies or pathological incidental findings identified through a quality assurance evaluation at the biobank includes verification of the biospecimen identity, verification of the diagnosis within the biobank, and re-review of the case by the pathologist at the biospecimen collection site. If the pathologist at the biobank and the original pathologist do not reach agreement, an impartial and knowledgeable third party is consulted. The decision as to whether and how to notify research participants of any confirmed changes in diagnosis would be determined by institutional procedures. Implementation of this proposed process will require clear delineation of the roles and responsibilities of all involved parties in order to promote excellence in patient care and ensure that researchers have access to biospecimens of requisite quality.Genet Med 2012:14(4):417-423.

Ethical considerations in alleged dermatologic malpractice.

Although dermatology does not lead the list of specialties most commonly sued for malpractice, anyone who has been the recipient of a malpractice claim is often traumatized both personally and professionally. Every day dermatologists must address various ethical concerns that have legal implications. Herein, we chose to discuss the following such issues: (1) the ethical and legal necessity of submitting a clinically benign appearing lesion for dermatopathologic review; (2) the ethical and legal considerations regarding frequency of screening after a patient has been diagnosed with melanoma; (3) the multiple ethical and legal considerations involved with the misdiagnosis of a melanoma; (4) the complex ethical and legal considerations of a dermatologist making a clinical diagnosis in a nonprofessional social and public setting; and (5) the ethical and legal implications of sharing care of patients with other dermatologists and specialists.

[Ethical problems in utilization of specimens after laboratory examinations for clinical studies].

Ethical Committee in Japanese Society of Laboratory Medicine published "Opinions of Japanese Society of Laboratory Medicine about utilization of specimens after laboratory examinations for laboratory work, education and clinical studies" in 2002. Ministry of Health, Labour and Welfare in Japan established "Ethical Guidelines for Clinical Studies" in 2003, and amended the document in 2008. According to the guidelines, Ethical Committee in Japanese Society of Laboratory Medicine revised the "Opinions of Japanese Society of Laboratory Medicine about utilization of specimens after laboratory examinations for laboratory work, education and clinical studies" in 2010. Ethical problems in utilization of specimens after laboratory examinations for clinical studies are discussed.