Research monitoring by US medical institutions to protect human subjects: compliance or quality improvement?

In recent years, to protect the rights and welfare of human subjects, institutions in the USA have begun to set up programmes to monitor ongoing medical research. These programmes provide routine, onsite oversight, and thus go beyond existing oversight such as investigating suspected misconduct or reviewing paperwork provided by investigators. However, because of a lack of guidelines and evidence, institutions have had little guidance in setting up their programmes. To help institutions make the right choices, we used interviews and document analysis to study how and why 11 US institutions have set up their monitoring programmes. Although these programmes varied considerably, we were able to distinguish two general types. 'Compliance' programmes on the one hand were part of the institutional review board office and set up to ensure compliance with regulations. Investigators' participation was mandatory. Monitors focused on documentation. Investigators could be disciplined, and could be obliged to take corrective actions. 'Quality-improvement' programmes on the other hand were part of a separate office. Investigators requested to be monitored. Monitors focused more on actual research conduct. Investigators and other parties received feedback on how to improve the research process. Although both types of programmes have their drawbacks and advantages, we argue that if institutions want to set up monitoring programmes, quality improvement is the better choice: it can help foster an atmosphere of trust between investigators and the institutional review board, and can help raise the standards for the protection of human subject

Ethical review from the inside: repertoires of evaluation in Research Ethics Committee meetings

Evaluating the practice of ethical review by Research Ethics Committees (REC) could help protect the interests of human participants and promote scientific progress. To facilitate such evaluations, we conducted an ethnographic study of how an REC reviews research proposals during its meetings. We observed 13 meetings of a Dutch REC and studied REC documents. We coded this material inductively and categorised these codes in two repertoires of evaluation: a repertoire of rules and a repertoire of production. In the repertoire of rules the REC applies rules, weighs scientific value and burdens to the participants and makes a final judgment on a research proposal in a meeting. In the repertoire of production, REC members check documents and forms and advise researchers on how to improve their proposals and can use informal communication. Based on these findings, we think that evaluations of the practice of ethical review should take into account the fact that RECs can use a repertoire of rules and a repertoire of production to evaluate research proposals. Combining these two repertoires can be a viable option so that the REC gives researchers advice on how to improve their proposals to prevent rejection of valuable researc

Experiences of parents and patients with the timing of Mucopolysaccharidosis type I (MPS I) diagnoses and its relevance to the ethical debate on newborn screening

Introduction: Newborn screening (NBS) techniques have been developed for several lysosomal storage disorders (LSDs), including Mucopolysaccharidosis type I (MPS I). MPS I is an LSD with a wide phenotypic spectrum that ranges from the severe Hurler phenotype to the attenuated Scheie phenotype. To improve the ethical discussion about NBS for MPS I, we performed an interview study to explore the experiences of MPS I patients and their parents with the timings of their diagnoses. Methods: We used a qualitative research approach consisting of 17 interviews with the parents of patients with all MPS I phenotypes and with patients with attenuated forms of MPS I. The interviews were audio-recorded, transcribed and subsequently analyzed to identify the main themes identified by the participants. Results: Five important themes, focusing on the experienced disadvantages of delayed diagnosis and the advantages and disadvantages of a hypothetical earlier diagnosis, were identified in our group of participants: 1) delayed diagnosis causing parental frustration, 2) delayed diagnosis causing patient frustration, 3) early diagnosis enabling reproductive decision-making, 4) early diagnosis enabling focusing on the diagnosis, and 5) early diagnosis enabling timely initiation of treatment. There was a remarkable similarity in the experiences with timing of diagnosis between parents of patients with the severe and the attenuated forms. Conclusion: This was the first study to explore the personal experiences of MPS I patients and their parents with diagnostic timing. Our study identified five important themes that are highly relevant to the ethical discussion on expanding NBS programs for MPS I. (C) 2012 Elsevier Inc. All rights reserve

Disentangling cancer patients' trust in their oncologist: a qualitative study

Objective: Patients' trust in their physician is crucial for an optimal treatment. Yet, among oncology patients, for whom trust might be especially important, research into trust is limited. A qualitative interview study was carried out to investigate (1) to what extent aspects of trust important to cancer patients reflect the aspects described in other patient populations and (2) which additional themes emerge. Methods: In-depth, semi-structured interviews were performed with a purposefully selected heterogeneous sample of 29 cancer patients. Transcribed interviews were analyzed using MAXqda. Data were clustered across interviews to derive common themes related to trust. Results: Three commonly described aspects, i.e., fidelity, competence and honesty, were strongly reflected in patients' accounts of trust in their oncologist. Confidentiality was irrelevant to many. An additional aspect, labeled 'caring', was distinguished. Central to the accounts of these patients was their need to trust the oncologist, arising from the severe and life-threatening nature of their disease. This necessity to trust led to the quick establishment of a competence-based trust alliance. A deeper, more emotional bond of trust was developed only after repeated interaction and seemed primarily based on the oncologist's interpersonal skills. Conclusions: The need for trust encountered in this study underscores the power imbalance between cancer patients and their oncologist. Additionally, these results imply that when aiming to measure cancer patients' trust, what we might actually be assessing is patients' intention and determination to trust their oncologist. Copyright (C) 2011 John Wiley & Sons, Lt

Patients׳ perspectives on how treatment can impede their recovery from depression

More than 50% of all major depressive disorder (MDD) patients experience insufficient improvement from the available treatment options. There is emerging evidence that patients׳ beliefs and experiences about MDD treatment influence treatment outcomes. The aim was to explore patients׳ perspectives on impeding characteristics of professional treatment for the recovery of MDD. In-depth interviews in a purposive sample with 27 recovered MDD patients who had received professional treatment. Data were qualitatively analyzed using constant comparison. Participants׳ accounts yielded four major impeding themes: lack of clarity and consensus about the nature of the participants׳ MDD and the content of their treatment; precarious relationship with the clinician; unavailability of mental health care; and insufficient involvement of significant others. The external generalizability may be limited due to missed other subgroups within depression. This study identified a comprehensive overview of impeding characteristics in MDD treatment from patients׳ perspectives. This may help clinicians to understand how patients experience MDD treatment, and to incorporate patients׳ perspectives about treatment into their joint decision-making. This can lead towards increased treatment adherence, motivation and finally succes

A qualitative participatory study to identify experiences of coronary heart disease patients to support the development of online self-management services

Web-based self-management services remain underutilized in current practice. Our aim was to gain insight into disease and self-management experiences of patients in early and progressive stages of coronary heart disease (CHD), to understand moderating effects of daily life experiences on the utilization of web-based self-management services and preconditions for use. We applied generative research techniques, which stem from the field of product design and are characterized by the use of creative processes. Three groups of patients with CHD received a sensitizing package to document and reflect on their health, and were subsequently either interviewed or participated in a focus group session. In total, 23 patients participated in this study. Emerging themes were (1) fear for recurrent events, (2) experiences with professional care, (3) the perceived inability to prevent disease progression, (4) the desire to go on living without thinking about the disease every day, (5) the social environment as a barrier to or facilitator for self-management, and (6) the need for information tailored to personal preferences. How patients experience their disease varies between stable and post-acute stages, as well as between early and progressive stages of CHD. Patients in post-acute stages of the disease seem to be most amenable to support, while patients in stable stages want to live their life without being reminded of their disease. In the context of self-management, web-based services should be adapted to the variation in needs that occur in the different stages of CHD and new strategies to fit such services to these needs should be developed. Furthermore, they should be tailored to patients' individual health situation and preferences, support patient empowerment, and manage expectations regarding the progression of their diseas