Ethical permission for the publication of routinely collected data

BACKGROUND: Data collected from undergraduate medical students for routine purposes on a non-consented basis, but subsequently perceived as being potentially valuable for research purposes, lie in an ethical grey area. Currently, such data appear to be used routinely without explicit consideration of ethical considerations. AIMS: This paper proposes a consistent framework that would permit the use of such data. It also provides an advance on current practice with regard to ethical considerations around the absence of consent. DISCUSSION: We argue that students should be informed of generic possible uses of such data and given the opportunity to opt out, that researchers should be able to analyse such data retrospectively, but should then seek ethical permission for publication, and that an ethics committee should determine if ethical practices have been upheld before giving permission for any study incorporating such data to be submitted for publication. FUTURE DIRECTIONS: It is hoped that these proposals will stimulate debate, and that the results of such debate will inform practice in medical schools and medical education publishing.     

Genetic research with stored human tissue: a coding procedure with optimal use of information and protection of privacy

To answer research questions concerning the course of disease and the optimal treatment of hereditary breast cancer, genetic typing together with the clinical and tumour characteristics of breast cancer patients are an important source of information. Part of the incidence of breast cancer can be explained by BRCA1 and BRCA2 germline mutations, which with current techniques can be retrospectively analysed in stored, paraffin-embedded tissue samples. In view of the implications of BRCA1- or BRCA2-carrier status for patients and other family members and the lack of clear legal regulations regarding the procedures to be followed when analysis is performed on historical material and no individual informed consent can be asked from the patients, an appropriate procedure for coding such data or rendering it anonymous is of great importance. By using the coding procedure described in this article, it becomes possible to follow and to work out in greater detail the guidelines of the code for 'Proper secondary use of human tissue' of the Federation of Biomedical Scientific Societies and to use these valuable databases again in the future.     

The use of routinely collected patient data for research: a critical review

Over recent years in the UK there has been growing interest in the potential for routinely collected NHS (National Health Service) patient data to be used for secondary purposes, facilitated by the potential of increasingly sophisticated electronic databases. This article is based on a critically reflective literature review which analyses the key debates pertaining to this issue. The work arose in the context of a programme of research concerning routine patient data use in neonatal care. The article includes analysis of commentary (opinion and ethical inquiry) as well as empirically derived claims. It aims to deconstruct the knowledge assumptions on which relevant research studies have been based or are proposed and it also incorporates ontological position and moral argument. Results are presented according to three predominant debates: the prevailing claim that all health research benefits civic society; the varieties of informed consent and choices open to patients regarding secondary uses of their data; and the 'rights and responsibilities' of patients when it comes to their data being used for research purposes. It examines the relevance of these themes specifically to the neonatal context and the implications for our own research, concluding that employing an alternative ethical model to the traditional professional one might be useful in order to provide a further perspective on the issue.     

Deferred consent for inclusion of patients unable to give their consent in studies in the field of emergency medicine

Respect for individual autonomy, expressed in the concept of informed consent, is a basic principle in research with humans. Many patients in intensive care are unable to give consent because of mental incapacity, and this can be further complicated in emergency research, in which the treatment or experiment needs to be initiated without delay. In those situations consent can be deferred. Randomization is done without prior consent, followed by patients' or relatives' consent at a later stage. Butwhat should one do with the data if the patient dies at an early stage after randomization before consent could be obtained? Should the data be used or not? Should the relatives be asked for consent for using the data? The Dutch Central Committee on Research involving Human Subjects (CCMO) states that asking for consent after the patient has died makes no sense, because with the death of the patient the research has ended. Relatives do not have the authority to give consent for the use of medical data after the patient has died. Data can be used anonymously in the final analysis of the trial. We propose a flowchart for this procedure.     

Ethical Issues in Case Study Publication: “Making Our Case(s)” Ethically

As chaplains develop richly detailed case studies for publication, ethical questions about case study construction and publication are emerging. Concerns about seeking patients' permission to publish material about them suggest additional questions and raise broad confidentiality and privacy issues. Confidentiality-related practices in health care and psychotherapy provide the most extensive guidance for chaplains, but healthcare chaplaincy has roots in religious and professional traditions with distinct notions of confidentiality that deserve consideration. Single case studies do not appear to be “research” requiring informed consent, yet their publication exposes patients to some risk of harm. Obtaining the patient's/“case study subject's” permission to publish, disguising non-essential information, and allowing the patient to review the case study can mitigate the risks. Striking a balance between protecting patients and providing sufficient detail to make case studies useful is a central ethical challenge of case study publication.     

Ethical issues in case study publication: "making our case(s)" ethically

As chaplains develop richly detailed case studies for publication, ethical questions about case study construction and publication are emerging. Concerns about seeking patients' permission to publish material about them suggest additional questions and raise broad confidentiality and privacy issues. Confidentiality-related practices in health care and psychotherapy provide the most extensive guidance for chaplains, but healthcare chaplaincy has roots in religious and professional traditions with distinct notions of confidentiality that deserve consideration. Single case studies do not appear to be "research" requiring informed consent, yet their publication exposes patients to some risk of harm. Obtaining the patient's/"case study subject's" permission to publish, disguising non-essential information, and allowing the patient to review the case study can mitigate the risks. Striking a balance between protecting patients and providing sufficient detail to make case studies useful is a central ethical challenge of case study publication.     

Learning from experience: privacy and the secondary use of data in health research

Health services research must continually address the question: Under what conditions may data not collected specifically for research, such as primary medical data, be re-used for research without compromising the privacy of the data-subjects? For secondary use of data in research there are basically three options. Option A: Use personal data with consent or other assent from the data-subjects. To make this both fairer and more practical, in many circumstances broader construals of consent, or permission or approval, need to be explored and instituted. Option B: Anonymise the data, then use them. For many studies, this is the most practical and desirable option. The craft of anonymisation, including reversible anonymisation, or key-coding, needs to be developed and more fully supported under law. Option C: Use personal data without explicit consent, under a public interest mandate. Whether and how the data should be anonymised will depend on the situation. Public health mandates and protections deserve to be clarified, strengthened and extended for a variety of surveillance, registration, clinical audit, health services research and other types of investigation. Safeguards are an integral part of the research promise to the public, offer crucial reassurance and should be emphasised. For health services research, databases are core resources, and their stewardship must be cultivated.     

Review of ethical aspects in biomedical research. The experience of the Ethics Committee of the Center for Toxic Oil Syndrome and Rare Diseases [CISATER]

This Field Note aims to make known the decisions taken by the Ethics Committee of the Instituto de Salud Carlos III for Toxic Oil Syndrome regarding the secondary use of research specimens in biological research when informed consent is lacking. This is a common concern in the field of biomedical research. After debating the ethical suitability of the secondary use of these samples, our main conclusion is that researchers conducting prospective studies should expressly solicit written informed consent from participants in the study about i) whether there will or could be any secondary use of the samples and, if so, ii) whether such secondary use would be conditional on the type of research.     

Assessing public attitudes on the retention and use of residual newborn screening blood samples: a focus group study

This paper discusses attitudes and opinions of a diverse group of participants toward the retention and use of residual newborn blood samples for research. Data were drawn from focus groups based in six states in the USA, and results provide support for the retention and use of residual newborn blood samples for research when parental permission is asked beforehand. However, there were a number of concerns that also warrant attention for the development of policy and maintaining trust with the public, such as timing of permission, use of samples already stored, level of personal control of sample use and education. The results demonstrate the complexity of the topic and the ethical ambiguities associated with the retention and use of residual newborn blood samples.     

R&P: the multiple meaning of a research project in general practice

Rischio e Prevenzione (Risk and Prevention) is a research project that is becoming the paradigm of the Italian research on General Practice. It started from a survey showing that treatment and control of cardiovascular risk is still far from optimal even in very high-risk patients. A group of general practitioners, coordinated by Istituto Mario Negri, wrote the protocol of the study with various proposals: Creating a research network. Building research infrastructure with good research capacity. Building a 'therapeutic alliance' with the patient while presenting the research, not only obtaining their signature for a 'bureaucratic' informed consent. Having the 'Collaborative Group' as the 'sponsor' of a research even if the funds are coming from Pharmaceutical Industry. It is a randomised controlled trial (RCT) carried out in primary care with the normal patient of our daily work, so transferability is very possible. The way to enroll the patients and the request to specify the reason for not joining the project of the outcome study are a kind of participatory research. The outcome study can become a model for implementing new strategy on cardiovascular risk. A specific questionnaire will enquire the different point of view of the patient and of the general practitioner/researcher. The result of this project will help us understand the phenomenon of the poor compliance of the high-risk patients. First results during enrollment allow some optimism.     

Principle agendas of doctors and patients in general practice consultations.

Seventy-three general practice interviews were analysed according to the method described by Butler et al. Results for the three principal agenda types (physical, emotional and social) are presented in terms of the control exerted by either doctor or patient in determining the content of the interview. Both doctor and patient address physical agendas to a similar high degree. In contrast, patients present emotional agendas to a far greater extent than doctors address these concerns. The findings for social agendas are intermediate between those for physical and those for emotional agendas. It is argued that doctors can facilitate the expression of emotional and social agendas by giving explicit or implicit permission for their presence in the interview.     

Parents’ Perspectives About Adolescent Boys’ Involvement in Biomedical HIV Prevention Research

Research on the use of pre-exposure prophylaxis (PrEP) among adolescents at high risk for HIV is urgently needed, and parents’ perspectives on these studies are essential for guiding the responsible conduct of adolescent PrEP research. We conducted interviews with 30 parents of adolescent boys (50% known/presumed heterosexual; 50% sexual minority) to understand their views of research risks and benefits and parental permission regarding their son’s involvement in a hypothetical PrEP adherence trial. Parents identified several health and educational benefits of the study and expressed that waiving parental permission would overcome barriers to accessing PrEP, particularly for youth who may benefit most. Among their concerns were medication non-adherence and risk compensation. Parents provided suggestions to facilitate informed, rational, and voluntary participation decisions and protect youth’s safety if parental permission was waived. These findings can inform ways to increase parental trust in PrEP research and create adequate protections for adolescent participants.     

Altruism in terminal cancer patients and rapid tissue donation program: does the theory apply?

Rapid tissue donation (RTD) is an advancing oncology research procedure for collecting tumors, metastases, and unaffected tissue 2–6 h after death. Researchers can better determine rates of progression, response to treatment, and polymorphic differences among patients. Cancer patients may inquire about posthumous body donation for research to offer a personal contribution to research; however, there are barriers to recruiting for an RTD program. Physicians must reassure the patient that their treatment options and quality of care will not be compromised due to participating in RTD. In this commentary we discuss how theories of altruism may explain cancer patients’ desire to participate in an RTD program, the ethical concerns of health care professionals and patients and the use of altruism as a recruitment strategy. We offer recommendations for examining the cultural and ethical climate of the institution prior to initiating such a program such as examining the relationship of healthcare professionals and patients, identifying ethical concerns, and examining ways to promote acceptance and buy-in across professionals, patients, and families.     

A qualitative study of subject recruitment for familial cancer research

PURPOSE: Familial epidemiological studies of cancer raise familiar ethical issues relating to informed consent and recruitment of participants. When the family is the unit of study, however, additional complexity arises. Educating and recruiting participants must be tailored to the relatives', as well as the proband's needs. An understanding of the prospective participants' concerns will aid the development of strategies for recruitment and will facilitate informed and voluntary consent. In the present study, qualitative methods were used to investigate these issues. METHODS: Focus groups with cancer patients, relatives of cancer patients, and individuals from the general population were separately conducted to identify issues that concern people who are asked to participate in family studies. RESULTS: Many of the issues which arose in the course of the focus group discussions were similar to those in any study. Yet, some of the themes emerging from the discussions were specific to familial research. In particular, participants expressed that the study should be endorsed by a trusted and familiar source; group discussions might facilitate the consent process; the benefit of the research should be clear and personal, as well as benefit the participants' family members; risks of participation should be explicit (e.g., insurance discrimination); and education about the disease and its familial nature would maintain commitment to the study. Finally, participants expressed concerns about being approached by programs to facilitate the identification and recruitment of other family members for research on family health issues. CONCLUSIONS: Findings from this study will aid future familial studies in developing a protocol that both adequately informs potential participants of the nature of familial research and maximize participation.     

Mental Health Providers’ Decision-Making Around the Implementation of Evidence-Based Treatment for PTSD

It is estimated that <15% of veterans with posttraumatic stress disorder (PTSD) have engaged in two evidence-based psychotherapies highly recommended by VA—cognitive processing therapy (CPT) and prolonged exposure (PE). CPT and PE guidelines specify which patients are appropriate, but research suggests that providers may be more selective than the guidelines. In addition, PTSD clinical guidelines encourage “shared decision-making,” but there is little research on what processes providers use to make decisions about CPT/PE. Sixteen licensed psychologists and social workers from two VA medical centers working with ≥1 patient with PTSD were interviewed about patient factors considered and decision-making processes for CPT/PE use. Qualitative analyses revealed that patient readiness and comorbid conditions influenced decisions to use or refer patients with PTSD for CPT/PE. Providers reported mentally derived and instances of patient-involved decision-making around CPT/PE use. Continued efforts to assist providers in making informed and collaborative decisions about CPT/PE use are discussed.     

Health literacy in health systems: perspectives on patient self-management in Israel

Health systems will face new challenges in this millennium. Striking the balance between the best quality of care and optimal use of dwindling resources will challenge health policy makers, managers and practitioners. Increasingly, improvements in the outcomes of interventions for both acute and chronic patients will depend on partnerships between health service providers, the individual and their family. Patient education that incorporates self-management and empowerment has proven to be cost-effective. It is essential that health care providers promote informed decision making, and facilitate actions designed to improve personal capacity to exert control over factors that determine health and improve health outcomes. It is for these reasons that promoting health literacy is a central strategy for improving self-management in health. The different types of health literacy--functional, interactive and critical health literacy--are considered. The potential to improve health literacy at each of these levels has been demonstrated in practice among diabetics and other chronic disease patients in Clalit Health Services (CHS) in Israel is used as an example to demonstrate possibilities. The application of all three types of health literacy is expressed in: (i) developing appropriate health information tools for the public to be applied in primary, secondary and tertiary care settings, and in online and media information accessibility and appropriateness using culturally relevant participatory methods; (ii) training of health professionals at all levels, including undergraduate and in-service training; and (iii) developing and applying appropriate assessment and monitoring tools which include public/patient participatory methods. Health care providers need to consider where their patients are getting information on disease and self-management, whether or not that information is reliable, and inform their patients of the best sources of information and its use. The improved collaboration with patient and consumer groups, whose goals are to promote rights and self-management capabilities and advocate for improved health services, can be very beneficial.     

Patient decision aids to support clinical decision making: evaluating the decision or the outcomes of the decision.

Decision aids (DAs) are tools to support patients make informed health decisions with their practitioner. They aim to improve patient knowledge of options, incorporate patient preferences and values, and increase patient involvement in health decision making. Increasingly, the debate about DAs concerns how they should be implemented in practice, with the view that DAs are superior to usual clinical care in facilitating health decisions. The authors challenge this view and suggest that DA research has focused on measures of decision process, leaving the effects on the outcome of the decision relatively unknown. It is still unclear in which conditions DAs are better for patient health and well-being than clinician-led decisions. The authors present a new randomized design to examine the effects of DA-supported patient choice on patient-centered outcomes to identify where DAs are best implemented in clinical practice. In this design, patients are randomized to 1 of 4 arms: intervention A, intervention B, choice of either intervention supported by a clinician, or choice of either intervention supported by a decision aid. Health and quality of life measured over the long term are presented as the primary outcomes. The authors propose that this design will allow the proper assessment of different modes of decision making.     

Reasons why patients do or do not participate in clinical trials; a systemic review of the literature

OBJECTIVE: To assess the factors that may influence a patient's consent to participate in a clinical trial. DESIGN: Systematic literature survey. METHOD: Studies on the characteristics of patients, trials, the physicians requesting informed consent and the informed consent procedures were looked for in Medline, Embase, and Cinahl. Articles published in English, German, Dutch or French in the period 1980-2002 and originating in Europe, the United States, Canada, New Zealand or Australia were included. Studies on non-adults, healthy experimental subjects or less than 30 patients were excluded. RESULTS: Thirty suitable studies were retrieved. Factors that may affect the granting of consent to participate in a clinical trial included: uncertainty of the patient, randomisation and the use of a placebo, the relationship between the person asking for informed consent and the patient, and the dissemination of information during the informed consent procedure. Since these factors are often interrelated, no single factor could be identified as decisive for participation in a clinical trial; they can influence the decision of the patient to participate in a trial in either a positive or a negative direction. CONCLUSION: Optimalization of the information concerning informed consent, the way the information is provided and the attitude of the person requesting informed consent are important and sometimes decisive factors that may determine the participation process.     

Preventing life-sustaining treatment by default

Many physicians will at some point care for patients who will receive life-sustaining treatment by default, because there are no instructions available from the patient as to what kind of care is preferred, and because surrogates are likely to ask for everything to be done when they do not know a patient's preferences. We use the methods of ethics informed by qualitative focus group research to identify 5 pathways to life-sustaining treatment by default originating with the patient's preferred decision-making style: deciding for oneself or letting others decide. We emphasize preventing the ethically unwelcome outcome of life-sustaining treatment by default by increasing the frequency with which patients make clear decisions or clearly express their values and goals that they then communicate to physicians or surrogates.