Background Randomized controlled trials are central to generating knowledge about effectiveness of interventions as well as risk, protective and prognostic factors related to diseases in emergency newborn care. Whether prospective participants understand the purpose of research, and what they perceive as the influence of the context on their understanding of the informed consent process for RCTs in emergency obstetric and newborn care are not well documented. Methods Conceptual review. Discussion Research is necessary to identify how the illnesses may be prevented, (...) to explore the causes, and to investigate what medications could be used to manage such illness. Voluntary informed consent requires that prospective participants understand the disclose information about the research, and use this to make autonomous informed decision about participation, in line with their preferences and values. Yet the emergency context affects how information may be disclosed to prospective research participants, how much participants may comprehend, and how participants may express their voluntary decision to participate, all of which pose a threat to the validity of the informed consent. I challenge the claim that the ‘understanding’ of research is always necessary for ethical informed consent for research during emergency care. I argue for reconceptualization of the value of understanding, through recognition of other values that may be equally important. I then present a reflective perspective that frames moral reflection about autonomy, beneficence and justice in research in emergency research. Conclusion While participant ‘understanding’ of research is important, it is neither necessary nor sufficient for a valid informed consent, and may compete with other values with which it needs to be considered. (shrink)

BackgroundInformed consent as stipulated in regulatory human research guidelines requires that a volunteer is well-informed about what will happen to them in a trial. However researchers are faced with a challenge of how to ensure that a volunteer agreeing to take part in a clinical trial is truly informed. We conducted a qualitative study among volunteers taking part in two HIV clinical trials in Uganda to find out how they defined informed consent and their perceptions of the trial procedures, study (...) information and interactions with the research team.MethodsBetween January and December 2012, 23 volunteers who had been in the two trials for over 6 months, consented to be interviewed about their experience in the trial three times over a period of nine months. They also took part in focus group discussions. Themes informed by study research questions and emerging findings were used for content analysis.ResultsVolunteers defined the informed consent process in terms of their individual welfare. Only two of the volunteers reported having referred during the trial to the participant information sheets given at the start of the trial. Volunteers remembered the information they had been given at the start of the trial on procedures that involved drawing blood and urine samples but not information about study design and randomisation. Volunteers said that they had understood the purpose of the trial. They said that signing a consent form showed that they had consented to take part in the trial but they also described it as being done to protect the researcher in case a volunteer later experienced side effects.ConclusionVolunteers pay more attention during the consent process to procedures requiring biological tests than to study design issues. Trust built between volunteers and the research team could enhance the successful conduct of clinical trials by allowing for informal discussions to identify and review volunteers’ perceptions. These results point to the need for researchers to view informed consent as a process rather than an event. (shrink)

Introduction Future HIV vaccine efficacy trials with adolescents will need to ensure that participants comprehend study concepts in order to confer true informed assent. A Hepatitis B vaccine trial with adolescents offers valuable opportunity to test youth understanding of vaccine trial requirements in general. Methods Youth reviewed a simplified assent form with study investigators and then completed a comprehension questionnaire. Once enrolled, all youth were tested for HIV and confirmed to be HIV-negative. Results 123 youth completed the questionnaire (mean age=15 (...) years; 63% male; 70% Hispanic). Overall, only 69 (56%) youth answered all six questions correctly. Conclusions Youth enrolled in a Hepatitis B vaccine trial demonstrated variable comprehension of the study design and various methodological concepts, such as treatment group masking. (shrink)

Little is known about the views of mothers when their children are invited to participate in randomized clinical trials (RCTs) investigating medicines and/or invasive procedures. Our goal was to understand mothers’ perceptions of the processes of informed consent and randomization in a RCT that divided uncooperative children into three intervention groups (physical restraint, sedation, and general anesthesia) for dental rehabilitation.

I denne artikel undersøges kroniske patienters beslutninger om forsøgsdeltagelse og betydningen af deltagerinformation. På baggrund af et års feltarbejde på fire danske forskningsklinikker argumenterer jeg for, at de observerede patienter opererer efter andre logikker, når de tager beslutninger om at deltage i kliniske forsøg, end hvad der antages i den gældende forskningsetiske regulering. Feltarbejdet fulgte et klinisk lægemiddelforsøg og inkluderede observationer af forsøgskonsultationer; interviews med investigatorer, projektsygeplejersker, forsøgsdeltagere og virksomhedsrepræsentanter; samt en mindre spørgeskemaundersøgelse blandt de danske forsøgsdeltagere. Resultaterne indikerer, at (...) for en gruppe af erfarne forsøgsdeltagere handler beslutningerne om forsøgsdeltagelse ikke om forsøget i sig selv, men om at opretholde en nær relation til forskningspersonalet. Disse patienter orienterer sig ikke efter deltagerinformation, men i forhold til tillidsrelationer. De agerer ikke som autonome individer, men oplever, at de er afhængige af sundhedssystemet. De udtrykker altruistiske motiver, men håber samtidig, at forsøgsdeltagelse vil give dem bedre helbredskontrol. For dem er forsøgsdeltagelse blevet en måde at leve med kronisk sygdom. Mulige implikationer af denne situation diskuteres, idet det understreges, at tillidsfulde relationer er en forudsætning både for god behandling og god forskning, men at de tætte relationer samtidig kan bevirke, at patienter bliver mindre kritiske, i forhold til hvilke forsøg de accepterer at deltage i, og at en bevidsthed om forsøgsrelaterede risici fortrænges fra forsøgssituationen.Nøgleord: informeret samtykke, deltagerinformation, deltagermotivation, kliniske forsøg, kronisk sygdom, DanmarkEnglish summary: Informed consent in clinical trials: technicalities, trust and intimate relationshipsThis article explores decisions about clinical trial participation in a group of patients with chronic conditions, focusing especially on motivation for trial participation and trial information. Based on ethnographic research in four Danish hospitals in conjunction with a clinical drug trial, I argue that these patients’ decisions follow logics other than those anticipated in research ethics regulations. I build on observations, interviews with physician-investigators, project nurses, patient-participants and trial sponsors, and a survey of the participants. The results indicate that for a group of experienced trial participants, trial information plays a very limited role because their decisions do not concern the trial per se but the sustainment of a close relationship with the research staff. They do not act as autonomous individuals weighing pros and cons based on the written information they receive. Rather, they feel dependent on the healthcare system and navigate in trust relations. For them, trial participation has become a way of living with chronic disease. I discuss implications of this situation underlining that trustful relationships constitute a precondition for high quality chronic care and research, yet the social dynamics may also lead patients to pay less attention to risks associated with trial participation. (shrink)

One of the ethical principles of medical research involving human subjects is obtaining proper informed consent (IC). However, if the participants’ actual awareness of medical research terminology is lower than the researchers’ prediction of that awareness, it may cause difficulty obtaining proper IC. Therefore, this study aims to clarify the presence of “perception gaps” and then discuss IC-related issues and measures based on the insights obtained. We conducted two online surveys: a “public survey” to understand the Japanese public’s awareness of (...) 11 medical research terms and a “physicians’ survey” to investigate physicians’ predictions regarding public awareness. In the “public survey,” for each term, respondents were instructed to select their situation from “understand,” “have heard,” or “have never heard.” In the “physicians’ survey,” respondents were asked to estimate the proportions of the general public who would “have understood,” “have heard,” or “have never heard” by using an 11-step scale. We analyzed separately in two age groups to understand the age-related difference. We received 1002 valid responses for the “public survey” and 275 for the “physicians’ survey.” Of the public respondents, more than 80% had never heard of terms such as interventional study, prospective clinical study, cohort study, Phase I clinical trial, or double-blind study. Concurrently, physicians overestimated general public awareness of the terms placebo, cohort study, double-blind study, and randomized clinical trial (in the group of people under 60). The results revealed the perception gap between the general public and physicians which raise serious concerns about obtaining proper IC from clinical research participants. (shrink)

BackgroundMany studies have been published about ethics committees and the clarifications requested about the submitted applications. In Finland, ethics committees require a separate statement on ethical aspects of the research in applications to the ethics committee. However, little is known about how researchers consider the ethical aspects of their own studies.MethodsThe data were collected from all the applications received by the official regional ethics committee in the Hospital District of Northern Savo during 2004–2009 (n = 688). These included a total (...) of 56 studies involving research on tissue other than blood. The statements by the researchers about the ethics about their own research in these applications were analyzed by thematic content analysis under the following themes: recruitment, informed consent, risks and benefits, confidentiality and societal meaning.ResultsThe researchers tended to describe recruitment and informed consent process very briefly. Usually these descriptions simply stated who the recruiter was and that written consent would be required. There was little information provided on the recruitment situation and on how the study recruiters would be informed. Although most of the studies were clinical, the possibility was hardly ever discussed that patients could fail to distinguish between care and research.ConclusionThe written guidelines, available on the webpages of the ethics committee, do not seem to be enough to help researchers achieve this goal. In addition to detailed guidelines for researchers, investigators need to be taught to appreciate the ethical aspects in their own studies. (shrink)

Zu den elementaren Rechtfertigungsbedingungen der medizinischen Forschung an und mit Menschen zählt die informierte Einwilligungserklärung („informed consent“) des Probanden/Patienten. Für die Gewährleistung eines „informed consent“ sind dem potenziellen Studienteilnehmer u. a. qualitativ hochwertige schriftliche Aufklärungsmaterialien zur Verfügung zu stellen. Wir entwickelten eine Liste von Prüfpunkten, um mit ihnen die Qualität schriftlicher Aufklärungsmaterialien zu bestimmen und zu bewerten. Mithilfe eines Kriterienkataloges bestehend aus über 100 Prüfpunkten wurde die Qualität von 128 zufällig ausgewählten schriftlichen Aufklärungsmaterialien zu Forschungsvorhaben beurteilt, die der Ethikkommission der (...) Universität zu Lübeck im Jahr 2006 vorgelegt worden waren. Jeder Prüfpunkt ist einem von sechs Qualitätsbereichen zugeordnet (z. B. Lesbarkeit und Verständlichkeit, Nutzen-/Schadenpotenziale). Die untersuchten Aufklärungsmaterialien erfüllten im Durchschnitt die Hälfte der 117 abgefragten Qualitätskriterien, die Spannweite reichte dabei von 20 % bis 76 %. Der höchste Qualitätsscore wurde für den Bereich „Einwilligungserklärung“ beobachtet (64 % der Kriterien erfüllt), am schlechtesten schnitt der Bereich „Nutzen- und Schadenpotenziale“ ab (35 % der Kriterien erfüllt). Aufklärungsmaterialien zu klinischen Prüfungen von Arzneimitteln zeigten dabei eine signifikant höhere Qualität als die Aufklärungsmaterialien zu anderen Studientypen. Nur 21 der 117 analysierten Qualitätskriterien wurden in mehr als 80 % der einschlägigen Aufklärungsmaterialien umgesetzt. Die vorliegende Arbeit zeigt deutliche Defizite in der Qualität der untersuchten Aufklärungsmaterialien auf. Forscherinnen und Forscher benötigen Hilfestellung bei der Erstellung von Materialien, die eine informierte Entscheidung für oder gegen eine Studienteilnahme ermöglichen. Der von uns eingesetzte Kriterienkatalog könnte u. a. im Rahmen von Doktorandenseminaren dazu genutzt werden, den Blick für die Vielfalt der Anforderungen zu schärfen. (shrink)

Background: Individual, comprehensive, and written informed consent is broadly considered an ethical obligation in research involving the sampling of human material. In developing countries, however, local conditions, such as widespread illiteracy, low levels of education, and hierarchical social structures, complicate compliance with these standards. As a result, researchers may modify the consent process to secure participation. To evaluate the ethical status of such modified consent strategies it is necessary to assess the extent to which local practices accord with the values (...) underlying informed consent. Methods: Over a 2-week period in April 2014 we conducted semistructured interviews with researchers from a genetic research institute in rural Pakistan and families who had given blood samples for their research. Interviews with researchers focused on the institute’s requirements for consent, and the researchers’ strategies for and experiences with obtaining consent in the field. Interviews with donors focused on their motivation for donating samples, their experience of consent and donation, and what factors were central in their decisions to give consent. Results: Researchers often reported modifications to consent procedures suited to the local context, standardly employing oral and elder consent, and tailoring information to the social education level of donor families. Central themes in donors’ accounts of their decision to consent were the hope of getting something out of their participation and their remarkably high levels of trust in the researchers. Several donor accounts indicated a degree of confusion about participation and diagnosis, resulting in misconceived expectations of therapeutic benefits. Conclusions: We argue that while building and maintaining trusting relationships in research is important—not least in developing countries—strategies that serve this endeavor should be supplemented with efforts to ensure proper provision and understanding of relevant information, specifically about the nature of research and measures for individual consent and opt-out. (shrink)

In recent years, informed consent has been suggested as a way to deal with risks posed by engineered nanomaterials. We argue that while we can learn from experiences with informed consent in treatment and research contexts, we should be aware that informed consent traditionally pertains to certain features of the relationships between doctors and patients and researchers and research participants, rather than those between producers and consumers and employers and employees, which are more prominent in the case of engineered nanomaterials. (...) To better understand these differences, we identify three major relational factors that influence whether valid informed consent is obtainable, namely dependency, personal proximity, and existence of shared interests. We show that each type of relationship offers different opportunities for reflection and therefore poses distinct challenges for obtaining valid informed consent. Our analysis offers a systematic understanding of the possibilities for attaining informed consent in the context of nanomaterial risks and makes clear that measures or regulations to improve the obtainment of informed consent should be attuned to the specific interpersonal relations to which it is supposed to apply. (shrink)