Arja Halkoaho

Ethical aspects in placental perfusion studies: Views of the researchers

Within the EU-project NewGeneris human placental perfusion has been used for predicting fetal exposure to food carcinogens. Within the work package of ethical aspects of the research, we studied opinions of the researchers (n = 23) who carried out perfusions of human placenta. Data were collected by focus group interviews (n = 12) and an open-ended questionnaire (n =19 of which 8 were also attending the group session) from scientists representing 9 different nationalities. Both types of data were analysed together thematically and with data triangulation. Studied researchers considered communication between all stakeholders extremely important. Good communication was considered a prerequisite for the recruitment of mothers to donate the placenta, as well as for the process of getting the informed consent. Voluntariness, confidentiality and societal meaning were mentioned as important by all studied researchers. Educating the hospital personnel was regarded as essential in order to provide the best possible information to the mothers. The researchers also pointed out that cultural aspects should be respected, and that in Western thinking placenta is mostly considered as waste. Some researchers suggested that current guidelines and processes for obtaining informed consent should be reviewed also from a cultural perspective. With the development of biobanks, the use of human tissues, including placenta will most probably increase in the future, and the awareness of ethical considerations both in legislation and in practice need support. Thus, continuous effort for better research ethics is essential and requires research on research ethics.

Duties of the patient: A tentative model based on metasynthesis

Patient’s duties are a topical but little researched area in nursing ethics. However, patient’s duties are closely connected to nursing practice in terms of autonomy, the best purpose of care and rethinking from the patient’s perspective. This article is a metasynthesis (N = 11 original articles) of patient’s duties, aimed to create a tentative model. In this article, a tentative model called ‘right-based duties of a patient’ was constructed. With its aid, a coherent structure of patient’s duties within different roles and objects of a patient can be defined. In addition, the ethical basis, prerequisites, outcomes and risks of patient’s duties can be named. In conclusion, so-called right-based duties of a patient constitute the basic argument. Patient’s duties are not unambiguous for all patients, and the global perspective to duties has been challenged. However, due to both conceptual and practical reasons, rethinking of patient’s duties is needed.

Does gestational diabetes affect women's health-related quality of life after delivery?

OBJECTIVES Our objective in this study was to investigate the effects of gestational diabetes (GDM) on womens health-related quality of life (HRQoL) after delivery. This study investigates the differences between a GDM group and a control group. STUDY DESIGN Using random sampling, 100 women who had had GDM were selected from a birth register. Glucose tolerance tests administered to these participants during pregnancy had yielded 1 or 2 abnormal values. The control group (n=100) consisted of women who had normal glucose tolerance test during pregnancy. The informants were invited to a personal meeting, where their weight and height were measured and where they also answered the 15D questionnaire. Data were analysed with chi(2) - test, Mann-Whitney-test, independent samples t-test and regression analysis. RESULTS The results for investigating the HRQoL indicated no significant differences on the 15D dimensions between the GDM group and the control group. The HRQoL for both groups was weakest on the dimensions of sleeping, discomfort and symptoms. Furthermore, the control group had a lower vitality score than the GDM group did. Analysis of the influence of background factors on HRQoL showed that women in a relationship experienced higher quality of life than single women. CONCLUSION This study showed no indication that womens lowered HRQoL, as measured by the 15D instrument, could be partly explained by GDM. Womens HRQoL was insignificantly decreased on the dimension of vitality only, so finding motivation for lifestyle changes and diabetes self-care may become challenging.

Views of midwives about ethical aspects of participation in placental perfusion studies

BACKGROUND Little is known regarding the role of the midwife in recruiting mothers to participate in scientific research. OBJECTIVE To describe ethical aspects of participation of midwives in placental perfusion studies. DESIGN Qualitative study involving thematic interviews and thematic content analysis. SETTING Two university hospitals in Finland in 2008-2009. PARTICIPANTS Midwives (n=20) who had been involved in recruiting mothers for a placental perfusion study. FINDINGS Midwives felt that the situation, when inviting the mothers to donate their placentas, was restless and hasty because of the considerable number of tasks required during a birth. For recruitment, they explained how they tried their best to find a quiet opportunity to provide information about the placental perfusion study, so that the mother could take her time reading the written information. During a birth, it was difficult to give information to the mother in such a way that she would truly understand. Information for the mother was planned to be provided in an equal, dialogic conversation, with the subject of research introduced by the midwife. Placental perfusion studies as carried out in this setting were not seen to have any risks for the mothers, and midwives were under less strain in this study than in other medical research projects. The midwives considered it normal to use placentas in scientific research, and did not see any associated ethical problems. In their opinion, the use of placentas was acceptable and even desirable, provided that the mother was informed about the research and gave voluntary informed consent. CONCLUSIONS AND IMPLICATIONS FOR PRACTISE Recruitment must be taken into account in management of the ward, and should be planned so that no recruitment is undertaken during medical procedures. Midwives need more education about the research including the important aspects of the creation of general knowledge about substances which may harm the fetus. Dialogue is needed between the mother and the midwife to ensure genuine informed consent.

Cultural aspects related to informed consent in health research A systematic review

Background: In order to protect the autonomy of human subjects, we need to take their culture into account when we are obtaining informed consent. Objective and research design: This study describes the cultural aspects related to informed consent in health research and is based on electronic searches that were conducted using the Scopus, PubMed, CINAHL, and Cochrane databases published between 2000 and 2013. A total of 25 articles were selected. Findings: Our findings indicate that cultural perspectives relating to the informed consent process are essential during the whole research process and particularly crucial in the planning phase of a study. Our study indicates that appropriate communication between different stakeholders plays a vital role in cultural understanding. Discussion and conclusion: The researchers’ awareness of cultural differences and their ability to work in a culturally sensitive way are key factors in improving study participation and retention in a multicultural context. Taking cultural aspects into account during the whole research process improves the quality of research.

Education of research ethics for clinical investigators with Moodle tool

BackgroundIn clinical research scientific, legal as well as ethical aspects are important. It is well known that clinical investigators at university hospitals have to undertake their PhD-studies alongside their daily work and reconciling work and study can be challenging. The aim of this project was to create a web based course in clinical research bioethics (5 credits) and to examine whether the method is suitable for teaching bioethics. The course comprised of six modules: an initial examination (to assess knowledge in bioethics), information on research legislation, obtaining permissions from authorities, writing an essay on research ethics, preparing one’s own study protocol, and a final exam. All assignments were designed with an idea of supporting students to reflect on their learning with their own research.Methods57 PhD-students (medical, nursing and dental sciences) enrolled and 46 completed the course. Course evaluation was done using a questionnaire. The response rate was 78%. Data were analyzed using quantitative methods and qualitative content analysis.ResultsThe course was viewed as useful and technically easy to perform. Students were pleased with the guidance offered. Personal feedback from teachers about students’ own performance was seen advantageous and helped them to appreciate how these aspects could be applied their own studies. The course was also considered valuable for future research projects.ConclusionsEthical issues and legislation of clinical research can be understood more easily when students can reflect the principles upon their own research project. Web based teaching environment is a feasible learning method for clinical investigators.

Placebo-controlled clinical trials: how trial documents justify the use of randomisation and placebo

BackgroundRandomised clinical trials (RCTs) involve procedures such as randomisation, blinding, and placebo use, which are not part of standard medical care. Patients asked to participate in RCTs often experience difficulties in understanding the meaning of these and their justification.MethodsWe reviewed RCT protocols, statements of the principal investigator (PI), and participant-information materials, as submitted for opinion to a research ethics committee. We evaluated how the justification for the use of placebo was described in these documents and how the participants had been informed about randomisation, placebo use, and the possible risks of receiving placebo.ResultsIn total, 52 RCTs were identified. Eighteen of the study protocols (35%) provided some rationale for the use of placebo. In 15 (29%) of the statements, the PI had provided justification for its use. Possible risks related to placebo use were described in nine (17%) of the statements. An explanation as to why placebo was necessary featured in only 12 (23%) of the sets of participant-information materials, and only six (12%) of the documents discussed the possible risks associated with placebo.ConclusionsThe justification of placebo control was inadequately described in the RCT study protocols, by principal or national co-ordinating investigators, and in participant-information documents. Furthermore, possible health-related risks associated with the use of placebo were poorly explained in the participant-information documents. Ethics committes and study participants need to be better informed of the rationale for the use of placebo, along with the associated risks.

Collaborative partnership and the social value of clinical research: a qualitative secondary analysis

BackgroundProtecting human subjects from being exploited is one of the main ethical challenges for clinical research. However, there is also a responsibility to protect and respect the communities who are hosting the research. Recently, attention has focused on the most efficient way of carrying out clinical research, so that it benefits society by providing valuable research while simultaneously protecting and respecting the human subjects and the communities where the research is conducted. Collaboration between partners plays an important role and that is why we carried out a study to describe how collaborative partnership and social value are emerging in clinical research.MethodsA supra-analysis design for qualitative descriptive secondary analysis was employed to consider a novel research question that pertained to nurse leaders’ perceptions of ethical recruitment in clinical research and the ethics-related aspects of clinical research from the perspective of administrative staff. The data consisted of two separate pre-existing datasets, comprising 451 pages from 41 interviews, and we considered the research question by using deductive-inductive content analysis with NVivo software. A deductive analysis matrix was generated on the basis of two requirements, namely collaborative partnership and social value, as presented in An Ethical Framework for Biomedical Research by Emanuel et al.ResultsThe findings showed that collaborative partnership was a cornerstone for ethical clinical research and ways to foster inter-partner collaboration were indicated, such as supporting mutual respect and equality, shared goals and clearly defined roles and responsibilities. In addition, the social value of clinical research was an important precondition for ethical clinical research and its realisation required the research partners to demonstrate collaboration and shared responsibility during the research process. However, concerns emerged that the multidimensional meaning of clinical research for society was not fully recognised. Achieving greater social value for clinical research required greater transparency, setting research priorities, shared responsibility for the dissemination and use of the findings and stronger community awareness of the ethics-related aspects of clinical research.ConclusionsCollaborative partnership and social values are essential for protecting the human subjects and communities involved in clinical research.

Ethical aspects in tissue research: thematic analysis of ethical statements to the research ethics committee

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.

Clinical features of Parkinson’s disease patients are associated with therapeutic misconception and willingness to participate in clinical trials

BackgroundClinical trials (CTs) are the “gold standard” to ensure the development of new effective treatments in medicine. A study was conducted to assess knowledge of, and attitudes toward, clinical trials among patients with Parkinson’s disease (PD), along with factors that motivate them to participate.MethodsA 50-item questionnaire on the views of patients with PD about CTs was developed. It included statements that the respondents assessed on a Likert scale from 1 (“strongly disagree”) to 5 (“strongly agree”). The questionnaire was mailed to a random sample (n = 2000) of members of the patient organization the Finnish Parkinson Association. In all, 708 response forms were returned, of which 681 were accepted after exclusion (a 34% response rate).ResultsIn general, attitudes of patients with PD toward CTs were positive. Older subjects and patients with lower education levels had inadequate knowledge of general issues related to CTs. Older age, low level of education, and lower number of PD medications were significant predictors for failure to understand the nature and purpose of clinical research. Additionally, significant positive correlation was found between education level and willingness to participate in CTs.ConclusionsPatients with PD have important gaps in their knowledge of methodological issues associated with CTs. The oldest subjects and those with a low level of education have the greatest information needs. Investigators should pay more attention to ensuring the comprehensibility of the information provided to potential CT participants.