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• W2111431666 abstract "The need for prospective studies in trauma radiology emerges as knowledge on the appropriate use of imaging becomes increasingly important in this field. Prospective observational studies enroll patients after research questions are articulated but only observe medical practice and should not compromise or change patient treatment. However, controversy exists regarding the requirement of informed consent from trauma patients in this type of study. This is reflected not only in differences in reporting informed consent in recent scientific publications on trauma radiology but also by the fact that policies regarding this topic vary in different parts of the world. The authors consider whether requesting informed consent is appropriate in prospective observational studies in trauma radiology from practical and different ethical perspectives. The need for prospective studies in trauma radiology emerges as knowledge on the appropriate use of imaging becomes increasingly important in this field. Prospective observational studies enroll patients after research questions are articulated but only observe medical practice and should not compromise or change patient treatment. However, controversy exists regarding the requirement of informed consent from trauma patients in this type of study. This is reflected not only in differences in reporting informed consent in recent scientific publications on trauma radiology but also by the fact that policies regarding this topic vary in different parts of the world. The authors consider whether requesting informed consent is appropriate in prospective observational studies in trauma radiology from practical and different ethical perspectives. Emergency radiologist X notices that her clinical colleagues request chest computed tomography (CT) in trauma patients with increasing frequency. Because it concerns her whether all these chest CT scans lend added value to the primary workup of these patients, she decides to investigate whether these studies find additional relevant diagnoses compared with conventional radiography of the chest. For this project, she plans to ask her colleagues to record injuries diagnosed on conventional radiography and CT in all patients who undergo CT according to her hospital's guidelines at the time of image interpretation. In addition, she will explicitly ask them to record radiographic findings before CT is performed (ie, prospectively). Before she submits the research proposal to the institutional review board, she wonders whether she should ask for patients' informed consent to perform this prospective observational research project. On one hand, she feels that in general, informed consent is needed in prospective studies. On the other hand, she presumes that patients will not be harmed or treated differently than according to the hospital guidelines. In addition, the consent requirement would not be feasible in a large number of potential (often obtunded) subjects, and consent might potentially delay emergency care. The need for the appropriate use of medical imaging is currently a hot topic. Whereas diagnostic possibilities increase with technical advances, rising costs and awareness of the hazards of excessive imaging cause concern [1Amis Jr, E.S. Butler P.F. Applegate K.E. et al.American College of Radiology white paper on radiation dose in medicine.J Am Coll Radiol. 2007; 4: 272-284Abstract Full Text Full Text PDF PubMed Scopus (695) Google Scholar]. This dilemma certainly arises in trauma radiology; although the young trauma population especially can be harmed by the excessive use of ionizing radiation [1Amis Jr, E.S. Butler P.F. Applegate K.E. et al.American College of Radiology white paper on radiation dose in medicine.J Am Coll Radiol. 2007; 4: 272-284Abstract Full Text Full Text PDF PubMed Scopus (695) Google Scholar, 2Brenner D. Elliston C. Hall E. Berdon W. Estimated risks of radiation-induced fatal cancer from pediatric CT.AJR Am J Roentgenol. 2001; 176: 289-296Crossref PubMed Scopus (2495) Google Scholar], the chance of missing injuries with undesirable consequences is substantial [3Pehle B. Kuehne C.A. Block J. et al.The significance of delayed diagnosis of lesions in multiply traumatised patients: a study of 1,187 shock room patients.Unfallchirurg. 2006; 109: 964-974Crossref PubMed Scopus (28) Google Scholar]. The problem of legal and financial consequences of missing injuries always plays a role in the United States and is starting to encroach in Europe as well. The appropriate use of trauma imaging can be established by investigating how to optimize the use of ionizing radiation and expensive imaging modalities [4Blackmore C.C. Clinical prediction rules in trauma imaging: who, how, and why?.Radiology. 2005; 235: 371-374Crossref PubMed Scopus (32) Google Scholar]. In trauma patients, it is especially prospective, observational diagnostic studies that can be used to gain knowledge on efficient use of trauma imaging [5Exadaktylos A.K. Sclabas G. Schmid S.W. Schaller B. Zimmermann H. Do we really need routine computed tomographic scanning in the primary evaluation of blunt chest trauma in patients with “normal” chest radiograph?.J Trauma. 2001; 51: 1173-1176Crossref PubMed Scopus (162) Google Scholar]. In prospective cohort studies, the research question is articulated before the first patient is enrolled and before any data are collected. In contrast to studies with retrospective designs, these studies collect and follow determinants and outcomes in a defined patient group over time. The chance of incomplete or nonrepresentative data collection is smaller than in retrospective studies [6Wright J.G. A practical guide to assigning levels of evidence.J Bone Joint Surg Am. 2007; 89: 1128-1130Crossref PubMed Scopus (61) Google Scholar]. Prospective studies are therefore preferred over studies with retrospective designs. Observational studies are studies that draw inferences from observations of interventions (such as imaging and radiologic reporting according to the hospital's protocol in our case) in which the assignment of these interventions is outside the control of the investigators [7Rosenbaum P.R. Observational studies. Springer-Verlag, New York1995Crossref Google Scholar]. This means that an observational study lacks an experimental design and should not compromise or change patient treatment. In contrast to randomized controlled trials, this kind of research can be executed without affecting common clinical practice. However, the combination of prospective and observational aspects in diagnostic studies means that these studies are executed concomitantly with patient care and that treating physicians or radiologists are aware that their patients are enrolled in research. Shouldn't patients be informed too? The purpose of informed consent is to respect the freedom of individuals to make intentional decisions. The question of whether informed consent is required in studies that prospectively evaluate standard diagnostic algorithms can be addressed from several perspectives. On one hand, practical barriers are that the informed-consent procedure in trauma patients can cause delays in treatment and that a substantial number of trauma patients are unable to give informed consent because they are unconscious, intubated, or intoxicated or have neurologic injuries. In addition, legal representatives are frequently unknown or not present to give consent. On the other hand, scientific journal policies demand that informed consent be explicitly obtained in all prospective studies. In this paper, we consider whether informed consent is appropriate in prospective observational diagnostic studies on trauma radiology. We first review how this issue has been addressed in the recent literature. We then examine relevant national and international guidelines on this topic, and finally, we consider the issue from 3 ethical perspectives. Both nationally and internationally, institutional review boards (IRBs) have different expectations and requirements for the ethical conduct of research with patients. It is therefore not surprising that several systematic reviews have reported wide variation in the requirements for and reporting of informed consent in medical studies [8Matot I. Pizov R. Sprung C.L. Evaluation of institutional review board review and informed consent in publications of human research in critical care medicine.Crit Care Med. 1998; 26: 1596-1602Crossref PubMed Scopus (37) Google Scholar, 9Vick C.C. Finan K.R. Kiefe C. Neumayer L. Hawn M.T. Variation in Institutional Review processes for a multisite observational study.Am J Surg. 2005; 190: 805-809Abstract Full Text Full Text PDF PubMed Scopus (43) Google Scholar, 10Goodyear-Smith F. Lobb B. Davies G. Nachson I. Seelau S.M. International variation in ethics committee requirements: comparisons across five westernised nations.BMC Med Ethics. 2002; 3: E2Crossref PubMed Google Scholar, 11Kass N.E. Hyder A.A. Ajuwon A. et al.The structure and function of research ethics committees in Africa: a case study.PLoS Med. 2007; 4: e3Crossref PubMed Scopus (88) Google Scholar]. Whether this also applies specifically to prospective observational studies in trauma radiology is unclear. We therefore performed a review of the literature on diagnostic procedures in trauma patients. The methods of this review are listed in Table 1. For all recent prospective observational studies on this topic, we considered whether informed consent was reported to have been requested.Table 1Systematic review of the recent literature: methodsPurposeTo review all publications on prospective observational studies of imaging procedures in trauma patients for the reporting of informed-consent procedures.SearchWe searched PubMed-cited studies using the MeSH terms “prospective studies” AND (“radiography” [subheading] OR “ultrasonography” [subheading]) AND “wounds and injuries” that were published between 2003 and March 2008. This search yielded 925 articles.InclusionWe evaluated all prospective, observational studies that were published in the English language. These studies were included if they reported on diagnostic imaging on trauma patients in emergency departments. We defined studies to be prospective if they had included patients prospectively from the start of the research project. We considered studies to be observational if no intervention was executed for research purposes only. Studies of patient cohorts that were previously described in the literature before 2003 (redundant publications) were not evaluated. This resulted in 158 included studies.Data collectionWe recorded whether it was reported that informed consent was requested and if IRB approval was sought. In addition, we collected data on population characteristics and locations where studies were executed.Note: IRB = institutional review board; MeSH = Medical Subject Heading. Open table in a new tab Note: IRB = institutional review board; MeSH = Medical Subject Heading. We found that of all studies involving children (n = 23), IRB approval was sought in 13 (57%), and informed consent was requested in only 9 studies (39%) involving children. Hence, in 10 studies (43%), IRB approval was not reported to be obtained, and in 14 studies (61%), no informed consent was requested or reported. Of the studies involving adults (n = 135), IRB approval was obtained in 82 (61%) and informed consent in 35 (26%). This means that in 74% of studies involving adults, informed consent was not reported to have been requested. However, we noticed a trend toward an increase in the reporting of informed consent and IRB approval over time (Figure 1). In Figure 2, the IRB approval rate is displayed per country and continent where studies were executed.Fig 2Number of publications of prospective observational studies (2003 to March 2008) on diagnostic imaging in pediatric and adult trauma patients: overview of informed consent report per country and continent. Percentages at the top of the figure represent the proportion of studies in each continent in which informed consent was requested. Afr = Africa; Au = Australia; IC+ = informed consent was reported; IC− = informed consent was not requested or not reported; Na = North America; Sa = South America.View Large Image Figure ViewerDownload Hi-res image Download (PPT) The results of this general literature review show that in a quarter of all prospective observational studies on diagnostic imaging in trauma patients, informed consent was requested and that this proportion did not substantially differ among continents. This implies that no consensus exists concerning the informed-consent requirements for this type of study. However, the reporting of informed consent has increased for this type of study in recent years. The Declaration of Helsinki [12World Medical AssociationDeclaration of Helsinki: ethical principles for medical research involving human subjects.http://www.wma.net/e/policy/pdf/17c.pdfGoogle Scholar] is one of the most fundamental bases for international ethical research jurisdiction. It states that for “every experimental procedure concerning human subjects … informed consent should be obtained.” In commentary on this [13Emanuel E.J. Wendler D. Grady C. What makes clinical research ethical?.JAMA. 2000; 283: 2701-2711Crossref PubMed Scopus (1659) Google Scholar], the Council for International Organizations of Medical Science [14Council for International Organizations of Medical SciencesInternational ethical guidelines for biomedical research involving human subjects.http://www.cioms.ch/frame_guidelines_nov_2002.htmGoogle Scholar] allows exemption from the requirement for informed consent in those cases in which the burden of such requirement would be great, the protections for confidentiality are adequate, and the research is of sufficient importance. However, the wording in these international guidelines is such that prospective observational research, as in the case described above, does not seem to come down to experimental procedures as mentioned in the Declaration of Helsinki. The implications of these international guidelines for the requirement for informed consent in observational or epidemiologic research are therefore differently interpreted in laws and directives in different parts of the world. In the United States, it is the “common rule” on the protection of human subjects [15US Department of Health and Human ServicesProtection of human subjects45 CFR 46.http://www.hhs.gov/ohrp/documents/OHRPRegulations.pdfGoogle Scholar] that reflects the Declaration of Helsinki. This rule states that an IRB can waive informed consent if 1) the research involves no more than minimal risk to the subjects; 2) it will not adversely affect the rights and welfare of the subjects; 3) the research could not practicably be carried out without the waiver; and 4) whenever appropriate, the subjects will be provided with additional pertinent information about the participation. Institutional review boards (IRBs) can seek a list of research categories that define whether a study is considered to carry minimal risk or not. Australia's National Statement on Ethical Conduct in Human Research [16Australian GovernmentNational Health and Medical Research CouncilAustralian Research CouncilNational statement on ethical conduct in human research.http://www.nhmrc.gov.au/publications/synopses/_files/e72.pdfGoogle Scholar] requires the review and approval of all epidemiologic research protocols and consent of the subjects even for research using already existing records, unless requiring consent would make a study scientifically impossible. The European Union provides directives and other legal instruments to the governments of its member states. It is the responsibility of these governments to incorporate and translate these directives into domestic law. Concerning informed consent, the directive Protection of Human Rights and Dignity of the Human Being With Regard to the Application of Biology and Medicine [17Council of EuropeConvention for the Protection of Human Rights and Dignity of the Human Being With Regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine.http://conventions.coe.int/treaty/en/treaties/html/164.htmGoogle Scholar] requires informed consent in any intervention in the health field, including research with regard to these interventions [18Council of EuropeAdditional Protocol to the Convention on Human Rights and Biomedicine, Concerning Biomedical Research.http://conventions.coe.int/treaty/en/Treaties/Html/195.htmGoogle Scholar]. However, it is unclear whether this directive applies to observational (ie, noninterventional) research, as in the case described above. Another European Union directive [19Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data.http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31995L0046:EN:HTMLGoogle Scholar] permits member states to use data from individuals without informed consent in the case of health-related research where the benefits to society outweigh any harm attributable to the invasion of privacy. In the Netherlands, several laws have been implemented on the protection of human beings in medical research. The Medical Research on Human Subjects Act [20Dutch Government, Regulations on medical research involving human subjects (Medical Research [Human Subjects] Act).http://www.ccmo-online.nl/hipe/uploads/downloads_catw/Medical%20Research%20involving%20Human%20Subjects%20Act%20March%2001%202006.pdfGoogle Scholar] provides clear guidelines that informed consent is needed in medical research. However, this law does not apply to observational research that merely consists of recording of medical data [21World Medical AssociationDeclaration of Helsinki: ethical principles for medical research involving human subjects.http://data.unaids.org/Publications/External-Documents-Restored/helsinki%20decl_en.pdfGoogle Scholar]. The only laws that cover observational research as in the case described above are the Law on Medical Treatment Agreement [22Dutch Government, Law on Medical Treatment Agreement.http://www.wgbo.nl/wetwgbo.pdfGoogle Scholar] and the Dutch Personal Data Protection Act [23Dutch Government, Personal Data Protection Act (unofficial translation).http://www.dutchdpa.nl/downloads_wetten/wbp.pdf?refer=true&theme=purpleGoogle Scholar]. These laws reflect respect for autonomy and the protection of patients' rights in the patient-physician relationship and the privacy of people in general, but they include the exemptions that information from medical records can be used for medical research without the patient's permission if asking permission is not reasonably possible or cannot be expected given the character and purpose of the study and if personal data are processed anonymously [22Dutch Government, Law on Medical Treatment Agreement.http://www.wgbo.nl/wetwgbo.pdfGoogle Scholar, 24Dutch Government, Exemption degree of the Personal Data Protection Act.http://wwwcbpweb.nl/indexen/ind_wetten_wbp_vrijstellingsbesluit.stmGoogle Scholar]. In summary, criteria for informed consent differ between official policies across the world—Australian rules seem to be stricter than US rules or European directives [25Brody B.A. The ethics of biomedical research: an international perspective. Oxford University Press, New York1998Google Scholar]. Whereas US policies seem to demand informed consent more as a means of duty, European countries tend to consider informed consent less a duty than a “matter of manners” [9Vick C.C. Finan K.R. Kiefe C. Neumayer L. Hawn M.T. Variation in Institutional Review processes for a multisite observational study.Am J Surg. 2005; 190: 805-809Abstract Full Text Full Text PDF PubMed Scopus (43) Google Scholar, 26Richardson L.D. The ethics of research without consent in emergency situations.Mt Sinai J Med. 2005; 72: 242-249PubMed Google Scholar]. In addition, it is hard to find generally valid guidelines that cover all prospective observational studies that consist only of recording, classifying, counting, and analyzing radiologic data. Finally, considering the wording of most directives and laws (which use the terms feasible, reasonably, and scientifically impossible), it is inevitable that these policies will be interpreted differently by professionals in the scientific and IRB communities. In conclusion, current policies do not provide a clear unified approach concerning informed consent in prospective observational studies, as in the case described above. This illustrates that more than just judicious liability is needed to meet moral requirements for good clinical research. We therefore address this issue in a broader, integrating light from 3 ethical perspectives. According to the main ethical requirements for medical research that are reflected in the Declaration of Helsinki, good research is based on moral principles, such as beneficence, justice, and respect for patients' autonomy. To make clinical research ethical, research with patients should therefore generate valuable knowledge, be scientifically valid, use fair subject selection, have a favorable risk/benefit ratio, be independently reviewed by an IRB, respect the privacy of potential and enrolled subjects, and incorporate informed consent [13Emanuel E.J. Wendler D. Grady C. What makes clinical research ethical?.JAMA. 2000; 283: 2701-2711Crossref PubMed Scopus (1659) Google Scholar]. However, in prospective observational studies, these moral requirements might interfere with one another to varying degrees. On one hand, the need for informed consent cannot be neglected. On the other hand, the value, validity, and justice of research are affected if informed consent (either from patients or from legally authorized representatives) is needed. Considering the latter, is informed consent really necessary for the ethical conduct of prospective observational studies if they meet all other of the aforementioned criteria? From a utilitarian point of view, medical research is good if it maximizes the summed utility across all those affected by the research [27Goodin R.E. Utility and the good.in: Singer P. A companion to ethics. Blackwell, Oxford, UK1993: 241-248Google Scholar]. Summed utility can be defined here as the sum of the preferences not only of all patients and their relatives, researchers, physicians, and others who will be involved in the research project, but also of the persons who are likely to be affected by generated knowledge in the future. We need to consider what gives the highest probability of the greatest preference satisfaction for the greatest number of people. In the decision on whether informed consent should be requested in prospective, observational diagnostic studies, we should therefore balance the interests or preferences of the patients not being asked informed consent and the interests or preferences of those who might benefit from the research. People vary in their individual perceptions and evaluations of their own needs, benefits, and harms [28Gillon R. Ethics needs principles—four can encompass the rest—and respect for autonomy should be “first among equals.”.J Med Ethics. 2003; 29: 307-312Crossref PubMed Scopus (357) Google Scholar]. Concerning the attitude of patients toward prospective observational studies without informed consent, little empirical research exists. One survey asked 225 patients in an emergency department if they would object to research with minimal to moderate risk. Seventy-five percent would not object in case of minimal-risk research, and 50% would not object in case of moderate-risk research [29Smithline H.A. Gerstle M.L. Waiver of informed consent: a survey of emergency medicine patients.Am J Emerg Med. 1998; 16: 90-91Abstract Full Text PDF PubMed Scopus (49) Google Scholar]. However, because in observational research, only data are collected, such research does normally not induce any risk to patients. It should, however, be noted that prospective studies might induce some adaptation of “common clinical practice” in case of research. One example is that radiologists might look more carefully at radiographs if they are monitored in a research project. As long as this is done on all patients, and as long as common clinical practice is based on the best knowledge available, this kind of research might theoretically improve care for patients under investigation rather than posing a risk. The interests of researchers and future patients concerning consent-free research have been surveyed more intensively. In a recent prospective survey of 1,734 severely injured trauma patients, 43% were unable to give informed consent within one hour. Whereas legal authorized representatives were available within approximately 3 hours, 20% remained unable to give consent [30Dutton R.P. Stansbury L.G. Hemlock B. Hess J.R. Scalea T.M. Impediments to obtaining informed consent for clinical research in trauma patients.J Trauma. 2008; 64: 1106-1112Crossref PubMed Scopus (34) Google Scholar]. It was subsequently demonstrated that the exclusion of nonconsenters from a study cohort induces selection (or “consent”) bias [31Buckley B. Murphy A.W. Byrne M. Glynn L. Selection bias resulting from the requirement for prior consent in observational research: a community cohort of people with ischaemic heart disease.Heart. 2007; 93: 1116-1120Crossref PubMed Scopus (52) Google Scholar, 32Al-Shahi R. Vousden C. Warlow C. Bias from requiring explicit consent from all participants in observational research: prospective, population based study.BMJ. 2005; 331: 942Crossref PubMed Scopus (87) Google Scholar]. Although this seems a valid argument for research without informed consent, the effect of unbiased knowledge on maximum welfare of the community is hard to quantify. Publication bias might exist on this topic because it was the researchers who submitted these reports. It is especially for researchers that achieving success will be less complex if informed consent can be omitted. Therefore, they might have elaborately stressed the dangers of consent bias. It should further be noted that no knowledge exists concerning the impact of alternatives to prospective informed consent (ie, deferred consent or community consultation) on study methodology in observational studies. In conclusion, prospective observational studies without informed consent do not seem unethical from a utilitarian point of view. The emergency radiologist in the case described above is therefore not required to request informed consent before she collects diagnosed injuries for the purposes of scientific research. However, the following should be considered: 1) empirical information on patient preferences is lacking, and 2) the value of knowledge without consent bias might be overestimated at the expense of potential patient preferences. Deontological ethics approaches the issue in a normative way from a more person-oriented point of view. As Immanuel Kant said, “Act only in accordance with that maxim or principle which you at the same time could conceive as a universal law.” According to Kant, this came down to nothing other than always treating people “as ends in themselves and never only as a means to other ends.” Treating people as means to other ends implies that we treat them as things or tools, not as people with capacities to decide for themselves. In contrast, if we treat people as ends in themselves, we respect their capacity to act on the principles we ourselves would like to be able to adopt. This reflects Kant's categorical imperative that demands that one should only perform actions that would be reasonable to want everybody to perform [33Davis N.A. Contemporary deontology.in: Singer P. A companion to ethics. Blackwell, Oxford, UK1993: 205-218Google Scholar, 34O'Neill O. Kantian ethics.in: Singer P. A companion to ethics. Blackwell, Oxford, UK1993: 175-185Google Scholar]. Deontological ethics absolutely bans actions through which a person would be reduced to being a means to other ends, irrespective of the consequences. Whether patients are actually harmed in observational studies is less important than whether they are treated as ends in themselves. However, whereas Kant's categorical imperative is not a ban on people being used, it warrants that this be done with the consent of the people involved [35Heubel F. Biller-Andorno N. The contribution of Kantian moral theory to contemporary medical ethics: a critical analysis.Med Health Care Philos. 2005; 8: 5-18Crossref PubMed Scopus (23) Google Scholar]. This consent, after all, implies that patients are being respected as people who are ends in themselves, not only means to other ends. We can conclude from the deontological point of view that patients should give their own free consent, even to take part in prospective observational research. So here, the moral requirement of treating people as ends overrules the duty that research should be practiced with the highest methodology feasible. From this approach, our emergency radiologist would be required to get informed consent from trauma patients before recording their injuries for study purposes. Virtue ethics also uses a person-oriented view, but considers the character traits of a good person. This is then manifested in this person's actions [36Pence G. Virtue theory.in: Singer P. A companion to ethics. Blackwell, Oxford, UK1993: 249-258Google Scholar, 37Gardiner P. A virtue ethics approach to moral dilemmas in medicine.J Med Ethics. 2003; 29: 297-302Crossref PubMed Scopus (87) Google Scholar]. In virtue ethics, a person of integrity does not depend on rational decisions only, but also on having well-educated emotions; it encompasses a morally admirable character [38Campbell A.V. The virtues (and vices) of the four principles.J Med Ethics. 2003; 29: 292-296Crossref PubMed Scopus (62) Google Scholar]. According to the Hippocratic oath, the main virtues to be pursued in patient care are beneficence, nonmaleficence, justice, and respectfulness [39The Dutch oath of Hippocrates.http://knmg.artsennet.nl/uri/?uri=AMGATE_6059_100_TICH_R155017769634208&xsl=AMGATE_6059_100_TICH_R15495243970383&PHPSESSID=7dab6a6cdad8971d850ae86e88e1d5acGoogle Scholar]. Hence, good doctors do not harm; they pursue the best for their patients. Observational studies are expected to neither substantially benefit nor harm the patients subjected to the studies. Requiring informed consent and consequently inducing study bias will therefore have no effect on beneficence and nonmaleficence, nor on justice concerning study patients. In contrast, future patients are likely to benefit from good prospective observational research. However, it remains doubtful whether the fourth item of the oath, respectfulness, is realized if patients are used for possible future benefits to others. Omitting informed consent does not seem compatible with this virtue. Apart from this, a good person in the role of researcher should pursue virtues that enable that person to attain the truth. These virtues can include objectivity, critical thinking, honesty, freedom from bias, and sharing knowledge [40Pellegrino E.D. Thomasma D.C. The virtues of medical practice. Oxford University Press, New York1993Google Scholar] or methodologic strictness, precision, truthfulness, and integrity [41van Es R. Meijlink T. Ethiek van het Wetenschappelijk onderzoek.in: Ethiek en professie. Kok, Kampen, The Netherlands1995: 66-92Google Scholar]. This implies, among other things, that a good researcher exhaustingly extends scientific knowledge with the best methodology possible. Although the observational design in the case described above is a pragmatic tool to achieve important knowledge, this certainly does not encompass the best methodology. Instead, a randomized, controlled trial would eliminate hindsight-, interpretation-, and validation bias. However, the latter methodology may conflict with the virtues of the Hippocratic oath and may generate even more practical difficulties than observational research does. Because virtue ethics is “person oriented,” it will try not to distinguish between the doctor and the researcher. So, as not to separate the two and to address the problem of conflicting virtues in our case, we refer to one of the cardinal virtues of Aristotle—prudence. This virtue is the inclination of the mind to choose the right actions and emotions in the actual situation, taking into account the ultimate goals as well as the concrete circumstances [42Dekkers W. Gordijn B. Practical wisdom in medicine and health care.Med Health Care Philos. 2007; 10: 231-232Crossref PubMed Scopus (4) Google Scholar]. This would probably imply that virtuous emergency radiologists would have the character that they are neither excessively concerned about showing respectfulness nor excessively interested in achieving the highest methodology. In addition, this means that virtuous emergency radiologists would refrain from strictly adhering to the general rules and instead have the character to balance appropriate virtues to make decisions per research project and per trauma case (although this would be rather impractical in daily health care). However, this also implies that from the point of view of virtue ethics, no uniform reply exists to whether the emergency radiologist in the case described above would have to ask informed consent from her patients. We conclude that for the ethical performance of prospective observational diagnostic studies that consist of no intervention other than collecting, recording, and analyzing medical data, no universal policy exists as to whether informed consent is required. The discussion of whether informed consent is required, therefore, not only depends on policies but should also take moral considerations into account." @default.
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• W2111431666 title "Observational Research in Trauma Radiology: Should Patients Be Informed?" @default.
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