Informed Consent for Retrospective Cohort Study Chart Review?
BMC Med Ethics. 2019; 20: 94.
Reporting of upstanding approving and informed consent in clinical research published in leading nursing journals: a retrospective observational report
Yanni Wu
1Nanfang Infirmary, Southern Medical University, Guangzhou, Guangdong People's Republic of Mainland china
Michelle Howarth
2The School of Health & Society, University of Salford, Greater Manchester, United kingdom
Chunlan Zhou
1Nanfang Hospital, Southern Medical Academy, Guangzhou, Guangdong People's Republic of Mainland china
Mingyu Hu
oneNanfang Hospital, Southern Medical University, Guangzhou, Guangdong People'south Republic of Red china
Weilian Cong
1Nanfang Infirmary, Southern Medical University, Guangzhou, Guangdong People's Republic of China
Received 2018 November 27; Accepted 2019 Nov 27.
- Data Availability Statement
-
The datasets used and/or analyzed during the current report are available from the respective author on reasonable asking.
Abstruse
Background
Ethical considerations play a prominent role in the protection of human subjects in clinical inquiry. To date the disclosure of ethical protection in clinical research published in the international nursing journals has not been explored. Our inquiry objective was to investigate the reporting of ethical blessing and informed consent in clinical enquiry published in leading international nursing journals.
Methods
This is a retrospective observational study. All clinical research published in the five leading international nursing journals from the SCI Journal Citation Reports betwixt 2015 and 2017 were retrieved to evaluate for show of upstanding review.
Results
A full of 2041 citations take been identified from the contents of all the five leading nursing journals that were published between 2015 and 2017. Out of these, 1284 clinical studies have been included and text relating to upstanding review has been extracted. From these, most of prospective clinical studies (87.v%) discussed informed consent. Merely half of those (52.nine%) reported that written informed consent had been obtained; few (3.six%) reported oral consent, and few (six.8%) used other methods such every bit online consent or completion and return of data collection (such as surveys) to denote assent. Notably, 36.ii% of those did non depict the method used to obtain informed consent and merely described that "consent was obtained from participants or participants agreed to join in the research". Furthermore, whilst almost of clinical studies (93.seven%) mentioned ethical approval; 92.5% of those stated the proper name of ethical committee and interestingly, only 37.1% of those mentioned the ethical approval reference. The rates of reporting ethical approval were different between different written report blazon, state, and whether fiscal support was received (all P < 0.05).
Conclusion
The reporting of ethics in leading international nursing journals demonstrates progress, but improvement of the transparency and the standard of ethical reporting in nursing clinical research is required.
Keywords: Clinical research, Informed consent, Ethical approval, Nursing journal, Research ideals
Background
Given the importance of protecting human subjects in clinical research, in that location is now greater scrutiny of researchers to ensure that ethical principles take been met during the process [1, ii]. The World Medical Association issued the Declaration of Helsinki in 1964 and established the international ethical regulations for medical studies involving human subjects with subsequent updates [3]. The Proclamation of Helsinki highlighted 2 aspects of ethical considerations: that all of the participants accept the right to be informed about the study, by giving informed consent, and that an ethics committee blessing should have got to ensure the appropriateness of design before initiating a research [iv]. Furthermore, journals and publishers, have a responsibleness to act as "gate-keepers", and are obliged to scrutinize whether ethical approval of man inquiry has been obtained priori to submission of papers [5]. This responsibility mirrors the requirement of the Declaration of Helsinki that "Researchers, authors, sponsors, editors and publishers all accept upstanding obligations……Reports of inquiry not in accordance with the principles of this Declaration should not be accepted for publication" [4]. This duty of journals and publishers is supported past the International Committee of Medical Periodical Editors (ICMJE) [6] and adopted past journal editors and publishers. Following this, the Nuremberg Code [seven], the World Clan of Medical Editors (WAME) [8], and the Committee of Publication Ethics (COPE) [ix] established upstanding principles to protect man right in medical research. For instance, COPE stipulated that journals should provide guidance to support the reporting of ethical blessing and informed consent when publishing human research.
However, the reporting of ethical considerations withal less than platonic in human research though it is acknowledged that some progress has made in contempo years. For example, Yank and Rennie [one] investigated the upstanding protections of clinical trials published in top v medical journals including The Lancet, JAMA, BMJ, The New England Journal of Medicine, and Register of Internal Medicine and found that 31 and 26% manufactures published before 1997 did not written report ethical approval and informed consent, respectively. Furthermore, xviii% of publications in these five journals after 1997 did not study ethical approval and informed consent. More recently, like findings were identified by a range of authors, suggesting that this is a mutual challenge faced past journals [10–17]. For example, Schroter, Plowman [10] reviewed five general medical journals and reported that 47 and 31% of man research did not draw whether informed consent and ethical approving have obtained. More than recently, the increasing concern on human being rights protection has influenced this and ethical transgressions take improved. This was illustrated past Bridoux, Schwarz [18], who reported that 92.two% of surgical trials described informed consent and 87.seven% stated ethical blessing. Still, publications that are non in accordance with the principles of ethical reporting remains common [19–22]. For example, White potato, Nolan [twenty] identified that 42.9 and 49.9% of clinical research published in iii leading European Otolaryngology periodicals did not written report informed consent and ethical approval, respectively.
Nursing research has progressed apace during the last iii decades and supported the evolution of efficient and loftier-quality care. This is observed in a number of nursing bookish journals, increased volume of nursing inquiry, and professors in nursing [23–25]. The growth in nursing inquiry presents a range of challenges, non least considering of the vulnerable groups that nursing research includes and the capability and chapters of nurses to conduct ethically audio research. Worryingly, it is best-selling that many nurses receive inadequate educational activity, frequently compounded with lack of ethical awareness and knowledge when conducting clinical inquiry [26–29]. This was reflected in findings reported by Negarandeh and Gobady [30] who identified that 70.8% of nurses and midwives lack of education on upstanding issues. These challenges within nursing enquiry has raised concerns and the International Council of Nurses Code of Ideals for Nurses [31] has founded to regulate inquiry ideals in the nursing profession. Therefore, information technology is essential to identify the extent to which ethical review is reported in nursing publications to both regulate and monitor ethics in nursing research involving homo subjects.
Currently, the majority of ethics investigation have focused on reports in medical journals. In society to identify the extent to which upstanding approval on human research is reported in nursing journals, nosotros conducted a study to explore the upstanding considerations amidst 12 Chinese top nursing journals. Our findings identified that simply 51.8 and 25.nine% of clinical trials reported informed consent and ethical approval, respectively [32]. The purposes of this report were to assess the rates of reporting of upstanding considerations in five leading international nursing journals following the piece of work of Yank and Rennie [1].
Methods
Report design and inclusion criteria
This is a retrospective observational report adhered to STROBE guidelines. All publications that reported clinical research in five high ranked nursing journals, according to the 2017 SCI Periodical Citation Reports' bear on factor between 2015 and 2017 were retrieved to evaluate for bear witness of ethical review. These journals, with a high impact factor, were International Journal of Nursing Studies (three.755), European Journal of Cardiovascular Nursing (2.763), Periodical of Family Nursing (ii.537), Nurse Education Today (two.533), and Nativity-issues in Perinatal Care (two.518). Publications were included if the following criteria were met: (1) Clinical research articles: as described past previous studies [x, xi, 13, 20], the sample frame selected included all original research articles involving human participants or human tissue. (two) Total-text articles. Supplement published studies, protocols, laboratory and animal studies, reviews, messages, editorials, discussion papers, erratum/corrigendum, commentaries, and news were excluded.
Data extraction
Data were extracted betwixt August 2017 and July 2018. The contents and full-text PDFs of the five top nursing journals betwixt 2015 and 2017 were extracted and downloaded from the Wiley Online Library or the ScienceDirect through the academy subscription. Two authors (W.C and M.H1) independently reviewed the manufactures published in the five nursing journals in keeping with the standardized eligibility criteria to ensure the accuracy and brownie of the process. All of the manufactures were identified and reviewed based on the contents of each issue of journal. The total text of each included article was carefully read and the results were recorded in a standardized data extraction form. Disagreements were resolved by consensus or the 3rd person (Y.W). Following this, manufactures that did not written report ethical review were checked again by the tertiary person (Y.West).
The primary outcome of our study was to define the rates of reporting informed consent and ethical approval. We included papers with any of the following types descriptions (with examples). (1) Informed consent – a. written informed consent obtained ("the written informed consent was obtained from participants or the legally authorized representative"), b. oral informed consent obtained ("the oral/verbal consent was obtained from participants"), c. other consent blazon (has been categorized as "the participants' consent was indicated by the completion and returning of the questionnaire", "consent was obtained through providing information and finishing consent section or a consent form inside the online portal", and "the informed consent was indicated by participants take part in evaluations"), d. the consent type not reported (just described that "consent was obtained from participants or participants agreed to join in the research", but did not indicate the way to get the consent), and e. consent was waived or not required ("informed consent was exempted or not required due to the policy or the constabulary of the government or the type of the enquiry"). The dates on informed consent in the written report were collected on prospective studies just [20]. (ii) Upstanding approving – we checked to make up one's mind if the study reported that it was approved by the ethics committee in the hospital or other institutions before undertaking the research. We also examined whether the name of the upstanding commission and ethical approval reference number was reported.
The secondary outcomes of our study included the rates of reporting other details related to ethical approval and informed consent including upstanding argument. For example, whether the author declared that the research conformed to the Declaration of Helsinki, and if the enquiry participants had been told that they have the right to withdraw from the study at any time without reprisal. There was excellent agreement on the two primary effect measures betwixt two authors (W.C and M.H1) (reporting of informed consent and ethical approving) (k > 0.95 for all).
We collated boosted data that included the study blazon, funding sources, and nationality of publishing institution to enable subgroup analysis. Firstly, the blazon of research was categorized as either prospective or retrospective based on prior studies [11, xiii, 15]. Following this, the prospective studies were divided into randomized controlled trial (RCT), nonrandomized trial, observational report (including audit, surveys, quality assurance activities, prospective cohort study, and qualitative study), unmarried-arm, specimen, and mixed methods written report. The retrospective studies were divided into specimen, chart review, and database analysis. Secondly, information were gathered on whether research received financial support following the work of Yank and Reinnie [1], regardless of the type of funding. Finally, given the unlike clinical ethical dilemmas in different countries [33], we identified the nationality of publishing establishment of each written report, divers equally the country of the research conducted institution.
Information assay
Data was analyzed using SPSS twenty.0 software (IBM, The states). The rates of informed consent and ethical approving between yr, study types, funding sources, and unlike countries were compared past utilize of Chi-square tests or Fisher's exact tests (where cell size was less than 5). All P values were two-sided, and a value of P < 0.05 was indicated pregnant.
Results
Written report selection
A total of 2041 citations were identified from the contents of all the five leading nursing journals published between 2015 and 2017. From these, 757 were screened out using the data extraction process. These were: 335 reviews, one laboratory investigation, one research protocol, and 420 other types (letters, editorials, word papers, erratum/blunder, commentaries, and news). In full, 1284 clinical papers were included to extract the data of ethical review (run into Fig.1).
Informed consent
Of the 1284 clinical studies, 99 were retrospective studies and 1185 were prospective studies. Of the 1185 prospective studies, 1037 (87.v%) mentioned informed consent. However, but 549 (52.9%) of those reported that written informed consent had been obtained, and just 37 (3.6%) of these had reported oral consent. Interestingly, seventy (6.viii%) of studies had used other ways to indicate participants' consent, such equally 'assent' through the completion and render of the questionnaire in surveys, or finishing online consent section, or unsaid by participants nourish enquiry evaluations. Notably, a small number 375 (36.two%) described that "consent was obtained from participants or participants agreed to join in the research" but did not elaborate on the methods used to gain consent. Furthermore, six (0.5%) studies stated that the informed consent from participants were waived or not required due to the policy or the law of the government or the type of the inquiry (Tabular arrayane). In improver, the rates of reporting informed consent between unlike publication years and bear witness of research funding demonstrated no statistical significance (all P > 0.05) just variances were observed between different country (P < 0.001) (Tabular array2).
Tabular array 1
Ethical review of studies published in leading nursing journals between 2015 and 2017
| Journal | Number of studies (N, %) | Informed consent in prospective studies (N, %) | Ethical approval (N, %) | Upstanding statement (N, %) | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Total | Prospective studies | Retrospective studies | Total | Written consent obtained | Oral consent obtained | Other consent type | The consent type non reported | Waived or non required | |||
| International Journal of Nursing Studies | 330 | 300 (90.9) | xxx (ix.1) | 259 (86.3) | 159 (61.four) | fifteen (five.8) | iv (ane.5) | 76 (29.iv) | 5 (1.9) | 324 (98.2) | 38 (xi.5) |
| European Journal of Cardiovascular Nursing | 170 | 160 (94.one) | 10 (5.ix) | 151 (88.8) | 104 (68.9) | one (0.7) | 3 (2.0) | 43 (28.iv) | 0 | 164 (96.5) | 107 (62.9) |
| Journal of Family Nursing | 45 | 45 (100) | 0 | 41 (91.1) | 32 (78.one) | 1 (2.4) | 0 | 8 (19.5) | 0 | 43 (95.vi) | 4 (8.9) |
| Nurse Educational activity Today | 621 | 611 (98.4) | ten (1.vi) | 525 (85.ix) | 217 (41.3) | 16 (3.1) | 62 (11.viii) | 229 (43.6) | i (0.ii) | 567 (91.three) | 32 (51.v) |
| Nativity-issues in Perinatal Intendance | 118 | 69 (58.5) | 49 (41.5) | 61 (88.4) | 37 (60.seven) | 4 ((6.6) | one (1.six) | 19 (31.1) | 0 | 105 (89.0) | 0 |
| Total | 1284 | 1185 (92.3) | 99 (seven.7) | 1037 (87.5) | 549 (52.9) | 37 (3.6) | 70 (6.8) | 375 (36.2) | 6 (0.5) | 1203 (93.7) | 181 (14.1) |
Table 2
Reporting of informed consent and upstanding approval in clinical enquiry in leading nursing journals between 2015 and 2017
| Items | Number of clinical researches | Number of Prospective studies | N (%) | |
|---|---|---|---|---|
| Informed consent reported | Ethical approval reported | |||
| Year | ||||
| 2015 | 398 | 364 (91.v) | 328 (90.1) | 376 (94.v) |
| 2016 | 510 | 477 (93.5) | 411 (86.two) | 477 (93.5) |
| 2017 | 376 | 344 (91.5) | 298 (86.six) | 350 (93.ane) |
| X ii | 0.462 | 0.045 | ||
| P value | 0.794 | 0.978 | ||
| Study blazon | ||||
| Prospective studies | 1185 | – | 1037 (87.5) | 1121 (94.6) |
| Randomized controlled trial | 122 | – | 113 (92.half-dozen) | 119 (97.5) |
| Nonrandomized trial | 62 | – | 52 (83.9) | 61 (98.iv) |
| Observational study | 835 | – | 734 (87.nine) | 792 (94.9) |
| Single-arm | 66 | – | 52 (78.8) | 55 (83.3) |
| Specimen | 0 | – | 0 | 0 |
| Mixed methods report | 100 | – | 86 (86.0) | 94 (94.0) |
| Retrospective studies | 99 | – | – | 82 (82.8) |
| Specimen | 0 | – | – | 0 |
| Nautical chart review | 21 | – | – | 20 (95.ii) |
| Database analysis | 78 | – | – | 62 (79.v) |
| P value | – | < 0.001 | ||
| Mentioning financial support | ||||
| Yes | 702 | 662 (94.3) | 587 (88.7) | 668 (95.2) |
| No | 582 | 523 (89.9) | 450 (86.0) | 535 (91.9) |
| P value | 0.185 | 0.021 | ||
| The land of conducting the research | ||||
| US | 186 | 155 (83.3) | 127 (81.9) | 175 (94.i) |
| Australia | 148 | 137 (92.6) | 118 (86.1) | 147 (99.3) |
| Uk | 144 | 136 (94.iv) | 111 (81.half dozen) | 138 (95.8) |
| China | 124 | 119 (96.0) | 107 (90.0) | 118 (95.2) |
| Sweden | 69 | 63 (91.3) | 59 (93.7) | 66 (95.7) |
| ≥ two countries | 63 | 59 (93.7) | 48 (81.4) | 52 (82.five) |
| Canada | 60 | 55 (91.7) | 51 (92.7) | 58 (96.7) |
| Netherlands | 47 | 44 (93.half-dozen) | 39 (88.6) | 42 (89.4) |
| Espana | 43 | 40 (93.0) | 35 (87.v) | 31 (72.ane) |
| Korea | 43 | 41 (95.three) | 39 (95.1) | 43 (100) |
| Turkey | 33 | 33 (100) | 33 (100) | 28 (84.9) |
| Norway | 25 | 23 (92.0) | 22 (95.7) | 24 (96.0) |
| Italy | 25 | 23 (92.0) | 21 (91.three) | 23 (92.0) |
| Japan | 19 | 16 (84.2) | xv (93.8) | 19 (100) |
| Finland | 17 | 16 (94.1) | 14 (87.5) | 15 (88.2) |
| Ireland | 17 | 16 (94.1) | 12 (75.0) | 13 (76.five) |
| Singapore | 17 | 17 (100) | xvi (94.i) | xvi (94.ane) |
| State of israel | 16 | 12 (75.0) | 9 (75.0) | 16 (100) |
| Germany | fifteen | 14 (93.3) | 11 (78.half dozen) | 13 (86.vii) |
| Denmark | 14 | 14 (100) | 14 (100) | 13 (92.9) |
| Kingdom of belgium | 13 | 13 (100) | 12 (92.iii) | xiii (100) |
| Iran | 13 | thirteen (100) | 12 (92.iii) | 13 (100) |
| Jordan | xi | eleven (100) | 10 (90.1) | 10 (90.1) |
| Brazil | eleven | 10 (90.1) | 9 (ninety.0) | eleven (100) |
| France | ix | 7 (77.8) | 5 (71.4) | 8 (88.nine) |
| New Zealand | 8 | 6 (75.0) | 4 (66.7) | 8 (100) |
| Switzerland | eight | 8 (100) | eight (100) | seven (87.five) |
| Thailand | 7 | seven (100) | vi (85.7) | 7 (100) |
| South Africa | half dozen | 6 (100) | 6 (100) | 6 (100) |
| Greece | v | 5 (100) | iv (eighty.0) | v (100) |
| Poland | five | 5 (100) | 5 (100) | 5 (100) |
| Portugal | five | 5 (100) | 5 (100) | v (100) |
| Iceland | 4 | three (75.0) | 3 (100) | three (75.0) |
| Republic of india | 4 | 4 (100) | 3 (75.0) | 4 (100) |
| Indonesia | four | 4 (100) | 3 (75.0) | iv (100) |
| Malaysia | iv | 4 (100) | four (100) | 4 (100) |
| Lebanese republic | 4 | 4 (100) | 4 (100) | 4 (100) |
| Philippines | 4 | four (100) | four (100) | 4 (100) |
| Saudi arabia | 4 | 4 (100) | ii (50.0) | 3 (75.0) |
| Croatia | 3 | 3 (100) | 2 (66.7) | 3 (100) |
| Afghanistan | 2 | 2 (100) | ii (100) | two (100) |
| Africa | two | 2 (100) | 2 (100) | 2 (100) |
| Chile | ii | 1 (50.0) | 1 (100) | 2 (100) |
| Mexico | 2 | 2 (100) | 2 (100) | 2 (100) |
| Nepal | 2 | ii (100) | 2 (100) | 2 (100) |
| Oman | 2 | two (100) | 2 (100) | ii (100) |
| Negara brunei darussalam | 1 | 1 (100) | 1 (100) | 1 (100) |
| Dutch | 1 | 1 (100) | ane (100) | 1 (100) |
| Egypt | 1 | 1 (100) | 1 (100) | ane (100) |
| Federal democratic republic of ethiopia | 1 | 1 (100) | ane (100) | 1 (100) |
| Florida | 1 | 1 (100) | i (100) | 1 (100) |
| Lithuania | 1 | 1 (100) | 1 (100) | i (100) |
| Republic of madagascar | 1 | 1 (100) | 1 (100) | 0 |
| Malawi | 1 | i (100) | 1 (100) | 1 (100) |
| Nigeria | i | one (100) | 1 (100) | ane (100) |
| Pakistan | ane | 1 (100) | ane (100) | ane (100) |
| Palestine | ane | 1 (100) | one (100) | 1 (100) |
| Qatar | i | 1 (100) | 1 (100) | 1 (100) |
| Serbia | 1 | ane (100) | ane (100) | 1 (100) |
| Slovenia | 1 | one (100) | 0 | 1 (100) |
| Srilanka | one | 1 (100) | 1 (100) | 1 (100) |
| P value | < 0.001 | < 0.001 | ||
Ethical approval
Our results bespeak that 1203 (93.7%) of 1284 clinical studies reported upstanding approval in the main text of the paper. Of the 1203 studies, 1144 (95.one%) reported that ethics committee approval was obtained before the study was undertaken and 59 (4.9%) of studies stated that the ethical approval for the study was not required or waived under the local or national laws. Notably, of the 1144 studies that reported ethical approval had been obtained, a larger number, 1058 (92.5%) of studies stated the name of ethical committee, still, only 424 (37.1%) of studies included the ethical blessing reference number. A small-scale number, 181 (14.ane%) of studies stated that ethical considerations of the inquiry conformed to the Declaration of Helsinki (Tabular array 1). Furthermore, no statistically significant differences were found between 2015 and 2017 in relation to the rates of reporting ethical approving (P > 0.05). Notably, the rates of reporting ethical approving were different between dissimilar study type, country, and whether mentioning financial support (all P < 0.05). The rates of reporting upstanding approving in prospective studies was much higher than retrospective studies (94.6% vs 82.8%). Moreover, the reporting of ethical approval in the studies that had financial support, was much higher than those who did not receive funding (95.2% vs 91.nine%) (Table 2).
Discussion
Our findings revealed a relative progression in the reporting of ideals as compared with prior studies such every bit Yank and Rennie [1], Schroter, Plowman [10], Pitak-Arnnop, Sader [14], and Fitzgerald [19]. For instance, we identified that 87.5% of prospective clinical studies reported informed consent and 93.vii% of clinical studies stated that ethical approval had been obtained. This is similar to Bridoux, Schwarz [18] findings that reported 87.7 and 92.two% of surgical trials stated ethical approval and informed consent, respectively. However, the reporting rates of ideals were much higher than most of other studies. For instance, informed consent and ethical approval were reported in 53 and 69% in v full general medical journals, 68.5 and 71% in six leading anesthesia journals, 36 and 39.three% in 4 major orthodontic journals, 57.1 and fifty.1% in three leading European Otolaryngology journals, likewise as 16 and 54% in 3 paediatric surgical journals, respectively [10, 11, 19, 20, 22]. Furthermore, the reporting of ethical considerations in the five leading international journals was more frequent than the twelve top Chinese nursing journals we previously investigated in 2017. These earlier findings highlighted that just 51.8 and 25.nine% of clinical trials stated informed consent and upstanding approval, respectively [32]. This more recent increase may have been influenced though the rapid development of medical engineering science which has enriched the content of nursing clinical inquiry. However, it is acknowledged that China's higher nursing education adult slowly considering of ceremonious wars and external invasion until 1949 and even so need more efforts to improve the cognition and awareness of ideals among nursing researcher [34].
Importantly, our findings indicated that the reporting of ethical approval in leading international nursing journals is less than platonic and piece of work is needed to develop a standardized approach. Whilst our research illustrates a welcome progression, equally, the reporting of upstanding approval is now recognized past leading journals as an essential pre-publication requirement. Notwithstanding, the detail of what is reported needs to exist developed to enable readers and editors to sympathise that the reporting of consent was more than than simply 'consent' and that it was truly informed, thus reflecting the autonomous rights of the research participants. Simply stating fact that 'informed consent' was obtained, does not necessarily mean that consent was actually informed [1]. Signing a consent grade or explicitly negotiated verbal consent presents ii traditional methods in which participants' informed consent is obtained [three]. With the rapid development of network techniques, using electronic methods to obtain informed consent is now considered to be a convenient as compared to other ways especially in some online questionnaire survey research. Furthermore, based on the 375 studies that did not describe the way to get the consent, determining whether the ethical considerations reported were implemented equally challenging. Moreover, the reason for exemption should exist alleged past the authors which should include a rationale for absenteeism of informed consent and/or ethical approval. For example, lack of informed consent maybe as a upshot of fully anonymised samples or legal reasons [xv]. In our study, simply 59 (four.9%) of studies stated that the ethical approval for the study was not required or waived nether the local or national laws. Of the studies that take been identified as not reporting ethical considerations, we are unable to report whether the ethical protections of these studies were deemed unnecessary or if the researcher did not consider it. Therefore, the reporting of upstanding protection of clinical research in leading nursing journals needs to be transparent and standardized.
Furthermore, our report identified progression in the reporting of ethical approval, however, only 37.one% of studies mentioned the ethical approving reference number. Although the upstanding principles of the Declaration of Helsinki and the ICMJE do not stipulate that authors report the proper name of ethics committee and the blessing number in the text, information technology has been recommended by many researchers [1, 20, 35]. Similar reporting expectations are included in the writer instructions in numerous medical journals such as the BMJ, the European Journal of Cardiovascular Nursing, and the Periodical of Family Nursing. This conflict in reporting of ethical committees and references numbers could be explained past the following two reasons. Firstly, the inclusion of the ethics committee details and reference helps to regulate upstanding statement and to make sure that the ethical approval is accurate. Secondly, at that place is stiff evidence to evidence the different effectiveness and practise between dissimilar local committees, stating the name of ideals committee could as well assistance readers or others make decisions on the ethical protections of the study [36, 37]. In addition, our report, but 5 clinical studies stated the organizational approval to conduct the research including the approving from the dean'south office, the schoolhouse management, and the head of the department. Though this may be due to the system policy, this approach does not comply with the principles of the Declaration of Helsinki which states that the inquiry should be approved past an independent ethics commission. Therefore, the argument of the ideals commission approval in clinical studies even so need to be standardized and improved.
It was surprising that there was no deviation betwixt publication year on upstanding considerations in leading international nursing journals, which is reverse to the results on twelve Chinese nursing journals demonstrated a sharp improvement previously identified betwixt 2013 and 2016 [32]. This may have been influenced past recent higher educational activity establishment, the ethics committee, and the nursing journals efforts in Red china in recent years.
Furthermore, our research demonstrated that the rates of reporting ethical approving in prospective studies was much higher than retrospective studies (94.6% vs 82.eight%). Specifically, RCTs showed a relatively high reporting rates whereas the report blazon of database and unmarried-arm need more attention to improve the reporting of upstanding considerations. This is supported by Block [13] who plant that the RCTs showed a loftier proportion in reporting of upstanding approving. Most of researchers obtained ethics committee approval for RCTs and were non realized that approval withal required for studies that do not enroll homo participants such as retrospective studies on chart or database review [15]. Moreover, although nosotros only retrieved the rates of reporting informed consent in prospective studies in line with prior studies [13, 20], we are enlightened that neither retrospective studies published in the five leading international nursing journals stated the informed consent. The Declaration of Helsinki states that if informed consent for medical research using existing human being data or material is impracticable to obtain, the research could exist done afterward blessing of an ethics committee. Furthermore, some researchers too stated that the informed consent is not required to the retrospective studies because this kind of study come across the criteria that "the research involves no more than minimal risk to the subjects" [13].
Conclusion
In summary, nursing journals presume an extremely important social, moral and ethical responsibility to ameliorate and regulate the reporting of upstanding considerations in clinical inquiry. The reporting of ethics in the five leading international nursing journals showed some progress, but attempt is withal required to standardize the transparency and detail of ethical reporting.
Acknowledgements
Non applicable.
Abbreviations
| COPE | The Committee of Publication Ideals |
| ICMJE | The International Committee of Medical Journal Editors |
| RCTs | Randomized controlled trials |
| WAME | The Globe Association of Medical Editors |
Authors' contributions
YW, MH2, and CZ were responsible for protocol blueprint of the research. YW, WC and MH1 extracted and analyzed the data from the five leading nursing journals. YW wrote the get-go draft of the manuscript and MH2 helped with the revisions of the article. All authors read and approved the final manuscript.
Funding
The project was funded by the Mainland china Editology Society of Science Periodicals (CESSP) of China Association for Scientific discipline and Technology (No. castqk2017-qnkt-01). The funder had no function in study design, information collection and analysis, decision to publish, or preparation of the manuscript.
Availability of data and materials
The datasets used and/or analyzed during the current written report are available from the corresponding author on reasonable request.
Ethics approving and consent to participate
The study is exempt from review by the Ethics Committee of Nanfang Infirmary based on the basis that this blazon of study is non-homo subject research, and waived the demand for informed consent.
Consent for publication
Non applicative.
Competing interests
The authors declare that they accept no competing interests.
Footnotes
Publisher'south Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Yanni Wu and Michelle Howarth contributed equally to this work.
References
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Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6896583/
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