Ethical and coordinative challenges in setting up a national cohort study during the COVID-19 pandemic in Germany.

With the outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), global researchers were confronted with major challenges. The German National Pandemic Cohort Network (NAPKON) was launched in fall 2020 to effectively leverage resources and bundle research activities in the fight against the coronavirus disease 2019 (COVID-19) pandemic. We analyzed the setup phase of NAPKON as an example for multicenter studies in Germany, highlighting challenges and optimization potential in connecting 59 university and nonuniversity study sites. We examined the ethics application process of 121 ethics submissions considering durations, annotations, and outcomes. Study site activation and recruitment processes were investigated and related to the incidence of SARS-CoV-2 infections. For all initial ethics applications, the median time to a positive ethics vote was less than two weeks and 30 of these study sites (65%) joined NAPKON within less than three weeks each. Electronic instead of postal ethics submission (9.5 days (Q1: 5.75, Q3: 17) vs. 14 days (Q1: 11, Q3: 26), p value = 0.01) and adoption of the primary ethics vote significantly accelerated the ethics application process. Each study center enrolled a median of 37 patients during the 14-month observation period, with large differences depending on the health sector. We found a positive correlation between recruitment performance and COVID-19 incidence as well as hospitalization incidence. Our analysis highlighted the challenges and opportunities of the federated system in Germany. Digital ethics application tools, adoption of a primary ethics vote and standardized formal requirements lead to harmonized and thus faster study initiation processes during a pandemic.

Ethical considerations referred to in child health research published in leading nursing journals: 2015-2019.

BACKGROUND: Child health research comprises complex ethical considerations. Understanding the extent to which the ethical process is reported in child health research is needed to improve reporting. AIMS: To identify reportage of ethical considerations in child health research in leading nursing and paediatric journals. METHODS: All child health research published between 2015 and 2019 in 10 leading nursing journals and two paediatric journals were retrieved and critically appraised for the reportage of informed consent and ethical approval. RESULTS: Eight hundred and fifty-one child health research papers were included. Although 544 (79.9%) of the prospective studies mentioned informed consent, only 300 (55.2%) reported that written informed consent was obtained from the participants. Overall, 748 (87.9%) of child health research papers noted obtaining research ethics committee approval. Articles that mentioned financial support were significantly more likely to report informed consent and ethical approval than unfunded studies (all P < 0.001). Prospective studies showed higher rates of reportage of ethical approval compared to retrospective studies (P = 0.027). Rates of child consent (assent) obtained in different age groups of children ranged from 29.6% to 66.3%. CONCLUSION: Despite improvements in the reportage of ethical review and approval processes in child health research, consistent and transparent reports are still lacking.

Challenges to conducting randomised controlled trials with adults with intellectual disabilities: Experiences of international experts.

BACKGROUND: Globally, conducting randomised controlled trials can be a complex endeavour. The complexity increases when including participants with cognitive or intellectual disabilities. A fuller understanding of the barriers and challenges that can be expected in such trials may help researchers to make their trials more inclusive for people with disabilities. METHOD: Semi-structured interviews were conducted with twelve international trial experts. RESULTS: Eight themes emerged relating to challenges linked to: 1) participant co-morbidities, 2) participant ability levels, 3) ethics and consent, 4) the RCT methodology, 5) gatekeeping, 6) staff turnover, 7) lack of technical understanding and 8) attitudes and perceptions. CONCLUSION: Conducting trials with cognitively disabled participants can pose unique challenges although many can be overcome with 'reasonable adjustments'. Challenges that are harder to overcome are attitudes and perceptions that people (professional staff, funding bodies, carers or fellow researchers) hold towards the utility of conducting trials with cognitively disabled populations.

Using a Delphi survey to gain an international consensus on the challenges of conducting trials with adults with intellectual disabilities.

BACKGROUND/AIMS: People with intellectual disability experience higher rates of multi-morbidity and health inequalities, they are frequently prescribed medications and more likely to have an avoidable or premature death. There is a recognised lack of randomised controlled trials, and subsequently a lack of evidence base, for many of the interventions and treatments provided to people with intellectual disabilities. Very few disability-specific trials are conducted, and people with intellectual, and other cognitive, disabilities are routinely excluded from mainstream trials. There is an urgent need to facilitate more disability-specific trials or to encourage mainstream trialists to include people with disabilities in their studies. Obtaining a thorough understanding of the challenges inherent in these trials, and sharing this knowledge within the research community, may contribute significantly towards addressing this need. The aim of this study was to explore the practical and methodological challenges to conducting trials with adults with intellectual disabilities and to reach a consensus regarding which are the most important challenges for researchers for inclusion in a resource toolkit. METHODS: A three-round modified Delphi survey was conducted with a panel of international trials researchers within the intellectual disability field. Items were assessed in terms of the consensus level and stability of responses. RESULTS: A total of 64 challenges and barriers were agreed upon, across all aspects of the trial pathway, from planning through to reporting. Some challenges and barriers had been noted in the literature previously, but many previously uncited barriers (both systemic and attitudinal) were identified. CONCLUSION: This is the first international survey exploring the experiences of researchers conducting randomised controlled trials with adults with intellectual disabilities. Many of the barriers and challenges reported can be overcome with creativity and some additional resources. Other challenges, including attitudes towards conducting trials with disabled populations, maybe harder to overcome. These findings have implications for conducting trials with other populations with cognitive or communication difficulties. Implications for disability researchers, funding bodies and ethical review panels are discussed.

Reporting of ethical approval and informed consent in clinical research published in leading nursing journals: a retrospective observational study.

BACKGROUND: Ethical considerations play a prominent role in the protection of human subjects in clinical research. To date the disclosure of ethical protection in clinical research published in the international nursing journals has not been explored. Our research objective was to investigate the reporting of ethical approval and informed consent in clinical research 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 between 2015 and 2017 were retrieved to evaluate for evidence of ethical review. RESULTS: A total of 2041 citations have 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 ethical review has been extracted. From these, most of prospective clinical studies (87.5%) discussed informed consent. Only half of those (52.9%) reported that written informed consent had been obtained; few (3.6%) reported oral consent, and few (6.8%) used other methods such as online consent or completion and return of data collection (such as surveys) to denote assent. Notably, 36.2% of those did not describe 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 most of clinical studies (93.7%) mentioned ethical approval; 92.5% of those stated the 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 study type, country, and whether financial 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.

Reporting of ethical considerations in clinical trials in Chinese nursing journals.

BACKGROUND: It is acknowledged that publishers now require all primary research papers to demonstrate that they have obtained ethical approval for their research. OBJECTIVES: To assess the rate of reporting of ethical approval in clinical trials in core nursing journals in mainland China. RESEARCH DESIGN: A retrospective observational study. PARTICIPANTS: All clinical trials published in all of the 12 core nursing periodicals from 2016 edition China Science and Technology Journal Citation Report (core version) between 2013 and 2016 were retrieved by hand to explicate rate of reporting ethical approval and informed consent. ETHICAL CONSIDERATIONS: The study did not require approval from the research ethics committee as it did not involve human subjects or records. RESULTS: In total, 40,278 papers were published in 12 nursing periodicals between 2013 and 2016. Out of these, 9488 (23.6%) focused on clinical trials. Informed consent obtained from patients or the legally authorized representative was reported in 51.8% of clinical trials. Notably, only 27.4% of clinical trials reported that they had obtained written consent. Furthermore, 25.9% of clinical trials described ethical approval; however, the rate of reporting informed consent and ethical approval in these 12 nursing journals in China during 4 years from 2013 to 2016 improved markedly, with 38.1%, 44.0%, 59.0% and 66.6%, respectively (p < 0.001), and 17.6%, 21.9%, 28.6% and 35.8%, respectively (p < 0.001). In addition, both reporting informed consent and reporting written informed consent had a positive significant correlation with the reporting ethical approval (p < 0.05 or < 0.01). CONCLUSION: Chinese scientific nursing journals have improved the rate of reporting informed consent and ethical approval in clinical trials during the last 4 years. However, it should be noted that nearly half of clinical trials still did not report either ethical approval or whether informed consent was obtained. Efforts from editors, researchers, sponsors and authors are needed to ensure the transparency of ethical scrutiny and adherence to ethical guidelines in publishing clinical trials in Chinese nursing journals.

[Ethical consideration of studies involving human subjects outside the regulatory framework: not mandatory, but of high relevance]. / Ethische Bewertung von Studien am Menschen außerhalb des regulatorischen Rahmens: nicht bindend, aber von großer Wichtigkeit.

According to the Declaration of Helsinki, ethics committees are obliged to evaluate any type of medical research involving human subjects in order to ensure an objective view on ethical considerations. This does not only mean considering whether the risks to study participants are ethically justifiable or not, but also checking whether the scientific quality of a study is sufficient. However, the role of ethics committees differs depending on whether the study to be considered is, for example, an approval study according to the German Medicines Act (AMG) or whether the study is outside the regulatory framework. For these so-called unregulated studies it is not always mandatory to obtain approval from an ethics committee or an institutional review board.In this paper, we first explain the term "unregulated studies" in detail and elaborate for which types of unregulated studies an application for ethical approval is required before we deal with the application for ethical approval as such and in particular with the study protocol as one of its major components. Registry studies, postmarketing surveillance studies, analyses of secondary data, surveys, intervention, and prognostic studies serve as examples to illustrate the broad range of unregulated studies.Finally, we discuss crucial aspects of the role of ethics committees with respect to the consideration of unregulated studies. In our conclusion, we point out the necessity of having ethics committees at each university in Germany that are also responsible for unregulated studies. In addition, the German legislature should define a stricter regulation such that unregulated studies also have to adhere to the vote of the ethics committee.

Identification of ethics committees based on authors' disclosures: cross-sectional study of articles published in the European Journal of Anaesthesiology and a survey of ethics committees.

BACKGROUND: Since 2010, the European Journal of Anaesthesiology has required the reporting of five items concerning ethical approval in articles describing human research: ethics committee's name and address, chairperson's name, study's protocol number and approval date. We aimed to assess whether this requirement has helped to identify and to contact the referenced ethics committees. METHODS: In this cross-sectional study, we analysed articles requiring ethical approval, according to the Swiss federal law for human research and published in the European Journal of Anaesthesiology in 2011. Ethics committees were searched through our institutional Internet access based on information provided in the articles. The last search was performed in November 2015. Numbers (%) of items reported, of ethics committees identified, and of those that confirmed having provided ethical approval are reported. RESULTS: Of 76 articles requiring ethical approval, 74 (97%) declared it. Ethics committees' names and addresses were mentioned in 63/74 (85%), protocol numbers in 51/74 (69%), approval dates in 48/74 (65%), and chairpersons' names in 45/74 (61%). We could identify 44/74 (59%) committees; 36/74 (49%) answered our inquiry and 24/74 (32%) confirmed their role. Thirty-four of 74 articles (46%) reported all five items; in 25/34 (74%), we were able to identify an ethics committee, 18/34 (53%) answered our inquiry, and 15/34 (44%) confirmed their role. Forty of 74 articles (54%) reported ≤4 items; in 19/40 (48%), we were able to identify an ethics committee, 18/40 (45%) answered our inquiry, and 9/40 (23%) confirmed their role. Reporting five items significantly increased identification of ethics committees (p = 0.023) and their confirmation of ethical approval (p = 0.048). Twelve of 74 ethics committees (16%) were unable to confirm their role in approving the study. CONCLUSIONS: Even when details concerning ethical approval were reported in these studies of human research, we were unable to identify almost half of the ethics committees concerned. The reporting of five items, compared with reporting ≤4, was associated with facilitated identification of ethics committees, and increased the likelihood that they would be able to confirm the study's approval. Future research should identify which information facilitates identification of, and contact with, ethics committees.

Using video in childbirth research.

BACKGROUND: Conducting video-research in birth settings raises challenges for ethics review boards to view birthing women and research-midwives as capable, autonomous decision-makers. AIM: This study aimed to gain an understanding of how the ethical approval process was experienced and to chronicle the perceived risks and benefits. RESEARCH DESIGN: The Birth Unit Design project was a 2012 Australian ethnographic study that used video recording to investigate the physical design features in the hospital birthing space that might influence both verbal and non-verbal communication and the experiences of childbearing women, midwives and supporters. Participants and research context: Six women, 11 midwives and 11 childbirth supporters were filmed during the women's labours in hospital birth units and interviewed 6 weeks later. Ethical considerations: The study was approved by an Australian Health Research Ethics Committee after a protracted process of negotiation. FINDINGS: The ethics committee was influenced by a traditional view of research as based on scientific experiments resulting in a poor understanding of video-ethnographic research, a paradigmatic view of the politics and practicalities of modern childbirth processes, a desire to protect institutions from litigation, and what we perceived as a paternalistic approach towards protecting participants, one that was at odds with our aim to facilitate situations in which women could make flexible, autonomous decisions about how they might engage with the research process. DISCUSSION: The perceived need for protection was overly burdensome and against the wishes of the participants themselves; ultimately, this limited the capacity of the study to improve care for women and babies. CONCLUSION: Recommendations are offered for those involved in ethical approval processes for qualitative research in childbirth settings. The complexity of issues within childbirth settings, as in most modern healthcare settings, should be analysed using a variety of research approaches, beyond efficacy-style randomised controlled trials, to expand and improve practice-based results.

Participatory research, people with intellectual disabilities and ethical approval: making reasonable adjustments to enable participation.

AIMS AND OBJECTIVES: The aim of this paper is to explore how making reasonable adjustments to the process of securing ethical approval for research can facilitate the meaningful involvement of people with intellectual disabilities as members of a research team. This is achieved through critical reflection upon the approach taken within one participatory research study whose objective was to explore how people with intellectual disabilities understand abuse. BACKGROUND: Internationally participatory research studies (in which active involvement of community members in all stages of the research process is sought) are becoming increasingly common in the context of health care and, more specifically, within research involving people with intellectual disabilities. However, whilst it is acknowledged that participatory research gives rise to specific ethical challenges, how (or if) involvement in securing ethical approval is facilitated, is not discussed in most research reports. The significance of this paper is that it seeks to address this gap by exploring how meaningful participation can be promoted by making reasonable adjustments. METHODS: Within the study, the research team worked in collaboration with the ethics committee to identify potential barriers that could prevent the participation of members of the research team who had intellectual disabilities. Reasonable adjustments (such as redesigning forms) were made to the processes involved in securing ethical approval. CONCLUSIONS: This study demonstrated that it is possible to ensure that ethical standards are upheld and the requirements of ethics committees met whilst also facilitating the meaningful involvement of people with intellectual disabilities. RELEVANCE TO CLINICAL PRACTICE: The reasonable adjustments approach explored within this paper can be translated into the context of clinical practice: making changes to the way that services are delivered can promote greater involvement of people with intellectual disabilities in their own health care.

Public involvement and engagement in scientific research and higher education: the only way is ethics?

BACKGROUND: Involving and engaging the public in scientific research and higher education is slowly becoming the norm for academic institutions in the United Kingdom and elsewhere. Driven by a wide range of stakeholders including regulators, funders, research policymakers and charities public involvement and public engagement are increasingly seen as essential in delivering open and transparent activity that is relevant and positively impacts on our society. It is obvious that any activities involving and engaging members of the public should be conducted safely and ethically. However, it is not clear whether conducting activities ethically means they require ethical approval from a research ethics committee. MAIN BODY: Although there is some guidance available from government organisations (e.g. the UK Health Research Authority) to suggest ethical approval is not required for such activities, requests from funders and publishers to have ethical approval in place is commonplace in the authors' experience. We explore this using case studies from our own institution. CONCLUSION: We conclude that any public-facing activity with the purpose to systemically investigate knowledge, attitudes and experiences of members of the public as research and as human participants requires prior approval from an ethics committee. In contrast, engaging and involving members of the public and drawing on lived experience to inform aspects of research and teaching does not. However, lack of clarity around this distinction often results in the academic community seeking ethical approval 'just in case', leading to wasted time and resources and erecting unnecessary barriers for public involvement and public engagement. Instead, ethical issues and risks should be appropriately considered and mitigated by the relevant staff within their professional roles, be it academic or a professional service. Often this can involve following published guidelines and conducting an activity risk assessment, or similar. Moving forward, it is critical that academic funders and publishers acknowledge the distinction and agree on an accepted approach to avoid further exacerbating the problem.

Involving and engaging members of the public is recognised best practice in university research and teaching. Involvement and engagement activities (for instance, working with the public to design a research study) continue to increase in priority and are an important part of an academic's role. However, there is often confusion amongst researchers and educators around whether involving the public in these activities requires prior ethical approval, similar to what would be the case when inviting members of the public to participate in a clinical research study, or to donate samples such as blood for experiments. As an example, sometimes researchers are asked for ethical approval by scientific journals when trying to publish the findings from their public involvement and engagement work, when in fact this is not needed. The ongoing uncertainty about the difference between actual research on one hand and public involvement and engagement on the other hand wastes precious time and resources, and is a barrier for scientists to working with the public. We have developed guidance for academic staff on when ethical approval is and is not required, using examples from our own experience. We wrote this article to bring awareness to this problem; share our views with the wider academic community; encourage discussion around the problem and possible solutions; and ultimately contribute to educating on when research ethics approval is needed, and when not.

Ethical considerations in public engagement: developing tools for assessing the boundaries of research and involvement.

Public engagement with research (PEwR) has become increasingly integral to research practices. This paper explores the process and outcomes of a collaborative effort to address the ethical implications of PEwR activities and develop tools to navigate them within the context of a University Medical School. The activities this paper reflects on aimed to establish boundaries between research data collection and PEwR activities, support colleagues in identifying the ethical considerations relevant to their planned activities, and build confidence and capacity among staff to conduct PEwR projects. The development process involved the creation of a taxonomy outlining key terms used in PEwR work, a self-assessment tool to evaluate the need for formal ethical review, and a code of conduct for ethical PEwR. These tools were refined through iterative discussions and feedback from stakeholders, resulting in practical guidance for researchers navigating the ethical complexities of PEwR. Additionally, reflective prompts were developed to guide researchers in planning and conducting engagement activities, addressing a crucial aspect often overlooked in formal ethical review processes. The paper reflects on the broader regulatory landscape and the limitations of existing approval and governance processes, and prompts critical reflection on the compatibility of formal approval processes with the ethos of PEwR. Overall, the paper offers insights and practical guidance for researchers and institutions grappling with ethical considerations in PEwR, contributing to the ongoing conversation surrounding responsible research practices.

Predictors of ethical approval and informed consent in orthodontic RCTs.

OBJECTIVES: Determine the number of orthodontic randomized controlled trials (RCTs) published in four key orthodontic journals from 1 January 2001 to 31 December 2010, whether details about ethical approval (EA) and/or informed consent (IC) were reported and identify predictors for reporting EA and IC in orthodontic RCTs. DESIGN: Retrospective observational study. SETTING: American Journal of Orthodontics and Dentofacial Orthopedics (AJODO), Angle Orthodontist (AO), European Journal of Orthodontics (EJO) and Journal of Orthodontics (JO) from 2001 to 2010. INTERVENTIONS: AJODO, AO, EJO and JO were handsearched to identify all RCTs published from 1 January 2001 to 31 December 2010. MAIN OUTCOME MEASURE: The RCTs were assessed to identify: inclusion of details about EA and IC, publication journal, number of authors, number and location of centres involved, perceived statistician involvement, publication year and inclusion of random* in either the title, abstract or body of the text. RESULTS: 218 RCTs were published. 109 (48·6%) had reported both EA and IC, 59 (27·1%) neither and 53 (12·9%) either EA or IC. Factors associated with an RCT reporting obtaining EA and IC: number of authors (P<0·001), random* in title (P<0·001), random* in abstract but not title (P<0·001), location of origin (P = 0·001), publication year (P = 0·003), journal of publication (P = 0·004) and number of centres (P = 0·008). Logistic regression suggested the most significant indicators of reporting EA and IC were: publication in the JO (P = 0·018), >6 authors (P<0·001), random* in the abstract but not title (P = 0·004) and publication after 2004 (P = 0·001). CONCLUSIONS: RCTs were most likely to have reported EA and IC when published in the JO, after 2004 while having more than six authors and random* in the abstract but not title.

Variability in Ethics Review for Multicenter Protocols in Buenos Aires, Argentina. An Observational Study.

It has been reported that significant variability in the ethics review process affects multisite studies. We analyzed 1,305 applications for multicenter studies (409 unique protocols), from 1st January 2020 to 20th September 2021. We examined the variability in the times to approval and the first observation and the variation in the level of risk assigned. The median [IQR] variabilities were 42.19 [15.23-82.36] days and 8.00 [3.12-16.68] days, for the times to approval and to the first observation, respectively. There was disagreement in the level of risk assigned by the Research Ethics Committee (REC) in 24.0% of cases. Independent predictors of variability included the number of REC members. In our study, we found substantial variability in the ethics review process among health research protocols. Also, we describe methods to readily measure the delays and the variations in the ethics review process.

Ethics reporting in forensic science research publications - A review.

An essential element of compliance with ethical standards in scientific research is the reporting of a verifiable declaration of ethical approval and, when human subjects are involved - informed consent, in published works. The level of reporting of ethical permission for research published in forensic and investigative sciences journals has not been explored to date. Hence, we examined the reporting of ethical approval and informed consent in original research utilising human or animal subjects published in six forensic science journals from 2010 to 2019. We identified 10,192 articles and retained 3010 that satisfied the inclusion criteria of utilising human (91.2%), or animal (7.0%) or both (1.8%) subjects or tissues in experiments. Just over a third (1079/3010) of all studies declared obtaining ethical approval, with 927 (85.9%) of those indicating the name of the ethical committee, but only 392 (36%) provided an approval code. Furthermore, while consent was said to have been sought in 527 (17.5%) of studies, only 155 of those reported that written informed consent was obtained, eleven stated oral (verbal) consent, while the remaining 357 studies (67.7%) did not report the process used to gain consent. Ethical approval reporting rates differed between different research types, availability of financial support and whether authors were affiliated to academia or industry. The results demonstrate a low level of declaration of ethical approval and informed consent in forensic science research and publication, requiring urgent rectification. We support the adoption of the model proposed by Forensic Science International: Genetics as baseline recommendations to facilitate consistent nomenclature, transparency, and standard of ethical reporting in forensic science.

Trend and Patterns of Research Proposals Submitted for Ethical Review in Nepal Health Research Council.

BACKGROUND: The characteristics of research proposals submitted to the Nepal Health Research Council reflect the trend of health-related researches being conducted in Nepal. The objective of the study was to analyze research proposals submitted for the ethical review in Nepal Health Research Council from 2017 to 2019. METHODS: A retrospective record review of research proposals received over three years from 2017 to 2019 were analyzed. A total of 2,305 research proposals was included in the study. The number of research studies per year, types of study design, priority area of research, and rejected proposal were the intended variables for the study. RESULTS: 91.45% (503), 92.19% (748), and 755 (80.1%) of received proposals were approved from Ethical Review Board in 2017, 2018 and 2019. The number of research proposals increased every year (550 in 2017, 812 in 2018, and 943 in 2019). Among the approved proposals non-communicable disease (n=150;15.90%) in 2019} was the topmost prioritized area in all three years followed by reproductive health [93 (9.86%) in 2019] and communicable disease [67 (7.10%) in 2019] respectively. Quantitative research was more than two-third in all the years. Among the approved proposals, more than half were for an academic purpose [610 (64.69%)]. The reason for the rejection of the proposal was the conduction of research before ethical approval [2 (0.36%) in 2017, 2 (0.25%) in 2018, and none in 2019]. CONCLUSIONS: There was a rising trend of research proposals for ethical clearance being submitted to the Nepal Health Research Council. Research related to non-communicable disease followed by reproductive health was the commonest one.

Comparison of regulatory framework of clinical trial with genetically modified organism-containing vaccines in the Europe, Australia, and Switzerland.

New vaccines production and manufacture have revolutionized by recombinant technology. Various regulatory associations are engaged with the appraisal of a clinical trial with genetically modified organisms. At present safe, effective vaccines are needed in order to control the various emerging diseases which are a major cause of mortality. In reality, most vaccines raise biosafety worries with respect to human wellbeing. "Federal Office for Environment" is the competent authority for environmental risk assessments in Switzerland. Gene Technology Act 2000 is the fundamental direction that provides the necessary information to carry the clinical trials with genetically modified organism-containing vaccines. In addition, regulatory framework for "clinical trial with genetically modified organisms-containing vaccines" is stringent and partially harmonized in Switzerland, the European Union and Australia. In this study, we mainly concerned with regulatory aspects of "clinical trial with genetically modified organism" containing vaccine in three regions. This review includes various aspects like ethics, guidelines related to clinical trials of vaccines with genetically modified organisms.

Roses and Balances: A Paradigm for Constructive Ethical Review of Health Professions Education Research.

Recently, the balance between value and necessity of ethical review of health professions education research has been debated. At present, there are large differences in how ethical review of research proposals for health professions education is organized. We present a framework that describes the organization of ethical review in health professions education research, based on the interpersonal circumplex model, also known as Leary's Rose. The framework is based on the two main balances in ethical review of health professions education research, being the protectiveness for the subjects and how ethical review is organized and responsibilities are shared. The axis/balance of protectiveness ranges between the extremes "paternalistic protective" to "liberal permissive". The axis/balance of organization and responsibility ranges between the extremes of "centralized" to "local/decentralized". This model offers insight in the position of an ethical review board and shows the dynamics of the decisions for ethical approval and the consequences of the different approaches to the organization of ethical review of health professions education research.

Quality criteria for randomized controlled studies: obstetrical journal guidelines.

BACKGROUND: Most retractions of obstetrics and gynecology manuscripts are because of scientific misconduct. It would be preferable to prevent randomized controlled trials with scientific misconduct from ever appearing in the peer-reviewed scientific literature, rather than to have to retract them later. OBJECTIVE: This study aimed to evaluate the policies of obstetrics and gynecology and top medical journals in their author guidelines and electronic submission systems regarding prospective randomized controlled trial registration, ethics committee approval, research protocols, Consolidated Standards of Reporting Trial guidelines, and data sharing and to detect the most common quality criteria requested for randomized controlled trials in these journals. STUDY DESIGN: Author guidelines were identified via online Google searches from the websites of selected peer-reviewed medical journals. Journals in obstetrics and gynecology were selected from the list of journals with impact factors based on the Journal Citation Report released by Clarivate Analytics on June 29, 2020, focusing on those publishing original clinical research in obstetrics, in particular randomized controlled trials. In addition, 4 of the top impact factor peer-reviewed general medical journals publishing randomized controlled trials were included. The requirements for selected quality criteria for randomized controlled trials analyzed in the author guidelines for each journal were details of 5 general issues: prospective randomized controlled trial registration (4 subcategories), ethics committee approval (4 subcategories), research protocol (3 subcategories), Consolidated Standards of Reporting Trials guidelines (3 subcategories), and data sharing (3 subcategories). To evaluate the requirements within the electronic submission system, a mock submission of a randomized controlled trial was also done for each journal, and the same criteria were assessed on the online software for submission. The primary outcome was the overall percentage for each of the quality criteria that were listed as required within the author guidelines or required in the submission system among all journals. Planned subgroup analyses were top general medicine vs obstetrics and gynecology journals and top 4 obstetrics and gynecology vs other obstetrics and gynecology journals. RESULTS: Most studied peer-reviewed journals listed in their author guidelines 7 specific criteria for submission of randomized controlled trials: prospective registration and registration number, statement of ethical approval with name of approving committee and statement of informed consent, statement of adherence to Consolidated Standards of Reporting Trials guidelines, and data sharing statement. For most journals, the submission software did not require these or any other criteria for submission. There were minimal differences in criteria listed for top medical journals vs other obstetrics and gynecology journals and among top vs other obstetrics and gynecology journals. CONCLUSION: Prospective registration and registration number, statement of ethical approval with name of approving committee and statement of informed consent, statement of adherence to Consolidated Standards of Reporting Trials guidelines, and data sharing statement are the randomized controlled trial quality criteria requested by leading medical and obstetrics and gynecology journals. These obstetrics and gynecology journals agree to make, as much as possible, these criteria uniform and mandatory in author guidelines and also through improved submission software.

Protocol and Researcher's Relationship with Institutional Review Board.

The document of ethical approval is an important official requirement for research involving human participants worldwide. It is the process whereby an investigator submits the full research proposal and related documents including detailed informed consent process to an independent Institutional Review Board (IRB) for scrutiny. The process of seeking review and approval is necessary to ensure adequate measure are in place to safeguard and protect research participants as entrenched in the principles of The Declaration of Helsinki and The Belmont Report. It is the responsibility of every clinical researcher to obtain ethical approval, therefore, their obligation to understand the process of review and establish relationship with local IRB in order to enhance smooth review and approval. This article, therefore, explains clinical research and distinguishes between research and clinical care, clarifies briefly what constitutes a study protocol and describes the researchers' relationship with IRB.