Research governance review of a negligible-risk research project: Too much of a good thing?

There are increasing concerns that research regulatory requirements exceed those required to manage risks, particularly for low- and negligible-risk research projects. In particular, inconsistent documentation requirements across research sites can delay the conduct of multi-site projects. For a one-year, negligible-risk project examining biobank operations conducted at three separate Australian institutions, we found that the researcher time required to meet regulatory requirements was eight times greater than that required for the approved research activity (60 hours versus 7.5 hours respectively). In total, 76 business days (almost four months) were required to obtain the necessary approvals, and site-specific processes required twice as long (52 business days/approximately 10 weeks) as primary Human Research Ethics Committee and Research Governance Office processes (24 business days/ approximately five weeks). We describe the impact of this administrative load on the conduct of a one-year, externally-funded research project, and identify a shared set of application requirements that could be used to streamline and harmonise research governance review of low- and negligible-risk research projects.

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The impact on authors and editors of introducing Data Availability Statements at Nature journals

10.1101/264929 ◽

2018 ◽

Author(s):

Rebecca Grant ◽

Iain Hrynaszkiewicz

Keyword(s):

Data Availability ◽

Research Articles ◽

Research Project ◽

Digital Curation ◽

Subsequent Research ◽

Time Required ◽

The Impact ◽

The Way

AbstractThis paper describes the adoption of a standard policy for the inclusion of data availability statements in all research articles published at the Nature family of journals, and the subsequent research which assessed the impacts that these policies had on authors, editors, and the availability of datasets. The key findings of this research project include the determination of average and median times required to add a data availability statement to an article; and a correlation between the way researchers make their data available, and the time required to add a data availability statement. This paper will be presented at the International Digital Curation Conference 2018, and has been submitted to the International Journal of Digital curation.

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The impact on authors and editors of introducing Data Availability Statements at Nature journals

International Journal of Digital Curation ◽

10.2218/ijdc.v13i1.614 ◽

2018 ◽

Vol 13 (1) ◽

pp. 195-203 ◽

Cited By ~ 4

Author(s):

Rebecca Grant ◽

Iain Hrynaszkiewicz

Keyword(s):

Data Availability ◽

Research Articles ◽

Research Project ◽

Subsequent Research ◽

Time Required ◽

The Impact ◽

The Way

This article describes the adoption of a standard policy for the inclusion of data availability statements in all research articles published at the Nature family of journals, and the subsequent research which assessed the impacts that these policies had on authors, editors, and the availability of datasets. The key findings of this research project include the determination of average and median times required to add a data availability statement to an article; and a correlation between the way researchers make their data available, and the time required to add a data availability statement.

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Conflict management systems for large scientific research projects

International Journal of Conflict Management ◽

10.1108/ijcma-04-2016-0022 ◽

2017 ◽

Vol 28 (3) ◽

pp. 322-345 ◽

Cited By ~ 6

Author(s):

Katharina Löhr ◽

Frieder Graef ◽

Michelle Bonatti ◽

Henry F. Mahoo ◽

Jane Wambura ◽

...

Keyword(s):

Conflict Management ◽

Management Model ◽

Management Systems ◽

Conflict Prevention ◽

Business Organizations ◽

Research Projects ◽

Research Project ◽

Content Type ◽

The Impact

Purpose This paper aims to analyze the transferability of a conflict management model developed for business organizations to a temporary and international research project to serve as a support tool for internal communication and in case of conflict. Design/methodology/approach The authors analyze the transferability of a conflict management model that was initially developed for business organizations to an international, inter-organizational and temporary research project that is third-party funded. Using a case study, a participatory approach is applied with both qualitative and quantitative methods used. Findings The transferability is possible but only with the adaption of conflict prevention. The project’s international and inter-organizational structure further results in a need for decentralization of conflict management responsibilities and diversification of conflict management approaches. Time, financial resources and a high autonomy of cooperation partners limit the degree of participation in the design process. Research limitations/implications The research is based on a case study. Research on comparative design processes are needed to verify or extrapolate findings and to help assess the impact of conflict management systems in other large research projects. Originality/value This paper contributes to the body of knowledge on conflict management systems. By implementing a conflict management system in a temporary, international and scientific project environment, this case study identifies contextual factors relevant for the system design and provides initial test results. As conflict management systems in research projects are not yet prominent, this adapted model of conflict prevention and management can benefit similar projects.

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CHANGING INFUSION PRACTICE GENERATES SIGNIFICANT EFFICIENCIES IN NURSING TIME AND RESOURCE USAGE IN PAEDIATRIC INTENSIVE CARE

Archives of Disease in Childhood ◽

10.1136/archdischild-2016-311535.23 ◽

2016 ◽

Vol 101 (9) ◽

pp. e2.16-e2

Author(s):

Adam Sutherland ◽

Liz Jemmett ◽

Rachael Barber

Keyword(s):

Patient Care ◽

Improve Patient Safety ◽

Control Policy ◽

Central Line ◽

Nursing Time ◽

Fixed Concentration ◽

Infusion Devices ◽

One Year ◽

Time Required ◽

The Impact

IntroductionInfusion preparation in British PICUs uses the Rule of Six (ROS) which was developed for administration without infusion devices. This method is inaccurate.1 Regulators recommend standardised approaches to IV infusions to improve patient safety and quality of care.2 Administration set changes also have an association with resource use and central line infections.3 We report the impact of fixed concentration infusions and reduced administration set changes on nursing time and infusion equipment cost.MethodsMorphine and midazolam infusions were standardised in September 2014. Direct observation of infusion preparation was carried out beforeand after the introduction of fixed-concentration (FC) infusions to quantify the nursing time required to prepare infusions. Administration was prospectively documented using purposive sampling until a population-representative sample for age and weight was obtained (1 month). This data was then scaled up to predict activity over one year. Syringe use and administration set use was calculated. Reducing frequency of administration set changes to 72 hrs in accordance with infection control policy was then calculated retrospectively.ResultsIt takes 40 minutes (2 nurses×20 minutes) to prepare ROS syringes and 30 minutes (2 nurses×15 minutes) for FC syringes.In total ROS infusions required 2433 hrs of nursing time to prepare. FC infusions reduced this time by 25% (608 hrs) releasing 0.5 WTE nursing time back to patient care.Mean duration of IV sedation in these patients was 100 hrs. The cost associated with replacing administration sets with each syringe was £16,060. By changing every 72 hrs, this cost is reduced to £4,400 – a cost saving of £11,660.ConclusionsFC syringes are more efficient than ROS. FC preparations have released 0.5 WTE nurses back to patient care. Changing administration sets 72 hrly realises significant cost efficiencies.

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Student’s Research Activity

Galician Medical Journal ◽

10.21802/gmj.2019.1.11 ◽

2019 ◽

Vol 26 (1) ◽

Author(s):

Nataliya Tymochko

Keyword(s):

Problem Solving ◽

Educational Institutions ◽

Research Projects ◽

Research Activity ◽

Research Project ◽

Critical Data ◽

Practical Research ◽

Fast Development ◽

Informational Basis ◽

Different Sources

Breakthrough technologies and fast development in the informational basis in medicine put on finding different sources for well-timed reception of necessary information in order to keep pace with achievements in medicine (journals, conferences, and webinars). Such demand can be often met only after individual studying, researching necessary information. Each student must be proficient in methods of research activity. In higher educational institutions of Ukraine students are taught to approach search and usage of scientific and practical research projects methodologically in their training. Objective. To teach students formulate hypotheses, collect and evaluate critical data for problem solving, writing of a research project.

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PHD STUDENTS’ TRAINING FOR MANAGING A RESEARCH PROJECTS: FROM THE EXPERIENCE OF IMPLEMENTATION OF THE EDUCATIONAL AND SCIENTIFIC PROGRAM «SOCIAL WORK»

Social work and social education ◽

10.31499/2618-0715.2(7).2021.244877 ◽

2021 ◽

pp. 322-331

Author(s):

Oksana Kravchenko ◽

Nataliia Koliada

Keyword(s):

Social Work ◽

Project Management ◽

Research Work ◽

Scientific Activity ◽

International Standards ◽

Scientific Program ◽

Research Projects ◽

Research Activity ◽

Research Project ◽

Scientific Level

The article is devoted to the specialists’ training in mastering the methodology of project management as an important component in the implementation of educational programs. It was found that an important condition for effective and innovative scientific activity is the readiness of the individual for research work, his research activity, research behaviour, and therefore, knowledge of the essence of methodology and organization of research project management is mandatory. In particular, it is reasonably expedient to form readiness for such activities in applicants of the third (educational-scientific) level of 'PhD' as future researchers who obtain an education and at the same time the first science degree. The objective of the article is to summarize the practical experience of preparing PhD applicants in the speciality '231 Social Work' to manage research projects as part of the educational and scientific program 'Social Work'. Analysis of the project activities of the Faculty of Social and Psychological Education allows us to conclude that active participants in the development and implementation of research projects are doctoral candidates (a third (educational and scientific) level of higher education, the educational and scientific program "Social Work"). It is important to note that these projects, although they have different forms of implementation (from socio-cultural practices to youth policy), at the same time meet the requirements of an interdisciplinary approach and have a social focus. This corresponds both to the national requirements for PhD training and to international standards and recommendations for ensuring the quality of PhD programs in social work. At the same time, such practical project activity, along with studying the theoretical principles of research project management, allows PhD students to form program results to determine the goals, content and structure of research projects, analyze financial needs and funding sources, control the project implementation process and adjust its implementation plan; project risk management, etc.

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One Year Survival Among Patients With Myocardial Infarction Complicated by Cardiogenic Shock Alive at 30 Days, and the Impact of Early Revascularization: Results From GUSTO-1

Journal of the American College of Cardiology ◽

10.1016/s0735-1097(97)84115-0 ◽

1998 ◽

Vol 31 (2) ◽

pp. 94A

Author(s):

P Berger

Keyword(s):

Myocardial Infarction ◽

Cardiogenic Shock ◽

Early Revascularization ◽

One Year ◽

The Impact

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Regulatory and sustainability initiatives lead to improved polyaminopolyamide epichlorohydrin (PAE) wet-strength resins and paper products

TAPPI Journal ◽

10.32964/tj17.09.519 ◽

2018 ◽

Vol 17 (09) ◽

pp. 519-532 ◽

Cited By ~ 1

Author(s):

Mark Crisp ◽

Richard Riehle

Keyword(s):

Health And Safety ◽

Cost Effective ◽

Worker Safety ◽

Regulatory Requirements ◽

Wet Strength ◽

The Past ◽

Consumer Safety ◽

Federal Institute ◽

Sustainability Initiatives ◽

The Impact

Polyaminopolyamide-epichlorohydrin (PAE) resins are the predominant commercial products used to manufacture wet-strengthened paper products for grades requiring wet-strength permanence. Since their development in the late 1950s, the first generation (G1) resins have proven to be one of the most cost-effective technologies available to provide wet strength to paper. Throughout the past three decades, regulatory directives and sustainability initiatives from various organizations have driven the development of cleaner and safer PAE resins and paper products. Early efforts in this area focused on improving worker safety and reducing the impact of PAE resins on the environment. These efforts led to the development of resins containing significantly reduced levels of 1,3-dichloro-2-propanol (1,3-DCP) and 3-monochloropropane-1,2-diol (3-MCPD), potentially carcinogenic byproducts formed during the manufacturing process of PAE resins. As the levels of these byproducts decreased, the environmental, health, and safety (EH&S) profile of PAE resins and paper products improved. Recent initiatives from major retailers are focusing on product ingredient transparency and quality, thus encouraging the development of safer product formulations while maintaining performance. PAE resin research over the past 20 years has been directed toward regulatory requirements to improve consumer safety and minimize exposure to potentially carcinogenic materials found in various paper products. One of the best known regulatory requirements is the recommendations of the German Federal Institute for Risk Assessment (BfR), which defines the levels of 1,3-DCP and 3-MCPD that can be extracted by water from various food contact grades of paper. These criteria led to the development of third generation (G3) products that contain very low levels of 1,3-DCP (typically <10 parts per million in the as-received/delivered resin). This paper outlines the PAE resin chemical contributors to adsorbable organic halogens and 3-MCPD in paper and provides recommendations for the use of each PAE resin product generation (G1, G1.5, G2, G2.5, and G3).

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