scholarly journals Regulatory Framework for Conducting Clinical Research in Canada

2017 ◽  
Vol 44 (5) ◽  
pp. 469-474 ◽  
Author(s):  
Josmar K. Alas ◽  
Glenys Godlovitch ◽  
Connie M. Mohan ◽  
Shelly A. Jelinski ◽  
Aneal A. Khan
Keyword(s):  
Clinical Trials ◽  
Human Subjects ◽  
Policy Statement ◽  
Institutional Research ◽  
Public Health Agencies ◽  
Clinical Trial Research ◽  
Health Agencies ◽  
Drug Regulations

AbstractResearch in human subjects is at the core of achieving improvements in health outcomes. For clinical trials, in addition to the peer review of the results before publication, it is equally important to consider whether the trial will be conducted in a manner that generates data of the highest quality and provides a measure of safety for the participating subjects. In Canada, there is no definitive legislation that governs the conduct of research involving human subjects, but a network of regulations at different levels does provide a framework for both principal investigators and sponsors. In this paper, we provide an overview of the federal, provincial and institutional legislation, guidelines and policies that will inform readers about the requirements for clinical trial research. This includes a review of the role of the Food and Drug Regulations under the Food and Drugs Act and the Tri-Council Policy Statement (TCPS2), an overview of provincial legislation across the country, and a focus on selected policies from institutional research ethics boards and public health agencies. Many researchers may find navigation through regulations frustrating, and there is a paucity of information that explains the interrelationship between the different regulatory agencies in Canada. Better understanding the process, we feel, will facilitate investigators interested in clinical trials and also enhance the long-term health of Canadians.

Informed consent in a research setting

2016 ◽  
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Care Setting ◽  
Human Subjects ◽  
Consent Process ◽  
Vulnerable Groups ◽  
Clinical Trial Research ◽  
Emergency Situations ◽  
Qualified Person

Informed consent is a legal requirement for all clinical trials conducted on human subjects. This chapter summarises the process for obtaining consent for non-clinical trial research and goes on to describe the more highly regulated consent process for clinical trials in investigational medicinal products (CTIMPs). The chapter defines consent and discusses the requirements for consent in capable adults. The process for CTIMP studies is outlined together with the required elements of consent to be documented in the patient information sheet and the process to be followed with withdrawal of consent is also described. Consent, assent and the concept of legal representatives in vulnerable groups is discussed including children and incapacitated adults. How to assess capacity is described along with consent in emergency situations. Formally documenting the consent process and how the information is given to the patient is vital. The role of the research team in consent is outlined. The investigator is advised to describe the process of consent and should identify which registered health professionals will undertake the process. In some situations a medically qualified person will be required to determine eligibility prior to enrolment, to discuss the study and assess capacity if necessary. A participant's decision to consent for research may be influenced by 'the research culture' in the country or the health care setting. Transparency and providing information continuously to participants throughout the study will re-assure them and reaffirm their willingness to continue.

scholarly journals Intergenerational monitoring in clinical trials of germline gene editing

2019 ◽  
Vol 46 (3) ◽  
pp. 183-187 ◽  
Author(s):  
Bryan Cwik
Keyword(s):  
Clinical Trials ◽  
Gene Editing ◽  
Ethical Issues ◽  
Human Subjects ◽  
Germline Gene ◽  
Ethical Challenges ◽  
Human Subjects Research ◽  
Follow Up Study

Design of clinical trials for germline gene editing stretches current accepted standards for human subjects research. Among the challenges involved is a set of issues concerning intergenerational monitoring—long-term follow-up study of subjects and their descendants. Because changes made at the germline would be heritable, germline gene editing could have adverse effects on individuals’ health that can be passed on to future generations. Determining whether germline gene editing is safe and effective for clinical use thus may require intergenerational monitoring. The aim of this paper is to identify and argue for the significance of a set of ethical issues raised by intergenerational monitoring in future clinical trials of germline gene editing. Though long-term, multigenerational follow-up study of this kind is not without precedent, intergenerational monitoring in this context raises unique ethical challenges, challenges that go beyond existing protocols and standards for human subjects research. These challenges will need to be addressed if clinical trials of germline gene editing are ever pursued.

scholarly journals Perspective: Measuring Sweetness in Foods, Beverages, and Diets: Toward Understanding the Role of Sweetness in Health

2020 ◽  
Author(s):  
Paula R Trumbo ◽  
Katherine M Appleton ◽  
Kees de Graaf ◽  
John E Hayes ◽  
David J Baer ◽  
...  
Keyword(s):  
Caloric Intake ◽  
Evidence Based ◽  
Global Public Health ◽  
Added Sugar ◽  
Public Health Agencies ◽  
Health Agencies ◽  
Future Direction ◽  
Optimal Approach ◽  
Support Evidence

ABSTRACT Various global public health agencies recommend minimizing exposure to sweet-tasting foods or beverages. The underlying rationale is that reducing exposure to the perception of sweet tastes, without regard to the source of sweetness, may reduce preferences for sweetness, added sugar intake, caloric intake, and body weight. However, the veracity of this sequence of outcomes has yet to be documented, as revealed by findings from recent systematic reviews on the topic. Efforts to examine and document the effects of sweetness exposure are needed to support evidence-based recommendations. They require a generally agreed-upon methodology for measuring sweetness in foods, beverages, and the overall diet. Although well-established sensory evaluation techniques exist for individual foods in laboratory settings, they are expensive and time-consuming, and agreement on the optimal approach for measuring the sweetness of the total diet is lacking. If such a measure could be developed, it would permit researchers to combine data from different studies and populations and facilitate the design and conduct of new studies to address unresolved research questions about dietary sweetness. This narrative review includes an overview of available sensory techniques, their strengths and limitations, recent efforts to measure the sweetness of foods and diets across countries and cultures, and a proposed future direction for improving methods for measuring sweetness toward developing the data required to support evidence-based recommendations around dietary sweetness.

scholarly journals Evidence for the use of probiotics and prebiotics in inflammatory bowel disease: a review of clinical trials

2007 ◽  
Vol 66 (3) ◽  
pp. 307-315 ◽  
Author(s):  
Charlotte Hedin ◽  
Kevin Whelan ◽  
James O. Lindsay
Keyword(s):  
Inflammatory Bowel Disease ◽  
Clinical Trials ◽  
Bowel Disease ◽  
Human Subjects ◽  
Specific Patient ◽  
Attractive Therapeutic Target ◽  
Patient Groups ◽  
Inflammatory Bowel ◽  
Mutual Tolerance

Human subjects and their enteric microbiota have evolved together to reach a state of mutual tolerance. Mounting evidence from both animal models and human studies suggests that inflammatory bowel disease (IBD) represents a malfunction of this relationship. The enteric microecology therefore represents an attractive therapeutic target with few side effects. Probiotics and prebiotics have been investigated in clinical trials as treatments for IBD, with conflicting results. The evidence for the use of probiotics in the management of pouchitis is persuasive and several studies indicate their effectiveness in ulcerative colitis. Trials of probiotics and prebiotics in Crohn's disease are less convincing. However, methodologies vary widely and a range of probiotic, prebiotic and combination (synbiotic) treatments have been tested in a variety of patient groups with an assortment of end points. Conclusions about any one treatment in a specific patient group can therefore only be drawn on evidence from relatively small numbers of patients. The present article reviews the role of the intestinal microbiota in the pathogenesis of IBD and addresses the clinical evidence for the therapeutic manipulation of bowel microbiota using probiotics, prebiotics and synbiotics in IBD.

scholarly journals The Role of Simulation Modeling in Planning Long-Term Clinical Trials in Type 2 Diabetes

2013 ◽  
Vol 16 (7) ◽  
pp. A587-A588
Author(s):  
V. Foos ◽  
D. Grant ◽  
J.L. Palmer ◽  
M. Lamotte ◽  
P. McEwan
Keyword(s):  
Type 2 Diabetes ◽  
Clinical Trials ◽  
Simulation Modeling

scholarly journals Long-term macrolide antibiotics in asthma therapy

2011 ◽  
Vol 2 (4) ◽  
pp. 243-258
Author(s):  
Daisuke Takekoshi ◽  
Patrick Belvitch ◽  
Israel Rubinstein
Keyword(s):  
Clinical Trials ◽  
Antimicrobial Properties ◽  
Inflammatory Cells ◽  
Macrolide Antibiotics ◽  
Oxygen Species ◽  
Immunomodulatory Effects ◽  
Diffuse Panbronchiolitis ◽  
Heterogeneous Nature

Macrolide antibiotics drew worldwide attention when their use was dramatically successful in the treatment of diffuse panbronchiolitis in 1980s. The success was attributed to their immunomodulatory effects, rather than their antimicrobial properties. Since then, studies have shown that macrolides exert their immunomodulatory effects through several mechanisms, including suppression of proinflammatory cytokines, promoting apoptosis of inflammatory cells, improving phagocytic function, ameliorating airway hypersecretion, and inhibiting production of reactive oxygen species. Macrolides have also been studied in the treatment of asthma. This review highlights the role of macrolides in the treatment of asthma, presenting an overview of the main clinical trials. Despite favourable preclinical data and reports of anecdotal successes, the results of clinical trials are conflicting. This may be due to the heterogeneous nature of asthma. Further studies are needed to identify particular subgroup of asthma that will respond to macrolides.

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