11 results on '"Avard, Denise"'
Search Results
2. Newborn blood spot screening in four countries: stakeholder involvement.
- Author
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Potter BK, Avard D, and Wilson BJ
- Subjects
- Community Participation, Humans, Infant, Newborn, Societies, Medical, Blood Specimen Collection, Health Policy, Neonatal Screening standards, Policy Making, Public Health Administration standards
- Abstract
While newborn blood spot screening has historically been viewed as a public health success, the potential harms and benefits are more finely balanced for new conditions being considered for program expansion. We highlight complex issues that must be addressed in policy decisions, which in turn requires a consideration of many stakeholder perspectives. Using national policy documents from the United Kingdom, the United States, Australia, and Canada, we describe the participation of stakeholder organizations in the newborn screening policy process, how such organizations have incorporated stakeholder views into their own policy writing, and their recommendations for inclusiveness. Stakeholder participation in newborn screening decision-making is widely acknowledged as important, and many methods have been endorsed - consultation as well as direct or indirect input into policy development. Differences across organizations and jurisdictions raise questions about the most effective approaches for facilitating inclusiveness, suggesting a need for formal evaluative research.
- Published
- 2008
- Full Text
- View/download PDF
3. Newborn Screening by Tandem Mass Spectrometry: Ethical and Social Issues
- Author
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Avard, Denise, Vallance, Hilary, Greenberg, Cheryl, and Potter, Beth
- Published
- 2007
- Full Text
- View/download PDF
4. FMT Happens: Regulating Fecal Microbiota Therapy in Canada; What You Need to Know.
- Author
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Salman, Shahad, Vardatsikos, George, Avard, Denise, Palmour, Nicole, Dewar, Ken, and Zawati, Ma'n H.
- Subjects
FECAL microbiota transplantation ,ANTIBIOTICS ,CLOSTRIDIOIDES difficile ,INTESTINAL infections ,HEALTH policy ,CLINICAL trials ,THERAPEUTICS - Abstract
By disrupting normal gut microbiota, antibiotic therapies pose a major risk to the treatment of Clostridium difficile infection (CDI), a debilitating and potentially fatal intestinal infection. Consequently, there is a pressing need for the development of an effective, novel, nonantibiotic treatment. One such treatment is fecal microbiota therapy (FMT), which restores gut microbiota in CDI patients and has gained popularity in recent years due to its high efficacy rate. Health Canada has recently proposed to regulate FMT as a 'biological drug' following the U.S. Food and Drug Administration's approach. Moreover, as an interim policy, Health Canada proposed to exercise a risk-based interpretation regarding the clinical trial requirements for FMT used in treating CDI, limited to patients unresponsive to conventional therapies. This article first discusses important considerations for an alternative classification of FMT and stresses the need to develop a policy dependent upon scientific developments in the field, away from a one-size-fits-all approach. Second, it briefly explores some concerns related to the recourse to this provisional interpretation to guide the use of FMT in the treatment of patients with CDI unresponsive to conventional therapies subject to Health Canada's recent policy. [ABSTRACT FROM AUTHOR]
- Published
- 2016
- Full Text
- View/download PDF
5. Expectations and values about expanded newborn screening: a public engagement study.
- Author
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Hayeems, Robin Z., Miller, Fiona A., Bombard, Yvonne, Avard, Denise, Carroll, June, Wilson, Brenda, Little, Julian, Chakraborty, Pranesh, Bytautas, Jessica, Giguere, Yves, Allanson, Judith, and Axler, Renata
- Subjects
HEALTH policy ,ATTITUDE testing ,CONSUMER attitudes ,FOCUS groups ,NEWBORN screening ,INFORMED consent (Medical law) ,RESEARCH methodology ,PROBABILITY theory ,QUESTIONNAIRES ,RESEARCH funding ,SCALE analysis (Psychology) ,PATIENT participation ,INFORMATION needs ,DESCRIPTIVE statistics - Abstract
Objectives Newborn bloodspot screening ( NBS) panels have expanded to include conditions for which treatment effects are less certain, creating debate about population-based screening criteria. We investigated Canadian public expectations and values regarding the types of conditions that should be included in NBS and whether parents should provide consent. Methods Eight focus groups ( FG; n = 60) included education, deliberative discussion and pre-/post-questionnaires. Data were analysed quantitatively and qualitatively. Results Quantitatively, the majority supported NBS for serious disorders for which treatment is not available (95-98, 82%). A majority endorsed screening without explicit consent (77-88%) for treatable disorders, but 62% supported unpressured choice for screening for untreatable disorders. Qualitatively, participants valued treatment-related benefits for infants and informational benefits for families. Concern for anxiety, stigma and unwanted knowledge depended upon disease context and strength of countervailing benefits. Conclusions Anticipated benefits of expanded infant screening were prioritized over harms, with information provision perceived as a mechanism for mitigating harms and enabling choice. However, we urge caution around the potential for public enthusiasm to foster unlimited uptake of infant screening technologies. [ABSTRACT FROM AUTHOR]
- Published
- 2015
- Full Text
- View/download PDF
6. CHARTING THE PRIVACY LANDSCAPE IN CANADIAN PAEDIATRIC BIOBANKS.
- Author
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Dove, Edward S., Black, Lee, Avard, Denise, and Knoppers, Bartha M.
- Subjects
DATA privacy ,BIOBANKS -- Law & legislation ,RIGHT of privacy ,PEDIATRICS -- Law & legislation ,PERSONALLY identifiable information -- Law & legislation ,LEGISLATIVE reform ,LAW ,CONFIDENTIAL communications ,GENETIC research & ethics ,INFORMED consent & ethics ,TISSUE banks ,MEDICAL research ethics ,MEDICAL ethics laws ,TISSUE banks -- Law & legislation ,ACCESS to information laws ,CLINICAL medicine research ,MEDICAL ethics ,PRIVACY ,COURTS ,DECISION making ,HUMAN genome ,LEGAL liability ,INFORMED consent (Medical law) ,PATIENT-family relations ,HEALTH policy ,PARENTS ,RESEARCH ethics ,TISSUES ,GOVERNMENT regulation ,RESEARCH personnel ,HUMAN research subjects ,GENETIC privacy ,CHILDREN ,ETHICS - Abstract
The article discusses a right to privacy in relation to Canadian paediatric biobanks, and it mentions the legal efforts to control access to and the use of personal information. Privacy legislation and policies are addressed, along with legislative reform and the Supreme Court of Canada's definition of information privacy. Public trust and the legal aspects of third parties are examined, along with the use and transfer of a child's data and the Canadian Charter of Rights and Freedoms.
- Published
- 2013
7. Pediatric Research and the Return of Individual Research Results.
- Author
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Avard, Denise, Sénécal, Karine, Madadi, Parvaz, and Sinnett, Daniel
- Subjects
- *
GENETIC research & ethics , *INFORMED consent & ethics , *MEDICAL research ethics , *DISCLOSURE , *ACCESS to information , *AGE factors in disease , *COMMUNICATION , *CONFIDENTIAL communications , *DECISION making , *GENETICS ethics , *HEALTH , *INFORMED consent (Medical law) , *MEDICAL personnel , *HEALTH policy , *LEGAL status of patients , *PEDIATRICS , *PRIVACY , *PROFESSIONAL associations , *RESEARCH ethics , *RESPECT , *INFORMATION resources , *ETHICAL decision making , *GENOMICS , *PARENT attitudes , *HUMAN research subjects , *PARTICIPANT-researcher relationships , *PATIENTS' families , *ETHICS - Abstract
The return of individual research results to participants raises many socio-ethical issues and is even more challenging when the participant is a child. The objective of this article is to present an overview of the few ethical guidelines and relevant literature addressing the return of individual results in pediatric research. By reviewing policies and the literature, we present some overarching considerations and delineate contextual issues in order to propose a framework. [ABSTRACT FROM AUTHOR]
- Published
- 2011
- Full Text
- View/download PDF
8. Regulatory Approval for New Pharmacogenomic Tests: A Comparative Overview.
- Author
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JOLY, YANN, KOUTRIKAS, GEORGIA, TASSÉ, ANNE-MARIE, ISSA, AMALIA, CARLETON, BRUCE, HAYDEN, MICHAEL, RIEDER, MICHAEL J., RAMOS-PAQUE, EMMA, and AVARD, DENISE
- Subjects
PHARMACOGENOMICS ,PUBLIC health ,PUBLIC safety ,HEALTH policy - Abstract
The article offers an overview on the regulatory framework for pharmacogenomic tests in Canada, the U.S., and Europe. It examines the different regulatory pathways for pharmacogenomic tests commercialized as test kits and laboratory-developed tests (LDTs). It evaluates the issues related to the regulatory framework and its impact in relation to meeting the goals of promoting the advancement of pharmacogenomics and ensuring public safety.
- Published
- 2011
9. Public involvement in health genomics: the reality behind the policies.
- Author
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Avard, Denise, Stanton Jean, Michèle, Grégoire, Gabrielle, and Page, Madeline
- Subjects
GENOMICS ,HUMAN genome ,GENETICS ,HEALTH policy ,BIOMEDICAL organizations ,SCIENTIFIC community ,HEALTH ,ENGAGEMENT (Philosophy) ,SOCIETIES - Abstract
Public involvement is increasingly becoming the norm as stakeholders recognize the need to inform, consult and engage the public. However, there is limited understanding about the meaning and implications of public involvement, in particular elements like the levels of public involvement, the goals of the involvement, the type of public to be involved, the methods of involving the public and the need to assess effectiveness. We conducted a systematic review of policy documents/guidelines published between 1998 and 2009, by governments, health professionals and the public regarding public involvement in the area of human genomics. Documents were identified using the HUMGEN database and organizational web sites. A total of 70 documents were retrieved addressing public involvement and human genomics. The review revealed that 22 documents mentioned the active process of partnership and collaboration, whereas 27 mentioned consultation and 29 mentioned education. The most common goals were building trust and respect, followed by education, governance and lastly, understanding risks and benefits. We found that less than a third of the documents defined who the public is, and when mechanisms for public involvement were mentioned, they were rarely placed into a context. Few documents drew attention to evaluation. It is reassuring to see that there has been an emphasis placed on public involvement in the area of health and genomics. The findings underscore the gaps existing in the actual policy documents/guidelines and the need to clarify the goals, the methods, who is the public, what mechanism are appropriate and the need for evaluation when addressing public involvement in health genomics. [ABSTRACT FROM AUTHOR]
- Published
- 2010
- Full Text
- View/download PDF
10. A Guide to the Perplexed: How to Navigate Conflicting Research Ethics Policies.
- Author
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Kimmelman, Jonathan, McDonald, Michael, and Avard, Denise
- Subjects
RESEARCH ethics ,MEDICAL laws ,PUBLIC health research ,HEALTH policy ,MEDICAL care - Abstract
The article explores the conflicting research ethics policies in Canada. It considers the Belmont Report, the Declaration of Helsinki, Council for International Organizations of Medical Sciences' (CIOMS) guidelines, International Conference on Harmonization-Good Clinical Practice (ICH-GCP) guidelines, and Tri-Council Policy Statement 1 (TCPS 1) and TCPS 2. It further notes their differences in scope, degree of detail, prescriptiveness and length.
- Published
- 2011
11. Are We Asking the Right Ethics Questions on Drug Shortages? Suggestions for a Global and Anticipatory Ethics Framework.
- Author
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Ozdemir, Vural, Joly, Yann, Dove, EdwardS., Karalis, Aspasia, Avard, Denise, and Knoppers, BarthaM.
- Subjects
HEALTH care rationing ,PUBLIC health ethics ,HEALTH policy ,WORLD health ,DRUGS ,ETHICAL decision making ,GENOMICS ,CULTURAL values ,ETHICS - Abstract
The article discusses the article "Unpredictable Drug Shortages: An Ethical Framework for Short-Term Rationing in Hospitals" by P. M. Rosoff. In the article the authors offer their opinions on several points which are raised in Rosoff's article and on problems related to drug shortages in hospitals across the globe.
- Published
- 2012
- Full Text
- View/download PDF
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