Blake Murdoch

Biobanks, consent and claims of consensus

Many scholars claim there is a consensus on broad consent for biobanking. We analyzed the literature in PubMed and found no evidence for consensus. Public perception studies report mixed findings on consent, but many biobanks adopt broad consent. A belief in consensus may stem from knowledge of biobank consent practices.

Selling falsehoods? A cross-sectional study of Canadian naturopathy, homeopathy, chiropractic and acupuncture clinic website claims relating to allergy and asthma

Objective To identify the frequency and qualitative characteristics of marketing claims made by Canadian chiropractors, naturopaths, homeopaths and acupuncturists relating to the diagnosis and treatment of allergy and asthma. Design Cross-sectional study. Setting Canada. Data set 392 chiropractic, naturopathic, homeopathic and acupuncture clinic websites located in 10 of the largest metropolitan areas in Canada, as identified using 400 Google search results. Duplicates were not excluded from data analysis. Main outcome measures Mention of allergy, sensitivity or asthma, claim of ability to diagnose allergy, sensitivity or asthma, claim of ability to treat allergy, sensitivity or asthma, and claim of allergy, sensitivity or asthma treatment efficacy. Tests and treatments promoted were noted as qualitative examples. Results Naturopath clinic websites have the highest rates of advertising at least one of diagnosis, treatment or efficacy for allergy or sensitivity (85%) and asthma (64%), followed by acupuncturists (68% and 53%, respectively), homeopaths (60% and 54%) and chiropractors (33% and 38%). Search results from Vancouver, British Columbia were most likely to advertise at least one of diagnosis, treatment or efficacy for allergy or sensitivity (72.5%) and asthma (62.5%), and results from London, Ontario were least likely (50% and 40%, respectively). Of the interventions advertised, few are scientifically supported; the majority lack evidence of efficacy, and some are potentially harmful. Conclusions The majority of alternative healthcare clinics studied advertised interventions for allergy and asthma. Many offerings are unproven. A policy response may be warranted in order to safeguard the public interest.

Pragmatic clinical trials and the consent process

Pragmatic clinical trials (PCTs) are a relatively new methodological approach to the execution of clinical research that can increase research efficiency and provide access to unique data. Some have suggested that the costs and delays associated with obtaining informed consent could make PCTs difficult or even impossible to execute. Alternative consent models have been proposed, some of which lower standards of disclosure, delay consent, or waive it altogether. We analyze the permissibility of changes to informed consent in the context of Canadian research ethics policies, legislation, common law, professional codes of ethics, and professional standards of practice. We find that Canadian law and policy relating to informed consent clearly applies to any clinician who might be involved in a PCT. In addition, existing consent norms seem unable to accommodate alternative consent models for pragmatic research if such models would involve lowering the standard of disclosure. The strong emphasis on the primacy of individual rights that exist in law and in research ethics norms cannot easily coexist with strategies that involve either waiver of consent requirements or the provision of incomplete information about the research prior to enrolment. If Canadian policy-makers wish to create the regulatory flexibility necessary to accommodate altered consent and disclosure, it is likely this will require the alteration of existing health information legislation, national research ethics policy, and professional standards.

Exploiting science? A systematic analysis of complementary and alternative medicine clinic websites’ marketing of stem cell therapies

Objective To identify the frequency and qualitative characteristics of stem cell-related marketing claims made on websites of clinics featuring common types of complementary and alternative medicine practitioners. The involvement of complementary and alternative medicine practitioners in the marketing of stem cell therapies and stem cell-related interventions is understudied. This research explores the extent to which they are involved and collaborate with medical professionals. This knowledge will help with identifying and evaluating potential policy responses to this growing market. Design Systematic website analysis. Setting Global. US and English-language bias due to methodology. Main outcome measures Representations made on clinic websites in relation to practitioner types, stem cell therapies and their targets, stem cell-related interventions. Statements about stem cell therapies relating to evidence of inefficacy, limited evidence of efficacy, general procedural risks, risks specific to the mode of therapy, regulatory status, experimental or unproven nature of therapy. Use of hype language (eg, language that exaggerates potential benefits). Results 243 websites offered stem cell therapies. Many websites advertised stem cell transplantation from multiple sources, such as adipose-derived (112), bone marrow-derived (100), blood-derived (28), umbilical cord-derived (26) and others. Plant stem cell-based treatments and products (20) were also advertised. Purposes for and targets of treatment included pain, physical injury, a wide range of diseases and illnesses, cosmetic concerns, non-cosmetic ageing, sexual enhancement and others. Medical doctors (130), chiropractors (53) and naturopaths (44) commonly work in the clinics we found to be offering stem cell therapies. Few clinic websites advertising stem cell therapies included important additional information, including statements about evidence of inefficacy (present on only 12.76% of websites), statements about limited evidence of efficacy (18.93%), statements of general risks (24.69%), statements of risks specific to the mode(s) of therapy (5.76%), statements as to the regulatory status of the therapies (30.86%) and statements that the therapy is experimental or unproven (33.33%). Hype language was noted (31.69%). Conclusions Stem cell therapies and related interventions are marketed for a wide breadth of conditions and are being offered by complementary and alternative practitioners, often in conjunction with medical doctors. Consumer protection and truth-in-advertising regulation could play important roles in addressing misleading marketing practices in this area.

The law of food allergy and accommodation in Canadian schools

BackgroundThere is ongoing controversy surrounding the appropriate standards and limits of accommodation of children with food allergies in schools. We identify and explain how relevant Canadian common law, legislation, constitutional law and human rights policy can inform future school policy around allergy, disability and food bans.Main bodyThe Canadian Charter of Rights and Freedoms applies to governmental laws or policies, including the policies of schools, and grants every individual the right to freedom from discrimination based on, among other things, disability. Canadian constitutional and human rights law define disability broadly including perceived disabilities. Provincial human rights tribunals in both Ontario and BC have explicitly found allergy to be a disability requiring accommodation, even in cases not involving anaphylaxis risk. However, the cases most pertinent to the scenarios faced by schools have found that food bans may not be required, due to recent scientific evidence that they do not render allergy sufferers safer.ConclusionAnaphylaxis-level allergy constitutes a disability under both the Charter and human rights legislation, despite the fact that higher courts have not definitively ruled on the matter. Accordingly, schools must make careful decisions about how to deal with life-threatening allergies among their students. Food bans are generally not legally necessary, and, in the absence of new legislation, are only likely to become so if sufficient scientific evidence demonstrates that they increase safety for students. School policies should be substantially informed by evidence-based research in order to ensure ongoing congruence with human rights law.

The challenge of human challenge research models: A Canadian perspective

Research in which healthy volunteers are exposed to pathogens or other aetiologic agents that may cause disease remains controversial. Proponents suggest such work is key to understanding pathways of infection and the efficacy of vaccines and treatments. Yet, this research creates ethical and legal issues surrounding consent, participant vulnerability and the potential for harm. Moreover, public trust in research could be compromised if avoidable, serious harm occurs, making challenge research risky. Among Canadian research ethics guidelines, overarching messages are that participant interests cannot be subservient to those of research and that risks must be proportional to likely benefits. Moreover, common law fiduciary obligations to clinical research participants and the deterrent effect of potential tortious or criminal negligence act to reinforce the idea that challenge protocols should be a strategy of last resort. Researchers could benefit from clear guidance directly addressing the unique issues with challenge research.

Compelled Disclosure of Confidential Information in Patient Safety Research.

The protection of confidential research data is of key importance to clinical patient safety research. A review of selected Canadian and American case law indicates that although the relationship between researcher and participant has not been recognized as privileged, court-ordered disclosure of confidential research information seems to be a rare occurrence. In this review, we examine how confidentiality issues are presented in informed consent form templates and in relevant research ethics policies. We find an agreement among research policy documents that all information gathered should be treated as confidential, unless otherwise required by law. Confidentiality provisions in informed consent forms reflect the reality that in some cases, the law can compel disclosure of confidential data. There is, therefore, a potential tension between the law and existing research ethics policy. It has been suggested that researchers have an ethical and possibly legal duty to actively resist disclosure requests. We conclude that it is reasonable for researchers to disclose, as part of the informed consent process, how rare successful disclosure demands are and that steps will be taken to oppose such demands.