Elaine Gibson

Access to medical records for research purposes: varying perceptions across research ethics boards

Introduction: Variation across research ethics boards (REBs) in conditions placed on access to medical records for research purposes raises concerns around negative impacts on research quality and on human subject protection, including privacy. Aim: To study variation in REB consent requirements for retrospective chart review and who may have access to the medical record for data abstraction. Methods: Thirty 90-min face-to-face interviews were conducted with REB chairs and administrators affiliated with faculties of medicine in Canadian universities, using structured questions around a case study with open-ended responses. Interviews were recorded, transcribed and coded manually. Results: Fourteen sites (47%) required individual patient consent for the study to proceed as proposed. Three (10%) indicated that their response would depend on how potentially identifying variables would be managed. Eleven sites (38%) did not require consent. Two (7%) suggested a notification and opt-out process. Most stated that consent would be required if identifiable information was being abstracted from the record. Among those not requiring consent, there was substantial variation in recognising that the abstracted information could potentially indirectly re-identify individuals. Concern over access to medical records by an outside individual was also associated with requirement for consent. Eighteen sites (60%) required full committee review. Sixteen (53%) allowed an external research assistant to abstract information from the health record. Conclusions: Large variation was found across sites in the requirement for consent for research involving access to medical records. REBs need training in best practices for protecting privacy and confidentiality in health research. A forum for REB chairs to confidentially share concerns and decisions about specific studies could also reduce variation in decisions.

Medical Confidentiality and Protection of Third Party Interests

In “A Defense of Unqualified Medical Confidentiality,” Kenneth Kipnis (2006) makes the bold, even audacious, assertion that the professional obligation to prevent harm to third parties does not ope...

Regulating prescription drugs for patient safety: Does Bill C-17 go far enough?

Canada was the last developed country in the world to remove thalidomide from the market, and doing so required an Act of Parliament. At the request of Health Canada’s then Food and Drug Directorate, thalidomide’s two manufacturers voluntarily withdrew the drug from the market on Mar. 2, 1962.[1

Is it Time to Adopt a No-Fault Scheme to Compensate Injured Patients?

The tort system is roundly indicted for its inadequacies in providing compensation in response to injury. More egregious is its response to injuries incurred due to negligence in the provision of healthcare services specifically. Despite numerous calls for reform, tort-based compensation has persisted as the norm to date. However, recent developments regarding physician malpractice lead to consideration of the possibility of a move to “no-fault” compensation for healthcare-related injuries. In this paper, I explore these developments, examine programs in various foreign jurisdictions which have adopted no-fault compensation for medical injury, and discuss the wisdom and feasibility of adopting an administratively-based compensation system for healthcare-related injury in Canada.A number of jurisdictions around the world have created administrative bodies whose role is to assess and allocate appropriate compensation in response to healthcare-related injuries. The primary motivation has been either to accomplish greater justice or to deal with burgeoning costs of the medical malpractice system (often accompanied by threatened collapse of the major insurer). The administrative scheme adopted may replace tort completely vis-a-vis claims within its purview, or it may permit the claimant to select either to pursue the administrative route or to launch a civil lawsuit. The scheme may be comprehensive, i.e., attempting to cover all healthcare-related injury, or may be limited to a particular type or extent of injury. For example, three jurisdictions have adopted programs exclusively focused on serious neurological injury surrounding birth trauma.Under these administrative schemes, an injured claimant must establish that the claimant fits within the program criteria, and therefore is entitled to compensation. The claimant is aided in the process by program administrative staff, and often by the complainant’s health care provider. Thus, the adversarial relationship between plaintiff and defendant is replaced by a system wherein the care provider may provide assistance to the injured person in seeking compensation.Numerous prominent individuals have argued in favour of reform of the Canadian tort-based medical malpractice, but governments have not been highly motivated to take action. However, the Canadian Medical Protective Association has recently sharply hiked the premiums paid for the defence of physicians and residents, in some cases an increase of close to 100 percent from 2014-15 to 2015-16. The lion’s share of these premiums is funded by provincial governments, whose budgets are straining as a result. The question to be addressed in this paper is: Are events now such that governments will indeed be motivated to take on reform, perhaps radical reform? These recent price increases, combined with an enhanced focus on patient safety, may provide the stimulus for revision of our system’s response to healthcare-related injury.

Concepts of bias and appointments to the Governing Council of the Canadian Institutes of Health Research

In October 2009, the academic health research community and the pharmaceutical industry were brought closer together with the appointment of Dr. Bernard Prigent, vice-president of Pfizer Canada, to the Governing Council of the Canadian Institutes of Health Research (CIHR). This bridging of the two worlds has stirred up considerable debate before the House of Commons Standing Committee on Health, in letters to CMAJ and in an online petition that garnered more than 4400 signatures. There are at least two distinct and vocal camps in the debate: those categorically in favour (including the federal minister of health and the president of CIHR) and those opposed to the appointment of someone from the pharmaceutical industry (including several senior Canada Research Chairs with a specialization in ethics and senior persons within CIHR). There are also some who support the appointment of a person with professional ties to the pharmaceutical industry, but not to this particular company (Pfizer) because of its history of ethical and legal violations.

Globalization, Public Health, and International Law

There is an effort underway to build an international network for public health law in Asia. Public health law in Asia is a relatively new field and is developing at a rapid pace, given the recent experiences of managing international infectious diseases such as SARS and the avian flu. The establishment of a comprehensive public health law network could help to influence each nation in Asia to comply with global governance of public health issues. It could contribute to the creation of public health infrastructures which would help to maintain the health of Asia’s population, and in turn, the health of the international community. The World Health Organization (WHO) is currently in the process of reforming the long-standing International Health Regulations (IHR). When first established, the IHR were proposed as a means of providing “maximum protection” by “minimum restriction ...[ of] ... trade” and were primarily designed for the management of cholera, plague, and yellow fever. As the world community is faced with newlyemerging infectious diseases since that time, such as Ebola and AIDS, there is a newfound need for revising the regulations. As it stands today, host countries cannot be held to the regulations’ enforcement standards for outbreak alerts, dissemination of information, and disease management protocols. Political and economic disparities also contribute to the inconsistent and ineffective application of enforcement measures with daunting consequences. A revised version of the IHR can be adapted to take into account the desirability, feasibility, and clarity of health standards for all member states, particularly those dealing with newly-emerging public health concerns and disease outbreaks. Hence, it is imperative that the Pan-Asian region takes an active role in the revision of the IHR, given the key measures which defined the nature of the recent SARS outbreak and a lack of open communication networks from which to bring a swift and effective response. The new IHR can also take into account newlyrecognized individual human rights. It can specify individual entitlements, set science-based standards and fair protocols for public health enforcement measures, and require states to take measures to prevent public stigma and discrimination against diseased individuals. An international network of public health professionals can assist in the determination of these standards. An international public health system can help achieve both transparency and effective surveillance and response without creating a volatile atmosphere of rumor and inaccuracy, which risk both national security and individual liberties. The revision of the IHR is just one step in creating a model WHO that can provide significant technical and financial support for effective public health action.