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.
To study variation in REB consent requirements for retrospective chart review and who may have access to the medical record for data abstraction.
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.
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.
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.
This paper begins with a discussion of the value of privacy, especially for medical records in an age of advancing technology. I then examine three alternative approaches to protection of medical records: reliance on governmental guidelines, the use of corporate self-regulation, and my own third hybrid view on how to maintain a presumption in favor of privacy with respect to medical information, safeguarding privacy as vigorously and comprehensively as possible, without sacrificing the benefits of new information technology in medicine. None of the three models I examine are unproblematic, yet it is crucial to weigh the strengths and weaknesses of these alternative approaches.
This article describes how the Canadian Health Measures Survey (CHMS) of Statistics Canada has addressed the ethical, legal and social issues (ELSI) arising from the survey. The development of appropriate procedures and the rationale behind them are discussed in detail for some specific ELSI. Health Canada's Research Ethics Board, the Office of the Privacy Commissioner of Canada, and the Data Access and Control Services Division at Statistics Canada, provided advice to the CHMS on ELSI. Statistics Canada's legal obligation to protect confidentiality, the oath of office, and security measures at Statistics Canada are explained. Additional information on safeguards specific to the CHMS is presented. The ELSI discussed include communication and consent, privacy and confidentiality, reporting results to survey respondents, inclusiveness, and storage of biospecimens. Common to all ELSI is the need for respondents' awareness and acceptance of their role in the survey process, and the obligation of the CHMS to respect respondents and the data they provide.
A judge in the Ontario Superior Court of Justice has dismissed a breach of privacy suit on the basis that the plaintiff failed to prove that the disclosure of his HIV status had caused him harm. The judgment set out guidelines for how future claims of breach of privacy should be addressed.
Newborn screening (NBS) programs may store bloodspot samples and use them for secondary purposes. Recent public controversies and lawsuits over storage and secondary uses underscore the need to engage the public on these issues. We explored Canadian values regarding storage and use of NBS samples for various purposes and the forms of parental choice for anonymous research with NBS samples.
We conducted a mixed-methods, public engagement study comprising 8 focus groups (n = 60), an educational component, deliberative discussion, and pre- and post-questionnaires assessing knowledge and values toward storage and parental choice.
Canadian citizens supported the storage of NBS samples for quality control, confirmatory diagnosis, and future anonymous research (>90%). There was broad support for use of NBS samples for anonymous research; however, opinions were split about the extent of parental decision-making. Support for a "routinized" approach rested on trust in authorities, lack of concern for harms, and an assertion that the population's interest took priority over the interests of individuals. Discomfort stemmed from distrust in authorities, concern for harms, and prioritizing individual interests, which supported more substantive parental choice. Consensus emerged regarding the need for greater transparency about the storage and secondary use of samples.
Our study provides novel insights into the values that underpin citizens' acceptance and discomfort with routine storage of NBS samples for research, and supports the need to develop well-designed methods of public education and civic discourse on the risks and benefits of the retention and secondary use of NBS samples.
The other day, several nurses on our medical-surgical unit got into a heated debate about staff identification. One nurse was upset that her uncle who had been a patient in another hospital had not been able to find out the names of the nurses who cared for him. Her uncle wanted to write the hospital about concerns he had on the nursing care he received and was very frustrated because the hospital wouldn't tell him the names of the nurses. Some of us said the hospital was right, employers have to protect nurses from harm and should not release the names.
A major moral problem in relation to the deCODE genetics database project in Iceland is that the heavy emphasis placed on technical security of healthcare information has precluded discussion about the issue of consent for participation in the database. On the other hand, critics who have emphasised the issue of consent have most often demanded that informed consent for participation in research be obtained. While I think that individual consent is of major significance, I argue that this demand for informed consent is neither suitable nor desirable in this case. I distinguish between three aspects of the database and show that different types of consent are appropriate for each. In particular, I describe the idea of a written authorisation based on general information about the database as an alternative to informed consent and presumed consent in database research.