Academic journal article SRA Journal

When Is Ethical Review of Research Protocols Necessary? A Proposed Classification System for Evaluating Canadian Hospital-Based Research

Academic journal article SRA Journal

When Is Ethical Review of Research Protocols Necessary? A Proposed Classification System for Evaluating Canadian Hospital-Based Research

Article excerpt

Introduction

In the United States, hospital-based research proposals must undergo a standardized, government-mandated ethical review (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979; Office of the Federal Register National Archives and Records Administration, 1993). No such requirements control Canadian hospital-based research.

In 1987, the Medical Research Council of Canada (MRC) published ethical review guidelines (Medical Research Council of Canada, 1987). A recent survey conducted by the National Council on Bioethics in Human Research (1995) reveals that the overwhelming majority of research ethics boards affiliated with Canadian university facilities of medicine use the MRC guidelines.

However, the current version of the MRC guidelines does not attempt to address the important issue of what types of activities require ethical review.(1) Moreover, no information on how research protocols are evaluated in Canadian hospitals, including the use and effectiveness of use of the current MRC guidelines, has been published.

This is surprising given that research and research-related activities are near universal in Canadian hospitals, even in hospitals that are not affiliated with a faculty of medicine (Harper, O'Hara & Sigouin, in press). As a result, Canadian researchers and administrators have had to develop guidelines and control measures, usually at the individual institutional level. These efforts have been inconsistent at best, and, at worst, inadequate.

The present paper describes the efforts of SCO Hospital, Saint-Vincent Pavilion, to develop a set of guidelines for evaluating hospital-based research. The following section describes the results of a national survey to identify the policies and procedures currently used to evaluate research protocols in Canadian hospitals. Results relating to other aspects of Canadian hospital-based research are presented elsewhere (Harper, O'Hara & Sigouin, in press).

The Canadian Hospital Research Survey

In May 1995, a 20-item questionnaire was sent to the CEOs, or the equivalent, of all Canadian hospitals with more than 100 beds (n=393). The questionnaire included basic questions about the organization of the hospital and the hospital's research activities. Additional information about each hospital was obtained from "Guide to Canadian Health Care Facilities 1994-1995" (Canadian Hospital Association, 1994).

This survey and a mailed follow-up reminder yielded an overall return rate of 58.4%. The response rate for the Members of the Association of Canadian Teaching Hospitals, an organization similar to the Council of Teaching Hospitals in the United States, was 79.3%.

Table 1 presents important characteristics of both the population and the sample of Canadian hospitals with more than 100 beds. Within the teaching hospital group, there were no significant differences between responding and non-responding institutions on these variables. This suggests that the sample used in this study is fairly representative of the population of Canadian hospitals that engage in research.

Subject responses reveal that formal ethical evaluation of traditional types of hospital-based research proposals is a near universal requirement for corporate initiated drug trials (95.5% of respondents). Respondents indicated that clinical trials (96.2%) and bench and epidemiological research (90.8%) are also consistently reviewed.

The "softer" types of research, however, appear to be reviewed less often. For example, 66.5% of respondents reported that the review of studies related to quality assurance. Reviews of formal chart audits (70.5%) and program evaluation studies (71.3%) were reported by only a slightly higher percentage of subjects.

Hospitals responding to the survey were compared on the following demographic variables: (a) university affiliation status, (b) types of services offered, (c) number of beds and, (d) the hospital's geographical location. …

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