What is research?
Commonly, we are asked if a given "study" is or is not research. This has to do with whether or not the "study" has to be submitted to our REC for review. Often it is difficult to answer this question, since the definition of research does not answer the question.
The definition of research continues to present difficulties, particularly with regard to the distinction between medical practice and medical research. The distinction derives from the intent. In medical practice the sole intention is to benefit the individual patient consulting the clinician, not primarily to gain knowledge of general benefit, although such knowledge may incidentally emerge from the clinical experience gained. In medical research the primary intention is to advance knowledge so that patients in general may benefit; the individual patient may or may not benefit directly.
Medical practice and research
The distinction between medical practice and research is often less clear than is suggested above because both may be practiced simultaneously on the same patient. Any activity aimed at obtaining new knowledge affecting the patient in any way which is additional to ordinary medical practice is to be regarded as research. As well, health systems research aims to improve efficiency, cost-effectiveness and equity in health care, is recognized as legitimate research, and is increasingly being given a high priority internationally and in Quebec.
Sometimes special circumstances of an individual patient's illness lead a clinician to step outside what is accepted as normal medical practice. Innovative treatment of this nature does not necessarily constitute research.
In innovative treatment, the sole motive for the action is to choose the best possible course for the individual patient even though it be unconventional. Responsibility for employing innovative treatment remains that of the clinician, who remains subject to the usual constraints which direct ordinary medical practice.
Where a clinician contemplates a marked digression from normal medical practice in an individual case, with the prime purpose of acquiring information for application in future patients, the activity clearly becomes research and must be subject to all the considerations of proper consent and scrutiny by Research Ethics Committees described here. When a major innovation is being called into regular use and the procedure is not yet incorporated into medical practice generally, the innovation should become the subject of formal research without delay so that its true worth can be established.
Quality Assurance or Research?
One of the most commonly confusing areas is differentiating a department audit from research. A department may decide for example to assess a given procedure that is routine and add a few more tests to be done on the patient for example. Is the patient then a participant in research? As is obvious, it may be difficult to determine whether one is in the area of research or departmental audit, and a discussion with the committee chairman may help solve the problem.
For any questions please contact us.