Health Research Ethics 101
What is health research?
Health research refers to a wide range of study and experiments that help to answer health – related problems. This includes research involving human participants or their health information, and research involving human biological samples, such as blood or tissue.
What are clinical trials?
Clinical trials try to test new medications, therapies, devices or new ways of using current treatment, and are used to determine if new drugs or therapies are both safe and effective. The goal is to improve the diagnosis, prevention and treatment of disease or injury and to improve the health and quality of life of individuals.
Why are health research ethics important?
Health research is always underway in Alberta. From experimental drugs to treat cancer and devices designed to minimize bed sores to improving the effectiveness of health professionals and understanding how environmental and other factors affect people, all health research starts with an idea to ease suffering or to increase well-being.
Ideas run through many steps on their way to becoming a reality—molecules are formulated; drugs are advanced; prototypes are built—but before they can be tested on people they need to go through a rigorous process called an ethics review.
Health research depends on people volunteering as research subjects, and governments have an obligation to protect and promote the liberty and welfare interests of human research subjects. They do so by creating regulations, guidelines and oversight structures like research ethics board (REB).
But that wasn’t always the case…
There are examples where unethical research was undertaken as a means to acquire knowledge. Well known instances include Nazi hypothermia experiments, the Tuskegee syphilis study and mind-control research at the Allan Memorial Institute in Montreal.
The birth and evolution of research ethics
The Tuskegee study, which ran from 1932 to 1972, provides a good starting point for the birth of research ethics.
As part of the study, researchers withheld known cures for syphilis from participants as a way to track the effects of the disease as it progressed. The participants were told that they were being treated for “bad blood,” but no real treatment was introduced.
News articles appeared in 1972 condemning the study. This created a scandal that led to a senate inquiry and to US federal regulations governing the conduct of human subject research in 1974.
It also led to the formation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974-1978). This commission produced a report in 1978 called the Belmont Report, which formed the foundation for modern research ethics.
These events were felt in Canada as the country moved in parallel with the US. The first Canadian guidelines governing the conduct of research involving humans was introduced by the Social Science and Humanities Research Council and by the former Medical Research Council in the late 1970s. Now, our nation’s most important policy governing research involving humans is the Tri-Council Policy Statement 2.
Canada’s Research Ethics Boards
Because health research exposes people to risk, at least in part, for the benefit of others, it must show that it lives up to high ethical standards set out in the Tri-Council Policy Statement before it even gets off the ground.
Canada’s Research Ethics Boards interpret and enforce the Policy. It’s their job to also ensure that the research projects being considered comply with other relevant regulations, guidelines, and ethical principles.
The scope of a research ethics board’s review extends to any research that involves human subjects, their health information, and/or research involving their biological samples, such as blood or tissue.
Research and non-research
According to the TCPS2, quality assurance, program improvement initiatives, or any other systematic investigation meant to inform change in only local practice or policy is not considered research and is not subject to research ethics board review. That, however, doesn’t mean these types of projects are without ethical risk. (See A pRoject Ethics Community Consensus Initiative for more information.)
Alberta’s Research Ethics Boards
Alberta’s research ethics boards have the added responsibility of adhering to a piece of legislation called the Health Information Act of Alberta.
This act sets out rules governing the collection, use and disclosure of health information. These rules apply to all healthcare providers operating in the public health system.
There are three such boards in the province that are able to review studies that use health information. They are as follows:
- The Health Research Ethics Board (HREB) housed at the University of Alberta;
- The Conjoint Health Research Ethics Board (CHREB) housed at the University of Calgary; and
- The Health Research Ethics Board of Alberta (HREBA) housed at Alberta Innovates.
Each research ethics board reviews the study protocol, patient materials (such as the consent forms or recruitment posters) and other documents to ensure that the rights, safety and well-being of research participants are protected.
Alberta’s research ethics boards consist of people who have expertise in research, ethics and law. There must also be individuals who have no affiliation with the institution, called community members.
Alberta Innovates – Health Solutions’ role in the ethics ecosystem
Alberta Innovates (AI) is a cornerstone of health research ethics in Alberta. AI is helping to streamline health research ethics review in the province through the Health Research Ethics Harmonization initiative. It plays a central role in developing and maintaining ARECCI, and it manages the Health Research Ethics Board of Alberta.