The governance of research integrity in Canada.

• Author: Master, Zubin

Introduction

Researchers have a moral and social contract to uphold several ethical principles in the conduct of research. Much of scientific, social science, and humanities research in many nations is paid for by society through public funds.' Hence, researchers have a social responsibility to ensure that their conduct of research is performed with the highest standards of professionalism, ethics and integrity.

The responsible conduct of research (also known as scientific or research integrity (1)) includes a set of norms and practices that applies to researchers in any discipline. Several principles underlie the responsible conduct of research (RCR), such as, honesty, carefulness, openness, fair credit, respect for colleagues, respect for human and non-human animal subjects, legality, education, and social responsibility. (2) These principles guide all aspects of RCR including research design, the collection, analysis and dissemination of results, the ethical treatment of human and animal subjects, providing appropriate credit to colleagues and students, being open to criticism and review, sharing data, reagents and methods, and avoiding conflicts of interest. A violation of these practices can lead to different harms to the researcher herself, other researchers, research subjects, or society. This can be in the form of research fraud, undermining the health and safety of research participants, preventing scientists from replicating results, or wasting resources. However, research is performed by human beings and human frailties inevitably appear, sometimes in the form of research misconduct. (3)

Much of the Canadian academic literature focuses on the ethics and governance of research involving humans, animals, and conflicts of interests. Little attention, however, has been paid to the ethics and governance of RCR. This paper aims to provide the scope of research misconduct cases reported as news in academic journals and the Canadian popular press, and review the RCR practices and policies in Canada, including various relatively recent initiatives conducted by different governmental and non-governmental organizations with the goal of strengthening the Canadian research integrity system.

Research Misbehaviours in Canadian Institutions

Awareness of RCR by scientists, bioethicists, the media, governing organizations, and the public has been heightened by widely publicized scandals of research misconduct. Many international RCR policies arose from major scandals hitting nationwide headlines and Canadian research misconduct cases have also been featured in the news.

In a large multi-centre breast cancer trial, Dr. Roger Poisson recruited patients who didn't fit the inclusion criteria claiming that he couldn't deny women the best available treatment because of a criterion that had little or no oncological importance. (4) This led to an investigation of several of his studies and in 1993, Poisson was convicted of research misconduct in the U.S. where 115 documented instances of fabrication and falsification were found. (5) Dr. Poisson, a member of the medical faculty at the University of Montreal, was forced to retire a month earlier due to these findings. (6) A second case that received considerable media attention, including an expose by CBC News, was with Ranjit K. Chandra--a retired professor at Memorial University of Newfoundland who was accused of research misconduct in several studies. (7) A third case involved plant researcher Fawzi Razem, who worked in a laboratory of a professor at the University of Manitoba and was found to have fabricated data. (8) Resigning from the University of Manitoba after the initial allegation was made, Razem later turned up to be working as faculty at the Palestine Polytechnic University. (9)

Another highly publicized case involved Dr. Eric Poehlman who was hired by the University of Montreal in 2001 while he was being investigated for fabricating research at the University of Vermont College of Medicine and previously at the University of Maryland. (10) Not only was Poehlman hired, he was awarded $1 million from the Canada Research Chairs and subsequently $200,000 from the Canadian Foundation for Innovation and the Canadian Institutes of Health Research (CIHR)." Similarly, a post-doctoral fellow began working at the Ottawa Health Research Institute (OHRI) in 2005, but was concluded to have previously committed research misconduct while at the University of Pennsylvania and her employment at OHRI was subsequently suspended. (12)

In addition to research fraud, accusations and findings of many research misbehaviours including plagiarism, ghost writing, duplicate publication, misuse of federal research funds, muzzling of scientists, and significant data errors causing publication retractions have been performed by researchers at Canadian institutions. (13) These cases provide some idea of the scope of research misconduct in Canada, yet there is no reliable data on the frequency or range of specific research misbehaviours.

One Canadian report approximated 1.4 allegations being addressed per year of the 29 institutions that provided information. (14) However, this number may be significantly underestimated due to underreporting and uneven enforcement standards by institutions. For example, between 2000/01 and 2010/11, CIHR received 97 allegations of which 61% were related to alleged research integrity violations while 13% were related to alleged violations of the policy governing ethical research involving humans. (15) Of the 97 allegations received, 72 were referred to the institutions for investigation and 48% were concluded that misconduct did occur while 10% remained a ctive. (16)

Studies from other nations point to differing frequencies of scientific misdeeds. A meta-analysis of several studies measured a misconduct frequency 0f 1.97% where misconduct was defined as fabrication, falsification, and the alteration/modification of research results to improve an outcome; on the other hand, questionable research practices (ii) were found to occur around 33.7% of the time. (17) Another research study sampled 3,247 National Institutes of Health-funded researchers and found that many anonymously self-reported engaging in various scientific wrongdoings including republishing data (4.7%), failing to present data that contradicts one's own research (6%), inappropriate authorship (10%), withholding methods/data in papers/proposals (10.8%), overlooking others' use of flawed interpretation of data (12.5%), using inappropriate study designs (13.5%), dropping data points from analyses based on gut feelings (15.3%), and poor record keeping (27.5%). (19) These studies raise a number of questions as to the effectiveness of RCR policies and education, but also indicate possibly where focus should be emphasized.

The Canadian Research Integrity Framework

Throughout the world, RCR practices have been codified into a variety of policies i.e., laws and regulations, professional guidelines, directions, good clinical/research practices, or inspirational policies. These policies are found at national, provincial/state and institutional levels, and in both public and private sectors where scientific research is performed. Different research integrity policies contain different types of provisions based on the mandate of the organization formulating the policy (see Table 1 for some examples). From 2007 onwards, there has been a series of policy research initiatives in Canada that have raised awareness and served to increase knowledge about the current Canadian research integrity system.

Table 1. Different Misbehaviours or Ethical Practices Outlined in Research Integrity Policies Practice Description Fabrication...