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Weekly UpdatesIntroduction
Research integrity is a global concern. When research lacks integrity, it destroys public trust in the academic and scientific community (The National Academies Press, 2002). While this issue is important for all research institutions, it becomes increasingly complex in the setting of internationally collaborative research, in which local standards vary despite considerable global consensus regarding many aspects of research integrity and ethics.
International interest in research ethics became pronounced following World War II (Deyhle, Hess & LeCompte, 1992). This interest resulted from the inhumane treatment of human beings by Nazi physicians (Crigger, 1992). Subsequently, numerous bodies offered standards to help ensure the ethical conduct of research (CIOMS; Declaration of Helsinki). While there are some differences among these policies, most support the prospective review of research and informed consent.
In addition, every profession is governed by implicit or explicit standards of competence and conduct (Bayles, 1988). These standards help to ensure that professionals perform as expected and that the profession itself maintains quality and integrity. Accordingly, institutions are concerned with both the review and the responsible conduct of research. Because allegations of misconduct tend to be unique rather than routine at most institutions around the globe, few have extensive experience in responding to allegations. The uniqueness of allegations of misconduct makes it difficult for an institution to develop expertise in conducting inquiries and investigations (Rhoades, 2000; Lock, 1995; Husemeyer, 1995). However, a research misconduct allegation has the potential for a high impact, both on the individuals involved and the institution (Rhoades, 2000).
Much of the recently published literature concerning research ethics, integrity, and compliance comes from Northern and Western nations. Nevertheless, internationally collaborative research has become more commonplace in locations that may have fewer financial resources to develop ethics and compliance programs. Yet constructing such programs is possible. In this paper we discuss some of the difficulties inherent to setting up these programs in the developing world and describe one program that may serve as a model.
Difficulties with setting up ethics structures in developing countries
Perlman (2005) maintains that, in the United States, reliance on regulations to enforce ethics requirements has resulted in a focus on compliance with requirements rather than the ethical principles that underpin them (National Commission, 1979). Despite this shortcoming, the U.S. approach helps to ensure that vulnerable subjects are protected and that their rights, safety and welfare take priority over the interests of science.
The situation in many developing countries is very different due to a lack of national legislation that would form the required umbrella for ethics policies. In Botswana, for example, there is no national legislation on ethics. In particular, although the country has for years depended upon South Africa for specialized medical services, there is no tissue act to regulate the movement of human tissues across national borders, nor to oversee their disposal once laboratory procedures are completed. The Ministry of Health is the only ministry with an active ethics body. Its institutional review board (IRB) ensures adherence to standard international ethics. The lack of a national legislative framework is not unique to Botswana, but common across the sub-Saharan region.
This situation--like ploughing on parched ground--makes it very difficult for an academic institution to formulate and effectively enforce an ethics policy. More importantly, this explains in part why so many university faculty members and students lack awareness of the responsible conduct of research. It is not always clear whether faculty members flout the rules for responsible ethical conduct deliberately or out of ignorance. Although the scale of academic misconduct by staff at the University of Botswana (UB) is not well documented, cases involving both students and staff have occurred (Moahi et al., 2005). Some of these cases have involved both intellectual and financial misconduct and are usually handled confidentially within the university. Some cases, however, some cases have also reached the public media, putting the university's integrity at stake (Odubeng, 2004).
University of Botswana Ethics Policy
The objective of the ethics policy at the UB is to ensure that research is conducted according to internationally recognized ethical standards. Further, the implementation of the ethics policy represents another step toward handling of cases of academic misconduct and helping the university achieve its vision as a leading academic centre of excellence in Africa and the world.
The ethics policy at UB was approved in 2004. The Director of the Office of Research and Development (ORD) implements the policy through the Research Risks Committee (RRC). The RRC and its associated committees, including the IRB, the Animal Use and Care Committee (AUCC) and the Chemicals and other Hazardous Materials Committee (CHMC), were established in April 2005. The ORD Director is therefore responsible for ensuring that all research at UB follows both the ethical principles that have been set by the university and the laws and regulations governing research in Botswana. The Director also is responsible for fostering a culture of respect for research integrity; for ensuring the education of the ethics committees, researchers and staff on the ethical conduct of research; and for monitoring UB's ethics program.
[FIGURE 1 OMITTED]
The organization and administration of research ethics is demonstrated in Figure 1, which illustrates the relationship between the URAC, the RRC, and the IRB.
The University Research Advisory Committee (URAC), established in November 2002, advises the ORD on implementation of policy. The URAC consists of the Deans of each Faculty, the Director and Deputy Director of the ORD, the Dean of the School of Graduate Studies, the Faculty Research Committee Chairpersons, one person appointed by the Deputy Vice-Chancellor (Academic Affairs) to represent support staff, and the Manager of Special Projects from the Office of Financial Planning and Control.
The RRC has two primary roles:
1. To provide guidance in research ethics to the UB community, including, questions about misconduct (falsification, plagiarism, or misrepresentation of data), the level of contribution that warrants inclusion as an author on a publication, or ownership of a research idea. The RRC promotes awareness and compliance with the UB Policy on Ethics and Ethical Conduct of Research through periodic release of information to staff and students.
2. To review and make recommendations about all research proposed by UB staff or students. This responsibility is delegated to the three committees for which the RRC has oversight: the AUCC, the CHMC, and the IRB.
The UB Institutional Review Board for Protection of Human Subjects
The UB IRB is responsible for review of all human subject research activities consistent with U.S. federal regulations (Protection of Human Subjects, 2005). These broader definitions are critical to protecting the human subjects with whom UB investigators interact or about whom they obtain private information. When there is a question about whether an activity constitutes human subject research, the UB requires "a qualified person or persons other than the investigator or research team" to verify that the activity requires IRB review (Protection of Human Subjects).
IRB review is also extended to student research activities. In some courses, students collect data by using professional research methods, even though the work is not expected to contribute to generalizable knowledge. Because some methods involve human subjects, and in some instances place these subjects at risk, student research projects are reviewed and approved prior to initiation to assure that the rights and welfare of human subjects are protected.
To direct its operations, the UB IRB has established guidelines used by staff and students in both courses and research, and it has the authority to require adherence to these practices. Deviation from these standards is usually reported to the Director of ORD, who then takes further action as recommended by the RRC. The IRB also reviews all research protocols of staff and students in which human subjects are used. The committee is authorized to communicate approval and disapproval actions to those submitting the proposal, and is required to report all review outcomes to the RRC.
The IRB consists of 12 members appointed by the Director, ORD. Membership includes knowledgeable individuals from the local community, the Government, and UB. Additional individuals with special expertise may from time to time be designated as ad hoc members to assist the IRB. The committee is chaired by a member of the UB staff.
The IRB review process requires researchers to submit 12 copies each of the entire academic proposal, the completed UB application for Approval of Human Research, instructions to participants, the consent form, any questionnaires (translated as appropriate), and the curriculum vitae of the Principal Investigator(s).
The review process of the IRB consists of:
1. Discussion of any policy issues, conflict of interest or procedural matters.
2. Review of protocols.
a. The IRB will establish and publicize to UB staff and students deadlines for submission of research projects for review,
b. Each protocol is assigned to a member of the IRB for review. When additional expertise is required, the protocol may be assigned to an ad hoc member for review and presentation to the IRB.
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