DR. MADUABUCHI JOHN-MOSES UWANDUOMA
Permit me to start this piece by zeroing in on some peculiar news that hit the Nigerian air waves within the last month; viz: that “Chinese drugs /capsules containing human remains from foetuses, infants and flesh imported into the country by some Chinese nationals” were used to manufacture drugs claimed to “boost stamina, cure cancer, diabetes and some terminal diseases”. It was also claimed that 18.7 billion viruses, including Hepatitis B, were isolated in these Chinese killer drugs.
When you read these kinds of stories, what comes to your mind? What would have informed such actions? Could there have been any form of “good” research involved in developing such products or was there a valid research activity that unveiled such a practice?
WHAT IS CLINICAL RESEARCH?
Let me start by saying that research could be categorized as academic, entrepreneurial and regulated. There are several classifications of research though; but I just want to point out that some people’s aim of embarking on research could primarily be to get academic qualifications for promotions and thereby attain “research popularity”. Some other people aim at getting intellectual properties through research and development. Any Research whose outcomes would or could be used for regulatory decision making and policy formulation is called Regulated Research.
Clinical research means “medical research involving people.” This definition is however relative to particular professions. In drug development, while animal studies are referred to as pre-clinical studies, veterinarians treat animals, and as such their research with animals is clinical research. Clinical research is not done by medical doctors alone. Any appropriately qualified professional who can run a clinic can do clinical research in that setting. Moreover, depending on a research protocol, it may not be a medical doctor that may head some special studies.
Clinical Research could be categorized as studies and trials. Clinical studies which include observational studies, have to do with researching on people in ‘normal settings’.”Researchers gather information, group volunteers according to broad characteristics, and compare changes over time. For exam researchers may collect data through medical exams, tests, or questionnaires…” Clinical trials, on the other hand, are research studies performed in/on people that are aimed at evaluating a medical, surgical, or behavioral intervention. This is why it is also called Interventional research, Our definition here, suggests that there are medical researches that do not qualify as clinical research and there could be clinical researches that are non-medical.
CLINICAL RESEARCH: HOW TO START
If a research design or its execution is not scientifically sound and valid, that research is unethical in the first instance. It is also possible to have a research with a good design that becomes unethically conducted; or a good research design, proper execution and unethical handling of the research outcome. For anyone interested in Research, part of the questions to ask is this:
1. How does one achieve scientific validity in research?
2. Who determines or adjudges whether a research is ethical or not?
The answers to these questions are not absolute and would be largely influenced by circumstances and the researchers’ immediate environment.
For one to do well in clinical research there is need to build ample capacity as a Subject Matter Expert (SMEs) in one’s field of interest. There is always the primordial need for one to be qualified for clinical research by education, training and experience. These virtues are so essential, that in quality assurance, we have tools and paradigms to evaluate them.
However, it is interesting to state that the research skills you may need for research is not what you acquire after becoming an expert but what you gather along the line of your training/capacity building. The Research enterprise has principles not exactly as obtained in academic settings. In essentially all academic environments there must, of necessity, be the distinction between students and lecturers, juniors and seniors. But in research, there is no such distinction. Once you know what to do, and have done it well, no one identifies you as a student or junior in the research product or outcome (which more commonly would be journal articles). Depending on the nature of the studies in question, students and junior academicians do well in research and take first positions in authorship. Some senior academicians would not allow this, perhaps because they were not well-trained in research principles or because they have a penchant for doing things unethically. There is a lot to be said here.
To conceptualize and design scientifically valid clinical research protocols, you have to be an avid reader of other research projects/publications. When you read research abstracts on websites like PubMed, and do not have all the money to purchase all the journal articles you need; look at the email contact of the authors and send them a letter, requesting them to give you their full publications. Once they understand that you are really passionate about research, and are interested in their work, but perhaps have resource constraints, they would oblige you.
Also be interested in collaborative research; including multi-disciplinary and international studies. This point is related to the need for the right environment to encourage research and the role of mentorship. You may never be able to choose your teachers, and lecturers in any institution, but no one chooses your mentor for you. The norm is that it is the mentee that seeks and gets a mentor, not the other way round. But exception is always the rule. Because of the role and importance of mentorship in research, there are formal research mentorship programmes that would benefit researchers, at all levevl–beginner, intermediate or advanced. It is also recommended that corporate professional organizations like CMDA Nigeria develop and operate such formal mentorship programmes; academic Institutions and tertiary/teaching hospitals should have clear cut policies for research and create a unit or office to oversee research.
The role of ethics committees has to be understood and appreciated for all kinds of Research. It is good to note that a very functional research ethics committee could also advise and train researchers on how to design quality studies. Every form of research with human subjects or about human beings, animals or the environment they are living in should be reviewed by ethics committees. For environments where there are no appropriately constituted ethics committees, researchers are expected to follow the advice of a bioethicist. When both are not available, one could still start research and rely on self- regulation. For this, the researcher is expected to have personally done a minimum level of online modular training for Responsible Conduct of Research (RCR), Human Subject Protections (HSPs), and Good Clinical Practices (GCPs) etc, as my be applicable. Although some folks argue against using expressions like Human Subject Protections, (as in their opinion; such connotes subjugation of fellow human beings. The issue about research is not just about sentiments, it borders much on Ethical, Legal and Societal Issues (ELSI). Research is guided by laws, regulations, guidelines and policies. Across many countries, there are subsisting laws that hold the researchers responsible to protect people in research. These are the laws referred to as HSPs. Until we get laws that would be called Human Participant Protections, we would still technically use the former. For more information on these and how to build personal capacity in research and gather the essential skills in self-regulation, I would suggest that you take free online courses hosted by CITI – Collaborative Institutional Training Initiative or other e-learning modules at https://elearning.trree.org/
To get free access to the CITI Training, enter through the West African Bioethics Training Program as your institution. For space and time, let me also recommend that you study articles like those written by Ezekiel J. Emmanuel on what makes Research Ethical, both globally and in developing countries. These publications can be accessed online by searching “What makes research ethical? – Ezekiel J Emanuel” on Google.
Prospects
Having mentioned the academic advantage of research, it is good to briefly state more benefits attendant to the enterprise. Huge global resources go into research and development, especially in the area of translational research where institutions, companies and individuals work on particular lines of studies from “the bench to the bed-side”. Making money is not necessarily a good individual aspiration for research, but institutions get a lot of grants and facility upgrade by engaging in research; the researchers themselves are not left out of this benefit notwithstanding.
Research provides opportunity for so-many professionals to travel round the World, for further capacity building, all expenses paid. There has also been remarkable transformation of societies and communities who embraced Community-Based Participatory Research (CBPR).
References
1. Vanguard Editorial of 26th October, 2018. ‘Alarm over Chinese “human flesh” drugs’. Accessed on 4th November, 2018. https://www.vanguardngr.com/2018/10/alar
m-over-chinese-human flesh-drugs/
2. What are Clinical Trials and Studies? Accessed on 6th November, 2018. https://www.nia.nih.gov/health/what-are-
clinical-trials-and-studies.
About the Author
DR. Maduabuchi John-Moses Uwanduoma
Bioethicist & Executive Director, Society for Quality Assurance in Nigeria (SQAN).
#Education #Research #2018