Abstract
Key historical landmark research malpractice scandals that shocked the international community (Nazi doctors’ experiments, Tuskegee study, Jewish chronic disease experiments, Krugman’s Willowbrook hepatitis study) were the origin of the institution of ethics review prior to carrying out research involving humans. Nonetheless, it is plausible that unethical research is ongoing or may have been conducted in recent times that has escaped public notice, especially in the vulnerable low- and middle-income country contexts. The basic constitution of these committees at some point has not been clearly defined, with most scientists declaring political maneuvers at times. These committees today are characterized by bureaucratic bottlenecks, financial interests, inadequate training in research ethics, and lack of control and coordination of their functions. Compulsory and adequate research ethics training for researchers and ethical committee members could guarantee trust, and appreciation of the utmost importance of the latter. The independence of protocol review should be guaranteed as much as possible so that the process attains its set goals. It might be too simplistic, and hypocritical, to allow ethics committees to continue to function on an ‘altruistic’ basis. Governments must strengthen the roles of national ethics committees – their independence, oversight roles, and as monitoring and evaluation bodies for smaller research ethics committees. Funding and objective constitution of board members is critical. Only then would research ethics committees be metamorphosed from the ‘bad guys’ to the trusted friends. The fear is preventing the research ethics committee from being seen and thus becoming an ethical oxymoron.
Introduction
It is almost impossible nowadays to undertake research on human subjects, and even on animals, without ethical approval from a research ethics committee (REC). Numerous historical unethical atrocities spanning from the Nazi experiments, through the Jewish chronic disease experiments, Krugman’s Willowbrook hepatitis study and the Tuskegee Syphilis Study prompted the US congress and the international committee to say a vehement ‘no’ to unethical research. The Nuremberg Code, The Universal Declaration on Human Rights, and the Helsinki Declaration all mandated preconditions for research to qualify as ethical before being carried out. But are codes or guidelines enough? The biomedical science community, however, deeply remembers the Tuskegee study, as well as the recent Pfizer meningitis study in Nigeria (1996), which were unimaginably unethical, but yet were recorded in the bad books of medical science research, despite the existence of such codes. Henry Beecher’s groundbreaking article, ‘Ethics and clinical research’, which was published two years after the Helsinki Declaration of 1964, and two decades after the Nuremberg code in
These observations have prompted the general move towards protecting the basic human rights of research subjects, generally vulnerable, from pure egoistic goals of the scientist. RECs are commonplace, and just almost everywhere today, and should serve as guardians of both research subjects and scientists, for research on human subjects to be considered ethical. However, they might not be doing enough.
Discussion
The basic constitution of these committees at some point has not been clearly defined, with most scientists declaring political maneuvers at times. RECs could also be used as instruments for internal discipline and settling of scores amongst researchers (Hedgecoe, 2016). Excessive waiting times and bureaucracy to review protocols is a key source of sorrow to most scientists. Junior scientists at some point do not really understand the major role of these committees, and see them as the ‘bad boys’. The role of trust in biomedical research cannot be overemphasized (Eyal, 2014; Kerasidou, 2016). Though not a justification, this could partly explain sad experiences of research malpractice like ghost publishing and the rapid growth of predator publishers. Most members of these committees are generally too busy with other faculty or research responsibilities. The quality and quantity of time spent in the review process could be sub-optimal. Remuneration of committee staff is almost negligible. It might be plausible to argue that exercising on altruistic grounds as a REC member, if deemed qualified, is a moral–ethical duty as a scientist. Pressure from pharmaceutical companies and, not so surprisingly, funding agencies, could predispose to softer and less stringent peer review for financial gain. On altruistic grounds, however, responsibility and accountability might become useless concepts, though key with regard to biomedical science research ethics.
It is time to make the RECs friendlier to researchers. Compulsory courses on research ethics to junior researchers could be key starting points for them to ascertain the utmost importance of doing ethical research, and passing their protocols for review by research committee. Comments from the committee could be very useful for the scientist to improve upon their study design and render it more ethical. The inherent morality of good science needs to be underscored. Scientists must know how the review process is carried on. Some scientists unintentionally and wrongfully undermine or ignore scientific validity assessment as an ethical requirement or as a constituent of the protocol review package. Scientists have narrowed the ethical review process to informed consent and social value. The meaning of ethical research deserves to be expanded. The role of the ethics committee is beyond the mere assessment of the ethics component per se, but also the scientific validity of the subject, which of course stands out as the basis for any scientific endeavor to be carried out (Atici and Erdemir, 2008). Atici and Erdemir have underscored the imperativeness of incorporating trained and certified (bio)statisticians into RECs, to contribute to proper evaluation of research validity and reliability, which is an often neglected ethical requirement in research protocol assessment (Atici and Erdemir, 2008). Training must insist on the fact that research methodology and statistical methods of the study, as well as other ethical norms (informed consent, confidentiality, social value, beneficence, risk–benefit ratio), do constitute key moments during the ethical review process. Informed consent and risk–benefit ratio assessment are commonplace as key ethical requirements. The complexities of these phenomena is growing (Boyd, 2015; Grady, 2015; Simonsen, 2012), and might require in-depth training in ethics for proper assessment, especially in clinical trials and implementation of emergency interventions or trials (e.g. Ebola vaccine trials, Zika virus epidemics). Ethical values do change over time, and getting a consensus on what ethical research is might be difficult to establish in some cases. For instance, while doing research with minors, inadequate appraisal of the ethical issues at stake, which are generally more challenging and conflicting in such cases, compels expertise in research ethics. These growing complexities can only be better handled through proper and continuous training of ethics committee members. This could contribute in making the very morality of the scientific endeavor clearer to the scientist. The general public needs to be informed on the existence and roles of RECs. Audrey et al. (2016) reported that young people, though vulnerable, are generally ignorant of what RECs are all about, or of their very existence. A recent study in Nigeria revealed a limited level of awareness amongst biomedical researchers (30%) of an existing code of health research ethics in the country (Ogunrin et al., 2016).
It would be hypocritical to fail to acknowledge the intimidating complexities of filling out forms and administration for ethical review for most committees today. Coupled with the unacceptably long waiting times to obtain responses from RECs, this could deter young scientists with extremely exciting ideas from engaging in any research endeavor. It is not rare, however, to see extremely worrisome charges being made for ethical review. In some countries, for instance Malawi, researchers are expected to pay about 10 percent of the total budget of the project to National Health Sciences Research Committee (NHSRC) for institutional capacity strengthening and operations (NHSRC, 2016). We argue that for ethics review committees to fund such quotas from research budgets needs proper evaluation to ascertain its appropriateness on ethical grounds. Governments have their responsibility in strengthening the appropriate functioning of their national ethics committees (NECs). This could facilitate the NEC to take a lead role in training, ensuring oversight and monitoring the activities of the local RECs (Ng et al., 2015). As in most open-access journals today, review waiver conditions should exist within the functioning of RECs, in order to encourage young researchers. We feel, however, that RECs could do better. Training of ethics committee members in research ethics must be mandatory (Suzuki and Sato, 2016). A key component of REC activities is the monitoring of research activities of cleared protocols. Whether researchers adhere to or actually implement purely what was submitted as intended research activities remains questionable.
For responsibility and accountability to reign, and also for timely review and feedback, putting committee members on salaries might be helpful. Uncontrolled proliferation of IRBs might end up doing more harm than good. The NECs need to properly ascertain the need, and ensure that the REC members receive adequate training in research ethics to operate as a REC. In addition, the type of research to be reviewed by the REC must be defined. Ethically charged robust research might avoid stricter committees in favor of softer committees. The very morality of constituent members is of utmost importance. The NECs must define ethical review procedure documents and continuously monitor the functioning of its RECs.
Conclusion
Compulsory and adequate research ethics training for researchers and ethical committee members could guarantee trust, and appreciation of the utmost importance of the latter. The independence of protocol review should be guaranteed as much as possible so that the process attains its set goals. It might be too simplistic, and hypocritical, to allow ethics committees to continue to function on an ‘altruistic’ basis. Ethics review could become a business, predisposing the world to enormous ‘Tuskegee-like’ research. Governments must strengthen the roles of NECs – their independence and oversight, and as monitoring and evaluation bodies for smaller RECs. Funding and objective constitution of board members is critical. Only then would RECs be metamorphosed from the ‘bad guys’ to the trusted friends. The fear is preventing the REC from being seen and thus becoming an ethical oxymoron.
Key messages
RECs could discourage scientists from practicing ethically sound research.
Constituent members of committees need to be properly chosen on grounds of diversity in background, expertise in research ethics integrity, and political neutrality.
Mandatory training in research ethics is required for committee members, graduate students, and researchers.
NECs could be given the powers and resources to coordinate, train, and oversee the creation and functioning of RECs.
Upgrading government funding to NECs to play their roles is imperative.
Compulsory and adequate research ethics training for researchers and ethical committee members could guarantee trust and appreciation of the utmost importance of the ethics review.
What is already known about this subject?
Research ethics communities are instrumental in ensuring ethical sound research involving human subjects.
Constitution of committee boards is not always transparent.
Training of committee members in research ethics is usually insufficient.
What are the new findings?
Financial conflicts of interest distort the ethics review process.
Bureaucracy discourages young scientists from doing research.
Inadequate training in research ethics makes ascertaining the importance of research ethics sub-optimal, and could distort the trust between researchers and ethics committees.
Government support in creating an enabling environment for NECs to play proper coordination, monitoring, and evaluation roles is imperative.
What are the recommendations for policy and practice?
Mandatory research ethics training to committee members, scientists, and graduate students.
Upgrading the financing of NECs to properly assume coordination, training and control of RECs. Guarding against the proliferation of ‘predator’ RECs is very important.
The constitution of ethics committees is critical. Diversity, competence, research ethics expertise, and political neutrality are also of the utmost importance.
Careful speeding up of review timelines and elimination of unnecessary bureaucratic bottlenecks are vital.
Footnotes
Declaration of conflicting interests
The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.