Why social disruption is needed for the research enterprise in Nigeria

Why social disruption is needed for the research enterprise in Nigeria

By Morenike Folayan
At the just concluded 5th Nigeria Global Health Trials Conference which held on the 30th and 31st of January 2018 at the Sickle Cell Foundation Centre, Idi-Araba Lagos, Dr Pelumi Adebiyi  challenged the over 250 participants present at the meeting to encourage social disruption of the research enterprise in Nigeria.
Just like many speakers who had made presentations before him, he challenged participants – many of whom were young researchers from multiple fields of practice – to promote inter-disciplinary collaborative research to redress health issues. This implies embracing diversity.
Unlike the drive to think outside the box, Dr Pelumi Adebiyi sees merit in thinking within the box. However, within the box, one has to learn to think deeper. Thinking within the box is shifting the current paradigm of thinking outside the box.  It is like ‘questioning the question’ like he continually reiterated throughout the meeting.
Questioning the question often results in the disruption of norms. It results in conduct of research that addresses specific needs. It moves people from convention to identifying more efficient and productive ways of getting things done. There will be shake ups, challenges, innovation and change.
For Dr Adebiyi, researchers in Nigeria will have to do things differently!
One of such new ways of doing things is moving from siloed research practices to research practices that embrace international collaborations (North- South; and South-South), multi-disciplinary collaborations, multi-site collaborations and academic-corporate collaboration.
Meanwhile, this same change had earlier being iterated by other speakers at the session.
Prof Folasade Ogunsola, one of the three Deputy Vice Chancellors of the University of Lagos, while speaking on North-South research collaboration, explained to participants how researchers can ensure such collaboration will be beneficial for the local community and country even when the agenda is driven by the North that brings the funding.
Funding is not all it takes to do good research- Ogunsola

Funding is not all it takes to do good research- Ogunsola

By Morenike Oluwatoyin Folayan.
Professor Folasade Ogunsola, the Deputy Vice-Chancellor, Development Services, University of Lagos, and one of Nigeria’s leading researchers, has said that funding is not all it takes to be a good researcher.
Ogunsola spoke during the just concluded 5th Nigeria Global Health Trials Conference which held between January 30 and 31st, at the Sickle Cell Foundation Centre, Idi-Araba, Surulere, Lagos and attracted over 250 participants comprising doctors, medical researchers and scientists from within and outside the country.
During her presentation titled ‘Health research and global health: Potentials and Promises of North-South Collaboration,’ Professor Ogunsola shared her experience concerning how she grew up the ladder to become an equitable partner with her Northern collaborators.
She also highlighted the importance of passion for the work you do, as well as trust being an essential ingredient for sustainable collaboration and partnership.
Professor Ogunsola further reiterated her point by sharing the story of the ninth graders who conducted some research based on awareness of events happening to them. Their extremely low cost experiment is now drawing the attention of renowned scientists to further explore their findings.
“Research requires you to be conscious about what is happening around you, develop evidence to substantiate your assumptions and looking for solutions applicable to your environment. Without the passion and the eye to address local needs, the funds will often not be put to efficient use,” she noted.
Participants identified the need to ensure subsequent meetings have policy makers attend the meetings. They also get to interact and learn. This was a missing target population at the conference. For future conferences, it was agreed that this should be rectified.
The role of effective communication, need to ensure research results are disseminated beyond the use of journal publication and the role of the media in disseminating research results were also noted.
The conference came to an end with participants feeling extremely motivated to do things differently. Hopefully, new networks, partnerships and collaborations had been formed at the end of the two-day meeting.

International research: How competent are local investigators named as collaborators?

By Morenike Oluwatoyin Folayan and Elhadji Mbaye
Countries in West Africa often require that international researchers have local collaborators as co-researchers for many good reasons. The local investigator can help ensure the design of the study is culturally sensitive and locally appropriate.
The investigator also gains knowledge and skills that can be used for planning and conduct of locally-relevant research. The local investigator also serves as the local contact on the management of the research.
Many of the 24 participants at the 3-day training on the review of research protocols during infectious disease epidemics organized by the West African Task Force for the Control of Emerging and Re-emerging Infectious diseases (WATER) agreed that this goal is often not achieved.
Local investigators often become data collectors with little or no significant inputs into the design of the study protocols. Many do not have capacity built: despite being local investigators for multiple studies, they still cannot independently write an award-winning grant. They therefore serve as tools for entry into the country rather than resources being developed for country relevance.
Participants therefore advocated that for all research protocols submitted for review, it is important to ask that the curriculum vitae of the local investigator be submitted along with the research protocols.
Often times, the same big-wigs in the industry are invited as local investigators. They simply become too busy to adequately play their roles. Institutional review boards need to review their curriculum vitae and query their ability to make out time to play their roles on researches they serve as investigators for.
This is in addition to reviewing the curriculum vitae to identify if they have the competency to play the role for that protocol.
The implication of such review was however, not defined.
Can institutional review boards not approve a research study protocol because they feel the local investigator may not be competent enough to handle the role because (s)he has too many ongoing studies?
Can ethics committee members ask that a research be suspended if they find the local investigator not adequately playing the oversight role during field visits?
The newly established Network for Ethics Committees operating in West Africa seem to have a big role to play in helping to define guidelines for ethics committee operations on the continent.
The future will tell the impact of this committee on improving competency for protocol review and monitoring in the sub-region.
Morenike Oluwatoyin Folayan is of New HIV Vaccine and Microbicide Advocacy Society (NHVMAS), Nigeria.
Elhadji Mbaye is of IRESSEF, Senegal.

Research is not an emergency

By Morenike Oluwatoyin Folayan and Elhadji Mbaye
Research is not an emergency. This must be clearly understood. While infectious disease epidemics require emergency response, research conducted during emergencies may need to be fast-tracked.
However, all due diligence for proper review of the protocol needs to be maintained. This is important as the study participants and the communities are important and all efforts need to be instituted to protect them.
The protection of study participants’ welfare during research is a priority obligation of institutional review boards, and they need to ensure this. This also requires that they monitor the research they approve knowing they are equally liable for possible research misconduct.
This was a consensus reached by the 24 participants who attended the 3-day training on the review of research protocols during infectious disease epidemics organized by the West African Task Force for the Control of Emerging and Re-emerging Infectious diseases (WATER).
The training was funded by OSIWA and IRESSEF with technical support provided by the New HIV Vaccine and Microbicide Advocacy Society. Participants included researchers, social scientists, bioethicists, lay persons and institutional review board members from seven countries in West Africa.
There was extensive dialogue about the Ebola epidemic in West Africa with recognition of some unethical practices. The group recognized the gap in competency to handle research protocols. During the epidemic, research protocols required for revisions increased 4-5 folds in many countries with implications for straining the manpower required for such expert reviews.
While participants recognized that the need to provide care for those infected and affected by diseases during such emergency epidemics like that witnessed with Ebola, research cannot be excluded as it can and will contribute to the public health response.
However, there is no justification to undermine the thorough review of any research protocol during this period as research is designed to answer questions for which there are no answers yet. Research itself is not an answer to solve any of the immediate issues arising from the epidemic.
Thorough review of research protocols are therefore required especially at this time, though the research process can be fast-tracked.
Fast-tracking review of research protocols implies that institutional review boards may hold emergency or unscheduled meetings to provide feedback on protocols, and or protocol reviewers may be asked to review protocols in a shorter time.
Fast-tracking does not imply that any of the statutory processes for research protocol should be breached neither should there be undue internal or external influence for protocol reviews.
Members of institutional boards in the region still need a lot of investment on how to handle protocols during emergency with focus on how to make the needed judgment to ensure ethical integrity of research protocols.
More home grown capacity-building efforts are required as these capacity-building programmes are more attuned to the socio-cultural, economic and political realities of the countries they serve.
 Morenike Oluwatoyin Folayan is of New HIV Vaccine and Microbicide Advocacy Society (NHVMAS), Nigeria.
Elhadji Mbaye is of IRESSEF, Senegal.

How do you determine compensation for research participation?

By Morenike Oluwatoyin Folayan and Elhadji Mbaye
In answering the question of how to determine compensation for research participation, the onus lies on institutional review boards to determine the appropriateness of compensations for injury suffered during research participation. This injury may be physical, financial, emotional or social.
Often times, research make compensations for financial loss resulting from time spent on the research. This often include transport reimbursement resulting from the need to travel down to the research site to participate in research.
Members of the Network for Ethics Committees operating in West Africa, during its meeting held between September 25 and 2017, had an unresolved dilemma: how to determine what is the right compensation for study participants?
They also recognise that beyond compensation for injury, participants may also be given incentives to motivate for study participation.
But then, how do ethics committee objectively define which incentive would not act as being coercive or cause undue inducement especially in a community where $1 makes a significant difference to a population with large number of people living below the poverty line?
Very recently, a joke circulated on the social media showing that for Nigerians who save N1.00 everyday, (s)he saves only $1.00 at the end of 365 days  of saving. The devaluation of the Naira also has implications for determination of compensation for off-shored research.
A joke showed the implication of such devaluation. A Nigerian employed in the civil service 33 years ago earned $800 monthly. Now 33 later, his salary is only the equivalent of $500.
Undoubtedly, the question of appropriate compensation and incentives have been a lingering question.
Brandon Brown of the Public Health, Department of Population Health and Disease Prevention, at the University of California, Irvine, California, had written several articles to try and address these issues.
He recognized the place of offering material incentives as an effective means of encouraging individuals to participate in research studies and it helps to fairly compensate participants for time and effort. Under certain conditions, it is ethically justifiable. He acknowledges that there are few empirical data for defining undue influence of incentives in research, including the possible coercive effects of medical benefits.
Undue inducement is also difficult to judge. Empirical studies of appropriate compensation and incentives have been difficult as most research do not report this.
Brown and his colleagues proposed that funders should be required to report about research-related compensations in protocols registered in public spaces like the ClinicalTrials.gov, and for researchers and editors to ensure that incentives are disclosed in publications.
While his recommendations may be of great help in the development of empirical studies that may help institutional review boards make decisions in the near future,  in the present, they will still need to make subjective decisions about this based on intuition, consultations and review of existing and accessible documents.
One way forward is to require that all researchers should discuss about appropriate compensation and incentives during community engagement programmes that take place during the research protocol development process.
Evidence of such consensus decisions on appropriate compensation and incentives should be attached to submitted protocols. The ethics board can then begin to develop its own database on what may be appropriate compensation and incentives for different types of studies conducted in the community they serve.
 Morenike Oluwatoyin Folayan is of New HIV Vaccine and Microbicide Advocacy Society (NHVMAS), Nigeria.
Elhadji Mbaye is of IRESSEF, Senegal.


By Morenike Folayan
New HIV Vaccine and Microbicide Advocacy Society, Nigeria
The communitarian nature of West Africa in particular and Africa in general is one of the reasons why community engagement in HIV prevention research has been rigorously pursued for the conduct of HIV prevention research. Most HIV prevention research are conducted in Africa. One of the strategies adopted to help promote community engagement in HIV prevention research was the development of the Good Participatory Guidance Document by UNAIDS and AVAC in 2007 (the document was revised in 2011). The document helps to streamline an ‘art’ of community engagement in a regulated ‘science’ of processes.
One of the potential areas where a community phenomenon may become regulated is the process of unwittily standardizing culture. Ethics committee members that attended the 2017 annual bioethics forum in Abuja, Nigeria on the 13th and 14th of December 2017 were constantly reminded about the need to review research protocols in ways that ensure respect for culture. However, there was a concern raised about the same ethics committee becoming caught in a quagmire of standardizing culture like they standardize clinical care or even standardize HIV prevention packages.
Culture is dynamic and ever evolving. Members of ethics committees reviewing research protocols may be at different ends of these evolving cultures spectrum. A very typical example shared at the meeting was the increasing recognition and adoption of the view that access of adolescents to contraception to prevent pregnancy needs to be enhanced to prevent the mirage of growing challenges associated with unwanted pregnancies. Sadly, custodians of local tradition on ethics committee may speak against research that facilitates adolescents’ access to contraception. This same cultural guidance may impact negatively on HIV prevention research that facilitates access of adolescents to pre-exposure prophylaxis.
This implies that for ethics committees to ensure research proposals are cultural sensitive and culturally appropriately designed, the ethics committee members need to keep abreast with evolving cultures, be less paternalistic in role as the custodians of culture, and their external engagement with stakeholders for the review of research protocols should also include learning about new cultural trends in the communities they serve. They consciously have to prevent the development of a standard of culture through which lens they review all their research protocols.
The meeting also discussed extensively the unethical exclusion of pregnant women from research resulting from an un-queried culture of research practice. This sadly has led to significant limited data on research outcomes for pregnant women. Researchers and ethics committee members were encouraged to also scrutinize the data analyses plan to ensure that the research analyze is gender and where possible, pregnant women sensitive so we can see more and more women and pregnant women related research data outcomes as we move into the future.