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.

DEVELOPING A ‘STANDARD OF CULTURE’ AND ITS IMPLICATION FOR COMMUNITY ENGAGEMENT IN RESEARCH – Morenike Folayan

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.

THE TRAP CREATED BY THE DESIRE FOR HEALTH AND THE CAPITALISM OF THE PHARMACEUTICAL INDUSTRY – Morenike Folayan

Morenike Folayan
New HIV Vaccine and Microbicide Advocacy Society
The 2017 Bioethics Forum has come and gone leaving a lot of thoughts for the 35 participants at the conference. The second edition of the bioethics conference was a two days meeting held at the Rockview (Royale) Hotel on the 13th and 14th of December 2017. The theme was ‘participation in research and research demand: striking the balance.’ In attendance were speakers and participants from the United States, Australia, Ghana, Senegal, Guinea and Nigeria.
The opening plenary speaker, Kris Peterson, highlighted how the economic meltdown in the United States made pharmaceutical industries turn to the Wall Street for financialisation of the pharmaceutical industry during the great depression. This in-effect meant that pharmaceuticals had to grow markets to enable them make the huge profits they need to pay back loans. One of the ways they have had to grow that market is to outsource significant number of their research to low and low-middle income countries where the costs of production of drugs are cheaper. The out-sourcing process also implies a significant fragmentation of the entire pharmaceutical enterprise in ways that makes the regulation of the entire industry practically impossible and unmanageable.
Another strategic approach is the development of alternative use of the same drug molecule or/and increase in marketing of drugs for prophylaxis and chronic illnesses. These forms of drugs have sustained long term demands thus are able to sustain the pharmaceutical markets for long. For this reason, there is an increase in the support of clinical trials by the pharmaceutical industry to identify disease risk and continue to lower the thresholds for these diseases. This in turn expands the market for these pharmaceuticals.

A recent event made the reality of this process titled ‘the economies of health through the lens of  the pharmaceutical industry by the forum organizers indeed a huge reality. The American Heart Association, American College of Cardiology and nine other organizations produced a new guideline lowering the threshold for treating hypertension with lifestyle changes and medication. Treatment is now recommended at 130/80 mmHg as oppose to 140/90 mmHg in January 2017. The implication of this is that 46% of the US adult population will now be considered hypertensive under the new guideline as opposed to 32% under the old guideline.
For the HIV prevention world, the renewed use of tenofovir based regimen for HIV prevention in addition to its continued use for HIV treatment was an all time booster for the pharmaceutical industry called Gilead. The medicalisation of the HIV prevention field continues to widen the prospect for pharmaceutical industries to invest in the field, make huge profits. While the field needs the investment of the pharmaceutical industries to help increase the HIV prevention armamentarium, it is equally important for HIV prevention advocates to keep an eye on the evolution of the pharmaceutical industries in this space so that the capitalism drive of the industry does not unwittingly drive advocates and activists to promote clinical trials that continue to drive down the HIV prevention thresholds.
The huge number of people chronically living with HIV infection that will continue to need first and second line drugs, salvage therapy is enough huge market for the pharmaceuticals. Medicalisation of HIV prevention is now expanding that space for the industry. We need to be watchful and ensure that the collective push of advocates for increased investment of pharmaceutical industries in the HIV prevention space does not end up getting we community members out-priced in our search to expand the armamentarium for HIV prevention. There is a need to strike a moral and ethical balance in this process.

PARTICIPATION IN RESEARCH AND RESEARCH DEMANDS: STRIKING THE BALANCE – Morenike Folayan

The 2017 Bioethics Forum that held at the Rockview (Royale) Hotel in Abuja on the 13th and 14th of December left an indelible mark in the memories of most of the 35 participants. Many key issues that will inform the practice of research were highlighted at the conference.
One of the highlights was the recognition that for research, the law regulates the minimum standard of practice. The standards are raised through the research ethical codes. Adherence to the high standards of research ethical codes can lead to research outcomes that can lead to the review of laws.
Second, vulnerability should not be a reason for unethical exclusion of research participants. Research protocols should be reviewed to ensure that the vulnerability of study participants is not exploited. The prospect for exploitation should however not be a reason to exclude any vulnerable population from research participation. Rather, ethics committees should put safe guard measures in place to prevent such exploitation. It is important to generate research derived evidence about vulnerable populations so as have needed information to plan for their health access.
Ironically, legal liabilities may restrict the respect for the principle of justice when designing and implementing research, leading to unjust exclusion. Researchers and ethics committee members need to strike a balance between the law and ethical practices when reviewing research protocols and when implementing research in the field.
Third, there was a huge debate on the choice between the universality of the standard of care packages for research and adherence to local standard of care for research. The debate remained unresolved though the majority of participants advocated for the universality of the standard of care for research.
Fourth, all communities are organized with recognized political leaders and mechanisms for communicating. The lack of visibility of the community does not imply they do not exist. In every community, there are persons educated and literates to engage with during with designing and implementing research protocols. Look for representatives of communities targeted in any research protocols; and engage educated community representatives during research protocol development and implementation. Community members best understand mechanism for communicating with one another. This is needed to be able to effectively engage with any community. Community engagement needs to be strategically planned and funded. A media engagement plan should be developed as part of any community engagement plan.
Fifth, health research design should not only have a public health approach but should also have a human right focus. The two should be inseparable.
Sixth, research is essential but not an emergency. Take time to do the right thing.
Finally, all research designs need to respect diversities. This implies that all community based research should be encouraged to include social scientists as part of their research team members. Ethics committee members were encouraged to screen for this during the review of community based research protocols. Targeted committee head should also give letter of permission for the research; and the letter should be submitted along with the research protocol at the time of application for ethics clearance.

COLLATERAL DAMAGES IN RESEARCH: THE NEED FOR STRATEGIC RISK AND BENEFIT ANALYSIS

Very often, researchers and ethics committees are stocked with thinking about the welfare of the study participants. Participants at the 2017 Bioethics conference that held on the 13th and 14th of December 2017 at Rockview Hotel Abuja encouraged researchers and ethics committee members to think beyond the study participants and prevent possible ‘collateral damages’ that can also results through affectation of research participants’ spouse, family and community. Bioethics thinking has to stretch beyond the only the study participants especially for communal societies like that found in Nigeria. Study participants are part of a community. As much as possible, researches should be designed in a way that ensures it is a win-win situation for all direct and remotely affected parties.