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

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

local investigators

 

By Morenike Oluwatoyin Folayan and Elhadji Mbaye

 

Countries in West Africa often require that international researchers have local investigators 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 boardsneed 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

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?

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, Riverside, 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.

Why civil society must be more involved in activities of institutional review boards in West Africa – Morenike Ukpong

Why civil society must be more involved in activities of institutional review boards in West Africa – Morenike Ukpong

 

 

By Morenike Oluwatoyin Folayan and Elhadji Mbaye

The Network for Ethics Committees operating in West Africa, at the conclusion of its meeting held last September 25th to 27th,  reached a consensus that civil society organizations need to be more involved in the activity of the Institutional Review Board.

This recommendation followed extensive discussions and deliberations on the important role the layperson on ethics committee plays.

They identified that Institutional Review Boards are in themselves, research gatekeepers for the community they serve. They are therefore critical in ensuring research they approve have social values.

They also need to conduct risk-benefit analysis prior to making the decision about protocol approval and compensation for research related injuries.

The component risk-benefit analysis should consider the impact on third parties which may not just be individuals at close proxy to the research participants, but may have impact for the community.

Lay persons on ethics committees are best positioned to provide insights into the socio-cultural, political, economic and health contexts of the community that can inform decision making about the social value of the research, and the component risk-benefit analysis.

Participants and facilitators at the training felt that having a layperson on the ethics board identified from a civil society organization has a number of merits.

The individual has a constituency through which (s)he can engage and ask relevant questions that are important for making critical inputs and decisions during research protocol review.

The need for such extensive consultation was highlighted by Prof Borodo at the just concluded 2017 Annual Bioethics Forum that held between December 13th and 14th.

He presented a case study where the ethics committee had to extensively consult on practices to determine the deferred standard of care for clients to be able to determine the social value of a specific research protocol they reviewed, and was thereafter able to make appropriate suggestions for protocol review.

One or two laypersons on the ethics committee do not have all the knowledge to enable them make critical decisions about norms and cultures moreso culture evolves. Additionally, community members are also rarely sent research protocols for external reviews.

 

Laypersons may therefore have to consult with the constituency they represent to elicit those critical information that may be required for protocol review purposes. Belonging to a civil society makes this feasible.

Institutional review boards are therefore encouraged to ask for representation on their board from credible civil society working in the communities they serve. Asking civil society organizations to send their representative to the ethics committee increases the sense of allegiance and accountability of the laypersons to the community. It also increases the prospect for taking the role serious.

A challenge with this, however, is first, the need to ensure confidentiality is maintained. The sense of allegiance and accountability to the community shouldn’t be a reason for public discussions of research protocol content.

This challenge can be addressed through in-house training of all members on the importance of confidentiality and the practice of confidentiality by the board.  Laypersons also need to be trained on how to review research protocols and provide constructive feedback. This is feasible as the New HIV Vaccine and Microbicide Advocacy Society has done this successfully for many years in Nigeria with excellent results.

In an evolving world with evolving practices, the way communities are engaged with research also seems to be evolving. It will be great to watch how this consensus decision by the Network of ethics committee members in West Africa is implemented.

Morenike Oluwatoyin Folayan is of New HIV Vaccine and Microbicide Advocacy Society (NHVMAS), Nigeria.

Elhadji Mbaye is of IRESSEF, Senegal.

Why clinical trials should prioritize community engagement – Morenike Ukpong

Why clinical trials should prioritize community engagement – Morenike Ukpong

By Morenike Oluwatoyin Folayan and Elhadji Mbaye

While the training meetings for the Ethics Committees members in West Africa on Emerging and Re-emerging infectious diseases epidemics which held in Senegal between the September 23 and 27, 2017, may have come and gone, many of the outcomes of the discussions leave resounding echoes.

And some of these echoes were reiterated during the 2017 annual Bioethics Forum which held in Abuja between December 13 and 14, 2017.

One of these was the need for clinical trials – off-shored and on-shored research – to prioritise community engagement from the concept development stage of the trial, to the implementation stage, and then the result dissemination stage.

Institutional review boards also have to look out for evidence of community engagement exercises that had taken place before protocol finalization to ensure their inputs are taken into considerations in the design of the study protocol.

Of course, this also raises a number of issues.

First, researchers often report that they are challenged with identifying what are the boundaries for the community they need to engage with for any research studies.

They are also challenged to think about what it means to engage communities with the conceptualization of a research especially when they have to deal with a community that has low research literacy.

How, for instance, can barely literate people make meaningful inputs into research designs?

Second, Institutional review boards in many countries in West Africa are just growing their competencies on how to review research protocols and will need to have access to continuous capacity-building opportunities that will enable them objectively evaluate protocols in an ever evolving field of bioethics.

They also need to learn about what to look out for in protocols on community engagement.

But this point must be made.

Community engagement in research – including clinical trials – is not new. Community-based participatory research has been promoted for decades in countries around the world with a lot of strong research practice influence in Canada.

The Microbicide Trials Network funded by the National Institute of Health, has evolved a system of engaging communities while they conceptualise their research.

In 2007, UNAIDS and AVAC also developed a set of guidelines that can promote conceptualizing what community engagement is for HIV prevention research. The guidelines were revised in 2011 and have since been adapted for use for tuberculosis-related research and by WHO for research during emergencies.

While the proposition by the 24 participants who constituted themselves to the Network for ethics committees operating in West Africa sound great and feasible, it is important to emphasise that the competency of all stakeholders – researchers, sponsors and ethics committee members, would be needed to make this a reality.

Clarity is also needed on how this needs to be implemented. Researchers and ethics committee members need continuous training on how to implement this requirement.

AVAC recently launched a course to train interested investigators on how to develop research protocols that adhere to the good participatory practice principles that promote community engagement in research. There may also be the need to develop such a course for institutional review board members.

Morenike Oluwatoyin Folayan, New HIV Vaccine and Microbicide Advocacy Society

Elhadji Mbaye, IRESSEF, Senegal

Adolescent girls want sex. But their risks of HIV infection and pregnancy remain high – Morenike Ukpong

Adolescent girls want sex. But their risks of HIV infection and pregnancy remain high – Morenike Ukpong

Adolescent girls who are already mothers

By Morenike Ukpong-Folayan

Adolescent girls keep rating the need to prevent pregnancy higher than the need to prevent HIV infection. Pregnancy outside marriage causes a lot of stigma in Nigeria. Pregnancy outside marriage is not welcome in most home in Northern, eastern and western Nigeria. Yet access to sexual and reproductive health commodities that will help prevent pregnancies are not easy to come by.

Despite the shame that comes with being pregnant, teen pregnancy is not a rarity. It is a growing problem for many communities, especially rural communities where procurement of abortion from professionals comes with lots of challenges.

Lots of girls who leave school are increasingly finding it difficult to be engaged productively due to low rates of admission into higher institutions, poor access to vocational training and low competency to start small-scale businesses.Being idle increases their risk of frolicking around with the opposite sex and engaging in sex.

A good number of adolescent girls enjoy having sex. They discover its pleasure and do not want to discontinue. They want a way to enjoy sex without becoming pregnant. Sadly, adolescents’ awareness about contraception options is poor.

For the few that are self-educated about possible contraception use, access to contraception is also poor. Health care workers are usually very unwilling to provide adolescents with contraception.

Many are often limited to the use of condom – a device that is dependent on the boy’s willingness to use the product and to use it correctly and consistently.The prevention of HIV infection is not a priority for many adolescent girls. HIV infection may well be hidden for many, many years. But pregnancy cannot be hidden.

The shame and consequences come rapidly – drop out from school, increased risk of not getting a suitor in the community,  further hardship for the girl and her family to name a few, and the stigma and shame the entire family has to face in the community.Yet the risk for HIV infection for adolescents who start having sex at a young age is high. She is likely to change sex partners multiple times, have challenges negotiating the use of condom, and risk selling sex to be able to have access to some needs in life.

Adolescent girls need easily accessible products that can help prevent or reduce the risk of pregnancy, sexually transmitted infection and HIV infection.  HIV prevention is as equally important as the prevention of unwanted adolescent pregnancies.The clear need for the development of technologies that will enhance the ability of adolescent girls to prevent pregnancy, HIV and sexually transmitted infection was highlighted very clearly by Pauline Irungu, the Policy and Advocacy Manager at PATH, during the Biomedical HIV Prevention Forum that held on the 3rd of December 2017 in Abidjan at part of the 2017 ICASA Conference.Pauline noted that 66% of global maternal deaths and 66% of the new HIV infections in 2015 occurred in sub-Saharan Africa.

While progress has been made in reducing mother to child transmission, much more remains to be done including the need to address the unmet need for contraception for 25% of women.Sadly, a growing number of young people aged 10–24years are living with HIV in the region. These young persons living with HIV have particular needs and challenges related to their sexual and reproductive health and rights.