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Consultancy for expert advice on Kenyan policy, guidelines & laws regarding application of ethical clearance for operational research and learning

Expert advice to PharmAccess Foundation (Kenya) on Kenyan policy, guidelines and laws with respect to the application of ethical clearance for operational research and learning

INTRODUCTION

PharmAccess Foundation (PAF) is a not-for-profit foundation that focuses on innovative digital health system interventions to ‘making health markets work for the poor[1]’. In this context PAF is working in various Kenyan projects on developing new (digital) products and services that facilitate inclusion of people into healthcare. The application and rollout of such products and services is often through reiterative step-wise approaches, allowing for learning and subsequent adaptation and fine-tuning to the needs of the respective target populations. The products and services are involving the health and healthcare of Kenyans and sometimes information is needed as to whether such interventions would be considered as (operational) research which would require ethical clearance.

For this reason, PAF is seeking applications for individual consultant(s) or institutions to advice on how to position PAF Kenya activities that involve collection, storage and operational analysis of health- and healthcare information of Kenyan individuals participating in the PAF cycles of product and service development. The objective for this consultancy is to provide an Advisory Document to PAF that stipulates the criteria according to Kenyan guidelines, policy and law for categorizing projects as research, requiring ethical clearance.

BACKGROUND PHARMACCESS

PharmAccess was founded in 2001 by Prof. Joep Lange to bring life-saving antiretroviral therapy for HIV/AIDS treatment to Africa. Initially, PharmAccess focused on treatment programs for employees and dependents of several multinationals in sub-Saharan Africa. While this approach of working with the private sector was highly controversial at the time, it ended up delivering proof that delivering HIV/AIDS treatment for those who needed it most was possible. Since this work on the front lines of HIV/AIDS, our focus broadened to making healthcare financing and delivery more effective and more inclusive. We pioneer innovations that explore new directions and provide real world solutions in order to drive systemic change and reverse the vicious cycle that stifles progress. The PharmAccess integrated approach spurred the introduction of the first public private health insurance schemes for the informal sector in Nigeria, Tanzania and Kenya; the development of SafeCare[2] (the only internationally recognized quality ratings for clinics in resource restricted settings),and the establishment of the Medical Credit Fund[3], the first dedicated social impact fund that provides loans and technical assistance to health SMEs in partnership with local banks. In 2015, Kenyan company CarePay[4] was established to develop, manage and own a health payment platform, locally branded as the M-TIBA platform. Finally, the Joep Lange Institute[5], launched in 2016, focuses on evidence-based advocacy to drive the global health agenda.

PURPOSE

The main objective for this consultancy is to advice PAF on the definition of its activities as being research (and requiring ethical clearance) or otherwise (product development, marketing, etc.) and align with Kenyan law in this respect.

The intended outcomes of the exercise are:

· Development of an Advisory Document for PAF that stipulates the definition of operational activities as being ‘research’ versus ‘non-research’

· Provide a description of the correct trajectory of ethical clearance for any PAF activity that is earmarked as ‘research’

· Awareness of pertinent PAF staff on definitions of operations being research or otherwise

SCOPE OF SERVICES

The consultant will:

· Prepare a work-plan clearly stating the methodology to be used as well as a sub-specified budget

· Systematically analyse all pertinent and up-to-date information/data sources available for Kenya with regard to criteria used for categorizing projects as ‘research’, requiring ethical clearance and

· Summarize key conclusions in Advisory Document

· Prepare and submit a brief Report of the assignment. The Report should present a brief summary of the consultancy process including:

o Executive Summary

o Introduction and background, including statement of work

o Methodology, including any limitations faced

o Findings, presented as analysed facts, supported by reference to the pertinent literature, laws, policy, guidelines

o Recommendations that are practical, specific and action-orientated and supported with evidence.

o Conclusion

o Annexes

· Do one-hour presentation to selected PAF staff on findings and recommendations

ROLES AND RESPONSIBILITIES

The consultant will be responsible for fulfilling all agreed deliverables and report on progress as agreed to PAF senior management. The PAF team will provide logistical arrangements as required and agreed throughout the consultancy.

Responsibilities under this assignment are summarised in the table below:

Consultant

· Design and present a detailed work-plan, clearly indicating the methodology to be used

· Weekly feedbacks to the PAF senior management on progress

· Develop an Advisory Document r.e. the criteria of categorizing activities as being ‘research’ or otherwise to PAF

· Provide a short final Report of activities to PAF

· Present a final research manual to PAF team

Country Director (Kenya)

· Approval of Consultancy and budget

· Approval of final report and manual

Country Research Coordinator (Kenya)

· Engaging and managing the consultant’s contract

· Liaise closely with the consultant in the development of the Advisory Document and final Report to ensure it fits PAF requirements

· Coordinating input and feedback from the PAF country office to the consultant on deliverables

International Research Director (Amsterdam)

· Review the content of the Advisory Document and Report and provide technical feedback

CONSULTANCY DURATION & DELIVERABLES

The consultancy will be carried out up to a maximum of 20 working days between May and June, 2018. This should include the development of the Advisory Document as above, final Report preparation and presentation to core staff at PAF, Nairobi.

OTHER CONSIDERATIONS

Confidentiality

The consultant agrees not to divulge confidential information to any person for any reason during or after completion of this contract with PAF. Upon completion or termination of this contract, the consultant undertakes to return to PAF any materials, files or property in their possession that relate to the business affairs of PAF.

Intellectual Property

All intellectual property and/or copyright material produced by the consultant whilst under contract to PAF remain the property of PAF. The consultant is required to surrender any copyright material he or she has created during the term of the contract to PAF upon completion and termination of the contract. The consultant also consents to PAF using any works produced as part of this consultancy without attribution and waives all other moral rights in this work.

Insurance

The consultant/s involved in this project will be required to have insurance arrangements in place appropriate to provision of the requirements in this Terms of Reference, including travel insurance.

Ethics

The assessment should be carried out in line with recognised ethical and professional standards. While acknowledging that this assignment holds minimal risk as it will not collect sensitive personal information, the consultant/s is expected to adhere to and uphold the principles of ethical research conduct at all stages of this assignment.

QUALIFICATION AND ESSENTIAL SKILLS

Successful applicants will have the following competencies:

i) Familiarity with the local research context and current trends in ethical conduct of research

ii) Expertise in operational research and health research in general

iii) Familiarity with Kenyan laws, guidelines, policy with respect to health research

iv) Strong oral and written communication skills and proven ability to deliver high quality reports

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