Consultant - Technical development of the guidance for community engagement in clinical trials

Purpose of consultancy

To contribute to the development of the guidance for community engagement in clinical trials and related training materials.

Background

At the World Health Assembly in May 2022, World Health Organization’s Member States passed resolution WHA75.8 on strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination. The resolution recognized the importance of strengthening the global and national clinical trial ecosystems to advance: 1) equitable clinical trial capacity development; 2) health outcomes related to burden of diseases at national and regional level; and 3) to provide functional capacities that can pivot in times of emergencies.

To forward these goals, a WHO Guidance for best practices for clinical trials has been developed with a 16-member Technical Advisory Group (TAG) and in consultations with global experts and all relevant stakeholders in clinical trials, including Member States, patient and community engagement organizations, funders, researchers, ethicists, regulators, and representatives from industry. The Guidance outlines key ethical and scientific considerations for well-designed and well-implemented clinical trials. A series of regional and global consultations, including the first WHO Global Clinical Trials Forum, took place in 2023, where stakeholders agreed to a vision of collective efforts in improving clinical research infrastructure and capabilities in countries and globally, and call for actions to enhancing engagements with patients, the public and communities throughout the clinical trial process.

To advance the implementation of the WHA75.8 and operationalize the vision agreed upon at the Global Forum, the Secretariat seeks a consultant who would provide technical expertise in developing the guidance for community engagement (referred to as ‘guidance’ hereafter) in clinical trials that will be part of the WHO Guidance for Best Practices for Clinical Trials. In addition, the consultant would provide input to the training materials development to operationalize the best practices for community engagement integral to the WHO online training course for best practices for clinical trials.

Deliverables

• Task 1: Draft the guidance in collaboration with internal and external experts, such as the Technical Advisory Group (TAG) for Clinical Trials. This includes:
  • Review relevant guidance, scientific publications and grey literatures on the relevant technical topics;
  • Synthesize recommendations and analyze their relevance for the guidance;
  • Develop draft guidance ready for internal and external review and consultations.
    • Deliverable 1.1: Draft guidance ready for review and consultation.
• Task 2: Facilitate expert reviews and stakeholder consultations for the draft guidance. This includes:
  • Setup review objectives, processes, platforms, and relevant communications;
  • Consolidate and analyze review responses, and propose for revision;
  • Setup and facilitate (virtual) stakeholder consultations;
  • Draft consultation report with recommendations;
  • Revise the draft normative guidance according to the review and consultation outcomes.
    • Deliverable 2.1:Report with consolidated review responses and consultation outcomes.
    • Deliverable 2.2: Final draft of the guidance expected by 31st October 2024.
• Task 3: Draft training course materials based on the final guidance. This includes:
  • Draft the PowerPoint slide deck outlining key recommendations as in the guidance;
  • Collate relevant case studies to support the delivery of key recommendations to use in the training;
  • Participate in external review meetings of the draft materials and contribute to the discussions with external reviewers;
  • Revise the slide deck and case studies integrating the review comments and suggestions.
    • Deliverable 3.1: Draft slide deck and case studies for the training.
    • Deliverable 3.2: Final slide deck and collation of case studies for the training.

Qualifications, experience, skills and languages

Educational Qualifications:

Essential:

• Advanced university degree (Masters) in clinical trials, behavioral science, biomedical sciences, or any related field.

Desirable:

• Advanced university degree (PhD) in one of the above-mentioned fields.

Experience:

Essential:

• Over 10 years of experience in clinical research, with a focus on patient, participant and/or community engagement in clinical research.
• At least 5 years of experience working in low-or middle-income settings.

Desirable:

• Experience working with WHO or other international agencies on consensus building, convening or norms and standards development.

Skills:

• Technical knowledge and skills in patient, community and public engagement in clinical research.
• Technical knowledge and skills in norms and standards development methodologies.
• Expert knowledge in writing technical documents.
• Excellent communication skills, including presentations and reporting.
• Ability to integrate, synthesize, and communicate ideas from various stakeholders' perspectives.

Languages required:

Essential:

Expert knowledge of English.

Location

Off site: Home-based.

Travel

The consultant is not expected to travel.

Remuneration and budget (travel costs are excluded):

Remuneration:

Band level C - USD 10,000 - 12,500 per month.

Living expenses (A living expense is payable to on-site consultants who are internationally recruited):

N/A

Expected duration of contract:

11 months - part-time at 50%. Remuneration will be pro-rated accordingly.

Additional Information

• This vacancy notice may be used to identify candidates for other similar consultancies at the same level.
• Only candidates under serious consideration will be contacted.
• A written test may be used as a form of screening.
• If your candidature is retained for interview, you will be required to provide, in advance, a scanned copy of the degree(s)/diploma(s)/certificate(s) required for this position. WHO only considers higher educational qualifications obtained from an institution accredited/recognized in the World Higher Education Database (WHED), a list updated by the International Association of Universities (IAU)/United Nations Educational, Scientific and Cultural Organization (UNESCO). The list can be accessed through the link: http://www.whed.net/. Some professional certificates may not appear in the WHED and will require individual review.
• For information on WHO's operations please visit: http://www.who.int.
• WHO is committed to workforce diversity.
• WHO has a smoke-free environment and does not recruit smokers or users of any form of tobacco.
• Applications from women and from nationals of non and underrepresented Member States are particularly encouraged.
• WHO prides itself on a workforce that adheres to the highest ethical and professional standards and that is committed to put the WHO Values Charter into practice.
• WHO has zero tolerance towards sexual exploitation and abuse (SEA), sexual harassment and other types of abusive conduct (i.e., discrimination, abuse of authority and harassment). All members of the WHO workforce have a role to play in promoting a safe and respectful workplace and should report to WHO any actual or suspected cases of SEA, sexual harassment and other types of abusive conduct. To ensure that individuals with a substantiated history of SEA, sexual harassment or other types of abusive conduct are not hired by the Organization, WHO will conduct a background verification of final candidates.
• Consultants shall perform the work as independent contractors in a personal capacity, and not as a representative of any entity or authority. The execution of the work under a consultant contract does not create an employer/employee relationship between WHO and the Consultant.
• WHO shall have no responsibility whatsoever for any taxes, duties, social security contributions or other contributions payable by the Consultant. The Consultant shall be solely responsible for withholding and paying any taxes, duties, social security contributions and any other contributions which are applicable to the Consultant in each location/jurisdiction in which the work hereunder is performed, and the Consultant shall not be entitled to any reimbursement thereof by WHO.
• Consultants working in Switzerland must register with the applicable Swiss cantonal tax authorities and social security authorities, within the prescribed timeframes (Guidelines issued by the Swiss Mission are available at: https://www.eda.admin.ch/missions/mission-onu-geneve/en/home/manual-regime-privileges-and-immunities/introduction/Manuel-personnes-sans-privileges-et-immunites-carte-H/Non fonctionnaires et stagiaires.html