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Creating and enhancing TRUSTworthy, responsible and equitable partnerships in international research

Deliverables

Compliance failures

Report identifying compliance challenges, gaps and failures in global ethical adherence through analysis and engagement with funders and industry

National and international compliance tools

Directory of current compliance tools used both nationally and internationally in research ethics

Sustainability roadmap and implementation strategy

Map of activities, which will go beyond TRUST, but are needed to improve adherence to high ethical standards around the world to include report on engagement activities DELIVERABLE EXTENDED TO MONTH 39. IN MONTH 34 THE GLOBAL CODE WAS ADOPTED BY THE EUROPEAN COMMISSION. THIS WILL ENSURE SUSTAINABILITY. HOWEVER, THE SUSTAINABILITY OF THE CODE COULD BE ENHANCED FURTHER IF OTHER FUNDERS WERE GOING TO ADOPT IT. ADDITIONAL DISSEMINATION EFFORTS MIGHT LEAD TO THIS RESULT. IF SO, THE ADDITIONAL ROADS TO SUSTAINABILITY NEED TO BE DESCRIBED IN THIS DELIVERABLE. (ALL ADDITIONAL PERSON MONTHS ARE IN WP2 DISSEMINATION, NOT IN SUSTAINABILITY. WRITING UP NEW SUCCESSES CAN BE DONE WITHIN EXISTING PERSON MONTH BUDGETS).

Brochure

Brochure developed in collaboration with partners

Proposals for strategic approaches to compliance in low and middle income countries

Based on Deliverables 15 and 16 report summarizing proposals for strategic approaches to compliance with research ethics in low and middle income countries

Springer Briefs Book

Short, hot topics, open access Springer monograph. TO CAPTURE THE IMPACT OF THE GLOBAL CODE (THE MAIN TOPIC OF THIS BOOK) THE NEW DELIVERABLE DEADLINE IS MONTH 39 (SUBMISSION OF FINISHED MANUSCRIPT TO SPRINGER). ETHICS CODES WITH POLICY IMPACT ARE MUCH MORE INTERESTING TO READERS AND THIS IS THEREFORE A VALUABLE ADDITION. (ALL ADDITIONAL PERSON MONTHS ARE IN WP2 DISSEMINATION, NOT IN SUSTAINABILITY. WRITING NEW SUCCESSES INTO THE BOOK CAN BE DONE WITHIN EXISTING PERSON MONTH BUDGETS).

Report on paradigmatic case studies

The deliverable is based on Task 1.1 In-house case studies (Ferci) Task 1.2 Case study gap analysis (ACF) Task 1.3 Bottom-up case studies (Inserm)

Industry Platform Report

Report on the Industry activities, to include: A. Provision of case studies for WP1 B. Organisation of Industry (and 1st Tools) Workshop for feedback on tools C. Industry input on deliverables. D. Examples of self-regulation mechanisms for WP4 E. Suggestions for ethics committee policy briefs

Report on Generic Risks of Exporting Non-Ethical Practices

Building on matrix included in proposal and using case studies from Deliverable 1, identify personal, institutional and community-based risks independent of discipline (generic risks) through themed and conceptual analysis.

Policy briefs for ethics committees

Building on compliance gaps from WP4, draft and disseminate policy briefs for ethics committees.

Funder Platform Report

Report on Funder activities, to include: A. Funder inventory B. Funder Workshop for feedback on tools C. Suggestions for ethics committee policy briefs and tools

1st Engagement Report

Report summarizing engagement and dissemination activities up to M19.

2nd Engagement Report

Report summarizing engagement and dissemination activities from M19. THIS REPORT WILL INCLUDE DESCRIPTIONS OF ALL ACTIVITIES I to L LISTED UNDER DISSEMINATION IN THE WP 2 DESCRIPTION. THESE WERE ADDED FOR THE JULY 2018 AMENDMENT TO THE GA.

Final Global Code of Conduct

Report with Global Code of Conduct including input from engagement panel and advisory board.

"Special Symposium in the ""Cambridge Quarterly of Healthcare Ethics"

First planned peer-reviewed international journal output in Cambridge Quarterly of Healthcare Ethics.

Matrix mapping case studies onto risks

Build draft matrix for checking by all case study leads (SASI, PHDA, ACF) to obtain input from local populations and test generic matrix in 3 disciplines (medicine PHDA, social science UCT, anthropology SASI).

Website and Twitter

Website dedicated to the project with internal and external pages hosted for the duration of the project. Twitter account YouTube Channel

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Publications

Healthy Volunteers for Clinical Trials in Resource-Poor Settings: National Registries Can Address Ethical and Safety Concerns

Author(s): FRANCOIS BOMPART
Published in: Cambridge Quarterly of Healthcare Ethics, Issue 28/1, 2019, Page(s) 134-143, ISSN 0963-1801
DOI: 10.1017/s0963180118000476

Working Together to Make the World a Healthier Place: Desiderata for the Pharmaceutical Industry

Author(s): KLAUS M. LEISINGER, KATE CHATFIELD
Published in: Cambridge Quarterly of Healthcare Ethics, Issue 28/1, 2019, Page(s) 153-164, ISSN 0963-1801
DOI: 10.1017/s096318011800049x

Continued Access to Investigational Medicinal Products for Clinical Trial Participants—An Industry Approach

Author(s): ARIELLA KELMAN, ANNA KANG, BRIAN CRAWFORD
Published in: Cambridge Quarterly of Healthcare Ethics, Issue 28/1, 2019, Page(s) 124-133, ISSN 0963-1801
DOI: 10.1017/s0963180118000464

Editorial: Looking for Justice from the Health Industry

Author(s): DORIS SCHROEDER, JULIE COOK
Published in: Cambridge Quarterly of Healthcare Ethics, Issue 28/1, 2019, Page(s) 121-123, ISSN 0963-1801
DOI: 10.1017/s0963180118000452

Applying an Ethical Framework to Herbal Medicine

Author(s): Kate Chatfield, Bahare Salehi, Javad Sharifi-Rad, Leila Afshar
Published in: Evidence-Based Complementary and Alternative Medicine, Issue 2018, 2018, Page(s) 1-7, ISSN 1741-427X
DOI: 10.1155/2018/1903629

Ethics Dumping

Author(s): Schroeder, D., Cook, J., Hirsch, F., Fenet, S., Muthuswamy, V. (Eds.)
Published in: Ethics Dumping - Case Studies from North-South Research Collaborations, 2018
DOI: 10.1007/978-3-319-64731-9

Equitable Research Partnerships - A Global Code of Conduct to Counter Ethics Dumping

Author(s): Schroeder, D., Chatfield, K., Singh, M., Chennells, R., Herissone-Kelly, P.
Published in: Springer Briefs in Research and Innovation Governance, 2019

Promoting Equity and Preventing Exploitation in International Research: The Aims, Work, and Output of the TRUST Project

Author(s): Julie Cook, Kate Chatfield, Doris Schroeder
Published in: Ethics and Integrity in Health and Life Sciences Research, Issue 4, 2018, Page(s) 11-31
DOI: 10.1108/s2398-601820180000004002