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GE2P2 Global Foundation on behalf of the Global Forum on Research Ethics and Integrity [GFREI] Working Group. (03 August 2022). GFREI RFI Submission: NIH Promoting Equity in Global Health Research, NOT-TW-22-001 – May 20, 2022 https://wordpress.com/page/ge2p2-center.net/22778

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[B] Full Author Citation for various uses, including co-author CVs, etc.
Curry, D.R., Adiabu, S., Andrade-Narvaez, F.J., Ang, L., Arawi, T., Asif, F., Aurich, B., Bierer, B.E., Bukini, D.A., Crawley, F.P., Dalla Costa, E., Diniz, N.M., Dobrova, V., Engler-Todd, Freitas, M., Hassan, M. Iceland, K., Ike, C., Kebede, S., Jumar, N., Kurihara, C., Lolas, F., Mboera, L., Muthuswamy, V., Pavlov, C.S., Prichep, E., Ross, G., Sitorus, R.S., Su, Y., Suzuki, M., Ukpong-Folayan, M., Yimer, G. as the Global Forum on Research Ethics and Integrity [GFREI] Working Group/GE2P2 Global Foundation. (03 August 2022). GFREI RFI Submission: NIH Promoting Equity in Global Health Research, NOT-TW-22-001 – May 20, 2022. https://wordpress.com/page/ge2p2-center.net/22778

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GE2P2 Global Foundation on behalf of the Global Forum on Research Ethics and Integrity [GFREI] Working Group. (03 August 2022). GFREI RFI Submission: NIH Promoting Equity in Global Health Research, NOT-TW-22-001. https://wordpress.com/page/ge2p2-center.net/22778

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GFREI Working Group – NIH RFI :: Promoting Equity in Global Health Research
Sedem Adiabu, GE2P2 Global Foundation, USA
Fernando J. Andrade-Narvaez, University of Yucatán, Mexico
Lynn Ang, UCL Institute of Education (IOE), London, UK
Thalia Arawi, American University of Beirut & Medical Center, Lebanon
Farah Asif, Shaukat Khanum Memorial Cancer Hospital And Research Centre, Pakistan
Beate Aurich, Drug Safety Consulting S.A.S.U., Strasbourg, France
David R. Curry, GE2P2 Global Foundation, USA
Daima Athurnani Bukini, Muhimbili University of Health and Allied Sciences, Tanzania
Barbara E. Brierer, Multi-Regional Clinical Trials Center, Brigham & Women’s Hospital Harvard (MRCT), USA
Ester Dalla Costa, Universidade Estadual De Londrina, Brazil
Francis P. Crawley, Good Clinical Practice Alliance – Europe (GCPA) & Strategic Initiative for Developing Capacity in Ethical Research (SIDER), Leuven, Belgium
Nilza Maria Diniz, State University of Londrina-UEL, Brazil
Viktoriia Dobrova, National University of Pharmacy, Ukraine
Lori Engler-Todd, Office of the Chief Science Advisor (OCSA), Canada
Cristina F. Mara de Sousa Freitas, University of Lisbon, Portugal
Mariam Hassan, Shaukat Khanum Memorial Cancer Hospital and Research Centre, Pakistan
Keneth Iceland, Kabale University, Uganda
Chiedozie Godian Ike, Irrua Specialist Teaching Hospital, Nigeria
Senait Kebede, Equitable Partnership/DGH Consultant, Emory Global Health Institute, USA
Nandini K. Kumar, , Forum for Ethics Review Committees in India (FERCI), India
Cheiko Kurihara, National Institutes for Quantum and Radiological Science and Technology, Japan
Fernando Lolas, University of Chile-Center for Bioethics, Chile
Leonard E.G. Mboera, SACIDS Foundation for One Health, Tanzania
Vasantha Muthuswamy, Forum for Ethics Review Committees in India (FERCI), India
Chavdar Pavlov, I.M. Sechenov First Moscow State Medical University, Russia
Elissa Prichep, Shaping the Future of Health and Healthcare, Switzerland
Barbara Redman, Senior Fellow, GE2P2 Global Foundation, USA
Gloria Mason Ross, National Research Ethics Board of Liberia, Liberia
Rita S. Sitorus, HREC Faculty of Medicine, Universitas Indonesia, Cipto Mangunkusumo Hospital, Indonesia
Yeyang Su, Institute of Basic Medicine and Cancer, Chinese Academy of Sciences, China
Mika Suzuki, Center for iPS Cell Research and Application, Kyoto, Japan
Morenike Ukpong-Folayan, Obafemi Awolowo University, Nigeria
Getnet Yimer, Center for Global Genomics and Health Equity, U Penn, USA

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Overview
The GFREI Working Group [WG] engaged a rapid response to this RFI given the relatively short timeline for submission.

Initially, WG member inputs were invited against the eight questions provided in the NIH RFI. In aggregating these responses, it became clear that the RFI questions were duplicative to some extent and we decided to explore a more ambitious approach.

Overall, the WG identified the following ten “elements of equity in global health research”:
Elements of Equity in Global Health Research

• Global Health Research Agenda – Inclusive/Relevant/Transparent
• Global Benchmarking
• Ethical Resilience
• Access to/Realization of Opportunity – Research Funding/Resources
• Access to/Realization of Opportunity – Research Leadership
• Access to/Realization of Opportunity – Parity/Equality in Roles/Responsibilities/Rewards Access to/Realization of Opportunity – Capacity Building
• Research Life Cycle – Operational Transparency/Accountability/Integrity
• Risk/Benefits Sharing/IP
• Evidence Integrity/Data Quality/Data Sharing

Melding the eight RFI questions, we proceeded to populate a data structure as below:
Element X.0:

• Summary
• Practice Realization [How would it look?]
• Current Ownership/Power Structures
• Barriers
• Positive Case Examples
• Current Guidance/Norms/Statements/Commitments
• Selected Supporting Literature/Analysis

In the case of some elements, not all the information categories are equally “mature” and articulated, and we identify this in the text. GFREI WG plans to continue to explore all these elements to bring them into full resolution.

The Working Group would like to stress the importance of the existing journal literature and other selected analysis in grounding our response. NIH reviewers of this submission will note that a selected bibliography is included for each element. We will continue to monitor the literature and extend our review to journal titles in other languages where relevant articles may be found.

We advise that this work has now emerged as a central theme in the programme of work in GFREI. We anticipate building out a web resource which will evolve and be updated as our analysis, experience and the literature further informs thinking about this critical issue.

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Final Published Version/Other Supporting Documentation
NIH Summary report on responses
The information collected in the responses was analyzed and categorized into three main areas: barriers and challenges, key thematic areas, and recommended strategies and solutions.
Read the full NIH Report on Request for Information on Promoting Equity in Global Health Research

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Original Call for Public Consultation
NIH Promoting Equity in Global Health Research, NOT-TW-22-001.
Release Date: May 20, 2022
Response Date: August 01, 2022
Purpose
This Notice is a Request for Information (RFI) on approaches NIH can take to promote greater equity in global health research, particularly research that engages scientists in low and middle-income countries (LMICs) (REF).

Background
As a global leader in biomedical and behavioral research, NIH is committed to supporting collaborative international research that harnesses the rich diversity of the biomedical workforce to advance timely solutions to global health challenges. Therefore, NIH has a responsibility to identify and address, to the extent possible given its mission, the challenges and barriers to equitable research, which for the purposes of this RFI is defined as research collaboration that is inclusive, elevates underrepresented voices and groups, and demonstrates fairness of opportunity and fair process (REF). This interest builds on NIH’s long-standing practice of funding highly meritorious research throughout the world, both through direct awards to non-U.S. institutions and indirectly through awards to U.S. institutions that then use those awards to support collaborating foreign institutions. NIH has long encouraged international research collaborations and is interested in exploring opportunities to further encourage and facilitate research that is conducted equitably, in true partnership with collaborators and for the benefit of all participants.

In practice, equity in global research may be achieved through collaborations based on true partnership, shared leadership, joint applications and publications, and the inclusion of previously disadvantaged individuals as research partners. Through this RFI, NIH seeks ideas and specific actions that NIH may consider to encourage the expansion and quality of such global research collaborations, particularly with scientists and institutions in LMICs.

NIH welcomes the global dialogue around increased equity in global health research and seeks to respond with insights and ideas generated through this RFI. In addition to promoting an ever more collaborative research environment, NIH recognizes that equitable research processes, strengthened scientific and research administrative capacity, the inclusion and sustaining of local talent and expertise, and a focus on local health priorities will advance scientific discovery and the development of more effective, appropriate, and sustainable health interventions. This RFI is intended to improve NIH’s understanding of potential research funding, priority setting, and administrative practices and strategies that could encourage or facilitate equitable global health research.

Information Requested
Respondents to this RFI are invited to provide input regarding current NIH practices that might be revised or new practices that could be implemented to enhance collaborative international research equity and the generation of mutual benefits and shared leadership; and to propose practical ideas that could help NIH enhance these practices. NIH acknowledges that thought leaders in this regard are widely distributed throughout the U.S. and the international scientific, academic, and public health communities. NIH looks forward to receiving input from these communities with a special interest in input from scientists in LMICs. Some subjects that may be of particular interest include: NIH funding mechanisms and approaches, elements of equitable scientific partnerships, inclusive community research-engagement strategies, practical research capacity building approaches, mutually beneficial data and material sharing approaches, publication access, training and career development, joint leadership strategies, and research priority setting.

For the purposes of this query, global health research collaboration involving scientists and institutions in LMICs are of particular interest. Of note, it is important to recognize that, as a U.S. research funding agency, while NIH welcomes all suggestions, it may be unable to adopt some options identified as potentially beneficial to achieving more equitable global research collaboration. In addition, issues such as equal access to health interventions, the governance of intellectual property sharing, and the equitable distribution of products of research are not within the scope of this RFI.

The NIH seeks comments on any or all of the subjects listed above, and as a starting point poses the following questions:

1. What are the most important elements of equitable global health research?
2. How is equitable global health research conducted? What does this look like in practice?
3. What are the main challenges or barriers to equitable global health research partnerships and the conduct of equitable research?
4. What are the current roles and responsibilities of LMIC researchers and institutions engaged in global health research partnerships? What are the optimal roles and responsibilities of LMIC researchers and institutions engaged in global health research partnerships?
5. Illustrative examples of equitable research partnerships and the way research is conducted between and across the low-, middle-, and high-income countries. What are the characteristics of these partnerships and approaches that make them exemplary?
6. What are key gaps in research capacity that impede equitable global health research?
7. Through the use of peer review, the NIH system is designed to identify and fund highly meritorious applications that address scientific opportunities. In this context, how can a focus on local health priorities and local talent be better integrated to promote global health research equity?
8. What can NIH as a research funder do to promote equitable global health research and research partnerships? Please share any specific suggestions for solutions and strategies.

NIH seeks input from all interested stakeholders around the world and across all regions and socioeconomic designations, but especially those from LMICs. This includes members of the scientific community, trainees, academic institutions, the private sector, health professionals, professional societies, advocacy groups, as well as other interested members of the public.