The CIOMS consensus report on clinical research in resource-limited settings

• Jurisdiction: South Africa
• Date: 01 December 2022
• Published date: 01 December 2022
• DOI: 10.7196/SAJBL.2022.v15i3.472
• Pages: 1-4
• Author: L Rägo,M Zweygarth

Month 20xx, Vol. x, No. x SAJBL 1

ARTICLE

The Council for International Organizations of Medical Sciences

(CIOMS) is an international, non-governmental, non-profit

organisation. Its mission is to advance public health through

guidance on health research and policy, including ethics, medical

product development and safety. CIOMS convened a Working Group

comprising senior scientists from various stakeholder groups, with

the objective of proposing pragmatic consensus recommendations

to advance clinical research in resource-limited settings.

In March 2021, the draft report was posted on the CIOMS website

for comment for 5 weeks, and Working Group members actively

invited comments from their peers working in low- and middle-

income countries (LMICs). The final report was published in June

2021.[1] An overview is provided below.

Backdrop and problem statement

Good-quality, ethical research is essential to identify and address

unmet health needs, including those of women and children. LMICs

bear the highest burden of preventable diseases globally.[2] While

resource limitations can exist in any country,[3] they are more common

in LMICs. They affect disadvantaged groups and individuals, migrants

and displaced persons in particular. The situation is aggravated in

global emergencies and in conflict areas.

Although new partnerships have emerged that address some of

the health issues in low-resource settings, most clinical research is

still conducted in the more conducive environment of high-income

countries (HICs). Many people in resource-limited settings view

research with distrust because they do not know what to expect, or

have had earlier negative experiences with research or treatment.

And instances of exploitative research in resource-limited settings

initiated by entities from high-income settings – so-called ‘ethics

dumping’ – continue to occur.[4] Lack of good-quality local research

is one of the reasons why entire communities are deprived of new

interventions to address their specific health needs.

The CIOMS report

The CIOMS Working Group’s consensus report provides a framework

to advance clinical research in low-resource settings. Key issues are

outlined below. The report builds on the 2016 CIOMS International

Ethical Guidelines for Health-related Research Involving Humans,[3]

but is not intended to supersede those guidelines.

Challenges to the research environment in LMICs

Research funders’ agendas do not always address the most pressing

problems in LMICs, and corruption, autocracy, legal uncertainties

and regulatory weaknesses create loopholes for players with undue

interests. Excessive bureaucracy and limited public funding are major

obstacles, which are often compounded by a lack of human resources

and necessary infrastructure, such as safe road transportation and

security.

Investments must be made in training and career structures,

data and safety monitoring, laboratory infrastructure and quality

assurance, robust technologies, and an adapted digital regulatory

and research framework. Researchers should learn from each other’s

experiences, for example by sharing locally derived information,

This open-access article is distributed under

Creative Commons licence CC-BY-NC 4.0.

The CIOMS consensus report on clinical research in

resource-limited settings

L Rägo, MD, PhD; M Zweygarth, Dip Transl DOZ

Council for International Organizations of Medical Sciences (CIOMS), Geneva, Switzerland

Corresponding author: L Rägo (ragol@cioms.ch)

Background. Responsible clinical research drives the advancement of healthcare. Despite tremendous improvements in the global

research and development environment since the 1950s, low- and middle-income countries (LMICs) are often left behind. There are several

reasons for this. Firstly, operational, social, ethical and regulatory challenges in LMICs make it difficult for researchers to conduct clinical

studies in those settings in line with international requirements. Secondly, many people living in low-resource settings distrust research

because some past studies have not benefited the participants or the communities involved.

Objectives. To present the consensus recommendations by a Council for International Organizations of Medical Sciences (CIOMS) Working

Group on how to advance good-quality, ethical clinical research in resource-limited settings.

Methods. CIOMS convened a Working Group of senior scientists from drug regulatory authorities, the pharmaceutical industry, public-

private partnerships for product development, and academia.

Results. This article summarises the Working Group’s report.

Conclusion. The report recommendations can foster the creation of a more enabling ecosystem for clinical research and promote

collaboration between policymakers, regulators, researchers and funders.

S Afr J Bioethics Law 2022;15(3):X-X. https://doi.org/10.7196/SAJBL.2022.v15i3.472