CIOMS Working Group on the Revision of CIOMS 2002 International Ethical Guidelines for Biomedical Research Involving Human Subjects

Dear reader,

In 2010 the Executive Committee of CIOMS decided to revise the CIOMS Ethical Guidelines for Biomedical Research. The document was last revised in 2002. Since then, several developments have taken place, both in the field of biomedical research itself and in the field of research ethics. Among the latter developments is the recent revision of the Declaration of Helsinki in 2013.
The research and research ethics community, as well as the wider public, are now cordially invited to provide the Working Group of CIOMS with comments until 1 March 2016. The Working Group will then process the comments and suggestions, and submit the final document to the Executive Committee of CIOMS. This Committee will approve the document.

The Working Group
The Working Group consists of 10 members, one chair (President of CIOMS), four advisers (from WHO, UNESCO, COHRED and WMA) and one scientific secretary. The composition of the Working Group ensures that different cultural perspectives are present, members vary in age and expertise, and a gender balance is reached. One of the members represents the patient perspective. The group has met three times each year from September 2012 until September 2015.

Status of the current draft
The current version of the CIOMS guidelines is a draft. Although guidelines address specific issues, such as choice of the control, individual informed consent, and research with children, the CIOMS guidelines should be read and understood as a whole.
In the final version the Working Group will add introductory texts and appendices.

Literature and guidance documents
The draft guidelines have been based on the results of literature searches and ethical reflection within the Working Group. Certain papers and guidelines have been particularly valuable for the current draft guidelines, such as the Declaration of Helsinki of the WMA, the Ethical considerations in biomedical HIV prevention trials of UNAIDS and Standards and operational guidance for ethics review of health-related research with human participants of the WHO. All sources used will be acknowledged in the final document.

Major changes
Most guidelines have been substantially revised. Guidelines have also been merged where possible. At the same time, new guidelines have been added to address new, pressing issues that require ethical guidance (such as disaster research or implementation research). The Working Group has also decided to merge the “Green Book” (the CIOMS Guidelines for Biomedical Research, 2002) with the “Blue Book” (the CIOMS Guidelines for Epidemiological Research, 2009) since the two guidelines substantially overlap each other. The scope of the guidelines has been broadened from biomedical research to health-related research with humans.

Providing feedback
The proposal of the Working Group is now open for comments. Below each guideline there are two boxes: one for general comments and one for specific comments. Please provide us as much as possible with concrete, specific comments and text proposals. Since we expect to receive a great number of suggestions, we would like to caution that we will not be able to respond individually to each commentator.

We are grateful for your support of this important project and hope the revised CIOMS Guidelines will help to foster ethical research worldwide.
Yours sincerely,

Dr. J.J.M. van Delden
President of CIOMS



Strategic partnering to improve community health worker programming and performance: features of a community-health system integrated approach



There is robust evidence that community health workers (CHWs) in low- and middle-income (LMIC) countries can improve their clients’ health and well-being. The evidence on proven strategies to enhance and sustain CHW performance at scale, however, is limited. Nevertheless, CHW stakeholders need guidance and new ideas, which can emerge from the recognition that CHWs function at the intersection of two dynamic, overlapping systems – the formal health system and the community. Although each typically supports CHWs, their support is not necessarily strategic, collaborative or coordinated.


We explore a strategic community health system partnership as one approach to improving CHW programming and performance in countries with or intending to mount large-scale CHW programmes. To identify the components of the approach, we drew on a year-long evidence synthesis exercise on CHW performance, synthesis records, author consultations, documentation on large-scale CHW programmes published after the synthesis and other relevant literature. We also established inclusion and exclusion criteria for the components we considered. We examined as well the challenges and opportunities associated with implementing each component.


We identified a minimum package of four strategies that provide opportunities for increased cooperation between communities and health systems and address traditional weaknesses in large-scale CHW programmes, and for which implementation is feasible at sub-national levels over large geographic areas and among vulnerable populations in the greatest need of care. We postulate that the CHW performance benefits resulting from the simultaneous implementation of all four strategies could outweigh those that either the health system or community could produce independently. The strategies are (1) joint ownership and design of CHW programmes, (2) collaborative supervision and constructive feedback, (3) a balanced package of incentives, and (4) a practical monitoring system incorporating data from communities and the health system.


We believe that strategic partnership between communities and health systems on a minimum package of simultaneously implemented strategies offers the potential for accelerating progress in improving CHW performance at scale. Comparative, retrospective and prospective research can confirm the potential of these strategies. More experience and evidence on strategic partnership can contribute to our understanding of how to achieve sustainable progress in health with equity.


Using a human resource management approach to support community health workers: experiences from five African countries



Like any other health worker, community health workers (CHWs) need to be supported to ensure that they are able to contribute effectively to health programmes. Management challenges, similar to those of managing any other health worker, relate to improving attraction, retention and performance.


Exploratory case studies of CHW programmes in the Democratic Republic of Congo, Ghana, Senegal, Uganda and Zimbabwe were conducted to provide an understanding of the practices for supporting and managing CHWs from a multi-actor perspective. Document reviews (n = 43), in-depth interviews with programme managers, supervisors and community members involved in managing CHWs (n = 31) and focus group discussions with CHWs (n = 13) were conducted across the five countries. Data were transcribed, translated and analysed using the framework approach.


CHWs had many expectations of their role in healthcare, including serving the community, enhancing skills, receiving financial benefits and their role as a CHW fitting in with their other responsibilities. Many human resource management (HRM) practices are employed, but how well they are implemented, the degree to which they meet the expectations of the CHWs and their effects on human resource (HR) outcomes vary across contexts. Front-line supervisors, such as health centre nurses and senior CHWs, play a major role in the management of CHWs and are central to the implementation of HRM practices. On the other hand, community members and programme managers have little involvement with managing the CHWs.


This study highlighted that CHW expectations are not always met through HRM practices. This paper calls for a coordinated HRM approach to support CHWs, whereby HRM practices are designed to not only address expectations but also ensure that the CHW programme meets its goals. There is a need to work with all three groups of management actors (front-line supervisors, programme managers and community members) to ensure the use of an effective HRM approach. A larger multi-country study is needed to test an HRM approach that integrates context-appropriate strategies and coordinates relevant management actors. Ensuring that CHWs are adequately supported is vital if CHWs are to fulfil the critical role that they can play in improving the health of their communities.


Towards an international taxonomy of integrated primary care: a Delphi consensus approach



Developing integrated service models in a primary care setting is considered an essential strategy for establishing a sustainable and affordable health care system. The Rainbow Model of Integrated Care (RMIC) describes the theoretical foundations of integrated primary care. The aim of this study is to refine the RMIC by developing a consensus-based taxonomy of key features.


First, the appropriateness of previously identified key features was retested by conducting an international Delphi study that was built on the results of a previous national Delphi study. Second, categorisation of the features among the RMIC integrated care domains was assessed in a second international Delphi study. Finally, a taxonomy was constructed by the researchers based on the results of the three Delphi studies.


The final taxonomy consists of 21 key features distributed over eight integration domains which are organised into three main categories: scope (person-focused vs. population-based), type (clinical, professional, organisational and system) and enablers (functional vs. normative) of an integrated primary care service model.


The taxonomy provides a crucial differentiation that clarifies and supports implementation, policy formulation and research regarding the organisation of integrated primary care. Further research is needed to develop instruments based on the taxonomy that can reveal the realm of integrated primary care in practice.


Can Mobile Health Applications Facilitate Meaningful Behavior Change?: Time for Answers.

Massive problems require pragmatic, scalable, and evidence-based solutions. Cardiovascular disease (CVD), the world’s leading cause of death, is the epitome of such a problem in need of such a solution.1 The World Health Organization and American Heart Association have both set goals of reducing CVD mortality 25% by 2025.2,3 Achieving the requisite success in CVD prevention, however, will be challenging and will require approaches and tools that (1) have proven clinical benefit, (2) can be scaled to reach a global population, and (3) are affordable. Mobile technologies provide a potentially scalable and cost-effective platform to facilitate these needs. In 2014, there were more than 5 billion mobile phone users worldwide, representing approximately 3 of 4 adults on earth.4 Mobile phones have already had a profound influence on human connectivity, commerce, media, and finance. Although health care has been somewhat slow to incorporate mobile technology, the potential effect of digital medical tools is similarly huge.5 What is still needed, however, is evidence that mobile technologies can indeed facilitate improvements in health….more

Hospital Evaluations by Social Media: A Comparative Analysis of Facebook Ratings among Performance Outliers.

An increasing number of hospitals and health systems utilize social media to allow users to provide feedback and ratings. The correlation between ratings on social media and more conventional hospital quality metrics remains largely unclear, raising concern that healthcare consumers may make decisions on inaccurate or inappropriate information regarding quality.

The purpose of this study was to examine the extent to which hospitals utilize social media and whether user-generated metrics on Facebook(®) correlate with a Hospital Compare(®) metric, specifically 30-day all cause unplanned hospital readmission rates.

This was a retrospective cross-sectional study conducted among all U.S. hospitals performing outside the confidence interval for the national average on 30-day hospital readmission rates as reported on Hospital Compare. Participants were 315 hospitals performing better than U.S. national rate on 30-day readmissions and 364 hospitals performing worse than the U.S. national rate.

The study analyzed ratings of hospitals on Facebook’s five-star rating scale, 30-day readmission rates, and hospital characteristics including beds, teaching status, urban vs. rural location, and ownership type.

Hospitals performing better than the national average on 30-day readmissions were more likely to use Facebook than lower-performing hospitals (93.3 % vs. 83.5 %; p < 0.01). The average rating for hospitals with low readmission rates (4.15?±?0.31) was higher than that for hospitals with higher readmission rates (4.05?±?0.41, p < 0.01). Major teaching hospitals were 14.3 times more likely to be in the high readmission rate group. A one-star increase in Facebook rating was associated with increased odds of the hospital belonging to the low readmission rate group by a factor of 5.0 (CI: 2.6-10.3, p < ?0.01), when controlling for hospital characteristics and Facebook-related variables.

Hospitals with lower rates of 30-day hospital-wide unplanned readmissions have higher ratings on Facebook than hospitals with higher readmission rates. These findings add strength to the concept that aggregate measures of patient satisfaction on social media correlate with more traditionally accepted measures of hospital quality.


Financial woes may be fuelling hidden depression

About 20 percent of South Africans live on less than R350 per month and this kind of poverty could be having real impacts not only on people’s physical health but also their mental well being. Each month, Mary* collects a child grant for her three-year-old daughter. Within hours of collecting the grant, Mary is queuing at the door of the local loan shark in an effort to pay off debts that began last Christmas. “I had to buy Christmas clothes and groceries for myself and my girl,” said Mary, who lives in Kuruman, Northern Cape. “I needed more than the grant itself.” ….more

The Three Major Trends that Shaped the Global Economy for Decades Are About to Change

Demographics can explain two-thirds of everything, University of Toronto professor David K. Foot famously quipped. And according to Charles Goodhart, professor at the London School of Economics and senior economic consultant to Morgan Stanley, demographics explain the vast majority of three major trends that have shaped the socioeconomic and political environments across advanced economies over the past few decades. Those three would be declining real interest rates, shrinking real wages, and increasing inequality…..more

Health is key to growth

Leading economists, including eight South Africans, have called on world leaders to spend more on health and ensure that “essential” health services are free.  A petition calling for universal healthcare, drafted by former Harvard economics professor Lawrence Summers, was signed by 257 economists on Friday, ahead of a UN meeting this week. Global leaders will commit themselves to 17 goals intended to end poverty and ensure “sustainable development” by 2030 – and economists want them to prioritise health…..more

Developing the evidentiary basis for family medicine in the global context: The Besrour Papers: a series on the state of family medicine in the world


To provide an overview of the main methodologic challenges to finding definitive evidence of the positive effects of family medicine and family medicine training on a global scale.

Composition of the committee:
In 2012, 2013, and 2014, the College of Family Physicians of Canada hosted the Besrour Conferences to reflect on its role in advancing the discipline of family medicine globally. The Besrour Papers Working Group, which was struck at the 2013 conference, was tasked with developing a series of papers to highlight the key issues, lessons learned, and outcomes emerging from the various activities of the Besrour collaboration. The working group comprised members of various academic departments of family medicine in Canada and abroad who attended the conferences.

We performed a scoping review to determine the methodologic obstacles to understanding the positive effects of family medicine globally.

The main obstacle to evaluating family medicine globally is that one of its core dimensions and assets is its local adaptability. Family medicine takes on very different roles in different health systems, making aggregation of data difficult. In many countries family medicine competes with other disciplines rather than performing a gatekeeping role. Further, most research that has been conducted thus far comes from industrialized contexts, and patient continuity and its benefits might not be achievable in the short term in developing countries when clinical demands are great. We must find frameworks to permit strengthening the evidentiary basis of the discipline across different contexts without sacrificing its beneficial adaptability.

We believe that developing family medicine and its attributes is one of the keys to achieving global health. These attributes—including its comprehensiveness, adaptability, and attention to both local and patient needs—are key to advancing global health priorities, but make common evaluative frameworks for the discipline a challenge. The spread of family medicine over the past decades is indirect evidence of its utility, but we need to generate more evidence. We present some of the initial challenges to a broader and more rigorous evaluative framework.

Leaders make bold development pledge

WORLD leaders have negotiated and agreed on an ambitious plan to end poverty and inequality in the next 15 years, adopting 17 sustainable development goals (SDGs) at the United Nations (UN) as a road map to tackle the world’s most troubling problems. More than 150 world leaders were scheduled to attend the three-day summit that ended on Sunday to formally adopt an ambitious new sustainable development agenda, said the UN. The summit was held ahead of the UN General Assembly this week…..more

Why SDGs won’t make the world a fairer place

The much-hyped Sustainable Development Goals to be adopted by the UN summit starting this week in New York will not deliver the new economy that the world so desperately needs. Their creators want to reduce poverty and inequality without touching the wealth and power of the global 1%. They fail to understand a basic fact: Mass poverty is the product of extreme wealth accumulation and over-consumption by a few…..more

Primary health care: foundational to healthy communities

WHOs PHC Performance Initiative: Effective primary health care is essential to strong health systems. Countries with high-performing primary health care achieve better health outcomes, more equitably and at lower cost compared to peers that over emphasize hospital and specialty care. On 26 September 2015, WHO, the World Bank Group and the Bill and Melinda Gates Foundation launch the Primary Health Care Performance Initiative (PHCPI). This initiative will assist low- and middle-income countries in improving primary health care through better measurement and knowledge-sharing. PHCPI helps countries identify which parts of their health system are working well and which ones need improvement in order to drive advancements and enhance accountability….more

Wonca Polaris: What is Quality (Improvement) in Primary Care?…

What is Quality (Improvement) in Primary Care? Where to start?

Keep Calm: EQuiP introduces the Back to Basics Training Package!

Find the package of free resources in the right column box here:


#EQuiP believes there is a need for continuous and permanent information and training about Quality (Improvement) in Primary Care. We noticed in the EQuiP Working Group on #Teaching #Quality that knowledge of basic principles was lacking in a lot of training institutes over Europe.

However, many young GPs, who sometimes attend EQuiP conferences, are very interested in this topic:

– What is Quality (Improvement) really about?

– How do you bring it into general practice in a feasible way?

This was a call to action for EQuiP:

– How could we, as a network for quality improvement and patient safety, lower the threshold for GPs to use Quality Improvement techniques in daily work?

– How could we reach Primary Care workers, promote individual training materials and train the trainers to maintain the highest level of quality possible?


The EQuiP Executive Board presented in Fishingen in Switzerland to the entire EQuiP Network a plan to start a Back to Basics Training Package for interested GPs and Primary Care workers. Thus, we will bring together online information and training possibilities on the EQuiP website.

In line with the Quality Framework, developed by EQuiP and partners in the EU Leonardo da Vinci project, we will offer workshops and training sessions in core competences at every open EQuiP and Wonca Europe conference.

In the EQuiP Conference in Fishingen in April 2015, we started off with a succesfull workshop on PDCA for Dummies. In an interactive way every participant was asked to try to develop his/her own small project plan, and we learned a lot from each other on how to realize this successfully.

At the Wonca Europe Conference in Istanbul, we are having a workshop on: Quality in my practice. How do I start?

And at the EQuiP Spring Conference in Prague in April 2016 about patient safety, we will have a session on dealing with mistakes and critical incidents.

You are very welcome to come and participate in one of these workshops.

The role of community health workers in the reengineering of primary health care in rural Eastern Cape


Background: Primary Health Care in South Africa is being re-engineered to create a model of integrated care across different levels of the health care system. From hospitals to clinics, in the community and in the home, health care will focus more on prevention, health promotion, and advocacy for healthy lifestyles and well-being, in addition to clinical services. We provide a best-practice model of integrating community health workers (CHWs) trained as generalists into a multi-level health system in the Oliver Tambo district of the rural Eastern Cape.

Methods: Based at Zithulele Hospital, a health care network between the hospital, 8 clinics, and 50 CHWs has been created. The functions of each tier of care are different and complementary. This article describes the recruitment, training, supervision, monitoring, and outcomes of CHWs who deliver maternal, child health, nutrition, and general care through home visits.

Results: CHWs, especially in rural settings, can find and refer new TB/HIV cases, ill children, and at-risk pregnant women; rehabilitate malnourished children at home; support TB and HIV treatment adherence; treat diarrhoea, worm infestation, and skin problems; and distribute vitamin A. CHWs provide follow-up after clinic and hospital care, support families to apply health information, problem-solve the health and social challenges of daily living, and assist in accessing social grants. Case examples of how this model functions are provided.

Conclusion: This generalist CHW home intervention is a potential model for the re-engineering of the primary health care system in South Africa.

(Full text available online at

S Afr Fam Pract 2015; DOI: 10.1080/20786190.2014.977063

South African Dyslipidaemia Guideline Consensus Statement


The European Society of Cardiology together with the European Atherosclerosis Society published updated dyslipidaemia guidelines in 2011. SA Heart and the Lipid and Atherosclerosis Society of Southern Africa officially adopt these guidelines. This statement adapts aspects of the guidelines to the South African situation. Using the updated Framingham risk charts, interventional strategies are based according to the cardiovascular risk score and low-density lipoprotein cholesterol (LDL-C) levels. The Framingham risk score refers to the 10-year risk of any cardiovascular event, and includes four categories of risk. Treatment targets are those of the European guidelines. The LDL-C goal is 1.8 mmol/l for the very high-risk group (>30%), 2.5 mmol/l for the high-risk group (15 – 30%), and 3 mmol/l for those below 15% risk. Intensive management of dyslipidaemia in South Africa will significantly reduce the cardiovascular disease health burden.

Full Text: PDF


The contribution of family physicians to district health services: a national position paper for South Africa


This position paper on Family Medicine in South Africa was written for the National Department of Health in 2014 for the purposes of delivering a comprehensive assessment of the contribution that family physicians could make to the health system, and the issues that need to be addressed in order to realise this contribution. The paper mainly addresses issues in the public sector. It outlines the policy environment, health and health services context, the contribution of family physicians, their role in relationship to other healthcare workers, the initial evidence of their impact, the implications for posts and career pathways and the current state of training programmes, as well as providing key recommendations. The paper represents the viewpoint of the South African Academy of Family Physicians and the College of Family Physicians of South Africa, and attempts to speak with one voice on the current situation and need for future action.

Full Text: PDF