Medical Students on the Declaration of Helsinki and Human Research Subjects

Declaration of Helsinki

The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data. It was first adopted at the 18th WMA General Assembly, Helsinki, Finland, June 1964 and last revised at the 59th WMA General Assembly, Seoul, October 2008.

The comments received during the pubic consultation process may be viewed at the following link: Click here to view DoH Public consultation 2013_submissions.

Dr. Margaret (Pres-Elect of WMA) and Dr. Kloiber  (Secretary) and Roopa Dhatt (IFMSA President)

IFMSA had the opportunity to participate in the final consultation in Washington D.C.  on August 26th 2013 hosted by the American Medical Association (AMA) at the Jay Adams Historical Hotel—where stakeholders discussed key aspects of this document. Once adopted the Declaration of Helsinki at the next WMA GA will set the new standards of medical research around the globe.

Comments

There was significant input from the U.S., Germany, United Kingdom, Brazil and Japan constituencies—as well as engagement from WHO and PAHO, and academics on both content and the specific language. Interestingly, consensus was reached on many areas of the draft document, but a fundamental debate existed about whether the declaration should be aspirational or should strive to be more pragmatic, similarly, there was clear notion that double standards should not exist in research practices around the globe.   Other areas that continued to spark controversial debate included the use of “placebo” in trial and justification of such usage.  As well, as whether the document should have greater flexibility or whether the document should be “stricter”—with requiring specific recommendations to be “must” versus “should.” Other hot points were on reporting of research trials–content of the reporting and making it mandatory.  Dr. Otmar Kloiber stated a strong position about open access to research and that all findings should be reported and made available–the outcomes and the lack of outcomes.

Roopa Dhatt, “Apple,” Dr. Mukesh, Ian and Xaiver

IFMSA representing a younger voice in the room brought attention to an area that was not explicitly stated in the section of Confidentiality, Privacy and Consent:

Special attention must be given to the storage of personal information on digital platforms. This information must be encrypted to ensure the privacy of the research subjects and only available to the responsible of the study.

(Consideration of social media is applicable to digital platform use).

Rationale: Every day, more patients’ data is being stored on digital platforms. These digital platforms exist in hospitals, schools, research institutions and many others. Any access to the platforms is a breach of privacy and violation of the rights of research subjects.  The system must be encrypted and ensure that only the responsible for the research is accessing that data. This a position that that Dr. Saxena from the WHO, Ethics department, also supported.

While the argument of including nitty-gritty details is valid for many aspects of the document, in our opinion, digital platforms are a reality of medical research and care–and often the principles of confidentiality, privacy & consent are not implemented in the case of digital data, especially when looking beyond clinical trials and health systems research.

As for social media, while it might not be necessary to explicitly included in the #DOH, it is still an area that requires consideration in the areas of medical research.  Please refer to a recent policy statement IFMSA passed built upon principles of HIPAA.

Global Health Information Privacy and Protection Statement (GHIPPS):

http://www.ifmsa.org/content/download/202203/2210099/file/2013MMPS_07-Global%20Health%20Information%20Privacy%20and%20Protection%20(GHIPPS).pdf.

Overall, the discussions were fruitful and led to not only space for voicing out opinions, but healthy dialogue among differing opinions, as well as a clear understanding of the drafting committee position.  The consultation demonstrated that this was an inclusive, open process. It was also apparent that the 150 inputs that were submitted were considered by the drafting committee and there was significant effort placed in improving the style, structure, content of the document to create a sound declaration for years to come.

WMA, JDN, IFMSA

The consultation ended with a splendid dinner bringing a wonderful closure to the meeting at the historic hotel! As well it was great to meet our Junior Doctors’ Network (JDN) colleagues at the meeting–as they provided continued support for the involvement of young people in the global decision making process.

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WCSDH in Rio: Chile: Steps forward and backward equity

Live from Rio, Cristobal Cuadrado, former president of IFMSA-Chile and member of the IFMSA Delegation to the WHO World Conference on Social Determinants of Health, writes about the Chilean experience in fighting health inequities and acting on social determinants of health. This October, IFMSA-Chile, with Cristobal as general coordinator, organized the First Congress on Health and Poverty in Santiago. The conference was graced by Professor Sir Michael Marmot, head of the 2008 WHO Commission on Social Determinants of Health.

In the context of the World Conference on Social Determinants of Health at Rio de Janeiro, we are having a wide discussion about evidence and experiences of different countries into this field. This entry talks about the Chilean situation on Health Equity from the perspective of the Social Determinants of Health. Dr. Jeannete Vega, past Health Minister Deputy of Chile during the government of Michelle Bachelet, had summit a draft paper (nº25) entitled “Steps towards the health equity agenda in Chile”, this represent a summary and reflection of this paper.

Generalities about Chile and its Health System.

US$ 14,300 in 2010; the minimum wage rose to US$ 350 in 2010 and the current inflation and unemployment rates are 1.4% and 8.6% respectively. Chile scores high in several health indicators, such as life expectancy at birth (81.2 years for women and years for men), infant mortality (8.3 per 1000 live births). The Health System in Chile it is decentralized with 29 local Public Health Services that serve approximately 75 % of the population. The other 25% of the population is covered by a private insurance and provision scheme administered by a number of private insurance institutions (ISAPRE) that provide mainly curative services mostly to those with the highest income, and of younger ages.

As a little history, the actual shape of the Chilean health system is related with the undertaken by the Pinochet military government following the coup d’état in 1973, establishing competition between public and private health insurers and promoted private health services, following neoliberal principles. These principles have changed very little since the early 90ths were the democracy had come again to our country.

The employee mandatory contribution accounts for 7% of the salaries and goes to either the public insurance (FONASA) or the private insurance companies. The National Health Fund (FONASA, Fondo Nacional de Salud) manages public health insurance. All citizens in Chile are insured by Fonasa unless they choose to contribute to a private insurer (ISAPRE). Individuals covered by FONASA may receive health services from either public facilities or a preferred private provider. The Ministry of Health manages vertical programs, public health interventions, and the health care personnel from public facilities. The focus on Primary Heath is location of the health centers and the income level of the municipality, where a health center located in historical context leading to action on Social Determinants and Health Equity

Timeline on Health&Equity issues during the past 20 years

1990-2000

Two streams of social policies were developed during the 1990’s. Firstly, sectoral policies, such as education, health and housing, centered on guaranteeing an adequate level of services and benefits for all the population in an equal opportunity perspective. Secondly, specific programs directed towards disadvantaged vulnerable groups to ensure access to the opportunities available through the sectoral policies, economic growth and development in general.

2000 -2010

Between 2000 and 2006 the emphasis was put in introducing programs to improve structural social determinants: improving neighborhoods conditions (Chile Barrio), diminishing extreme poverty (Chile Solidario) and others. All these programs had in common a policy and programmatic approach centered on the perceived needs of the person, in a family and in a community, rather than on the supply based normative needs, with services built around them on an integrated (intersectoral) manner.  The landmark social program of the last government of this period is Chile Crece Contigo, a program with deep roots on the perspective of SDH, so we will go a little bit further on this experience.

 

Chile Crece Contigo (Chile Growth with you): an intersectoral approach to tackle inequities from the beginning.

The central principle on this program is “Equity from the beginning”. Chile Crece Contigo initiative for action included the Rights of Children and the State’s responsibility to ensure them as a universal principle, creating a integrated system based on rights during the life course. The Ministries of Planning and Finances leveraged funding to investigate policy alternatives, systematize and evaluate innovative local projects and develop possible interventions, including pilot experiences. The evidence base of effective interventions, that the Ministry of Planning and other sectors were building, also looked at international experience

After a long work, in October 2006 President Bachelet announced the creation of the integrated and integral social protection system for early child development, called Chile Crece Contigo. Its social equity goal was ambitious and aimed to eliminate socioeconomic differences in achieving maximum development potential across the social gradient.

The system would accompany children and their families from gestation until they entered the school system in pre-kinder, age 4 years. Chile Crece Contigo would provide all boys and girls access to universal benefits and services to take care of their necessities and support their development in each stage of the life cycle, during early childhood. Additionally, it would contribute to induce basic conditions in the psycho-emotional and physical environment in order to favor harmonious and integral development, in accordance with the evolution of their life course. During 2007 new programs were introduced that required integrated action by two or more sectors: Support for Biopsychosocial Development (Ministry of Health, Ministry of Development, the Fund for initiatives to support local child development initiatives (Ministry of Planning– municipalities) and Fund for Childhood Initiatives (Ministry of Planning – public, private and community agents).

Chile Crece Contigo offers different levels of support and guaranties for all boys, girls and their families. To each according to his/her specific needs.

  1. Strengthened legislation and standards of protection for maternity and paternity for all population.
  2. Free Nursery and Preschool access for the 60% of more vulnerable families
  3. Improved quality in prenatal care.
  4. Humanized birth (with participation of the father)
  5. Improved well child care, especially for the first 2 years (Biopsychosocial support)
  6. Strengthened access to health care for all boys and girls from the first prenatal control until entry into the school system
  7. Increased support and guarantees for boys and girls from the 60% of homes with lesser income or in special situations of vulnerability.

The process of implementation of Chile Crece Contigo to date includes the action in all the Municipalities within the Country through generation of the local intersectoral networks in charge. Since 2007:

  • More than 649.132 pregnant women have enter the program
  • Almost 75% of eligible births (non-emergency) have occurred with the presence of the father since 2009.
  • More than 90.000 visits to the households of pregnant women with social risk.
  • More than 1.000.000 educational sessions to promote early child development (ECD) with families of children at risk.
  • More than 270.000 visits to the household of families with children at risk in their development.
  • Since September 2009, every child born in Chile receives a set of basic implements for initial child care including a cradle, a baby carrier, massage oil, diapers, and much information on first care needed by babies and infants.

The decree that accompanied the Law established a Committee of 9 Ministers, headed by the Minister of Planning and including Health, Education, Justice, Women’s National Service (SERNAM), Finance, Presidency, Labor, Housing. The national technical committee has also been expanded to include all the public services related to children. The preeminence of Health for early child development is expressed in a permanent working group.

The principles of intersectorial approach, equity as a key social goal, focus on education and early childhood, high political commitment and social participation are remarkable aspects of this program that probably will produce outstanding results on the future development of the Chilean society.

National Agenda on SDH. And some lessons of the Chilean experience.

Given the presidential mandate to improve Equity in health as part of the broader objective of improving social Equity, in early 2008, the Chilean Ministry of Health decided to create the Executive Secretariat on Social Determinants of Health, as part of the Subsecretariat of Public Health, within this area an special plan had been create: the “13 pasos hacia la Equidad” (13 steps towards Equity – www.equidad.cl) initiative, aimed at improving the level and distribution of health within the population of Chile. As part of the agenda, six objectives were defined, each of them involving concrete actions aimed at contributing to equity in health in Chile:

Specific objectives of the agenda:

  1. To contribute to the reduction of social inequalities which generate health inequities
  2. To reduce inequities which restrict and limit access to health and health services
  3. To implement actions for the “social inclusion” of excluded groups and territories
  4. To develop competencies on equity and social determinants of health within the Ministry of Health staff
  5. To generate tools for planning, monitoring and evaluation of the SDH and equity in the health sector
  6. To establish bodies and mechanisms for the coordination and integration of various sectors to develop the necessary actions to reduce health inequities

The first of these objectives had been addressed partially through the Chile Crece Contigo that we had already talked about. Another example is the objective 3 had become practical with the implementation of the programs “Vulnerable Counties” and “Vulnerable Neighborhood” focusing on the 96 most vulnerable counties and 68 neighborhood of the country with the goal to promote the reduction of inequities in health in the most communities, by means of interventions aimed at the main barriers of access to health services and to the social protection system, which were identified and prioritized by the community itself.

This Secretariat and his worked until March 2010 promoting a work agenda. We had to make the point that one of the first actions of the new central right party Goverment was to close this important secretariat

Some lessons

The “13 pasos” agenda is also one of few experiences in Chile where the Ministry of Health has been able to play a true leading role. The process of developing and implementing the “13 pasos” agenda influenced the philosophy of people within the ministry of Health but also from other sectors. During the process, we learned some lessons that could be generalizable to others that are involved in similar processes.

  • Lesson 1: In order to strengthen health equity, there must exist explicit political commitment at the highest level
  • Lesson 2: The need for an explicit agenda with incentives
  • Lesson 3: Building trust is a must
  • Lesson 4: Intersectoral relationships are crucial
  • Lesson 5: The community is essential
  • Lesson 6: Training as a strategy for institutionalization

Actual challenges, civil society participation and the future

 

The inequalities in Chile area a huge problem. On income measures for example, the richest 10% earn 36 times more than the poorest 10% and the 20% richest group of Chile share about 50% of the GDP of the country. Taking some health examples, with a very good Infant Mortality Rate of 7.7 as average, there is a 3-fold difference between the less educated and better educated groups. Even more, in life expectancy, the gap increase till 14 and 10 years between the richest and poorest groups, for woman and men respectively. Nevertheless, the worst statistical analysis is that the trends are not diminishing but increasing in the last decades.

In this context we organize and held at Santiago, past 7,8,9 and 15 of October the first Congress on Health and Poverty in Chile, as a voice from the Civil Society to contribute to maintain the health and equity issues and social determinants of health approach into the national agenda. IFMSA was of course involved. It was more concretely, a Health and Equity congress, to widely discuss this issue, the actual policies and problems, gathering civil society, politicians, academicians and other stakeholders with a perspective of future. For Spanish speakers you could enter to our webpage to have more information and access to the presentations. Soon we will have all the conferences online for free access.

At the actual context, the urgent situation and critical inequalities on our country, the civil society is reacting and taking their own responsibility. So different NGOs and young leaders are getting around a platform todiscuss, propose, advocate and create whole society awareness of the needed actions to tackle the terrible inequalities of our country. Heath&Equity will be the future on that. You could check a small presentation with the graphs and a wider analysis and some proposals from the Health&Equity civil society movement in Chile for the future: http://www.saludypobreza.cl/wp-content/uploads/2011/10/Towards-Equity-in-Health.pdf

Do you want to know more about Chilean experience on Health and Equity? Discuss a little bit about? Share your troughs? More than welcome. ccuadrado@saludypobreza.cl

Cristobal Cuadrado

WCSDH in Rio: Medical students’ perspective on the Rio Declaration

The most important output of the WHO World Conference on Social Determinants of Health is the Rio Political Declaration on Social Determinants of Health, which can be downloaded here: http://www.who.int/sdhconference/declaration/en/index.html. In response to the Declaration, the IFMSA delegation to the WCSDH raises some vital issues that the Declaration failed to address. The statement below was distributed to all participants of the conference during the time the Declaration was unveiled in Rio de Janeiro.

The 10-member delegation of the International Federation of Medical Students’ Associations (IFMSA), a unique network of 106 national organizations in 99 countries, was thrilled to be part of this inspirational conference that has no doubt changed us all.

The delegation welcomes the Rio Declaration as it symbolizes a major step in the quest for global health equity. However, we also wish to express some of our concerns regarding the Declaration and the most important points that it missed.

The main problem of the Rio Declaration is that it failed to explicitly tell us how the unfair distribution of power, resources and wealth will be addressed, especially by Member States. The WHO Commission on Social Determinants of Health has been adamant about the need to tackle this lingering issue, as health inequities within and between countries are rooted in power relations and resource maldistribution. We understand that changing the current dynamics of power will not happen overnight. However, we believe that this Declaration could have been the watershed moment for leaders to make a strong commitment in making this world a fairer place.

  1. We believe that democracy is the key instrument in fixing the existing imbalances in power and in ultimately reducing health inequities. However, the Declaration is weak in emphasizing the value of democracy in all processes – from decision-making to evaluation – and at all levels – from community to global level. The Declaration should have encouraged the creation of democratic institutions within and between countries that will allow active engagement among all sectors.
  1. We noted that the Declaration mentioned the line “private sector, safeguarding against conflict of interest” three times. It is established that large multinational corporations wield disproportionately large power in influencing both intermediate (i.e. tobacco, alcohol, unhealthy food, breastmilk substitutes, working conditions) and structural (i.e. intellectual property and trade agreements) determinants of health. The Declaration could have been a perfect opportunity to specifically define the specific role of the private sector in reducing health inequities and to clearly draw the lines governing engagement between government and the private sector.
  1. Global economic governance institutions, such as the IMF, WTO and World Bank, wield disproportionately large power in influencing many of the upstream determinants of health, i.e. through loan conditionalities, free trade agreements, TRIPS+ provisions and agricultural subsidies. We welcome the mention of health impact assessments and call for this to become a mandatory step when creating FTAs and imposing IMF conditionalities. The Declaration should also ask of these powerful institutions the same standards of transparency, accountability and democracy as that urged of Member States.
  1. It cannot be denied that action on social determinants of health will require substantial funding. However, the Declaration is silent about how tackling health inequities will be financed. Commitment to adoption of innovative financing schemes such as progressive taxation on capital gains or extremely-high earners, implementing a financial transactions tax, as well as preventing tax evasion, should have been enshrined in the Declaration.
  1. Although the Declaration recognizes the importance of engaging with civil society, we feel that it should specifically advocate for the creation of spaces for dynamic dialgogue, venues that will enable civil society to be heard and to also directly hear from governments. The writing of the Declaration has been disappointing, as civil society, which could have meaningfully contributed in strengthening the Declaration, was shunned away in the official process. Governments should value the voice of civil society as these groups, having been working on reducing health inequities for many decades, have the capacity to see these defects and propose innovative solutions.
  1. Finally, we would have hoped that the Declaration explicitly include the inclusion of young people and youth organizations such as ours in the movement for action on social determinants of health. As early as now, young people should be made to understand the principles of equity and social determinants to ensure smooth transfer of knowledge and deeds and eventually the sustainability of this global movement. Moreover, youth today has the sheer capacity to effect positive change, a capacity which remains largely untapped. With their innate energy, fresh vision, and advanced grasp of technology, young people, who will be inheritors of global health sooner rather than later, can largely and meaningfully contribute in advancing the movement for “health and equity for all.”

Now, as we all go back to our respective homes, we medical students ask all conference participants to take time to look at the Declaration once more, to reflect on the discussions and lessons of the conference, to consider the voice of civil society and young people, and to think of the next bolder steps that will move us forward in reshaping the distribution of power and combating health inequalities around the world.

On our part, we medical students commit ourselves to continue engaging with all sectors involved in the work towards global health equity, spreading awareness of the social dimensions of health to our fellow young people, mobilizing them to take action in their respective communities and countries, doing our part, little by little, but with courage, constancy, and conviction.

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