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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Taking Steps Forward: Adopting a vision and mission

One may ask: why is that so important for IFMSA? The answer is quite simple. A clear vision gives us the strength to move forward, a mission pushes us to thrive in the international community. 

Over the past years, IFMSA has expended its priorities to include societal issues, such as climate change, universal health care, noncommunicable diseases, social determinants of health and many more to address those current issues that challenge achieving quality, accessible health for all. As our federation has been continuously evolving and growing since more than 62 years, its members felt it was time to take an internal review of the values, principles and objectives of the federation.

The story of IFMSA’s Vision Building began in the term 2011-12, when IFMSA’s leadership began exploring key questions about the direction that IFMSA should be striving for and as well how should IFMSA strive to achieve.  A small working group led by Roopa Dhatt, IFMSA VPE 2012/13 on Mission and Vision sparked momentum for the Federation to officially commit to this process.  (Past Blog– Moving Ahead IFMSA, What our members are saying?)

IFMSA members Vision Building

Through guidance, creativity and great dedication,  Claudel P-Desrosiers (IFMSA-Québec) led the IFMSA Task Force on Vision and Mission. They had a great challenge–to deliever a a new mission and vision for IFMSA by August Meeting 2013, while ensuring that all voices were included in its creation. “The journey wasn’t easy. The process had started in 2007 but no conclusion was reached until recently. It’s not simple to give a Federation something that truly represents the spirit, values and ideals of its 1.3 million members coming from 110 different countries. But with your help, your valuable input and your trust, we were able to make it a success. And I would like to sincerely thank you for that. We are extremely proud that this mission and vision reflect the voices of medical students worldwide, your voice.” -Claudel P-Desrosiers (IFMSA-Québec)

Mission and Vision Survey 2012/13

Vision
A world in which all medical students unite for global health and are equipped with the knowledge, skills and values to take on health leadership roles locally and globally.

Mission
IFMSA unites medical students worldwide to lead initiatives that impact positively the communities we serve. IFMSA represents the opinions and ideas of future health professionals in the field of global health, and works in collaboration with external partners. IFMSA builds capacity through training, project and exchange opportunities, while embracing cultural diversity so as to shape a sustainable and healthy future.

As we work to make this Federation reflect who we are and what we want to achieve, this newly adopted mission and vision statement provide us with a foundation to expand our impact and to shape the healthy world as we envision it.

August 5th was a memorable night in which the plenary has seized the opportunity to make IFMSA history and to do as the head of PAHO, Dr. Carissa Etienne, told us to do just a few days before: “it cannot be business as usual”.

We are very excited about our mission and vision, as the process of strengthening IFMSA has just been realized, the new few months and years will be very exciting for the Federation!

A special thanks to the the Task Force and those that contribute to the process.

Claudel P-Desrosiers (IFMSA-Québec), joint author of this post
Coordinator of the 2012-2013 Task Force on IFMSA Mission & Vision

Members of the Task Force: James Lawler (AMSA-Australia), Elizabeth Wiley (AMSA-USA), Khalid Almak (medsin-Sudan), Kimberly Williams (CFMS-Canada), Jason van Genderen (IFMSA-NL), Jelte Kelchtermans (BeMSA-belgium),  Thomas Adongo (MSAKE-Kenya), and Roopa Dhatt (IFMSA President).

IFMSA President’s Opening Speech on IFMSA Reform

 

 

Opening Speech AM13 on Reform, Roopa Dhatt
Opening Speech AM13 on Reform, Roopa Dhatt

 

Dear IFMSA family and friends, especially to our honorary guests, welcome to the 62nd General Assembly August Meeting of IFMSA!

 

The weather here in Santiago may be chilly, but the hall is full of fiery energy and vitality. Partly it’s because of the fiesta spirit that thrives in the Latin America, but certainly the heat is coming from the burning passion of each and every IFMSA member in this hall who wants to make a difference in IFMSA and in the world.

 

This General Assembly is extra special. For decades, IFMSA has been making a difference in the world, at the forefront of cultural exchange, building friendships, and health action. Our previous General Assemblies have served as platforms for healthy discourse about the world and the challenges it faces. Last GA, we were learned how to become advocates for social change to improve health. Certainly this GA will provide more venues for capacity building and project brainstorming.

 

However, this General Assembly will be a defining one in IFMSA history, as we devote an entire General Assembly to discuss our Federation’s internal future. We have spent years pointing out the problems, needs, and gaps within our Federation, and several teams of IFMSA leaders have attempted to effect incremental improvements. Indeed, reforming the IFMSA, just like any other international organization, takes time and understanding, but importantly a collaboratively effort by all.

It was not too long along that I experienced something similar in my country. The US was experiencing a whirlwind of emotions during the 2008 elections. The country was facing a time of uncertainty, great challenges and exploring unchartered territory–but more than anything the spirit of the country was that we were hopeful, we were hopeful that change would bring our nation to a better place.  We were hopeful and we took a leap for a new America by electing President Obama. [Audience responds–Yes, we can]. (Shared personal story about the night of elections—the energy in the room, in the country, as we all watched for the results.)

 

While we have already overcome the birthing pains of the reform process, now we have to work towards its full realization and ensure that a renewed IFMSA is born. This is the responsibility that we have assigned ourselves, and this is a responsibility that our generation will not shy away from.

As we move forward, we should approach this process with courage, understanding and an open mind. Think outside the box.

Challenge ourselves to imagine the IFMSA we want without any limitations and constraints.

We should use this opportunity to create together the IFMSA we want.

I strongly believe that, through respectful dialogue and with serious commitment, we can make a great leap forward in this IFMSA reform journey. While we may not be able to fully finish the whole reform process up to its smallest details – again, reform is a learning experience – we are certainly expected to lay down strong foundations and fix critical control knobs that will ease the path towards full reform in the next few years to come. This will already be an enormous achievement and an invaluable contribution to the next IFMSA generations.

 

Meanwhile, although we are just about to start, I cannot help but already thank everyone who made this GA a possibility.

 

Thank-you to PAHO and Dr. Etienne.
Thank-you to PAHO and Dr. Etienne.

In behalf of the Federation, I wish to convey special thanks to you, Dr. Etienne, for gracing our General Assembly. Your presence is indeed a testament of WHO’s commitment to meaningful engagement with young people and future health professionals towards achieving health for all.

Even before the GA begins, the discussions have already begun. The lead up to this GA has already been encouraging. IFMSA members are motivated and inspired. Let’s continue the momentum that has been built, and I encourage each and every IFMSA member present here in Santiago to embark on this five-day journey with the rest of us. Don’t leave Chile without leaving an imprint on IFMSA’s future.

 Untitled

Together, let us make this General Assembly a huge success and a historic moment for our Federation.

 

Together, let us ensure that the Federation that emerges from this reform process is, borrowing the post-2015 agenda’s catchphrase, the IFMSA we want.

 

Together, let us be the generation that, with dynamism and optimism, with unity amidst diversity, will create a better future for the world’s medical students to reach our communities for better health. 

 

Thank you.

 

Roopa Dhatt

IFMSA President 2012/13

IFMSA Team of Officials 2012/13