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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