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What's in a name?

27 February 2012

By Ruth Saunders

Appeared in BioNews 646
In July 2011, the US Department of Health and Human Services (DHSS) announced its plans to improve the rules governing the protection of human subjects in research, after admitting current regulations were 'developed years ago'.

Some of the planned improvements included a clearer and more concise informed consent processes, and clarification on definitions of data privacy.

It noted that changes in human subject research 'highlighted ambiguities in the current rules', and questioned whether these rules were 'effectively keeping up with the needs of researchers and research subjects'.

Despite this acknowledgement, the DHSS hasn't quite grasped the challenges brought on by web-based genetic research. In its proposals the DHSS made no comment on the use of the phrase 'human subject' - the subject of the rights and the protections set out in the Common Rule, which sets federal-level standards of protection for human research subjects in the USA. It is designed to ensure that the consent of the subject is sought and that their privacy is maintained.

The term 'human subject' was introduced by the writers of the Nuremberg Code in 1947, and subsequently has been used in large numbers of international, professional and bioethical guidelines.

The Genetic Alliance was quick to pick up on this in its response to the public consultation, with president and CEO Sharon Terry saying: 'Individuals should be active and full participants in biomedical research. We eschew the word 'subject' and know that individuals are more willing to participate'.

Take the innovative research model introduced by the founders of openSNP.org. OpenSNP was launched by a group of life sciences students in September 2011. It provides a web-based platform for people to upload specific raw genetic data after having their genomes sequenced by the direct-to-consumer genetic testing companies 23andMe or deCODE.

With a social networking format, users have an online profile where they are also encouraged to upload their medical and lifestyle data. The openSNP team manually scan open access publications such as PLoS Genetics, to enable users to learn about any associations linked to this data.

Once uploaded, this data becomes publically available and can be accessed and downloaded by anyone from researchers and amateur geneticists, to friends and even nosy members of the public. In this sense it resonates with one of the functions of the Personal Genome Project, which makes the whole genome sequence data, alongside the medical and lifestyle information of its volunteers, publically available for unrestricted download.

As well as uploading data and learning about their genetic information, users are encouraged to create and take part in surveys to collect phenotypic data designed to be useful to researchers. As one of the founders puts it, the model of openSNP is to allow the 'crowd-sourced gathering of raw data to enable more research'.

User surveys range from colour blindness, lactose intolerance to eye colour and nicotine dependence.

To my mind, the term 'human subject' is unsuited to this type of user-generated research. It implies a certain passiveness on the part of the person who takes part in research. The 'human subject' merely has to agree or disagree to the terms of the research put before them.

The people who make up openSNP, however, actively engage in the research because they control the amount and type of data about them that is uploaded.

In light of these facts, revisions to the Common Rule fail to account for the growing, small, but significant, minority of the population who are willing to be actively involved from the bottom-up in genetic research.

Getting people actively interested in research projects is hard. In an age of Internet start-ups and recreational genomics, the Common Rule is perhaps part of the problem, rather than the solution.

SOURCES & REFERENCES
Genetic Alliance | 26 October 2011
 
HHS | 22 July 2011
 
OpenSNP | 
 

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