Granting research participants access to raw data

[Jason Bobe]

It seems strange to me that most research studies today simply refuse to make raw data available to the human subjects who enroll in those studies.  Sometimes researchers attempt to purposefully design "memory holes" and other obfuscation, so it is difficult to figure out which data belongs to which volunteer, etc.  

With the rise of citizen science, improved computing, decentralized access to sequencing and other tools, it seems inevitable to me that this set of institutional practices will eventually go away, or be reserved only for special cases rather than be the standard operating procedure.  

One way to hasten the decline of data hoarding and accelerate its liberation is for more people to request access to raw data and to vote with their feet by favoring studies with equitable research practices.  There are several "large cohort" studies in the planning stages, like the Genome 100k in the United Kingdom or the million veterans program in the US, that hope to enroll and perform genome sequencing on many thousands of citizens.

The Wellcome Trust Sanger Institute in the United Kingdom launched a public survey that will inform policy on how genome studies in the UK are governed.  If you have a minute, even if you don't live in the UK, please take the survey and express your favor for access to raw data:

https://survey.sanger.ac.uk/genomethics/

Hopefully that doesn't dissuade you from getting involved, but...To give you a sense of how hopeless activism on this issue can be at times, consider the million veterans project (mvp).  Back in 2009, they published a survey of veterans' attitudes about their participation in genomic research (much like the Sanger survey above).  Two major findings were that:

a. "Nine of 10 [veterans] agreed that they would want to know all of their research results"

b. "two-thirds of respondents said they would be less likely to join the study if they did not receive research results back"

So, mvp plans to return data to participants right?  Wrong.  As their FAQ states: "It will not be possible to give participants results of the blood tests"

Jason Bobe

[Jason Bobe]

On Friday, July 12, 2013 5:04:35 PM UTC-4, Jason Bobe wrote:

Hopefully this doesn't dissuade you from getting involved, but...To give you a sense of how hopeless activism on this issue can be at times, consider the million veterans project (mvp)...

On the positive side of things, activism has been effective with commercial DNA service providers so far.  For example, pressure from customers of Ancestry.com (mostly customers who were also vocal bloggers), motivated them to change their practices and make raw data available.

Jason

[Nathan McCorkle]

On Fri, Jul 12, 2013 at 2:04 PM, Jason Bobe <jaso...@gmail.com> wrote:
> It seems strange to me that most research studies today simply refuse to
> make raw data available to the human subjects who enroll in those studies.
> Sometimes researchers attempt to purposefully design "memory holes" and
> other obfuscation, so it is difficult to figure out which data belongs to
> which volunteer, etc.

Isn't that (at least some of that) built-in to ensure the
double-blindedness of the study?

> The Wellcome Trust Sanger Institute in the United Kingdom launched a public
> survey that will inform policy on how genome studies in the UK are governed.
> If you have a minute, even if you don't live in the UK, please take the
> survey and express your favor for access to raw data:
>
> https://survey.sanger.ac.uk/genomethics/

Will the data collected from that survey be open-access?

> So, mvp plans to return data to participants right? Wrong. As their FAQ
> states: "It will not be possible to give participants results of the blood
> tests"

But that doesn't /seem/ to be a choice they've made. Here's the rest
of the FAQ answer:
"Due to regulations under the Clinical Laboratory Improvement
Ammendments (CLIA), we are legally unable to return research results
to participants. Results from the blood tests will not be placed in
participants' electronic health record. Participants should discuss
any health concerns with their doctor or other health care provider,
who can arrange any necessary and appropriate tests."


--
-Nathan

[Jason Bobe]

On Friday, July 12, 2013 5:19:04 PM UTC-4, Nathan McCorkle wrote:

On Fri, Jul 12, 2013 at 2:04 PM, Jason Bobe <jaso...@gmail.com> wrote:
> It seems strange to me that most research studies today simply refuse to
> make raw data available to the human subjects who enroll in those studies.
> Sometimes researchers attempt to purposefully design "memory holes" and
> other obfuscation, so it is difficult to figure out which data belongs to
> which volunteer, etc.

Isn't that (at least some of that) built-in to ensure the
double-blindedness of the study?

no, blindness need not apply and it is does not apply to this observational study.  Double-blindness is applied in some clinical trials, especially for therapies.

> So, mvp plans to return data to participants right?  Wrong.  As their FAQ
> states: "It will not be possible to give participants results of the blood
> tests"

But that doesn't /seem/ to be a choice they've made. Here's the rest
of the FAQ answer:
"Due to regulations under the Clinical Laboratory Improvement
Ammendments (CLIA), we are legally unable to return research results
to participants. Results from the blood tests will not be placed in
participants' electronic health record. Participants should discuss
any health concerns with their doctor or other health care provider,
who can arrange any necessary and appropriate tests."

There are many excuses that researchers will be put forth as to why they are unable or unwilling . CLIA is one.

Jason

[ruphos]

The reason is generally a legal one. 23andme bypasses some of it with their "click here if you really want to know you have BRCA" checkboxes, but if the study is on say high cholesterol and the genotyping reveals a susceptibility to early onset Alzheimer's the company is often required to have that information relayed by a genetic counselor or face liability issues of someone claims emotional damages upon receiving that information. It's pretty fucked, but that's basically the back room discussion when the concept of data return is brought up.

Source: used to work for a project affiliated with a major research university where this was a concern. 

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