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Of Citizen Science, Ethics, and IRBs – the view from Science Online

The views expressed are those of the author and are not necessarily those of Scientific American.


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The "Unconference"

I had the wonderful opportunity to co-moderate two sessions at this past week’s Science Online “unconference” in Raleigh, affectionately known as #scio13. Sessions are proposed and moderated by volunteers, and there is a broad range of attendees, leading to rich discussion…and lots of fun.

#SciOctopus & Karyn Traphagen captured by Russ Creech

 

There were three sessions devoted to different aspects of Citizen Science. We met in cyberspace and then via a Google hangout for initial planning, then planned more details within our own session. I worked with Kelly Hills (@rocza), a woman whose energy and youth belie a wealth of diverse experiences. Our focus was to discuss “What happens when citizen scientists start doing research outside the scope of institutional review boards, medical ethical committees or institutional animal care and use committees?”

Kelly and I first struggled to define “Citizen Science” (#citsci) vs. “DIY” science and the maker crowd. Kelly describes our discussion well in her post, The Difference Between Citizen and DIY Science. From our discussions and review, it appears to us that “Citizen Science” is generally affiliated with an institution, and receives funding, support, and guidance from the mother ship. Most appear to be related to natural history or astronomy. A prime example of this would be the Cornell University’s Great Backyard Bird Count, which enlists community volunteers to help with scientific observations.

In contrast, the DIY enthusiasts are generally independent and are more likely to be unaffiliated with any formal institution. They are more often the mavericks, and may be unaware of either ethical concerns or some of the potentially troublesome implications of some of their research—or what kind of deep trouble they might find themselves in.

A couple of basic questions came up:

When do you need an ethics review?

There is a simple answer—any time human subjects are involved in research. This applies not only to direct interventions with people, but also to the use of any data or samples that can be linked to an identifiable living person? (i.e., privacy concerns, see HIPAA).

Unfortunately, the current system for research review was designed with the presumption that all research is done in academic centers or similar research institutions, via the “Institutional Review Boards” (IRBs).

Dr. Caren Cooper (@coopsciscoop) stressed the importance of proper animal care–humane and regulatory aspects–as well.

How can #citsci or #DIY explorers learn about ethics and the responsible conduct of research?

Fortunately, there are many resources now available for self-study, as well as courses. These include:

What kind of ethical review or oversight can or should be available to those not affiliated with a university?

Clearly, there can be considerable debate as to what kind of oversight should be available—while many of us cringed at the idea of a “DIY” IRB or ethics review, both institutional and commercial IRBs have had conflicts of interest and their own lapses in oversight. (e.g. University of Minnesota and the Dan Markingson case, Coast IRB, Texas Applied Biomedical (TAB) Services IRB and Celltex).

One of the problems is that IRBs generally charge on the order of $2500 for their review and seal of approval—something clearly impossible for many individuals or small groups, or for students looking to explore research. And many such researchers have no access to an institution or university. While many researchers might have no intention to publish results formally, they encounter problems if they try—access to publishing in most journals requires that the research received IRB approval. (Bastian Greshake and the OpenSnp group have reported on this here.

While we cringed at the talk of a “DIY” ethics group or IRB, it turns out that it is not hard to set one up—and a call to OHRP revealed that there is no fee and the process can generally be completed in less than 3 weeks. Instructions can be found here and more background regarding regulatory requirements are  in the Code of Federal Regulations 45 CFR 46.

Dr. Holly Menninger (@DrHolly) also noted that there are guidelines for non-institutionally affiliated researchers.

We will continue the discussion regarding Citizen Science and Ethics, and explore the possibility of providing research support (IRB and education) via an association. Please contribute to the discussion on the Science Online wiki.

Further recommended reading:

DIY Science, Art, Biotech Hackers, and Citizen Science and Research
- The Rise of Citizen Scientists and Patient Initiated Research by Kent Bottles, MD
- DIY Biotech Hacker Space Opens in NYC by Dave Mosher (Wired coverage of Genspace)
- SpotOn NYC: DIY Science – Bringing Biotech Home by Cathal Garvey (Nature SpotOn guest editorial)
- Critical Art Ensemble: Biotech
- Eduardo Kac: multimedia, communications, and biological artist. Bio Art projects.

And as Kelly noted, “When Things Go Bad, They Can Go Very Bad
Think nothing can go wrong when doing DIY science, art, and general extra-institutional experimentation? Oh, think again…
- Steve Kurtz and the Critical Art Ensemble

Credits:

Special thanks toBora Zivkovic (@BoraZ), Anton Zuiker (@mistersugar), Karyn Traphagen (@kTraphagen) for making the awesome ScienceOnline conference possible, to Kelly Hills, my dyanamic co-moderator, and to the other Citizen Science moderators and attendees, for great discussion and provocative questions.

“Molecules to Medicine” banner © Michelle Banks.

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Judy Stone About the Author: Judy Stone, MD is an infectious disease specialist, experienced in conducting clinical research. She is the author of Conducting Clinical Research, the essential guide to the topic. She survived 25 years in solo practice in rural Cumberland, Maryland, and is now broadening her horizons. She particularly loves writing about ethical issues, and tilting at windmills in her advocacy for social justice. As part of her overall desire to save the world when she grows up, she has become especially interested in neglected tropical diseases. When not slaving over hot patients, she can be found playing with photography, friends’ dogs, or in her garden. Follow on Twitter @drjudystone or on her website. Follow on Twitter @drjudystone.

The views expressed are those of the author and are not necessarily those of Scientific American.





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