Open Access Tenure: Institutional Review Boards

A comment on a listserv about a rejected survey, submitted after completion for Human Subjects Protection review, prompted me to wonder about who of my librarian colleagues had gone through Institutional Review Board (IRB) or Human Subjects Protection training.

When I started at my current place of work, one of the first things Madame Department Head required that I do was sign up for IRB training. The initial training can be completed through a 3-6 hour online program or you can sit through a four hour marathon session with the trainer who is just across the street from my library. As those first couple of weeks were rather shy on meetings (how I envy those halcyon days), I opted for the four hour session.

Because I work for an ARL library, an R1 library, a library that supports a whole lot of research and a library that requires it’s faculty to do research, we often come up against the subject of human protection. The training was certainly  more engaging than I expected, told through case studies of things gone wrong and what protection is in place because of it. We also learned about research institutions who were found to be non-compliant with renewing their paperwork or making sure patients were given materials in their own languages by which they could give informed consent.  Non-compliance leads to thinks like a revocation of permission to accept grants to do human research, which could be a bit of a blow for a research focused institution.

Once this initial training was done, I am considered certified for two years. To get recertified, I need to get at least 2 continuing education hours within that two years to re-up.  The Office for the Protection of Research Subjects offers periodic training and, to ensure that all librarians were up to date, the library scheduled training specifically to get everyone’s certification renewed.  As I attended that renewal, I have another 18 months left–so I should probably set a calendar reminder for a year from now to make sure that I set time aside to update again.

Because I work in medicine, the chances of my being involved in something that will require human subject protection are higher.  While it’s unlikely that I’ll be assisting any of the professors in gathering data from patients, I might very well be doing their literature reviews and working on methods sections and whatnot.  And everyone who is involved is supposed to be current on their IRB, at the risk of the study being thrown out and unhappy PIs and grant funders.

However, I think Institutional Review Board/Human Subjects Protection training is valuable for the vast majority of librarians–those conducting research,  participating in research, or helping patrons.

Library literature is known for being full of surveys and listservs are frequently plagued with calls to fill out just a “quick short survey” that asks one to then write at length about personal experiences at places of work for 20-30 minutes and hopes one will submit these with name and email for follow up.  As I was pondering amongst my library friends as to who had taken IRB training, the question arose: who is minding human subject protection for school libraries or public libraries? Is someone reviewing those questions to ensure human subject protection and verifying that there is no potential harm? It isn’t that I expect harm from answering those questions, most of the surveys I’ve filled out were strictly  “Do you do x at your library yes/no” kind of things but some of the open ended questions could lead to potentially embarrassing revelations with repercussions if the survey was filled on with blatant honesty. Having a set of  non-librarian eyes review it the survey before it is sent into the wild world of social media prompts consideration of answers, alternatives, and potential survey effects.

For those who are not actively involved in conducting research, recognizing the need for IRB Review or Exemptions (most of the library research is reviewed and granted exemption from human research protection protocols as it is focused on straight forward work-related questions–but it is reviewed) and Human Subject Protection.  If you’re filling out a survey, it’s good to understand the review processes that a survey may or may not have received. If you’re helping patrons who are researching clinical trials to join, it’s certainly good to have understanding of what protections should be in place for the patron.

Are there any public librarians who have taken this kind of training? If so, where did you take it? I don’t recall seeing any offered at the public libraries where I worked.

If you are at an academic institution, even one that isn’t focused on research,  someone around campus should be offering it. I’d recommend sitting through it at least once to find out about what rules exist and finding out if there are any requirements that you should follow.

And if you want to collaborate with me, my place of work requires that everyone is covered by IRB and that review happens through our board, which means for at least one project I”m working on I have to get dual exemption–once from each institution.

 

 

3 Comments

  1. Comment by Courtney F:

    While IRB training is not required for librarians at MPOW (we’re a teaching university, not a research university), I was surprised to find it explicitly stated in our IRB documentation that “there is no study that is without risk to the subjects. The risk may be small and the consequences light, such as the risk of wasting an hour of your life, or the risk of adding an annoyance to an already trying day, but any intervention in someone’s life carries risk. Submitting research applications to the IRB requires the researcher to identify, assess, and take steps to manage this risk”.

    Although my IRB request is an expedited request because we’re doing only surveys and interviews, it changed my thinking when I read the paragraph above. And I think this gets overlooked a lot by those who are doing “quick surveys”. I tend to agree that librarians should know more about IRB and should submit IRB requests for approval whenever they’re doing surveys, whether there’s an intent to publish or not. It’s better safe than sorry, right? 🙂

  2. Comment by Abigail:

    Courtney,

    What a thoughtful paragraph! I can certainly think of some surveys that have been the annoying part of a long day 🙂

  3. Comment by Alan Schwartz:

    The IRB system is an important protection for human subjects, and there have been egregious abuses of research subjects in both medical and social sciences. That said, I (and many others) think it’s a mistake to characterize “wasting an hour” on an anonymous, voluntary survey with no traumatizing questions as a risk of any sort – it distracts attention from risks that are actually significant, and this is why such research is exempt from IRB review (although typically an IRB administrator must make a determination that the review is exempt, this is not the same as review by the IRB).

    It’s also important to recognize what “human subjects research” means. A “human subject”, in the USA regs, is “a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual; or (2) identifiable private information.” If I send a survey to librarians to obtain data about what they do, they are human subjects, because I am interacting with them to obtain data about them. If I send a survey to librarians asking them about their library (e.g., facilities or subscriptions), I am not collecting data about a living individual, and that is not human subjects research. At UIC, the investigator is still supposed to submit a short registration form to the IRB about the project (presumably so the administrator can quickly tell them that it really is human subjects research if they’re wrong), but the IRB has no oversight of such research. (“Human subjects research” also has to be “research”, which has a specific definition, but everything I’ve mentioned is research in this context.)

    USA HHS is actually considering significant changes to the Common Rule (see http://www.hhs.gov/ohrp/humansubjects/anprm2011page.html). One effect of these changes would be to drop even the administrative review for most exempt studies, replacing it with a registration approach, and instead being more specific about what is exempt and mandating better data security procedures, as the most significant typical risk (and this can be a real risk, not an annoyance) is loss of privacy/confidentiality.