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Summary: IRBs and Alcohol Research |
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| Posted by: | Scott Eidelman |
| Title/Position: | Assistant Professor |
| School/Organization: | University of Maine |
| Sent to listserv of: | SPSP |
| Date posted: | July 18th, 2005 |
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Dear Colleagues,
A few weeks back I requested help regarding some difficulties I was having with my institution’s IRB. The difficulties concerned a proposal to conduct field research involving alcohol. I wished to ask those leaving bars to fill out a 7-item survey and blow into a breathalyzer, after obtaining verbal consent.
My IRB raised three concerns: I might have a legal/ethical responsibility to participants if those who I knew were drunk later hurt themselves or others; I might somehow be responsible if a participant was under 21 years of age; and that I couldn’t really obtain informed consent if participants were drunk.
Thanks to everyone who offered opinions, advice, and encouragement (special thanks to Tara MacDonald, Tim Lawson, and Don Forsyth, whose comments were particularly thorough). I’m pleased to report that my project is now approved, largely due to these thoughtful responses. Below I summarize these responses, and note how my IRB’s concerns were eventually met.
Legal/Ethical Responsibilities
More than one person suggested that my project fell under guidelines outlined by the Belmont report, and its principles concerning “Beneficence” (see http://ohsr.od.nih.gov/guidelines/belmont.html#gob2). However, others indicated that IRBs should consider only those risks associated with the research itself, and not activities a potential participant was involved with prior to (or following) my research (see http://www.hhs.gov/ohrp/irb/irb_chapter3.htm#e1, and in particular, the section on Identification and Assessment of Risk).
Two people suggested that I check with an attorney to find out what my legal responsibilities might be (according to my university’s attorney, in Maine I have none beyond the usual/possible civil liabilities...)
Many found it ironic that i was being told my procedure was considered problematic even though it might prevent folks from driving drunk (by delaying them, providing BAC information, informing them of alternatives, etc.)
Many possible solutions were suggested: that I send participants home in paid cabs, or take advantage of local safe-ride programs; that I have research assistants drive participants home; that I conduct my research inside (and under the auspices of) the bar; and that I somehow screen participants.
My IRB and I eventually agreed on a screening procedure. All patrons will be asked two questions – how they got to the bar, and how they planned on getting home. If the answer to either question was “drive,” they become ineligible for participation (thanks to Tara MacDonald for this excellent idea).
Underage Drinking
Some respondents noted that age limits are statutory, and not a function of ethics. Others suggested a “Don’t ask, don’t tell” policy. My IRB agreed to this policy.
Informed Consent
A few respondents suggested that I obtain consent before patrons enter the bar, catching these same people on their way out. Many of these same respondents noted that this could make for a long night.
Others suggested that I give patrons a short test of cognitive impairment. Another suggested that I ask for the emails of those participants who’s BAC was over a certain number (say .10), and contact these people at a later date asking for their consent when sober. Similarly, it was suggested that I obtain contact information for everyone in the study, and later contact them with the opportunity to rescind consent.
My IRB agreed to a similar procedure. All participants will be given a referral card with an ID number and my contact information. This card will ask participants to contact me if they decide to rescind consent.
Other comments
Most (though certainly not all) thought my IRB went well beyond their purview, and I quickly sensed that I was not the only one with IRB woes.
One very helpful comment that I received was the reminder that IRBs balance benefits against risk, and that it is therefore extremely important to make clear the information/beneefits one’s research will yield.
I should also note that two respondents raised concerns regarding the safety of research assistants. Of course, both the IRB and I shared this concern. Our solution: three research assistants will always be present during data collection, and an “exit strategy” is in place should an altercation arise. It's worth noting that others who conduct this type of research mentioned one persistent problem: drunk men who flirt with female RAs.
Thanks again for everyone’s help and interest!
Scott Eidelman
University of Maine
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