Right Not To Be Offended?

This post represents a return from a blogging hiatus (both personal and professional), during which I've had the lucky opportunity to switch jobs.  After 2.5 years in my university's IRB office, I've moved over to work as a research administrator in a lab on the same campus.  I'm excited about the opportunity to get back to blogging and hopefully make this a more developed reference for others interested in IRB issues!

So as a person who works around ethical issues on some days (on many others I work around practical operational issues like, "Why can't I access the online survey?!?"), I keep up with some random blogs out there.  Today, I read an interesting blurb on Practical Ethics, a website I sort-of read but which doesn't usually seem so "practical" to me. (It's practical compared to some of the Great Big Ethical questions though.)

The author purports, in a really open and fairly engaging fashion, that people do not have a right to not be offended.  Basically, there's no right that you can assert to tell people that they can't be mean to you.  Now, that's interesting in the sense that there are freedom of speech issues and implications for things like hate crimes (i.e., there is a "practical" part of this ethical exercise).  So if I do have a right not to be offended, then that means someone else does not have the right of free speech - they don't have the right to, as the author suggests, say "Oy pigface! You smell like a rat’s backside!" (It's a British website.) If I don't have the right to be not-offended, then is there any defense of a victim of hate-speech against the attacker who is just basically be offensive?

Now, why am I posting this on my IRB blog?  I think there's an implication to this discussion for a lot of social behavioral (SB) IRB work.  Often, SB IRB's are accused of putting up silly road blocks to research in the name of protecting subjects from minimal risk surveys.  Sometimes this takes the form of IRBs arguing that subjects have a right not to be bothered - which can limit recruitment avenues like cold calling if someone decides that cold-calling violates that right to be left alone.  Sometimes this takes the form of hyper-concern about study topics that might be offensive or disturbing to some of the subjects.

There are solutions to each of these issues, but as with all IRB-concerns, these solutions require people on both side of the table to be open to working together.  And that means that both sides of the table need to be able to talk in the same language and from the same place of concern.  Recognizing that an IRB member or administrator is concerned about violating a "right not to be offended" is important when trying to convince them that cold-calling is acceptable or that a topic is not radical or offensive for a subject population. Since that right is sometimes thought to be an integral component of the respect-for-persons ethos that IRBs uphold, an informed researcher (or research administrator that a brilliant and well-funded researcher has hired to deal with the IRB *cough, cough*) can help keep those lines of communication open by probing to discover what exactly the IRB member considers that "right" to entail.  There are also opportunities for actual research (or use of already conducted research) on what the "everyday" experience of individuals is - is cold calling normal in the age of cell phones and do not call lists?  Remember, IRB members make decisions based on their experience in the absence of facts provided by researchers. I'm not saying that providing those facts will necessarily change their minds or force their hands, but it can provide a starting point for a discussion on what rights are actually part of the "real world" for the subjects.

Personally, I think I would have to say that I don't believe an IRB has a responsibility to enforce a right not to be offended in order to satisfy respect-for-persons.  Respect-for-persons also means respecting the rights of individuals to act as free thinking adults, capable of making decisions when presented with complete information. Heck, that ability is one of the foundational principles in the doctrine of informed consent! In DHHS IRB regulations, IRB's are mandated to minimize risk (45 CFR 46.111(a)(1)), not eliminate it.  The same regulations define minimal risk as meaning "the probability and magnitude of harm or discomfort ... are not greater in and of themselves than those ordinarily encountered in daily life." (45 CFR 46.102).  I think here are some risks of offense inherent in everyday life and that IRB's have a responsibility to ensure that researchers are held to a standard consistent with the subjects' everyday experience.  For a cold-calling recruitment plan, this could include keeping an eye on the max number of calls in a certain period, the type of message left ("Hi, This is Beth from XXX University." vs "Hi, This is Beth, with the AIDS clinic at XXX University."), the existence and use of a "do not call" list for a department or lab, etc.  

There are alternate ways of thinking about this issue though.  Perhaps researchers have a fiduciary duty to take care of subjects (as has been suggested by some courts) beyond the care we extend to others in everyday life - and this might even include respecting the right not to be offended.  Perhaps researchers just owe more-than-common courtesy to individuals whom they are asking to volunteer to provide data for the researcher's study.  Either of these could justify the enforcement of a "right not to be offended" under the umbrella of respect-for-persons.

Edited to add this link: I know I didn't talk much about it, but maybe researchers should be held to a higher standard than "everyday" life when we talk about minimizing risk.  In the "real world" businesses don't have an obligation to minimize risk, so maybe that's the reason a right not to be offended should be part of an ethical study design? Prompted by a quick post over at Global Bioethics.

PRIM&R Webinar: Preparing the Certified IRB Professional (CIP(R)) Certification Exam

On Wednesday, I attended the PRIM&R Webinar "Preparing the Certified IRB Professional (CIP(R)) Certification Exam: What You Need to Know."  I took the exam this year in March and received my CIP designation, but I wanted to attend to see how relevant the advice was for my coworkers who qualify to sit for the exam this Fall and next Spring.  Info about the CIP program itself is available on the PRIM&R website  (check out the demo info or the FAQ), but there are some basics below and a summary of what I thought about the test in March and the webinar today.

First, a little about the CIP...the certification of IRB professionals is part of a credentialing process.  The CIP is for people "whose primary job responsibilities include substantial participation in overseeing, administering or performing the daily activities associated with an IRB." (quote from the webinar)  After two years of relevant IRB experience (and a bachelor's degree or higher; it's three years without the bachelor's degree), an IRB administrator can sit for the CIP exam.  The exam is offered twice a year in a testing center.  If an individual passes, they get to promote themselves as a CIP.  There is a renewal process every three years in order to maintain the distinction.  There are currently ~1360 CIPs out there.

Now, a little about the webinar on May 25...the webinar's purpose is to provide some of that overview information and then some strategies on preparing for the exam.  The webinar was hosted by PRIM&R and conducted by Susan Delano, CIP (Chair of CCIP, the organization in charge of the CIP program) and Jaime Arango, EdD, CIP (Asst. Director of education for human subjects protection, CITI program, University of Miami).  I met Susan Delano on the elevator at the April PRIM&R SBER Conference in Boston when she asked me about my CIP pin (I was so excited to wear it for the first time!) and from that 5 minute conversation, I can assure you, she is very enthusiastic about the CIP program! She led the discussion about the what, why and how of taking the CIP test. It felt a little bit like a sales pitch at the beginning, but since I got my CIP for all the reasons she mentioned (personal development, confidence, as part of a job qualification and to become part of a community of CIPs), I can't complain. Jaime Arango got on the line to talk about his experience in preparing for and taking the test and to impart some of his wisdom about adult education strategies (note cards, no cramming, studying with a mentor or a group, etc.)  Overall, the webinar was well done - the right information from the right people and for the right length of time (60 minutes.)

About the advice they actually gave...I agreed with most of it and wish I'd thought about some of those solutions and references myself!
What I agreed with:

• When reading the questions, don't imagine facts that you aren't given! Just read the question as written and trust that you have all the information you need to answer that question.
• Consider using some online free trainings as part of your study prep.  CITI is free for PRIM&R members, and the NIH Bioethics Webcast is free to anyone.
• Give yourself plenty of time to prep.  Studying can help you refine your everyday practice as an IRB professional; start studying early and give yourself time to figure out how the concept you are studying can be incorporated into your everyday work.  Not only will this help you remember it better, it helps immensely on the scenario questions.
• Know the regs, but also know the other guidance material (like CIOMS, ICH E6, FERPA, PPRA, GINA, etc.)
• Use the power of your peers - join the LinkedIn group, use IRBForum.org, read Ampersand (PRIM&R's blog).  They mentioned using the Facebook group and I cannot agree more strongly that this group was helpful in not only giving me knowledge but in helping me feel confident that I could pass this test.
• Use books and journal articles to shore up your knowledge.
• Study other IRB's policies and procedures.  Jaimae Arango mentioned that he started by reviewing the OHRP determination letters and then looked at the current policies and procedures for those groups.  I know that a lot of my knowledge came not from studying, but from two years of benchmarking different policies in our organization by consulting those very sources.

What I didn't agree so strongly with:

• It's hard to "disagree" with this, but I do personally wonder if the "best practices" style questions are appropriate sometimes.  My IRB tends to push towards using the regs for most efficiency - determining exempt status whenever possible, suggesting waivers of documentation to investigators whenever they might qualify, etc. - so our best practices might be a little more aggressive in these areas.  It's hard to say that an exam is designed to test at the national or transnational level and that it is not to cater to local norms, but then ask best practice questions.  I appreciated hearing about the local item review sessions that help establish the answers to these questions, but I also wonder how someone who is the only IRB professional working with a small group can be expected to know (and agree with) "best practice" at a larger institution. On the other hand, there are 240 questions and even if those are difficult, there is ample opportunity to pass the test.
• I have yet to talk to anyone who took the March 2011 exam who felt the practice exam was worth the extra $50.  It might help the really nervous, but since the results don't include specific feedback, it can (and has) made many people more nervous rather than less.  I say avoid it and use the free Facebook group to test yourself instead.
• The CIP Handbook for Candidates is a great starting place, but I wouldn't suggest limiting yourself to only those topics.  For example, I don't remember seeing anything about GINA in the Handbook I downloaded, but it made up at least 4 questions on the exam.  Fortunately, I use that in my everyday job, so it wasn't a problem for me.  If there's something you or a study buddy use at work regularly that you don't see on the list, don't just ignore it.
• The recommendation to read the FDA regs didn't resonate with me.  I deal primarily with OHRP regs and only a smattering of FDA in my job.  I read through the FDA regs years ago when I was working at a commercial IRB, but I felt like the best study prep for this exam was using the Bankert & Amdur book and the study guide, rather than just reading and re-reading the regs themselves.

Overall, it was a very well put together webinar, and I would have appreciated this advice myself when I was making my study plan in January.  I still think the most important thing anyone can do though is find someone to study with - and the Facebook group that Andy Burman works with is a fantastic place to start.

What's It All About?

In my opportunities to attend national training events and conferences, I've realized how lucky I am to work in an office full of smart, talented and driven research ethics professionals.  I've always been able to turn around and talk to an office mate when a thorny regulatory issue comes up or when there's a researcher (or department full of researchers!) particularly resistant to some action that I or the IRB has taken.  When I was studying for my Certified IRB Professional exam, I was able to network with a great group of other professionals looking for support over a Facebook group created by PRIM&R and that was invaluable in helping me prepare for the exam and feel less alone while doing so. I'm hoping this blog can become something valuable in the same vein - not only a place for me to discuss issues that come up in my day-to-day work, but also a place to collaborate and discuss for those IRB professionals without a local network of helpful and supportive colleagues.

I've maintained a personal blog for a few years now and love how this forum fosters conversation.  I've also been an avid follower of many health and fitness blogs over the years and seen how they are able to use this format to collect and disseminate information about topics that interest people all over the world.  Deep down inside, I'm an IRB-nerd.  I love working in the field that I do and the challenge in operationalizing the idea of "protecting subjects" in everyday, real world situations.  (Well, "real world" to me means an academic institution, so that may be a little further away from "real world" to you.)  I hope that enthusiasm carries over into this blog and that it might help support that enthusiasm in others!