Thursday, March 5, 2015

#TBT: Looking Back at the 2005 IACUC Conference

With the 2015 Institutional Animal Care and Use Committee (IACUC) Conference rapidly approaching, our staff is busy getting ready to welcome more than 600 professionals from across the fields of animal care and use and research ethics to our hometown, Boston, MA. Amid all our planning, we found ourselves wondering: How has the IACUC Conference changed over the years? The conference is always a great opportunity to learn about the latest insights, best practices, and challenges in the field, but how have those transformed in recent years?

We dug into our archives to look at the 2005 IACUC Conference and found some interesting comparisons:

  • Managing efficient and effective IACUC programs remains one of your top concerns, as both the 2005 and 2015 IACUC Conferences have plenary sessions devoted to the topic. In 2005, we looked specifically at “doing more with less” and the question of managing an effective program while balancing resources. This year, our first panel explores self-imposed regulatory burden, focusing on strategies for improving IACUC efficiency and reducing burdens on researchers. 
  • Sessions on nontraditional species were rare, but important, in 2005. Sessions explored IACUCs and birds, fish, reptiles, amphibians, and field studies. We know these topics continue to be relevant to your work, and this year we've built a new "Not Your Average IACUC" track for sessions that focus on research with nontraditional species, or uncommon situations. From protocols using wild species and laboratory aquatics oversight to large animal models and challenges for smaller organizations, we hope to cover these topics in greater depth through this new track. 
  • A final highlight of the 2005 IACUC Conference was the introduction of our poster presentations. The 2005 conference included poster abstracts, exploring research topics of Fear, Anxiety, and Stress in the Laboratory; Novel IACUC Outreach Efforts to Facilitate Animal Protocol Submissions; and Developing an Integrated Post-Approval Auditing Program for IACUCs Focusing on Assessment, Trending, Education, Auditing, and Adjustments. Our poster presentation program has grown substantially since 2005, and members can learn more about past poster abstracts in our Knowledge Center!  

As you can see, the conference has changed in meaningful ways over the past 10 years. Some areas of interest have expanded, and we continue to recognize the importance of communications, efficiencies, and collaborations in the success of your IACUCs. What will the next 10 years hold, for both the IACUC Conference and the field at large? Share your predictions in the comments, and visit the 2015 IACUC Conference website to learn more about this year’s program and how to register.

Tuesday, March 3, 2015

The Need to Do What is Right: An Interview with Bruce Gordon

by Caroline Slymon, executive coordinator

In January, PRIM&R welcomed two new members to its board of directors, including Bruce Gordon, MD. Dr. Gordon is professor of pediatrics in the section of pediatric hematology/oncology and stem cell transplantation at the University of Nebraska Medical Center (UNMC). Dr. Gordon has been a member of the UNMC institutional review board (IRB) since 1992, served as chair since 1996, and served as executive chair since 2011. He also organized, and is first chair of, a joint pediatric IRB with the Children's Hospital and Medical Center in Omaha. He has served on a variety of national committees and task forces, including the Secretary's Advisory Committee on Human Research Protections Subpart A Subcommittee, and the National Cancer Institute Pediatric Central IRB, where he served as its first chair. Dr. Gordon has been a faculty member at PRIM&R's regional and national conferences, served as the planning committee co-chair for the 2009 Advancing Ethical Research (AER) Conference, and is the author of numerous papers, review articles, and abstracts regarding human subjects protections and research ethics.

I recently had the opportunity to speak with Dr. Gordon about his experiences in the field as well as his involvement with PRIM&R.

Caroline Slymon (CS): When and why did you join the field?
Bruce Gordon (BG): I was an assistant professor at the University of Nebraska and did not even know what an IRB was. Ernie Prentice called me to let me know that they needed an oncologist on the UNMC IRB and persuaded me to sign up. I agreed to serve for one year, and here I am twenty years later.

CS: What skills are particularly helpful in a job like yours?
BG: I was raised in New York City, and no one has ever suggested that I am quiet. I find that this is an asset for an IRB chair. It is also important to be able to both have your own opinions and see other views. Being good with people, as well as organized, also help as an IRB chair.

CS: What motivates you to maintain your commitment to advancing ethical research?
BG: Justice, the need to do what is right, has always been a value to me and my family. This work is my way of serving that value.

CS: Tell us about one or more articles, books, or documents that have influenced your professional life.
BG: I'm fascinated by the simplicity of all seven clear and lucid pages of The Belmont Report. I also love history, and I learned an incredible amount from Susan Lederer's Subjected to Science.

CS: Have there been any PRIM&R events or talks that you have attended that have significantly impacted your approach to your work? If so, what were they, and how did they influence you?
BG: PRIM&R's annual Advancing Ethical Research Conference consistently makes me consider what I am or should be questioning. I've learned to question what I think I know, and I've learned that there are valid viewpoints other than my own.

CS: What is one thing you wish the general public knew about human subjects research?
BG: It is not a competition. Nothing is all good or all bad, and neither are people. There is a need to be cognizant of bad things in research, but also to be aware of its tremendous benefits.

CS: What challenges do you see ahead for medical research in general? Any ethical challenges in particular?
BG: I think we should be looking at that which does not fit into our paradigm. Coming down the pike, there are things that we do not know how to approach. I see big data, healthcare system research, QA/QI research, and research on the edge among these challenges.

CS: What advice do you have for young professionals interested in pursuing a career in research, research ethics, and/or a related field?
BG: This is a communal experience, and you must work with other colleagues. You also have to love what you do. You have to wake up in the morning and want to go to work. Success and productivity come from liking what you do.

CS: Why did you agree to serve on PRIM&R's Board of Directors?
BG: PRIM&R stands for the things that I feel are important in life. The opportunity to serve this organization is such an honor. I'm excited to be given the opportunity to shape the field as well as serve an organization that I really respect.

CS: What advice have you found most helpful in your career?
BG: My father told me once, "Never attribute to malice what you can just as easily attribute to stupidity." We must help people think the right way and help researchers who are pursuing good, quality research protect their subjects.

Thank you for sharing your story, Bruce. We are so thankful for all of your contributions to PRIM&R and to the field.

The complete 2015 Board of Directors roster is available on our website.

Friday, February 27, 2015

Research Ethics Roundup: The Return of Psychedelic Research, Organs on a Chip, and More

This week’s Research Ethics Roundup highlights ethical issues related to clinical trials studying the psychedelics, as well as moves toward making research more efficient, innovative, and transparent.

The Trip Treatment: Author and journalist Michael Pollan reports on the reemergence of research on psychedelics. In this article from The New Yorker, Pollan shares stories of participants and their experiences in clinical trials studying the psychedelic psilocybin.

Clinical-Trial Specialist Could Be Next FDA Chief: In this article from Nature, journalist Heidi Ledford provides background on Robert Califf, who was recently appointed a deputy commissioner at the Food and Drug Administration (FDA). There is speculation that Califf will be named as the next commissioner for the FDA, following the departure of Margaret Hamburg.

Research Misconduct Often Goes Unreported In Published Studies: Ed Silverman of The Wall Street Journal discusses issues with transparency and underreported cases of research misconduct in published studies. Silverman also explores the role of the FDA in disclosing allegations of misconduct.

Young Scientists Lead the Way on Fresh Ideas: In this article from Nature, journalist Ewen Calloway discusses new research by economists Mikko Packalen and Jay Bhattacharya of the University of Waterloo in Canada that suggests that younger scientists are more innovative than older scientists.

Reducing Animals in the Lab One Chip at a Time: Editor-in-chief of Laboratory Equipment Magazine Michelle Taylor reports on efforts to reduce the need for traditional animal studies by implementing new methods for evaluating drug safety. Highlighted in the article is Donald Ingber’s work on the development of organs-on-chip, "which allows researchers to recreate the physiological and mechanical functions of the organ, and to observe what happens in real-time."

Thursday, February 26, 2015

When is it Unethical Not to Engage in Research?

by Anne Meade, MS, PMP, Senior Manager for Website and Social Media  

For its February Question of the Month, PRIM&R’s People & Perspectives  program wants to know why you think collaboration is important.

Need inspiration? One thing to consider is how you approach conflicts of interest at your organization. Can you consider these as opportunities for convergence, as opposed to simply conflicts of interest? Instead of seeing a conflict of interest as a means of discontinuing research, take it as an opportunity to collaborate to execute the research.

For more on this topic, watch the following People & Perspectives interview, in which Ann Bonham, PhD, chief scientific officer at the Association of American Medical Colleges (AAMC), discusses the value of true partnership between the major stakeholders in research.

Dr. Bonham emphasizes that acknowledging conflicts of interest is not merely "checking the box"—one also has to think about ways to move research forward if there is significant financial conflict of interest. It may not be ethical to form a partnership because of a conflict, but when is it unethical not to partner and move the research forward?
“Let’s elevate the discussion that finances [are] one part of it, but there are lots of other parts of it. It’s not asking, ‘This is not ethical so let’s not engage in research.’ Let’s ask ourselves how to put that into context, and also ask ourselves when would it be unethical for us not to engage in partnerships to do the research. And to me that’s the crux of the principled partnerships: thinking about the ethics of not doing it and the ethics of doing it.”

Watch the full video.

How do you handle opportunities for convergence of interests, and how are those opportunities important for collaboration? Respond to the Question of the Month on the People & Perspectives website, or share a comment below.

Wednesday, February 25, 2015

Opting Out: Who’s Protecting Human Research Subjects Online?

by Anita Pascoe, MS, CIP, project coordinator at Intermountain Healthcare

Time has flown by since December’s 2014 AER Conference. The holidays came and went, and, believe it or not, spring has announced its extremely premature arrival here in Salt Lake City. Two months post-conference, I am, however, still contemplating several of the key themes discussed during the four days in Baltimore. Topping my list of memorable conference moments is John Wilbanks’ keynote address, which hit home for me on a personal as well as a professional level.

Wilbanks noted that the nature of our global research enterprise has forever been altered because of the widespread use of mobile technologies, which enable easy and inexpensive access to myriad amounts of data. PRIM&R as a whole clearly agreed, as several other conference sessions were dedicated specifically to addressing issues related to the exponential growth of real-life, real-time data collection enabled by mobile technologies.

One of Wilbanks' most poignant points, however, was his description of how our contemporary culture endorses the practice of blindly clicking "I agree" or "OK" to online user agreements or disclosure documents without reading so much as a single word. Hence, Wilbanks concluded, cheap data amassed daily by modern technologies intersects with efforts to protect consumers from potential risks and harms, which in turn also ends up being a concern for researchers.

As I mentioned in one of my posts during the conference, I recently acquired my first smartphone. Wilbanks' remarks therefore had particular impact on me. I had never focused any personal attention on the phenomenon of "blindly agreeing" online. Now, smartphone in hand and fresh from the 2014 AER Conference, I decided I would pay attention to offers and requests I received to see if the problem really is as widespread as Wilbanks claimed. Since then (early December), I have received and accounted for 198 invitations to download free apps, 102 games, and hundreds of commercial solicitations, coupon offers and "specials." I am simply stunned by the sheer volume of unsolicited "stuff" that comes my way every day. When did I consent to receiving any of it? I haven’t a clue.

From an institutional review board perspective, informed consent is a pillar of a human research protections framework. If, as Wilbanks suggested, our current data protection infrastructure is indeed no longer efficient or adequate in this era of online apps and big-data, how can we retool, restructure, and revamp our current practices to better fit our current situation?

I am personally favoring the notion of going back to using a "dumb phone" to stop the incessant bombardment of data. But I know the suggestion of rolling back technological advances like some anti-Internet Luddite is not the answer. My tech savvy son says I just need to "delete some junk, change my preferences, and set my filters." That might be the answer for my phone, but who and what is out there to protect potential human research subjects in a world where the default is now "opt in” not "opt out?"