Monday, October 20, 2014

Remembering Felix A. Gyi: A wise, generous, and kind leader

Felix A. Khin-Maung-Gyi, PharmD, MBA, CIP, RAC, an active and valued leader in the field of human subjects protections and proud family man, passed away on October 2, 2014.

A pharmacist by training, Dr. Gyi received a bachelor’s degree in pharmacy from the University of Maryland School of Pharmacy in 1983, and went on to receive his doctorate in the subject from Duquesne University in 1986. He also obtained a master’s in business administration from Loyola University Maryland (The Baltimore Sun).

Among his many accomplishments, Dr. Gyi founded Chesapeake Research Review LLC, an independent IRB, in 1993, and served as its CEO for more than 20 years. During his time at Chesapeake IRB, Dr. Gyi helped raise important questions about the growing role of central IRBs.

Dr. Gyi was also instrumental in the creation of the Certified IRB Professional (CIP®) credential. Gary Chadwick, PharmD, MPH, another of the credential’s founders, spoke to Dr. Gyi’s contributions: “He was one of the first persons I tapped to get the CIP credential off the ground back in 1999. I saw firsthand his dedication and extensive knowledge, which, when put with his easy going nature and great sense of humor and fun, produced outstanding results and spurred others to excel.”

Dr. Gyi also served alongside Gary Chadwick, Susan Delano, Marianne Elliot, Nancy Hibser, Moira Keane, Susan Kornetsky, Peter Marshall, Daniel Nelson, and Lucy Pearson as inaugural members of the Council for Certification of IRB Professionals. Ms. Delano reflected: “He could always be relied on for his sound judgment and in-depth knowledge of the complex regulations and guidance governing research involving human subjects. He demonstrated a deep commitment to the ethical conduct of research and the welfare of research subjects. His positive attitude, generous spirit and sense of humor were very much appreciated by his fellow Council members and the IRB community.”

Dr. Gyi also offered his expertise on issues related to human subjects protections to the Secretary’s Advisory Committee on Human Research Protections (SACHRP), for which he served as a member from 2003 to 2006. Later, he was also a member of SACHRP’s Subpart A Subcommittee, charged with reviewing and making recommendations related to the regulations found at 45 CFR 46 Subpart A.

Throughout his career, Dr. Gyi was a sought-after speaker both in the United States and abroad. His ability to capture the spirit of human subjects protections served as a passionate reminder to all about the importance of such work. At the 2013 Association of Clinical Research Professionals Global Conference and Exhibition, Dr. Gyi spoke on a panel  titled, “Should We Exploit Hope to Enhance Enrollment of Oncology Research Participants?”, about Nicole Wan, a 19-year old student at the University of Rochester who died as a result of her participation in a non-therapeutic research study. He lamented:
We failed Nicole because we didn’t stop to think about what was in her best interest. Would it not have been simpler if some nurse had said to the physician: ‘Doc, I’ve seen you do this [procedure] hundreds of times—this is particularly difficult. Let’s not distress the poor lady anymore; give her $75 and let’s call it a day.’ 
But, we didn’t do that, and I believe we failed because we were stuck on the culture of obtaining data, and, to use a phrase that the first [Office of Human Research Protections] director, Greg Koski, used early on in his career, we were stuck on [a] ‘culture of compliance.’ We did not shift to a culture of caring, or a culture of excellence, in a way that [would have allowed] us to do what we need[ed] to do in a societally responsible manner.
Dr. Gyi’s unique ability to elucidate the importance of human subjects protections has ensured that his legacy will endure. The countless individuals who had an opportunity to hear him present over the years were without a doubt struck by the dedication and commitment with which he spoke about human subjects protections.

“Felix was a tireless worker and supporter of human subject protection. He always made himself available for any organization or group that was trying to improve the system,” reflected Dr. Chadwick. Dr. Gyi will also long be remembered for his spirit and attitude, as Dr. Chadwick attested: “Felix was an absolute joy to be around–he always had a kind word and was supportive of family and friends. His generosity was boundless–he personally hosted many a dinner and reception for ‘official functions’ of organizations that didn’t have the funds to support this important professional networking or provide amenities.”

Immediately prior to his death, Dr. Gyi was elected to the PRIM&R Board of Directors. While Dr. Gyi was not aware that he had been elected to the board at the time of his passing, he was aware of his nomination and indicated that he was eager to contribute. The PRIM&R Board and staff were looking forward to welcoming Dr. Gyi to the Board, and we feel a deep the sense of sorrow that he will not be joining us come January.

Ethical, humble, and generous, Dr. Gyi was an extraordinary leader, whose impact can be felt in the way the regulations governing the conduct of research with human subjects are interpreted and operationalized throughout the research enterprise. He touched the lives of many in the field and his wisdom, warmth, and humanity will be deeply missed.

Wednesday, October 15, 2014

Big Data, Commercial Research, and the Protection of Subjects

by Elisa A. Hurley, PhD, Executive Director

Much has been written in the past few months—pro and con—about the results of the Facebook emotional contagion study published in June in the Proceedings of the National Academy of Sciences. The study manipulated the News Feeds of 700,000 unknowing Facebook users for a week in January 2012 by adjusting Facebook’s existing algorithm to over-select for either more positive or more negative language in posts. At the end of the week, the results showed that these users were more likely to follow the trend of their manipulated feed, that is, to use more positive or negative language in their own posts, respectively, based on their study grouping. Additionally, the study revealed that lowering the emotional content of posts overall caused users with affected News Feeds to post fewer words in their own statuses.

The public reaction to the revelation of the study in June was swift, loud, and dramatic. I myself was surprised by the uproar and still am not sure what to make of it.

Those who have written about the study in scholarly and popular media have voiced differing opinions about whether adequate informed consent for the study was provided via Facebook’s Terms of Service, as well as whether informed consent was even needed. Further debate has centered on whether the study required IRB review. And still other commentary has zeroed in on the merits of the research itself. As James Grimmelmann, a law professor from the University of Maryland said (quoted in The Atlantic, June 2014):
[The Facebook study] failed [to meet certain minimum standards]…for a particularly unappealing research goal: We wanted to see if we could make you feel bad without you noticing. We succeeded.
But are these the reasons users have been so incensed? I’m not sure.

Consider that, by their own admission, Facebook routinely manipulates its users’ News Feeds, filtering 1,500 possible news items down to 300 each time a user logs in. Many Facebook users object to this filtering (wanting instead to see everything and choose the content they engage with themselves), but that’s not enough to make the majority of account holders abandon or deactivate their accounts. The algorithm is also used to deliver related advertising content to users, and words in posts are parsed to target that advertising precisely to users’ recent activity: post enough about being on the treadmill, and your ads begin to feature running gear and related products. Yet again, no hue and cry, no mass exodus from Facebook by its billion plus worldwide users.

So it would seem that commercial audience manipulation—the basis for every marketing campaign the world over—is held to a lower standard than the presumably more noble and societally beneficial work of acquiring knowledge for the larger public good. Why is that?

The outcry about the study might be due to several factors: the perceived hubris of publishing a research paper about what perhaps should have remained internal commercial research; the fact that hundreds of thousands of Facebook users are left wondering if they were part of the experiment (as of this writing, there has been no indication that Facebook debriefed the subjects whose News Feed were affected); or the realization by those users and others that Facebook is able and willing to manipulate its user population in a variety of ways, and for purposes other than product enhancement or selling goods and services. In the words of Robinson Meyer (The Atlantic, June 2014):
And consider also that from this study alone Facebook knows at least one knob to tweak to get users to post more words on Facebook. [Author's emphasis] 
Perhaps we’re so accustomed to commercial manipulation that the instances that occur in our everyday lives—the placement of items on grocery store shelves, the tempo of music in shopping malls during the holidays, commercials for junk food peppered liberally through children’s television programming—don’t register as manipulative. Perhaps, too, we’re so used to them that we don’t even realize the effects they have on us. Some have suggested that the Facebook study and the public reaction to it should make us question our complacency about how our information is provided to and used by commercial entities. As Janet D. Stemwedel noted (Scientific American, June 2014):
Just because a company like Facebook may “routinely” engage in manipulation of a user’s environment, doesn’t make that kind of manipulation automatically ethical when it is done for the purposes of research. Nor does it mean that that kind of manipulation is ethical when Facebook does it for its own purposes. As it happens, peer-reviewed scientific journals, funding agencies, and other social structures tend to hold scientists building knowledge with human subjects to a higher ethical standard than (say) corporations are held to when they interact with humans. This doesn’t necessarily mean our ethical demands of scientific knowledge-builders are too high. Instead, it may mean our ethical demands of corporations are too low. [Author’s emphasis]
I think this is a point well taken. I also think there is an analogy to be drawn here to our collective attitudes about clinical care versus research. Consider the daily interaction between clinical care providers and patients. Patients trust doctors to make treatment decisions via prescriptions, referrals to specialists, and other interventions—some of which present more than minimal risk to a patient’s life or well-being. But not all doctors are equally knowledgeable, up-to-date on the current research, or without their own biases. And many of those decisions are made without any sort of consent process. It’s only when interventions—and sometimes the very same interventions, as in the case of comparative effectiveness research—are presented within the context of a research study that that the requirements for informed consent, and indeed an entire set of ethical questions and considerations, get triggered.

There are surely good reasons for this. Whether or not research is always inherently riskier to subjects than care is to patients—and I don’t believe it is—the very fact that one is participating in research, an enterprise whose goal is the creation of generalizable knowledge rather than personalized benefit, seems to me good reason for invoking a fairly robust ethical and regulatory machinery (though I acknowledge that the “machinery” we currently have in place may not be a good fit for much contemporary research). To make the parallel point to Professor Stemwedel’s, the fact that we seem to have different ethical standards or thresholds for research than for practice doesn’t, or doesn’t necessarily, mean that our standards for research are too high. Maybe it should, though, raise the question of whether our ethical standards for clinical practice are too low.

So, as with the Facebook case, I am left wondering, do we unfairly hold research to a higher ethical standard than we do clinical practice, or marketing practice?  And if so, are we, as some argue, thereby hindering important scientific progress?  Or does this highlight that we are we too lax about ethical considerations in other domains?  What do you think?

I invite and encourage you to join PRIM&R for a webinar on lessons learned from the Facebook study Thursday, October 30, at 1:00 PM ET. The Future of Internet Research: What We Can Learn from the Facebook Emotional Contagion Study, features Elizabeth Buchanan, PhDMary L. Gray, PhD, and Christian Sandvig, PhD, who will discuss the study and some of the commonly raised questions pertaining to internet and social media research, including: questions about how to classify social data; the ethical principles that accompany any such classification; how consent and debriefing strategies can be redesigned to scale up beyond the lab or field setting; how minimal risk can be assessed in online settings; and how to determine what constitutes publicly available information, communication, or social interaction versus private information, communication, or social interaction.

Thursday, October 2, 2014

Six tips to help you get the most out of the 2014 Advancing Ethical Research Conference

by Meghan Timmel, Communications Coordinator

I recently heard PRIM&R’s annual Advancing Ethical Research (AER) Conference described by a member as the “three days a year where I don’t have to explain what I do for a living.” This sentiment is echoed by many in attendance at our annual conference, which provides all those involved with research ethics and human subject protections a chance to meet, reconnect, and work with others who share their daily experiences, struggles, and questions. It’s helpful. It’s re-energizing. And—perhaps most important—it’s reaffirming.

The conference can be an especially valuable experience for first-time attendees, whether new to the field, to PRIM&R, or just to AER. To help out first-time attendees and others who might find professional conferences a bit intimidating, I’d like to share a few tips to help ensure that your experience at this year’s conference—AER14—is a success:

Plan Ahead. Consider: What do I want to bring back to my office from AER14? You might have more than one goal, but let those goals—from making more contacts to getting face-to-face time with the feds—drive your conference planning. Then, review the conference schedule ahead of time and prioritize those sessions and events that you most want to attend.

Don’t be shy! Ask questions in your sessions. Approach others at networking events. Conference faculty members can offer valuable insight, and AER is full of people who—like you—want to connect with and learn from others in the field. If you’re an introvert, and this fills you with panic, you’re not alone. Take a look at one strategy that can help get you more comfortable with networking successfully. And, with this in mind…

Practice your elevator speech. You will introduce yourself to new people over and over and over again at AER14. Preparing a brief, polished, “Who am I?” statement will make this process so much easier. Not sure where to start? Here are some helpful tips.

Create a clear plan for tackling the exhibit hall. AER14’s Conference Connection will be home to meals, breaks, poster presentations, and exhibitors and supporters. With so much going on in one place, navigating The Conference Connection can be an overwhelming experience, but there’s a great deal of value to be gained by connecting with our exhibitors and supporters and exploring the poster presentations. Avoid any stress by reading the exhibitor and poster presentation lists beforehand and making a list of the companies you want to speak with and the posters you want to see. And don’t forget your map! We will be posting maps online in advance of the meeting, and you will also find them in the conference guide you receive onsite.

Pack wisely. As important as your conference schedule and networking strategy are, the little things can make a huge difference in your conference experience. In particular, don’t forget comfortable shoes and business cards as you pack for AER14.

Follow up! When you exchange business cards, make a few notes about your new contact on the back of their card. Those notes will come in handy when you follow up with all the new contacts you have made after the conference. Connect with the individuals and companies you met, whether via email, phone, or even LinkedIn. Strengthening those connections will help make your next AER Conference even better.

Do you have other tips for AER14 attendees? Questions about the conference? Let us know in the comments!

Still haven’t signed up for AER14? Register today. The regular registration rate ends on November 20

Friday, September 26, 2014

Diplomacy is a must: An interview with Steven O’Geary

by Megan Frame, Membership Coordinator 

Welcome to another installment of our featured member interviews where we introduce you to our members—individuals who work to advance ethical research on a daily basis. Please read on to learn more about their professional experiences, how membership helps connect them to a larger community, and what goes on behind-the-scenes in their lives!

Today we’d like to introduce you to Steven “Steve” O’Geary, assistant vice president for research compliance at Oklahoma State University-Stillwater in Stillwater, OK. 

Megan Frame (MF): When and why did you join the field?
Steve O’Geary (SO): I joined the field in January 2002 when my alma mater, the University of Oklahoma (OU), began restructuring its research compliance programs. I left a tenure-track faculty position to return to OU to serve as the director of the Office of Human Research Participant Protection. That was the beginning of an amazing career that led me to the University of California-Berkeley and now Oklahoma State University. Although I miss the challenges of engaging students in active learning, I have never regretted my decision to directly support the mission of IRBs. After 14 years, I remain earnest and diligent in my efforts to safeguard the rights and welfare of human subjects.

MF: What skills are particularly helpful in a job like yours?
SO: Diplomacy is a must. A person needs to possess solid interpersonal skills, especially the ability to communicate effectively with people from diverse backgrounds. You need a robust understanding of all pertinent regulations, and you also need to be patient, detail oriented, organized, and even-tempered. Enthusiasm, passion, and a sense of humor help, too.

MF: Tell us about one or more articles, books, or documents that have influenced your professional life. 
SO: Along with books like Bad Blood: The Tuskegee Syphilis Experiment and Acres of Skin: Human Experiments at Holmesburg Prison, which many of us read when joining the field, there are several books that have influenced me:
Some may seem far afield at least at first glance, but each one helped me to better appreciate the principles of the Belmont Report.

MF: Have any of the PRIM&R talks you’ve attended had a significant impact on your approach to your work? 
SO: Former Office for Human Research Protections (OHRP) director Greg Koski, MD, PhD, spoke at PRIM&R’s 2005 Human Research Protection Program Conference, one of the first PRIM&R conferences I attended. This was shortly after he had stepped down as director and returned to a faculty position at Harvard Medical School. During his presentation, he spoke about the challenges of being the first director of the newly created OHRP. He spoke very eloquently about the moral obligations that accompany research involving humans and about why IRBs matter. He also discussed the sad circumstances surrounding the death of Jesse Gelsinger, the first subject publicly identified as having died as a result of his participation in a gene therapy trial. Dr. Koski struck a chord with me. He helped me realize, even more so than I had previously, the significance of the professional decisions I make every day. I was left with the realization that I was a part of something far greater than myself.

MF: What advice have you found most helpful in your career?
SO: To surround myself with people who drive me forward rather than those who would hold me back. I’ve done this at Oklahoma State, where I have the privilege of working with outstanding professionals who truly function as a team. The sense of community that exists on our campus is stronger than I’ve experienced. Collectively, my colleagues and I have created an office where talented people want to work.

Thank you for being part of the membership community and sharing your story, Steven. We hope to see you at the 2014 AER Conference, where Dr. Koski will be joining us once again as a member of our conference faculty

If you’d like to learn more about becoming a member, please visit our website today.

Wednesday, September 24, 2014

Poster Spotlight: Ethical Challenges and Solutions Involved in Reviewing a Protocol with Sex Offenders as Participants

by Meryn Robinson, Educational Program Intern

When reviewing a study that sought to investigate how sex offenders used networked technologies and communications for human trafficking, Hila Berger, MPH, CIP, and her colleagues on the IRB at Montclair State University faced a unique challenge: balancing protections for the study’s subjects—sex offenders—against protections for potential victims. The potential for subjects to incriminate themselves and potential legal obligations related to information disclosed during the research further complicated the protocol review. To overcome these challenges, the IRB and legal counsel worked together to implement additional protections for the group.

At the 2013 Advancing Ethical Research (AER) Conference, as a poster presenter and panelist, Hila discussed her experience and the systems put in place to manage such a challenging protocol at her institution. Recently, I connected with Hila to see how her work has progressed since last year’s conference.

Meryn Robinson (MR): It’s been nine months since you presented your poster at PRIM&R’s 2013 AER Conference. How has your research changed or evolved in the past nine months?
Hila Berger (HB): The work presented at the conference revolved around identifying and developing solutions for research involving sex offenders. The research in question is still ongoing, and the IRB and compliance team continue to informally assess whether the solutions we chose have been implemented successfully. Discussions with the principal investigator (PI) during additional submissions and at the time of continuing review have brought to light any concerns. Initially, during the review process, the PI had concerns about whether certain limitations would impact recruitment. However, according to the PI, while the project has struggled with recruitment, it is not as a result of the additional protections set forth by the IRB.

MR: What challenges have you faced in implementing these solutions?
HB: As a predominantly social-behavioral research-based institution, some assume that we do not have to regularly deal with greater than minimal risk research. This is far from the truth, but the nature of our greater than minimal risk studies do look different than those found in biomedical institutions. For example, since this initial protocol we have actually had another researcher request to conduct a study that would study involve assessing the effect of sexual offender legislation on registered sex offenders. Fortunately, the IRB was able to use some of the same protections put into place with the previous study. One of the most important lessons we’ve learned is that while a Certificate of Confidentiality may be appealing, as it offers additional protections for greater than minimal risk behavioral research, it may not always be attainable. Weighing the risk of subpoena against the benefits of the research may be something that can only be done with input from counsel, law enforcement, and other experts.

MR: What is one principle that guided you in your research?
HB: When reviewing this type of research, the key ethical principle that guides us is beneficence, as described in the Belmont Report. The moral dilemma of protecting sexual offenders did not escape the IRB’s discussions, but the group worked diligently to separate personal biases from the need to protect the subject population, in this case sex offenders, and to focus on the potential benefits that could emerge from such research.    

MR: What is one thing that you learned or took away from your experience?
HB: When it comes to human subject protections, there are always going to be unique research designs or populations that require the IRB to think critically and create a new recipe for protecting participants. There is no cookie-cutter solution that can be applied to every research study. Bringing in experts and taking the time necessary to fully understand the risks associated with a particular protocol will ultimately better serve the research and the participants.

Thank you for connecting with us and providing an update on your work, Hila. We hope that you are planning to join us for the 2014 AER Conference, which will take place December 5-7 in Baltimore, MD. This year’s program will feature more than 100 posters highlighting best practices and research related to human subjects protections, including nine exemplary posters, which will be presented during a special panel series.