Focus on the intrinsic rewards: An interview with Wendy Charles

Welcome to another installment of our featured member interviews where we will continue to introduce you to more of 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 Wendy Charles, director of Research Regulatory Affairs at National Jewish Health in Denver, CO.

MF: When and why did you join the field?
WC: I first became involved in research 22 years ago. I performed my senior thesis in neuroscience on pain receptor modulation in rats. I loved the challenge of research methodology and I was hooked! I went to graduate school in neuropsychology to study recovery mechanisms after severe closed head injury, and soon after, I joined an institutional review board (IRB). The regulatory compliance field was a perfect fit with my desire to advance science in an ethical manner. As director of Research Regulatory Affairs, I oversee the regulatory compliance of the human and animal research conducted at my institution. It is extremely gratifying to see animal research translate into advances in human research.

MF: What skills are particularly helpful in a job like yours?
WC: It is critical to be detail-oriented and have a fondness for learning in a constantly changing research climate. I believe that it is also critical to have an open-minded approach to solving problems.

MF: Tell us about one or more articles, books, or documents that have influenced your professional life. 
WC: I am grateful for my institution’s library, which performs a literature search for me every week. I read between one and three academic articles each week that help me broaden my perspective on human and animal research protections. Newsletters are helpful, but only scratch the surface. There is an incredible wealth of published literature about ethical issues that arise in research.

There isn’t a single article or book that has influenced my professional life, but I have certainly been influenced by the body of research performed by Laura Stark, PhD. Her research provides valuable insight into how IRBs arrive at decisions and why IRBs make different determinations from other IRBs.

MF: 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?
WC: I attended the 2012 Institutional Animal Care and Use Committee (IACUC) Conference where Dennis Orgill, MD, PhD, a surgeon at Brigham and Women’s Hospital, presented on how the animal research he was conducting could be used to improve the lives of human burn victims. During his talk, he showed before and after pictures of burn victims’ skin. The skin grafting research performed on pigs had such a profound benefit for these burn victims that some in the audience were moved to tears. It was a very emotional presentation. I will forever cite that research to skeptics who don’t understand why we need animal research. The benefits of this research were immediately tangible.

MF: How has membership in PRIM&R’s community of research ethics professionals helped you to advance in your career? 
WC: The PRIM&R certification program helped me prepare me for the Certified IRB Professional (CIP®) exam. I believe that this certification has added credibility to my position. I also highly value PRIM&R conferences for connecting me with other individuals in my profession. I always come away from each conference with a stack of business cards. The conferences have helped me feel that I am a member of a tight-knit, supportive community.

MF: What advice have you found most helpful in your career?
WC: When I was in my first year of my first IRB manager position, a mentor from a larger IRB shared that, “If everyone likes you, you are not doing your job right. This is not a popularity contest, and sometimes you have to take a stand.” That advice has improved my confidence tremendously, and I often repeat it to my staff.

MF: What is something you know now that you wish someone had told you when you first entered this field? 
WC: I wish I had known that a compliance administrator needs incredibly thick skin to survive. The criticism may come from every angle, including from the people who are supposed to support us. The work that we do is so valuable—sometimes we have to focus on the intrinsic rewards.

MF: What is your proudest achievement?
WC: When I first arrived at my institution four and a half years ago, the IRB review office was largely viewed as an “obstacle to research.” As a result, the review office undertook aggressive efforts to improve turnaround times and customer service. It was extremely gratifying to recently hear from the institutional official that researchers could directly see the benefits of our efforts. Researchers have noted that IRB reviews are much faster and that staff members are more helpful. Our IRB staff knew they were making a difference and our metrics demonstrated improvement, but it took a while to change our image at the institution. All of that effort was worth it!

Thank you for being part of the membership community and sharing your story, Wendy. If you’d like to learn more about becoming a member, please visit our website today.

Developing an effective QA/QI program

by Alexandra Shlimovich, Online Learning and Certification Coordinator

On Thursday, April 25, PRIM&R hosted a webinar titled Quality Assurance/Quality Improvement (QA/QI): Study Review from Conception to Completion. Kristen Burt, JD, interim director of the Michigan State University (MSU) Human Research Protection Program (HRPP), and Eunice Yim Newbert, MPH, manager of the Education and Quality Improvement Program (EQuIP) at Boston Children’s Hospital (BCH), participated as speakers, with Amy Davis, JD, MPH, senior director for program and publications at PRIM&R, as moderator.

Following the webinar, we connected with the presenters, and they kindly answered a few more questions that came in from webinar participants, for Ampersand.

Alexandra Shlimovich (AS): What triggered your institution to implement a QI program? Was it proactive, or due to/following an event?

Eunice Newbert (EN): A bit of both—prior to 2003, institutional review board (IRB) analysts initiated periodic QA/QI efforts; implementing a separate program was a proactive measure, but most likely expedited by publicized events from other institutions that emphasized the importance of having a program in place.

Kristen Burt (KB): Similarly, MSU IRB administrators had conducted periodic QA/QI efforts. We modeled our Human Research Liaison program after our Animal Care Program’s Animal Research Liaison program which has been successful.

AS: How do your institutions handle investigators that do not respond to reports?

(EN): At BCH, our general policy is that principal investigators (PIs) have one month to respond to reports using the PI Response Form. We try to make it as easy as possible to respond (i.e. checkboxes) and extend the time frame upon request. If a PI does not respond within 30 days and they have not asked for an extension, reminders are sent by email first, then by phone and page. Reminders are also sent to the research coordinator or other contacts. Many of our PIs have requested extensions and some have needed reminders, but to date, all our PIs have eventually submitted their responses. In the event they do not, our policy is to notify the director of research compliance who will then notify the PI, and if there is still no response, the protocol is subject to suspension.

(KB): At MSU, responses are typically due within 10 working days. Because the letter is sent by both the human research liaison and the IRB, the IRB manager follows up with investigators who do not respond by the date requested.

AS: I'd like clarification concerning the practice of NOT sharing reports with the IRB. Is this true if you identify protocol deviations or unanticipated problems?

EN: Yes, our reviews and reports are confidential between our office and the PI. The reviews focus not only on identifying deviations/areas for improvement, but on educating PIs about what, how, and to whom each deviation/unanticipated problem should be reported. By not sharing reports directly with the IRB, we find there is ultimately more openness between our office and the PI/staff.

But yes, there is a risk that a PI may not ultimately report the deviation after we leave, though we have not found this to be an issue, as most PIs ask us for assistance in reporting to the IRB and/or list us on the report (e.g. the following deviation was discovered during an EQuIP review).

If the event is significant, especially with immediate increased risk to subjects, we do make an exception—we would report to the director of research compliance, who would then determine what the next steps would be. However, even in these instances, the PI would be informed and would be encouraged to contact them as well.  In the last 10 years, we have only used this option a few times.

KB: MSU does share the reports with the IRB.

AS: How do you audit the IRB itself if your IRB administrator or staff do the auditing? Do you have outside people/customers volunteer to audit the IRB? I think it is important for the IRB to be audited, but I do not feel I can audit myself.

EN: At BCH, since we are separate from the IRB, this has not been an issue in terms of ensuring an unbiased review. However, since we are not part of the IRB, we have to be careful about how the reports are handled; if required, the IRB responds and implements corrective actions as necessary. IRB audit reports are reviewed by the director of research compliance who determines any follow-up action. We have limited access to the electronic IRB system, so if we need additional information (metrics, reports), we need to put in a special request.

KB: Similarly, the MSU Human Research Liaisons are separate from the IRB office.

If you’re interested in learning more about QA/QI and did not have a chance to participate in last week’s webinar, the archive is available for purchase. PRIM&R members can also access additional readings related to this topic on our Knowledge Center.

Push yourself to see things in a different light: An interview with Susan Fish

by Megan Frame, Membership Coordinator

Today we’d like to introduce you to Susan “Sue” Fish, PharmD, MPH, who serves as chair of PRIM&R’s Membership Committee and as a member of the Diversity Advisory Group. She is also the secretary of PRIM&R’s Board of Directors and co-chairs the Poster Abstract Sub-Committee for the 2013 AER Conference.

Sue Fish has been a PRIM&R member for ten years. She is a professor of Biostatistics and Epidemiology at the Boston University School of Public Health. She is also the director of the Masters in Clinical Investigation program at Boston University School of Medicine (BUSM). Sue previously held positions as director of Human Subjects Protection and associate director of the Office of Clinical Research at Boston University Medical Center (BUMC), director of the BUMC Institutional Review Board (IRB), director of Research Participant Safety at the General Clinical Research Center at BUSM, among many others. Sue has been a medical researcher for more than 30 years. She was a member of the Human Studies Committee at Boston City Hospital/Boston Medical Center from 1989-1999, and served for five years as associate chair of the committee.

Megan Frame (MF): When and why did you join the field?
Sue Fish (SF): I was a clinical researcher in emergency medicine when, in about 1997, I called the IRB office to understand the submission process at my new institution. When the IRB administrator heard that I was a pharmacist, she immediately recruited me to join the IRB. It was serendipity. I subsequently became a vice chair of the IRB and other opportunities have derived from that. Because I was both an emergency medicine researcher and an IRB member, I was very involved with the activities to revise portions of the Common Rule and the Food and Drug Administration regulations to allow emergency research to be conducted without subject consent. Due to that activity, I became involved in PRIM&R, and I have never looked back.

MF: What skills are particularly helpful in a job like yours?
SF: Attention to detail and an appreciation of the perspectives of others.

MF: Tell us about one or more articles, books, or documents that have influenced your professional life. 
SF: Zeitoun by Dave Eggers: "The true story of one family, caught between America’s two biggest policy disasters: the war on terror and the response to Hurricane Katrina. Abdulrahman and Kathy Zeitoun run a house-painting business in New Orleans. Told with eloquence and compassion, Zeitoun is a riveting account of one family’s unthinkable struggle with forces beyond wind and water." This book opened my eyes to yet another perspective and set of experiences that I had not considered. How could I have been so blind? This book has haunted me since I read it a few years ago.

MF: 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?
SF: Eva Mozes Kor’s talk at the 2010 AER Conference was remarkable. In addition, I had the opportunity to spend the day with her as her host, and hear her conversations with so many people during the book signing. What compassion she has! She continues to challenge my understanding of the effects my actions have on others and of the effects of the actions of others on me.

MF: How has membership in PRIM&R’s community of research ethics professionals helped you to advance in your career?
SF: My involvement with PRIM&R has meant almost everything to my recent career. The conferences and webinars and other educational events and documents have taught me so much and made me think. They have encouraged me to keep the ethics on the table with the regulations. The people with whom I have worked and interacted have broadened my experiences. PRIM&R has provided numerous fora for brainstorming to figure out how to do “the right thing” in so many unique situations. I have a set of trusted colleagues at other institutions who help keep me sane, and I never feel alone.

MF: Why is the issue of diversity important to you?
SF: Diversity is like motherhood and apple pie to me; it is just what makes the world interesting. How boring my life would be without people who are different from me in it! I like being pushed to see things in a different light and to dig deeper within myself to figure out why I feel the way I do about an issue. Even for topic or cause about which I am firmly committed, I try to understand why someone else comes to a different conclusion.

MF: Why did you agree to serve on PRIM&R’s Diversity Advisory Group (DAG)?
SF: Because diversity is important to the organization, and to have a DAG states the importance of this value. Also, I am hoping to learn from the members of the group, which has already happened.

Thank you, Sue, for bringing your skills and dedication to the PRIM&R community! 

Celebrating the life and work of Barbara Brenner

Last Friday, the world lost a powerful advocate for breast cancer awareness and research. Barbara Brenner passed away from complications of amyotrophic lateral sclerosis (ALS) on May 10, 2013. Ms. Brenner, a lawyer by training and a civil rights activist by design, was diagnosed with breast cancer at the age of 41, an experience that compelled her to become involved with what was then a fledgling grassroots advocacy organization in San Francisco, Breast Cancer Action (BCA). 

Over the next twenty years, Ms. Brenner helped the organization grow into one of the most respected voices in a crowded advocacy field, and her powerful vision and leadership fundamentally shaped the discourse surrounding breast cancer. During her 15 year tenure as BCA’s executive director, Ms. Brenner worked to advance research on both prevention of and treatment for breast cancer, while speaking out against a system that was, in her opinion, driven by profit and politics.

Upon her diagnosis with ALS in 2010, Ms. Brenner started a blog, Healthy Barbs, to share her reflections on living with illness. In 2011, Ampersand was fortunate to have an opportunity to share a post from Ms. Brenner’s blog in which she illuminates the experience of participating in a clinical trial. In honor of her passion, moxie, and contributions as an advocate, we are pleased to repost that piece today.

Please read about Barbara's extraordinary life and life's work via the below post and the above-included links, and we hope that you will be as inspired as we were by these accounts.  If you are, thank you for doing whatever you can to keep her memory and mission alive.

That's why they call them "trials"

by Barbara Brenner

Given the times we seem to be in, maybe you’re thinking you’re about to read a blog about the trials and tribulations of Donald Trump, who can’t seem to tear himself away from the big bucks of an NBC contract to run for president, or the upcoming trial of Dominique Strauss-Kahn, managing director of the International Monetary Fund, on sexual assault charges, or the struggles of Maria Shriver, who turns out to have been married to another adulterous male politician.

While those topics are undoubtedly more fun to explore, they are not my subject today. I want to address the serious topic of drug clinical trials, a topic that most people who aren’t doctors—and, tragically, some who are—don’t understand.

What is a drug clinical trial? Clinical trials are used to advance scientific research into the treatment of illnesses.

A clinical trial is a medical research process used to determine if a drug is safe for humans to take and effective to treat the medical condition that it is intended to address. The drug under investigation—called the treatment—is compared to what is called a “control,” which is either a placebo (a pill or infusion that looks like the drug under investigation, but that has no biological properties) or an existing treatment for the condition, so that researchers can determine whether the drug under investigation is more effective than the alternative to which it’s being compared. The treatment group of patients and the control group of patients have to be balanced in number so that the results of the trial are meaningful.

Drug trials are necessary because without them, there is no way of knowing whether the treatment drug that is the subject of the trial will work for the patients in the trial.
Two other features of well-designed trials, randomization and blindness, are important to ensure that the trial reflects how the drug works, rather than a bias on the part of those administering the trial.

Randomization is the process by which patients in the trial are assigned to receive either the drug under investigation or the control. By assigning to patients at random, researchers avoid any bias that might creep into trial results by choosing, for example, the apparently healthier patients to receive the drug, or the less-healthy patients to receive the control.

Blindness refers to who knows what about which patients are in the treatment group or the control group. Ideally, drug trials are “double blind,” meaning that neither the researchers nor the patients know which group the patient is in. Double-blind trials keep researchers from making judgments about how patients are doing based on what they are known to be taking. They may also keep patients from deciding to drop out of trials because they didn’t get into the treatment group. (Open-label trials – where both the patients and the researchers know what drug is—have become much more common in breast cancer than double-blind trials.)

A drug trial is considered a success if the patients getting the treatment drug do better than patients in the control group by a statistically significant percentage. A successful trial tells nothing about whether the treatment drug actually worked in an individual patient. After all, it’s possible that the patient would have improved without the drug in question. Miracles do sometimes happen in medicine, and not necessarily because doctors make them happen.

Clinical trials in the abstract

I know a lot about clinical trials from my work as a breast cancer activist. From that work, I have come to believe that trials should demonstrate that the drug being tested can do at least one of three things before it is marketed to the public:

• Improve survival
• Improve quality of life
• Cost less than existing, equally effective treatments

These ideas about the goals and structures of clinical trials are fine in the abstract. It’s harder when they have very personal implications, either for you or for someone you love. While no promises are ever made to patients entering clinical trials, it’s hard for the patients or the people who love them not to believe at some level that the drug under investigation will improve their lives. People often enter trials believing this, no matter what they are told about the purpose of the trial.

The personal side

That my friends share this belief was evident when I told them that I am being screened to see if I’m eligible to be in a clinical trial. Many have hoped that, if I was eligible for the trial, I would get the drug being investigated, not the control, which in this case is a placebo. That hope seems to convey the belief that the drug will work. Whether it will or not is, in fact, what the trial is intended to test.

I know that participating in a clinical trial means taking a chance that I won’t get the drug under investigation, as well as the chance that that drug won’t work anyway. I know that it’s impossible to know from a clinical trial whether the drug under investigation will help me, even if it shows benefit for a significant percentage of people in the trial.

At the same time, I know there is only one approved treatment for ALS, the disease I have. At best, that treatment only delays progression. Better treatments are needed: ones that will extend patients’ lives or improve the quality of the lives they live with this devastating illness. I know that only through clinical trials can better drugs be found, and I hope that this trial—and other trials—will advance the knowledge of what does and doesn’t work to treat ALS.

And I’ll also keep in mind, as I enter the trial that placebos also work sometimes.

The following piece was originally re-posted on Ampersand in 2011 from the blog, Healthy Barbs, with permission from Ms. Brenner. If you are interested in learning more about Ms. Brenner's work and life, we encourage you to read the transcript from her oral history, which is part of the Sophia Smith Collection at Smith College. 

Research Ethics Roundup: Preparing for pandemics, Congressional-level grant review, and much more!

Spring is in full swing! Take advantage of the mild weather and enjoy the great outdoors while reading the full text of this week’s Research Ethics Roundup selections.

#NIHSequesterImpact: Last week, Francis Collins, director of the National Institutes of Health, asked Twitter followers to share how the federal sequester has affected their biomedical research. The American Society for Biochemistry and Molecular Biology collected responses on their Storify page.

Privacy Protections: The Genome Hacker: Nature profiles Yaniv Erlich, creator of lobSTR, a software program that analyzes anonymized genomic data in public databases, allowing users to re-identify study participants. Erlich’s study reveals the tensions between balancing access to valuable research information and ensuring patient confidentiality, and predicts possible ways in which study data may be used in the future.

To Fight Pandemics, Reward Research: In light of the latest avian influenza outbreak in China, economics professor Tyler Cowen considers how the United States should best equip itself to prepare for a pandemic. Not only should innovators be encouraged to engage in research, but the government needs a way to cheaply and widely distribute drugs and vaccines, he argues.

Solving an Alligator Mystery May Help Humans Regrow Lost Teeth: Researchers have been studying the tooth regeneration abilities of American alligators, whose teeth are replaced up to fifty times during their lifespan, in hopes of replicating this phenomenon with humans via stem cell technology.

Leave Judging Science in the Hands of Scientists: Ann Bonham, chief scientific officer of the Association of American Medical Colleges, posted an essay about the importance of peer-reviewed research in response to the proposed High Quality Research Act. The Act would require additional Congressional review of all grants extended by the National Science Foundation and NASA.

Emergency and military research benefits abound in the heroics at Boston hospitals following the Marathon bombings

by Joan Rachlin, Executive Director

Today marks one month since the heartbreaking and horrific Marathon bombings here in Boston. Some things in the city remain unchanged: the ubiquitous springtime walks for worthy charities and important organizations are taking place—safely—each weekend, U-Haul and Budget trucks clog the streets in neighborhoods with high student density as college kids decamp for home and/or jobs elsewhere, and white sails are starting to dot the Charles River.

A lot of things are different, though, from that bright Marathon-morning when the trees were still bare, and excitement and energy were in the air. In the intervening 30 days, magnolias, ornamental cherry trees, dogwoods, and azaleas have bloomed in an almost-defiant sign of the Boston-strong rebirth. Police officers and members of the National Guard are now posted on every block during those above-referenced weekend walks. And, most notably, instead of talking about the highs and lows of Boston sports teams, many, if not most, folks are still talking about the attacks and their aftermath.

The intervening month has also brought certain truths into sharp relief in every sense of that word. I am relieved that the FBI and local law enforcement were able to collaborate so quickly and effectively, and relieved that they were able to bring an end to the surreal and violent chapter before any more lives were lost. I am relieved that the Boston Athletic Association (BAA) had taken the lessons of 9/11 so seriously that they had annual disaster drills and were thus prepared for the unthinkable. I'm relieved that the first responders were so well-trained, so courageous, and so quick-thinking, and that the fatalities were not as numerous as they might otherwise have been.  And I'm relieved, and enduringly grateful, that those BAA personnel and first responders had one of the best, if not the best, networks of trauma centers and hospitals to which wounded could be sent.

Although no one says this in a voice higher than a whisper for fear of invoking some ancient evil eye, it is remarkable that not one victim who made it to a hospital that day has died. Given the more than 260 wounded, many of them critically, it is nothing short of a miracle that there were not more fatalities. More miraculous still is the fact that many of the torn and damaged limbs were reattached by the talented and determined transplant and other surgeons in Boston who were fresh off face transplants, hand transplants, and the myriad other transplants that take place daily in our city’s hospitals. Although no numbers are available, it is understood that every limb that could be reattached, was reattached, and the skill demonstrated by every member of those operating teams is a story in itself.

Part of that story originates in battlefield research and other forms of emergency research. Faced with injuries more reminiscent of those sustained in modern day warfare, physicians at Boston-area hospitals were quick to leverage the knowledge that has been gained from battleground trauma in Iraq and Afghanistan. Take for instance the tourniquet—at one point dismissed as an outdated tool—the tourniquet has gained favor in military medicine in recent years and is credited with saving many lives in Boston on that spring afternoon. Years of research and innovation in treating wartime injuries have also resulted in significant advances in prosthetic technology, which will help those individuals who lost one or more limbs maximize their mobility and thus independence.

The knowledge and advances from which the victims benefited on Marathon Monday have not come easily, however. There are inherent challenges when conducting research on a battlefield or in other emergency settings. Potential harms must be weighed against potential benefits and carefully balanced with protections for those involved. Institutional review boards and/or research ethics committees have grappled with difficult and complicated questions—When it is ethically permissible to waive consent in emergency research? What, if any, other elements of the regulations can be waived when doing research on the battlefield? Where are the boundaries between innovative surgery and experimental surgery in emergency situations?—to find the balance that best protects subjects while advancing lifesaving procedures.

Through the careful review and ongoing oversight of these protocols, the path of progress was paved and led to Copley Square in Boston on Marathon Monday. While the review process is filled with dilemmas and deliberations, the insight gained from such efforts has and will continue to prove invaluable. Research in emergency situations, including on battlefields, will continue to bear fruit in countless other hospitals around the world.

Thank you for your role in advancing ethical research.  It is because of the knowledge gained from such studies that I can today send our community’s continued hopes for healing to the bombing victims, who are living testaments to the power and purpose of research.

Stay open to other perspectives: An interview with Matt Stafford

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 Matt Stafford, manager, Clinical Investigations at Boston Children’s Hospital in Boston, MA. 

Megan Frame (MF): What skills are particularly helpful in a job like yours?
Matt Stafford (MS): I am perhaps biased because I waited tables for a few years and put myself through college by bartending, but I think experience in food service or some form of customer service is a great asset to the research ethics field. We essentially serve in a compliance function and are frequently in the position of telling people what they have to do. For many, the phrase “institutional review board (IRB)” is synonymous with “roadblock” or “delay.” But, if you achieve a reputation for customer service and collaboration, rather than one for hard-fisted governance and red tape, then the institution is in a better position compliance-wise. If you can make the experience more pleasant by providing prompt, courteous, and helpful service to investigators, they are more likely to approach you early and often, rather than after they have a problem.

MF: Have you attended  any PRIM&R events or talks that that have significantly impacted your approach to your work? If so, what were they and how did they influence you?
MS: Rebecca Skloot’s talk at the 2010 Advancing Ethical Research (AER) Conference was amazing. I can’t stop thinking about the problem of science and health literacy in our country. It’s an issue that researchers have to face every day and something I think our profession has a duty to address. Imagine how different our world would be if there was universal understanding (or at least consensus and competency among leaders) of basic scientific truths about how our bodies work, how disease happens, and what forces affect our environment and our health.

MF: How has membership in PRIM&R’s community of research ethics professionals helped you to advance your career? 
MS: I remember my first Advancing Ethical Research (AER) Conference. There was a small group of us neophytes and we clung together that weekend and compared notes. I think we were all a little shy about mingling with veterans and still a little overwhelmed by our new careers. The conference was a real eye-opener. I realized both that I had so much more to learn, but also that I was not alone—there was a network of people just like me out there who were collaboratively tackling the problems we face in the IRB world. I learned so much that weekend and continue to get a lot out of each conference I attend.

MF: What advice have you found most helpful in your career?
MS: Keeping an open mind (and open ears) is key. The regulations afford a great deal of flexibility and it’s important to understand them well enough to apply them differently to varied situations. I have had a lot of great mentors in my short career, and each of them has taught me the importance of staying open to other perspectives. I struggle most with the listening part. It has always been difficult for me to listen, as I am an impatient person who likes to talk. But you get more mileage out of listening. If you don’t listen, people stop talking to you and you lose sense of what is happening. How can you be effective without knowing what’s going on?

MF: What is one thing you wish “the man on the street” knew about your work?
MS: I think it’s unfortunate that the average person, even one who may have participated in research, has no idea that IRBs exist or even a remote understanding about what we do. It takes about five minutes to explain what I do for a living to an educated person. I think we as a profession should work to make people more aware of research and the protections in place for those who participate. Knowledge is power in this case. Those who know and understand the protections are better poised to weigh the risks and benefits of participation, which makes them more likely to regard the IRB as a resource for information (as well as a place where they can share their grievances). The system of protections would function better with a well-informed public. Increased awareness might also better engage the public in the research enterprise.
I think the average PRIM&R member believes that science is important and that we contribute to progress through our work, so educating “the man on the street” is something we should work toward.

Thank you for being part of the membership community and sharing your story, Matt. We look forward to seeing you at the 2013 AER Conference in Boston this November!

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

Just how vulnerable are we? Just how are we vulnerable?

by Dahron Johnson

Dahron Johnson has worked as the Chaplain for HighPoint Hospice in Gallatin, TN, as well as serving two and a half years as an Association for Clinical Pastoral Education chaplain resident and intern at the Department of Veterans Affairs' Tennessee Valley Health System’s Nashville campus. He continues to serve at the latter as a community member on the IRB, and is involved with other area ethics roundtables.
 
A woman peers apprehensively out of a window of her home. She holds a phone to her ear as she tries to piece together information from the person on the other end of the line, and the confusing melee of events that just so happens to be unfolding in front of her house—a setting that otherwise doesn’t host much outside the routine of daily life. She’s been told by someone of authority that her options are limited (stay inside; leave the area entirely). Maybe she’s also listening to a police scanner (or, as it so happens, watching it).  Regardless, or more likely exactly because of this variety of informational sources, a cohesive, full view of events and options is hard to come by. Even as separated as we are by distance and time from that moment, from her place, it is hard not to also feel anxiety well up and turn our stomachs— what is going on? What will happen next?

I relate this scene for a number of reasons: First and foremost, with PRIM&R headquartered in Boston, it feels appropriate to again share our sympathy and solidarity with those affected by last month’s bombings, and all that has followed and continues to unfold in their aftermath. Second, when asked if I might write a post for Ampersand well before these events unfolded, my initial instinct was to share some of my observations from the discussions surrounding vulnerability that took place at the 2012 Advancing Ethical Research Conference this past December, a topic that I had recently presented on. But, in sitting down to write, I felt outpaced by the events in Boston. The vulnerability people felt in the moment the bombs went off spoke far more than I ever could.

In particular, it raises questions about a distinction made at the 2012 AER Conference, one I admit that I latched onto myself: the distinction between “situational” and “decisional” vulnerability. In a nutshell, situational vulnerability is vulnerability caused by circumstance, which does not impair decision-making. It implies a severely delimited field of options because of circumstances, but does not imply any impairment in the ability to make choices among those limited options. Decisional vulnerability, by contrast, refers to situations “when one is relatively or absolutely incapable of protecting their own interests” (Dr. Alan Wertheimer’s presentation “The Nexus of Vulnerability and the Minimization of Risk” is available through the AER Conference Passport). If one were to hold strictly to the above definitions in the wake of the events that unfolded recently in Boston, the relevant people’s vulnerabilities would appear to be primarily situational ones; these events, though in extremis, do not necessarily negate people’s ability to choose among a now-altered field of options.

I still consider the distinction between situational and decisional vulnerability to be important, since, quoting Dr. Wertheimer again, it helps to “guard against debasing the currency” of vulnerability qua vulnerability. And yet, a series of events such as those in Boston seems to me to collapse such a distinction.

Descriptions by people in the moment provide examples of how such situations can also create, to use the decisional vulnerability definition, relative (perhaps even absolute) incapabilities with regard to making decisions in one’s own interests. Such is the nature of piecemeal information, informational gatekeeping, and emotions, that it would seem difficult to argue that the decisions made in such moments are subject only to situational vulnerabilities as described. How fully capable is someone of protecting his or her own interests in the extremes of such events? Especially when events are so extreme? Or, put differently, to treat moments of crisis and distress—a bomb ripping through mid-morning revelry; a mother putting up a wall of faith between herself and her dying child; receiving an unexpected call informing you of your newly-diagnosed disease—as only situational “externalities” with which we must contend, does not account for the myriad ways such events can cause an inward change. Perhaps such changes are fleeting and relative, or perhaps they are chronic and create more permanent effects. In either case, it is not necessarily any more respectful or humane to assume a person’s ability to maintain whatever level of rational decision-making he or she was capable of prior to such moments.

Such considerations are at the crux of ethical research. A majority of the time, researchers and those who oversee research establish relationships with potential subjects just at that moment when their information is limited; when the ability to understand and contextualize the information available is likely diminished; and when the dynamics of power and authority are tilted severely away from them. While we want to hold on to the conception of the person as a capable actor with regard to his or her own interests, despite a field of winnowed options, that patient-participant (the phrase itself doing tidy semiotic work on the simultaneous roles) is also, at the same time, a person not fully capable of protecting his or her own interests. A person in such circumstances may pursue a fool’s errand, even as each decision along the way seems rational in and of itself.  While we on the research side certainly cannot prevent such situations, we do have some ability—even obligation—to provide decisional support that recognizes and allows for the flux and ebb of a person’s decisional capabilities. That is, when considering whether a person is vulnerable either because of situational or decisional concerns, the answer is likely a simple, encompassing “yes.”

Let me end with two admissions:  First, there is a bit of a strawman being swung at here.  As described at the 2012 AER Conference, these two types vulnerability are not mutually exclusive (though I don’t believe I’ve overstated the desire to reassert the value of the term by separating out these varieties of vulnerability and treating them in turn as “scarce resources” to be used with deliberate thought and care). Second, people may very well figure out ways to negotiate their paths forward through the midst of more- and less- calamitous events. I agree fully that it is paternalistic at best, degrading at worst, to overassume and overascribe decisional impairment. However, I sense that recent events issue a caution to this corrective. Perhaps the best we can do—the best thing to do—is to figure out approaches through which we can keep ourselves attentive and responsible to how any given set of situations play out and affect not just those with whom we work, i.e., research subjects, but ourselves as well.  In the wake of a tragedy the best first move is still to meet people where they are, and to figure out with them how to best move forward from there.

It's More Than Meets the IRB

by Michael Leary, MA, CIP, Education and Compliance Specialist in the Human Research Protection Office at Washington University in St. Louis

There is an odd thing happening to institutional review boards (IRBs); they are becoming interesting. We are all familiar with the classic perception of the IRB as yet another administrative burden tucked away in the research process. But at many institutions, this perception is shifting. With the publication of books like Laura Stark’s Behind Closed Doors: IRBs and the Making of Ethical Research, and the steady increase in reporting and editorials on research ethics issues in our most widely-read news outlets, the general public is also starting to understand the historic significance of our field.

At Washington University in St. Louis, we have a number of human research protection program (HRPP)-based educational and media resources that are geared toward making the IRB process more transparent and collaborative. This increases efficiency across the board. But more importantly,  these kinds of programs help stakeholders better understand the historical and ethical backgrounds of IRB review.

One of the programs we have created is More Than Meets the IRB, a podcast featuring interviews, panel discussions, and reviews of issues related to human research ethics. In this series, we discuss current events in the human research world, talk with investigators and research subjects, and review literature relevant to those interested in research ethics. Our first installment featured Rebecca Dresser and her recent book, Malignant: Medical Ethicists Confront Cancer. During that conversation we talked about the “ethics of survivorship,” the nuance of patient and participant autonomy, the recipe for a “fair offer,” and the role volunteerism plays in both the research and research ethics review process.

We have a future segment planned with Robert "Skip" Nelson, MD, PhD, senior pediatric ethicist at the Food and Drug Administration, about the participation of children in research. This podcast will address key ethical considerations in a way that will be informative even for those of us who have significant experience in applying subpart D. We will also be talking with Robert Levine, MD, professor of medicine and lecturer in pharmacology at Yale University, about the background and implementation of component analysis. Other podcasts about the proposed revisions to the Common Rule and transnational research ethics are in the planning stages.

These podcasts are not just of interest to researchers, IRB members, or HRPP staff, but are thought-provoking for an even wider audience. As noted above, IRBs and the issues faced during the review process are interesting to the general public, even though the topic is typically introduced only through the lens of scandal. While serving as a helpful resource for those in the IRB orbit, More Than Meets the IRB also hopes to engage public perceptions of research that involves human subjects and expose our communities to the rich ethical history of research.

We invite you to join us in this project. If you have any suggestions for future segments, don’t hesitate to share them in the comments.

Digging into the HIPAA/HITECH Act Omnibus Final Rule

by Alexandra Shlimovich, Online Learning and Certification Coordinator

On Monday, March 4, PRIM&R hosted a webinar titled PRIM&R’s Primer on the HIPAA/HITECH Act Omnibus Final Rule. Emily Chi Fogler, JD, senior legal counsel in the Office of General Counsel at Partners HealthCare System, and Jennifer Geetter, JD, partner in the law firm of McDermott Will & Emery LLP, participated as speakers, with P. Pearl O’Rourke, MD, as moderator.

Following the webinar, we connected with Emily Chi Fogler, and she kindly answered a few more questions that came in from webinar participants, for Ampersand.

Alexandra Shlimovich (AS): In terms of the elements for opting in to the unconditioned sections of research, would these elections necessarily need to be a part of the informed consent form (ICF) and HIPAA authorization forms if these forms are separate? For example, should check boxes for opting in be included on ICF and mirrored on HIPAA authorization?

Emily Chi Fogler (ECF): If I understand this question correctly, you are asking whether, if your entity/IRB uses separate ICF and authorization forms (two freestanding documents), you have to repeat/include an opt-in for the unconditioned activity (e.g., banking) in both forms.

The final rule and its preamble do not address this specific example, but, given the clear intent of the US Department of Health and Human Services (DHHS) for entities/IRBs to have flexibility in implementing the requirements and to reduce administrative burden for participants and researchers, we think a practical reading of the rule would permit the opt-in mechanism (for example a check box) to be located in either form without having to be repeated/included in both.  If the opt-in is located in the ICF, the authorization should very clearly incorporate the opt-in by reference. in other words, since the opt-in is a required part of the authorization under the final rule, the authorization form should state that it is incorporating by reference the opt-in checkbox option selected by the participant in the consent form and that the participant’s choice indicated in the consent will apply to the use and disclosure of their protected health information (PHI) requested in the authorization. If the opt-in is located in the authorization, the ICF should cross-reference that the person will be asked to provide their authorization to the unconditioned activity in the authorization form and that if they do not authorize the activity it will not occur.  

AS: Is the National Cancer Institute (NCI) model consent template compliant with HIPAA where it says that your sample will be used for any future research including diabetes, etc? The answer offered during the webinar was it was probably ok if it was consistent with the purpose of the original research but if the original research was cancer research, how can one say that future research on diabetes would be covered by this?

ECF: During the webinar we noted that the NCI consent language is quite broad and that it will be a judgment call for IRBs whether they would be comfortable with the breadth of it, and specifically whether it meets the “reasonable person” standard now established in the preamble to the final rule – i.e., whether a reasonable person would understand from the description in the form how her PHI might be used/disclosed for the future research. We also noted that, while language in a form may be “legal,” and meet the requirements of DHHS, it still may be too broad or nonspecific for the preference of some IRBs or participants.

We do not think that the analysis hinges on whether the future research was consistent with, or within the same scope or area as, the original research study. Although that might be one criterion for an IRB to use in assessing the appropriateness of the future research use (from both a Common Rule and a HIPAA perspective), it is not the definitive criteria for determining whether the description of future research is acceptable under the new Omnibus Final Rule. As we understand the final rule, future research could be in an entirely different disease area, and still be acceptable under the Final Rule if it is determined by the covered entity/IRB that a reasonable person would understand the scope of possible uses of their PHI from the description in the form.  In other words, the question is more, is the description of the future uses clear and meaningful enough that the planned future use would be reasonably expected or anticipated based on that description.  If the future research were within the same disease area or clearly related to the disease being studied in the initial study, it might create a stronger argument that a participant would understand the planned future use, but we don’t think that’s the dividing line or the only factor to consider.

If you’re interested in learning more about HIPAA/HITECH Act Omnibus Final Rule and did not have a chance to participate in last week’s webinar, the archive is available for purchase. PRIM&R members can also access additional readings related to this topic on our Knowledge Center.

Work-life balance is key: An interview with Melanie Mace

Welcome to another installment of our featured member interviews where we will continue to introduce you to more of 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 Melanie Mace, human research protections program (HRPP) education and training coordinator at the University of California, San Francisco (UCSF) in San Francisco, CA

Megan Frame (MF): When and why did you join the field?
Melanie Mace (MM): I joined the institutional review board (IRB) world completely by chance in 2003. After getting my master’s degree in the humanities from the University of Chicago, I had a hard time finding a full-time job. A friend helped me secure a temporary position filing gigantic protocols and making copies in the Biological Sciences Division IRB at my alma mater. Working in an IRB office was an eye-opening experience. I had applied for IRB approval for my Master’s thesis, but I was pretty clueless about what IRBs actually do. As I learned more, I became emboldened by the office’s mission to protect human subjects and enjoyed learning about the cutting-edge research our investigators were doing. When a permanent IRB administrator position opened up a few months later, I went for it and have been working in an IRB office ever since.

MF: What skills are particularly helpful in a job like yours?
MM: I am currently the human research protection program education and training coordinator at UCSF, so I speak with a lot of different people on a variety of topics. I get asked questions out of left field all the time, so it is essential that I am able to think on my feet and promise to get more information if I don’t know the answer. Being able to crack a joke doesn’t hurt either.

MF: 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?
MM: Early in my career, I attended IRB Administrator 101 in Chicago. Before the program, I often felt like I was trying to complete a frustrating, complicated crossword puzzle filled with acronyms – OHRP, FDA, FWA, HIPAA, etc. After the program, I felt like I saw the big picture, which made it much easier to tackle the puzzle.

MF: What is your proudest achievement?
MM: Keeping a healthy work-life balance is very important to me, and I am proud that I’ve been able to pursue a fulfilling career while raising an adorable toddler, Maisey.

Thank you for being part of our membership community and sharing your story, Melanie. We are glad to hear that the IRB Administrator 101 course helped you gain confidence early in your career, and look forward to seeing you at a future event!

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

Research Ethics Roundup: HIV vaccine trial halted, recovering from Sandy, and more

Hopefully April showers have brought you May flowers! We’ve done some weeding ourselves and have found some articles of interest for this week’s edition of our Research Ethics Roundup.

NIH Stops HIV Vaccine Trial: The National Institute of Allergy and Infectious Diseases halted its HVTN 505 study, the largest HIV vaccine study of its kind, after an independent monitoring board found during a routine interim review that the vaccine failed to either prevent new infections or decrease the viral load of those who were infected. Over 2,500 volunteers in nineteen cities around the country participated in the trial, which began in 2009.

The Psychology of Lying: A New York Times Magazine profile of Diederik Stapel, the Dutch social science researcher who has admitted to faking research results for at least 55 studies, provides insight into his motivations for committing such extensive fraud.

Hurricane Sandy Research Recovery: New York University brain researcher Gordon Fishell shares his post-Hurricane Sandy recovery experience. Most of Fishell’s mice died after their basement animal colony flooded; some of his colleagues lost years’ worth of research. Fishell states that he was overwhelmed with offers from colleagues and competitors to assist him in rebuilding his research program.

Harvard’s Primate Research Center to Close: Harvard Medical School announced that it will be shutting down its New England Primate Research Center over the next two years due to financial uncertainties. The school stated that citations from the US Department of Agriculture in recent years were not a factor in the decision to close the program. All 2,000 primates at the facility will be moved to other laboratories across the country.