Ampersand

Developing an effective QA/QI program

2013-05-24T12:00:00.000-04:00

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

2013-05-21T13:06:00.003-04:00

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

2013-05-17T11:00:00.000-04:00

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!

2013-05-16T17:52:00.001-04:00

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

2013-05-15T16:48:00.000-04:00

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

2013-05-10T10:30:00.000-04:00

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?

2013-05-09T18:02:00.002-04:00

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

2013-05-08T14:05:00.003-04:00

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

2013-05-06T15:45:00.001-04:00

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

2013-05-03T10:30:00.000-04:00

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

2013-05-02T18:35:00.000-04:00

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.

2012 AER Conference: What You Liked

2013-04-30T10:30:00.000-04:00

by Maeve Luthin, JD, Project Coordinator

Yesterday, we shared with you our to-do list of changes for the 2013 Advancing Ethical Research (AER) Conference. Today, we’ll be sharing your favorite aspects of the 2012 meeting:

Eyes Wide Open: Pillars of PRIM&R Memorial Lecturer Elyn Saks, JD, PhD, spoke about the dangers of stigmatizing and stereotyping those with mental illness. We received an outpouring of positive feedback about her talk, with many of you sharing that her presentation completely changed your perspectives on mental illness, and how the mentally ill are treated in research.

The Best Present is Your Presence: Those of you who took advantage of the numerous networking activities offered throughout the conference reported that, in speaking and strategizing with colleagues who face the same challenges, you came back to the office re-energized and ready to ignite change.

Story Time: Those of you who attended the multiple Book Group Lunches, all of which featured talks delivered by the books’ authors, found them to be valuable, unique opportunities to hear the authors speak and answer questions in a smaller setting,

Duck, Duck, Goose (or, Mentor, Mentor, Mentee): Thanks to the enthusiasm of both our volunteer mentors and mentees, the Speed Mentoring event was a success. Participants from both sides of the table found the conversations they shared to be full of meaningful and practical information.
Movie Magic: We had the opportunity to screen the Oscar-nominated documentary, How to Survive a Plague, twice during the conference, and feedback has been uniformly positive. Some of you shared that you remember this time period, and others shared that you were too young to have remembered. However, this film transcended the generation gap and many attendees of all ages wrote about the importance of finding your voice, the power of perseverance, and the responsibility to initiate change.

We hope to deliver yet another successful conference this year, and encourage you to reserve November 7-9, 2013 (with pre-conference programs on November 6) for the 2013 AER Conference, which will be held in Boston. Registration opens June 3 for PRIM&R members, and you can learn more about the conference here.

2012 AER Conference: What You Asked Us to Improve

2013-04-29T10:30:00.000-04:00

by Maeve Luthin, JD, Project Coordinator

We are sending out a big, belated thank you to those who completed the 2012 Advancing Ethical Research (AER) Conference evaluation, and we want to share with you some key feedback we received. Today I’ll be tackling the top five items that you named as most in need of improvement for 2013.

You are cordially invited: We hosted many events during the AER Conference, and many of you told us you enjoyed the social aspects of the meeting. However, you also told us that our repeated invitations to these gatherings were confusing. So we’ll be doing our best to smoothly disseminate information about the events you need to sign up for prior to arriving onsite, while making sure that we don’t send out our invitation emails too often.

Did I RSVP to the wrong session?: Some attendees expressed frustration after attending sessions that covered material tangentially related to what the program indicated would be addressed. There were also instances in which attendees felt that sessions marked “advanced” only focused on basic content. We understand that this isn’t an efficient use of your valuable time, and we are working on ways to make sure that these miscommunications do not occur in the future.

Hide-and-Go-Seek: We heard from many of you that there was a scarcity of sessions exclusively about social, behavioral, and educational research (SBER). We also understand that some of the sessions designated as SBER went off-topic and addressed biomedical issues. We will definitely work on improving offerings for our SBER friends who will be attending the 2013 AER Conference in Boston .

Party Favors: We know that the best “gift” we can share with you, our attendees, is reliable information—such as session handouts and related resources—that will help you work more effectively. Many of you prefer to receive your handouts before your arrival onsite, so you can read them through in advance. However, sometimes these materials are not available until the session begins (or even after), which we understand can be frustrating. We’ll be making a concerted effort to find a better balance in the timing of these “treats” going forward.

Posters, Posters Everywhere: Those of you who attended poster presentation sessions shared your enthusiasm for the posters and their presenters, and asked us to make sure that they are given a more prominent place on the program in 2013. We chose to hold the moderated poster discussions during an evening reception in 2012 to increase attendee awareness about the posters, and it turns out there was probably too much hustle and bustle for listeners to fully appreciate the presentations. Therefore, we’ve already put a plan in place to address this concern in 2013.

Look for another post from us tomorrow about what you liked at the 2012 AER Conference, and thanks again for sharing your feedback!

Witnessing an IACUC Meeting in Session

2013-04-26T18:31:00.000-04:00

On March 19, I was able to view the final plenary session of the 2013 Institutional Animal Care and Use Committee (IACUC) Conference in real time, by attending the conference’s Virtual Meeting; this session was an interactive simulation of an IACUC meeting, complete with fictional scenarios the audience could to respond to via a text-message voting process. Overall, the panel was dynamic and thought-provoking; the four chosen scenarios that were reviewed by the panel of “IACUC members” allowed for an inside look at some of the more nuanced issues these committees face, as well as some of the most effective methods for confronting common challenges.

I found the first scenario particularly interesting. In this case study, an investigator proposed a study to test the ability of a new immunomodulator to inhibit/reduce infection in rats. The puncture group had a 90% predicted mortality rate at four to five days out. The investigator aimed to decrease death or increase survival times. The work had undergone successful peer review through the National Institutes of Health (NIH).

The IACUC’s primary concern was death as an endpoint. The investigator claimed that while other endpoints could predict death, they would not be able to accurately and precisely predict when mortality would occur. As a result, the data may be significantly skewed if alternatives were used. She also claimed that in her previous work at another institution, some animals that appeared moribund actually recovered.

After the protocol was summarized, the panelists examined potential issues in front of the audience, without shying away from the complications that can arise when member attitudes and personalities come into play during deliberations.

In the discussion among the virtual IACUC members, death as an endpoint was explored from several different angles. Since the use of death as an endpoint is extremely controversial, some members suggested the use, instead, of more humane and reliable endpoints, such as inability to feed or decreased body temperature. It was noted that humane endpoints should have been enumerated in her protocol, per the Guide for the Care and Use of Laboratory Animals.

The virtual IACUC members were particularly interested in the length of time between the cecal ligation and morbidity. The fact that this was, on average, four to five days, prompted objections to the protocol on the basis that it might be inhumane. One panelist suggested that this protocol might appear more scientifically acceptable if the investigator had arranged a more aggressive sepsis, which may have made the protocol more humane. Additionally, the role of pain and use of analgesics or anti-inflammatory agents should have at least been addressed in the protocol. The panelists also questioned whether the fact that the protocol had been subject to NIH peer review was relevant to their own considerations. After this discussion, the virtual IACUC members voted not to approve the protocol. 85% of the audience agreed.

When the audience was called upon to participate in the discussion of the protocol, several interesting points were raised. One participant called for an emphasis on cost/benefit analysis in determining the legitimacy of using death as an endpoint. Another individual expressed interest in having the investigator include statistics to provide a more robust justification for the research.

The next three scenarios followed a similar format, yet focused on different IACUC dilemmas.

As someone relatively new to this field, I found this panel to be very informative. I was able to get a firm sense of the way an IACUC works and how it confronts the daily challenges that are faced when approving protocols, looking at continuing review, dealing with noncompliance, and more. And, to top it off, the panelists kept it light and made quite a few great jokes!

Looking forward and looking back

2013-04-25T12:52:00.000-04:00

by Joan Rachlin, JD, MPH, Executive Director

The year was 1975—Saturday Night Live premiered, the Oscar-winning Best Picture One Flew Over the Cuckoo’s Nest was drawing people to the movie theaters, and the first VCRs were developed, allowing us to watch our favorite shows and films at home. Saigon fell, and the Apollo soared into space for a link-up with the Soviet spacecraft, the Soyuz. The Red Sox roared to a first place finish in the American League East, but eventually lost the World Series to the Cincinnati Reds.

I was a second-year student at Suffolk University Law School, studying to become a health lawyer. What I really wanted to become, though, was a doctor, but since not many “girls” were going to medical school in those days, I instead joined the droves heading to law school, hoping to work in the field of women’s health and/or patient advocacy.

True confessions—I was a child of the ‘60s and had grand visions, or, more accurately, grand illusions, about making a difference in the world. I was committed to helping the most vulnerable in society, and resonated with the poet Stanley Kunitz’s question, however rhetorical, “To whom can one pledge allegiance except to the victims?”

As fate would have it, I found a part-time job at a small health law firm here in Boston, Chayet and Sonnenreich, which at that time represented several of the area teaching hospitals. I had a variety of responsibilities, among them taking notes at the dinner meetings of two newly formed organizations: the first was known as CIRBEM, or Chairpersons of IRBs in Eastern Massachusetts, and the second was PRIM&R. I knew nothing about clinical trials or research ethics, and although I had certainly heard about the atrocities that had occurred under the Nazi regime, that seemed long ago and far away.

The issues I heard discussed around those tables—fetal research, testing psychoactive drugs on persons with diminished capacity to consent, research on organ transplantation, and the emergence of recombinant DNA—all fascinated me, and I was hooked. Although these topics grabbed me and held me fast, it was—and has remained—the people with whom I was privileged to work that turned me into a PRIM&R “lifer.”

In preparation for today’s announcement that I will be stepping down as PRIM&R’s founding executive director in early 2014, I have been reflecting upon my engaging and inspiring years at the helm of this very special organization. I have tried to learn from everyone with whom I have come into contact and feel grateful beyond measure for all of my teachers. I have learned about the dignity and worth of any form of work from chambermaids; wisdom from the many “philosopher king” taxi drivers who ferried me hither and yon; empathy, commitment, and dedication from the community of IRB and IACUC professionals; ethics and excellence from the giants on whose shoulders we are standing; extraordinary work ethic, patience, and the meaning of teamwork from my staff; and friendship and kindness from more people than I can count or even remember.

I consider myself the luckiest of individuals to work for an organization that has come to stand for the pursuit of justice, asking the hard questions, and the use of education to erode ignorance. I look forward to keeping those important fires burning in the months to come, and with your help, I know they will continue to burn brightly, as this organization has always been about the whole being more than the sum of its parts.

I wish each of you the same joy, fulfillment, and relevance that I have found in my work. I urge you not to accept the status quo because “that’s the way it is,” but to keep rising ever higher to ensure that we treat everyone the way we would like to be treated. We are all connected by invisible threads, and I hope you will keep working to strengthen and make visible those essential connections.

I’m not going anywhere any time soon, and will be back in touch. Until then, thank you for your support, and please keep it coming to this organization I so love and admire.

Animal research ethics: New resources on science, values, and alternatives

2013-04-23T14:00:00.000-04:00

by Susan Gilbert, Public Affairs and Communications Manager at The Hastings Center

A curious aspect of the debate over the use of animals in research is that the two “sides” see themselves as making different kinds of arguments when in fact they have some fundamental similarities. For example, a recent post in Ampersand discussed the line between emotions and fact in debates over the use of animals in research. It referred to the keynote speech given by Allyson Bennett, PhD, at the 2013 Institutional Animal Care and Use Committee (IACUC) Conference, which characterized animal rights groups as engaging in a “hearts and minds campaign” using imagery and rhetoric about animal suffering. That’s accurate, but it’s not the full story.

Animal activists also marshal facts and use them to make logical arguments. The same can be said of research advocates: they draw on facts and logic, but they also make emotional appeals to the lives saved because of the knowledge gained from animal experimentation.

Many of the educational resources about research with animals come from groups with distinct viewpoints, such as The Humane Society and the National Association for Biomedical Research. And while these materials are authoritative and helpful, my colleagues and I at The Hastings Center, a nonpartisan, nonprofit bioethics research institute, see a need for resources not driven by advocacy.

We began by bringing together people with different views and areas of expertise for a workshop in November 2011 to discuss contemporary issues in research with animals. The group consisted of people on both sides of the debate. A fascinating exchange took place. A laboratory veterinarian argued that there is room for improvement in selecting animals for particular experiments. A laboratory scientist outlined a “paradigm shift” underway in toxicology testing, which aims to replace animals with more accurate alternative models (it turns out that rodents predict human toxicity only 43 percent of the time). A neuroscientist made the case that experiments with monkeys are essential to curing Parkinson’s disease, whereas an animal rights activist asserted that the value of nonhuman primates for research on human diseases is overstated. From this workshop, we created a special report of commentaries and a website: animalresearch.thehastingscenter.org.

The website is designed to be useful to multiple audiences, including members of IACUCs, students in biomedical research and law, and anyone else who is concerned with research ethics. It contains the special report and many other resources. There are fact sheets on animals used in research in the U.S. and alternatives to animal models. There is information on U.S. animal welfare laws, links to major recent reports on the scientific utility and ethics of animals in research, and a bibliography. In the interest of supporting civil and productive dialogue about using animals in research, we also included a glossary of terms on topics whose interpretation is sometimes contested. The glossary is interactive, allowing visitors to submit additional terms.

Given the heated nature of the debate over research with animals, it’s probably unrealistic to expect discourse to be free of emotions. But let’s find strategies that can help shift the focus to facts, foster respectful conversations, and move the debate forward. What can we do to improve the ethics of research with animals? Share your thoughts in the comments.

Susan Gilbert is the public affairs and communications manager of The Hastings Center. She was co-director of the Center’s project on animal research ethics.

Research Ethics Roundup: Proposed changes to the Helsinki Declaration, considering gene patents, and more

2013-04-22T09:54:00.000-04:00

It’s been a busy two weeks in the research world and we have the articles to prove it. Read on to learn about some of the current issues that are impacting research from court deliberations on gene patents and oral history research to revelations about the regulatory and ethical failures of a study involving premature infants.

Supreme Court considers gene patents: The US Supreme Court is considering a case challenging the patents issued to Myriad Genetics for isolating genes that indicate a hereditary link to ovarian and breast cancer. The Court must balance the need for maintaining incentives to conduct scientific research with the need to curb monopolization of research in a particular area.

Study of babies did not disclose risks, US finds: The New York Times reports that the Office for Human Research Protections (OHRP) found that the University of Alabama at Birmingham failed to properly disclose risks of a study on oxygen levels for extremely premature infants. OHRP stated that risks of eye disease, blindness, and death were not properly communicated to the parents of the subjects. The NIH-funded multisite study, which was conducted by twenty three institutions, took place between 2004 and 2009.

Public consultation opens on WMA Helsinki Declaration: A draft revision of the Declaration of Helsinki is now available for public comment through the middle of June. Proposed changes include additional protections for vulnerable groups; more quality and transparency in the functioning of research ethics committees; and a more systematic approach to the use of placebos. Additionally, the issue of compensation of study participants will be addressed for the first time.

Human genome, then and now: National Human Genome Research Institute director Eric D. Green reflects on the game changers that have resulted from the completion of the Human Genome Project, which is celebrating its tenth anniversary this month. Green cites rapidly declining costs for genome sequence testing and the ability to trace disease outbreaks in a matter of hours as examples of the program’s success.

Court rejects appeal over secret IRA tapes at Boston College: The US Supreme Court declined to hear an appeal of a lower court ruling that forces Boston College’s Belfast Project, an oral history initiative, to turn over recordings of interviews conducted with a deceased, convicted Irish Republican Army car bomber. Boston College argued that by doing so, the identities of the other participants would be revealed, thus putting their lives in danger. The US government had subpoenaed the recordings pursuant to a treaty with the United Kingdom, which requires both countries to aid one another’s criminal investigations.

A Message from Our Executive Director about Monday's Bombings in Boston

2013-04-18T09:26:00.000-04:00

Dear friends,

Thank you for your continuing calls, emails, and texts. My co-workers and I feel blessed to be surrounded by such a caring community, especially at times like these. Boston will rebound, but those families who have been touched more directly by this senseless act of violence will never be the same, and our hearts go out to them.

The reaction of Bostonians has been unified and clear: we won’t succumb to the fear and retreat that would hand those who perpetrated this horrific act a second victory. Come next April, we will once again watch the Boston’s Marathon--with its inspiring parade of people of every size, ability/disability, color, culture, age, and “t-shirt-short-story” unique identity, cheer on the Red Sox, and think about Paul Revere and the other courageous Patriots who took the risks necessary to defend their principles. Our City is overflowing with sadness and strength in equal measure, and it has come together in a “we will not be bowed” spirit.

Those who perpetrated these brutal acts want us to stay shaken, afraid, and permanently diminished, so among the things I have resolved to do to fight those instincts is to remember how strong and special a city this is. Join me, please, and check out “29 reasons to love Boston” on BuzzFeed. Please also have a look at one of the many articles that speak of Boston’s determination to transcend this tragedy and the trauma that came with it.

We all want to do whatever we can to heal not just this broken city of ours, but the broken world that gives rise to such terror. Toward that end, PRIM&R has made a donation to the “One Fund Boston” that was set up to help victims of Monday’s tragedy.

Thank you for being part of the PRIM&R family, and be safe and strong today and always.

My best,

Joan

Never stop learning: An interview with Tony Valero

2013-04-12T13:00:00.000-04:00

by Megan Frame, Membership Coordinator

Welcome to another installment of our featured member interviews series where we 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 Tony Valero, institutional animal care and use committee (IACUC) director at Loyola University Chicago Stritch School of Medicine in Maywood, IL.

Megan Frame (MF): When and why did you join the field?
Tony Valero (TV): In 2003 I was recruited as an IACUC coordinator at the Loyola University Chicago Stritch School of Medicine (SSOM) in Maywood, IL. Subsequently, I attended my first PRIM&R IACUC Conference in 2004 in Boston, MA, and I knew that I had a lot of catching up to do in my new profession. I then considered it as a challenge and a worthy career.

MF: What skills are particularly helpful in a job like yours?
TV: I was an IACUC member for five years while I was working as a research scientist at a large pharmaceutical company. It made me aware of the compliance issues that exist when working with laboratory animals. It also helped that I have a Doctor of Veterinary Medicine degree from the University of the Philippines and passed the American Association for Laboratory Animal Science (AALAS) Laboratory Animal Technologist (LATG) certification.

MF: Tell us about an article, book, or document that has influenced your professional life.
TV: The IACUC Handbook, 2nd Edition, by Jerald Silverman, Mark Suckow and Sreekant Murthy. It was the last reference that I used when I studied for my Certified Professional IACUC Administrator (CPIA) exam. Participation in PRIM&R’s IACUC Conferences and the information made available to me from these meetings was also very helpful.

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?
TV: All of the PRIM&R conferences that I have attended have impacted my work. They provide me with updates on compliance matters and freshen my everyday approach to the work that I do.

MF: What advice have you found most helpful in your career?
TV: Never stop learning; I accomplish that through attending conferences, periodically checking out regulatory websites, viewing webinars, and reading emails from IACUC listservs.

MF: What is something you know now that you wish someone had told you when you first entered this field?
TV: Do not work to preserve the status quo and do not reinvent the wheel! There is a lot of information out there that can help to improve your program and bring your institution into full compliance with regulations and best practices.

MF: What is your proudest achievement?
TV: My proudest achievement was when I passed the CPIA exam in the spring of 2011.

MF: What is one thing you wish “the man on the street” knew about your work?
TV: My job is to ensure that animal research subjects are adequately protected, and to promote ethical and responsible research. In other words, my work is to improve the health and care of laboratory and domestic animals.

Thank you for being part of the membership community and sharing your story, Tony. We hope to see you in Denver next year at the 2014 IACUC Conference!

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

Exploring the legacy of unethical research

2013-04-11T15:55:00.002-04:00

by Joan Rachlin, JD, MPH, Executive Director

Last week, Lawrence Altman, MD, The New York Times’ senior statesman of science writing, published a piece titled “Of Medical Giants, Accolades and Feet of Clay.” The article focused on the life and work of Dr. Thomas Parran, Jr., the sixth surgeon general of the United States (from 1936 to 1948). Dr. Parran was, by most accounts, a committed, proactive, and effective “giant of medicine.”

But it was under his watch that two of the most egregious violations of research ethics in this country occurred, and, as a result, the American Sexually Transmitted Disease Association (ASTDA) is now debating whether or not to remove Dr. Parran’s name from the eponymous award that is conferred annually for “lifetime achievement in preventing and controlling sexual infections.” These two studies were funded and conducted under the aegis of the United States Public Health Service during his tenure, and both are well known to those in the PRIM&R community. Despite that, I’d like to provide a brief recap of each study and then ask whether you think Dr. Parran’s name should be stripped from the ASTDA award.

The "Tuskegee Study of Untreated Syphilis in the Negro Male," which was carried out from 1932 to 1972, was designed to observe and record the natural course of syphilis in black men who were living and working as sharecroppers in Macon County, Alabama. Of the 600 subjects who were enrolled in the study, 399 in the experimental group had the disease and the rest were used as controls. At the outset of the study, there was no treatment for syphilis, but in 1947, penicillin became standard therapy for the disease. Despite its availability and efficacy, though, the drug was not given to either the infected men or those being used as controls. A number of the subjects died during the course of the study, and many of their wives, children, and sexual partners were infected.

There was no informed consent, and the men were never told the truth about the study; instead, they were told that they were being treated for “bad blood,” which was an umbrella term used at that time for sexually transmitted diseases, anemia, and other blood disorders. The men were enticed into participating by the promise of medical care, free meals, rides to the clinic, and, perhaps most importantly for these impoverished individuals, burial insurance. It was only when Peter Buxtun, a courageous epidemiologist studying sexually transmitted diseases, leaked word of the study to reporter Jean Heller that the world learned of this volcanic violation of human rights, ethical principles, and medical precepts. Ms. Heller’s story appeared in the Washington Star on July 25, 1972, and was picked up by The New York Times the following day. A public outcry ensued, an advisory panel was convened, and the study was subsequently terminated. Years later, in 1997, a formal apology was issued to the survivors, their families, and to the families of the deceased men by President Bill Clinton.

The second study that occurred under Dr. Parran’s watch wasn’t exposed until October 2010, when Wellesley College professor and medical historian, Susan Reverby, reported in a journal article that physicians from the United States had deliberately infected Guatemalan prostitutes, prisoners, soldiers, and mental patients with syphilis, gonorrhea, and chancroid. The U.S. researchers enlisted Guatemalan health ministries and officials in this study, and before it ended, nearly 700 men and women had been exposed to these infections without their informed consent. Unlike the Tuskegee study, the subjects in Guatemala were given antibiotics, but the records don’t indicate whether or not they were successfully treated. Dr. John Charles Cutler, who worked on the Tuskegee research, was the principal investigator in the Guatemalan study. According to the article, Dr. Parran told a colleague at the time that “the Guatemalan experiments could not have been conducted in the United States.” In October 2010, both then Secretary of State Hillary Clinton and Department of Health and Human Services Secretary Kathleen Sebelius formally apologized to Guatemala for conducting these experiments.

Dr. Altman, in the best journalistic tradition, reports “just the facts, ma’am,” and leaves the conclusion-drawing task to the readers. If you were on the ASTDA committee being asked to decide the future of the Parran Award, what would you recommend? Would, as the article suggests, retaining his name and including the full story of his involvement in these amoral studies be a useful consciousness raising reminder? Or, does the ignominy of his involvement trump the many productive things he did in the course of his career and tarnish the meaning of the award? In any case, the New York Times article reminds us that tending the research ethics flame requires courage, commitment, consistency, and constancy, and I thank you for your vital and essential work as flame tenders.

Research Ethics Roundup: The implications of publishing the HeLa genome without consent, new guidance on incidental findings, and more!

2013-04-05T11:52:00.000-04:00

Do April showers have you stuck indoors? Take a moment to peruse the latest installment of our Research Ethics Roundup. This week’s issue features articles on a wide range of topics, including how history should remember researchers with checkered pasts, why science tends to favor positive results, and much more.

Building public trust in genomic research: In this response to Rebecca Skloot’s op-ed about Henrietta Lacks’ DNA being sequenced and publicized without consent, author Michelle Huckaby Lewis, MD, JD, raises some very interesting and important points about public trust and privacy in genomic research. Of particular concern to Lewis is the possibility of de-identified blood samples—the use of which does not require consent under current regulations—being re-identified through sequencing. She argues that more extensive privacy protections for possibilities such as this are a necessary component of building public trust.

Incidental findings from genome sequencing – nuances and caveats: The American College of Medical Genetics and Genomics recently released a report containing recommendations for the reporting of incidental findings in clinical exome and genome sequencing. This blog post from Scientific American highlights twelve key points from that document, including which genes should be analyzed for mutations when examining a genome, and whether a patient may opt out of notification of incidental findings.

How health research misdirects us: This article from The Atlantic highlights a concerning trend in scientific publishing—namely, that positive results are disproportionately likely to be published. The author cites an incentive structure that rewards positive results, both financially and academically, as a possible explanation. The tendency to overlook negative trial results may lead to a proliferation of false positives that may incorrectly influence medical knowledge.

Of medical giants, accolades and feet of clay: The complex history of Dr. Thomas Parran Jr., which includes both a courageous and largely successful campaign to destigmatize and treat venereal disease, as well as an endorsement of two of the most egregious examples of misconduct in American medical history, has resulted in a thought-provoking debate: Should the scientific community continue to recognize the achievements of those individuals who also participated in unethical research? This question has come to a head as the American Sexually Transmitted Diseases Association considers changing the title of a prestigious, 40-year-old award named for Dr. Parran.

Looking for more news? PRIM&R members can visit our Knowledge Center to find more recent scholarly journal and popular media articles pertaining to research ethics. Not yet a member? Learn more about becoming a member by visiting our website.

Tailored human subjects protection training for community research partners is key

2013-04-03T10:27:00.001-04:00

by Emily E. Anderson, PhD, MPH, Assistant Professor of Bioethics, Loyola University Chicago Stritch School of Medicine

Academic investigators who partner with communities to conduct research face many challenges. But many find that the rewards of collaborating, such as increased community trust and support and better recruitment and retention rates, are worthwhile. And communities benefit from these collaborations by receiving health-related programming, skill and capacity building, data, grants, and maybe even a few jobs.

There’s a lot of talk these days about community engagement in research—from community advisory boards providing input on project materials, to partner organizations helping to get the word out about participation opportunities or key findings—and the number of community-based institutional review boards (IRBs) is growing. Somewhat less attention has been paid to the involvement of community members in the day-to-day implementation of research studies, such as directly recruiting participants, obtaining informed consent, and collecting data. But when it comes to human subjects protections, this is where the proverbial “rubber hits the road.”

When community research partners with no previous research experience or training take on these roles, first and foremost, they need to be trained—not only so that they can do their job well, but also to comply with federal requirements. But most available research ethics training programs are primarily geared toward learners who possess some research experience and working knowledge of research methods – like graduate students or junior faculty. They do not usually address the unique context of community-engaged research, and therefore may not be well-received by community partners. A mismatch between the training needs of community partners and existing training programs can result in limited understanding of key concepts and rules. Community research partners may also feel disenchanted or uncertain about the research process if what they are learning isn’t directly relevant to what they will be doing.

Human research protections training should provide relevant, meaningful information and skills to help community partners translate their unique knowledge and skills to research collaborations. In order to help institutions and research teams around the nation meet this goal, the Center for Clinical and Translational Science (CCTS) at the University of Illinois at Chicago (UIC) developed CIRTification: Community Involvement in Research Training. CIRTification is designed specifically for community research partners with little or no prior research experience. CIRTification curriculum materials can be downloaded for free on our website. FAQs, materials, and more information to help you get started offering CIRTification to your community-engaged investigators and research teams are also available on our site.

Ideally, using tailored training materials like those available from CIRTification will not only teach community research partners about the importance of protecting research participants, but also enhance the overall contribution that they are able to make to their respective research teams towards the goal of becoming co-researchers. I welcome you to take a look and share what you think of these resources in the comments.

Emily Anderson is currently assistant professor in the Neiswanger Institute for Bioethics at the Loyola University Chicago Stritch School of Medicine. She developed CIRTification while she was working at UIC and expresses sincere gratitude for the input she received from a variety of community research partners, academic investigators, and IRB professionals.

Walking the line between emotion and fact: Advocating for animal research

2013-04-01T14:59:00.000-04:00

by Avery Avrakotos, Education and Policy Coordinator

What do you picture when you think of animal research? What has shaped that image? More likely than not, the public discourse surrounding animal research has had an impact.

Ever since the story of Pepper the Dalmatian was featured in Sports Illustrated in 1965, powerful imagery has accompanied the discussion of animal research in the news media. Photographs depicting animals that appear to be suffering have been pervasively employed by animal rights groups to gain public support. Graphic ad campaigns and protests have effectively fostered public unease with animal research.

Recently, at the 2013 Institutional Animal Care and Use Committee (IACUC) Conference, keynote speaker, Allyson Bennett, PhD, discussed the efforts of animal rights groups to engage in what she described as a “hearts and minds campaign.” Bennett, a developmental psychobiologist at the University of Wisconsin—Madison, whose own work with primates has drawn the attention and ire of animal rights groups, has seen firsthand how evocative imagery, harassment campaigns, and threating language can create a climate that silences researchers and animal care and use professionals.

Bennett argued that the use of powerful, emotional rhetoric also “starts to shift our culture into believing, maybe subconsciously, that all [researchers] are actually maybe kind of guilty until proven innocent and that has an effect.” For proof of this cultural shift, one does not have to look farther than Google. Displaying the top ten image search results for the term ‘animal researcher,’ Bennett convincingly demonstrated her point; the work of animal rights activists to portray animal researchers negatively has been successful.

It is in this climate, then, that Bennett called upon the audience to act and speak out. She argued that in order to change public opinion the onus is on researchers—the majority of whom care just as deeply about the welfare of animals as the public does—to engage in fact-based dialogue about the full range of harms and benefits of animal research. “When they have questions, answer them. Don’t leave the microphone empty,” Bennett implored the audience. She continued, “Reasonable people are listening and they want to hear from us to make an informed decision.”

The reticence of animal researchers and animal care and use professionals to speak publicly about their work has cleared a path for animal rights activists to paint the picture they want of animal research in the media. But the media, in turn, has also undoubtedly played a role in the public’s understanding of animal research. Plenary speaker, Greg Miller, PhD, staff science writer at Wired, spoke to the role of journalists in reporting on animal research, but also offered insight into the role of researchers and animal care and use professionals in shaping public opinion.

Miller explained, “In the discourse such as it is about animal research, activists, I think, have erred on the side of arguing from emotion using graphic images of animals and that sort of thing to tug on the heartstrings of the public to make their case. But, I think the research community ignores emotion at their peril.” Not engaging with the public in a dynamic, passionate way does little to combat the perception already ingrained in the public’s mind, Miller contended.

Both Bennett and Miller encouraged the audience to link the work being done in laboratories—from the basic science to the cutting edge protocols—to tangible innovations that the public can see and appreciate. But, is that enough? In an emotion-laden debate, are animal researchers at an inherent disadvantage? Can stories of hope, survival, and medical innovation affect the public’s impression of animal research? What strategies can animal care and use professionals use to engage in and change the tone of this conversation? Share your perspectives in the comments.

Understanding the greased and malleable nature of online and social media research

2013-03-29T14:43:00.002-04:00

by Alexandra Shlimovich, Online Learning and Certification Coordinator

On March 12, 2013, PRIM&R hosted a webinar titled Online Research, Social Media, and the IRB: Assessing Ethics, Norms, and Risks. The presenters, Elizabeth Buchanan, PhD, and Joseph Konstan, PhD, answered many questions from the attendees during the lively question and answer period following this program. After the conclusion of the webinar, we asked Elizabeth and Joe to consider the remaining questions, and I’m pleased to share their answers with you today.

AS: Can you clarify what a crowdsourced dataset is, and provide examples, if possible?
EB & JK: Crowdsourcing is defined as "the practice of obtaining needed services, ideas, or content by soliciting contributions from a large group of people, and especially from an online community, rather than from traditional employees or suppliers." It has been used in an array of research activities and one of the most well-known is the Mechanical Turk Workforce, which is a “marketplace for work that requires human intelligence.”

Specific concerns for institutional review boards (IRBs) include considerations of identification of workers' privacy (usernames can be easily correlated with the individual's Amazon account, among other things), incentives/payment to individuals (a typical payment is under $1.00), legal eligibility for participating in research activities, and jurisdictional issues.

Many examples of crowdsourced projects are listed here; some of these are not datasets but crowdsourced activities. In addition, the literature is full of fascinating discussion on crowdsourcing. Just a few examples include:

Crowd-sourced data hold potential for positive change and human rights abuses (Scientific American)
The Roar of the Crowd (The Economist)
Crowdsourced Health Research Studies: An Important Emerging Complement to Clinical Trials in the Public Health Research Ecosystem (Journal of Medical Internet Research)

AS: What is the overarching approach to recruitment via research-specific Facebook pages or Twitter accounts? Is this generally allowed and what are the stipulations?
EB & JK: The Office of Human Research Protections (OHRP) considers subject recruitment part of informed consent; therefore, the recruitment plan must receive IRB review and approval prior to initiation. Many types of social media are used for recruitment, including: Twitter feeds, blog posts, YouTube videos, robocalls, and text messages. In terms of clinical trials website recruitment, OHRP offers the following guidance.

No IRB review is needed for descriptive information, such as:

study title;
purpose of the study;
protocol summary;
basic eligibility criteria;
study site location(s); or
how to contact the study site for further information.

IRB review is needed if additional information is provided, such as:

description of research risks/potential benefits;
solicitation of identifiable private information (e.g. eligibility survey); and
incentives – monetary and non-monetary.

The IRB will review the recruitment plan, but not the actual web page. However, screen shots of the web pages may be helpful to the IRB, so it is good practice for researchers to provide them along with information from the forum or site that explains the "rules" or "practices" for recruiting participants and conducting research on the site. These are often found in FAQs or use/user agreements. In addition, the nature of social media could generate additional risks when they are used for recruitment, as individuals' social media profiles may reveal that an individual visited a recruitment site. This is what we mean by the "greased and malleable" nature of social media data, specifically, if recruitment methods can identify individuals, researchers must consider potential harms downstream, and whether such risks are minimized.

AS: Can you suggest any "rules of conduct" or other resources that an IRB can make available to researchers interested in conducting internet research?
EB & JK: Some resources include:

You may review the complete question and answer session here. If you’re interested in learning more about this topic, but did not have a chance to participate in last week’s webinar, the archive is available for purchase.

Can an ethical framework for conducting animal research be modeled after the existing framework for conducting human research?

2013-03-28T10:09:00.001-04:00

by Amy Davis , Senior Director for Programs and Publications

During the final series of breakout sessions at the 2013 IACUC Conference there was a discussion of the Implementation of the Institute of Medicine (IOM) Report on the Use of Chimpanzees in Biomedical and Behavioral Research. Hope Ferdowsian, MD, MPH, moderated the discussion which featured Tom Beauchamp, PhD; Margaret Landi, VMD, MS, DACLAM; and David Wendler, MA, PhD.

Dr. Landi set the stage by presenting a summary of the 2011 IOM report, explaining that the committee’s charge was to develop a report on whether and under what circumstances it was necessary to use chimpanzees in either biomedical or behavioral research. (For more information, view the report here.)

For biomedical research, research with chimpanzees is justified only when the following conditions are met:

There is no other suitable model available, such as in vitro, nonhuman in vivo, or other models, for the research in question, and
The research in question cannot be performed ethically on human subjects, and
Forgoing the use of chimpanzees for the research in question will significantly slow or prevent important advancements to prevent, control and/or treat life-threatening or debilitating conditions.

The use of chimpanzees for behavioral research is justified only when:

Studies provide otherwise unattainable insight into comparative genomics, normal and abnormal behavior, mental health, emotion, or cognition, and
All experiments are performed on acquiescent animals, in a manner that minimizes pain and distress, and is minimally invasive.

Applying these criteria to current practices, the IOM Committee concluded in 2011 that while the chimpanzee has been a valuable model in the past, there is decreasing need for such studies given the increasing availability of alternative models and technologies.

Dr. Beauchamp continued the discussion by pointing out the challenges of developing a report under the conditions established by the National Institutes of Health for the project, which included the single animal model and the instruction not to consider the ethical issues. In spite of these limitations, the IOM Committee succeeded in producing a significant report that changes the landscape of chimp research by establishing comparatively restrictive criteria for justifying such research. As an example, he pointed out the criterion that limits behavioral research to “acquiescent” animals, establishing a relatively high level of respect for the chimpanzee.

Dr. Beauchamp criticized the IOM report’s lack of consideration of the “moral costs” of using chimpanzees in research. He sees a need for a new standard defining a pain threshold. Given the increasing difficulty to justify such research, Dr. Beauchamp predicts its imminent cessation.

Dr. Wendler focused on the question of whether an ethical framework for conducting animal research could be modeled after the existing framework for conducting human research. He presented three areas of inquiry for analyzing the question: research value, level of risk, and assent/dissent.

Research value: Human subjects research is justified only when the risks are reasonable in relation to the potential benefits. Most research using chimpanzees is solely for the benefit of humans, not chimpanzees. Dr. Wendler asked whether we can justify non-beneficial research on sentient beings, particularly ones who cannot consent to such research? The IOM principles are relevant to the question of research value in that they limit research with chimpanzees to studies necessary for advancing a public health goal that could not be otherwise accomplished. The question remains, however, whether such research should be further limited by requiring potential benefit for the animal subjects.

Level of risk: Dr. Wendler asked whether animal research ethics framework should include a risk threshold. Under the human research regulations risk is measured against a comparator. Are the risks of the research greater or less than those of daily life activities? Dr. Wendler presented the standards for permissible research involving children as a useful model for research involving chimpanzees given the comparably limited capacity to consent to such research. For research involving children, federal regulations present different requirements for potential benefit depending on the level of risk to the child subjects. Dr. Wendler wondered whether this framework could be adapted to some extent to animal research by establishing a range of “burden” levels based on potential for pain and suffering. In general, observational studies would be considered minimally burdensome, while some pain and suffering would be considered moderately burdensome, and prolonged pain, suffering would be considered highly burdensome. Each level would require increasing potential for benefit.

Assent/Dissent: Finally, Dr. Wendler examined the applicability of the assent requirement in research with children to research with animals. With children and other populations who do not have the capacity to consent, researchers consider the preferences of potential subjects. The IOM report referred to “acquiescence” as a requirement for behavioral research with chimpanzees. Is acquiescence too passive a standard? Should there be an effort to assess “assent?” Should researchers consider the animals’ expression of dissent as they would in a child? And then where do you draw the line for this requirement? While it might be possible to discern assent in a chimp, it may not be for a rabbit, for example.

Given advances in technology and the decreasing need for certain animal models, is now the time to develop an ethical framework for conducting all animal research? What do you think? Please share your opinions below.