Featured Member Profile: Fredeswinda Rivera Ocasio

Welcome to another installment of our featured member profiles where we introduce you to a PRIM&R member who works to advance ethical research on a daily basis. Please read on to learn about this member’s professional experiences, perspectives on  membership, and personal outlook.

Today we’d like to introduce you to Fredeswinda Rivera Ocasio, institutional review board (IRB) administrator at the Inter American University of PR in San Juan, Puerto Rico.
   
When and why did you join the field?
I joined the field in 2000 when my institution decided it was the right time to start moving from a purely educational institution to one that includes research as a part of the learning process. At the same time, my institution confronted the “reality” that research compliance was here to stay.

What is your favorite part of your job?
My favorite part of the job is the constant learning and the interdisciplinary aspects of my role.

What do you most value in your friends?
I value honesty and strong personal values.

Why did you join PRIM&R?
To be able to network with colleagues, share field knowledge, and learn, learn, learn!

What is your favorite member benefit?
The educational resources PRIM&R makes available for members and the chance to be able to network with colleagues annually.

What would you say to someone who is considering PRIM&R membership?
Go ahead!!! It’s an excellent experience that is not to be missed!

What do you believe is a key challenge facing the field of research ethics?
Ensuring that institutions and researchers alike understand that following  high ethical standards can, and will, result in extraordinary research.

Thank you for being part of the membership community and sharing your story, Fredeswinda. We hope to see you again in San Diego at the 2012 Advancing Ethical Research Conference this December!

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

Time Capsule Tuesday: “I just keep thinking that it could be said in a simpler way.”

Marcia Ellis, chair of the Board of Directors of The Women’s Collective and an HIV/AIDS advocate, lent her perspective to the Living Room Conversation titled In Their Own Voices: What Do Research Subjects Have to Say About Informed Consent at the 2011 Advancing Ethical Research Conference.

In this excerpt, she laments the complexity of the informed consent form—an ongoing issue in the field of human subjects protections. What initiatives has your institution undertaken to increase the accessibility of these forms?  We welcome you to share in the comments.

Research Ethics Roundup: Examining the nocebo effect, new clinical trial rules in India, and more!

India plans to reform oversight of medical research, while Harvard University agrees to restructure  their Primate Center. Learn about these changes and more in this week’s Research Ethics Roundup!

Testing what we think we know: This opinion piece from The New York Times posits that researchers ought to spend less time investigating novel technologies, and more time evaluating whether standard treatments are actually effective and efficient.

Beware the nocebo effect: Though the positive effects (both real and imagined) of placebo treatment are well documented, less attention is paid to the negative impact of sugar pills. The author of this article believes that “the nocebo effect”, or the manifestation of negative side effects in patients taking a placebo, can be mitigated through careful word choice when describing potential side effects to patients.

India shakes up rules on clinical trials: In an effort to increase ethical oversight in Indian clinical trials, regulators have released detailed proposals on planned reforms. Proposed changes aim to encourage safe and innovative research.

Panel recommends changes at Harvard Primate Center: An independent panel of scientists and veterinarians enlisted by Harvard Medical School to review its troubled primate research facility in Southborough—the New England Primate Research Center—is recommending that new leadership positions be created and a committee be formed to assure animal safety and foster closer ties with the medical school.

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.

Book Review: Open Wound explores early medical research and the roots of human ambition

by Ariella Green, MSc, program planner

Medical historians may be familiar with the story of Dr. William Beaumont, but Jason Karlawish casts it in a new light in his novel, Open Wound: The Tragic Obsession of Dr. William Beaumont. The story is fascinating on many levels, but it is Karlawish’s portrayal of Beaumont’s unstoppable, desperate, and almost dangerous ambition that takes center stage in this engaging historical account.

In 1822, on a remote army outpost in Northern Michigan, a misfired shotgun leaves a wound in the torso of a young fur trapper, Alexis St. Martin. The young man seems certain to die, and is therefore deemed by the company unworthy of expensive medical treatment. William Beaumont, an assistant surgeon in the Army, defies his orders and, surprisingly, saves the young man’s life. St. Martin is left with both a permanent hole in his side, as well as a sizable debt of gratitude to the surgeon. Desperate to advance his career and achieve the recognition he feels he deserves, Beaumont immediately recognizes the value of St. Martin’s wound as a window into human digestion, and capitalizes on the opportunity to make St. Martin the subject of experiments he hopes will improve his fortune.

Karlawish deftly renders Beaumont as a man who endeavors to overcome his humble beginnings to gain respect and admiration as a surgeon. He has no formal training in medicine, and constantly judges himself against his university-trained peers. He is a man the reader may find difficult to like, but who personifies an intensely American determination to rise above his past. Convinced of his own greatness, but crippled by self-doubt, Beaumont cannot resist the opportunities offered by St. Martin’s condition, and eventually succumbs to his own ambition.

St. Martin is more than just Beaumont’s patient; he is his salvation, and his downfall. For St. Martin, Beaumont is a doctor and a savior, but also his jailer and benefactor. The two are locked in a complex dance of hostility, need, and codependence. Whose rights are more important: the doctor, who saves his patient’s life and seeks to advance medicine (as well as himself); or the patient, who is young and irresponsible, but a free man who can choose to walk away?

In his own time, Beaumont was criticized for his treatment of St. Martin and ultimately remained an obscure medical presence, undermined by the very ambition that dictated his life. But the story of the man with the hole in his side remains important, not only as a narrative of the early days of medical research and the emerging ethical issues, but as a cautionary tale and case study of that most American of personality traits – ambition.

Breaking Down the Solitudes in Research Participant Protections

by Michael McDonald, PhD

Michael McDonald is emeritus professor of applied ethics at the W. Maurice Young Centre for Applied Ethics in the School of Population and Public Health at the University of British Columbia and the webmaster for  Quality Improvement for Research Ethics (QI4 research ethics).

It often seems to me that there are three solitudes in research participant protections:

1. Institutional review board (IRB) members and staff;
2. Researchers; and
3. Research participants.

Despite having a shared commitment to the protection of research participants, communication between these groups can be limited, and in some cases, the groups may be largely unaware of one another.

In these mutual solitudes, it is easy to develop misconceptions of one another because there is no practice of direct exchange. This happens for understandable reasons: IRBs are often understaffed and overworked, researchers face intense competitive pressures, and participants often deal with difficult individual life circumstances.

However, the results of this are unfortunate. Mental images are filled with stereotypes—the evasive researcher, the sclerotic IRB, and the passive research subject.  Misunderstandings occur, and important opportunities for more meaningful and less burdensome participant protections are missed.  Most importantly, the very object of concern in human research protections—the research participant—is rarely given a real voice in the process.

It was with this in mind that a group of us from the Canadian Network for the Governance of Ethical Health Research Involving Humans came together in the summer of 2011 to brainstorm about developing tools for improving communications among these groups. 

What we ultimately developed, field tested, and put on online were three free, easy-to-use surveys for canvassing the attitudes and beliefs of these stakeholders.  The surveys provide rich quantitative and qualitative data that can be used to understand the perspectives of others, and are easily modifiable for local circumstances. 

You can access these surveys on our website, Quality Improvement for Research Ethics (QI4 research ethics).  These surveys are meant to enhance communications rather than to audit or enforce policies or regulations.  We have found that the surveys can be a vital first step for improved protections that address the needs of participants as expressed by participants.

I invite you to take a look at our website, give the surveys a try, and let me know what you think.

Let’s work together to break down the solitudes in research protections for the benefit of all concerned—particularly research participants.

Featured Member Profile: Brandon Jonson

Welcome to another installment of our featured member profiles where we will continue to 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 Brandon Jonson, regulatory associate, institutional animal care and use committee coordinator, conflict of interest coordinator, scientific review board coordinator, and institutional biosafety committee coordinator at MedStar Health Research Institute in Hyattsville, MD.

When and why did you join the field?
I joined the field when I was looking for a change. I was working in childcare for six years and a parent suggested coming to work for her. I joined her independent institutional review board (IRB) in 2007.

What is your favorite part of your job?
My favorite part of the job is the fact that I learn something new every day. That is very exciting to me.

What is the last movie you saw? What is your after-hours guilty pleasure? And what do you most value in your friends?
The last movie I saw was American Reunion. My after-hours guilty pleasure is sports, and the quality I value most in my friends is loyalty.

Why did you join PRIM&R?
I joined PRIM&R to learn more about the field and to improve my ability to perform my job responsibilities.

What is your favorite member benefit?
Attending the conferences and making new connections with other research ethics professionals.

What would you say to someone who is considering PRIM&R membership?
The membership is definitely worth it. The wealth of knowledge and information available is incredible. In the last two years, I have learned so much.

What motivates you to maintain your commitment to advancing ethical research?
Finding a way to encourage more young people to take an interest in research ethics, and finding people willing to learn and explore the various types of research taking place.

Thank you for being part of the membership community and sharing your story, Brandon.

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

Conducting a Risk/Benefit Evaluation For IACUC Proposals

by Farah Moulvi, MSPH, Institutional Animal Care and Use Program Manager and Biosafety Officer at the University of South Flordia

In sunny Florida, as summer sizzles on, I keep reminiscing about the buzz surrounding the Eighth Edition of the Guide for the Care and Use of Laboratory Animals (Guide) at the 2012 Institutional Animal Care and Use Committee (IACUC) Conference, including a very fruitful discussion on the new “harm/benefit” statement.

Page 27 of the Guide indicates that animal use protocols with a potential for unrelieved pain or distress or other animal welfare concerns should be scrutinized thoroughly and evaluated by the IACUC. More specifically, the Guide states that “the IACUC is obliged to weigh the objectives of the study against potential animal welfare concerns." This seems to indicate that, for studies involving potential for pain and distress, the IACUC should conduct a harm/benefit analysis.
A harm/benefit analysis is analogous to cost/benefit and risk/benefit analyses, both of which are not new to the IACUC world, and is conducted through the application of the three R’s (replacement, reduction, and refinement).

A well-designed IACUC application requires a principal investigator (PI) to provide a rationale for the proposed research that explains the potential scientific benefit and the study’s relevance “to human or animal health, the advancement of knowledge, or the good of society,” as stated in the US Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training.

Although not specifically stated as harm/benefit analysis, the Animal Welfare Regulations, Public Health Service Policy, and the Guide all instruct IACUCs to evaluate protocols by weighing the potential for scientific gains (“benefits”) versus potential animal welfare concerns, pain, distress and discomfort (“harm”).

IACUCs must also consider the magnitude and severity of harm, and the significance of the scientific benefit. If the potential benefit is significant and potential harm minimal, the IACUC may consider approval. If, on the other hand, the potential benefit is significant and potential harm significant, the IACUC should consider implementing contingencies for the protocol’s approval, such as guidance from experts, a pilot study to assess outcomes increased frequency of observations, periodic progress reports, , post-approval monitoring, increased frequency of IACUC review of the protocol, or retracting “approval” based on outcomes.

Additionally, if the potential benefit is minimal, and potential harm is significant, the IACUC can withhold approval or require significant modifications to adjust the potential for harm to more reasonable levels.  These modifications should address factors such as assessment for humane endpoints through frequency of observation, criteria for monitoring severity of pain and distress, defined point(s) and nature of intervention, and training of individuals assigned for animal pain assessment and monitoring. The IACUC must not approve research in which the risks are judged unreasonable in relation to the anticipated benefits.

An IACUC’s harm-benefit review should evolve over time as new procedures and techniques are developed, as old ones are refined, and as set precedents are adjusted. What are the innovative enhancements or fine-tuning that your organization has developed in order to comply with and document the harm/benefit evaluative process? Please share with us before you head off for the summer sizzle, the barbecue grill, and, hopefully, the sunscreen.

Poster Spotlight: Perspectives of Egyptian Chairs of Research Ethics Committees Regarding Barriers that Affect Proper Functioning

by Avery Avrakotos, Education and Policy Coordinator

Preparations for the 2012 Advancing Ethical Research (AER) Conference  are gearing up, and I for one am getting excited about the annual poster presentations. To channel my excitement, I reached out to some of our past presenters to find out what they have been up to. This week, I chatted with Amal Matar, PRIM&R’s 2010 Pillar of PRIM&R Award recipient, to see how her work has progressed since she shared her work at the 2011 AER Conference.

In 2011, Amal and her colleagues conducted in-depth interviews with research ethics committees (RECs) throughout Egypt. Using the interview data, the team was able to pinpoint common issues that impede the proper functioning of RECs in the region.

Avery Avrakotos (AA): It’s been a year since you presented this abstract at the 2011 AER Conference.  How has your research since evolved?
Amal Matar (AM): I am writing the final part of my thesis now. However, it seems that more than one paper might emerge—we are planning to write one paper on research ethics in Egypt and another on the perspectives of different research stakeholders on RECs and research ethics in general. We are also trying to expand the original research we presented at the 2011 AER Conference to involve Arab and Eastern European countries. I have already communicated with participants in a few Arab countries like Jordan, Saudi Arabia, and Lebanon. I am planning a trip to Europe to attend two conferences and I am hoping to be able to recruit participants from the Czech Republic and other Eastern European countries. Wish me luck!

AA: What challenges have you faced in implementing this research?
AM: My research is qualitative. It built a hypothesis that will require further testing. At this stage, there was nothing really to implement. Maybe when it gets published someone will be interested in testing the hypotheses I put forward.

AA: What is one principle that has guided you in your research?
AM:  Amid the chaos and political unrest in Egypt being focused and persistent is important.

Thank you for sharing, Amal! We hope that you will consider joining us at the 2012 AER Conference.

Research Ethics Roundup: The latest on the H5N1 moratorium, regulating online research, and more!

In this week’s Research Ethics Roundup, hear the latest developments in the H5N1 debate, explore one doctor’s plan to minimize research misconduct, and learn about a recent study that found that some physicians may be doing research for all the wrong reasons.

Private-sector physicians run clinical trials mostly for the money, study finds: There has been a dramatic shift in those conducting most clinical trials from academically-affiliated physicians to private-sector physicians. A new study suggests this shift might be the result of big money’s influence over medical research, with many doctors thinking of trials as business ventures rather than scientific endeavors.

NIAID director urges continuation of H5N1 research moratorium: National Institute of Allergy and Infectious Diseases (NIAID) director Anthony Fauci has recommended that the self-imposed, six-month moratorium on experiments with H5N1 remain in effect until the benefits can be better justified to the public. Research on the H5N1 virus generated a lot of attention due to a lack of transparency combined with the virus’ high potency and potential for spreading.

To deter research misconduct, diminish fears of failure, detection: In light of increasing reports of research misconduct, one professor has offered a potential solution. Donald Kornfeld, MD, believes that cases of misconduct that result from trainees who are afraid of academic failure, and faculty who are convinced of their ability to avoid detection—the majority of reported cases—could be minimized through the implementation of strong mentoring and whistleblower programs.

When medical muckraking fails: In this piece, Carl Elliott attributes lack of successful medical muckraking stories over the past 40 years to the advent of the institutional review board (IRB) system. The author argues that because so many people are professionally invested in the system, which he views as secretive and inefficient, there is a strong resistance to any major change regardless of its potential benefit.

Government panel updating rules for online research: The internet has had a profound effect on many aspects of research. As government officials debate changes to the current regulations surrounding research, special attention is being paid to the relatively new online frontier. Among the topics discussed in this article are the definition of public space online, what constitutes a human subject, and how consent should be obtained.

The Curious Case of IRB Voting

Laura Stark, PhD, serves as an assistant professor of medicine, health and society at Vanderbilt University. Her research focuses on medicine, morality, and the modern state. Her recent publication, Behind Closed Doors: IRBs and the Making of Ethical Research, explores the development of human subjects protections regulations and the manner in which these rules are played out within institutional review boards (IRBs) today. Stark will be onsite at the 2012 Advancing Ethical Research (AER) Conference to lead a research ethics book group lunch and sign books on Wednesday, December 5. Leading up to her talk, Stark will be sharing a series of blog posts based on her book. For more information and to register for the book group lunch, please visit our website.

As Americans count down to the November presidential election, one thing is certain: neither candidate will win a unanimous vote. President Barack Obama and Governor Mitt Romney can only dream of getting the same level of consensus from American voters that IRB members reach in their decisions on protocols. Think back to your last full-board meeting. At the end of deliberations, were there any split decisions or were all of the votes unanimous?

Voting is typically thought of as a way to settle disagreements. Yet at the end of IRB meetings, boards rarely report split decisions. A board with ten members will be more likely to report a 10-0 decision rather than a 6-4 decision about whether to to approve, request modification, or decline approval of a protocol.

What explains this distinctive approach to voting, and why does it matter?

Critics often claim that IRBs create bureaucratic road blocks and do little actually to protect research participants or encourage greater respect for human rights. From this view, it would be easy to read IRBs’ unanimous votes as thoughtless votes—as bureaucratic formalities rather than as end products of hefty moral, legal, and scientific debates.

As a social scientist, I studied three IRBs intensely over the course of one year, and some critics might be surprised by what I found.  Board members typically started meetings with serious disagreements over protocols. There were no gnashing teeth and slashing claws, to be sure. IRB members, instead, had respectful and honest differences of opinion. Yet by the end of the meetings, everyone agreed with the best course of action. They voted. And the outcomes were almost always unanimous. The puzzle was how members moved from disagreement to unanimity—with civility and swiftness.

I found that IRB members used what I call “warrants for expertise.” Warrants are people’s reasons for holding their opinion or taking action. We often use warrants in everyday conversation to justify our views and deeds.

IRB members justified their opinions in patterned ways—using one of three types of “warrants.” They justified their views using either “matters of fact” (a recent article reported similar failure rates); “personal experience” (my father would not understand this form); or “professional experience” (the participants I studied responded differently). Once they decided whose “warrant” was the best, then they were persuaded to agree with the person's opinion, too.

The next question is which of the three warrants is most often convincing. What is your guess?  I report these findings and more analysis in the first chapter of my new book, Behind Closed Doors: IRBs and the Making of Ethical Research. Spoiler alert: professional experience tends to be most persuasive. In the book I explain why this is the case and what effect it has on boards and researchers.

I will be speaking at the 2012 AER Conference in December about more findings from  my new book—and how IRB members can harness these findings for more effective meetings and relationships with researchers and each other. The book also reports details of  my research methods:  I sat in on the full-board meetings of these IRBs, audio recorded most meetings (with consent), analyzed how the deliberations unfolded, and interviewed most of the board members. I interviewed a national-sample of IRB chairs, as well, to see whether the boards I studied were unusual or typical. (It turned out they were unusually open—to being studied and to fostering improvements in the regulatory system.) 

I am eager to learn about your experiences and hear your responses to the book. I hope to see you at the conference, but in the meantime, feel free to leave a comment below or send me an email.

And let's all wish the presidential candidates sweet dreams of consensus!

Survey: What do you think about a degree program in research ethics?

by Henry Silverman, MD, MA, professor of medicine, chair of the ethics advisory committee, and director of the Middle East Research Ethics Training Initiative at the University of Maryland School of Medicine

For more than 10 years, the Fogarty International Center at the National Institutes of Health (NIH) has funded several educational programs that aim to strengthen research bioethics expertise in in low- and middle-income countries (LMICs).  Such programs offer intensive education on research ethics to in-country academics who then can enhance local ethics review of research, develop a local curriculum in ethics, conduct research on distinctive ethical issues in their countries, and contribute to the global discussions surrounding the ethics of health research.

Through the receipt of a Fogarty grant, my colleagues and I at the University of Maryland Baltimore (UMB) have been fortunate to direct a training program in research ethics for individuals from the LMICs in the Middle East since 2005. This program, called the Middle East Research Ethics Training Initiative (MERETI), has provided graduate-level education in the form of a certificate program  to more than 50 people from Egypt, Jordan, Sudan, Lebanon, Yemen, and Syria. 

We are now ready to take our program to the next level by formalizing our training into degree programs.  Specifically, we are considering developing a research ethics concentration in our Master of Public Health (MPH) program at UMB (42 credits).  The MPH program is intended to highlight the importance of research methodology and research ethics for academics.  The MPH program will consist of courses taught face to face and courses that incorporate distance learning.  This blended format will minimize the time needed on the UMB campus.  We are also developing a formal certificate program in research ethics (12 credits) that will be offered entirely by distance learning.

However, we also want to open up these programs to people from the US.  When our Middle Eastern trainees have come to UMB to do their face-to-face training, we have always encouraged our MPH graduate students to take courses in research ethics and global ethics with our trainees.  The discussions and the bilateral learning that followed have truly been a highlight of our program.

Accordingly, we would like to invite you to take a short (five-minute) survey to share your thoughts and opinions regarding these programs and their teaching structure (e.g. face-to-face or distance learning) and whether you would be interested in applying for them. Your opinions would help us gauge the level of interest in these programs.  And, please visit our MERETI blogging website and learn more about our scholars and trainees and maybe even write a blog. Thanks for your help!

Book Review: Memoir provides a remarkable and ultimately hopeful glimpse into the experience of mental illness

by Elisa Hurley, PhD, Education Director

Elyn R. Saks’ 2007 memoir, The Center Cannot Hold: My Journey Through Madness is not an easy book to read.  In it, Saks, a distinguished law professor at the University of Southern California, paints a vivid, terrifying, and very human portrait of a life lived with schizophrenia.  

Saks tells the story of her unfolding mental illness in almost novelistic terms. Her account begins at age eight when she starts to develop obsessive fears and terrifying hallucinations, signs of the devastating illness incubating within her. The subsequent chapters tell the story of Saks’s adolescent, college, law school, and early professional years, introducing us along the way to a cast of friends, mentors, therapists, and medical professionals who will play significant roles, for better and worse, in her journey into and through full-blown schizophrenia.

Saks’ narrative style is very matter-of-fact; even when she describes her most frightening and disorienting hallucinations, she does so without dramatic editorializing, instead letting the vivid descriptions of her experiences speak for themselves. The effect is gut-wrenching—though we cannot know exactly what it feels like to have “faceless, nameless beings. . . controlling [our] thoughts,” we nevertheless share in her disorientation, helplessness, denial, and rage both at what is happening to her and at the failure of so many to understand it.

Given that Saks is now a successful and well-published academic, it will not spoil things to reveal that she has found ways to manage her mental illness. Indeed, one of the most remarkable features of Saks’s story is how, even while she is struggling through her most serious psychotic episodes, she finds solace, calm, and lucidity in her work. And though her education is at points interrupted by hospitalizations, she manages to not only complete but excel in programs of study at Vanderbilt, Oxford, and Yale Law School. 

Saks is explicit about how her ability to thrive, not only professionally, but personally—she forms incredibly close friendships and also finds a loving and supportive spouse—influenced her decision to write her memoir. Not surprisingly, perhaps, this fact has also shaped her work in mental health law, much of which focuses on the dignity, autonomy, and rights of the mentally ill, for instance, the right to refuse treatment.  One of Saks’ most important contributions to legal scholarship is to remind us that mental illness is not equivalent to decisional incapacity, and that, regarding the question of whether a person should be permitted to make his or her significant life decisions, it is the latter, not the former, that is relevant. 

During her keynote address at this year’s Advancing Ethical Research (AER) Conference, Saks will bring this distinction between mental illness and decisional incapacity to bear on the context of research participation. As a schizophrenic and current research subject herself, her remarks promise to shed important, perhaps disconcerting, new light on the little-discussed domain of research with the mentally ill, just as her book does on the personal experience of psychosis.

Featured Member Profile: Patti Brodbeck

Welcome to another installment of our featured member profiles 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 Patti Brodbeck, institutional review board (IRB) coordinator at Kettering Medical Center, Kettering Health Network in Kettering, OH.

When and why did you join the field?

I joined the field in February of 2011 after working for a year as a registrar in the emergency department of one of our health network’s hospitals. Although there was rarely a dull moment in the emergency department, I was interested in finding a position that would allow me to apply my psychology and research background every day. Fortunately for me, an IRB coordinator position was available within our network!

What is your favorite part of your job?

One of my favorite aspects of my job is providing human subjects protections education to our student researchers (e.g., residents, nurses, college students, etc.). My hope is that through collaboration and education, researchers will feel confident in their ability to conduct ethically-sound research. With my efforts in this regard, I know that I am providing a service not only to the researchers, but also to research participants.

What is the last movie you saw?

The last movie I saw was The Hunger Games. I had read the trilogy, which was fantastic, and was excited to see the story played out on film. I would recommend reading the book prior to seeing the movie!

Why did you join PRIM&R?

Upon beginning my work in the IRB office, my manager suggested joining PRIM&R and spoke excitedly about the organization, the benefits of membership, and the annual Advancing Ethical Research (AER) Conference. It was very clear to me that a membership with PRIM&R would be greatly beneficial for my professional growth.

What is your favorite member benefit?

I have to pick a favorite?! One would definitely be the networking opportunities available online and at conferences. These interactions are fantastic and I greatly appreciate the opportunity to build such positive professional connections. I was able to attend the AER Conference in 2011 and had the chance to meet several incredibly talented and knowledgeable young professionals. We attended different workshops/sessions, met up for lunch, exchanged information, and enjoyed some lively debates. (A quick shout-out – Hi Felicia, Kelly, Rebecca, Sandra, Susan, Alex, Joe, Mike, and Raj!)

What would you say to someone who is considering PRIM&R membership?

Do not hesitate! From the resources available online, such as the webinars and Ampersand, to the conferences and networking opportunities, PRIM&R is a fantastic organization providing many paths for professional growth.

What advice do you have for young professionals interested in pursuing a career in ethical research?

Speak up! One of the most wonderful aspects about this line of work is the respectful, mind-stimulating discussions it fosters with co-workers, researchers, and other professionals in the field. We come from all walks of life, but we share a passion for protecting research subjects – how awesome is that?! So, ask questions, and challenge yourself and others while discussing what can be done in order to improve research protections.

Thank you for being part of the membership community and sharing your story, Patti. We are glad to hear that you had such a great time at the 2011 AER Conference – we hope to see you this December in San Diego!

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

Book Review: Uncaged challenges readers with what-ifs

by Avery Avrakotos, Education and Policy Coordinator

I have to admit it—I’ve never read a thriller before.  When I head into bookstores, my eyes always home in on the newest nonfiction releases. So when I picked up Paul McKellips’ 2011 release Uncaged: A Thriller, I was dubious of how long this book would last on my nightstand.

My instinct was right. It didn’t last long—McKellips’ captivating story had me flipping the page every chance I got.

In the beginning of the novel, rapid shifts in scenery—from Morocco to Arizona to Japan—keep the reader engrossed. Dozens of characters from researchers to animal rights activists to government employees are introduced, but it is two members of the military who come into the foreground as the plot unfolds.

Commander “Camp” Campbell, a trauma surgeon, and Lieutenant Colonel Leslie Raines, an infectious disease expert, are likeable, engaging characters who find themselves called to duty when bioterrorism puts the United States in peril. The situation they find themselves in is made more complicated by a one-year moratorium on animal research, which had been declared in the United States following acts of violent animal rights activism.

McKellips, who is also the executive vice president of the Foundation for Biomedical Research, paints a clear picture of the vulnerability and importance of animal research—especially for medical advancement.

At first blush, the plot seemed far from plausible to me—something that could only happen in books or movies—but McKellips makes it abundantly clear how just a few events—some connected, some not—have the power to alter our national perspective and change our public policy.

In a recent interview McKellips shared his goal for his writing. He said, “I want to find things that are coming out of the news that are relevant, that are current, that we’ve uncovered, and then weave them into a fictional story that the reader says ‘Woah, this is more than just feasible, it’s plausible.’”

Uncaged: A Thriller clearly meets that goal.

Through a portrait of both deliberate actions and coincidence, McKellips delivers a most powerful message: No matter how vital, animal research remains vulnerable and anything can happen. For animal care and use professionals, this is a message that is known all too well.

Poster Spotlight: Incentive Parameters for International Human Subjects Research

by Avery Avrakotos, Education and Policy Coordinator

Preparations for the 2012 Advancing Ethical Research (AER) Conference are gearing up, and I, for one, am getting excited about the annual poster presentations. To channel my excitement, I reached out to past presenter Brandon Brown to see how his work has progressed since he shared his poster  at the 2011 AER Conference.

As you may recall, in 2011, Brandon and his colleagues developed a database of previously approved research incentives used in low-resource  settings. The database included different parameters that can be used for reference when new protocols are submitted to the institutional review board (IRB). 

Avery Avrakotos (AA): It’s been a year since you presented this abstract at the 2011 AER Conference.  How has your research since evolved?
Brandon Brown (BB): My research has evolved a great deal in the past 12 months. My attendance at the 2011 AER Conference was my first step into the realm of research ethics. Since attending the conference, I have used pilot data from my work to apply for and be accepted to the Fordham HIV Prevention Research Ethics Training Institute (RETI). I will utilize my time in this program to delve deeper into the ethical issues surrounding the use of incentives in clinical research in developing countries. My plan is to work under the guidance of Dr. Celia Fisher, and start with focus groups and key informant interviews in Peru this November. I am also working with my co-authors to submit the paper version of the poster presented at the conference to PLoS Medicine.

AA: What challenges have you faced in implementing this research?
BB: The biggest challenge in implementing the research highlighted at PRIM&R is securing funding and setting aside an adequate amount of time to conduct the work. With funding from the Fordham RETI program, I now have the capability to further develop my research during an intensive summer ethics institute and continue this work in the next two years. I made it a point to expand my knowledge of ethical issues further after PRIM&R, including implementing and teaching a course in public health ethics at the University of California, Irvine, and applying for an NIH grant in international research ethics training with the Universidad Peruana Cayetano Heredia in Peru.

AA: What is one principle that has guided you in your research?
BB: The main principle that has guided me in my research is respect, coupled with my hope to make a substantial contribution to the lives and experiences of clinical trial participants. As the principal investigator (PI) or co-PI on several clinical studies in Peru and Mexico, I have made note of ethical issues and worked to improve the knowledge and experience of study participants. Unfortunately, due to time constraints, I was not able to address the issues in a specific and significant way. The Fordham RETI program has provided me with this opportunity. In reviewing the academic literature, I feel that the use of incentives in developing countries is an under studied issue that deserves additional research and attention, as coercion is a significant issue that can affect participants in any study. My new study will fill this gap.

Thank you for sharing, Brandon! We hope that you will join us for the poster presentations at the 2012 AER Conference.