2012 AER Conference: What You Liked

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:  

1. 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.


2. 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. 


3. 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,


4. 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. 
5. 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

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.

1. 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.


2. 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.


3. 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 .


4. 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.


5. 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

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

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

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

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

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

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

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!

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

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

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.