The importance of understanding bias

by Christine Scheuring, PRIM&R Blog Squad Member

PRIM&R is pleased to bring you the second live blog post from the PRIM&R Blog Squad at the 2011 Social, Behavioral, and Educational Research (SBER) Conference. The PRIM&R Blog Squad is composed of PRIM&R members who are devoted to blogging live from our conferences. The PRIM&R Blog Squad member for the 2011 SBER Conference is Christine Scheuring.

One of the most memorable speakers on the first day of the 2011 Social, Behavioral, and Educational Research (SBER) Conference was Mahzarin Banaji, PhD, from Harvard University. Dr. Banaji, during her talk Blindspot: The Hidden Biases of Good People, used different visual cues and examples to illustrate the biases we unknowingly act upon.

One example Dr. Banaji presented included two different news stories and pictures published after Hurricane Katrina. One photo showed a young, black male waist-deep in water with a garbage bag full of items. The news story stated that the boy had been looting after the hurricane hit.

A similar picture of a middle-aged white couple also waist-deep in water with their backpacks full of items, described the couple as having “found” these items at a local grocery store. Interestingly, these articles appeared in the same journal and were edited by the same person, thus affirming the thesis of Dr. Banaji's talk that we do, indeed, have hidden biases we may not be aware of.

Dr. Banaji also showed photos of different faces and informed the audience that within one second our mind makes decisions about whether a person is trustworthy or not. Within one second! Think how many times this comes into play at work, during interviews, dates... We are constantly making assumptions about people without knowing a single thing about them.

Still not convinced about how powerful perception and biases are? I welcome you to try for yourself one of the examples that Dr. Banaji shared. Watch the following video and count how many times the person in the black t-shirt passes the basketball to another team member in who is also wearing a black t-shirt. View the video here.

How many times did you count? Did you notice anything else strange in the video? Try taking a closer at the video, and this time keep your eye on the right side of the screen. Did you see a woman walk by with an umbrella this time? Freaky, right?!

Watching the clip in the session, we were all miffed at how we could have missed what now seems so obvious. This is because we have a perception of what happens at a basketball game and it certainly doesn't involve women with umbrellas!

So what can we do to counteract these biases? Being aware of the existence of such biases and opening ourselves up to meeting people who are different from ourselves seems to be key.

While exploring this topic, Dr. Banaji managed to keep the audience engaged, laughing and at the edge of our seats to hear more. One audience member even commented that hearing her speak on this topic had been life changing. I don't know if there is a ranking system for compliments, but I'd say that's got to be one of the best to receive. The first day of the conference proved to be educational, interesting and insightful, but then again, who knows, I just might be a little biased.

Sharing wisdom at IRB Administrator 101

by Christine Scheuring, PRIM&R Blog Squad Member

PRIM&R is pleased to introduce the PRIM&R Blog Squad at this year's 2011 Social, Behavioral, and Educational Research (SBER) Conference. The PRIM&R Blog Squad is composed of PRIM&R members who are devoted to blogging live from our conferences. The PRIM&R Blog Squad member for the 2011 SBER Conference is Christine Scheuring.

At the beginning of Institutional Review Board (IRB) Administrator 101, the audience was asked to self-identify as IRB administrators who had been in their role for a long time or IRB administrators who had been in their position for a short time. The two individuals who were identified as having served in their role for the most and least amount of time, respectively, had an 11-year, 11-month, three-week difference in experience.

Wow! I was truly among a group with diverse degrees of expertise. I came to this pre-conference program assuming it would be a room full of fellow newbies like myself. However, much to my surprise, a lot of the attendees were seasoned veterans who were willing and able to share valuable insight.

Occasionally throughout the course we were given scenarios that asked, “What would you do?” These scenarios proved to be one of the most opportune times for attendees to share their experiences, insight, and successful processes. What I observed throughout these exercises is that there is not always a clear-cut answer. The lack of clear-cut answers is what makes programs such as IRB Administrator 101 so critical. The program taught participants the fundamentals to figure out the "hows" and "whys" so that we will have the tools necessary to proceed and ultimately come up with a solution.

Eager to learn about community-based participatory research

by Christine Scheuring, PRIM&R Blog Squad Member

PRIM&R is pleased to introduce the PRIM&R Blog Squad at this year's 2011 Social, Behavioral, and Educational Research (SBER) Conference. The PRIM&R Blog Squad is composed of PRIM&R members who are devoted to blogging live from our conferences. The PRIM&R Blog Squad member for the 2011 SBER Conference is Christine Scheuring.

Internet research, expedited review, community-based participatory research, undergraduate studies—is there an area that you or your institutional review board (IRB) would like to learn more about? Which seminar are you looking forward to the most at the upcoming 2011 Social, Behavioral, and Educational Research (SBER) Conference? Personally, I am looking forward to all of it!

As part of my introductory training to the land of all things IRB, I am attending both a pre-conference program and the conference itself. During the conference, I am really looking forward to the Challenges in Community-Based Participatory Research (CBPR) workshop.

At my institution, Creighton University in Omaha, NE, the IRB is on the brink of establishing more formal policies and procedures for conducting CPBR. In order to familiarize myself with the topic, I have spent quite a bit of time conducting internet research, which has led me to conclude that this is an area that many institutions are struggling with.

At Creighton, we are working closely with investigators to establish checklists to help us in the preparation and implementation of CPBR. Upon realizing there was a session dedicated to this very topic at the 2011 SBER Conference, I was eager to attend. Not only do I imagine that the workshop will prove insightful, but I am hoping to network and join forces with others who are coping with the same challenges.

So, enough about me! I want to hear from you now! Which session are you looking forward to most? Which session do you think will be the most helpful in allowing you to more effectively do your job when you return?

Meet the PRIM&R Blog Squad: Christine Scheuring

by Christine Scheuring, PRIM&R Blog Squad Member

PRIM&R is pleased to introduce the PRIM&R Blog Squad at this year's 2011 Social, Behavioral, and Educational Research (SBER) Conference. The PRIM&R Blog Squad is composed of PRIM&R members who are devoted to blogging live from our conferences.

The PRIM&R Blog Squad member for the 2011 SBER Conference is Christine Scheuring.

Who’s excited for PRIM&R’s 2011 Social, Behavioral, and Educational Research (SBER) Conference?! I am!

As a brand-new institutional review board (IRB) administrator, I was delighted when I discovered that the start date of my position coincided with the 2011 SBER Conference.

Over the years, I have been involved in research in varying capacities. From coordination to regulations, I have had the opportunity to explore many of the responsibilities associated with IRBs. As I begin my new role as IRB administrator, I have no doubt that these experiences will prove helpful.

My new position is bound to present challenges, but this is also exactly the opportunity that I was looking for. Am I still nervous? You bet! But that is why I am so excited about the upcoming 2011 SBER Conference. What better resources could I have hoped for than the pre-conference program IRB 101—SBER, and interesting, diverse sessions taking place throughout the conference?

Applying for the PRIM&R blog squad is a good example of one of the ways in which I am attempting to accomplish my goals. Upon being offered the position, I felt a mix of trepidation and excitement; I questioned whether I was ready for this step in my career. After a bit of a mental tug-of-war, I realized that if my employers had faith in my qualifications, then I should as well.

Of course, I wish I was naturally imbued with all of the necessary knowledge and confidence to guarantee immediate success in my new position, but wishful thinking aside, it’s reassuring to know that, come April 29, I am going to feel a lot more confident after spending a week in Boston. I hope that you will join me for my journey of discovery as I share my experience as a new IRB administrator from the 2011 SBER Conference here, on Ampersand.

Featured Member Profile: Hallie Kassan

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 Hallie Kassan, institutional review board (IRB) manager at the Feinstein Institute for Medical Research in Manhasset, New York.

When and why did you join the field?
I began working for an IRB in April 2003. Before that, I had been working in regulatory affairs for a biotechnology company. When looking for a new job, I thought it would be interesting to continue doing regulatory work, but from the other side of the industry.

What is your favorite part of your job?
I feel like I am making a difference and helping protect people. I also enjoy working with investigators to solve problems and develop protocols that are ethical and that protect human subjects.

What's playing on your iPod?
My five year old son's top 40 music.

What is the last movie you saw?
Inception.

What’s for dinner tonight?
Steak.

What are you reading?
The Immortal Life of Henrietta Lacks by Rebecca Skloot.

What's your after-hours guilty pleasure?
Watching Gossip Girl.

What are three websites you visit on a daily basis?
Facebook, the Weather Channel, and CNN.

Why did you join PRIM&R?
I joined in order to learn more about the profession of human subjects protections from others in the field.

What is your favorite member benefit?
My favorite benefits are the webinars and monthly Newsletters.

What would you say to someone who is considering PRIM&R membership?
PRIM&R is a great resource for networking and learning more about the field of human subjects protections.

What do you believe is a key challenge facing the field of research ethics?
The field is always rapidly changing—there is always new technology, new research methodologies, new ways to recruit—and, the regulations are not always a direct "fit" with the current research environment. Finding ways to assist investigators in developing their research studies, while being ethical and complying with regulations, is a constant challenge.

Thank you for being part of the membership community and sharing your story, Hallie. We hope you had a chance to see Rebecca Skloot speak at our 2010 AER Conference in December! If not, please watch her talk in the Conference Portal.

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

“Science Times” synthesis

Just as allergy season reaches its apex, this week’s “Science Times” synthesis offers news of the potential link between allergies and depression. So, stifle your sniffles and explore the latest research findings below. Of course, when you’re done reading, we encourage you to share your thoughts in our comments section.

Week of April 12:

Allergies can increase the risk of depression: Several studies suggest that individuals suffering from severe allergies are almost twice as likely to suffer from depression.

Risks: Focus on heart deaths in student-athletes: An article in Circulation suggests that one in every 43,770 National Collegiate Athletic Association student-athletes experience a sudden-cardiac death each year.

In macaques, familiarity breeds…more macaques? Experimental evidence suggests that a male macaque will demonstrate more interest in a fertile female if he already knows that female.

Week of April 19:

To tug hearts, music first must tickle neurons: Researchers have linked classical music’s emotional impact to subtle timing differences in the performance of the piece.

Eighty years along, a longevity study still has ground to cover: The Friedman/Martin/Terman study spent the last eight decades tracking participants in order to study longevity. Their research has led them to attribute longevity to a single factor: conscientiousness.

Come on, I thought I knew that: Research suggests that font size does not impact memory. Hard–to-read font type, on the other hand, increases memory and comprehension.

Drug that stops bleeding shows off-label danger: Complications resulting from the unapproved use of NovoSeven, a drug used to control bleeding in those who lack a certain blood-clotting protein, have caused renewed concern over the use of drugs for off-label purposes.

Tracing the roots of research ethics

by Sylvia Baedorf Kassis, MPH

We often think of our current ethical framework as having been born out of the atrocities of World War II Nazi experimentation, the subsequent Nuremberg trials, and the resulting Nuremberg Code of 1947. Did you know, however, that some principles for the ethical conduct of research date back to the 1800s?

This fact was discussed at a recent lecture I attended titled, “Deadly Medicine in the Nazi Era: What Turned Physician Healers into Killers?” In examining the issue of how scientists, physicians, public health professionals, and academics legitimized the Nazis’ murderous program of racial hygiene , Matthew Wynia, MD, MPH, debunked as a fallacy the notion that modern ethical codes of medical research originated in Nuremberg.

In a related article, Wynia and his co-author note that the world’s first legislated code of conduct for medical research came about in Prussia in the 1890s as a result of public outcry against an experiment in which prostitutes and orphans were intentionally infected with syphilis in order to test new treatments. In the early twentieth century, Germany went on to adopt national regulations for physicians that called for “unambiguous” consent from research participants. This set of regulations remained in place throughout the Nazi era. Furthermore, German concerns about the ethics of research even extended to animals, as evidenced by a 1933 ban on vivisection of laboratory animals on the grounds that it was unethical.

Given that ethical codes clearly existed, how did so many professionals not just accept, but support, the Nazi agenda? And, are there any lessons to be learned today?

I can’t count how many times I’ve heard a researcher say, “times have changed,” or “we would never do that now,” referring to some egregious violation from the past. And while it may be true that there are now international standards of conduct and research oversight bodies , ethical codes must consistently be taught and discussed as living, relevant documents that require supportive policies and social structures to buttress the standards they set.

Our responsibility, as champions of ethical research, is to make the past relevant by encouraging researchers to recognize that the people who committed some of the worst crimes against humanity were in fact professionals who were internationally respected and scientifically innovative. If laws were so easily ignored in the early part of the last century, couldn’t they be ignored again? Consider the role that medical professionals have played in the US government’s illegal medical experimentation on detainees in its custody post 9/11 .

If you are interested in learning more about medicine under the Nazi regime and will be in Boston this spring, consider attending the exhibition “Deadly Medicine: Creating the Master Race ” produced by the United States Holocaust Memorial Museum (USHMM).

PRIM&R is pleased to be partnering with the USHMM to offer PRIM&R members a complimentary private tour of the “Deadly Medicine: Creating the Master Race” exhibition, a lecture by Dr. Michael Grodin, and a reception in Boston, MA, on Wednesday, May 18 . To learn more about this event or to register, please visit PRIM&R's website.

Preparing the next generation of professionals in human subject protections

We are thrilled to welcome guest blogger Nick Slack, director of consulting services at the HRP Consulting Group, to Ampersand.

We are all here by accident—or at least that’s what we keep telling each other. When human subject protections professionals get together at conferences and meetings, it’s hard to ignore the many serendipitous stories about how our colleagues entered the subject area from so many different and unintended career paths. And, while this grand accident has led to a unique and intellectually driven field characterized largely by its multi-disciplinary base of professionals, we are at a critical point in our domain’s history when we must realize that a career in human subject protections must stop being a fortuitous accident and start becoming an established profession. As the pioneers and current leadership of the field retire and move on, solidifying human subject protections as a viable and free-standing career path will be of great importance to the sustainability of its future.

One of the core goals of professionalizing the field of human subject protections should be to make becoming a “human subject professional” an intended career goal rather than an accident. It is difficult to conjure up images of a field that has advanced and evolved over time without first arriving at some agreed-upon norms for training its next generation of professionals. And so, in the same way that individuals intend on becoming doctors, teachers, or lawyers, one of our loftier goals should be to encourage university students to structure their educational paths around the goal of becoming an institutional review board (IRB) or human subject professional upon graduation. Such a goal requires strategies for raising awareness about career opportunities in the field of human subject protections as well as developing some agreed-upon credentials and experiences to prepare students for a profession in the field.

It goes without saying that in order for students to structure their education around becoming an IRB or human subject protections professional, they must first know that such a career is even possible. And, as those of us currently working in the discipline well know, the general population is mostly unaware that our profession exists at all. While it seems that students share in the naiveté of the general public, the university setting makes for fertile ground for introducing students to this emerging field and presenting them with another career opportunity that they may not previously have recognized as viable. This could certainly resonate with students seeking entry into a competitive knowledge-based economic environment that values highly specialized skills and experiences. Students of philosophy, bioethics, psychology, public health, and the biological sciences all stand to gain from a profession where they can combine their academic interests with some additional and specialized training in human subject protections.

Organizations such as PRIM&R are in the best position to take the lead in raising awareness about careers in human subject protections. Using PRIM&R’s vast network of experts and affiliated institutions, a work group or subcommittee can be formed with the task of developing information about careers in human subject protections. This information can then be distributed to students through their academic departments or the IRB/human research protections program (HRPP) offices at PRIM&R members’ home institutions. Based on the level of student interest, PRIM&R can begin to develop undergraduate conferences, educational webinars, and workshops for those interested in pursuing a career in human subject protections upon graduation. Such an approach is not unlike those used by The Hastings Center, the American Society for Bioethics and Humanities, and the American Journal of Bioethics to raise awareness about the emerging field of bioethics. Where only a few academic programs in bioethics existed 10 years ago, now more than 50 master’s programs in bioethics and a growing list of undergraduate programs can be counted with a quick web search.

Professionals currently working in human subject protections must also share some of the responsibility in educating students about career opportunities in the field. Leaders of IRB and HRPP offices, for instance, can raise awareness and create career opportunities for students by developing internship programs at their respective universities or hospitals, presenting students with the ability to observe or participate in the IRB review process, and working with the career services departments on campus to provide information to students about careers in human subject protections. Universities can also partner with nearby hospitals to provide students with additional experiences in human subject protections that aren’t available on campus.

If we do not believe that this kind of evolution is possible or even necessary, we simply need to look to South Korea for a telling example about what the educational path of human subject protections professionals might look like in the future. Not even a year ago, the Korean FDA (KFDA) along with the Catholic University of Korea established the first post-graduate degree program in IRB/institutional animal case and use committee (IACUC) administration, culminating in the formation of the Department of Institutional Research Ethics and Administration within the university. The first group of students was accepted into the program to begin their coursework this spring semester. Undoubtedly, this program will replicate itself at other universities and hospitals in South Korea and abroad, and when it does, it will be no accident that the US has fallen behind in developing formal career paths for the next generation of IRB and HRPP professionals.

The future of our field depends on having a next generation of professionals equipped with the kind of training and education to allow them to assume leadership positions once their predecessors retire. But, just as importantly, this next generation must be able to build on the great work that has already been done so that our field continues to expand and evolve over time.

Featured Member Profile: Cheri Davis

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 Cheri Davis, supervisor of medical staff services at the Lakeland Regional Medical Center in Lakeland, FL.

When and why did you join the field?
I joined the field in 2006. I was hired as a supervisor of a medical staff office that was credentialing 700 practitioners. The IRB coordinator position was just another piece of the job.

What is your favorite part of your job?
I have grown to love the IRB coordinator position as much, if not more, than the credentialing position. I love that it is on the cutting edge of all that is new and upcoming with drugs and devices.

What’s playing on your iPod?
Lady Gaga - Bad Romance

Why did you join PRIM&R?
I became a member to gather more information and meet people doing the same job as myself.

What is your favorite member benefit?
The mentoring program.

With whom have you made a lasting professional connection through your membership?
Marilyn Horn

What motivates you to maintain your commitment to advancing ethical research?
The patient—plain and simple.

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

We hope to continue helping you make lasting connections in the field! If you’d like to learn more about becoming a member, please visit our website today.

Post-approval monitoring: A Canadian perspective

by Amanda Plante, PRIM&R Blog Squad Member

PRIM&R is pleased to bring you the final live post from the 2011 IACUC Conference and the PRIM&R Blog Squad. The Blog Squad is composed of members who are devoted to blogging prior to, live from and after the PRIM&R's conferences.

Hello again! On Thursday I participated in a moderated poster abstract discussion and presented my poster titled, “Post-Approval Monitoring Programs Across Canada – Building on Strengths and Facing Challenges.” If you are interested in receiving a copy of my poster, please feel free to e-mail me. As a Canadian, I am constantly seeking to learn more about US animal care and use policies. As such, I thought you might find insights on post-approval monitoring (PAM) from the Great White North to be of interest.

Canadian standards for experimental animal care and use are regulated by the Canadian Council on Animal Care (CCAC). Institutional compliance is monitored through the CCAC assessment program (similar in its use of peer review assessments to the AAALAC International accreditation program). The CCAC program is based on scientific peer review, policy making, and responsibility at the institutional level. During a CCAC assessment visit, the CCAC evaluates how the PAM program is working and how effective it is in ensuring that protocols and standard operating procedures (SOPs) are applied by the animal care committee (ACC).

The CCAC Policy Statement on Terms of Reference for Animal Care Committees (section 2) has required that: “Each institution must establish procedures for PAM of animal use protocols, and must define the roles and responsibilities of the members of the animal care and use program in the monitoring process.”

The CCAC Policy Statement for Senior Administrators Responsible for Animal Care and Use Programs also outlines PAM requirements. The CCAC does not prescribe what a PAM program should look like, but encourages a program to be based on best practices and focused on institutions’ needs.

The Natural Sciences and Engineering Research Council of Canada is one of the three major federal funding agencies that comprise the Tri-Council. In order to receive funding from the Tri-Council, universities must sign a memorandum of understanding (MOU). Schedule 3 of the MOU specifically covers the ethical review of research involving animals. One requirement is: “The institutions must have procedures in place to monitor ongoing work and to ensure conformity with federal and provincial guidelines, regulations, and laws covering the use of animals in research, teaching and testing.”

Many Canadian institutions have recently begun to develop and implement PAM programs. In order to learn about common issues and best practices, the research ethics office at the University of Saskatchewan conducted a survey of Canadian institutions with PAM programs. The survey was distributed via a PAM coordinators listserv.

Fifteen institutions responded to the survey, which offered key findings such as:

• Most institutions have designated personnel to coordinate PAM programs
• PAM programs are generally conducted by animal health technicians and/or veterinarians
• The CCAC category of invasiveness (CofI) determines which animal use protocols are selected for a PAM visit, as well as the frequency of visits
• CofI level D and E protocols are given highest priority
• Protocols were selected randomly or for cause
• The animal care committee is at the center of PAM with reports from the PAM visits being reviewed by the ACC

The main challenges faced by Canadian institutions in developing PAM programs include:

• Lack of support from senior administration/institutional official (IO)
• Lack of education on the need for, and importance of, PAM
• Lack of financial and human resources
• Workload and time limitations
• Scheduling PAM with team and principal investigator
• Communication with internal units (e.g. biosafety)
• PAM for field studies
• Bridging jurisdictional issues; collaborative projects
• Achieving set targets for review

Best practices for PAM identified by the institutions include:

• Good communication between researchers, the ACC and the PAM panel
• Partnership approach; collaborative to facilitate research and compliance
• A flexible, adaptive PAM program
• Online electronic protocol review system
• Efficiently functioning ACC with ‘open door’ policy
• PAM program is well received by researchers and open to collegial visits
• SOP databank assists researchers and helps PAM identify deviations
• Integration of PAM training and opportunity for knowledge transfer

As noted at a workshop on Post-Approval Monitoring: Formal and Informal Approaches, there are a variety of ways in which PAM can be incorporated into an animal care and use program, including formalized audits, lab surveys, reviews and facility inspections, reviews of protocols, adverse event reporting, veterinary rounds, animal care staff reporting to facility managers, casual lab visits, veterinary follow-up to morbidity and mortality reports, consultations, and pre-reviews.

For the success of any PAM program, it is vital to embrace a collaborative approach, one that facilitates and maintains a collegial environment where the health, welfare, and care of animals is given highest priority while still ensuring excellence in research and teaching.

Ensuring protocol and grant congruency

by Farah Moulvi, MSPH, PRIM&R Blog Squad member

PRIM&R is pleased to bring you live post from the final day of the 2011 IACUC Conference and the PRIM&R Blog Squad. The Blog Squad is composed of members who are devoted to blogging prior to, live from and after the PRIM&R's conferences.

When faced with comparing information in an IACUC protocol to federally funded grant proposals some institutions find the issue particularly challenging. As such, the 2011 IACUC Conference session titled, Ensuring Consonance Between Grants and Protocols: Who, How, and When? caught my attention.

According to Section IV.D.2 of the Public Health Services Policy on Humane Care and Use of Laboratory Animals (Policy), “applications or proposals…from institutions which have an approved assurance on file with OLAW shall include verification of approval…by the IACUC of those components related to care and use of animals“ In theory, it may sound easy, but how does one actually put that policy statement into action?

The Policy does not elucidate how the IACUC is intended to review and approve the animal care and use components of the grant proposal. There is no specific requirement that mandates comparing the information in the grant proposal to the IACUC protocol form information to verify the congruency. It is up to each institution to come up with a process to review the grant proposal itself and/or compare it with an approved IACUC protocol.

The institution also has to determine who should be assigned such a task. Should this verification be performed by IACUC members, administrative staff, the IACUC chairperson, or the chairperson of the department? Or, is a cross-divisional collaborative approach warranted?

At my institution, the IACUC is assigned this responsibility. The primary reviewing member of the IACUC compares the protocol application form with the federal and major funding agency grant proposal, ensuring that the following items match: the title of project, the research investigator’s name, the species, animal numbers, and overall procedures.

My IACUC has also instituted a “One Protocol, One Grant ” policy, whereby a single IACUC protocol cannot be used to represent the animal use activities of multiple grants. Conversely, though, a single research grant may be represented by more than one IACUC approved protocol. If a grant, not originally declared in the IACUC application, is awarded later in the three-year approval period of the protocol, the investigator must inform the IACUC by submitting an amendment form for full committee review.

Each PHS grant recipient institution must ensure consistency between the original proposal and the protocol form submitted to the IACUC. Moreover, the signature of the authorized institutional official on the grant application form constitutes a declaration that the IACUC has reviewed and approved all animal-related activities in the grant application.

There are other polices in addition to PHS policy that also apply. For example, the National Institute of Health (NIH) Grants Policy considers its awardee institutions collaborative partners that share obligations as stewards of Federal funds to comply with all Federal requirements.

The Ensuring Congruency session reviewed the requirements for assuring agreement between grants and protocols and discussed mechanisms for to achieving this goal. The word “congruent” was defined in context; reviewing for congruency does not require an exact match. A good standard is to match the research design methods sections in the grant and the vertebrate animal section in PHS 398 research plan section F.

When it comes to dealing with instances of incongruity, it’s important to address whether differences between the two documents could be considered a change in scope. If so, would they require confirmation of approval from the funding agency? Differences between the two documents that might raise these questions include change in specific aim of the research, substitution of animal models, change of study location, shift in the disease under examination, or a change in the investigator. I was pleased to hear that grant management offices typically respond quickly when an investigator contacts them regarding such changes.

To become familiar with the intricacies of these situations, I recommend reading OLAW’s frequently asked questions, NIH grants’ policy pages, and NIH’s Instructions for Completion and Peer Review of the Vertebrate Animal Section (VAS) in NIH Grant Applications and Cooperative Agreements.

I also encourage you to share what mechanism your institution has developed for assuring consonance between grants and IACUC protocols, as well as your overall experiences, challenges and solutions.

Call of the wild: Review of animal use protocol involving field studies

by Amanda Plante, PRIM&R Blog Squad member

PRIM&R is pleased to bring you live posts from the 2011 IACUC Conference and the PRIM&R Blog Squad. The Blog Squad is composed of members who are devoted to blogging prior to, live from and after the PRIM&R's conferences. Read on to find out what's happening on the ground in Chicago!

At my institution’s animal research ethics board (AREB) meeting just last week, we discussed a field study in the Canadian north involving the trapping of small mammals. Our clinical veterinarian suggested that due to the AREB’s concerns about trapping methods, the updated 2011 Guidelines of the American Society of Mammalogists for the Use of Wild Mammal in Research (Guidelines) should be provided to the principal and research team. In everyday IACUC review of field protocols, the Guidelines serve as useful resources for the IACUC, as well as the researchers themselves.

Having attended Wildlife Protocol Oversight, Including Special Challenges When Conducting Field Studies from the Hot Topics, Trends, and Special Issues Track yesterday, I found the content to be relevant to my recent experience.

At the session, we were provided with a hot-of-the-presses copy of the Guidelines, which were written by Robert Sikes, who also co-facilitated the session, William Gannon, and the animal care and use committee of the American Society of Mammalogists (ASM).

This workshop discussed the special circumstances IACUCs face when reviewing field studies. One commonly cited struggle is the need to categorize studies’ invasiveness levels for reporting to the United States Department of Agriculture (USDA).

There also appears to be confusion regarding the USDA definition of field studies and how institutions interpret the USDA categories of pain and distress. Generally speaking, if a study involves a simple capture of free-ranging mammals, birds using live traps, or capture techniques covered by the ASM or Ornithological Council Guidelines, then the animal usage is consistent with the USDA category C.

While speaking with a USDA representative over lunch, I came to the understanding that events in which animals undergo surgery in the field, or are captured and housed, need to be reported to the USDA. Any non-invasive studies, including capturing to collect blood samples, do not need to be reported to the USDA. Of course, an IACUC would still need to review and approve the protocol.

During the session there was also discussion as to what category should be used for fish studies, especially in cases where feeder fish are used, since this involves a predator-prey relationship (which needs to be assessed at a higher level), or where electro-shocking is used to capture fish. Without clear-cut answers, it falls upon the IACUC to interpret the guidelines and use its best judgment to come up with a determination. This often requires reviewing literature, assessing the particular situation, consulting outside experts, and a willingness to change if new information is discovered.

Understanding how procedures are conducted and what training is provided to research team members is also important. The public should always have confidence in the decisions made be the IACUC. By ensuring that all research is justified, this assurance is maintained. Public perception is an important force to consider, especially in field studies where the general public may be in a position to see the research activities.

Post-approval monitoring (PAM) of field studies also presents challenges. While every member on the IACUC might like to travel to Peru to help monitor a study, it likely won’t be an option! Instead, researchers can submit videos of the procedures being performed, or photos and records that might document their actions.

Finally, wildlife studies introduce a whole host of other concerns relating to occupational health and safety. Do personnel have all their required vaccinations? Have they signed a waiver if they choose not be vaccinated? Considerations need to be given for the various zoonoses to which students and other research members will be exposed, and what protections might need to be in place in the event that an accident happens. Training requirements (boat, firearms, etc.) also need to be addressed. The IACUC should liaison very closely with other units to ensure that all concerns are addressed and all personnel on a protocol have completed any required training before a protocol is approved.

In order to continue learning, I recommend you consider attending an upcoming workshop on the Animal Welfare Act and compliance for studies of wildlife in the field in captivity. The session will be held in October in Albuquerque, New Mexico. Stay turned for more details here.

From the eyes of a tourist, last night I enjoyed a meal out with several other IACUC coordinators. We dined at Gino’s Pizzeria to indulge in Chicago’s infamous deep dish pizza-definitely recommended and worth the wait!

Post approval monitoring: Balancing risks and benefits

by Farah Moulvi, MSPH, PRIM&R Blog Squad

PRIM&R is pleased to bring you live posts from the 2011 IACUC Conference and the PRIM&R Blog Squad. The Blog Squad is composed of members who are devoted to blogging prior to, live from and after the PRIM&R's conferences. Read on to find out what's happening on the ground in Chicago!

Although late in the afternoon, the session titled Formal and Informal Approaches to Post-Approval Monitoring featured a lively discussion about post-approval monitoring (PAM). This topic was also presented at the pre-conference course for IACUC administrators and compliance staff titled Essentials for IACUC Administrators.

PAM is a process that was developed and instituted at various academic research institutions in order to support the humane care and use of animals. PAM’s intent is to provide institutions with an ongoing mechanism for ensuring compliance with animal care and use policies, guidelines and laws. This, in turn, ensures the humane care and use of animals in research, testing, and teaching activities. The essential components for program development are planning, communication, management, and assessment.

Monitoring the use of live vertebrate animals in research, teaching and testing after IACUC approval is currently a hot topic in the IACUC research community. Each institution or organization must determine, independently, whether the risks of not instituting a PAM program outweigh the benefits of developing, instituting, and overseeing one.
Among the myriad resources available on the internet, one useful example is the Institute for Laboratory Animal Research (ILAR) Journal.

Much of the literature on animal research suggests the need for PAM:

• The Office of Laboratory Animal Welfare’s (OLAW’s) Frequently Asked Questions states that monitoring of animal care and use is required, although they do not explicitly specify PAM procedures.
• The 2010 edition of the ILAR Guide for the Care and Use of Laboratory Animals (Guide) states, “continuing IACUC oversight of animal activities is required,” and that ”a variety of mechanisms can be used to facilitate ongoing protocol assessments and regulatory compliance.”
• Public Health Service (PHS) Policy requires IACUCs to conduct continuing review. However, PHS Policy does not require a formal PAM program.
  

PAM is not a substitute or replacement for the IACUC’s required responsibilities such as semiannual review, outside facility inspections, new protocol review, annual/triennial protocol review, and non-compliance and allegation investigations. Some may assert that these procedures already compose an informal PAM program, as they all serve to help maintain an institution’s compliance.

There are various approaches to conducing formal and informal PAM. One proactive approach emphasizes education and training through constructive engagement. Some institutions monitor high-risk areas such as survival surgeries, activities involving procedures for pain, distress and or discomfort, use of regulated USDA species, activities involving use of anesthesia and or analgesia, and protocols previously sited for a deficiency or repeat deficiencies. Other institutions monitor a random selection of IACUC-approved protocols. Either way, it is critical for an institution to have clear written polices and standard operating procedures for an effective PAM program.

A one-size approach will not fit all institutions and organizations. Each institution should adapt PAM models to fit their needs. PAM is a system of self regulation; in order for it to work effectively, a robust culture of institutional responsibility and commitment to compliance is needed. Each institution needs to balance support for high-quality research with the maintenance of a high standard of humane care and use of animals.

In order to achieve this goal, institutional stake holders (i.e. the institutional official, attending clinical veterinarian, IACUC chairperson/members, IACUC administrators) should be involved prior to the institution of a PAM program.

For those of you already engaging in PAM, keep up the good work and continue to share your resources, knowledge and experiences. For those who don’t have a PAM process in place, I encourage you to give it some thought and determine what approaches may work for your institution. Please feel free to share your thoughts with me online or offline.