Words of wisdom: Essentials of IACUC Administration

by Amanda Plante, PRIM&R Blog Squad member

PRIM&R is pleased to bring you the first 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, IL.

Greetings from the 2011 IACUC Conference! As a member of the PRIM&R Blog Squad for this conference, I’m pleased to provide you with a post regarding Essentials of IACUC Administration, one of the pre-conference programs offered in advance of the conference.

All participants in the workshop received a thick manual with copies of the presentation slides and lots of additional resource materials. I am sure this will serve as handy reference information as I reflect back on the workshop discussions. Essentials of IACUC Administration is coordinated by Molly Greene, BA, CPIA; Marky Pitts, CPIA; and MJ Shepherd, DVM, CPIA – three very experienced IACUC advisors and coordinators who are sharing their words of wisdom with IACUC coordinators, chairs, and other committee members. This workshop consists of eight modules that cover the full breadth of IACUC administration. On the first day, we reviewed organizing an animal care and use program and managing semiannual reviews and inspections.

Additionally, the role of the institutional official, the IACUC, the attending veterinarian, and the principal investigator were detailed. It was suggested that the freely available OLAW pamphlet What Investigators Need to Know about the Use of Animals might be a valuable resource for new investigators. This information, when combined with an institution-specific handout covering the IACUC policies and guidelines, can be utilized to help faculty better understand their responsibilities.

Elements of effective team leadership including planning, communication, management and assessment were also discussed. Communicating effectively means listening, questioning, and relating. It is essential to recognize the needs of a principal investigator and to engage them in the process of helping to find solutions.

For the latter part of the afternoon, we broke into smaller groups based on our administrative roles. The session I attended was aimed at IACUC administrators working at academic institutions. The group was led by Monte Matthews, BA, CPIA, from the University of Oregon. He led an interactive discussion based on a number of questions that attendees had previously provided to the workshop organizers. We covered topics ranging from how to better engage IACUC members (perhaps through the use of annual report cards, or the IACUC chair specifically calling upon members for comments during meetings), to how various institutions handle delegated member review (DMR).

One idea with respect to workflow was to incorporate a white board outlining the triage needed to track the progression of protocols through the review process. Other institutions use spreadsheets whereas those using online electronic systems (e.g. IRBNet, Click Commerce, TOPAZ) already have this functionality built into the system. Microsoft SharePoint is currently being used by other institutions; it was suggested this could be an intermediary process until an institution has the financial resources in place to move to a fully online system. The group discussed the requirement to confirm congruency between protocols and grant applications. I thought the use of a “congruency letter,” where the principal investigator signs to confirm that the procedures described in the animal use protocol are consistent with what is proposed in the grant, was interesting. This signed sheet would then be filed with the protocol.

One the second day of the course we covered managing protocol review; policies, procedures, and databases; post-approval monitoring (PAM); qualifications, training, and occupational health programs; and the role of IACUC administration. I especially enjoyed the presenters’ use of real-life situations to illustrate common challenges. It helps to reaffirm what one is already doing, but also allows one to consider how to better respond to situations in the future.

With regard to PAM, it is often best to target high-risk areas and principal investigators with a history of non-compliance. (While your institution may use a ‘random’ draw for determining which animal use protocols are monitored, specific principal investigators may be entered into the draw more frequently). PAM visits (especially initial visits) should emphasize education and training to ensure visits are non-threatening and collegial.

On a side note – the sitting, thinking, and discussing at these conferences can certainly build up an appetite (especially if you have been awake since 4:30 AM to catch a flight from Saskatoon!). Last evening, I had dinner at the Indian Garden which is within easy walking distance from the hotel. I had a great vegetarian meal, and would definitely recommend it if you enjoy East Indian cuisine. The concierge in the front lobby has a list of local restaurants, as well as maps of the immediate area, that as a first-time visitor to Chicago, I found very helpful.

Also, I was excited to see in the conference agenda that there are two yoga sessions planned for Thursday and Friday mornings from 6:00 to 7:00 AM. Even though I’m not really a morning person—what better way to get the blood flowing than with a few sun salutations before the conference begins!

As a reminder, at the conference I am wearing a red PRIM&R Blog Squad t-shirt. Please feel free to introduce yourself; I would love to chat with you!

Namaste, Amanda (Yoga Mom and IACUC coordinator)

Composition of lay summary for IACUC protocols: A challenging task

by Farah Moulvi, PRIM&R Blog Squad Member

PRIM&R is pleased to bring you the first 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, IL.

Hello from Chicago! I hope you are as excited to be a part of the 2011 IACUC Conference as I am. The week started with a dynamic, engaging, one-and-a-half-day pre-conference course for IACUC administrators and compliance staff members titled Essentials of IACUC Administration. The course provided an overview of how to effectively manage an animal care and use program. One topic of conversation during the course that resonated with me was the use of lay language in IACUC protocols.

Investigators are commonly unaware why certain portions IACUC protocols must be written in terms a layperson can understand. The lay description sections in IACUC protocols originate from the US Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training -US government principle II , which states that “procedures involving animals should be designed and performed with due consideration of their relevance to human or animal health, the advancement of knowledge, or the good of society.”

Using animals in research and teaching is a privilege given to the scientific community by the general public on the basis that researchers meet the highest ethical and regulatory standards; consequently, the burden rests on the scientific community to justify and assure the public that the use of animals, per the federal guidelines, has scientific benefit “to human or animal health, the advancement of knowledge, or the good of society.”

Most IACUC applications require that summarized research objectives are written in lay language understandable to members of the general public. This is reinforced in the 2011 edition of the Institute for Laboratory Animal Research (ILAR) Guide for the Care and Use of Laboratory Animals (Guide) that specifies protocols include “clear and concise descriptions” that non-scientists and unaffiliated members of the IACUC understand.

These people represent the interest of the general public and, as laypeople, serve as a litmus test for the clarity and conciseness of a protocol’s language. That is to say, the federal law mandating clear and concise writing allows the IACUC members to understand the study and make informed decisions.

As IACUC members often possess diverse backgrounds, the inclusion of lay language also assists non-scientist and scientific members understand material that may not lie within their realm of knowledge.

Providing an adequate lay summary can be a challenging task for research investigators. It is common that the lay summaries provided for IACUC review are neither brief nor in lay terminology. When writing an application for vertebrate animal use, investigators should compose the lay summaries as if explaining the concepts to an audience of high school students with non-scientific backgrounds. Some institutions define the lay language as a ninth-grade level, while others use approaches such as, “imagine explaining it to your elderly neighbor, or your kid, or writing it for a newspaper.” As an investigator, you should try to convey how you’re trying to explore new treatments that benefit society, resolve a scientific dilemma, or advance the understanding of an area of science.

Frequently, investigators use abstracts directly from their grant proposals and overlook the fact that the purpose and relevance of the study should be in lay language. Researchers should be cognizant of the fact that some institutions may use the lay summary section of the IACUC protocol for press releases and public relations announcements. Therefore, the procedure descriptions should be simple, brief, and general. This section should be limited to what you intend to do and why it is important, rather than the specific details of the “how.”

There are several resources available for investigators, such as a glossary of non-scientific terminology provided by various institutions, and examples of well written lay summaries from IACUC applications. Investigators can also use high school educators’ tools for determining readability levels (e.g. Flesch Reading Ease and the Flesch-Kincaid Grade Level), which are commonly built into the newest versions of word processing software. It is important that investigators pay special attention to this requirement as protocols not written in lay language may be returned to the investigator for revisions. This can be both time consuming and frustrating for the investigator, especially those who are inexperienced in addressing a non-scientific public. What approaches do you use at your institutions use to inform, instruct, guide, and educate investigators? What grade level is reasonable to be defined as lay language?

In the interest of full disclosure, this blog has a Flesch Reading Ease of 40.7 (numbers 30 and below are more difficult to read) and a Flesch-Kincaid Grade Level of 13.4. The score correlates to the number of years of education generally required to understand this text

Happy Flesching!

Connecting the dots between animal care and biosafety

by Amanda Plante, PRIM&R Blog Squad member

PRIM&R is pleased to bring you more blog posts from 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 registering for the 2011 Institutional Animal Care and Use Committee (IACUC) Conference, it was a challenge to select workshops to attend; there are simply so many topics of interest to animal care committee members! I am particularly looking forward to participating in the Friday morning workshop titled, Select Agents and Biohazard Research in Animals: Integration of Animal Research Programs with Lab/Biosafety and Occupational Health Programs from the “Hot Topics, Trends, and Special Issues” track. The session emphasizes the intersection of animal research and biohazardous agents – a topic that has been particularly salient in my own career as an animal care committee coordinator.

At the University of Saskatchewan, the animal research ethics board (AREB) reviews all proposed uses of animals for research, testing, and teaching for potential ethical considerations. Meanwhile, the biosafety protocol approval committee (BPAC) reviews applications for the use of biohazardous materials or notifiable biological substances. All animal use protocols, where applicable, must have an up-to-date biosafety permit for the protocol before the AREB will approve it.

Before all AREB meetings, as the animal care committee coordinator, I meet with the BPAC chair and the biosafety manager—who serves on the AREB as a non-voting member to clarify biosafety requirements—to review all animal use protocols with respect to biosafety. We confirm that all biological agents listed on the animal use protocol are, in fact, on the principal investigator's biosafety permit. In addition, we confirm that the related biosafety permit lists all animal users as authorized workers.

The AREB, in consultation with workplace safety and environmental protection (WSEP), recently developed a new appendix that is now included with our animal use protocols. This appendix is required whenever a hazardous material or agent is used in an animal experiment. The form must be completed and signed by the appropriate personnel from WSEP, the principal investigator, and the manager of the facility where the animals will be housed. The intent of this form is to provide information about hazardous materials that will be used in order to minimize occupational exposure.

As a condition of the AREB's approval, after the AREB meeting, a memo is sent to the principal investigator that outlines any biosafety updates that need to be addressed. Until the principle investigator meets outstanding biosafety requirements a certificate of approval for the animal use protocol is not issued.

We strive to ensure efficient communication between our animal care and biosafety committees. By participating in the Select Agents and Biohazard Research in Animals: Integration of Animal Research Programs with Lab/Biosafety and Occupational Health Programs workshop I hope to gain valuable insight to apply at my own institution. I am very keen to learn from other people's experiences and to discover new ideas and ways in which we can work on improving our processes. By attending this upcoming session at the 2011 IACUC Conference, I am confident that I will come away with some great ideas that I will be able to share with my colleagues in Saskatchewan.

The 3Rs and methodologies for alternatives revisited

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

PRIM&R is pleased to bring you more blog posts from 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.

A recent article in PRIM&R’s Research Ethics Digest, titled, “The Role of Organizational Culture in Compliance With the Principles of the 3Rs," made me stop to think about alternatives to the use of animals in research. As required by the Animal Welfare Act (AWA), the PHS Policy on Humane Care and Use of Laboratory Animals (PHS Policy), as endorsed by the Guide for the Care and Use of Laboratory Animals: Eighth Edition (Guide), and as executed by institutional animal care and use committees (IACUCs), research investigators must consider alternatives to procedures that may cause pain or distress to animals used in research. According to the US Government Principles for the Utilization and Care of Vertebrate Animals in Testing, Research, and Training, there are three central concepts, named by Russell and Burch in 1959, that need to be explored when considering alternatives: replacement, reduction, and refinement.

The replacement principle suggests substituting living animals with other living systems such as human and animal cell cultures, tissue cultures, non-living systems, or computer simulations when conducting research. Replacement also encourages researchers to substitute, when possible, a higher phylogenetic species, such as a vertebrate, with a lower, less sentient species, such as an invertebrate.

Reduction encourages scientists to use fewer overall animals to acquire the same scientific information.

Refinement refers to the modification or enhancement of procedures and techniques so as to minimize or eliminate pain or distress wherever possible.

The AWA requires that investigators demonstrate they have considered alternatives by providing a written documentation of the methods and resources used to determine the availability of alternatives. The USDA’s Animal Care Policy Manual provides guidance on the required written documentation, which includes performing a literature search within appropriate databases. The policy specifies that when conducting a database search the narrative must, at a minimum, include:

1. The names of the databases searched;


2. The date the search was performed;


3. The period covered by the search; and


4. The keywords and/or the search strategy used.

By performing the appropriate literature search, the investigator fulfills not only the requirement to search for alternatives to the use of animals and alternatives to potentially painful procedures, but also determines that the described research animal use does not duplicate previous or existing studies.

Because there are no universal IACUC protocol forms or templates for exploring alternative methods, I believe forms should include adequate information for the IACUC to determine whether the investigator has made a good-faith effort to demonstrate the presence or lack thereof of alternatives, and the reasons why he/she will or will not adopt them.

There are many resources available for investigators to explore alternatives in research, such as the USDA Animal Welfare Information Center (AWIC), which makes use of multiple database literature searching. Other resources include searchable databases such as AGRICOLA, TOXNET, the Johns Hopkins University Center for Alternatives to Animal testing (ALTWEB), the University of California’s Center for Alternatives, PubMed, and MEDLINE. Moreover, AWIC provides additional in-depth informational guides such as Tips for Searching for Alternatives to Animal Research and Testing and Worksheet and Instructions for Alternatives Literature Searching.

Whether you are a new investigator, veteran investigator, new IACUC member, an IACUC community member, or an IACUC coordinator, knowing these methodologies is critical. As an investigator, if you need assistance searching the literature for animal alternatives you can contact your IACUC chairperson, IACUC members, IACUC administrator, or your institutional veterinarian. Additionally, you can consult with AWIC , an information service specifically established to provide information about alternatives via e-mail.

What mechanism or processes has your organization developed to facilitate the IACUC’s review of this regulatory requirement? I would love to hear your thoughts. It’s your feedback that makes this a dialogue. If my blog makes you think, rethink, ask questions, or points you in a new direction—great! Please feel free to share.

Signing off from the electronic world for now, from the state of sun, sand, and surf (Florida, of course!) until the next blog…

"Science Times" synthesis

Roar. Croak. Meow. What’s that sound? Animals! With the 2011 Institutional Animal Care and Use Committee (IACUC) Conference right around the corner, the stars have aligned. Not only was the March 15 edition of the New York Times’ “Science Times” devoted to our animal friends, the issue also mentioned the research of 2011 IACUC Conference keynoter, Hal Herzog. So read on, get the conversation started, and prepare for a roaring good time as we celebrate animal care and use in Chicago. And, not to worry human subjects researchers, there’s a little something tucked in here for you too!

Week of March 15, 2011

The creature connection: Researchers and scientists, including upcoming keynoter Hal Herzog, attempt to explain the diverse and complex relationships that exist between humans and animals.

For whom the cell mutates: The origins of genetic quirks: In Key West, at the former home of Ernest Hemingway, an analysis of preaxial polydacylous cats confirms scientists’ suspicions.

Forget the treadmill. Get a dog: A recent study from Michigan State University echoes other research that suggests that dog ownership increases an individuals’ physical activity by an average of 30 minutes a week.

Supremacy of a social network: A researcher from the University of Montreal explains the role of natural selection in the development of a social infrastructure in chimpanzees and, subsequently, humans.

No face, but plants like life too: One long-time vegetarian questions widely held assumptions about the consumption of plants.

Week of March 22, 2011

Riddled with metal by mistake in a study: Breast cancer patients were inadvertently left with traces of tungsten in their bodies following the use of a surgery device. The implications of the metal’s presence in the body remain unknown.

Tortoise and hare, in a laboratory flask: Scientists, using E. coli bacteria, are able to observe natural selection and mutations that impact evolution.

Older elephant matriarchs keep the lions at bay: The link between age and wisdom is evidenced in the habits of African elephants that have demonstrated that older elephants are more adept at fending off predators.

…And, because we couldn’t resist, one scintillating article from this week’s Boston Globe:

Patients take on expanded role: At the Massachusetts Biotechnology Council’s annual meeting, researchers and physicians discussed the newest trend in the field, “participatory medicine.”

Featured Member Profile: Amy Smith

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 Amy Smith, institutional review board (IRB) coordinator at Boise State University in Boise, ID.

When and why did you join the field?
During my sophomore year at Boise State University, I started working as a student employee in the office of research compliance. I had no idea such an office even existed at my university! In the beginning, I mostly put together protocol application files, printed labels, and delivered mail.

Over time, I was given more tasks related to the IRB, institutional animal care and use committee (IACUC) and institutional biosafety committee (IBC). I was involved with the administrative duties of the committees and researchers, and became familiar with the federal regulatory requirements. After graduating in 2008, I was hired as the full-time IRB coordinator. Idid not see myself working in the field of research compliance when I started college seven years ago, but I am grateful to have discovered it. I plan to go back to school for a master's degree in the spring of 2011, and have started studying for the CIP® exam.

What is your favorite part of your job?
Meeting new faculty and student researchers! I enjoy working to help researchers understand the review process and why the committee asks certain questions about research. I try to make the IRB a positive experience for our researchers.

I also appreciate having a job where I'm constantly learning. There is always a new guideline or interpretation of a guideline, and every protocol application is different. I'm relatively young and new to this field, but I enjoy the challenge of educating myself as much as possible. It has been a great professional working experience so far. (I am also able to put my English degree to use with all those policies and procedures that need writing!)

What’s playing on your iPod?
Lately, I've been rocking out to Jack Johnson, Minus the Bear, Ingrid Michaelson, some classic Salt-N-Pepa, and the soundtrack to Whip It.

What’s for dinner tonight?
Dinner will be out tonight at one of my favorite local restaurants in town, Bittercreek Ale House.

What's your after-hours guilty pleasure?
My after-hours guilty pleasure is watching Gossip Girl on Monday nights with a glass of wine.

Why did you join PRIM&R?
My boss highly recommended I join.

What is your favorite member benefit?
The new complimentary access to selected PRIM&R webinar archives. It's great to be able to get information from past webinars that I was not able to attend.

What would you say to someone who is considering PRIM&R membership?
Do it! If you want to continue in the field of research compliance you must be aware of and absorb a lot of information, especially guidelines and regulations. PRIM&R is a central source to find references and increase the efficiency of your own search efforts.

What motivates you to maintain your commitment to advancing ethical research?
I personally benefit from the results of research every day. I have Type 1 diabetes and am able to live because of insulin. I can check my blood sugar in five seconds due to advanced testing technologies. I have research to thank for that.

Perhaps there will even be a cure in my lifetime. However, even with all its exemplary accomplishments, I am aware (even from recent headlines about Guatemala) that research was not, and is not, always done ethically. I know that research can continue to progress and improve our world while protecting the individuals that are willing to give researchers the chance. Boise State is growing tremendously in research and I am eager to educate and support our student and faculty researchers about the importance of the IRB and upholding ethical standards.

Thank you for being part of the membership community and sharing your story, Amy. Join our CIP study group on Facebook to meet others preparing for the CIP exam. Good luck on your CIP certification exam!

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

May is Member Appreciation Month at PRIM&R

Here at the PRIM&R headquarters, we have been gearing up for Member Appreciation Month, and today we are happy to announce two very special webinars to be held in May.

If you’re interested in the Certified Institutional Review Board (IRB) Professional (CIP®) exam or the Certified Professional Institutional Animal Care and Use Committee (IACUC) Administrator (CPIA®) exam, you will not want to miss these webinars. We are calling in the experts to guide you on your journey toward certification.

If the CIP examination is in your future, tune in to hear Susan Delano, CIP, Chair of the Council for Certification of IRB Professionals, speak about the qualification requirements and preparation process along with Jaime Arango, assistant director of education for human subjects protection at the CITI Program at the University of Miami.

For those of you interested in taking the CPIA exam, Mary Jo Shepherd will represent the Council for Certified Professional IACUC Administrators, and Jamie Gothro will share her experience obtaining the CPIA credential.

These webinars will be complimentary to PRIM&R members, and we encourage you to watch our website for updates—we’ll be opening registration next Thursday. In the meantime, become a member and you, too, can access this (and the many other!) benefits that PRIM&R has to offer.

Understanding Vulnerabilities

By Courtney Jarboe, CIP

What does it mean to be vulnerable?

When researchers begin to learn about vulnerability, it’s usually with a conversation about cases such as the United States Public Health Service Syphilis experiments, the Nazi experiments, and the many other historical examples of unethical research with vulnerable populations. We also tend to look to the regulations 45 CFR 46 and 21 CFR 56, which offer this limited list of vulnerable participants:

• Women
• Human fetuses
• Neonates
• Prisoners
• Children
• Persons with physical handicaps
• Persons with mental disabilities
• Persons who are disadvantaged economically or educationally

The Belmont Report also describes racial minorities, the very ill, and the institutionalized as vulnerable. Even with this guidance, there is always a question of exactly who should be considered a member of a vulnerable population, and how to handle those situations.

Vulnerability in Research by James M. Dubois provides the pros and cons of two approaches to addressing vulnerability: group-based and analytic. The group-based approach, Dubois states, “makes it easier to identify individuals as vulnerable.” However, he also argues that, “such an approach may become unwieldy if we seek to craft special regulations for every group that may be vulnerable,” adding:

"A recent study of prisoners’ decision-making capacity and motivations for entering into research found that decision-making capacity was more significantly impaired by cognitive factors than by environmental factors, although current regulations focus almost exclusively on the threats to voluntariness posed by incarceration and the subordinate relationships it creates."

The National Bioethics Advisory Committee (NBAC) recommends the analytic approach to addressing vulnerability. Although my institution does not review bioethical research, the approach may be useful when reviewing institutional review board (IRB) applications. The NBAC has identified six traits of vulnerability that may “interfere with an individual’s ability to protect themselves in research especially during the informed consent process.” The vulnerability traits are:

1. Cognitive or communicative
2. Institutional
3. Deferential
4. Medical
5. Economic
6. Social

Just in the past several weeks, the National Transgender Discrimination Survey (NTDS) results were shared with the public. This survey included more than 6,450 responses from participants. “The NTDS is the first large-scale national study of discrimination against transgender and gender non-conforming Americans, and paints a more complete picture than any prior research to date.”

This study shows the complexity of vulnerability in the transgender and gender non-conforming individuals. Researchers can utilize the study’s results to better understand the population’s vulnerability.

No matter what approach researchers take the question remains: What is the definition of vulnerability?

It’s important to remember that IRBs are responsible for reviewing research in relation to ethical conduct and for ensuring that participants can make an informed decision about their participation. In addition, the IRB reviewer or committee should acknowledge what, if any, special accommodations need to be made in order to protect the population without indirectly scrutinizing the population (implication of stereotypes rather than actual evidence regarding the characteristics of the population).

Dubois strongly encourages IRBs to consult the research community rather than making an assumption that persons with severe mental disorders are “unable to provided informed consent, despite evidence that most individuals with depression or schizophrenia retain decision-making capacity.”

What are your thoughts on these varied approaches to understanding vulnerability?

Meet the PRIM&R Blog Squad: Farah Moluvi

PRIM&R is pleased to introduce the members of the inaugural Blog Squad at this year's 2011 Institutional Animal Care and use Committee (IACUC) Conference. The Blog Squad is composed of two PRIM&R members who are devoted to blogging live from the conference.

Interested in becoming a member of the PRIM&R Blog Squad? There is still time to submit your application to become a member of the Blog Squad at the 20011 Social, Behavioral, and Educational Research Conference in Boston, MA!

We are proud to introduce you to the second of our two Blog Squad members, Farah Moulvi.

Greetings PRIM&R community, and hello from sunny Florida! My name is Farah Moulvi, and I am excited and honored to be joining the PRIM&R Blog Squad for the 2011 Institutional Animal Care and Use Committee (IACUC) Conference in Chicago, IL.

Nearly 10 years ago, I transitioned into academic research through current position as the IACUC program manager and biosafety officer at the University of South Florida (USF), Tampa, with the division of research integrity and compliance.

For as long as I can recall, science and medicine have always fascinated me. It was no surprise to my family, the majority of whom work in banking and finance, when I decided to pursue a bachelor’s degree in chemistry and a master’s degree in toxicology from the USF College of Public Health.

Before working in academia, I served as a toxicological technologist and conducted biocompatibility studies and quality and safety testing of medical products and devices. My duties included in vivo and in vitro assays. Next, I ventured into the position of chemical analyst for two pharmaceutical companies where I performed quality control testing of finished products and raw materials. Following my work as chemical analyst, I found an opportunity in which I could facilitate the translation of scientific discoveries into medical applications—the wonderful world of academic biomedical research! I found professional fulfillment in assuring compliance and facilitating research at a large and continually growing research institution.

The theme of the upcoming 2011 IACUC Conference, Assuring Compliance While Facilitating Research: Achieving the Delicate Balance, captured my attention, as balancing regulatory requirements with research endeavors is the overarching philosophy under which I operate. Participating in the PRIM&R conference will put me in touch with like-minded peers and provide an opportunity to learn from experts, share ideas with colleagues, and contribute to my professional growth. I look forward to meeting you at my first IACUC Conference and drawing upon your knowledge, experiences and insights. I am particularly looking forward to the Panel II and IV discussions: Oversight Updates: AAALAC International, OLAW, and USDA and Facilitating Research and Institutional Accountability, respectively.

As a new PRIM&R member, I am very excited to add my voice as a member of the PRIM&R Blog Squad. I view the PRIM&R blog as a starting place for dialogue among peers that mirror conversations occurring at the national and international level. I hope to make my blog posts solution-oriented. However, this requires a key component in the form of your ideas, your perspectives, your know-how, and your interpretations. Your involvement will allow for the development of solutions based on collective wisdom. I believe in community service and want to do my part in contributing to conversations that promote the safe and ethical use of animals in the conduct of research. I hope that you will do the same.

So, Farah O Farah, who art thou? I am a social butterfly who loves to meet people and interact with others. I have a high level of professionalism, operate with integrity, have a team mentality, and enjoy being creative. I have fun taking digital pictures, love reading about current affairs in the news, and enjoy playing computer games on mobile devices in my spare time.

With great enthusiasm I embark on this journey of learning and sharing as a member of the PRIM&R Blog Squad at the 2011 IACUC Conference. I hope you will look to PRIM&R’s blog as we discuss the everyday challenges and seek solutions in the care and ethical treatment of animals in research. Stay tuned!

“Science Times” synthesis

Wondering what’s the latest in the synthesis of silk? Curious about the healing capacity of newborn mammals’ hearts? Read to explore these and other topics in this week’s edition of the “Science Times” synthesis. We invite you to weigh in on this week's news stories by commenting.

March 1, 2011

Newborn mice’s hearts can heal themselves: For the first time in mammals, scientists were able to observe a newborn heart fully healing itself.

Call it a reversible coma, not sleep: Dr. Emery Neal Brown explains his research examining the mechanism of anesthesia and the ethical considerations of his work.

Having a baby: Stress doesn’t hamper fertility treatment, researchers conclude: Researchers conducting a multicounty review of fertility studies found no association between stress and conception.

Wound care may matter more than antibiotics: A recent study suggests that perhaps it is not antibiotics, but good wound care that is essential to treating infections.

March 8, 2011

The reinvention of silk: Researchers lament their inability to recreate spider silk while others attempt to replicate silkworms’ processes for making silk.

On the left hand, there are no easy answers: Handedness is linked to brain asymmetry; researchers, however, struggle to understand the reason for brain asymmetry.

New tool gives a virus-level view of the world: A new microscope allows scientists to explore the minute world of viruses in real time.

Leisurely meals don’t curb snacking, study finds: A study out of the Netherlands suggests that meal pace does not impact snacking.

Meet the PRIM&R Blog Squad: Amanda Plante

PRIM&R is pleased to introduce the members of the inaugural Blog Squad at this year's 2011 Institutional Animal Care and use Committee (IACUC) Conference. The Blog Squad is composed of two PRIM&R members who are devoted to blogging live from the conference.

We are proud to introduce you to the first of our two Blog Squad members, Amanda Plante.

Hi there! My name is Amanda Plante and I am excited to be one of PRIM&R Blog Squad members for the 2011 IACUC Conference. This conference will be a fantastic opportunity to meet others in the field of research ethics administration and learn from their experiences. Travelling from Saskatoon, Saskatchewan, I am looking forward to escaping from our snow and -20 Fahrenheit weather, visiting the Windy City and indulging in deep dish pizza.

When not enjoying the local food and weather, you will find me eagerly attending Essentials of IACUC Administration on March 29-30. During the 2009 IACUC Conference, I had the pleasure of attending IACUC 101, which I found the workshop very informative and relevant to my position, especially as a new IACUC coordinator.

I obtained a Bachelor of Science degree in biology from the University of Windsor in Windsor, ON in 1995 and a Master of Science degree in toxicology from the University of Saskatchewan in 1999. I have worked at the University of Saskatchewan since 1998, where I currently serve as the animal ethics research facilitator in the research ethics office. I support the implementation and administration of the university’s animal care and use program under the direction of the University Committee on Animal Care and Supply (UCACS), as well as maintaining compliance with the Canadian Council on Animal Care (CCAC) guidelines and policies. Prior to joining the research ethics office in November 2007, I worked as a research technician for the department of biology, as a lecturer for the University of Regina and the University of Saskatchewan, and as a grants officer in research services.

Although I consider myself quite new (just three years) to research ethics administration, I’ve been ‘pushing paper’ in the office of the vice-president of research for a few years now. I try to maintain a good sense of humor about the bureaucracy and administrative burden that our office is charged with imposing. There is certainly a fine balance to be attained between striving to meet all regulatory requirements while also providing a good level of service to our researchers. How to strike this balance? I am hoping to find answers in the April 1 session titled Strategies for Ensuring Your IACUC is a Customer Service-Oriented Organization!

I am eager be a member of the PRIM&R Blog Squad and share my thoughts and experiences from the conference relating to specific workshops, speakers, and events. It is a great chance for me to become a truly active and engaged participant, reacting to the conference activities via Ampersand. I look forward to meeting you at the 2011 IACUC Conference at the end of the month. Be sure to keep an eye out for the individuals in the bright red Blog Squad shirts—we shouldn’t be hard to miss!

Featured Member Interview: Denyse Pettersson

Welcome to another installment of our featured member interviews 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 Denyse Pettersson, IRB manager at the Children's Hospital and Research Center in Oakland, CA.

When and why did you join the field?
I jumped into the IRB arena in 2000 at the US Army Institute of Surgical Research in San Antonio, TX. Before that I was next door at Brooke Army Medical Center for two years, assisting the chief of nursing research with grant submissions, grant budgets and data analysis. Submitting many research studies to the IRB was a good introduction to the field of human subjects research. I am detail oriented and intellectually curious, so research is a good fit for me.

What is your favorite part of your job?
My favorite part of the job is customer service. The IRB partners with investigators to facilitate research that meets all regulatory and ethical criteria. We welcome questions from investigators and research coordinators, and take the time to explain the basis of IRB requirements. Submissions receive very timely review.

What's playing on your iPod?
Joe Satriani and Steve Vai .

What is the last movie you saw?
The Last Mistress, by my favorite filmmaker, Catherine Breillat.

What’s for dinner tonight?
Fish, steamed fingerling potatoes, and sweet pea pods.

What are you reading?
Olive Kitteridge by Elizabeth Strout.

What's your after-hours guilty pleasure?
Spider Solitaire, difficult level. I waste so much time on this!

Why did you join PRIM&R?
I joined in order to participate in education related to the protection of human research subjects and to network with my peers at the annual conference and by e-mail. It is important to have the opportunity to discuss "shared experiences" and solutions to regulatory and ethical concerns and to learn from more experienced members.

What is your favorite member benefit?
RED, PRIM&R's electronic Research Ethics Digest and the Newsletter.

If you were planning our next conference, who would you select as a keynote speaker?
Bernard Lo, MD, professor of medicine and director, program in medical ethics, University of California San Francisco.

What motivates you to maintain your commitment to advancing ethical research?
Our research mostly involves treatment protocols for children with life-threatening illnesses and rare diseases. I believe research with children is essential, for these children and those in the future. Children are vulnerable, as are the parents of very ill children, and the highest ethical standards should be attained.

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

What’s the worst question you can ask during the consent process?

We are thrilled to welcome guest blogger Margo Michaels , executive director of ENACCT, to Ampersand. Margo has been in her position at ENACCT for the past six years.

Before a patient or prospective research participant walks in the door, what are the policies and procedures that can create opportunities for more effective discussions with caregivers and optimize understanding among all parties involved?

Over the last five years, my organization has trained hundreds of oncology professionals on strategies to enhance their recruitment and accrual practices, with a strong focus on literacy and language. In the course of this training, we have found that the informed consent process in many institutions relies too heavily on the consent form itself, rather than on a meaningful discussion about risks and benefits, and researchers seldom assess understanding.

Since most consent forms exceed 20 pages and are written at a 12th-grade level or above, we cannot continue to rely on this document to ensure understanding. What does this have to do with institutional review boards (IRBs)? Four issues come to mind:

First, IRB professionals should work with investigators to address literacy levels in informed consent documents, which means not only looking at the language used, but also at the length of the document itself. In "Health literacy and cancer communication," Davis and colleagues state: "IRBs are designed for patient protection; however, IRBs rarely take literacy into full account when reviewing consent documents.”

Second, IRB professionals need to understand the processes through which consent is given that optimize patient understanding- otherwise the consent form itself is meaningless. For example, does a member of the research staff read the form out loud to “consent” the participant? Do they assume the prospective participant has read the document himself or herself, because it was sent home ahead of time? Finally, how do research staff assess understanding? As a recent study pointed out, “strategies to increase patients' knowledge need to be elaborated in order to improve the fulfillment of the requirements of informed consent in participants in cancer clinical trials.”

Third, IRB professionals should consider how well the consent process itself is explained to the public. Through our work in communities nationwide, we still see what Corbie-Smith and colleagues pointed out in their study of African Americans: “[Few understand] the concept of informed consent and [see] signing the document as relinquishing their autonomy and as a legal protection for physicians.”

Fourth, how can IRB professionals respond to the fact that more than 50 million US residents do not speak the same language as their physicians, i.e. how do we address the need of limited English proficiency (LEP) patients/prospective participants? Are translated informed consent documents and an available interpreter all that is needed? Is it legitimate for government-funded studies to exclude LEP populations?

What can we do to enhance the informed consent process? How can IRBs ensure that research staff or physicians discussing the trial optimize understanding for their patient?

I understand that these and related questions are addressed regularly at PRIM&R’s Advancing Ethical Research conferences, but I’d really like to take this opportunity to hear your thoughts, so please post a comment so that we can benefit from of our shared efforts in this complex area.

I’d like to end this post by returning to the question I posed at the outset: What’s the worst question you can ask during the consent process?

In my opinion, and the opinions of literacy and language experts, it’s relying on “do you understand?” to assess understanding. A prospective participant is very likely to answer “yes,” or nod, regardless of whether she/he actually does understand. The question shifts the burden to the prospective participant, when in fact it should lie with the researcher and the research staff. It’s our obligation to provide the information in a manner that promotes and ensures understanding. Furthermore, it’s our responsibility to ensure that understanding is achieved in an appropriate and interactive manner. Some excellent tips on doing so can be found in the American Medical Association video, "Health literacy and patient safety: Help patients understand". A simple question such as “do you understand?” does not accomplish any of this and as a result just may qualify as the “the worst question.”

I welcome and encourage your questions and comments!

"Science Times" synthesis

This week’s edition of PRIM&R’s “Science Times synthesis” brings us hope for hair loss, insight into how the brain processes words, and a glimpse at the increasing power of artificial intelligence (AI). What does it all mean? As always, we invite you to read and comment on your favorite stories.

February 22, 2011:

The threatening scent of fertile women: Researchers examine how attraction is linked to fertility in a study on “relationship maintenance.”

A romp into theories of the cradle of life: At a conference sponsored by the Origins Project, researchers reached across disciplines to explore diverse explanations for the origin of life.

In surprise finding, bald mice find their fur again: Mice provide surprising insight into the potential role of stress in hair loss.

Brain’s reading center isn’t picky about vision: New evidence suggests that the same section of the brain is responsible for word formation in sighted and non-sighted individuals.

Hibernating bears keep thermostat turned up: Scientists in Alaska have found that black bears experience only a minimal decrease in body temperature, while decreasing their metabolic rate by almost a quarter.

February 15, 2011:

A fight to win the future: computers versus humans: A showdown between Jeopardy’s best players and an IBM computing system named Watson raises questions about AI.

Lucy walked tall, a foot bone suggests: A new discovery confirms that Australopithecus afarensis had arched feet and walked upright.