A “Second Wave” of Women in Medical Research

Ruth Faden, PhD, MPH, is director of the Johns Hopkins Berman Institute of Bioethics and a senior research scholar at the Kennedy Institute of Ethics at Georgetown University.  She was co-recipient of PRIM&R’s Lifetime Achievement Award in 2011 with her husband, Tom L. Beauchamp.

When I was pregnant with my first child more than 30 years ago, I developed a serious medical problem (deep vein thrombosis) and was put on heparin, a blood thinner. With every injection, I worried about whether I was doing the right thing, for me and for my baby. My wonderful physicians tried to be reassuring, but there was precious little by way of evidence or data to back up their claims.  It was a difficult, sometimes scary experience.

I wish I could say that a lot has changed in the intervening years, but, sadly, it has not. Although it is widely recognized that the pregnant body is in many respects biologically unique, there is still little known about how pregnant women respond to most drugs for most diseases. This makes doctors hesitant to prescribe them, creating a cycle of no-information-so-no-new-information that has proved difficult to break. In the US alone, that lack of knowledge leaves hundreds of thousands of pregnant women in the lurch every year.

The good news is this is a solvable problem! The solution lies in shifting the current research ethics framework from a focus on the risks that pregnant women and their fetuses face from medical research to the risks they face without medical research. It’s time that pregnant women are treated justly by the medical research community, and it’s time that the health interests of pregnant women are given their fair share of resources and creativity.

That is why I’ve worked with fellow bioethicists Margaret Little and Anne Drapkin Lyerly to found The Second Wave Initiative, so named to reflect a connection to the “first wave” of widespread inclusion of women in medical research in the late 1980s.

Since its founding, Second Wave has established its role as an advocate for the inclusion of pregnant women in medical research. Other colleagues have joined us in leading the effort, and many more are actively working on its behalf. In 2009, we made sure pregnant women were part of the discussion around the H1N1 vaccine.  More recently, we sent a letter to the Department of Health and Human Services (DHHS) to urge specific changes to regulations governing research with pregnant women, as part of our response to the DHHS Advanced Notice of Proposed Rulemaking (ANPRM), and we worked to secure congressional support for this effort.

In January, 36 members of the House of Representatives responded to our call by sending a letter to the Secretary of DHHS, Kathleen Sebelius. “It is critical that we understand how to safely and effectively treat pregnant women,” the letter states, calling the lack of knowledge a “public health issue.”

As DHHS prepares to revise the “Common Rule,” all of us in the Second Wave Initiative are hopeful that the changes will be positive for pregnant women, following the recommendations we’ve made. As the congressional letter says, “It is imperative that these regulations encourage the gathering of this critical information in safe and appropriate ways.”

Regardless of what happens with the “Common Rule,” however, progress can be made. The ethical and legal challenges to research involving pregnant women are real, but they are not insurmountable. Under the status quo, any number of valuable research projects that pose no or minimal risks are not undertaken or even contemplated, at least in part because researchers and funders don’t want the headache of trying to have research involving pregnant women approved.  Those of us in the PRIM&R community could do a lot to alleviate these concerns. At Second Wave, we are all about starting with the (ethically) low-hanging fruit—epidemiological and pharmacokinetic studies, and the like.  Please think about what you can do; with today’s science, there is just no excuse for pregnant women still to be facing what I faced all those decades ago.

For more information on Dr. Faden, visit the Johns Hopkins Berman Institute of Bioethics website.

The New Guide is All the Buzz

PRIM&R is pleased to share a piece from the PRIM&R Blog Squad at the 2012 Institutional Animal Care and Use Committee (IACUC) Conference. The Blog Squad is composed of PRIM&R members who are devoted to blogging live from our conferences. This is Farah Moulvi's second year serving as a member of the PRIM&R Blog Squad.

Spring is here and the buzz at the 2012 IACUC Conference (aside from whether your alma mater made it to the Sweet 16) was the impact of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals, and how to proceed with implementing the required changes.

Most of us IACUC bookworms know that since the release of the Institute for Laboratory Animal Research’s (ILAR) Eighth Edition of the Guide, the IACUC world has changed. The Eighth Edition of the Guide, released in December of 2010 and copyrighted in 2011, is an update to the seventh edition, which was published in 1996.

Effective January 1, 2012, institutions that receive Public Health Service funding must base their animal care and use programs on the Eighth Edition of the Guide, and they must complete at least one semiannual program review and facilities inspection using the new edition as the basis for evaluation by December 31, 2012.

The release of the updated Guide was followed by a flurry of responses. From discussions on professional listservs to in-depth analyses by various institutions and organizations, everyone is talking about the Guide’s new standards. As such, it was no wonder that many sessions at the 2012 IACUC Conference focused on this topic. Panel II: Oversight Updates: AAALAC International, OLAW, and USDA was packed with IACUC stakeholders eager to gain insight into the updates and expectations for implementation of the changes.

Another session I attended, workshop C7, Science, OLAW, and the Adoption of the Eighth Edition of the Guide, also focused on this topic. Presented by Dr. Pat Brown, VMD, MS, DACLAM, director of OLAW; and Dr. William White, VMD, MS, DACLAM, corporate vice president of veterinary and professional services at Charles River Laboratories, this session provided attendees with information on how the Guide has expanded and offered an opportunity for attendees to discuss the changes.

Dr. White commented on how performance standards that deviate from the Guide might provide better conditions for animals as they may allow new information to be gained in the field. He added that the decision-making process for these deviations must be structured and must involve the IACUC to determine acceptability. If an IACUC approves such a departure from the Guide, key performance indicators should be monitored.

It was very interesting to hear the buzz about the updated Guide in the corridors, at lunch breaks, and during the question-and-answer sessions throughout the conference. With the 2012 IACUC Conference behind me, I am eager to take the insight I gained back to my institution. As now is the time for all of us IACUC administrator worker bees to get back to work and to get “buzzy” with the work that is ahead of us!

Let’s Meet the Wild Side of the IACUC

PRIM&R is pleased to share a piece from the PRIM&R Blog Squad at the 2012 Institutional Animal Care and Use Committee (IACUC) Conference. The Blog Squad is composed of PRIM&R members who are devoted to blogging live from our conferences. This is Farah Moulvi's second year serving as a member of the PRIM&R Blog Squad.

IACUC administrators involved with wildlife research are familiar with the diversity of wild animals and the unique scenarios that arise when reviewing research proposals involving wildlife.

Wildlife research includes animals living in their natural habitats as well as those captured from the wild. Although general welfare principles apply to wildlife studies, the traditional approaches and procedures for laboratory-bred animals may not be appropriate.

Wildlife studies often differ from biomedical research, as the objectives usually relate to understanding the species’ behavior, ecology, or disease, rather than human benefit.
Robert Sikes, one of three presenters in Wildlife Protocol Oversight, Including Special Challenges When Conducting Field Studies at the 2012 IACUC Conference, mentioned that the diversity of wildlife animals is made up of around 52,000 species, and that procedures used in field studies vary according to the taxa and environment. Considering that the Guide for the Care and Use of Laboratory Animals provides only four paragraphs on wildlife research and that this guidance applies only to the use of vertebrates covered by Public Health Service (PHS) assurances in PHS-funded research,  this resource may not be specific enough for the diversity of wildlife represented.

There are guides put out by several professional societies’ that serve to supplement the information contained within the Guide . The presenters mentioned several examples, such as the American Society of Mammalogists, the American Society of Ichthyologists and Herpetologists, the Ornithological Council, and the American Fisheries Society. The guidelines of these four groups serve as references for best practices for both principal investigators (PIs) and IACUC members. They also contain useful information relating to wildlife-specific items, such as the capture and marking of natural populations , occupational health concerns, personal protective equipment usage, and the inspection and monitoring for these studies.

This session also emphasized the need for IACUCs to balance the welfare of wild animals with the unique model required for this type of research. Speakers mentioned several factors such as the locale of the research (e.g. the terrain, altitude), the climate, whether site visits are feasible, and how recordkeeping of audio and visual documentation is accomplished.

Jon Geller discussed unexpected outcomes associated with capturing and marking animals. He suggested that IACUCs consider asking PIs to provide a description of unexpected outcomes. For example, a PI may want to provide information on the potential of an adverse event occurring during the capture and restraint process.

The presenters suggested that when reviewing wildlife protocols IACUCs also consider the risk to the indigenous population of a habitat, the impact on captive animals if released, and how would animals would interact with other species. A PI should anticipate any collateral or opportunistic captures, and estimate what the effect and disposition of the animal would be. Other circumstances IACUCs face when reviewing field studies include pain and distress categories, and mortality rates during capture and release.

Another topic of discussion was how the IACUC ensures that the value of such research is worth the use of the animals involved and how the knowledge gained from the research can be applied to the population being studied. Statistical methods cannot always be used to determine the number of free-ranging animals needed in experimental groups. Sometimes the IACUC may have to take the type of animal being used into consideration (e.g. dolphins and elks are very different from mice and rats). Although a mathematical formula for determining the research population may be needed for valid results, practical considerations must be applied when using free-ranging wildlife. These statistical questions are answered differently when using smaller animals in high densities, rather than rare, endangered, or threatened species.

With such diverse issues, an IACUC that reviews wildlife protocols must have a field researcher and/or field biologist serving on the committee. Ad hocs and/or society representatives should also be utilized for consultation as needed.

The take-home message from this session was that one size does not fit all. Because of the diversity of issues IACUCs and researchers face, they must learn to work together to comply with the law and protect the privilege of using free-ranging animals in research. Welcome to the world of the IACUC’s wild side!

Essentials of IACUC Administration: An Alternate St. Patrick’s Day Parade Route

PRIM&R is pleased to share a piece from the PRIM&R Blog Squad at the 2012 Institutional Animal Care and Use Committee (IACUC) Conference. The Blog Squad is composed of PRIM&R members who are devoted to blogging live from our conferences. This is Farah Moulvi's second year serving as a member of the PRIM&R Blog Squad.

Essentials of Institutional Animal Care and Use (IACUC) Administration is a not-to-be-missed course for those seeking the knowledge and skills necessary to manage an animal care and use program. Although I have been involved with IACUCs for more than 10 years, I always learn something new in this engaging course. And, many others must agree: Despite gorgeous spring weather, and Boston’s renowned St. Patrick’s Day parade taking place nearby, the course had a solid turnout with almost 100 participants. 

The famous “3Ms” (Marky Pitts, CPIA; Molly Greene, BA, CPIA; and Mary Jo Shepherd, DVM, CPIA) possess a wealth of information, with a collective 75 years of experience in the IACUC field. This day-and-a-half workshop was segmented into eight modules for attendees, who took home a range of tools and templates that will be helpful for managing an animal care and use program. Presenters gave examples of key components of a quality program, and suggested ways to integrate these components at individual institutions.

The presentations cover a broad range of topics, including protocol review and inspections, policies and procedures, post-approval monitoring, noncompliance reporting, semiannual reviews, IACUC training, and occupational health programs. Information provided included the requirements from sources such as the Guide for the Care and Use of Laboratory Animals: Eighth Edition, Public Health Service policy, U.S. Department of Agriculture regulations, and the Association for Assessment and Accreditation of Laboratory Animal Care International.

Prior to the workshop, the faculty solicited questions from registrants to foster discussion at the breakout sessions. Eighty-five attendees formed smaller groups by professional affiliation, among them, academic IACUC administrators, industry and governmental (Department of Defense and Department of Veteran’s Affairs) IACUC administrators, veterinarians, institutional officials, and IACUC chairs. With a smaller group, the breakout session served as a platform to network and discuss solutions that have been implemented by various institutions.

The breakout group I attended was led by Marky Pitts and Mary Beran, MA, CPIA. They discussed various methods of enhancing training and tracking experience, as well as certification strategies to align with the requirements in the Eighth Edition of the Guide. Other topics in the breakout session included specific challenges of dealing with non-traditional biomedical research models such as agricultural and wild animals in field investigations.

Even though the session was filled with copious amounts of information the course moderators provided a broad spectrum of resource documents including articles, frequently asked questions, and standard operating procedures that will serve as invaluable resources to attendees. In an effort to go “green,” many of these resources were made available in a digital format this year. Although I didn’t take part in the parade, I am sure that my colleagues will be green with envy over the resources I just landed at this pre-conference program. Must be the luck of the Irish!

Let’s Engage In a Collaborative Activity!

PRIM&R is pleased to introduce this year's member of the PRIM&R Blog Squad at the 2012 Institutional Animal Care and Use Committee (IACUC) Conference: Farah Moulvi. The Blog Squad is composed of PRIM&R members who are devoted to blogging live from our conferences. This is Farah's second year serving as a member of the PRIM&R Blog Squad at PRIM&R's annual IACUC Conference.

Whether it’s spring break, March Madness, Super Tuesday, Lent, or the upcoming 2012 IACUC Conference, a lot is happening in the month of March for IACUC stakeholders. Good thing multitasking is second nature for IACUC professionals.

So here I am, for round two, as a member of the PRIM&R Blog Squad covering the 2012 IACUC Conference for fellow attendees and those individuals unable to attend in person.

Attending the 2011 IACUC Conference last year was a true game changer. As IACUC and biosafety administrator at the University of South Florida, it was an invaluable experience that provided me a platform to network with experienced members of the IACUC community. As the 2012 IACUC Conference approaches, I look forward to networking with my peers once again. 

The theme of this year’s conference, Assuring Compliance While Facilitating Research: Keeping a Healthy Tension, is a perspective that all IACUC professionals can relate to and strive to accomplish. The conference offers a wide variety of sessions, workshops, panels, and forums to keep with this theme and meet the needs of a diverse body of attendees, including IACUC members, IACUC administrators, veterinarians, compliance officers, new IACUC staff, federal representatives, community members, and institutional officials.

The knowledge and experiences that have been available to me during the conference have aided me in making decisions and influencing my institution’s performance.  It is a reassuring when you meet like-minded animal care and use professionals and you realize that you are not alone and that you have the opportunity to learn from those Individuals who have already been through what you might be going through.  The individuals that I met at the 2011 IACUC Conference have truly become friends. They are a helpful, friendly, smart, and fun group of professionals who are committed to collaboration.

So I encourage all of you to engage with other animal care and use professionals in a collaborative activity or dialogue at the upcoming 2012 IACUC Conference.  In the precipitously evolving domain of animal care and use, teamwork and networking are the keys to ensuring the safe and ethical use of animals in the conduct of research.

As I blog from the conference lobby at the Boston Westin Waterfront Hotel (in my easy-to-spot  PRIM&R Blog Squad attire), please stop by and share your experiences, your opinions, and your interpretations of the conference’s events. With your help, I hope to share conference insights to the larger community through the power of blogging. Till the next blog—live from Boston!

The Belmont Report and Beyond: My Introduction to Research Ethics

by Alysa Perry 

Alysa Perry recently joined the staff of PRIM&R as program coordinator. Prior to joining PRIM&R, she worked at a start-up that hosted alumni job fairs throughout the country. At PRIM&R, Alysa will be working as an integral part of the team that plans, organizes, and executes PRIM&R’s one-day educational courses, including regional programs, pre-conference programs, and At Your Doorstep offerings. Here, Alysa reflects on her first weeks on the job and her entry into the field of research ethics. Welcome to PRIM&R, Alysa!

I’m amazed by just how far reaching the world of research ethics can be. Before coming to PRIM&R, I had a basic understanding of research standards and their relevance to everyday life. I knew of the Nuremberg Trials and the U.S. Public Health Service Syphilis Study at Tuskegee, but had very little idea about the whole range of professionals dedicated to making sure history doesn’t repeat itself.  

Institutional review boards and institutional animal care and use committees (IACUCs) were foreign concepts to me. So it may come as no surprise to you when I say that the learning curve has been steep and thrilling. It feels as though I have peeked behind the magician’s curtain, and an entire world I never knew existed has been revealed to me. “Compliance,” “protections,” and “oversight” are fast becoming my new favorite vocabulary words.  

As I was, those unfamiliar with the field of research ethics may not be aware of the comprehensive federal regulations, or the human subjects protections and animal care and use systems to which they have given rise.  The research professionals at the heart of these systems are responsible for ensuring the welfare of research subjects, a role that, I can now appreciate, helps to further public trust in research. So I am really looking forward to having the opportunity to meet some of the individuals who have chosen to take on this responsibility at the 2012 IACUC Conference and subsequent March Regional Program in Boston next week. 

I’ve been told that the new-job glow will fade and the honeymoon phase will end, but with so much left to learn, I think my new friend, Belmont, and I are in it for the long haul.

Poster Spotlight: Post-Approval Monitoring Programs Across Canada: Building on Strengths, Facing Challenges

by Avery Avrakotos

With the 2012 Institutional Animal Care and Use Committee (IACUC) Conference right around the corner, I invite you to join me as we revisit the work of Amanda La Plante, one of the poster presenters from the 2011 IACUC Conference.


In 2011, Amanda shared her institution’s work on post-approval monitoring (PAM) programs. By conducing a survey of Canadian institutions, Amanda and her colleagues at the University of Saskatchewan assessed institutional PAM programs. The results of the survey illuminated the importance of fostering a collegial environment between all parties involved in the care and use of animals. To read Amanda’s full abstract, please visit our website.

Avery Avrakotos (AA): It’s been a year since you presented this abstract at the 2011 IACUC Conference.  How has your research since evolved?
Amanda Plante (AP): The University of Saskatchewan Post-Approval Review Program now focuses more specifically on continuing education and evaluation during the post-approval review of animal use protocols (AUPs). The university veterinarian conducts the post-approval review, visits with principal investigators and members of their research team, which creates a much more collegial environment. The university’s post-approval review is an opportunity for learning, improving upon practices, and highlighting changes that benefit both the animals and the research. The review process also includes participation from a trainee observer (generally a graduate student), expanding upon the education component of the program. 

AA: What challenges have you faced in implementing this research?
AP: The most significant challenge is the scheduling of meetings to correspond to active animal use or that is convenient for the individual conducting the post-approval review, the trainee observer, the principal investigators, and the research team members. The cyclical nature of the animal usage in protocols and the use of off-campus animal facilities creates challenges with respect to coordination of meetings.

AA: What is one principle that has guided you in your research?
AP: The development and maintenance of cooperative and collegial relationships are key to supporting an effective and open communication strategy. Such interaction strengthens both the post-approval review program and interactions that relate to the University Committee on Animal Care and Supply (UCACS). It is also important that the UCACS and the research ethics office provide fair and consistent best practices and procedures across campus to all animal users.


Thank you for sharing, Amanda! We hope that you will have the opportunity to enjoy the dynamic poster presentations at the 2012 IACUC Conference. For more information on the poster presentations, please visit our website.

Featured Member Profile: Alicia Cook

Welcome to another installment of our featured member profile 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 Alicia Cook, institutional review board (IRB) director at The Chicago School of Professional Psychology in Chicago, IL.

When and why did you join the field?
Working as an audit coordinator for a cancer cooperative group, I was aware of IRBs and their role in research. During the same period, I was diagnosed with breast cancer and decided to receive treatment via a clinical trial. This new perspective, as a research subject, gave me a greater understanding of the importance of the IRB in research. So, in 2004 when I was encouraged by the IRB chair (who was also my anesthesiologist) to apply for an open IRB administrator position, I jumped at the opportunity. I was recently promoted to IRB director at my current institution.

What is your favorite part of your job?
My favorite part of my job is advising researchers on how to design studies within the parameters of the regulations that investigate challenging issues. I also enjoy conducting educational sessions for students who are conducting research for their dissertations. This is often their first introduction to research ethics, so they are very nervous. I enjoy being able to calm their fears about IRBs.

What is the last movie you saw?
Red Tails produced by George Lucas. Although I knew about the Tuskegee airmen, this movie highlighted their important role in history and the sacrifices they made for our country.

Why did you join PRIM&R?
In 2008, I left my previous position in a biomedical IRB to work in a social-behavioral IRB. I had attended the Advancing Ethical Research (AER) Conference through my previous institution, so I knew the valuable information that could be gained. Starting my new position, I knew PRIM&R membership would prove essential in providing me resources and support I needed to help me understand the regulations from a social-behavioral perspective.

What is your favorite member benefit?
The access to resources on research ethics and the ability to network with colleagues at the conferences have been invaluable. In addition, I think having access to the IRB Workload and Salary Survey will be a valuable resource in my new position as director.

What would you say to someone who is considering PRIM&R membership?
It is difficult to explain what we do to people outside of the field. Joining PRIM&R  gives you an opportunity to network with other members of the field and that helps to remind you that you are a member of a community. Also, the conferences and webinars are great educational resources.

What motivates you to maintain your commitment to advancing ethical research?
As a breast cancer survivor for almost 10 years, I have directly benefited from human subjects research. Incidents such as the U.S. Public Health Service syphilis study & the case of Henrietta Lacks remind us of the need to balance the quest for answers with the need to protect the rights of research subjects. As an African American who directly benefited from participation in a clinical trial, it is my goal to encourage African Americans to consider clinical trials participation by ensuring for them that there is now a mechanism in place to protect their rights.

Thank you for being part of the membership community and sharing your story, Alicia. We hope, we here at PRIM&R, can help you keep up with all the new regulations!

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

Sharing My Knowledge: Informed Consent Across Borders

 by Amal Matar, 2010 Pillars of PRIM&R Award Recipient

As a relatively young, Middle Eastern woman, who has only taken baby steps in the field of research ethics, I was surprised to be named the 2010 Pillars of PRIM&R Award recipient. The award involved presenting my research to almost 2,500 attendees at PRIM&R’s 2011 Advancing Ethical Research (AER) Conference. Participants came from all over the United States, but there were more than 100 individuals from the developing world.

The experience was very valuable. Besides networking with research ethicists, researchers, contract research organizations, and institutional review board members, I lead a section of a pre-conference program titled "Obtaining Consent in the Face of Culture, Religion and Language in Resource-Limited Countries." In a room with more than 50 attendees, we discussed a case study (developed with the help of Dr. Henry Silverman and Dr. Hany Sleem) that addressed the most common issues regarding informed consent in Egypt.

One of the major concerns discussed was the language of the informed consent. In the Egyptian context, care must be taken when translating the informed consent form (ICF) into Arabic, because the content is then read in an Egyptian dialect for research participants who may be illiterate. Important questions to consider include how simple should an ICF be so low-literacy populations can comprehend it, and whether a high school or lower grade language level is more appropriate. We also discussed methods for shortening the length without obscuring any of the ICF components as defined in international guidelines (as long as 40 pages sometimes!).

Another issue we considered was the local culture’s impact on consent.  For example, considering gender issues in research—this would entail having a female researcher approach a female participant, particularly in research of gynecology/obstetric nature.  Also considered was the need to obtain permission from a chief (Omda) or village leader, which might make the consent process more complex. It was emphasized that permission from the village leader should not undermine the autonomy of the research participants, but rather provide support to their decision-making process.

In a country where the illiteracy rate is as high as 40% and 20% of the population is under the national poverty line, many research participants could be categorized as vulnerable and therefore extra measures should be taken to avoid their undue inducement and protect against their exploitation.

After the lengthy discussion of the case, a role play was acted out where I became a poor Egyptian woman who could not read or write and was being recruited for breast cancer research involving genetic analysis. The interchange between one of the attendees and I was quite demonstrative, because she tried to use the simplest language possible to explain medical terminologies such as genes, genetic analysis, and research. In her recruitment strategy, she considered the husband and village chief. I think the audience was able to comprehend some of the challenges that are faced when obtaining consent from research participants in Egypt.

I have to admit that the session gave me insight into how pharmaceutical companies, researchers, and IRB members in one country may find it difficult to understand the nuances and differences across cultures. Though we all agreed on general principles of research ethics—autonomy, beneficence, non-maleficence, and justice—implementing such principles varies widely across cultures and only through sessions such as these can we communicate the differences and the best way of addressing them.