Friday, July 31, 2015

In Memoriam: Warren K. Ashe

Warren K. Ashe, PhD, retired associate dean for research at Howard University and former PRIM&R Board member, passed away on July 26, 2015. He was 85.

Dr. Ashe had a self-described love affair with Howard University from childhood, when he dreamed of being involved in the medical school. After receiving his bachelor’s degree in psychology from Howard, Dr. Ashe enlisted in the US Marines Corps. He remarked that the day he enlisted was both the best—and the worst—day of his life. “[The Marines] have a motto that I still remember. They say, ‘the difficult we do immediately; the impossible takes a little time.’…I live my life on that principle.”

After an honorable discharge in 1953, Dr. Ashe was hired at the National Institutes of Health (NIH). He worked at NIH for 20 years, and was the first African-American to become a senior scientific advisor at the National Institute for Dental Research. In 1961, after spending time studying the herpes simplex virus, he published his first paper in the journal, Archives of Oral Biology. In 1962, he earned a master’s degree in microbiology from Howard.

In 1971, Dr. Ashe received a call from the dean of Howard University College of Medicine, asking him to join the administration. Dr. Ashe began his work at Howard later that year, starting as an assistant dean and instructor of microbiology. In 1976, Dr. Ashe enrolled as a PhD student in the department of microbiology, working during the day and taking classes at night. He completed his longed-for doctoral degree in 1984.

When Dr. Ashe first arrived at Howard, there was no formal process for reviewing research. He formed the Human Research Review Committee, charged with reviewing all human research in the College of Medicine, which eventually transformed into the first institutional review board (IRB) at the University. He served as executive secretary for the IRB from 1971 until 2006.

While involved with the IRB, Dr. Ashe began attending PRIM&R conferences, and was invited by William Freeman, a PRIM&R Board member, to speak at a conference sponsored by the Applied Research Ethics National Association (PRIM&R’s former membership division) on a panel titled Can Tuskegee Happen Again? Held in 1998, this conference marked the beginning of Dr. Ashe’s involvement with PRIM&R; he was elected to PRIM&R’s Board of Directors that year, serving until 2010.

During his time on the board, Dr. Ashe and Dr. Freeman created the organization’s Institutional Capacity Building Scholarship Program, which was established to help individuals from under-represented minority institutions take advantage of participating in PRIM&R’s annual conferences. The program continues today, and has been instrumental in bringing professionals from historically Black colleges and universities, tribal colleges, and Hispanic-serving institutions to PRIM&R events for more than a decade.

Dr. Ashe also worked with Charles McCarthy, another PRIM&R Board member, to develop the Pillars of PRIM&R Program to recognize sustained contributions from members of the PRIM&R board to PRIM&R and to provide support for early career professionals.

Dr. Freeman noted Dr. Ashe’s passing by sharing the following: “I learned much from Warren. It was my pleasure to work closely with him on several PRIM&R Board issues, including the creation of our scholarship program. When I last met him in DC, he gave me a tour of the area in and near Chinatown, including the building that was first a synagogue, then [his beloved] Turner Memorial AME Church and now is the historic I Street Synagogue. To Warren’s family, I say, May his memory be a blessing. His memory is a blessing for me.”

In 2013, Dr. Ashe sat down with Gigi McMillan for an interview for PRIM&R's People and Perspectives initiative. During his interview, Dr. Ashe discusses his life, from early childhood in the segregated South to becoming the first African-American senior scientific advisor at the NIH.



He goes on to describe his time at Howard, his quest to earn a PhD, and his involvement with PRIM&R’s Board of Directors.


Though Dr. Ashe experienced some health challenges toward the end of his life, he maintained his positive outlook. “I pray constantly to…let me live my life to the best I can…Let me come to the end of my journey, and I can say truthfully that I have not wounded any souls…I have lived by what I believe is right, not what other people think should be right. And I try to be true to that.”

Dr. Ashe was an important friend, colleague, and mentor to so many, touching many lives with his wisdom and sincerity. “Because I’ve had so many experiences, I want to share them with everybody I possibly can. [There are] some people who may think ‘well that’s just an old Black guy just talking.’ But believe me it’s not that. I want to leave a legacy behind me so people know that Warren Kelly Ashe has been here.”

As PRIM&R’s Managing Director, Kimberly Hensle Lowrance, noted: “I am very lucky to have known Warren. He was such a special man—so committed to research, to doing better, to supporting one another. He always provided great advice to our staff and was a warm, lovely human being. I will miss him.”

The PRIM&R Board and staff extend their deepest sympathies to Warren’s beloved family.

Memorial contributions and donations may be made to The Lee B. Ashe/Enta M. Ashe Endowment Fund at the Howard University College of Medicine.

Monday, July 27, 2015

Capacity, Consent, and Progress: Recommendations from the Bioethics Commission

By Nicolle K. Strand, JD, M.Bioethics, research analyst at the Presidential Commission for the Study of Bioethical Issues

Earlier this year, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) released the second part of its report on neuroscience and ethics—Gray Matters: Topics at the Intersection of Neuroscience, Ethics, and Society (Gray Matters, Vol. 2). The report examines in depth several controversial topics that bring ethical issues to the fore, including cognitive enhancement, neuroscience and the law, and the ethical conduct of research with participants with impaired capacity for informed consent.

The challenge of impaired consent capacity has been a perennial issue in research ethics for decades yet it is nonetheless well-placed in a report about contemporary neuroscience. Neuroscientists commonly study the very diseases that can cause impairments in decision-making capacity, making informed consent difficult or impossible. These include head trauma, stroke, dementia, schizophrenia, and major depression, among others. Neuroscience research can promote progress towards understanding and alleviating these conditions, but that progress requires the participation of persons affected. Informed consent is a central tenet of research ethics and, in its absence—when working with participants whose capacity is impaired—researchers and IRBs need clear guidelines for whether and how to proceed ethically.

It is vital to find ways whenever possible to ethically and responsibly include individuals with impaired consent capacity in research, but researchers must also vigilantly protect participants from exploitation and abuse. In addition, researchers must guard against and mitigate stigma and harmful assumptions about individuals based on diagnoses or impaired consent capacity.

With all of this in mind, Gray Matters, Vol. 2 explains the long and complex history of national bodies crafting guidance about impaired consent capacity, describes the current regulatory framework to protect participants, and elucidates additional protections that can be employed when consent capacity is impaired or in question. These additional protections include using improved assessment techniques, respecting assent and dissent, engaging independent consent monitors, limiting acceptable levels of risk, requiring legally authorized representatives, honoring research advance directives, and ensuring meaningful stakeholder engagement. The Bioethics Commission made four recommendations in this area, emphasizing responsible inclusion, and calling for clearer requirements for identifying legally authorized representatives to provide permission on behalf of participants when consent capacity is impaired.

As a part of its continued efforts to distribute its findings and recommendations to relevant stakeholders, the Bioethics Commission has developed educational materials to accompany its reports. Included among the Gray Matters educational material is a primer for researchers on neuroscience and consent capacity. Researchers can use the primer to aid ethical decision making and ensure that they have considered and implemented appropriate safeguards. All of the Bioethics Commission’s materials are free and available at http://bioethics.gov/education.

Friday, July 24, 2015

Research Ethics Roundup: Female Mice in Research, IRB Member Conflicts of Interest, and More

From a new report that indicates that the use of regulated animals in biomedical research is declining to an editorial arguing for the use of female mice in research, animal research takes center stage in this week’s Research Ethics Roundup.

Conflicts of Interest on Institutional Review Boards Remain Problematic: A recent study in JAMA Internal Medicine concluded that while there has been significant progress with respect to reporting and managing institutional review board (IRB) member conflict of interests, there is still more work to be done. Ed Silverman reports on the findings in this article from The Wall Street Journal’s Pharmalot.

Genome Researchers Raise Alarm Over Big Data: In this piece for Nature, Erika Check Hayden reports on the growing concern among biologists and computer scientists that the challenge of managing genomic data will exceed the capability of current computing resources.

The FDA’s Medical Device Problem: In this opinion piece for The New York Times, Rita F. Redberg and Sanket S. Dhruva argue that the 21st Century Cures Act will “severely weaken, not strengthen, the FDA’s already ineffective regulatory scheme for medical devices. The device industry may stand to benefit from this legislation, but the health of the public does not.”

Use of Regulated Animals in US Biomedical Research Falls to Lowest Levels on Record: In this article from Science, David Grimm reports that new statistics posted by the United States Department of Agriculture reveal that the “number of federally regulated animals used in U.S. biomedical research dropped last year to its lowest level since data collection began in 1972.”

Why Science Needs Female Mice: This editorial from The New York Times reflects on a recent study published in Nature Neuroscience, which “suggests that research done on male animals may not hold up for women.” The authors of the editorial argue that new grant requirements from the NIH, which require justification for only using one sex in research, are a step in the right direction.

Wednesday, July 22, 2015

Opportunities for Advancement: Promoting Employee Engagement in Animal Care and Use Programs

By Angela Craig, DVM, lab animal veterinarian and institutional animal care and use committee (IACUC) member at the University of Minnesota

Each of us has a unique path that brought us to our career in laboratory animal care and use. I started my career in laboratory animal medicine twenty years ago as a member of the husbandry staff. I enjoyed the close connection I made with the animals under my care, and I understood that they depended on me for their basic needs. I further realized how the scientific discoveries unfolding were dependent on physically and psychologically healthy animals. When you feel deeply invested in the work you do, it is natural to think about the ways you can improve your knowledge, skills, and experience for the benefit of the animals and the research program. You think about how the work you enjoy might develop into a lifelong career. For me, the connection I felt to the animals in my care led me to become a laboratory animal veterinarian.

Opportunity for advancement is frequently cited as a key factor affecting employee job satisfaction. Advancement may include the development of new skills, greater responsibility, and/or promotion. Within an animal care and use program, there are many options for growth, but staff members are not always aware of how to get on the right track. They also may not realize the various directions they can go with their interests. In addition to careers oriented toward husbandry and veterinary care, there are also the paths of laboratory animal resource management, and animal program administration and compliance.

Managers and supervisors are in a position to learn about the goals of their staff and mentor each on to achieve his or her personal best within the field. One way to do this is to direct people to training and certification which will lead to new opportunities for advancement. As a lab animal veterinarian I frequently direct staff to technician certification through the American Association of Laboratory Animal Science (AALAS), but this is just one of many sources for career-advancing education. For staff members who are interested in management, pursuing the Certified Manager of Animal Resources (CMAR) certification is another route.

When ethics, welfare, and compliance are at the top of a staff member’s list of interests, PRIM&R offers two unique opportunities for education and growth. They are a Certificate in the Foundations of Animal Care and Use and Certified Professional IACUC Administrator (CPIA®) credential. Each of these programs promotes the acquisition of skills and expertise necessary for a career supporting ethical animal care and use and compliance, both of which require knowledgeable and dedicated individuals.

Lifelong learning in each of the roles described is further supported by PRIM&R’s yearly IACUC Conference, webinars, short courses, and mentoring from others in the field. Similarly, AALAS has a National Meeting and offers continuing education.

Every day in our institutions, we have the opportunity to encourage the growth of our staff members and give them guidance which can lead to advancement and greater job satisfaction. The more invested they are in their careers and engaged in lifelong learning, the better it is for the animals we serve. With educational offerings from AALAS and PRIM&R, we do not have to invent the path or the opportunities, merely introduce staff to what is possible and support their journey.

Monday, July 20, 2015

From the Director: Shedding Light on Compassion Fatigue

By Elisa A. Hurley, PhD, executive director

PRIM&R is unique in the research ethics world, serving as we do both the human subjects research and animal care and use communities. And from this unique position, we often see bridges and links between work with animals and work with humans, whether it’s thinking about the translational impact research with animals has on understanding and treating human disease; identifying and addressing similarities in research oversight processes between human research protection and animal care and use programs; or recognizing parallels between the ethical concepts called into play in each domain – for example, risk/benefit analysis— and gleaning generalizable lessons from such commonalities.

I’ve recently been thinking about another bridge between humans and animals in the research world: compassion fatigue among the people who work with, care for, and oversee the welfare of laboratory animals. As a phenomenon, compassion fatigue is not limited to animal care and use—indeed, the topic is widely discussed in other caring professions (see for example, Compassion Fatigue: A Nurse’s Primer, this article from the Journal of Hospice and Palliative Nursing, or this Emergency Nurses’ Association Topic Brief)—but it is a predictable outcome of working with research animals.

For the purposes of this discussion, I define compassion fatigue as the unintended emotional distress, fatigue, or apathy that develops from caring for, investing in the wellbeing of, and bonding with, animals whose health or lives may be sacrificed for the good of discovery through research. Given the documented power of the human/animal bond, compassion fatigue can affect the well-being of highly skilled animal care and use professionals, and, ultimately, the care of the animals themselves.

While not all animal care and use professionals develop bonds with the animals for which they care, research in this area suggests that the majority of laboratory animal technicians “experience some form of attachment to a laboratory animal at least once in his or her career.” (Arluke, A. 1994. The Ethical Socialization of Animal Researchers. Lab Anim. 23(6):30-35; cited in Cost of Caring.) Indeed, the very practices designed to enhance research animal welfare can serve to strengthen these bonds. According to the American Association of Laboratory Animal Science’s (AALAS) publication, Cost of Caring:

Practices of gentle handling, compassion and patience serve to build the bond between humans and animals. The development of the human/animal bond can improve animal welfare by minimizing stress [on the animal], enhancing [the animal’s] sense of safety and security, and fostering trust [by the animal with the human handler]. The same can be said for what those practices do for the human handler. It is well documented that close contact with animals can create feelings of satisfaction and affection, lower blood pressure, and provide an overall sense of well-being. For an animal care professional, “…feelings of satisfaction can arise from knowing that not only basic husbandry needs are met, but that animal welfare is enhanced by connecting through compassion, affection, and respect.

This topic caught my interest because it seems to get relatively little attention. In fact, as pointed out in a recent AALAS webinar on the topic (Compassion Fatigue and Compassion Satisfaction in the Workplace: Is the Cost of Caring Affecting Me?), the phenomenon has only very recently been recognized as relevant in the laboratory animal field. There are few if any support services for those who work with research animals and suffer from compassion fatigue, and very little exists in the way of print or online resources. Moreover, animal care and use professionals who find themselves struggling with compassion fatigue may be ashamed of their feelings, and fear discussing them with either peers, who might ridicule them, or family members and others outside the lab, who might express disgust about the specific work or disapproval of research with animals all together.

In fact, this last point may be one reason why the topic doesn’t get more coverage in the research community. Given the sensitive and sometimes very polarized climate around animal research, we likely worry that even acknowledging compassion fatigue exists in our ranks might give fodder to animal rights groups, calling into question the commitment to the research, or the belief in its value, on the part of those who work with animals and feel this way, and becoming a talking point, or worse, a politically inflated and misconstrued headline.

So what can and should the animal care and use community do? First and foremost, we should acknowledge the very real emotional impact of caring for research animals. Indeed, there are a number of important reasons why we should talk about compassion fatigue more often, and more publicly. First, doing so will send a clear message to animal care and use staff that their feelings—whether of anxiety, stress, guilt, fear, sadness, denial, or apathy (all of which can be manifestations of compassion fatigue)—are natural, expected, and valid, and are, in fact, appropriate responses to emotionally difficult work.

Second, acknowledging compassion fatigue may help to build bridges with those who remain unconvinced of the value of well-conducted animal research: talking openly about the toll caring for animals takes on those who work in the lab or oversee lab animal research humanizes these front-line individuals, and demonstrates that it’s possible to think that research with animals is incredibly important and valuable, yet still react with empathy, guilt, or grief to the experiences and loss of the animals in the lab.

Third, talking about the issue within labs and more broadly within institutions might also serve to stop compassion fatigue from becoming an animal welfare issue in its own right. This last point alone should prompt institutional animal care and use committees (IACUCs) to give this topic space in their meetings. As AALAS’ Cost of Caring notes,

To safeguard against feelings of loss, individuals may engage in anticipatory grief practices in preparation for loss… Once the loss occurs, individuals may choose to ignore feelings of anxiety, grief, or bereavement rather than acknowledge and accept these emotions. [This] building of emotional walls, ignoring feelings, and disengaging from the animals can lead to personal emotional vulnerability, a potentially ineffective emotional safeguard, and a loss for the animals in developing feelings of trust, safety, and security.

There are, as a result, practical concerns for the institution in not addressing the impact of compassion fatigue on staff, including high rates of attrition and absenteeism, poor performance, low morale, and an uncaring or callous attitude toward animals that can lead to noncompliance around animal care and use.

A second step, beyond recognizing the issue, is to provide support, both culturally and operationally, within the organization. For instance:

Cultural

Operational

Create an open atmosphere for discussion that encourages staff to acknowledge feelings; consider partnerships with counseling providers if your institution permits

Institute a safe open-door policy, and processes/spaces for employees to reflect and remember

Consider institutional adoption program for animals suited to transition to a home or sanctuary environment (per institutional policies)

Rotate staff to distribute job responsibilities and share difficult tasks, for instance have long-term care givers not participate in euthanasia, or excuse those who do not feel able to participate

Encourage individuals to build an outside support network of family and friends

Offer educational opportunities that address humane animal care and use, animal welfare and ethics

Discuss why the research is important and potential benefits of the results

 
List derived from AALAS, Cost of Caring

It seems clear that well-constructed, successful animal research programs will only benefit from acknowledging and helping to ameliorate the existence of compassion fatigue among all of those who have a role in promoting the welfare of laboratory animals, whether directly, in the lab, or indirectly, by overseeing research procedures as part of an IACUC. Addressing compassion fatigue and its effects is an emerging challenge for our community, and one where great gains can be made by just starting a conversation. So tell me, does your IACUC or institution deal with the issue of compassion fatigue? How? Do you talk about it with colleagues? Do you provide any support mechanisms? What could PRIM&R do to facilitate the conversation and help IACUCs and institutions manage compassion fatigue among staff?

Sources for additional resources: