PRIM&R’s Abstract Spotlight

In this new series of Ampersand posts, PRIM&R touches base with those who presented programmatic and research-based findings at past PRIM&R conferences.

Spotlight on an abstract from the 2009 IACUC Conference

Title: IACUC Oversight of Collaborative Work with the Private Sector and Federal Agencies

Authors: Kathy Partin, Ph.D.; Laura Martin, B.S.; William Moseley, M.A.

Affiliation: Research Integrity and Compliance Review Office, Colorado State University, Fort Collins, CO

Abstract summary: Academic research institutions are actively seeking research collaborations with the private sector and federal agencies. Institutions may need to prepare for such endeavors with a concerted recalibration of several offices...

Colorado State University has explored implementing new training in different areas of research, developing new ways to write and submit animal protocols, and defining new ways to think about who can serve as an investigator. This poster addressed how the IACUC, institutional official, administrative staff, and principal investigators worked with the current system; the policies governing this system; future considerations; and actions needed for successful collaborations.

(View the full abstract here.)

PRIM&R Staff (PS): It’s been a year since you presented this abstract at PRIM&R’s 2009 IACUC Conference. How has your program changed or evolved in the past 12 months?

Kathy Partin, Ph.D. (KP): Since the conference, the planned “Research Innovation Center” facility designed to house collaborative and private sector infectious agent research projects has gone from an architectural draft to a real building, and it’s scheduled to open this summer.

We held discussion with critical stakeholders, including the IACUC, sponsored programs, researchers, IT professionals and compliance officers to find a consensus path forward. A necessary element of expanded IACUC purview has been to find an IT solution that allows non-credentialed users (private sector employees) secure access to IACUC protocol software that typically can only be accessed by credentialed users (CSU employees).

Another necessary element has been to establish expectations for non-CSU employees regarding ethical standards for the use of animal subjects, and to develop sufficient tools to allow the IACUC to oversee such projects. These goals have been accomplished on paper, and starting this summer, will be put into practice.

PS: What challenges have you faced in implementing this program?

KP: The greatest challenge has been the number of administrative policies/procedures involved.

There was good consensus among staff within the various units of the office of the vice president for research that we could and should make the changes, which was very helpful. It took many meetings with staff in different units to identify specific language in policies and guidelines that would have to be changed, and then additional meetings to “vet” the changes and be sure we did not introduce unanticipated negative consequences.

Although we have made great strides in getting buy-in from all stakeholders, there are still individuals and groups who do not necessarily agree that the traditional mission of this land-grant university is compatible with an expanded mission of the university that includes private sector partners and the consequent entrepreneurial development that such collaborations permit.

For questions or comments about this program, please contact Dr. Partin or Mr. Moseley.

Interested in submitting an abstract to present at PRIM&R’s next animal or human research ethics conference? Please e-mail us for more information.

Dr. King on education, a core PRIM&R value

By Joan Rachlin, executive director

During a time when the world seems especially fragile and broken, we need the teachings and example of the Reverend Dr. Martin Luther King, Jr., now more than ever.

No words can capture the profound impact he had on so much of life as we know it today, and so I’ve included below some of his own words on education, one of the core values nearest and dearest to PRIM&R’s heart.

Among the many extraordinary qualities Dr. King possessed was the clarity of his vision and power from a very early age. Remarkably, the below excerpt on “The Purpose of Education” was written when he was a 19-year-old student at Morehouse College in Atlanta.

With thanks for his life for the enduring inspiration and teachings he left behind…

…”As I engage in the so-called "bull sessions" around and about the school, I too often find that most college men have a misconception of the purpose of education. Most of the "brethren" think that education should equip them with the proper instruments of exploitation so that they can forever trample over the masses. Still others think that education should furnish them with noble ends rather than means to an end.

It seems to me that education has a two-fold function to perform in the life of man and in society: the one is utility and the other is culture. Education must enable a man to become more efficient, to achieve with increasing facility the legitimate goals of his life.

Education must also train one for quick, resolute and effective thinking. To think incisively and to think for one's self is very difficult. We are prone to let our mental life become invaded by legions of half truths, prejudices, and propaganda. At this point, I often wonder whether or not education is fulfilling its purpose. A great majority of the so-called educated people do not think logically and scientifically. Even the press, the classroom, the platform, and the pulpit in many instances do not give us objective and unbiased truths. To save man from the morass of propaganda, in my opinion, is one of the chief aims of education. Education must enable one to sift and weigh evidence, to discern the true from the false, the real from the unreal, and the facts from the fiction.

The function of education, therefore, is to teach one to think intensively and to think critically. But education which stops with efficiency may prove the greatest menace to society. The most dangerous criminal may be the man gifted with reason, but with no morals.

The late Eugene Talmadge, in my opinion, possessed one of the better minds of Georgia, or even America. Moreover, he wore the Phi Beta Kappa key. By all measuring rods, Mr. Talmadge could think critically and intensively; yet he contends that I am an inferior being. Are those the types of men we call educated?

We must remember that intelligence is not enough. Intelligence plus character--that is the goal of true education. The complete education gives one not only power of concentration, but worthy objectives upon which to concentrate. The broad education will, therefore, transmit to one not only the accumulated knowledge of the race but also the accumulated experience of social living.

If we are not careful, our colleges will produce a group of close-minded, unscientific, illogical propagandists, consumed with immoral acts. Be careful, "brethren!" Be careful, teachers!”

This pin—not to mention the benefits of being certified—could be yours!

By Emily Butler, program assistant

More and more employers are asking for the Certification for IRB Professionals (CIP®) credential. This means they’re seeking an advanced level of knowledge, understanding, and relevant competencies in human research protection program (HRPP) and institutional review board (IRB) administration.

Add your name to the ranks of the more than 1,000 individuals who have achieved this important milestone by applying to take the exam by Friday, January 15, 2010.

The CIP® Credential...

• Promotes the ethical conduct of research by strengthening the professional administration of IRBs.
• Demonstrates a mastery of the body of knowledge determined by national experts to be essential to competent IRB/HRPP administrative practices.
• Encourages personal growth and professional development.
• Provides an expanded array of career advancement opportunities.
• Strengthens the quality of HRPPs by certifying a cadre of committed and educated individuals.

The CIP Handbook provides useful resources and sample exam questions, while the online practice test consists of 75 questions of the type that one might encounter on the actual exam.

For more information, please visit PRIM&R's website, e-mail Emily Butler, program assistant, or call 617.423.4112, ext. 25.

Dilemmas, no-brainers, and ethical implications

By Catherine Rogers, marketing coordinator

Everyone deals differently when it comes to making tough decisions, especially when the “right” choice poses potentially dire consequences for all involved.

But for humanitarian Miep Gies, weighing future outcomes against present situations posed no ethical dilemma whatsoever: In spite of the Nazi stronghold on the Netherlands, and the atrocities they caused, Mrs. Gies and her husband Jan chose to help shelter eight Jews, including Anne Frank’s family, for two years.

With the help of some colleagues, as described in her obituary, Mrs. Gies unquestioningly provided the families with the food, supplies, and information they needed—including paper for Anne Frank, who was composing what would become a classic in the literary canon.

Sympathetic to their well-being, Mrs. Gies made their physical and emotional comfort her first priority, until her home was raided in 1944.

Though Mrs. Gies lived to see her centennial birthday, the world lost a hero with her January 11 death.

Still, the research world can—and should—look to Miep and Jan Gies as examples of what it means to protect the people it serves. The Gies’ personal ethics directly affected how their commitments fared against their assumed risks, much like the way in which researchers’ personal ethics influence their decisions. Similarly, without the Gies’ assistance, Anne Frank’s diary might never have been recovered. Just imagine the void such an absence could have created.

Research oversight is replete with opportunities to ensure ethical conduct, and it’s no small task to treat every opportunity to protect human subjects as the most important. After all, the positive contributions from any given study are unlimited.

New Year, New Lineup: Changes in PRIM&R’s Board of Directors

By Catherine Rogers, marketing coordinator

With the turn of the New Year, PRIM&R’s Board of Directors—composed of 27 experts in human subject protections, animal care and use, biotechnology, the pharmaceutical industry, and more—has also undergone a transition.

The complete 2010 Board of Directors roster is available on our website, and we would like to extend a warm welcome to the group, especially the 2010 officers: Board Chair Walter L. Straus, Vice Chair Cynthia Gomez, Secretary Alexander Capron, and Treasurer Judy Norsigian.

We also wanted to thank former Board members Steven Niemi and Nelson Garnett for their years of service. Their energy will be missed, but we’re hopeful they will keep us abreast of their new adventures and endeavors.

Upcoming Winter Webinars

This January and February, join PRIM&R for two interactive learning opportunities!

On Thursday, January 28, at 1:00 PM ET join PRIM&R for Who “moved” my approval? Managing Suspended Research, a 90-minute webinar of great value to those working with an IRB/HRPP and/or those engaged more broadly in the conduct of human subject research.

Let Don Workman and Michele Russell-Einhorn answer questions such as…

• What is the meaning of IRB approval in the context of continuing review, revisions, and ongoing compliance?
• How do you respond when research transcends the IRB's approval (research that has lapsed, continued beyond the scope of the approval, or changed based on what the IRB approved)?
• Why might a protocol be suspended temporarily or permanently?
• What is the IRB's responsibility with respect to problematic studies?

Then, on Tuesday, February 9 at 1:00 PM ET, join PRIM&R for Top Tips for IACUCs: Perspectives in Animal Care, a webinar that will address some of the current issues facing institutional care and use committee (IACUC) professionals.

During this program, Pat Brown and Monte Matthews will cover...

• A review of top reportable issues to the Office of Laboratory Animal Welfare (OLAW) at the NIH;
• An OLAW perspective on crisis preparation and management;
• Selection and training of new IACUC chairs and committee members; and
• The fundamentals of program review and inspections.

We’ve got other webinars in the works, so keep an eye on our website to see what others are planned for 2010.