Thanks for having us, AAHRPP!

Posted by Catherine Rogers, marketing coordinator

We’ve just wrapped up a trip to Los Angeles, CA, where the annual meeting for the Association for the Accreditation of Human Research Protection Programs (AAHRPP) was held. For three days, approximately 300 professionals attended breakout and plenary sessions, all of which centered on accreditation. PRIM&R was one of 10 exhibitors, and in spite of it being our first time at AAHRPP, there were dozens of familiar faces—from our Board of Directors, faculty, and membership—in the crowd. (A special thanks to all those who visited our booth and inquired about our upcoming events, membership benefits, and certification initiatives!)

In its simplest form, accreditation is an investment that recognizes an institution’s commitment to excellence through an evaluation process composed of paperwork, site-visits, and audits. AAHRPP’s primary goal is to enhance protections for human subjects by promoting high quality research practices that meet demanding ethical standards. Through the accreditation process participants learn best practices for running effective and compliant human subjects research programs.

The road to accreditation can be rocky, but AAHRPP officials highlighted some reasons to make the investment through a four-part series of sessions titled, “The Value of Accreditation.” In one session, AAHRPP president and CEO, Marjorie Speers, PhD, argued that accreditation can contribute to the likelihood of favorable outcomes following inspections by regulatory bodies. Through an informal study of site inspections, decision letters, and warning letters published by the OHRP and the FDA, AAHRPP found that institutions requiring corrective action were often not AAHRPP-accredited. Looking ahead, Dr. Speers said, “AAHRPP will continue to examine government inspection outcomes, and work closely with the FDA and OHRP to recognize [AAHRPP] accreditation.”

It’s inspiring to witness dozens of professionals come together for the purpose of protecting the human subjects that help researchers advance science. This time at AAHRPP, and as ever, we were thrilled to be a part of it.

Ethics of Community-Engaged Research

Guest blog by Community-Campus Partnerships for Health Senior Consultants Sarena D. Seifer, Nancy Shore, and Elaine Drew

A growing body of literature exists that raises questions about whether IRB processes for assuring ethical research are sufficient when applied to community-engaged research (CER).¹ IRBs are designed to protect the rights and welfare of individual study participants, but are less equipped to protect the rights and welfare of communities involved in research. Specifically, some authors suggest that the Belmont principles do not fully cover the scope of ethical considerations that arise in CER (e.g., community relevance, community participation, mutual capacity building, community benefit) thus IRB application of these principles may not provide a relevant or thorough ethical analysis.^{2, 3}

Indeed, in an analysis of 30 university-IRB application forms, Flicker et al. found that community considerations were often missing.⁴ While all the reviewed forms inquired about scientific rationale, none asked about the involved community’s perception or input regarding the justification for the study. Only four forms asked about community or societal level risks and benefits, and only five inquired how findings would be disseminated. Deeds et al. analyzed IRB feedback on a multi-site HIV prevention proposal and found that only 17% of IRB comments focused on community issues.⁵

Community-Campus Partnerships for Health and the Tuskegee Bioethics Center recently sponsored a conference call series to examine strategies for assessing and addressing ethical issues that arise in CER, including alternative models to institution-based IRBs for research ethics review, such as community advisory boards (CABs) and community IRBs.⁶ A growing number of community groups and community-institutional partnerships have established such processes for ethics review, operating independently, in parallel, or in partnership with institution-based IRBs.

To better understand these processes, we conducted an online survey of community groups and community-institutional partnerships in the U.S. involved in research, funded by the Greenwall Foundation. We identified 109 community-based processes for research ethics review that operate through a wide range of structures, from committees that report to a community-based organization’s board of directors to CABs that vet all research conducted in a community to coalition-based IRBs that review research conducted by their member community organizations. We found their main reasons for forming include ensuring that the involved community is engaged in and directly benefits from research and is protected from possible research risks. Among the benefits cited for having a process are being able to assure communities have a voice in determining which studies are conducted in their communities and that the research is relevant, feasible and builds community capacity.⁷

As we consider strategies to engage and protect the individuals and communities involved in research, we ask you to share your thoughts on these questions:

• What ethical issues have arisen in your review of CER and how have you addressed them?
• What, if any, relationships do you have with community-based processes for research ethics review?
• How can we ensure that human subjects research protections extend to both the individuals and communities involved in research? What should be the roles of institution-based and community-based processes for research ethics review?

We look forward to an active online dialogue about the ethics of CER.

References

1. Shore N, Wong K, Seifer SD, Grignon J, Gamble VN. (2008). Advancing the Ethics of Community-Based Participatory Research. Journal of Empirical Research on Human Research Ethics. 3(2), 1-4.

2. Ball, J. & Janyst, P. (2008). Enacting research ethics in partnerships with indigenous communities in Canada: “Do it in a good way.” Journal of Empirical Research on Human Research Ethics, 3(2): 33-52.

3. Shore, N. (2006). Re-conceptualizing the Belmont Report: A community-based participatory research perspective. Journal of Community Practice, 14(4): 5-26.

4. Flicker, S., Travers, R., Guta, A., McDonald, S. & Meagher, A. (2007). Ethical dilemmas in community-based participatory research: Recommendations for Institutional Review Boards. Journal of Urban Health, e-pub (DOI 10.1007/s11524-007-9165-7).

5. Deeds, B., Castsillo, M., Beason, Z., Cunningham, S., Ellen, J., Peralta, L., & Adolescent Trials Network for HIV/AIDS Intervention. An HIV prevention protocol reviewed at 15 national sites: Do ethics committees protect communities? Journal of Empirical Research on Human Research Ethics, 3(2): 77-86.

6. Grignon J, Wong KA and Seifer SD. Ensuring Community-Level Research Protections. Proceedings of the 2007 Educational Conference Call Series on Institutional Review Boards and Ethical Issues in Research. Seattle, WA: Community-Campus Partnerships for Health, 2008.

7. Shore N, Seifer SD, Bajorunaite R, Wong K, Moy L, Cyr K and Baden AC. Understanding Community-Based Processes for Research Ethics Review (poster presentation). Presented at Public Responsibility in Medicine and Research's 2008 Advancing Ethical Research Conference, November 16-19, 2008.

Monday Memories: Where were you in 2002?

Posted by Catherine Rogers, marketing coordinator


Was it San Diego?

Here's a photo we found near the top of our archives. Can you find yourself in the crowd? If you were present at this meeting, we'd love to hear from you.

















As part of our 35th anniversary, we'd like to remind you (and ourselves) of PRIM&R's journey, so we will periodically post interesting photos and ask that YOU to jog our memories and fill in the details.

Items of Note

There’s a lot going on here at PRIM&R and we wanted to be sure you were aware of some of the important details:

• Registration for the February 25 webinar New Solutions to Ongoing Problems When Reviewing Social, Behavioral, Educational Research closes tomorrow at 5:00 PM ET.
• The late registration rate for the 2009 IACUC Conference goes into affect on Tuesday, March 10, so register now!
• Going to the 2009 IACUC Conference? Don’t forget to check out the special events, including Speed Mentoring, the Research Ethics Book Group, and a March Madness Elite Eight Party!
• We’ve put up the information about our May Regional Program, IRB 101sm, IRB 201, and IRB Administrator 101, May 6-8 -in San Diego, CA.
• Checkout the conversations that have been taking place in our discussion forums (members only):
• "Research Assistants and Required Human Subjects Training”
• “Reading Level Software”
• “Requesting Listing of State Regulations for Human Subjects Research”
• The Gaylord Opryland Resort and Convention Center is now taking hotel reservations for the 2009 Advancing Ethical Research Conference.

If you have questions, please don’t hesitate to be in touch (info@primr.org or 617.423.4112). Thank you!

A Conversation with Temple Grandin

Posted by Catherine Rogers, marketing coordinator

When it comes to empathy, Temple Grandin knows how to walk in the shoes of another being. And that’s especially true if that other being doesn’t have shoes at all, but hooves, paws, or claws.

Dr. Grandin is one of the world’s leading animal scientists, known for her sensitivity to the details that affect animals’ stability and well-being. The roots of her experience with animals extend from early childhood into Dr. Grandin’s adult life as a professor, author, inventor, and animal-handling expert.

You can begin to see why she was PRIM&R’s top choice to deliver the Henry Spira Memorial Lecture at the 2009 IACUC Conference next month.

In spite of her demanding schedule, Dr. Grandin took some time out of her national book tour to talk with me about her acclaimed book, Animals Make Us Human, and how it relates to the many unique challenges animal care and use professionals face on a daily basis.

She explained that her book looks at the way animals see the world, and how their emotional systems share qualities of the human’s: Fear, rage, separation anxiety, and the need for companionship are just a few of the commonalities between humans and animals.

“You have to ask yourself, ‘what is motivating this animal?’” she said, to begin understanding its actions and reactions. “For instance, little animals, like gerbils, want cover. They don’t like being exposed, so you give them a tunnel or some paper towels, and they’ll dig, dig, dig, dig…”

Dr. Grandin further explained that those paper towels aren’t just filler for the bottom of the gerbil’s cage. They provide the enriching, protective environment that plays a large role in the animal’s well being. Therefore, she urges people—animal handlers, livestock workers, institutional animal care and use committee members, and pet owners alike—to accept that an animal’s wellness is directly related to its environment and take necessary steps to ensuring its comfort.

“When handlers pick [animals] up roughly, the creature’s cortisone levels can increase five hundred percent, and this will affect research results,” she said. “If you’re testing a drug, for instance, the animal is a model for a human. You wouldn’t test drugs on a person just mugged in the subway, now would you?”

Overall, Dr. Grandin’s message hinges on decreasing an animal’s fear and increasing the enrichment in its surroundings. In doing so, scientists can garner more accurate test results, while still upholding high standards in the conduct of research.

PRIM&R looks forward to hearing more from Dr. Grandin on March 30 when she delivers the Henry Spira Memorial Lecture. We look forward to welcoming her—and you—to San Diego in March!

Comments on updating the Guide

Posted by Guest Blogger Steven Niemi, director of the Center for Comparative Medicine at Massachusetts General Hospital and PRIM&R Board Member

To the Select Committee Appointed to Update the Guide for the Care and Use of Laboratory Animals:

I am writing to urge emphasis on performance standards over engineering standards in the next edition of the Guide, for the reasons provided below. For the purpose of this commentary, an engineering standard is any guideline or directive that includes a measurable unit (expressed as a number or range of numbers for time, space, mass, velocity, etc.) versus a performance standard that involves a desired outcome without quantified parameters.

First, some engineering standards commonly in use today are unnecessary or wrong. For example, the engineering standard of 180°F water for washing cages is a waste of energy and money if those cages are going to be sterilized before their use. We routinely use cold water (and no detergent) to sanitize rodent microisolator cages that will be autoclaved prior to their return to animal rooms; visual inspection and testing for microbial residue post-wash/pre-sterilization confirm those cages to be clean. Another example of inappropriate engineering standards involves maximum cage change intervals of 14 days. If ventilated mouse cage changing is performed faithfully on a 14-day cycle but too soon after a new litter of mice is born, there is risk of increased pup mortality (Reeb-Whitaker, et al., Laboratory Animals 35:58­ 73, 2001). A third example involves the ambient temperature in which laboratory rodents are routinely maintained, expressed as an engineering standard in the Guide of 18-26°C. While this temperature is comfortable for humans because it corresponds to our thermoneutral zone, the thermoneutral zone of mice and rats is 28-31°C. Maintaining laboratory rats and mice at or below 26°C significantly increases their blood pressure, heart rate, and pulse pressure because these animals feel cold (Swope, et. al., Am J Physiol Regulatory Integrative Comp Physiol 287:391-396, 2004). This is not to suggest that rodent rooms should be maintained at higher temperatures; that would result in higher energy costs and a workplace uncomfortably warm for personnel. However, like the other examples above, it does point out the risks involved with using engineering standards that may be easy to follow, but which avoid the need for justification.

Second, engineering standards discourage innovation. One could argue that every engineering standard is always accompanied with an allowance for effective alternatives or IACUC exemptions, thereby providing sufficient flexibility. But it's been my experience in laboratory animal care over the past 35 years that engineering standards are almost always adopted verbatim because "they're in the Guide" and become embedded in our policies and practices. This ingrained culture may forestall adoption of new modalities incorporating engineering and design, construction, and operational processes that could provide a more environmentally benign, less expensive and safer workplace without risk to animal health and welfare. For example, it is conceivable that the technology of conditioning air may advance to the point where 100% recycled air is not only cheaper but cleaner than 100% fresh air. This should render the engineering standard of 10-15 single-pass air changes per hour obsolete, but changing to the new technology would be conceptually difficult as long as that standard remains in the Guide. On the other hand, an updated Guide that promotes performance standards may encourage more creative thinking about how to improve rather than prolong established methods and constraints.

Third, the advent of genomics, in vivo imaging, nanotechnology, and synthetic biology may create novel situations in which laboratory animals will be used for research, testing, and education. Engineering standards may not be compatible with how animals are used with such technologies even though animal welfare would not be impaired in specific protocols. This could result in missed opportunities to advance knowledge and medicine. Furthermore, these same technologies may be used to better define animal comfort as well as detect pain or distress more accurately. Consider that someday we will be able to detect expression of particular genes in situ that indicate in real time when an animal is occasionally stressed (a positive state) versus chronically distressed (a negative state). We should employ such tools and signals to identify unmet animal needs and to challenge engineering standards, with the objective of continuously improving how animals are cared for and used. But sustained promulgation of engineering standards conflicts with the practice of continuous improvement and makes it less likely that these new technologies will be leveraged for advancing animal welfare.

In conclusion, laboratory animal needs and protections are necessary. The Guide provides standards describing those needs and protections with unmatched credibility and authority to an increasingly global audience. Animal needs and protections that are entrenched as engineering standards may be insufficient or inappropriate today or tomorrow. By contrast, performance standards that are evidence-based reaffirm past improvements as laboratory animal care and use has evolved and are more likely to facilitate similar progress in the future.

Respectfully submitted,

Steven M. Niemi, DVM, DACLAM
Director, Center for Comparative Medicine
Massachusetts General Hospital
149 Thirteenth Street, Room 5249
Charlestown, MA 02129 USA
e-mail: sniemi@partners.org

In January’s Newsletter…

The most recent issue of the PRIM&R Newsletter (members only) was distributed on Friday, January 30.

In addition to our regular features, such as Recent Headlines, Government and Legal News, and Public Policy (to name a few), this issue included…

• A welcome to PRIM&R’s new membership manager, Joanna Cardinal;
• PRIM&R’s interview with a newly Certified Professional IACUC Administrator (CPIA), who explained how he prepared for the exam and why the certification is important to his career;
• A featured talk from PRIM&R Through the Years, a unique compilation of presentations delivered by internationally esteemed experts in the field of research ethics at PRIM&R's past annual meetings. This month feature is Jay Katz’s speech, “Human Experimentation with Human Rights,” which he gave in December 1992 at PRIM&R’s Annual IRB Conference, IRB Review: The Changes and the Challenges;
• “Jerry Notes,” an educational resource provided by the Journal of Empirical Research on Human Research Ethics (JERHRE), which is designed to introduce key concepts and develop evidence-based ethical problem-solving skills;
• A new feature (Benefit Spotlight) highlighting one of PRIM&R’s many membership benefits.

Can’t find the Newsletter in your inbox? Check out the Newsletter Archives.

Want to become a PRIM&R member? Learn more.

Lessons from the headlines

Guest blog by Brad Noren, research administrator at Oregon Health & Science University

The story of Bernard Madoff’s alleged Ponzi scheme is already falling off the front pages. Our fast-paced society has moved on to the next headline of the moment. But before we forget entirely, it should be noted that there are lessons (or reminders) that relate to our efforts toward the regulation of research that utilizes human and animal subjects.

First, the case reminds us that trust can be misplaced. A colleague of mine had a sign on his cubicle that said, “Trust in God. Monitor everyone else.”

Ronald Cass, dean emeritus of Boston University School of Law, pointed out in a December 2008 issue of the Wall Street Journal, that the Securities and Exchange Commission (SEC) warned of a number of “affinity fraud” cases, wherein investors were targeted and duped by a member of their own community (be it religious, racial, ethnic, or professional). Upon hearing a sales pitch from “one of us,” potential investors were more willing to buy in.

Now, replace “investors” with “IRB/IACUC members.”

Review committee members should take this as a reminder to avoid deferring to perceived reputation or experience when considering proposals submitted by a peer. Our charge requires a thoughtful examination of each proposal.

Second, the Madoff case makes one wonder, where were the regulators? How could an elephant with $50 billion in a brief case so easily sneak out of the room? In part, one could point at the inadequate allocation of resources. This should sound familiar to IRB and IACUC administrators. When money is tight, “manage the risk” becomes code for “do more with less.”

Linda Chatman Thomsen, director of the division of enforcement at the SEC, testified before the Senate Committee on Banking, Housing and Urban Affairs on January 27. Her office is responsible for identifying and halting schemes such as the one allegedly perpetrated by Madoff. In her testimony, she described a 50 percent increase in the number of registered investment advisors since 2002. Those are the people she’s charged to monitor. Guess what. The resources allocated to her office have not kept pace with that increase. “While we always do our utmost to do more with less,” she said, she needs technology, access to expertise, and the means to educate investment advisors and potential investors. Sound familiar?

Thomsen ended with a statement that could have well been made by any IRB administrator. She said, “and all of us need to do everything we can to encourage a tone and culture… that mere compliance with the law, narrowly viewed, is not the highest goal to which we aspire, but the base from which we start.”

Amen, Sister.

(I would like to thank PRIM&R for the opportunity to appear as a guest on Ampersand. Blogs reflect the opinions of the bloggers and should not be mistaken as true journalism. My contribution is no exception to that rule.)