My first IRB meeting

by Argelis A. Ortiz, MSW, University of Southern California, Social/Behavioral IRB Community Member

The night before the first meeting where I would serve as a community member on an institutional review board (IRB), I feverishly reviewed research analysis and statistics books, read and re-read the federal regulations (45 CFR 46), and Googled the meaning of “common rule.”

The next morning, I ate breakfast and was impressed by my newfound ability to recite a list of vulnerable populations in alphabetical order: children, human fetuses, neonates, pregnant women, and prisoners. I even made a song out of it, so I would remember when it came time to put my skills to use.

However, none of that mattered.

As soon as I stepped into the boardroom, my nerves got the best of me; I was instantly intimidated by the PhDs, MDs, lawyers, and prestigious research professors sitting around the table. All I could remember was my father’s favorite motto, “fake it ‘till you make it,” which meant the other IRB members didn’t have to be made aware of what I knew and didn’t know. For all I know, I might have intimidated them!

Before the meeting started, the IRB director introduced me to the group and stated my expertise: navigating the child welfare system, working with foster and gang-involved youth, HIV/AIDS counseling, and psychotherapy. Wow! Even I was impressed with the listed qualifications. The introduction provided me with validation for my presence there, and confidence in the fact that I had been chosen to provide the group with my perspective—the community perspective.

The first meeting was relatively uneventful; we reviewed a few new protocols and participated in an educational session. During the meeting, it was of the utmost importance to me that people took the time to listen to my questions and points of discussion. The IRB administrators proved extremely helpful through their willingness to break down the research design and protocol jargon into lay terms for me.

Since my first meeting, I’ve developed my stance:

1. Review each research project as if I'm one of the participants;


2. Be able to explain in sufficient detail and lay terms the procedures associated with a study; and


3. Examine whether the risks of a given study are properly weighed and made clear to the research subject.

Do you have any self-imposed criteria that you use to guide your review of protocols?
In my next few posts as a guest blogger, I plan to discuss the importance of the community member perspective. I hope that you will join me in starting a conversation about the importance of community members on IRBs here.

Furthermore, I hope that you will continue engaging with this topic through PRIM&R’s webinar, Community IRB Members: Supporting Their Involvement to Advance Research. This webinar, dedicated to examining the role of IRB community members, will be offered on July 12, 2011.

The Advancing Ethical Research Conference, A to Z

by Wendy Tate, PSM, CIP

I can’t believe it’s been almost seven months since the 2010 Advancing Ethical Research (AER) Conference in San Diego, CA, and that we are already looking ahead to the 2011 AER Conference in National Harbor, MD.

Since coming home, there have been so many good articles on Ampersand covering topics such as the Certified Institutional Review Board (IRB) Professional (CIP®) exam, networking, repositories, Office for Human Research Protections guidance, and informed consent. This made it hard to find a good post-AER topic to write about, but ultimately, it made me remember what this whole process is about: protecting human subjects. So, I decided to summarize what I have brought back from AER by reciting my ABCs.

Ask subjects if they want to receive research results or participate in unspecified future research instead of assuming that the IRB knows what is in the best interest of the subjects

Bridge the gap between the IRB and the research community to create a partnership that promotes cutting edge, high-quality, ethical human research

Community-based participatory research truly partners the community with the researchers, builds trust, and promotes results that everyone can benefit from

Develop and use robust assurance tools to ensure that your human research protections program (HRPP) does not stagnate

Equivalent protections are a legitimate way to protect human subjects outside of the federal regulations, if you have “unchecked your box”

Find resources in your academic community to create a more robust review process within and outside of the IRB

Get CIP certified; it adds credibility to you and your program

Have good communication networks and processes in place with other compliance units in your institution to ensure 360-degree human subjects protections

Informed consent is not informed unless the language (in both oral and written forms) is understandable to the subject

Justice, beneficence, and respect for persons must be first in mind when reviewing human research

Keep educating IRB members, HRPP staff, researchers, and the community about research and subject rights

Listen to and learn from everyone’s story

Make it a priority to send new staff members to the AER Conference and IRB 101sm

National Institutes of Health will challenge IRBs across the nation to rethink specimen research and biorepositories

Others have dealt and/or are dealing with the same problems and issues as you, so don’t be afraid to discuss your weaknesses

Pregnant women are not always vulnerable and should be included in clinical trials

Quality assurance within the IRB helps assure researchers that you recognize their concerns and are addressing them

Regulations are not perfect, and it is not taboo to point out their faults and limitations

Solicit permission from other institutions to use and re-purpose their forms; don’t re-invent the wheel

Take your staff to the AER Conference and cover as many of the sessions as possible so that everyone learns

Unchecking the box on the Federalwide assurance allows HRPPs to be creative and innovative

Validate techniques with other institutions and compare your results

Write up your professional development experience to teach others who did not participate and to solidify the information you obtained

Xenodochial people make up PRIM&R and make you feel like old friends before the conference is over

Yesterday’s answers are not enough as research becomes more global and more interdisciplinary

Zeal for your career in human subjects protection may be nerdy, but not uncommon as demonstrated by the 2000+ people who attended the 2010 AER Conference

Member registration is now open for the 2011 AER Conference. Learn more about this year's conference by visiting our website. Nonmember registration will open on June 29, 2011.

Featured Member Profile: Scotty Jenkins

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 Scotty Jenkins, education and quality assurance (QA) analyst assistant at Emory University in Atlanta, Georgia.

When and why did you join the field?
About a year ago, I started working at Emory on the education and quality assurance team for their institutional review board (IRB). When I started I had no experience in human subjects protections, but I was happy to have found a position that provided me with an opportunity to protect research volunteers. Since taking the position, my interest in the field has grown exponentially, and I will be starting a master’s program in bioethics at Emory in August.

What is your favorite part of your job?
My favorite part of my job is the intellectual satisfaction. Working in research ethics requires a certain level of intellectual curiosity that many jobs do not, and my office is filled with people who enjoy engaging with the various ethical concerns that inevitably arise in research.

What are you reading?
The Social Animal, by David Brooks.

Why did you join PRIM&R?
A PRIM&R membership was one of the benefits I received through my position on the IRB at Emory, but I certainly would have joined on my own had my office not paid my membership dues.

What is your favorite member benefit?
I really enjoy the Research Ethics Digest (RED).

What would you say to someone who is considering PRIM&R membership?
Do it.

What motivates you to maintain your commitment to advancing ethical research?
The knowledge that what I do makes a difference.

Thank you for being part of the membership community and sharing your story, Scotty.

Congratulations on beginning your master’s program in bioethics! Let us know how it goes. If you’d like to learn more about becoming a member, please visit our website today.

Oh the places ethics will go: PRIM&R Regional Connections

Over the years, I have attended many PRIM&R conferences—the programming is always strong, the speakers excellent, and the content cutting edge. However, these things are not what keep me coming back.

Working in the field of human subjects protections, I am constantly immersed in gray—no one rule can be applied to every situation and no one situation boils down to one rule. In the absence of black and white answers, I am endowed only with the knowledge of core ethical principles and the support of colleagues and peers. It is this very support, which is found in abundance at PRIM&R’s conferences and through the membership community that keeps me coming back to the organization.

Over the years my involvement in the organization has grown. I currently serve on PRIM&R’s membership committee. Perhaps it is ironic, only in this capacity have I come to realize that networking, which is so vital to understanding and making sense of those gray areas, does not have to end at the conference. Take, for instance, PRIM&R Regional Connections—who knew that PRIM&R had a program to help "fund events for members to share resources and engage in debate"?

Even if you do know about the program, I’ll bet that you haven't paid much attention to it, or, like me, you simply think you don’t have enough time to put a program together.

For years, starting with my first year on the Applied Research Ethics National Association (ARENA) Council and now, as a member of the membership committee, I’ve heard about PRIM&R Regional Connections. I’ve reviewed requests for funding. I’ve watched other PRIM&R members dedicate time and effort to developing an easy-to-use, relevant toolkit of tips and ideas. I encouraged others to host a program and take advantage of this member benefit, all the while thinking that it sounds great; but I do not have time.

Several weeks ago I found myself once again saying that I wanted to host a program. Someday. When I have time. Then a little voice in my head challenged me to make time, and before I had a chance to silence that voice, I was planning a PRIM&R Regional Connections event. The moment I said it I wanted to take it back. But I took a deep breath and decided to stick with it. The task of figuring out how to make it happen and where to begin loomed in front of me— the very part that had always seemed the most overwhelming.

With lots of encouragement and guidance from PRIM&R staff and fellow members, I realized that it’s not nearly as difficult as I had built it up to be. I made some basic decisions: length - half-day; location – on site at my institution; date – that was easy as the availability of the space was limited. Next came who to invite. PRIM&R staff provided me with a list of everyone in the PRIM&R database from Mississippi. That gave me a place to start. I am still contacting people, trying to identify the human research protections professionals and institutional review board members at each location, but everyone we’ve talked to so far has expressed great interest in the program.

Over the next few months, I will be joining you on Ampersand to share my struggles and successes as I work to facilitate a PRIM&R Regional Connections program. As my journey continues, I welcome you to join me by sharing any advice, guidance or questions that you might have!

The PI and IACUC Administration

It has been more than two months since the 2011 Institutional Animal Care and Use Committee (IACUC) Conference, and yet, I still find myself thinking about one of the sessions I attended on the last day of the conference in March: Strategies for Ensuring your IACUC is a Customer Service-Oriented Organization.

Within the realm of research ethics and animal care and use, it is important to recognize who your customers are and what their needs are. There are a number of customers who should be considered, including the principal investigator (PI), the general public, the institution as a whole, the animal care staff, and the animals that are used for teaching and research purposes.

The key to the success of an animal care and use program is an effective IACUC, and this is largely dependent on good communication and teamwork. In The Care and Feeding of an IACUC, M. Lawrence Podolsky and Victor Kukas say, “IACUC members should be able to freely express opinions while listening to the opinions of others…critically and logically evaluate issues without bias…not monopolize discussion; [and] be polite and respectful of other members and researchers.”

The session emphasized the importance of communication about regulations, their relevance to the research, institutional policies, as well as the IACUC review process, timelines, and deadlines. One example presented explored protocol review deadlines, which should be clear and well-communicated to the PI. If a protocol is received after a deadline then it is recommended that the PI provide justification for the protocol to be considered at the upcoming IACUC meeting, and that the IACUC chair provide approval for such an exception.

Education for PIs, another area underscored in this session, can include external online programs, as well as in-house training. Workshops can also be held to further educate PIs as to the review process and their responsibilities. Consider including a “How to Write an Animal Use Protocol” workshop, a “New PI Training Session,” or “lunch–and-learn” workshops to your program. The University of California San Diego (UCSD) maintains a webpage, which could serve as a useful template, to provide new researchers with information about the review process.

It is critical for everyone—researchers and institutional officials especially—to know their responsibilities and the consequences of not fulfilling them. While the IACUC may strive to serve researchers as much as possible, it is not an obligation to meet every single request. Sometimes the greater good of the institution may overrule the wishes of an individual PI, so that compliance for the institution is maintained, thereby protecting all the other researchers and ensuring that funding continues to flow to the institution.

Communication is so important when it comes to ethics administration. Joining a listserv is a great way to share ideas and converse with colleagues around the country who are confronting the same issues. If you are an IACUC coordinator and you would like to join a listserv dedicated to IACUC administrations, Michigan State University manages a particularly useful one. To subscribe, send an e-mail with “subscribe” as the subject.

As this is my final official post as a member of the PRIM&R Blog Squad, I would like to thank PRIM&R for this great opportunity to attend Essentials of IACUC Administration and the 2011 IACUC Conference, and for the chance to blog about my experiences before, during, and after the meeting.

Thank you for reading!
Amanda

Thirty years of trials, failures, leadership, and inspiration

Thirty years ago the global health landscape changed. Young gay men were suddenly being diagnosed with diseases previously seen only in individuals with weakened immune systems. What emerged as unusual patterns of disease in 1981 quickly escalated into the AIDS pandemic.

A recent article in the New York Times, “30 years in, we are still learning from AIDS”, looks back at the emergence of the disease, and the obstacles we still face today. Of course, the past 30 years has also brought considerable progress—progress that would not have been possible without the dedication of countless researchers, scientists, physicians, nurses, auxiliary health professionals, including health educators, ethicists, and, last but certainly not least, activists.

Today, we’d like to share the stories of two inspired and inspiring leaders who changed the face of the pandemic during those early years. PRIM&R was privileged to have both as keynote speakers, and their humanity, determination, courage, principles, and remarkable impact affected all who were in attendance.

In October 1992, Jonathan Mann, MD, MPH, spoke at AIDS Clinical Research and Care: Meeting the Challenges of an Epidemic in Flux, a conference sponsored by PRIM&R and the Tufts University School of Medicine.

Dr. Mann was, by all accounts, a unique leader in the fight against the pandemic. As the founder of the World Health Organization’s Global Program on AIDS, he confronted the disease with unparalleled passion and zeal. Dr. Mann did not simply seek out the biological causes of the disease; he advocated for a more holistic understanding of AIDS as a human rights issue. When he spoke at PRIM&R in 1992, he shared this message:

“It has become increasingly clear that to work against AIDS, regardless of whether in the laboratory, the clinic, or the streets, is to become, to some extent, a revolutionary, or, if you prefer, an activist. A revolutionary because in order to achieve the goals of the work, whether to make a vaccine which will be available to the world's population in need, or to ensure care for those who need care, or to prevent infection through sex education, or even to conduct research on sexual behavior. In all these ways, our goals and the concrete needs of people require changes in the status quo of society, in our approach to AIDS, and more generally, to health.

Thus, even more than changes in the face of AIDS epidemiology, it is our understanding of AIDS that has changed. AIDS is the first health crisis to be seen and understood and felt as global. Our new global AIDS strategy is more than about AIDS, it is part of a deeper, more fundamental struggle: whether health, a central concern of all peoples, will or will not become a central, defining principle guiding national and global purpose.

Around the world, AIDS has drawn forth people who are not over health issues which are already clear and evident. We need leadership to give voice to the deeper, deeply felt but often inarticulate desire for health; to help give shape to the global groundswell. Imagine what it would be like to live in a country with a real health policy. Imagine what could be if health and human rights were placed at the center of debates about community, national, and global purpose. Just imagine what real global health leadership could mean for problems like drug abuse, the environment, and AIDS."

The full text of Mann’s speech can be found here. Sadly, Dr. Mann was on Swissair Flight 111 when it crashed off the coast of Halifax in 1998. His commitment to human rights and to fighting AIDS endures, and we are all richer for his extraordinary life and body of work.

Another leader in the fight against AIDS was C. Everett Koop, MD, ScD. As Surgeon General of the United States under President Ronald Reagan, Koop was at the helm during the early days of the pandemic. Faced with the decision of how to educate Americans about the disease, Koop made what was at the time a difficult decision: to talk directly to the American people. In 1988, Koop was responsible for sending a pamphlet, Understanding AIDS, to every US household. In a recent article, “The early days of AIDS, as I remember them”, Koop shares his reflections:

“The first phase of America and AIDS, from the first cases in 1981 until the AIDS report in 1986, was marked by mystery, fear, suspicion, judgment, the unknown. The second phase, and the time where I made my contribution, saw health officials overcome considerable opposition—some misguided, some mean-spirited—to at last bring the facts of AIDS before the American people: in the AIDS report, the AIDS mailer, and the hundreds and even thousands of articles and television programs about AIDS.

The press did a commendable job of communicating the issues of AIDS. The American people learned that except for babies who got AIDS from their mothers, except for innocent sexual partners of AIDS carriers who took no precaution, that in order to get AIDS you had to engage in risky behavior, behavior that many Americans thought illegal or immoral in addition to being risky.

And in that second phase of AIDS, Americans sorted through the issues of testing, discrimination, and civil rights, and in general rejected the bad laws and approved the good ones, assuring people who did not practice high risk behavior that they were protected from the disease, and also in general protecting the civil rights of those who contracted AIDS. But the disease, the epidemic, continued to grow in American society, claiming more victims each month. And so we entered the third phase of America and AIDS, the phase when the society, the health care system, and probably each American will have to come to grips with people dying of AIDS. But with a formerly acute fatal disease becoming chronic and some AIDS patients living out their hitherto normal life span, being burned in effigy doesn’t hurt a bit. Each of us must keep HIV/AIDS from becoming the forgotten epidemic.”

The full text of Koop’s article can be found here.

In 1998, Dr. Koop spoke at Hospital, Health Care Professionals and AIDS sponsored by PRIM&R, the American Foundation for AIDS Research, the American Hospital Association, and the American Public Health Association. He was a larger than life figure in every way back then, and nothing has changed. He is 95 years young, and still actively involved in a range of health-related issues.

Both Mann and Koop were early leaders in the fight against AIDS. While their contributions were different, both left an indelible impact on the way that we understand and communicate about the epidemic today. As we consider what the next 30 years might bring, we must look toward today’s leaders in the disease– the researchers, the scientists, the physicians, the nurses, the health professionals, the health educators, the ethicists, and the activists.

“Science Times” synthesis

National Donut Day is here! Head out to your favorite bake shop and celebrate, but before you do, check out this week’s “Science Times” synthesis and discover how the cup of coffee you enjoy with your doughnut just might be helping to prevent prostate cancer. Share your thoughts in our comments section, and let us know which article (or donut) is your favorite!

Week of May 24, 2011

Prevention: Coffee lowers risk of prostate cancer, Harvard study says: A recent study indicates that higher levels of coffee consumption may help prevent prostate cancer.

On your marks, get set, measure heart health: A growing body of research suggests that an individual’s midlife fitness level can be used to predict future heart health.

Getting wise to the owl, a charismatic sentry in climate change: Twenty years of research into the population trends of snowy owls illuminates the connection between ecosystems and climate change.

Week of May 30, 2011

The bilingual advantage: Through her research on bilingualism, cognitive neuroscientist Ellen Bialystok has discovered that bilingual Alzheimer’s patients remain symptom free nearly five to six years longer than monolingual patients.

Viral outbreaks in dogs yield clues on origins of hepatitis C: The recent discovery of genetic similarities between the hepatitis C virus and canine hepacivirus has left scientists wondering about the origin of these viruses.

The claim: A diet high in protein is bad for your kidneys: New research challenges the claim that a high-protein diet may be harmful to your health.

A good night’s sleep isn’t a luxury; it’s a necessity: One woman explores the issue of chronic sleep deprivation, and how the human body responds.

A Guide to Semiannual IACUC Facility Inspection Success: Preparation, Coordination, Training, Documentation

by Farah Moulvi

Both the Animal Welfare Act (9 CFR §2.31 subpart c) and the Public Health Service (PHS) Policy on the Humane Care and Use of Laboratory Animals (IV.B.) require that every organization’s institutional animal care and use committee (IACUC) inspect all institutional animal facilities at least once every six months using the Guide for the Care and Use of Laboratory Animals (the Guide) as a basis for evaluation.

The question, of course, becomes how can IACUC administrators and staff assist IACUC members with these inspections when so many different vivaria are involved? My institution has put in place several key policies and procedures in an effort to overcome this obstacle.

As per the requirements, the IACUC must use a subcommittee consisting of at least two voting members of the IACUC. At my institution, we schedule at least three IACUC members for each site visit, in addition to an attending veterinarian, biosafety officer, and IACUC staff member.

Approximately two months before the scheduled start of the site visit, IACUC members and their alternates confirm their availability for the five-week period and select tentative dates and time slots. Involving alternates increases the pool of available site visitors. However, it is important to ensure that a regular member and his/her alternate are not scheduled for the same day.

Once all members have responded with their availability, we provide attendees with a calendar, maps, and participant list for the five-week inspection period. Typically, an IACUC member is scheduled for two inspections that last from two to four hours.

Participation by all IACUC members is very important to limit the burden of the inspections on any given member. Making a time commitment to the semiannual facility and program review process is a vital part of the IACUC member’s responsibilities. Members at my institution are encouraged to participate in multiple inspections and can attend any site inspection irrespective of their assignments. IACUC members are also rotated to different inspection sites to ensure members bring a fresh perspective.

At this point, IACUC members are enrolled in the occupational health program so they are aware of the requirements and informed of any risks involved in inspecting the animal facilities or laboratories. Members are also provided with additional resources such as previous site visit reports, institutional policies, and lists of protocols for PIs using outside vivarium laboratories. A team member also has the Guide available during inspections.

In preparation for the inspection, we send notifications to investigators and animal care facility managers so that appropriate personnel are available for questions, educational opportunities, and to foster dialogue with researchers and staff.

Forty-eight hours before the scheduled inspection day, IACUC members are given a courtesy reminder by telephone to confirm attendance.

During site visits, a member of the IACUC staff is assigned to take notes. Items identified include deficiencies, concerns needing attention, and recommendations for improvement or enhancement. The deficiencies are classified as either minor or major. Before leaving the facility, a verbal debriefing of the findings is provided by the IACUC site visit team to the animal care facility manager or the principal investigator (PI). The animal care staff is also given kudos for items that are well maintained.

The final report, prepared by the IACUC administrator, is then provided to the IACUC at a convened meeting. The discussion focuses on the classification of the deficiencies, a reasonable and specific corrective action plan and schedule, and the inclusion of minority reviews, if applicable. The report is finalized by a vote before its transmission to the institutional official (IO). After the IO signs off on the report, the IACUC administrator distributes copies to the facility managers. Letters are also sent to individual investigators with a description of the noted deficiency, the referenced policy or regulation, and the required corrective action and timeline for correction.

Once all deficiencies are corrected, and an appropriate response is provided, a report is compiled that is sent to the IO and IACUC members. Items are tracked on a monthly basis until all deficiencies are addressed in the time specified in the original inspection report.

Needless to say, depending on the size of an institution, the preparation, scheduling, coordination, documentation, and follow-up can take several months. Some institutions determine that these semiannual inspections should all be done over a one- or two-month period, while others stagger the inspections throughout the year. It’s no wonder that most administrators go through this process, and soon after it is finalized, the next inspection is almost due, producing the feeling of “Didn’t we just do this inspection?”

I’ve shared the process at my institution—now, it’s your turn! Please share your experiences, methods, and ideas for preparing and coordinating a robust and meaningful semiannual facility inspection through this blog forum.