Planning your 2011 AER Conference experience

It’s hard to believe that in a few days I will be bound for the airport and off to AER 2011. Going to a PRIM&R conference is like a breath of fresh air. It gives me a chance to “get outta Dodge,” and to gather with others that have chosen this career path. It’s always amazing to me that there are thousands of other people that do what I do. It’s rare that I find anyone who can rattle off the regs like I can, but at PRIM&R events I find a convention center full of “reg geeks” just like me, but with new ideas!

Now that I have “ANPRM” rolling off my tongue like butter, it will be my four-day PRIM&R goal to know the 23 separate proposals and 74 questions of the ANPRM intimately. I’m also dying to know what HRPP professionals really think about the proposed changes to the “Common Rule.” 

I’ve considered emulating Ivor Pritchard and trying to come up with a “Four Days of PRIM&R” rendition of “The Twelve Days of Christmas” about the ANPRM as a conference opener, but I don’t play the ukulele, harmonica, or anything else, so doubt I’d be as riveting!

If you’re left scratching your head about all this, ANPRM stands for Advance Notice of Proposed Rulemaking, and is the federal government’s way of proposing changes and collecting public comments on an issue.  OHRP has a really nice table comparing the existing rules with some of the changes being considered. 

Huron Consulting Group put on a really helpful webinar in September, offering additional insight into the ANPRM proposal by polling participants. Key results are available here.

My personal favorite proposal is the elimination of the “Common Rule” for expedited research. I also detest the idea of allowing investigators to make their own determinations regarding institutional review board (IRB) exemptions. I’m looking forward to hearing the pros and cons from the experts, and I will share any juicy insight I gain from the conference in subsequent blog posts.

Don’t forget to check out the posters at the Conference Connection. This is another way to see what your colleagues are doing and to find collaborators if you’re interested in a particular project. Poster presentations will also be made during some of the breakout sessions. I try to walk away with a list of my favorite speakers each year so that I know who I will contact if I ever have the nerve to plan my own conference.  If you love a speaker, let them know. Talk to them after the session and make a connection!

My last words of pre-conference advice are: Don’t be a hermit! Don’t go up to your room and hide under the covers of the comfy bed (this is not from experience…ha!).  Branch out and attend the welcome reception, the networking lunches, and the Meet and Greet with exhibitors and supporters. And make sure to watch the respected PRIM&R icons boogie at the DJ and Dancing on Friday. I hear they are taking requests!

Come talk to me and share your ideas on the ANPRM or challenge me on my knowledge of the regs. I’ll be the straight-haired redhead in the Blog Squad tee!

Wishing you safe travels to National Harbor!

Science Times synthesis

As we contemplate the things we are thankful for as part of our annual holiday celebration, you may find it interesting to know that researchers believe gratitude has real health benefits. Learn more about how being thankful can improve your health and relationships, and enjoy your day!

Week of November 15

Chimps’ days in lab might be dwindling
The NIH has commissioned a report on the usefulness of chimps in research, and the federal  Fish and Wildlife Service is considering a petition to declare chimps an endangered species. How will this impact biomedical research? Read on to find out.

Cloaks of invisibility, switched in a flash
Research shows that some species of cephalopods have developed the ability to switch between two “disguises” designed to ward off predators. Learn more about the study, authored by Duke University ecologist Sarah Zylinski.

The claim: Exercise can ward off migraines
A recent study shows that exercising 40 minutes three times a week may decrease migraines, as can use of topiramate (a drug that helps prevent migraines) and regular relaxation exercises.

Scientists decode the protective element sickle cell anemia offers against malaria
Scientists have figured out how the genetic mutation that causes sickle cell anemia also protects against fatal malaria. Learn more about the new study published in Science.

Solvent linked to higher Parkinson’s risk
A new study of twins finds that trichloroethylene (TCE) is associated with a higher risk of Parkinson’s disease. Find out more about this solvent, widely used in refrigerants and as a metal degreaser.

A watch-and-wait prostate treatment
Jane Brody reports on one doctor’s proposal that the least invasive approach should be taken for most men with early-stage cancer that is not particularly aggressive.

Week of November 22

A serving of gratitude may save the day
A new series of studies shows that gratitude is linked to better health, sounder sleep, lower rates of aggression, and less anxiety. Read on to learn how being thankful can positively impact your health.

In body’s shield against cancer, a culprit in aging may lurk
Researchers at the Mayo Clinic have reported that in a body purged of its senescent cells, tissues remain youthful. Learn more about senescent cells and how they work.

The case of the birds that knew too much
In the age of information overload, a new study of the European starling suggests that less information may result in better choices. Read about the study here, or review the findings in the journal Science.

Chewing gum can prevent ear infections
Researchers at the University of Toronto take on the claim that chewing gum can prevent ear infections, finding that children who chewed xylitol gum were 25% less likely to develop acute ear infections.

Getting a handle on why 4 equals green
Neuroscientists in England are trying to determine why the brains of those who suffer with grapheme-color synesthesia see colors when thinking about letters, numbers, or words. A new study appearing in the journal Current Biology suggests that those who suffer from this condition experience heightened activity in the region of the brain that controls vision.

Presidential Commission: Research ethics norms and professional standards

by Elisa Hurley, PhD

Last  week, the Presidential Commission for the Study of Bioethical Issues held its seventh public meeting in Boston. This was the final meeting devoted to President Obama’s charge to assess how well current regulations protect human subjects in research. The President’s instruction came in response to the revelation last year that from 1946 to 1948 the US Public Health Service (PHS) supported research on sexually transmitted diseases in Guatemala involving the intentional exposure and infection of subjects. Much of the commission’s agenda was devoted to discussion of a draft of the report it will deliver to President Obama this December.

As I sat in the audience, I was particularly intrigued by a session launched by commissioner John Arras’ observation that John Cutler, the principal investigator of the US PHS Guatemala Study, viewed the norms of research ethics as onerous obstacles to conducting research. This led the commission to grapple with the question of how to help researchers see research ethics norms as professional standards. 

At first glance it might seem that there is a tension between approaches to protecting human subjects that focus on external sets of rules or regulations, and those that focus on the internalization of ethical norms. Certainly the previous generation of physician-researchers viewed things this way.  As Arras pointed out, Henry Beecher—the anesthesiologist who exposed unethical practices in research in a seminal 1966 New England Journal of Medicine—was against the imposition of external, law-like regulations on research ethics.  He believed that the intelligent, informed, conscientious, and  compassionate investigator—who Aristotle would have called the “virtuous” researcher— would make ethically sound decisions.

But Beecher’s view is as dubious as Cutler’s. The protection of human subjects should not be left solely to the discretion of the “benevolent” researcher. With research this complex, varied, and large-scale, we need a system of public rules that is transparent, enforceable, and practically applicable.  Yet there is a kernel of wisdom in Beecher’s view, one that seems to have been lost amid the layers of complex regulations and guidance around human subjects research: the idea that the norms of research ethics should be part of the researcher’s professional identity. In other words, such norms must be embodied in the very idea of what it means to be a good researcher. 

The key, according to the commission, is to promulgate a system of regulations that fosters an ongoing and lively engagement with ethical norms among those who are involved in research.  And with the release of the recent Advance Notice of Proposed Rulemaking (ANPRM)  regarding human subjects protections, we have an opportunity to transform the regulations to do just that—to, in the commission’s language, “prune” away the unnecessarily onerous aspects of the regulations and strive for harmonization.  If we mindfully pare down the regulations, we might end up with a set of rules that elicit greater respect from investigators.  Of course, as the commission suggested, and as PRIM&R and many others noted in their comments on the ANPRM, a revised “Common Rule” must first address investigator responsibilities and obligations directly, something the current “Common Rule” fails to do.

 

As the commission recognized last week, regulations that speak directly and palatably to investigators so they feel supported, as well as responsible, solve  only half the puzzle of how to help professionals internalize research ethics norms.

The missing pieces involve education. Here we probably need better data, but the commission seemed to be in agreement on three recommendations regarding research ethics education:

1. It should begin long before people are research professionals, perhaps in high school and certainly at the undergraduate level;
2. It needs to be interactive, case-based, and focused on details; and
3. It must be ongoing, in the form of collegial mentoring and, once professionals are established, coaching and consulting.

In the words of one commissioner, “How do we institutionalize a lively culture of ethical thinking in our professional organizations?” 

What do you think?

Being an IRB coordinator: What it means to me

Why do I enjoy being an IRB coordinator? At the University of Tulsa, the IRB’s focus is primarily on social and behavioral research (SBER). Of the many things I enjoy, at the top of my list is the interaction with faculty and students. I appreciate it when researchers stop by to discuss their projects before they get started.  I like the collaborative atmosphere and enjoy listening to bright new ideas. I get warm fuzzies when I think about doing something with my life that serves the greater good.

Although most SBER protocols reviewed on campus fall into the exempt or expedited categories, there is still a risk of harm to participants. In studies that are designed to be anonymous, subjects’ identities must be protected to minimize the risk of potential physical or financial harm. For example, compromising a battered woman’s anonymity could incite further  abuse, if her attacker were to learn that she spoke up.

I am proud that my institution studies post-traumatic stress disorder (PTSD). I get those warm fuzzies—a feeling of real satisfaction—again when I hear a piece on National Public Radio (NPR) about our soldiers, and that PTSD is now being recognized as a serious but treatable disorder by the military.

The University of Tulsa has also run ground breaking studies on people who endure chronic nightmares, and we are seeing real results. I love hearing from one of our graduate students about her work with veterans who suffer with nightmares. When she tells me about the results of her work and how they will help veterans in the future, I am as happy as she is!

Are there down sides to my job as an IRB coordinator? Sure there are. I’ve had more than one sleepless night over a confounding study, and sometimes I feel like everyone on campus has my personal cell phone number.  However, I am glad to say that by and large the pros outweigh the cons, and that I enjoy what I do and its positive impact on others.

An interview with AAMC’s chief scientific officer, Ann Bonham, PhD

By Catherine Rogers
Among the esteemed faculty for the 2011 Advancing Ethical Research (AER) Conference is Ann Bonham, PhD. As the chief scientific officer of the American Association of Medical Colleges (AAMC), Dr. Bonham plays a critical role in advancing ethical research. Conference attendees can look forward to her presentation during the pre-conference program The Buck Starts & Stops Here: Investigator Responsibilities for the Ethical Conduct of Research on December 1. For more information or to register for this program, please visit our website.


What are your key goals/agenda items as chief scientific officer at AAMC?
We have four specific goals. The first is to advocate and educate broadly about the benefits of biomedical research, from basic and clinical research, to community based participatory research (CPBR), to health services research, to implementation science.

The second goal is to work with academic medicine to come up with business models and strategies that will sustain biomedical research through economic constraints. This includes creating models and strategies that focus on quality and impact over growth and ensuring outcomes that matter to patients, the public at large, and Congress. AAMC just released a report showing that in 2009, the immediate economic impact of biomedical research in AAMC member medical schools and teaching hospitals was close to $45B and 300,000 jobs.

The third goal is to help establish pathways for academic medicine to build principled partnerships with industry. The shortage of new drugs and diagnostics in the pipeline call for innovative partnerships in which efforts are combined to ensure the development of new therapeutics to improve health in the next decade. 

The fourth goal is to use science to create an evidence base for improving patient and population outcomes while reducing costs in delivery of care. Health care legislation pointed to the need to fix the fragmented care delivery system and to broaden the concept of comparative effectiveness research.

What other programs or research initiatives are you involved with outside of your work with AAMC?
At AAMC, my responsibilities for engaging with policy makers and the leadership of academic medicine keep me busy.

At the 2011 AER Conference you will be participating as a faculty member for the pre-conference program, The Buck Starts & Stops Here: Investigator Responsibilities for the Ethical Conduct of Research. Given your own experience as a researcher, what do you think is needed to better facilitate effective and ethical research?
I believe that 99.99% of investigators are committed to performing ethical research that advances health and protects the privacy and safety of human subjects. What would be helpful is to clarify the roles and responsibilities for all those involved in clinical research. It would also be beneficial to have a clearer understanding of the rules and regulations surrounding the requirements for research. Clarity about the rules and showing compliance are the most helpful, but then the question is, how best to accomplish that?

What motivates you to maintain your commitment to advancing ethical research?
I believe that research is a social contract to improve the health of the public through discovering new knowledge and applying existing knowledge so that all of society benefits.

What challenges do you see ahead for medical research in general? Any ethical challenges in particular?
Some future research involving personalized medicine based on genomic variations; increased probability of using stem cells; and an emphasis on doing research with communities will bring significant attention to informed consent. However, that will be become complicated in terms of what’s needed to complete the research, and how we go about understanding a community’s perceptions of informed consent and transparency.

What advice do you have for young professionals interested in pursuing a career in research, research ethics, and/or a related field? 
Despite current national economic challenges, it’s a privilege and an opportunity to make and apply discoveries related to improving health. Imagine making a new discovery that will improve the health of not one or two or 10, but thousands of individuals. It would be impossible to have that commitment to improving health without a commitment to ethics, as real and true research must have ethics embedded in it.

Featured member interview: Mathia Sanders

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 Mathia Sanders, a retired community representative at Creighton University in Omaha, NE. 

When and why did you join the field?

I am retired after having worked in the field of social work for 30 years.

What is your favorite part of your job?

My favorite part of the field is the opportunity it provides for advocacy work. Hopefully I am a strong advocate for research participants and their families in making sure that consent forms are clearly worded, the risks and benefits are clearly stated, and participants are treated fairly. I feel fortunate being asked to serve in such a capacity .

What is your current state of mind?

I am a very positive person.

What is the last movie you saw? 

I saw Limitless with my family .

What are you currently reading?

I am reading Little Bee by Chris Cleave, and The Immortal Life of Henrietta Lacks, by Rebecca Skloot.

Which living person do you most admire?

I most admire President Barack Obama and his family.

What is your favorite member benefit?

My favorite member benefit is the opportunity to attend all the PRIM&R conferences. At the last conference I attended, the speakers were enthusiastic and extremely knowledgeable, the panel discussions were very good, and the personal testimonies were inspiring.

What motivates you to maintain your commitment to advancing ethical research?

I have very good working relationships with PRIM&R members on the IRB.

What advice do you have for young professionals interested in pursuing a career in ethical research?

I would encourage them to become life-long learners regarding cultural diversity. Historically, African Americans  generally have a mistrust of research, and feel they do not need to participate. I believe more education is needed to encourage their participation. It is vital that young professionals look for ways to involve more African Americans and other diverse groups in research.

Thank you for being part of the membership community and sharing your story, Mathia. Enjoy some quality holiday fun with your family!

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

Science Times synthesis

It seems a number of recent studies are taking issue with common myths about weight gain, the benefits or drinking eight glasses of water a day, and how coffee impacts sleep. Put your feet up, grab a cup o’ joe and read on to learn more about recent myth-busting studies.

Week of November 7

Decoding the brain’s cacophony
Read this profile of Dr. Michael Gazzaniga, professor of psychology at the University of California, Santa Barbara, and learn about the brain’s “split personality.”

Snakes’ feat may inspire heart drugs
Researchers say a better understanding of the process by which pythons digest their prey could help them develop new ways to treat various hereditary diseases in humans.

Midnight labs and martini time
Some observations by Michael Gazzaniga from a recent interview with Benedict Carey.

In some cases, even bad bacteria may be good
Read about a study that suggests the overuse of antibiotics may contribute to an increase in obesity, allergies, inflammatory bowel disease, asthma, and acid reflux disease.


For a more restful nap, drink a cup of coffee beforehand
Sleep researchers in England find that drinking a cup of coffee and immediately taking a 15- minute nap is more effective than either coffee or napping for tired drivers.

Study suggests obesity hinders flu vaccine
A new study suggests that flu vaccine effectiveness has a direct relationship to a patient’s weight.

Week of November 14

Focus on home, not meals, led spiders to diversity
A new study by Dimitar Dimitrov, a biologist at the University of Copenhagen, suggests that spider web diversification started with a need to create specialized habitats.

Drink eight glasses of water a day to protect the kidneys
Enjoy a cool glass of water while you learn about research that suggests drinking extra water helps the kidneys to clear sodium, urea, and other toxins from the body.

Four-year test seeks better ways to treat a persistent disease spread by sand flies
Learn about kala azar, a widespread parasitic disease prevalent in India and Bangladesh, and the four-year study that hopes to find the most effective and practical treatment.

‘Freshman 15’ is a myth, a study suggests
College freshman will be happy to hear that a recent study at Ohio State University suggests the “freshman 15” is a myth, and that students typically gain between 2.5 and 3.5 pounds during their first year of school.

IVF brings a slightly higher cancer risk
Dutch researchers have concluded that women undergoing in vitro fertilization (IVF) are at a slightly higher risk for borderline ovarian cancer, bringing the risk to .71 percent. According to the author of the study, this should not be a concern to women who choose to undergo IVF.

Introducing the newest member of the PRIM&R Blog Squad: Mindy Reeter

Welcome to a special installment of our featured member interview series in which we introduce you to our 2011 AER Conference Blog Squad members. Please read on to learn more about their professional experiences, how membership helps connect them to a larger community, and why they're excited about blogging for PRIM&R!

Today we’d like to introduce you to Mindy Reeter, BS, CIP, director of the office of human research oversight at the University of Illinois College of Medicine in Peoria, IL.

When and why did you join the field?

1999. My first job out of college actually using my degree!

What is your favorite part of your job?

Wrapping my head around some of the really cool research we review in order to allow the research to happen in the most ethical way possible.

Why did you join PRIM&R?

Because it is the biggest community of human subject professionals available.

What is your favorite member benefit?

The discounts of course… and meeting “human subjects” icons at the meetings. I once had Greg Koski sign his autograph on a PRIM&R sticker and I have a picture with Ivor Pritchard from a conference.

If you were planning our next conference, who would you select as a keynote speaker?

I think Neal Dickert is a great resource for planned emergency research and he should team up with my emergency room physician IRB chair, John Hafner, who is an excellent researcher and research mentor!

What advice do you have for young professionals interested in pursuing a career in ethical research?

It never gets old.

What are you most excited to blog about at the 2011 AER Conference?

What vendor booth offers the best pens… ha! And all the opinions regarding the ANPRM!

Introducing the 2011 AER Blog Squad: Dawnett Watkins

Welcome to a special installment of our featured member interview series in which we introduce you to our 2011 AER Conference Blog Squad members. Please read on to learn more about their professional experiences, how membership helps connect them to a larger community, and why they're excited about blogging for PRIM&R!

Today we’d like to introduce you to Dawnett Watkins, IRB coordinator at the University of Tulsa, OK.

When and why did you join the field?

I was hired to work as an accountant in the research department at the University of Tulsa in September 2001. I noticed that my boss was trying to wear several different hats, and heard her complain that the university IRB was not in the shape it should be in, and that it did not have a good system for tracking protocols. The work of the IRB sounded much more interesting than what I was doing, so I took it upon myself to develop a database for tracking research protocols. While developing the database, I learned a lot about the IRB, and my institution recognized the need for a full-time IRB coordinator. Fortunately, I was the natural choice for this newly created position; I guess you could say I worked my way in!

What is your favorite part of your job?

There is always a new and exciting challenge. And I love the interaction with students and faculty.

What are you reading?

I’ve always got a stack of books by my bed. The last book I read was Night by Elie Wiesel. I’m also currently in year two of my quest to read the Bible from front to back.

Why did you join PRIM&R?

I joined originally to get the discount on the conferences. My favorite membership benefit is the monthly Newsletter, which helps to keep me current on the issues.

If you were planning our next conference, who would you select as a keynote speaker?

Dr. Elana Newman. Her trauma research is quite interesting, as is her work with the Dart Center for Journalism and Trauma.

What advice do you have for young professionals interested in pursuing a career in ethical research?

The pay may not be great, but feeling like you are doing something to help mankind is very rewarding.

What are you most excited to blog about at the 2011 AER Conference?

I hope to blog about social, behavioral and educational research (SBER), and to bring a fresh outlook to this area.