Wednesday, September 28, 2011

Revisiting the Guatemala Syphilis Experiments with Susan Reverby

It’s almost the one-year anniversary of the United States’ formal apology to Guatemala for the experiments carried out during the 1940s syphilis inoculation project co-sponsored by the US Public Health Service (PHS), the National Institutes of Health (NIH), the Pan American Health Sanitary Bureau, and the Guatemalan government.

Featured yesterday on Boston’s local NPR station, WBUR, PRIM&R member and Wellesley College professor Susan Reverby spoke about being the first to uncover the truth about this project. Listen to her podcast, ‘Ethically Impossible:’ Revisiting the Guatemalan Syphilis Experiments, in which she reviews the Presidential Commission’s recent findings.

Susan will be delivering the inaugural Pillars of PRIM&R lecture, "Escaping Melodramas: On Telling the Histories of the PHS Studies in Tuskegee and Guatemala," at the 2011 Advanced Ethical Research Conference, which will be held December 2-4, 2011, in National Harbor, MD.

Tuesday, September 27, 2011

"Science Times" synthesis

How concerned should you be about a viral pandemic coming soon… to a theater near you? According to the New York Times, not very. In an article about the movie Contagion, readers are assured that “you can still be very afraid if you want, if a contagious apocalypse happens to be your thing. But it’s not going to happen this way.” Read The Cough that Launched a Hit Movie below to get the scoop.

Week of September 13

The cough that launched a hit movie
Dr. Abigail Zuger analyzes the accuracy of Hollywood’s latest outbreak disaster movie. Read the full review, and let us know what you think—is it a hit or a miss?

An immune system trained to kill cancer

Scientists say the experimental treatment that helped leukemia patient William Ludwig may herald a turning point in the struggle to develop gene therapies effective in fighting cancer.

Indecision pays off for a doctor who loves the lab
Dr. Arthur Horwich, a medical geneticist at Yale University, wins this year’s Lasker Basic Medical Research Award for his work with misfolded proteins. Read on to learn more about his research and how it may impact the treatment of diseases like Alzheimer’s.

Blood test could be a breakthrough in field of tropical diseases
Learn how a new test for sleeping sickness might be a major breakthrough in diagnosing tropical diseases.

A squirt of insulin may delay Alzheimer’s
A small study finds preliminary evidence that insulin delivered through the nose may keep early Alzheimer’s at bay. Read more about the results of this pilot trial run by researchers at the University of Washington, and published in the Archives of Neurology.

Week of September 20

Scientists at Johns Hopkins University work with Lonnie Sue Johnson, artist and illustrator, to answer questions about memory, identity and art. Ms. Anderson, stricken with viral encephalitis that caused severe damage to part of her brain, is exhibiting her recent drawings at the Walters Art Museum.

A knack for bashing orthodoxy
Read an interview with influential evolutionary biologist Richard Dawkins, best known for his 1976 book, The Selfish Gene, in which he turned the traditional view of evolution and natural selection upside down. This interview is the second in a New York Times series on leaders in science.

Remark on HPV vaccine could ripple for years
Experts disagree with Rep. Michele Bachmann’s assertion that the vaccine to prevent cervical cancer is “dangerous.” Read about the controversy, and see what the experts have to say.

Health gains from a small drink a day
Harvard researchers find that women who drink one-half to one ounce of alcohol per day are 28% more likely to age successfully. Discover what scientists mean by “successful aging.”






Friday, September 23, 2011

Featured Member Profile: Beth Bresee

Welcome to another installment of our featured member interviews in which we introduce you to 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 Beth Bresee, program specialist at the Association of American Medical Colleges (AAMC) in Washington, DC.


When and why did you join the field?


I joined the field in 2010 when I had the opportunity to hold a research assistant position at Johns Hopkins School of Medicine. I’ve now moved on to the AAMC to assume a role in human subjects research protections. This position allows me to blend my knowledge of research regulations with my formal training in ethical considerations obtained through an undergraduate philosophy degree.

What is your favorite part of your job?


My favorite part of this job is the fulfillment. I’m responsible for ensuring that my organization maintains the highest ethical standards in its research practices. At the end of the day, I know that my work is important to the subjects we’re protecting. It’s also an exciting time to be in this field, as the changing policy landscape on research regulations provides an opportunity to share opinions on improving current practices.

What are you reading?


I’m currently trying to get caught up on weekly subscriptions to the New England Journal of Medicine and the interdisciplinary science journal Nature. Although I work on the regulatory side of research, I like to follow the actual content of medical and scientific advances.

Why did you join PRIM&R?


I joined PRIM&R because it’s a great resource for information and updates on human subject research issues.

What is your favorite member benefit?


My favorite member benefit would have to be the monthly Newsletter. It provides a wealth of information that keeps members up to date on the latest happenings in the field.

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


If I could choose the next keynote speaker for a PRIM&R conference, I would pick Dr. Jerry Menikoff. As the director of OHRP and co-author of the recent ANPRM, I’d love to hear his thoughts on the proposed changes to the “Common Rule” and the likelihood of reform.

Thank you for being part of the membership community and sharing your story, Beth. We hope we can help you keep up with all the new regulations here at PRIM&R! If you’d like to learn more about becoming a member, please visit our website today.




Wednesday, September 21, 2011

3...2...1 Lift Off - of Another School Year!

By: Wendy Tate, PSM, CIP

While everyone is talking about DHHS’s advance notice of proposed rulemaking (ANPRM), I thought I would discuss another topic on many people’s minds right now: the start of the school year.

Here at the University of Arizona, we are gearing up for the influx of students, faculty, and support staff returning from their summer vacations and ramping up their human research projects. This time of year is filled with orientations, the start of classes, and new funding cycles. Students and faculty (especially new ones) are inundated with training sessions crucial to their success. This makes it difficult as an educator to tell if your information is sticking. So what can we do to remind people about the important work being done to safeguard human subjects?

1. Make it interesting

People do not remember what they have heard if a presentation is boring. We’ve all been there—slides that have too much text or bad color schemes. Involve your audience. Include questions or case studies in your presentation. Use humor and interesting anecdotes. Engage the audience so that they retain the information. Use the history of the IRB to your advantage. Show them that we are here to provide an ethical framework in which to work, not to create more “red tape.

2. Make it relevant
Nobody wants to feel that they have just wasted an hour (or more) of their precious time on information they will never use. Tailor training to your audience. Don’t teach the basics to your seasoned researchers. Build off of what they already know. Conversely, don’t assume that first-year graduate students even know what an IRB is. Use the regulations that are appropriate for your crowd. Refer back to point number 1 above and ask questions to get more information about your audience. Better yet, do your homework ahead of time!

3. Don't just reuse the same slides from last year
Building on points 1 and 2, recycling slides risks inaccuracies. Information may have been updated since you used the slides last. That information may be as simple as your phone number or email address, or as complex as a new FDA guidance or a revamp of federal regulations. When developing your presentation, ask yourself if your audience needs to know FDA regulations, VA regulations, or oral history guidance (among other topics).
4. Keep track of time
Even if it means letting go of some material, stop when your time is up. Staying within your time limit indicates professionalism and respect for your audience. Your audience will remember if you go over the allotted time, and the next time you come and talk, it will be all they remember.

“Hey, are you going to that training today?”
“Yep, how about you?”
“Sure am. I’m not looking forward to it though. It was so long last year. It better stay within the hour this time or I’m going to scream.”


If necessary, allow people to leave on time but offer to stay and talk more with those who are so inclined.

There are lots of great ways to run effective training programs. I have barely scratched the surface here. The most important thing is to get out there, get to know your researchers (seasoned and new), and share your love of human subject protections with them. Passion may be the most important training tool of all!

Wednesday, September 14, 2011

Update on PRIM&R's response to the ANPRM



by Elisa
Hurley, PhD
PRIM&R Education Director

As many of you may know, the Department of Health and Human Services (DHHS) has extended the public comment period on the advance notice of proposed rulemaking (ANPRM). The revised closing date for submitting comments to DHHS is October 26, 2011.

If you are interested in what others having been saying about the proposed changes to the “Common Rule,” instructions for browsing comments may be found here.

PRIM&R’s ANPRM Task Force is still hard at work drafting and compiling comments. We will continue to update you on our progress here, on our website, and on Twitter. If you’re not already following us, you can find us @primrconnect.

In the meantime, we encourage you to submit your comments to DHHS. And of course, we’d still love to hear what you and your colleagues are thinking about the proposed changes in the ANPRM. Please feel free to post your comments below.

Tuesday, September 13, 2011

"Science Times" synthesis

Love chocolate? That might not be such a bad thing! New research provides more evidence that consuming significant amounts of chocolate is good for your heart. This article in the Science Times takes the guilt out of one of America’s favorite treats.

Week of August 14

Autism Risk for Siblings Higher Than Expected: Researchers now believe that parents of an autistic child have a 1 in 5 chance of having another child with autism.

Charting Brain Growth in Humans and Chimps: Learn about the patterns of brain growth in humans and chimps, and what region of the brain causes our cognitive differentiation.

Regimens: Soothing Melodies for Cancer Patients:
Recent studies show that music therapy decreases anxiety and pain for cancer patients.

Common Sleep Problem Raises Risk of Dementia: Researchers are finding a link between sleep apnea and dementia.

Perks of Cross-Training May End Before Finish Line: Although cross-training improves cardiovascular health, it does not directly impact performance in other physical activities.

Week of August 21

Born, and Evolved, to Run: Read an interview with Daniel Lieberman, professor of evolutionary biology at Harvard, and learn about the evolution of the human head and foot.

Malaria Gets the Foil-in-a-Microwave Treatment: Learn about an innovative technique that may lead to a cure for malaria.

Examining the Mystery of Skeleton, Sugar, and Sex: New studies demonstrate how bones regulate blood sugar and fertility.

A Protein That Bosses Plant Cells Around: Read about Clasp, a protein that controls the direction of growth in plants.

Really? The Claim: Drinking Green Tea Can Help Lower Cholesterol: Take a look at the debate over one of the benefits of green tea.

Week of August 30

The New Generation of Microbe Hunters: Researchers look to genome sequencing for clues to the causes, and prevention, of epidemics.

Bacteria-Busting Oil Behind a Popular Spice: Researchers from the University of Beira Interior in Portugal report that that coriander oil can kill bacteria related to food-borne diseases.

Possible Culprit is Found for Lou Gehrig’s Disease: Dr. Teepu Siddique of Northwestern University posits a new theory about what causes amyotrophic lateral sclerosis (ALS.), commonly referred to as Lou Gehrig’s Disease.

Evidence of Heart Benefits from Chocolate: Read an analysis of recent studies on the correlation between chocolate consumption and cardiovascular health.

Infections Follow Rise in Cardiac Implants: According to a study published August 30 in The Journal of the American College of Cardiology, while the number of cardiac device implants has doubled since 1993, the number of infections associated with these devices has tripled.

Friday, September 9, 2011

When Great Trees Fall

As we remember the lives lost on September 11, and the responders who heroically risked their lives on that day and the days afterward, we share with you this poem by Maya Angelou.

When great trees fall,
rocks on distant hills shudder,
lions hunker down
in tall grasses,
and even elephants
lumber after safety.

When great trees fall
in forests,
small things recoil into silence,
their senses
eroded beyond fear.

When great souls die,
the air around us becomes
light, rare, sterile.
We breathe, briefly.
Our eyes, briefly,
see with
a hurtful clarity.
Our memory, suddenly sharpened,
examines,
gnaws on kind words
unsaid,
promised walks
never taken.

Great souls die and
our reality, bound to
them, takes leave of us.
Our souls,
dependent upon their
nurture,
now shrink, wizened.
Our minds, formed
and informed by their
radiance,
fall away.
We are not so much maddened
as reduced to the unutterable ignorance
of dark, cold
caves.

And when great souls die,
after a period peace blooms,
slowly and always
irregularly. Spaces fill
with a kind of
soothing electric vibration.
Our senses, restored, never
to be the same, whisper to us.
They existed. They existed.
We can be. Be and be
better. For they existed.

Thursday, September 8, 2011

Featured Member Profile: Sylk Sotto-Santiago

Welcome to another installment of our featured member interviews in which we introduce you to 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 Sylk Sotto-Santiago, MBA, MPS, CPIA, research compliance manager/officer in the office of research and sponsored programs at the University of Denver.



When and why did you join the field?
I joined the field more than five years ago. At the time it seemed like a logical transition from research to research compliance. The fact that I love research is probably what keeps me interested in compliance, although some people may disagree!

What is your favorite part of your job?
My favorite part of the job is learning about the research being done at my institution and at other impressive institutions, along with meeting our great faculty and students—such brilliant minds.

What are you reading?
I am currently in the middle of two books: The Secret Daughter, by Shilpi Gowda and The Devil in the White City: Murder, Magic, and Madness at the Fair that Changed America, by Erik Larson.

What is the last movie you saw?
The latest movie I saw was Horrible Bosses. It was REALLY funny, and I guess I should point out that I have never had any boss like that, and I am certain I’m not one of them either!

Why did you join PRIM&R?
I was referred to PRIM&R by a colleague.

What is your favorite member benefit?
There are quite a few benefits that I enjoy. I like reading the Newsletter and having such great educational opportunities through conferences and webinars. The most important benefit is the network of professionals I can consult with and learn from.

With whom have you made a lasting professional connection through your membership?

I think the network of PRIM&R members is great, and I am even more thankful to have met PRIM&R members in the Colorado region. (Salute to my Mile High IRB Consortium peers!) I have also made wonderful connections with people in the field who have similar positions to mine, not just overseeing the IRB, but other regulatory bodies such IACUCs, IBCs, COIs, etc. These people have an enormous wealth of knowledge and scarily enough, they have human subjects, animal, and biosafety regulations at the tip of their tongue.

What motivates you to maintain your commitment to advancing ethical research?
My commitment in terms of the ethical side has to be about participants’ dignity and autonomy, and, of course, scientific progress. This applies regardless of the area of research, biomedical, social, behavioral, or educational research. Regulations in this area may be burdensome but ultimately we are all thinking about participants. My other motivation is to support our faculty and students in navigating the regulation maze and institutional processes, which are not always just about conducting ethical research.

Thank you for being part of the membership community and sharing your story, Sylk. We are glad to have facilitated your networking of peers in Colorado!

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






Thursday, September 1, 2011

Featured Member Profile: Julie Washington

Welcome to another featured member interview in which we introduce you to PRIM&R members, a group of dedicated individuals working to advance ethical research on a daily basis. Please read on to learn more about Julie Washington, CIP, senior IRB administrator at New York University.



When and why did you join the field?

I joined the field in 1989 as the result of a job promotion.



What is your favorite part of your job?

My favorite part of my job is educating investigators about human subjects protections, and helping them navigate smoothly through the IRB process.



What is your idea of perfect happiness?


My idea of perfect happiness is spending time with my family doing something fun that we all enjoy.




What are you reading?

I am currently reading The Emperor of All Maladies: A Biography of Cancer, by Siddhartha Mukherjee.



Why did you join PRIM&R?

I joined PRIM&R because my boss suggested that it would be good for me to attend the conferences and meet other IRB professionals.



What is your favorite member benefit?

There are so many, I can't just pick one!



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

If you can only join one organization, PRIM&R is it. It is the best organization for meeting other IRB professionals and for learning more about the field of human subjects protections.



What is the last movie you saw?

The last movie I saw was Harry Potter and the Deathly Hallows.



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

I would like to hear an update from Paul Geslinger.



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

The memory of my parents motivates me to maintain my commitment to advancing ethical research.



My mother suffered acute radiation burns in 1937 at the age of 17, when her family doctor used x-rays to treat her acne. He left the machine on too long and her face was severely burned. I grew up watching her suffer with skin cancer, then scleroderma and finally Hodgkin's disease. Her doctor never said he was conducting research in 1937, but better knowledge of the damages of radiation may have prevented this from ever happening. The one good thing to come out of her suffering was that she always told me to wear sunscreen long before it became the popular thing to do. I thank her every day for that advice.



My father suffered from Alzheimer's. I remember watching him waste away in the nursing home wishing that there was something I could do to get rid of this horrible disease.



My dedication to the IRB profession allows me to work toward ensuring that human subjects are adequately protected while participating in research. It also gives me hope that researchers will be able to find a cure for diseases like Alzheimer's. This is my way of honoring my parents.



Thank you for being part of the membership community and sharing your story, Julie. Your parents’ stories are moving and profound, and we wish you the best as you better the field of ethical research in their memory.



To learn more about becoming a PRIM&R member, visit our website.







 
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