Featured member profile: Kerri Cote Plaud

Welcome to another installment of our featured member interviews where 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 Kerri Cote Plaud, MS, IRB coordinator at St. Anne's Hospital in Fall River, MA.

When and why did you join the field?

I have worked in the clinical research environment for 12 years, first as a clinical research assistant and project manager for Dana Farber Cancer Institute, which is affiliated with Brigham and Women's Hospital and Harvard Medical School, and then as the coordinator for the IRB at Steward St. Anne’s Hospital Corporation. My initial exposure to clinical research was simply by chance and good fortune.

What is your favorite part of your job?

My favorite part of the job is being presented with thought-provoking situations to which solutions are not always readily apparent. The job requires me to be resourceful and analytical. There is always something for me to learn.

What are you reading?

I am currently reading two books: Eat, Pray, Love by Elizabeth Gilbert, and The Holy Bible.

What's your after-hours guilty pleasure?

My guilty pleasure is eating sundaes: watermelon sherbet, hot fudge, whipped cream, and chocolate sprinkles. Perhaps by the time I finish reading the Bible, I’ll be better able to control the temptation!

Why did you join PRIM&R?

I joined PRIM&R for purpose, networking, and educational support.

What is your favorite member benefit?

Speeches delivered by keynote speakers at several of the conferences have been inspiring and riveting, to say the least. I silently challenge the conference planners after each session, “Go ahead, PRIM&R. Try to outdo yourself next time.” And they do! I also like to take advantage of the many learning opportunities.

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

If you can choose only one professional organization to belong to, I would highly recommend PRIM&R. PRIM&R leaders have helped construct and support the ethical and regulatory framework for research through education, influence of public policy, mentoring, and opportunity for professional development.

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

Progress and survival depend on trial and error. However, life is an inalienable right that should be respected and protected.

Thank you for being part of the membership community and sharing your story, Kerri! That sundae sounds delicious!

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

PRIM&R's comments on the ANPRM

by Elisa Hurley, PhD, PRIM&R education director

On October 26, 2011, PRIM&R submitted to the Office for Human Research Protections (OHRP) comments in response to the Advance Notice of Proposed Rulemaking (ANPRM) titled, "Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators," published in the Federal Register on July 26, 2011.

In its comments, PRIM&R addressed many of the specific proposals and 74 questions embedded in the ANPRM. We also took this opportunity to highlight some broad themes that cut across specific regulatory proposals, including:

• There is a need for more robust and effective education about the ethics and regulation of human subjects protections for IRB members, chairs, and investigators. Revised educational requirements should be placed on the regulatory agenda.
• A human subjects regulation system should include and apply to all of the stakeholders in human subjects research, including institutions, investigators, and sponsors, as well as IRBs. The creation of such a system is, however, just one step in creating a research culture where everyone takes responsibility for human subjects protections.
  
• Federal regulations should be understood to set a minimum standard for the protection of human subjects below which institutions may not fall, and should never be viewed as a ceiling an institution cannot surpass. Additionally, an institution should never be required to justify additional measures it adopts to augment the protection of human subjects.
  
• While there are clearly potential benefits to making human subjects protections more efficient, efficiency itself is not a moral imperative or an ethical value. Human subject protections should never be compromised by a desire for increased efficiency.
  

In its comments, PRIM&R provides more detailed suggestions and recommendations, divided into the following five substantive sections:

• Informed consent
• Privacy
• Centralized review
  
• Calibrating level of review to level of risk
• Post-IRB human subjects protections

You can read PRIM&R’s comments in their entirety here. We invite your reflections and responses.

We also invite you to have a look at the comments submitted by the American Psychological Association (APA); the Association for the Accreditation of Human Research Protection Programs (AAHRPP); the Association of American Medical Colleges (AAMC); and the Secretary’s Advisory Committee on Human Subjects Protections (SACHRP).

If you are interested in browsing the over 700 responses submitted to OHRP during the comment period, please follow the instructions here.

Science Times synthesis

Do you ever wonder if a good scare on Halloween is enough to send a pregnant woman into labor? Read on to find out why scientists think women may be able to control when they give birth around particular holidays, including Halloween!

Week of October 11

Prostate test finding leaves a swirl of confusion
New information suggests that Prostate-Specific Antigen (PSA) testing does more harm than good. For men living with a diagnosis of prostate cancer, this is disturbing news.

Hearing bilingual: How babies sort out language
By analyzing neurological activity as babies hear language, and comparing it to childhood responses to the same words, researchers explain how the early brain listens to language.

Envy may bear fruit, but it also has an aftertaste
Thanks to the work of researchers at Texas Christian University in Forth Worth and the University of Texas at Austin, we now know more about envy. Can it make you smarter? Find out here.

Week of October 18

Chimp to human to history books: The path of AIDS
In his book, The Origins of AIDS, Dr. Jacques Pepin, an infectious disease specialist at the University of Sherbrooke in Quebec, Canada, describes the often circuitous path the virus took during its earliest years.

Two cancer studies find bacterial clue in colon
Research by Dr. Robert Holt, a genomics researcher in British Columbia, Canada, shows that colon cancer may be caused and advanced by bacterial infection.

On teamwork at least, chimps and children vary
Researchers find that cooperation is more appealing to children than to chimpanzees. Learn more about the study, which was conducted by biologists at the Max Planck Institute for Evolutionary Anthropology.

Yoga can manage pain
Studies show that yoga is one of the most common alternative therapies for the relief of chronic pain. Read about the results of recent clinical trials, and why researchers do not feel they have reached any definitive conclusions.

Clarity on cancer and Barrett’s Esophagus
People with Barrett’s Esophagus, a complication of acid reflux disease, may have a higher risk of developing cancer. Danish research data that suggests .12 percent of patients with Barrett’s Esophagus develop esophageal cancer.

Week of October 25

From marine ecology to drug discovery
Read this report from Mark Hay, biology professor at Georgia Tech, who is investigating coral-seaweed competition in the coral reefs of Fiji.

Mammogram’s role as savior is tested
Medical experts say it’s time to set the record straight on mammography screening for breast cancer. Learn about the reasons doctors say that mammograms do not necessarily prevent breast cancer.

Troubles with heart are linked to human papillomavirus (HPV)
Read about a new study that suggests HPV may be linked to cardiovascular disease in women.

Holidays can affect when expectant mothers deliver
In a study published this month, Yale researchers find a 5.3 percent dip in births on Halloween, as well as a 16.9 percent decrease in Caesarean births. Learn more about new research that suggests women may be able to control the timing of unscheduled births around holidays.

Featured Member Profile: Lisandra Gonzalez

Welcome to another installment of our featured member interviews where 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 Lisandra V. González, MPH, an HRPP integrity and education specialist at Baystate Health Medical Center in Springfield, MA.

When and why did you join the field?

I was first exposed to the IRB while working as a research coordinator at my previous job. They added a third IRB panel and asked me to join. I accepted and was impressed with panel’s hard work and dedication to protecting human subjects. It gave me the foundation I needed, and when it was time to move on, it seemed logical to pursue a career in human subjects protections.

What is your favorite part of your job?

When I was working on my master’s thesis and needed to do a submission to the IRB, I had no one to guide me through the process. In my current position, I love guiding medical residents and investigators through the IRB submission process. Most people don’t speak “IRB” and they find the submission process difficult. Since I was once “lost,” it gives me great pleasure to help others.

What are you reading?

I am currently reading Institutional Review Board: Management and Function by Bankert and Amdur and Protecting Study Volunteers in Research: A Manual for Investigative Sites by McGuire, Dunn and Chadwick. I am hoping to sit for the CIP^® exam this fall.

What's your after-hours guilty pleasure?

I love to watch old episodes of StarTrek and Stargate.

What is your favorite member benefit?

My favorite member benefit is access to educational materials and webinars (especially the free ones!), and of course, I love the yearly Advancing Ethical Research Conference!!

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

Don’t think twice. PRIM&R is on top of changes taking place in the regulatory world—just recently they ran a webinar informing members of all the proposed regulatory changes in the ANPRM. The education and support is invaluable.

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

I would invite Mindy Fullilove, MD, professor of clinical psychiatry and public health at Columbia University.

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

I believe that research and the advancement of knowledge is absolutely necessary for progress. However, that progress cannot come at the expense of ethical research. I believe in the Belmont Principles and when these are upheld, we can se the benefits in our communities.

Thank you for being part of the membership community and sharing your story, Lisandra. Good luck studying for the CIP exam! If you are studying for the CIP exam like Lisandra, please join our CIP Study group on Facebook!

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

Champions of Change: Leaders in the Fight Against Breast Cancer

As part of PRIM&R’s ongoing support of National Breast Cancer Awareness Month, we are pleased to share this post by Shira Sternberg, daughter of longtime PRIM&R friend and faculty member Pat Barr. Shira is the special assistant to the associate administrator of external affairs and environmental education at the Environmental Protection Agency (EPA). This piece was originally published October 6, 2011, on the White House blog.

In the words of PRIM&R’s executive director Joan Rachlin, “We are sharing Shira’s thoughtful and touching piece with you in memory of Pat, who lost her battle with cancer eight years ago, and to honor all those around the globe currently living with breast cancer. Stay strong and keep up the fight. We are right behind you!”

You can also watch the video of the complete Champions of Change event on the White House blog.

To kick off Breast Cancer Awareness Month, last week leaders in the fight to end breast cancer participated in a roundtable discussion at the White House. The leaders included activists, scientists and health care providers who are making a difference in this fight every day. The discussion was led by Chief of Staff to the First Lady and Executive Director of the Council on Women and Girls, Tina Tchen, and it focused on the progress and challenges in the fight to end this devastating disease.

The fight against breast cancer is a personal issue for me. I learned the importance of this issue from my late mother Pat Barr, who first brought me along organizing with her when I was 10 years old. Back in the early 90’s, I trekked all over my little town of Bennington, VT collecting petitions for the National Breast Cancer Coalition’s 300 Million More campaign supporting more breast cancer research funding.

My mother was diagnosed with breast cancer when I was 4 and my younger sister was just 9 months old. Her breast cancer first metastasized when I was 6 and when I was 13, it spread to the lining of her lung. From that point on, she had regular recurrences in her bones, brain, eye, again in her lung, and finally in her liver. She passed away from liver failure when I was 20. My grandmother, who was one of the women who helped play the role of mother for me and my sister when my mom was too sick to do so, also died this past August of metastatic breast cancer.

The White House Champions of Change roundtable was important because my story is not unique. All of us in that room had similar stories. You can read more about the Champions of Change who participated in the conversation here.

In 1991, 119 women died a day of breast cancer, today it is about the same, 110 women die daily of the disease. And this year alone over 230,000 women will be diagnosed with the disease. We gathered at the White House because we know we can do better. Together with hard work, continued education and persistence, we can end this disease for the millions of families who are affected by it every day and the millions more who can be protected from it once we end it.

Although there is still a lot of work to do, I am proud to be a part of an Administration that is taking action to provide quality health care for all Americans. The Affordable Care Act allows millions of women the ability to get a mammogram without paying an extra penny out of their own pocket. Women can also get a well-woman visit to help them stay healthy. This kind of health care can help millions of women nationwide get the care they need.

Featured Member Profile: Rebecca Banchik

Welcome to another installment of our featured member interviews where 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 Rebecca Banchik, an IRB manager for the program for the protection of human subjects (PPHS) at the Mount Sinai School of Medicine, New York, NY.

When and why did you join the field?

I joined the field in 2006. I started working for the IRB because a job opened up at the medical school, I was unemployed and a friend who was working as a research coordinator mentioned it to me. I liked the IRB concept and was excited about applying my undergraduate experience in psychology and research. Here I am…five years later!

What is your favorite part of your job?

One of my favorite parts of working for an IRB is feeling that I contribute to research in an important but subtle way. I know that my work affects others, and that the decisions I make have an impact on many levels—from administrator to doctor to patient.

I am most affected by the patients that are being recruited into studies. Few people know about our little IRB world. We're the stage crew of a play—the doctors and patients are the actors getting the attention and applause, but without us, research would be a whole different game, as we know from looking back on our history.

What is the last movie you saw?

The last movie I saw was The Fighter.

What are you reading?

I am reading Intuition by Allegra Goodman. I’m actually reading this for our office book club. We read novels or non-fiction related to the research world, ethics, and some of the controversies in the work we do.

What's your after-hours guilty pleasure?

Right now I confess—a nightly dose of Shark Week!

What do you most value in your friends?

My friends, my true friends, let me be me when I’m around them. They love me as I am, faults and all. Having company like that is invaluable.

Why did you join PRIM&R?

Our office encourages all staff to become members. I enjoy attending the PRIM&R Advancing Ethical Research Conference every year.

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

Being a member of PRIM&R is a great way to stay in the loop . It's a friendly reminder that there is a support group of others doing what we do every day. The conference also provides a place to network, educate and receive additional training.

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

This field can be incredibly invigorating and challenging, but it doesn't come without struggle and some frustrating moments. I think it's important to know that there are always going to be people with higher degrees and more experience—but that doesn't mean our work is somehow less important or less valued. It's also meaningful to take into account that we didn’t choose this work to become wealthy or famous—we chose this path because we believe in ethics and human subjects protections.

Thank you for being part of the membership community and sharing your story, Rebecca. We would love any reading suggestions from your book club, and if you’re at the 2011 Advancing Ethical Research Conference, we hope you can join us for the Research Ethics Book Group Lunch!

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

What's missing in the ANPRM?

Wendy Tate, PSM, CIP

By this time almost everyone is familiar with the advance notice of proposed rulemaking (ANPRM) that recommends vast changes to the human subject regulations known as the “Common Rule.” As I read the memorandum, table of changes, and 92-page document, one thing kept popping into my mind: What about the subparts?

Being “in the trenches” at a university that supports both medical and social/behavioral research, I find it frustrating to apply subpart B (research involving pregnant women) to non-biomedical research and/or minimal risk biomedical research. Granted, subpart B is not technically part of the “Common Rule,” and as such is not included in the recent ANPRM. However, its omission is disconcerting for IRB members, IRB staff, and researchers who use the “Common Rule” as a litmus test for our decisions involving human subjects research.

Subpart B is a good discussion point for understanding how important it is for the subparts to be included in the ANPRM discussion. Having been a pregnant woman myself and speaking to other women who have been pregnant, there are very few times in a pregnancy when a woman is vulnerable. These times generally center around labor and delivery. Pregnant women make decisions every day that can affect their unborn children. These decisions range from what to eat and drink, to taking prenatal vitamins, to long distance travel, to choosing medical care. Research needs to be done in this population.

The FDA has stated that excluding pregnant women from clinical trials is unethical. Revision or removal of subpart B will go a long way toward harmonizing regulations and gathering important information on how drugs work in women, as well as to avoid the discriminatory status of being a “woman of childbearing potential.” It seems to me that combining necessary changes to the subparts with the ANPRM review process would be the most expeditious way to accomplish this.

I hope that individuals and institutions responding to the ANPRM will join me in commenting on the absence of content that addresses the subparts, including those that might adversely affect the ability to conduct ethical research. Comments are due no later than October 26. As we haven’t seen this level of revision in almost 30 years, we can expect that it may be 30 more before we have this opportunity again. Let your voice be heard.