Featured Member Interview: Tanya Carrillo

As an extension of our Member Appreciation Month interview series, we will continue to introduce you to more of our members, people 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 Tanya Carrillo, human research protections program (HRPP) coordinator at ProHealth Care Research Institute in Waukesha, Wisconsin.

When and why did you join the field?
My first IRB-related position was in March of 2005, although I spent several years during my undergraduate career on “the other side” preparing IRB submissions for anthropology and psychology research teams that I worked with closely. It was this initial interaction that intrigued me about the human research protections world. Having the opportunity to review many studies in different fields seemed like a good option should I decide to put my own research interests on hold. It was intended to be temporary, until I decided to go back to graduate school for anthropology or psychology, and now here I am considering graduate programs in bioethics instead.

What is your favorite part of your job?
My favorite part of this job might also be my least favorite on certain days–the ever-changing dynamic of this field. It seems like just when we think we have everything settled or figured out, there is a new guidance document or recommendation, or a new kind of research on our desk that forces us to reevaluate the regulations and ethical standards through a different lens. Although we follow our meeting cycles and deadlines, no day is ever the same or predictable. The evolution of this field keeps me challenged and interested in whatever will come next.

What are you reading?
When it is not a stack of work-related articles next to my bed, I try to indulge in fiction. Currently, I am trying to get through Wicked. I am a little late on that one, I know, but the musical is finally coming to Milwaukee in August, which is a great motivator to finish the book.

Why did you join PRIM&R?
Initially it was probably some slight peer pressure; everyone else was doing it at my last organization. But in the long run, the resources and connections I have developed are what keep me renewing this membership when others fall off my radar. And thanks to the discounted rates on education, my membership ends up paying for itself by the end of the year.

What is your favorite member benefit?
I just started the mentoring program last year and I find it to be a great resource. Even though I wear the “mentor hat,” I have developed a great working relationship that is an invaluable resource to us both. We are each HRPPs of one staff person, so having someone to talk to on the challenging days, in addition to our regular meetings and discussions, is such a great benefit.

What would you say to someone who is considering PRIM&R membership?
Do not debate the cost; if you are involved, it ends up paying for itself. And once you join, set aside a few hours to browse the site and see all it has to offer. The resources are endless, well organized, and top quality.

What motivates you to maintain your commitment to advancing ethical research?
At the end of the day, I try to remember that everything we do is for the research participants. Having a participant who can understand a consent form and give true, ongoing, non-coerced, informed consent to participate in research is no small feat, and should not go unrecognized.

Thank you for being part of the membership community and sharing your story, Tanya. Let us know what you think of Wicked!


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

Research must include pregnant women, article says

A recent article in the New England Journal of Medicine asserts that it is "imperative" that pregnant women become more involved in research.

In spite of the fact that the majority of pregnant women in the United States take prescribed medications (excluding vitamins and minerals) for chronic or acute medical problems, very few are involved with clinical trials, say the authors.

They also point out that pregnant women were among the populations at highest risk during the H1N1 epidemic, and this may be because the correct dosage of an antiviral flu drug was not evaluated in clinics.

As the debate over including pregnant women in clinical trials continues, we’d like to know: How can pregnant women be included in clinical drug trials without placing undue risk on mother and fetus? What are the ethical implications of including an unborn child in research?

We’re eager to hear your thoughts!

NIH plans research with Gulf oil spill workers

The National Institutes of Health will reserve $10 million to study health effects connected to the cleanup of the Gulf oil spill, after health problems among the expanding cleanup workforce were reported in early June.

According to a recent Science News article, Health and Human Services and the CDC are already working with local agencies to track the health of cleanup workers, including the short- and long-term health effects of oil spill cleanup exposures.

The pace and urgency of research in emergency and disaster settings can raise unique ethical concerns about research with human subjects. What ethical issues do you foresee arising from research with these workers? And, what lessons can we learn from past disaster research that should be considered in planning and approving Gulf oil spill studies?

ILAR announces the new Guide for the Care and Use of Laboratory Animals

Calling all IACUC staff and members, all animal researchers, and anyone else in the field of animal research...the day you’ve been waiting for is finally here!

The Institute for Laboratory Animal Research (ILAR) of the National Academy of Sciences has released a prepublication copy of the 8th Edition of the Guide for the Care and Use of Laboratory Animals (Guide), the first update since 1996.

ILAR also published a free Report in Brief, which includes an overview of the key changes in the new edition. According to the Report, the new edition “integrates recently published data, scientific principles, and expert opinion to recommend practices for the humane care and use of animals in research, testing, and teaching...Additions to this eighth edition of the Guide include expanded coverage of the ethics of laboratory animal use; components of effective Animal Care and Use Programs; and new guidelines for the housing, environment, and enrichment of terrestrial and aquatic animals, and for veterinary and clinical care.”

We’d like to hear your initial reactions to this newly revised and long awaited Guide. What updates do you see as most significant? And, for those of you working with animals on a daily basis, how do you think the updates will affect your day-to-day activities?

PRIM&R joins with NIH on survey to examine offers of payment to research subjects

PRIM&R is joining the National Institutes of Health (NIH) Clinical Center’s Department of Bioethics to investigate the diverse viewpoints regarding the ethical acceptability of payments to research subjects. Although there is anecdotal evidence about the content and nature of these viewpoints, little systematic knowledge exists. Therefore, it is hoped that this web-based survey will capture the attitudes, opinions, and experiences of individuals who conduct and oversee research regarding offers of payment.

PRIM&R and the NIH are inviting those who are interested in human subjects protections, including those who serve on or staff institutional review boards, and/or have some familiarity with the world of research to participate in the online survey. You may have already received a letter and email requesting your participation.

The Center for Survey Research (CSR) at the University of Virginia will conduct this assessment for the survey sponsors. PRIM&R and the NIH Department of Bioethics would appreciate your participation but would like you to know that participation is entirely voluntary and you do not have to answer any questions you do not wish to. All responses will be confidential. If you’d like more information about the study, please visit CSR’s website here.

White paper suggests prisoner research without consent

by Emily Butler, content coordinator

In the wake of World War II, the 1947 Doctors’ Trial caught the world’s attention in describing the atrocious experiments Nazi doctors conducted on prisoners without their consent. The subsequent Nuremberg Code outlined ten tenets of ethical human subjects experimentation, and the first principle could not be more explicit: “The voluntary consent of the human subject is absolutely essential.”

Now, more than 60 years later, the organization Physicians for Human Rights (PHR) has issued a white paper, Experiments in Torture, alleging CIA medical personnel conducted human subjects research in the “enhanced” interrogation techniques used to extract information from imprisoned terrorist suspects following the September 11, 2001 attacks.

During interrogations, the Bush administration authorized medical monitoring to ensure that the physical and emotional impact of interrogation techniques did not cross the legal threshold of torture. The report claims “health professionals working for and on behalf of the CIA monitored the interrogations of detainees, collected and analyzed the results of those interrogations, and sought to derive generalizable inferences to be applied to subsequent interrogations. Such acts may be seen as the conduct of research and experimentation by health professionals on prisoners, which could violate accepted standards of medical ethics, as well as domestic and international law. These practices could, in some cases, constitute war crimes and crimes against humanity.”

In an article describing the release of the report, The New York Times quotes CIA spokesman Paul Gimigliano as saying “The report is just wrong…The C.I.A. did not, as part of its past detention program, conduct human subjects research on any detainee or group of detainees. The entire detention effort has been the subject of multiple, comprehensive reviews within our government, including by the Department of Justice.”

The report makes several explicit recommendations, namely calling on President Obama and Congress to initiate a thorough and immediate investigation.

Time and the judicial process will tell if the medical monitoring of terrorism suspects is in fact human subjects research, and if the PHR’s claims are accurate. Did the CIA violate the first principle of the Nuremberg code, and if so, what steps need to be taken to assure ethical conduct in these situations? What are your thoughts on this report?

University of Maryland Opens Center on Health Equity

The University of Maryland, College Park, recently announced its plan to open the Maryland Center on Health Equity with the help of five new faculty members from the School of Public Health.

The faculty members are the University of Pittsburgh’s Drs. Stephen Thomas, Sandra Crouse Quinn, James Butler, Craig Fryer and Mary Garza. These experts will build upon the school’s ongoing effort to bring equal opportunities for healthy living to all residents of the surrounding area.

Dr. Thomas, who delivered a keynote address at the 2008 Advancing Ethical Research Conference, will serve as the center’s director. “Our challenge and mission is to find new ways to bring the fruits of health care reform to the underserved, poorly served and never served segments of our community,” he said.

Because the issue of equal access to healthy living extends beyond the borders of Maryland, the center may evolve into a model for others like it, far outside of the community of which Dr. Thomas speaks.

PRIM&R is also proud to support the University of Pittsburgh in its commitment to improving the recruitment and retention of minorities in research on a separate but related program, Building Trust Between Minorities and Researchers: A National Bioethics Infrastructure Initiative.

With the help of a two-year grant from the NIH National Center on Minority Health and Health Disparities and Office of the Director at NIH as part of the American Reinvestment and Recovery Act (ARRA), PRIM&R and the University of Pittsburgh are planning a series of educational opportunities that aim to address the challenge of public health disparities among minority populations, including the Distrust, Race, and Research: Overcoming Barriers to Recruitment and Retention of Minority Populations webinar on July 14.

You can read more about the Center on Health Equity here, or watch a video clip from the unveiling ceremony at The Healthy Turtle here.

New vaccine prevents breast cancer tumor growth in mice

by Julie Herman, website and social media coordinator, and Emily Butler, content coordinator

Scientists claim a new vaccine currently in mice trials could potentially eliminate breast cancer in women. An article in yesterday’s Business Week explains that a vaccine was able to prevent tumor growth in a population of mice genetically engineered to be at a high risk of developing the disease.

"We could eliminate breast cancer," say the study’s authors, who are based at the Cleveland Clinic's Lerner Research Institute, "if [the vaccine] works in humans the way it works in mice." The authors also added that women may be able to take part in the research as soon as next year.

Women at high risk for breast cancer will no doubt be eager to enroll in the trials, but pioneering steps in medicine require careful consideration of possible new risks for human subjects.

How can investigators, IRBs, and HRPPs be sure to account for risks that may only appear in human subjects? What are the unique ethical considerations to address in moving this vaccine to a first-in-human trial? We’re eager to hear your thoughts on this exciting development, so please share your ideas and questions here on Ampersand.