Research in times of disaster: What’s really ethical?

by Courtney Jarboe, PRIM&R Blog Squad member


PRIM&R is pleased to bring you more blog posts from the PRIM&R Blog Squad. The Blog Squad is composed of four PRIM&R members who are devoted to blogging prior to, during, and after the 2010 Advancing Ethical Research Conference.

As I mentioned in my first blog for Ampersand, I am very interested in ethical issues relating to internet research. This is one area of the 2010 Advancing Ethical Research Conference that I can’t wait to explore. However, there are other topics that I’m curious about as well, and one very important one is research and humanitarian disaster settings and war zones.

With the ongoing events in Haiti—earthquakes and aftershocks, cholera outbreaks, and hurricane Tomas, is there enough scientific importance to warrant research? Would conducting research provide benefits that could outweigh the immediate benefits of humanitarian aid? Could conducting research there result in distractions from the directive to rebuild the Haitian community, as well as their mental and physical health? Even if research is allowed, would you obtain fully informed consent from such a vulnerable population? Finally, would the researchers have the ability to conduct the research without harm or additional liability issues to themselves?

What about the Chilean mining incident? During the crisis, Chris MacDonald, PhD, Professor of Ethics at St. Mary's University, wrote a blog article on whether it would be ethical to conduct research on the miners during their entrapment. Dr. MacDonald writes:

Doctors are already monitoring (remotely) the men’s health; why not go
further and study the men, so that we can learn about the effects of prolonged
isolation on the human body and mind? Consent forms could be sent down (and back
up) the newly-drilled access tube. Would doing so be ethical? Informed consent
is certainly possible, but would it be legit? Do trapped miners count as a
"vulnerable population," in the same sense as prisoners and children and people
in mental health institutions?

I’m not sure if research was allowed, but it seems that since the main directive was to rescue the miners, there would not yet be a focus on studying the effects of isolation on the human mind. There are, however, several ethical issues at hand should researchers move forward now. For example, if a researcher wanted to have direct interactions with these men, what measures would have to be in place to protect the men from serious risks of psychological damage (if that is not already occurring)? How could a researcher obtain the miners’ fully informed consent knowing that they’ve been surged with requests from media outlets for interviews, movies, and novels? What should be released in terms of the data (i.e. video and health data) that was gathered during the crisis? And, perhaps most importantly, how could any researcher protect the privacy and confidentiality of the 33 men whose names and general health are already posted all over the internet?

While most of the research I see at my institution is fairly minimal risk, I do see occasional ideas for "after-the-fact" research on environmental disasters or war zones. One of the issues I’ve come across is that of safeguards. What is considered additional versus standard safeguards? For example, is it adequate to provide a data monitoring board and counseling services for participants? Can a researcher get by with conducting survey-based research rather than face-to-face research? Is that as risky, or worse? In addition, while the institutional review board (IRB) is solely charged with protecting the rights and welfare of human participants, who is to safeguard the researcher? What if a researcher is conducting interviews with participants who have experienced devastating catastrophes, or actually is conducting research during these catastrophic events, and there are potential impacts to the health of that researcher?

I’m hoping to take what I learn at AER back to Capella University’s IRB, to provide the IRB members and human research protections program (HRPP) staff with resources, as well as inspiring ideas about some of the ongoing issues with this type of research.

PRIM&R joins the University of Illinois at Urbana-Champaign to create a national center for professional and research ethics

PRIM&R is thrilled to announce that we will be working with the University of Illinois at Urbana-Champaign (UIUC) on a multi-year project designed to make ethics information and training resources readily accessible to those working in the fields of science and engineering. This five-year, $5 million grant was awarded to UIUC by the National Science Foundation (NSF).

The online center, which will be called the National Center for Professional and Research Ethics, will develop, gather, preserve, and provide comprehensive access to resources related to ethics for teachers, students, researchers, administrators, and other audiences. As such, it will provide information and expertise for several populations, including:

• instructors who teach ethics,
• students with questions about research integrity,
• researchers and engineers who encounter ethical challenges in practice, administrators in universities and businesses who oversee ethics and compliance policies,
• scholars who conduct research on professional and research ethics, and
• others with questions or interests in these areas.

"Almost everybody wakes up every day and wants to do the right thing," said Center director C. K. Gunsalus, Coordinated Science Laboratory research professor and professor of business at the University of Illinois at Urbana-Champaign, as well as longtime friend of PRIM&R. "Many people who face ethical dilemmas know the general principles but not necessarily how to apply them in the complexity that real-life professional and research practice present. The Center seeks to create an online environment that encourages the life-long development of ethical practices through materials and interaction with other professionals."

PRIM&R’s role will be small but, we hope, significant, as we will be involved in the development and coordination of human and animal research ethics resources. The planning process has just begun, and we look forward to sharing more details here soon as we begin working on the project. We also look forward to hear more from our community about what resources are missing from the current "cupboard," so that we can more responsively fill the void.

PRIM&R’s executive director, Joan Rachlin, is thilled about our involvement in this project and believes that it will provide a unique opportunity to connect the many ethical and educational threads that already exist, and to at the same time identify and integrate new ones.

PRIM&R is proud to be a member of this team, and we look forward to the development of this exciting Center.

Read more about the grant award in the NSF press release.

'Science Times' synthesis

No time to read the New York Times? No worries! We continue to devour the Tuesday NYT science section at PRIM&R, and are pleased to bring you our bi-monthly blog devoted to a digest of those articles we consider relevant and useful to our community. Enjoy!

November 9, 2010

For edge on Alzheimer’s, testing early treatments: Some Alzheimer’s research will be focusing on earlier stages of what happens to patients’ brains.

Glimpsing a scientific feature as fields heat up: A columnist describes the excitement surrounding unpredictable scientific discoveries.

Behavior: Too much texting is linked to other problems: A study suggests that teens who text are more likely to participate in other risky behaviors.

Genes as mirrors of life experience: How might people’s experience and environment affect the function of their genes?

November 16, 2010

When the mind wanders, happiness also strays: A study examines how focusing may make you happier than letting your mind wander.

MRIs help fight high risk of cancer: Yearly MRIs may help save lives.

Study ties ovarian cancer and hormone therapy: A newly released European study reports that women who take hormones are at significantly increased risk for ovarian cancer, which is rare, but often fatal.

50 years of chimpanzees: An interview with Jane Goodall reviews the past 50 years of her productive and prolific career.

And, in the "little known facts" category, did you know that Joan Rachlin, PRIM&R’s executive director, was one of Grub van Lawick’s (Jane Goodall’s son) pre-school teachers? In a former life, Joan taught at the Bing Nursery School, the lab school at Stanford University, and Grub was a student there while Jane was a visiting professor.

Joan reports that Grub was smart, curious, sweet, and that his play resembled that of the chimps (such as running to trees, hugging them, and looking around from behind the trunks to see who was out there). This was no surprise, though, since he had been raised in Gombe with the chimps, and Bing was his first introduction to school.

Good news and bad from a heart study: A study concerning a heart failure drug yields both positive and negative results.

And even though it’s not really related to research, who can resist an article about serving as the president’s physician? Surely not us!

How much is "just right"? Informed consent and the Goldilocks dilemma

by Sylvia Baedorf Kassis, MPH, PRIM&R Blog Squad member

PRIM&R is pleased to bring you more blog posts from the PRIM&R Blog Squad. The Blog Squad is composed of four PRIM&R members who are devoted to blogging prior to, during, and after the 2010 Advancing Ethical Research Conference.

One of the issues that I have been grappling with more and more these days is the notion of informed consent for tissue banking. The informed consent process itself can be somewhat nebulous—what does it mean to explain a study, and all its consequences, to someone who is considering participating? How can researchers ensure processes are in place to foster comprehension of the procedures that participants will be asked to undergo? Most importantly, what might be the potential risks and consequences, and what alternatives exist outside the research realm?

This process can be difficult enough for a "simple" survey study or a "basic" clinical trial, where the procedures are already defined and there is an isolated question to be answered. What if a researcher wants to bank samples in a repository for use in future research studies? What does this really mean to research participants? And how can we, as regulatory and ethical professionals, better advise researchers on the language that should be used in consent forms and infused into the consent process?

To me, it seems like Goldilocks’ dilemma. If the consent language is too specific, future research on the banked samples might be limited. If the language is too broad, the participants may not really be able to appreciate the implications of storing their samples for future research uses. Even though those future uses may secure IRB approval, does that mean the participants would have consented? Consider the obvious example of the plight of the Havasupai, and how the tribe’s stored biological samples were used in ways that, despite IRB approval, betrayed their understanding of the research. So, just like Goldilocks, we’re unsure how we can get informed consent for future use of samples "juuuust right!"

I’m excited to attend the 2010 AER conference to find answers to questions like these. While in past years I have covered a veritable smorgasbord of topics, this time my focus is specifically on tissue banking. Starting with the Advanced Tissue Banking pre-conference program, and following up with various related sessions at the conference, I hope to gain the knowledge to address the recurring key issues when advising researchers at my institution on storing research samples for future uses.

The Havasupai case has been so interesting because it has, once again, brought to the foreground the principle of respect in research. Respect is at the heart of ethical research. Even if research on stored samples is IRB-approved, it does not necessarily follow that the research participants who originally provided the samples would agree to that use if they were to be asked. In our day-to-day efforts to review and approve human research studies, I believe this is an important lesson to remember.

Medical marijuana, the FDA, and the voting public

by Wendy Tate, PSM, CIP, PRIM&R Blog Squad member

PRIM&R is pleased to bring you more blog posts from the PRIM&R Blog Squad. The Blog Squad is composed of four PRIM&R members who are devoted to blogging prior to, live from and after the 2010 Advancing Ethical Research Conference.

So, medical marijuana is on the ballot in Arizona…again. For my non-Arizona resident friends out there, this is the fourth time in the last 14 years that the issue has been sent to the voters. To date, a statewide proposition has passed twice but was never enacted, failed once, and now, is pending a final decision. Ten days post-election, Proposition 203, the 2010 measure, is still too close to call. According to this article from the Arizona Daily Star, out of 1.6 million ballots, the measure is failing by 3,500 votes with 89,000 ballots yet to be counted.

Any use of marijuana is prohibited under federal law. In 1996, California was the first state to pass a law allowing the use of marijuana for medicinal purposes. Since then, medical marijuana use has been approved in a total of 14 states plus the District of Columbia, either through ballot measures or legislative bills.

Marijuana is not a stranger to the Food and Drug Administration (FDA) regulations. Cannabis, the marijuana plant, is listed in the FDA poisonous plant database. It is also classified as an opiate under the Controlled Substance Act (21 CFR 13).

However, marijuana is not exempt from being an FDA approved drug. Classification as a controlled substance does not imply the presence or absence of medical benefit. In fact, 21 CFR 13.801(1) states, “Many of the drugs included within this subchapter have a useful and legitimate medical purpose and are necessary to maintain the health and general welfare of the American people.” Permits and licenses can be obtained to conduct research with controlled substances. To apply for approval of a controlled substance to be prescribed as a drug, there are several investigational new drug (IND) and institutional review board (IRB) requirements that apply.

This discussion naturally leads to the question, “Why hasn’t marijuana gone through the FDA drug approval process?” One reason may be that marijuana is not a profitable drug. As a plant, marijuana cannot be patented. Since the research and development process to get a drug through the approval process can cost millions of dollars, marijuana may be too much of a risk for a company to undertake.

There has, however, been some research done on the clinical effects of marijuana. In a brief PubMed search, more than 100 articles on randomized controlled trials came up regarding the use of cannabis for pain (some support the claim that marijuana helps control pain, some do not; however, my evaluation of the efficacy is not the point of this article).

To recap, we have the regulatory structure to approve a controlled substance as a drug, clinical research papers on the effects of medical marijuana, and public interest in the legalization of marijuana for medicinal use. But what is the FDA’s stance on the matter? In a memorandum dated April 20, 2006, the FDA issued an official opinion regarding the use of marijuana for medicinal purposes. In it, the FDA states:

“A past evaluation by several Department of Health and Human Services (HHS)
agencies, including the Food and Drug Administration (FDA), Substance Abuse and
Mental Health Services Administration (SAMHSA) and National Institute for Drug
Abuse (NIDA), concluded that no sound scientific studies supported medical use
of marijuana for treatment in the United States, and no animal or human data
supported the safety or efficacy of marijuana for general medical use. There are
alternative FDA-approved medications in existence for treatment of many of the
proposed uses of smoked marijuana.”

The issue of medical marijuana is a politically charged platform that hits a personal note with many people. Nobody wants to see another human being, especially a loved one, suffer. The area of pain management is progressing, but the number of diseases that cause chronic pain seems to be overshadowing any accomplishments.

While many voters are highly educated, knowledgeable about current events, and potentially involved in the fields of medicine and/or science, politics should not supersede the FDA review process. Instead of using the polls to undermine the safety review process that past atrocities have helped define, voters can use the political process to better support funding research studies in areas of public interest, and giving the necessary infrastructure to the FDA to review data in an expeditious manner.

Featured Member Profile: Sharon Post

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 Sharon Post, chief compliance officer at St. Jude Children’s Research Hospital in Memphis, TN.

When and why did you join the field?
I began a compliance career 20 years ago. In 2001, my career began to include research compliance and consideration of human subjects.

What is your favorite part of your job?
Finding solutions when issues arise, i.e. helping researchers do their jobs compliantly.

What's playing on your iPod?
Johann Sebastian Bach, Goldberg Variations

What is the last movie you saw?
Alice in Wonderland

What’s for dinner tonight?
Leftovers.

What are you reading?
Re-reading Victor Hugo’s Les Miserables

What are three websites you visit on a daily basis?
Bestcrosswords.com, AOL.mail, and, of course, stjude.org.

Why did you join PRIM&R?
I joined for educational opportunities, networking, and inspiration.

What is your favorite member benefit?
The Advancing Ethical Research Conference is the ultimate benefit.

What would you say to someone who is considering PRIM&R membership?
Don’t hesitate.

If you were planning our next conference, who would you select as a keynote speaker?
George Q. Daley, M.D.

What motivates you to maintain your commitment to advancing ethical research?
I don’t need motivation to maintain my commitment to ethical research ethical—it’s a personal mission.

What advice do you have for young professionals interested in pursuing a career in ethical research?
Always remember that the goal of science and research is the betterment of man, but that the ends do not justify the means.

Thank you for being part of the membership community and sharing your story, Sharon. Enjoy the leftovers!

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

Meet the PRIM&R Blog Squad: Courtney Jarboe

PRIM&R is pleased to introduce the members of the inaugural Blog Squad at this year’s 2010 Advancing Ethical Research Conference. The Blog Squad is composed of four PRIM&R members who are devoted to blogging live from the conference.

We are proud to introduce you to the final of our four Blog Squad members, Courtney Jarboe, CIP.

Greetings from Minneapolis, Minnesota! My name is Courtney Jarboe, and I am the IRB administrator and IRB office supervisor for Capella University’s Institutional Review Board (IRB). I’ve been with Capella’s IRB, which reviews social behavioral student research, for about three years. I conduct exempt and continuing reviews, provide support to researchers and research supervisors, as well as manage and support the daily functions of the IRB office and committee. What is truly unique about our university is that our interactions with most of the research community are online or through the phone.

I’m glad to share that I recently received my CIP® (Certified IRB Professional) certification this fall. It is quite exciting to receive the certification letter in the mail after hours and hours of preparation! What I’ve enjoyed most about my position as an IRB administrator is educating novice researchers not only about the IRB application process but more importantly, what the IRB stands for outside of the acronym.

I’ve always been passionate about research ethics. During my undergraduate years, we were all asked to participate in psychology research studies. Some thought this might be a bit boring and merely for extra credit purposes, but I always enjoyed the opportunity to assist fellow students in their practice of conducting a research study. Researchers have to find results somehow, right?! Since the undergraduate years, I’ve participated in many research studies and have found that being a participant, and an IRB administrator, can be quite interesting to say the least!

Outside of the IRB, I balance two children, a husband, a house, and my other fancy, literature. Currently, I’m combining my two passions of reading and research ethics by focusing on authors from the 1790s such as William Godwin, Mary Wollstonecraft, and Mary Hays. Their general focus was on the humane treatment of men and women during the French Revolution. I’m really enjoying seeing how many of these principles we stand by today.

To me, a most important part of our field is in collaborating with other institutions and sharing ideas and resources. I have always wanted to attend PRIM&R’s annual Advancing Ethical Research Conference and will finally get to go this year as a member of the AER Blog Squad.

Come December, I am most interested in attending sessions surrounding internet research and qualitative research. The first on my list is one of the pre-conference sessions, Navigating Research Regulations and Research Ethics in the Internet-Age. Our institution sees quite a few protocols that are internet-based, like surveys and forums. While we think we have a handle on some best practices, we still struggle with key issues. What is the appropriate informed consent process? What does data ownership mean? How can we minimize risks, while maintaining privacy and confidentiality? There have been several articles on the topic, but having a live discussion will help us truly answer these questions, and work out grey areas, such as “Second Life”-based research. I think most institutions are still trying to grapple with the ethics of technology. More importantly, I’m curious to see how research will impact the general use of the internet and I can’t wait to bring back what I learn from AER to begin to solve these puzzles.

Amazon Selects AER Keynoter’s Book as Best in 2010

Based on Amazon’s unanimous decision, The Immortal Life of Henrietta Lacks has won the top spot on their “Best Books of 2010” list.

Written by PRIM&R’s 2010 Advancing Ethical Research Conference keynote speaker Rebecca Skloot, this work explores the life of a woman named Henrietta Lacks, who died of cervical cancer, but whose cells live on. A sample of Lacks' tissue was taken without her knowledge or consent, as was standard at the time, and still thrives in labs today. Skloot's book raises many ethical questions about the use and ownership of tissues in research.

PRIM&R congratulates Ms. Skloot for this honor, and reminds everyone that there’s still time to join us in San Diego this December, where Ms. Skloot will sign books and host a Research Ethics Book Group Lunch. Space is limited, so please visit our website to learn more.

Meet the Blog Squad: Sylvia Baedorf Kassis

PRIM&R is pleased to introduce the members of the inaugural Blog Squad at this year’s 2010 Advancing Ethical Research Conference. The Blog Squad is composed of four PRIM&R members who are devoted to blogging live from the conference.

We are proud to introduce you to the next of our four Blog Squad members, Sylvia Baedorf Kassis, MPH.

When I first started attending AER in 2005, I was very green, not only to the conference, but to the entire field of research ethics. Having just started as an IRB analyst, and despite having worked as a clinical research coordinator for five years before that, it was shocking to me just how little I really knew (and understood) about the regulations and policies governing human subjects research.

As a coordinator, I knew what was required based on human subjects protections training and workshops about the proper conduct of research. However, it was only as a result of my attending AER that I gained an appreciation for the scope of ethical deliberation and decision-making that applies to every single research study.

Over the years I gradually gained more confidence in my regulatory and ethical expertise, first in reviewing protocols for the IRB, and now in my current position managing a clinical research education program for clinical investigators and their study teams. I find it most rewarding when, in explaining the application of some previously foreign or nebulous regulation, I get to witness the click of comprehension as the relevance to their research becomes apparent. Advancing ethical research is all about making research ethics accessible in an environment where protections can be viewed as a limitation to progress, and that’s why I enjoy the AER conference so much. It is, simply put, relevant.

And so, here I am again, five years after attending my inaugural AER. Now, I’m a member of the inaugural PRIM&R Blog Squad, more firmly planted in my career in research ethics and regulatory education, definitely more knowledgeable, but still humbled by the realization that there is always so much more to learn… and I can’t wait!

Let me leave you with my “top five” list of things that I am looking forward to at the 2010 AER Conference.

1. Networking with so many like-minded individuals who care about the principles of ethical research.
2. All the great information I’ll be able to share with the investigators at my institution.
3. That super-cool pre-conference program on tissue banking.
4. The Great Debate featuring Leonard Glantz.
5. Sunny San Diego in December!

See you in California!

'Science Times' synthesis

No time to read the New York Times? No worries! We love the Tuesday NYT science section at PRIM&R, and thus, have begun to post a bi-monthly blog devoted to a digest of those articles that we consider relevant and useful to our community. Enjoy!

October 26, 2010

They fetch, they roll over, they aid tumor research: Read about a collaboration between a neurosurgeon and some veterinarians that’s leading to successful brain tumor treatments.

Approach may matter in advice on weight: Learn that a new study suggests that the approach in giving advice about someone’s weight may make a great difference in results.

Encased in amber, a trove of new species: Find out about an amber excavation in western India that led to the uncovering of more than 700 ancient insects, arachnids and crustaceans.

November 2, 2010

Seeing the natural world with a physicist’s lens: Explore research focusing on why and how the human vision system works.

At the age of peekaboo, in therapy to fight autism: Learn about studies that are part of an effort by a network of scientists across North America to look for signs of autism in children as young as 6 months.

It costs how much? My brain says otherwise: Read findings from a new study that indicates that skilled negotiators are using extra brainpower for their talents.

For youths, depression often has a sequel: Examine results from a study that show depression recurs in about half of adolescents who have recovered from the disorder.

Meet the PRIM&R Blog Squad: Wendy Tate

PRIM&R is pleased to introduce the members of the inaugural Blog Squad at this year’s 2010 Advancing Ethical Research Conference. The Blog Squad is composed of four PRIM&R members who are devoted to blogging live from the conference.

We are proud to introduce you to the second of the four Blog Squad members, Wendy Tate, PSM, CIP®.

I really dislike starting introductions with “Hello, my name is Wendy Tate.” It feels generic and impersonal. So, my name is above, and here’s my real story.

I am the assistant director, process improvement and compliance for the University of Arizona (UA) human subjects protection program in Tucson, AZ. You should know that I am a diehard Wildcat (even before we had a nationally ranked football team, and after our nationally ranked basketball team tanked). I received both my bachelor’s and master’s degrees in molecular and cellular biology and applied biosciences, respectively, from the University of Arizona. I started working at UA as an undergraduate student and continue to do so. I have worked specifically in human subjects regulations for more than four years now, and I love it. At the risk of sounding cheesy, I truly feel I have found my occupational passion.

What else do you want to know? Here are some facts that I’d like to share:

PRIM&R member status: Of course I’m a member (and have been since 2008)!
Family: I have a husband and three young kids.
Hobbies: I enjoy camping, hiking, running, yoga, and reading science books. (I don’t do fiction.)
Favorite book of 2010: The Immortal Life of Henrietta Lacks (required reading for all human subjects professionals, in my honest opinion)
Favorite regulation: I got you! Did you really think I would have only one favorite? They’re all awesome!
Favorite TV show(s): How I Met Your Mother and The Big Bang Theory
Random fact: I have never lived further than 30 miles from where I was born.

This will be my third time attending AER. I attended in 2006, in Washington DC, after being in human subject protections for only four months. It was an overwhelming and exciting experience filled with knowledge I took the IRB 101sm pre-conference program, and was enamored by meeting the faculty that I had only read about before. It wasn’t until 2009 that I was able to attend the conference again, this time in Nashville, and it was so invigorating to have a similar experience.

I attend AER to network and expand my knowledge base; but also, I attend because I think the best way to protect human subjects and grow an ethical research program at my home institution is to see what others are doing, be challenged to think outside the box, and brainstorm new ideas. It is so easy to believe that your institution is the only one facing issues with researchers, sponsors, and ethics, and that there is only one way to solve the issue. The AER Conference is a great place to meet others and to remember that no matter where you are in the world, you are probably experiencing the same ethical, regulatory, and efficacy issues as others. You will make some good friends and solve a problem or two at the same time.

As my staff will tell you (and probably my family too), once you get me talking about regulations and bioethics, it takes awhile to quiet me down. I love a good debate, and will take on any topic. That is why I applied for the Blog Squad. I want to relay the enthusiasm and depth of knowledge that AER provides to others, and maybe even start a debate. I hope you enjoy this journey as much as I do, and I look forward to discussing all the happenings with you before, during, and after the conference.