Understanding the greased and malleable nature of online and social media research

by Alexandra Shlimovich, Online Learning and Certification Coordinator

On March 12, 2013, PRIM&R hosted a webinar titled Online Research, Social Media, and the IRB: Assessing Ethics, Norms, and Risks. The presenters, Elizabeth Buchanan, PhD, and Joseph Konstan, PhD, answered many questions from the attendees during the lively question and answer period following this program. After the conclusion of the webinar, we asked Elizabeth and Joe to consider the remaining questions, and I’m pleased to share their answers with you today.

AS: Can you clarify what a crowdsourced dataset is, and provide examples, if possible? 
EB & JK: Crowdsourcing is defined as "the practice of obtaining needed services, ideas, or content by soliciting contributions from a large group of people, and especially from an online community, rather than from traditional employees or suppliers." It has been used in an array of research activities and one of the most well-known is the Mechanical Turk Workforce, which is a “marketplace for work that requires human intelligence.”

Specific concerns for institutional review boards (IRBs) include considerations of identification of workers' privacy (usernames can be easily correlated with the individual's Amazon account, among other things), incentives/payment to individuals (a typical payment is under $1.00), legal eligibility for participating in research activities, and jurisdictional issues.

Many examples of crowdsourced projects are listed here; some of these are not datasets but crowdsourced activities. In addition, the literature is full of fascinating discussion on crowdsourcing. Just a few examples include:

• Crowd-sourced data hold potential for positive change and human rights abuses (Scientific American)
• The Roar of the Crowd (The Economist)
• Crowdsourced Health Research Studies: An Important Emerging Complement to Clinical Trials in the Public Health Research Ecosystem (Journal of Medical Internet Research)

AS: What is the overarching approach to recruitment via research-specific Facebook pages or Twitter accounts? Is this generally allowed and what are the stipulations? 
EB & JK: The Office of Human Research Protections (OHRP) considers subject recruitment part of informed consent; therefore, the recruitment plan must receive IRB review and approval prior to initiation. Many types of social media are used for recruitment, including: Twitter feeds, blog posts, YouTube videos, robocalls, and text messages. In terms of clinical trials website recruitment, OHRP offers the following guidance.

No IRB review is needed for descriptive information, such as:

• study title; 
• purpose of the study; 
• protocol summary; 
• basic eligibility criteria; 
• study site location(s); or 
• how to contact the study site for further information. 

IRB review is needed if additional information is provided, such as:

• description of research risks/potential benefits; 
• solicitation of identifiable private information (e.g. eligibility survey); and
• incentives – monetary and non-monetary. 

The IRB will review the recruitment plan, but not the actual web page. However, screen shots of the web pages may be helpful to the IRB, so it is good practice for researchers to provide them along with information from the forum or site that explains the "rules" or "practices" for recruiting participants and conducting research on the site. These are often found in FAQs or use/user agreements. In addition, the nature of social media could generate additional risks when they are used for recruitment, as individuals' social media profiles may reveal that an individual visited a recruitment site. This is what we mean by the "greased and malleable" nature of social media data, specifically, if recruitment methods can identify individuals, researchers must consider potential harms downstream, and whether such risks are minimized.

AS: Can you suggest any "rules of conduct" or other resources  that an IRB can make available to researchers interested in conducting internet research? 
EB & JK: Some resources include:

• Association of Internet Researchers Ethics Guide
• University of Wisconsin – Stout IRB/HRPP Guidelines
• SACHRP meeting, March 2013 - Considerations and Recommendations Concerning Internet Research and Human Subjects Research Regulations
• Stanford Encyclopedia of Philosophy Internet Research Ethics

You may review the complete question and answer session here. If you’re interested in learning more about this topic, but did not have a chance to participate in last week’s webinar, the archive is available for purchase.

Can an ethical framework for conducting animal research be modeled after the existing framework for conducting human research?

by Amy Davis , Senior Director for Programs and Publications

During the final series of breakout sessions at the 2013 IACUC Conference there was a discussion of the Implementation of the Institute of Medicine (IOM) Report on the Use of Chimpanzees in Biomedical and Behavioral Research. Hope Ferdowsian, MD, MPH, moderated the discussion which featured Tom Beauchamp, PhD; Margaret Landi, VMD, MS, DACLAM; and David Wendler, MA, PhD.

Dr. Landi set the stage by presenting a summary of the 2011 IOM report, explaining that the committee’s charge was to develop a report on whether and under what circumstances it was necessary to use chimpanzees in either biomedical or behavioral research. (For more information, view the report here.)

For biomedical research, research with chimpanzees is justified only when the following conditions are met:

1. There is no other suitable model available, such as in vitro, nonhuman in vivo, or other models, for the research in question, and
2. The research in question cannot be performed ethically on human subjects, and
3. Forgoing the use of chimpanzees for the research in question will significantly slow or prevent important advancements to prevent, control and/or treat life-threatening or debilitating conditions.

The use of chimpanzees for behavioral research is justified only when:

1. Studies provide otherwise unattainable insight into comparative genomics, normal and abnormal behavior, mental health, emotion, or cognition, and
2. All experiments are performed on acquiescent animals, in a manner that minimizes pain and distress, and is minimally invasive.

Applying these criteria to current practices, the IOM Committee concluded in 2011 that while the chimpanzee has been a valuable model in the past, there is decreasing need for such studies given the increasing availability of alternative models and technologies.

Dr. Beauchamp continued the discussion by pointing out the challenges of developing a report under the conditions established by the National Institutes of Health for the project, which included the single animal model and the instruction not to consider the ethical issues. In spite of these limitations, the IOM Committee succeeded in producing a significant report that changes the landscape of chimp research by establishing comparatively restrictive criteria for justifying such research. As an example, he pointed out the criterion that limits behavioral research to “acquiescent” animals, establishing a relatively high level of respect for the chimpanzee.

Dr. Beauchamp criticized the IOM report’s lack of consideration of the “moral costs” of using chimpanzees in research. He sees a need for a new standard defining a pain threshold. Given the increasing difficulty to justify such research, Dr. Beauchamp predicts its imminent cessation.

Dr. Wendler focused on the question of whether an ethical framework for conducting animal research could be modeled after the existing framework for conducting human research. He presented three areas of inquiry for analyzing the question:  research value, level of risk, and assent/dissent.

1. Research value: Human subjects research is justified only when the risks are reasonable in relation to the potential benefits. Most research using chimpanzees is solely for the benefit of humans, not chimpanzees. Dr. Wendler asked whether we can justify non-beneficial research on sentient beings, particularly ones who cannot consent to such research? The IOM principles are relevant to the question of research value in that they limit research with chimpanzees to studies necessary for advancing a public health goal that could not be otherwise accomplished. The question remains, however, whether such research should be further limited by requiring potential benefit for the animal subjects.


2. Level of risk: Dr. Wendler asked whether animal research ethics framework should include a risk threshold. Under the human research regulations risk is measured against a comparator. Are the risks of the research greater or less than those of daily life activities?  Dr. Wendler presented the standards for permissible research involving children as a useful model for research involving chimpanzees given the comparably limited capacity to consent to such research. For research involving children, federal regulations present different requirements for potential benefit depending on the level of risk to the child subjects. Dr. Wendler wondered whether this framework could be adapted to some extent to animal research by establishing a range of “burden” levels based on potential for pain and suffering. In general, observational studies would be considered minimally burdensome, while some pain and suffering would be considered moderately burdensome, and prolonged pain, suffering would be considered highly burdensome.  Each level would require increasing potential for benefit.


3. Assent/Dissent: Finally, Dr. Wendler examined the applicability of the assent requirement in research with children to research with animals. With children and other populations who do not have the capacity to consent, researchers consider the preferences of potential subjects. The IOM report referred to “acquiescence” as a requirement for behavioral research with chimpanzees. Is acquiescence too passive a standard? Should there be an effort to assess “assent?” Should researchers consider the animals’ expression of dissent as they would in a child? And then where do you draw the line for this requirement? While it might be possible to discern assent in a chimp, it may not be for a rabbit, for example. 

Given advances in technology and the decreasing need for certain animal models, is now the time to develop an ethical framework for conducting all animal research? What do you think? Please share your opinions below.

Research Ethics Roundup: The latest on participant-led research, reporting standards, and much more!

Spring is finally here, and with it comes a new edition of the Research Ethics Roundup! Before you head out to the garden this weekend, take a moment to review these articles from the world of research ethics. From an appeal for stricter reporting standards worldwide, to a discussion of oversight in participant-led research, this bouquet of recent headlines is sure to brighten up your day!

Ethics panel sets high bar for anthrax vaccine research in children: The Presidential Commission for the Study of Bioethical Issues has established a set of restrictive guidelines for testing the anthrax vaccine on children. Experts argue that because the threat of an anthrax attack is theoretical rather than real, research should be performed only if it poses no more than a minor increase over minimal risk. There is no consensus yet on whether these guidelines will prevent this type of research from happening in the future.|

Ethical oversight necessary for participant-led research: This blog post from FierceHealthIT summarizes the findings of a recent study of research conducted through the use of online social networks. “Crowd sourced” or “participant-led” research raises some interesting ethical questions relating to regulation and oversight. As Jeffrey Kahn of Johns Hopkins said, the internet “should not be turned into the Wild West of health research; rather, its unique features must be used to effectively and creatively satisfy the ethical requirements of the research consent process."

Fight for clinical data 'needs to go global': This blog post from Nature reports on a current debate in the UK over how to improve the public image of medical research, without discouraging clinical research from being conducted in Europe. Many argue that strict enforcement of reporting standards must be conducted at a global level to be effective.

Doubts about Johns Hopkins research have gone unanswered, scientist says: When Daniel Yuan, a medical doctor and statistician, raised concerns about the methods involved in a particular research study, he encountered significant resistance from the research institution, the publishing journal, as well as the federal funding agency. This article documents the subsequent events which led to Yuan’s dismissal from his post, and the apparent suicide of the lead investigator.

Can animal rights activists and research advocates engage in productive dialogue?

by Elisa Hurley, PhD, Education Director

Although some might argue that I’m biased, one of the things that I think is most special about PRIM&R as an organization is its desire always to acknowledge and respect the incredibly rich and varied history of the research ethics field.

PRIM&R’s conviction that honoring the field’s past is crucial to the field’s future was evident yesterday, when Andrew N. Rowan, PhD, chief scientific officer of the Human Society of the United States (HSUS) and President and CEO of the Humane Society International, delivered the Henry Spira Memorial Lecture at PRIM&R’s 2013 IACUC Conference in Baltimore, Maryland.

Titled A Beacon for Constructive Engagement and Disagreement in a Contentious World: What is the Dispute about Animal Research Really About? Dr. Rowan’s remarks began on a personal note with some warm reminiscing about, and a charming photograph of, his friend Henry Spira.  As many know, Henry Spira was a passionate animal rights activist, perhaps best known for leading a 12-month protest of a cat lab at the Museum of Natural History in 1976; as a result, the lab was shut down, a seminal event in the animal rights movement.

Dr. Rowan laid out Mr. Spira’s general prescription for a successful animal rights campaign, which included a number of precepts such as understanding public attitudes, setting achievable goals, changing behavior—not just awareness, not dividing the world into saints and sinners, and creating opportunities for dialogue with those on the other side.

Those who know Dr. Rowan and his professional history will recognize the influence on him of this last tenet. In 1983, Dr. Rowan and PRIM&R’s executive director Joan Rachlin launched the IACUC Conference to provide a forum for productive dialogue between the scientific research advocacy and animal research communities. Yet, Dr. Rowan expressed his disappointment that, three decades later, there hasn’t been more such dialogue, at least in the United States. In fact, he suggested that the US approach, unlike the approach in Europe, Canada, Australia, or New Zealand, has been mostly characterized by confrontation, rather than conversation.

Nevertheless, Dr. Rowan’s core conviction remains that the research community and animal activists need to engage in such discussion and, more specifically, that the activist community has useful things to contribute. The rest of his talk seemed to suggest two things that the animal activist community can contribute to a productive discussion about the use of animals in research. The first is providing evidence to counterbalance the often unsubstantiated claims about the value of animal research that come out of research advocacy groups and get picked up, wholesale, by the media.  For example, Dr. Rowan cited evidence suggesting that animal models are predictive of human toxicities only about 70% of the time.

The second contribution that animal activists may make is to find and advocate for replacement opportunities, opportunities which are currently exploding, with the emergence of new, high-throughput technologies such as gene sequencing, stem cells, and systems biology. 

As I listened to Dr. Rowan’s eloquent remarks, I couldn’t help wondering whether his disappointment in the state of dialogue between animal activists and research advocates is overstated.  As he himself noted, lab animal use has decreased by 50% after its peak in the 1970s.  And there is no question—indeed, I heard it several times today, from research advocates, amongst others—that everyone, no matter which “side” they are on, would like to see the end of the use of animals in research.

What do you think?  Do you believe that we have a culture of confrontation, rather than of conversation, when it comes to differences of views about the use of animals in research?  If so, what strategies for change might you suggest?

MJ Shepherd: Honoring an exemplary PRIM&R member for her contributions to animal care and use

by Ali Hall, Education Assistant

Yesterday, PRIM&R had the honor to present the 2012 Distinguished Service Award (DSA) to Mary Jo “MJ” Shepherd, DVM, CPIA, at the 2013 IACUC Conference in Baltimore, MD. She graciously accepted this award, which recognized her dedication and unique contributions to the field of research ethics.

Another leader in the field and PRIM&R’s 1999 DSA recipient, Molly Greene, presented the DSA to Dr. Shepherd. In doing so, Ms. Greene shared a few of the countless statements of praise that have been submitted by Dr. Shepherd’s colleagues over the years. Her hardworking nature and dedication to the field were highlighted, as was her love of animals—a fact that is evidenced by her love of cats. To the delight of the audience, she admitted to having 16 of them at one time.

Since first becoming involved in the field of laboratory animal medicine in 1988, Dr. Shepherd has served as an instructor, clinical veterinarian, attending veterinarian, IACUC member, consultant, scientist, and administrator/director of several IACUCs. In all, she has been affiliated with an impressive eleven different IACUCs, which span contract research organizations, academic institutions, and pharmaceutical companies. One colleague noted that Dr. Shepherd “was really loved by the PIs [she worked with] because she worked so hard to make the IACUC review process as painless as possible for them while assuring that [the IACUC] did a very thorough and credible job of executing [their] regulatory responsibilities.”

In addition to these accomplishments, there can be no doubt as to Dr. Shepherd’s commitment to PRIM&R. She co-chaired the IACUC Conference Planning Committee from the 2004 to 2008 and has been on the PRIM&R’s faculty or conference planning committee or both since the mid 1990s.  She is equally devoted to the certification of IACUC administrators.  As a current member of PRIM&R’s Certification Committee and as one of the founders of the Certified Professional IACUC Administrators (CPIA®) credential. Dr. Shepherd truly is a ‘driver and sustainer of the CPIA credential.’

Dr. Shepherd said she was “thrilled and humbled to be so honored” to receive the DSA and professed that all of her labors for PRIM&R have been “labors of love.”  After thanking her coworkers, fellow founding members of the CPIA credential, the PRIM&R staff, she called on all in the audience to never lose sight of what she believes to be the most important reason we are here: the animals.

Start by asking “Is it research?”

by Alexandra Shlimovich, Online Learning and Certification Coordinator

On February 28, 2013, PRIM&R hosted a webinar titled Key Decision Points: Is it Research Involving Human Subjects? It is Exempt? Is IRB Review Required? Following the webinar, I had a chance to connect with the presenters, Karen Hale, RPh, MPH, CIP, and Daniel Nelson, MSc, CIP, to discuss some of the questions that came in that they were unable to cover during the allotted time. Below, they share their perspectives on a few of the questions.

Q: Why can't I determine if a study involves "human subjects" before I determine if it is "research"?

A: From a regulatory standpoint, the definition of a “human subject” requires one to have first determined that research is being conducted.  Department of Health and Human Services (DHHS) regulations state: “Human subject means a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.” Similarly, Food and Drug Administration (FDA) regulations refer to: “An individual who is or becomes a participant in research, either as a recipient of the test article or as a control.” Both definitions require a prior determination that an individual in involved in “research” before a determination that the individual is a  “human subject.”

From a more practical standpoint, as stressed in the webinar, many activities involve human beings, but not all are research. Failure to consider these definitions in the proper order may lead to unintended or counterproductive consequences. For example, if webinar participants who responded to polling questions or a course evaluation were considered “human subjects,” prior consent might be considered necessary for participating in the webinar.. Such a result would be illogical and serve to protect no one.

Whether you rely on regulatory or practical lines of reasoning, it simply works better to first determine that an activity is “research” before you consider the status of the humans in that activity!

Q: If professors at our institution partner with other institutions, we assume our institution is not engaged in research. Yet, how do we know that all proper review occurred at the other institution without asking to see that paperwork?

A: The first sentence is not necessarily true, if it was intended as a blanket “rule,” since engagement depends on the nature and level of involvement. Merely partnering with other institutions does not mean that your institution is not engaged (or that it is).  We would advise institutions to use the OHRP engagement guidance to determine if/when the institution is engaged in non-exempt human subjects research. When an institution is not engaged, there are no requirements to determine what reviews (if any) are occurring at a collaborating institution. However, when two or more institutions are engaged, this presents an opportunity for institutions to cooperate or streamline IRB review. Often this takes the form of an IRB authorization agreement, which should spell out the responsibility of both institutions (including sharing of “paperwork”). See also OHRP’s Terms of the Federalwide Assurance for the Protection of Human Subjects for more information.

Q: My question concerns records-based studies. We are currently engaged in a public health surveillance collaboration with the Centers for Disease Control and Prevention (CDC) to develop a data repository. This is a retrospective study and no subjects will be consented. Medical charts will be reviewed and the data will be de-identified. The data will be linked later by the CDC, but it will remain de-identified.  Is there a resource or a set of rules that are relevant to this kind of study? Ultimately, we had to start over and submit a data repository submission for review, but is there a resource available that addresses public health surveillance studies, for instance?

A: Here, we would ask some of the same questions regarding the purpose of developing the data repository to determine if the data will be collected and retained for future research purposes. If so, since medical records (the data source in this case) contain private, identifiable information, it appears that the study involves human subjects. On the other hand, if the purpose of the repository is to collect information to potentially identify and implement prevention and/or interventional strategies for public health issues, then creating the repository may not constitute research. Often, since repositories are created for multiple purposes, one of which may be research, obtaining IRB review for developing a repository provides additional flexibility for future research projects.

Note: Subsequent “secondary” uses of the data from the repository may not meet the definition of human subjects research if the data is coded or de-identified. For more information, see OHRP’s Guidance on Research Involving Coded Private Information or Biological Specimens.

In addition to these questions, Dan and Karen weighed in on a number of other challenging dilemmas facing research professionals with regard to exempt and expedited review. Take a peek at their complete question and answer session. If you’re interested in learning more about this topic, but did not have a chance to participate in last week’s webinar, the archive is available for purchase.

Professional development is a two-way street

by Royell Sullivan, IRB Education Specialist at the New York University School of Medicine

It has only been a few months since the 2012 Advancing Ethical Research (AER) Conference, but it seems as though the 2013 AER Conference is just around the corner, and I am certainly excited for what is in store.

I really enjoyed attending the 2012 AER Conference, a fact that I initially attributed to having gained more experienced as a human research protections professional since my first time attending. However, I am starting to realize that my role in interactive conference activities helped to keep me tuned in to what was going on in the world of research ethics. Take, for example, my place on the PRIM&R Blog Squad, which encouraged me to really focus in my sessions and challenged me to think critically about what I was learning. I really feel that more members of the human research protections community should look into serving on PRIM&R’s Blog Squad.

I believe that successful professional development involves effort from both the teacher and the learner. It’s great being able to attend and participate in panels and workshops, because so much is gained when discussions take place. The part I enjoy most is when people start asking questions about specific issues or situations that their institutions are facing because it gives me a chance to learn about their processes and hear about the challenges that others are facing. I might even discover a few solutions to issues I am confronting.

The annual poster presentations at the AER Conference offer a similar benefit. I like being able to hear about what does and does not work for my peers, while sharing my own experiences.

As you begin looking ahead to the 2013 AER Conference, I want to encourage you to get involved! Attend conferences whenever you can! For some of us, getting there can be a struggle—approval can be difficult to obtain, but look into scholarships or other programs such as the PRIM&R Blog Squad. Once you get to the conference, really take advantage of all that it has to offer and get involved. You can start small. Ask a few questions or offer a few suggestions when you’re sitting in a workshop. Submit a poster abstract about the pros and cons of a new process being implemented at your institution. For those of you who are already doing the things I mentioned above, I simply urge you to keep doing what you are doing!

It may take a bit more time and effort, but it is completely worth it. So, put what you have to offer out there and we will all benefit.

Seven requirements for ethical clinical research?

by Anne Meade, senior manager for website and social media

Each member of the PRIM&R staff is responsible for making sure that PRIM&R runs smoothly, whether their job is answering calls and planning programs, or updating the website and talking to members. No matter which job function we fulfill, it’s important that we stay informed about research ethics, and so we periodically review pertinent articles during our staff meetings. At last month’s meeting we discussed “What Makes Clinical Research Ethical?,” by Ezekiel Emanuel, David Wendler, and Christine Grady, and published in the May 2000  issue of the Journal of the American Medical Association.

In this article, which has become a seminal piece in the field, the authors propose seven requirements that a clinical research study needs to fulfill in order to be considered ethical: social or scientific value, scientific validity, fair subject selection, favorable risk-benefit ratio, independent review, informed consent, and respect for potential or enrolled subjects.

While these requirements may seem obvious, the suggestion that all seven conditions must be met is novel. The authors reference examples of where some of the principles presented have previously appeared (such as The Belmont Report and the Nuremberg Code), but each of those examples exclude a relevant requirement. They argue that only when all seven requirements are addressed can a clinical trial be considered ethical.

Of note, these requirements presented by Emanual et al. also expand on informed consent as presented in The Belmont Report. There, the principle of respect for persons is operationalized primarily by the procedure of  asking for informed consent, but for the authors of this piece, respect for subjects must be broader, and includes respect before, during, and after a trial, and also respecting the right of subjects to change their mind.

Scientific validity brought up a lot of questions for the PRIM&R staff.  In order for research to be considered scientifically valid, “there must be some controversy within the scientific community about whether the new intervention is better than standard therapy (p. 2704)." However, there has been increasing evidence that study results can be incorrect, which raises the question, is there value in running a study again in order to validate earlier results, even if there isn’t a controversy about whether those results are valid?

Additionally, does requiring scientific validity stifle the scientific process? For example, suppose there is a proven treatment used as the standard of care in Western medicine. But suppose there is also a treatment from Eastern medicine for that same condition. Assuming that most clinicians and researchers are involved in Western medicine, one might think that a study comparing the two treatment  is not scientifically valid, since there is no controversy within this scientific community; however, it seems possible that the Eastern treatment could provide an alternative that proves to be superior.

There was consensus among the PRIM&R staff that this article was compelling and served to expand on the ethical principles introduced in the The Belmont Report. PRIM&R’s executive director, Joan Rachlin, explained she felt this article was a testament to how far the field has evolved, specifically regarding the  concept of informed consent (which at one point only consisted of signing on the dotted line), to fully encompass ethics and value over legality.

The impact of sequestration looms for biomedical research

by Avery Avrakotos, Education and Policy Coordinator

One of the stories that lined the front pages of newspapers earlier this week was that of a young girl from Mississippi. Born HIV positive and treated with an aggressive drug regiment from birth, the girl’s physicians were surprised when at the age of two and a half testing revealed her to be “functionally cured” of the virus.

The story of this little girl in Mississippi is exciting and intriguing, but one thing is clear, and was reiterated by the scientists who first shared her story: more research is needed before any conclusions about early and aggressive HIV treatment for infants can be made.

Of course, it will come as no surprise to anyone who is familiar with biomedical research in the United States that the research that prompted this revelation is at least partially funded by the National Institutes of Health (NIH). NIH is the largest funder of biomedical research in the world, and it is one of the many government agencies facing uncertainty as a result of sequestration.

NIH faces a budget reduction of roughly $1.5 billion. What that means exactly for the organization that funds much of the basic science responsible for medical breakthroughs is still unclear.

In advance of the sequester, the agency issued a notice stating, “Should a sequestration occur, NIH likely will reduce the final FY 2013 funding levels of non-competing continuation grants and expects to make fewer competing awards to allow the agency to meet the available budget allocation.” Since the passage of the sequester deadline, NIH grantees and contractors have received similar news in the form of letters from the deputy director for extramural research at the agency, Sally Rockey, PhD, but specifics remain speculative.

One thing is for certain, funding cuts will have an impact on biomedical research and discoveries like the one in Mississippi. President and CEO of the Association of American Medical Colleges, Darrell G. Kirch, MD, reflected on this aspect of the cuts in a recent op-ed. “Medical research cannot be turned on and off like a spigot. Research interrupted by budget cuts, even for a few weeks, may mean years lost—years that could mean life or death for patients for whom medical research right now is their only hope,” Kirch explained.

It’s a tenuous time for research as budget cuts loom, and the future of the basic research that powers so much of the innovation in the United States is seemingly in jeopardy. In the coming weeks, we will do our best to keep you apprised of new developments on Ampersand, and, as always, we invite you to share your own reflections on the impact of the sequester below.

Research Ethics Roundup: Consent to research buried in a doctor’s form, details on how and why research is conducted on animals, and much more!

On this day in 1817, the New York Stock exchange was founded. In recognition of this historic milestone, this week’s installment features articles on various aspects of the research industry, from relationships with corporate financiers, to maintaining positive public opinion. With so much to learn, we hope that you will invest some time in this week’s Research Ethics Roundup!

Herbalife cozies up with UCLA: This report from the Los Angeles Times investigates an unsettling relationship between the University of California, Los Angeles (UCLA) and nutritional supplement firm, Herbalife. The company has contributed millions of dollars to the public research university, and has even referred to their facilities as “our labs.” In turn, UCLA representatives and employees have endorsed Herbalife products, though it appears no clinical trials have been performed to determine their safety or efficacy.

A closer look at how animal research progresses from idea to study: This post, from the blog Speaking of Research, addresses a perceived lack of public understanding on how research proposals involving animals are formulated, developed, and executed. The author, Allyson Bennett, who will be a keynote speaker at this year’s 2013 Institutional Animal Care and Use Conference, argues that this lack of understanding “serves as an impediment to an informed evaluation of science… and weighs heavily against productive dialogue about core issues of public interest.” Bennett takes the reader step-by-step through the process of conducting research with animals.

Pharma pipeline transparency makes it hard to hide negative clinical trials: This opinion piece from John LaMattina argues that the commonly-held opinion that pharmaceutical companies try to hide negative trial results is bunk. According to the author, increased scrutiny from Wall Street investors, as well as from regulatory agencies, patient advocacy groups, physicians, and the media, has encouraged Big Pharma to increase transparency about research throughout all stages of development.

Should patients understand that they are research subjects?: At a recent doctor’s appointment, article author Jenny Reardon was asked to sign a Terms and Conditions of Service Form, which included an acknowledgement that access to her biological specimens may be given to researchers. This article from the San Francisco Chronicle outlines what consenting to such a condition may mean for a patient.

Looking for more news? PRIM&R members can visit our Knowledge Center to find more recent scholarly journal and popular media articles pertaining to research ethics. Not yet a member? Learn more about becoming a member by visiting our website.

Time Capsule Tuesday: Unsound science is unethical

At a 1985 PRIM&R meeting titled IACUCs & the Ethics of Animal Research: A Conference on Institutional Animal Care and Use Committees, David Britt, PhD, addressed the question of whether animal care and use committees can evaluate animal use proposals without considering scientific merit. Britt, then a research associate in the department of veterinary parasitology at the Liverpool School of Tropical Medicine, argued they cannot. He reasoned:

“Unsound science is unethical. If the research does not engender suffering or squander precious resources, this may be unimportant, but very little biomedical research avoids both of these. If all research projects to be reviewed ethically are evaluated elsewhere for their scientific merit, so that the soundness of the science is not in doubt, I still believe that there is reason to consider the science again in the ethical review. Welfare considerations and ethical considerations are one side of the ethical equation. Scientific merit and potential value of the project to society are the other. Both must be taken into account in any rational evaluation.

Scientific merit, for me, involves both the 'why' and the 'how' of research. The 'why' is clearly of vital importance.  It will modify the cost-benefit equation and may increase the allowable costs in terms of animal distress or suffering. Many of the animal welfare problems will be associated with the 'how'—the methodology of research. If it is outside the remit of the committees to discuss this, then they become very toothless structures indeed. The committees should be able to recommend modifications to methodology, aimed at reducing the costs to the experimental subjects.”

The debate in which Britt engaged is one that continues today. The eighth edition of the Guide for the Care and Use of Laboratory Animals, which was officially adopted by the Office of Laboratory Animal Welfare in December 2011, emphasizes the IACUC’s obligation “to weigh the objectives of the study against the potential animal welfare concerns.”

This revision has pushed the topic of scientific merit review and harm/benefit analysis back to the forefront of the animal care and use communities’ attention. PRIM&R will once again engage in this conversation at the 2013 IACUC Conference during Panel I – Practical Strategies for Conducting Harm/Benefit Analysis of Animal Research on Monday, March 18 from 9:00 to 10:00 AM.

Failures are just as important as successes: An interview with Hope Violette

by Megan Frame, Membership Coordinator

Welcome to another installment of our featured member interview series where we introduce you to more of our members-individuals who wok to advance ethical research on a daily basis. Please read on to learn about their professional experiences, perspectives on membership, and and what goes on behind-the-scenes in their lives!

Today we’d like to introduce you to Hope Violette, manager of the Office of Research at Newton-Wellesley Hospital in Newton, MA.  

Megan Frame (MF): When and why did you join the field?
Hope Violette (HV): I joined the field in August 2000. I had been working as director of pharmacy in a hospital, and I was looking for a new and interesting position that would utilize my previous knowledge and skills. I liked the idea of pursuing a career in a field that would always be changing.

MF: Tell us about one or more recent articles, books, or documents that you feel are particularly relevant to the field.
HV: I recently read The Emperor of All Maladies: A Biography of Cancer by Siddhartha Mukherjee.  I thought the book was excellent. It presented the history of oncology research in a very easy-to-read, well-written format that highlighted the setbacks and incremental shifts that have occurred in the war on cancer, as well as the issues with politics and funding. I thought it was an excellent book and a must read for anyone who is involved in oncology clinical trials.

MF: How has membership in PRIM&R’s community of research ethics professionals helped you to advance in your career?
HV: Being a member of PRIM&R has helped me stay current on regulations and best practices. The annual conferences are very well done. The presenters are very professional and I always leave with several ideas for improving the program at my institution. I also look forward to receiving PRIM&R’s Research Ethics Digest every two months because it helps me keep up to date.

MF: What advice have you found most helpful in your career?
HV: Early in my career, one of my mentors told me that if I did my job as a manager well the department would run just as smoothly when I was away as it did when I was there. This was an important lesson for me. Setting up systems that make information easily retrievable and empowering employees to make decisions are key.

MF: What is your proudest achievement?
HV: My proudest achievement in my role as manager of the Office of Research is leading the team that achieved  accreditation from the Association for the Accreditation of Human Research Protections Programs in 2004.  We were one of the first 12 institutions in the country to receive accreditation and also one of the first community hospitals.

MF: What is one thing you wish “the man on the street” knew about your work?
HV: Failures are just as important as successes. It is just as important to know that something does not work as it is to know that something does work. Making public what has failed will save those down the road from wasting time and energy pursuing something that will not help people. Patients benefit when researchers share negative results.

Thank you for being part of the membership community and sharing your story, Hope. We look forward to seeing you at the 2013 Advancing Ethical Research (AER) Conference!

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