Ampersand

2015-09-10T10:19:00.002-04:00

Thank you for visiting PRIM&R's blog, Ampersand. It has a new home, and a new look, but remains an important resource for those working in the field of research protections and those committed to the ethical conduct of research.

Check out the new Ampersand.

Research Ethics Roundup: The Reproducibility of Psychology Studies, the Effect of Clinical Trial Registration, and More

2015-09-04T15:06:00.001-04:00

Two recent studies have generated debate within the research community. We explore those studies, as well as other recent stories about research in the popular media, in this week’s Research Ethics Roundup.

Has US Biomedical Research on Chimpanzees Come to an End?: In June, the US Fish and Wildlife Service announced its plans to classify captive chimpanzees, including those used for research purposes, as endangered animals under the Endangered Species Act. In this article for Science, David Grimm explores the effect of that decision.

Review: ‘Informed Consent’ Tests the Ethics of Genetic Research: “Informed Consent,” a new off-Broadway play, brings to life the story of the Havasupai, a Native American tribe who sued Arizona State University over the misuse of their blood samples for genetic research. Charles Isherwood reviews the play in this piece for The New York Times.

Many Psychology Findings Not as Strong as Claimed, Study Says: Following an evaluation of 100 psychology studies that were published in leading journals, researchers concluded that many of the original findings were not reproducible. Benedict Carey reports on the researchers’ findings in this article for The New York Times.

Biohackers Gear Up for Genome Editing: In this article for Nature, Heidi Ledford reports on how amateur biologists are exploring and using CRISPR, a new technology that can be used to edit DNA.

Registered Clinical Trials Make Positive Findings Vanish: A new study published in PLoS One found that reports of positive clinical trial findings declined significantly following the enactment of a law that required the registration of clinical trials in 2000. Chris Woolston explores the recent study in this article for Nature.

DHHS Releases Long-awaited Proposed Changes to the Common Rule

2015-09-03T12:58:00.000-04:00

On Wednesday, the Office of the Federal Register made available a pre-publication version of a much-anticipated Notice of Proposed Rulemaking (NPRM) that proposes changes to the Federal Policy for the Protection of Human Subjects, or the “Common Rule.”

The release of the NPRM comes four years after the publication of an Advance Notice of Proposed Rulemaking (ANPRM), which first put forward proposals to modernize the regulations governing human subjects research in the United States. The NPRM, which was issued by the Department of Health and Human Services (DHHS), as well as fifteen other Federal agencies, is the next step in the process leading to a final rule. Its contents have been influenced by ongoing dialogue and debate in the years since the release of the ANPRM, as well as by recent policy proposals, including the Office for Human Research Protections’ “Draft Guidance on Disclosing Reasonable Foreseeable Risks in Research Evaluating Standards of Care” and the National Institutes of Health’s “Draft Policy on the Use of a Single IRB for Multi-Site Research.”

The NPRM, which is 519 pages long, puts forward eight major proposals that address improving the informed consent process; strengthening consent requirements for the research use of stored biospecimens; adding categories of activities that are not subject to regulation under the Common Rule; calibrating the level of review to the level of risk involved in research; limiting the use of waivers or alterations of consent for research involving biospecimens; mandating the use of a single IRB for cooperative research; modifying requirements for continuing review; and extending the scope of the Federal Policy for the Protection of Human Subjects.

For each proposed change, DHHS outlines the goal of the change, the current rule, the discussion generated by the ANPRM proposal on that topic (if applicable), and the NPRM proposal. The document also puts forward a number of questions for public comment. The comment period for the NPRM will be 90 days, and the official deadline for comments will be made available once the NPRM is published in the Federal Register, which is scheduled to happen on Tuesday, September 8.

Over the next several weeks, PRIM&R will be synthesizing, analyzing, and digesting the proposed changes for our community. We will post a descriptive chart comparing the current regulations with the proposals in the NPRM next week. We will also be featuring a series of blog posts closely examining the proposals contained in the NPRM here on Ampersand.

PRIM&R’s Public Policy Committee, which oversees the development of written comments on policy items relevant to PRIM&R's mission, will also be considering the proposed rule. The Public Policy Committee invites and encourages PRIM&R members to be involved in this process by sharing your input on the proposed changes. Feedback shared with PRIM&R by September 29, 2015 will be provided to PRIM&R’s Public Policy Committee for review, and all comments will be considered as the Committee prepares its response.

We will also be hosting several events aimed at fostering understanding of the proposed changes. On September 15, Heather H. Pierce, JD, MPH, senior director for science policy and regulatory counsel in scientific affairs at the Association of American Medical Colleges, and P. Pearl O’Rourke, MD, PRIM&R board member and director of human research affairs at Partners HealthCare Systems, Inc., will facilitate a webinar aimed at helping all those involved with human subjects protections understand the proposals put forward by DHHS. The webinar will be free to PRIM&R members. And in November, the issues and questions raised by the NPRM will be highlighted throughout the 2015 Social, Behavioral, and Educational Research Conference and the 2015 Advancing Ethical Research Conference, which are being held November 12-15 in Boston, MA. We encourage you to join us for these exciting events as we explore the future of human subjects research.

From the Director: Informed Consent, Fair Transaction, and Fond Remembrance

2015-09-01T14:29:00.002-04:00

by Elisa A. Hurley, PhD, executive director

I recently had occasion to think fondly of a member of our PRIM&R community whom we lost in April: Alan Wertheimer, PhD. Alan was a senior research scholar in the Department of Bioethics at the National Institutes of Health, professor emeritus of political science at the University of Vermont, and a long-time PRIM&R faculty and conference planning committee member. He was also a cherished friend and mentor to me. He passed away on April 10.

Ever the scholar and truth-seeker, Alan never hesitated to let me know—collegially, of course—if he disagreed with something I said. For instance, he wrote me a note about my Ampersand post on informed consent last year, and in it, reminded me that it’s actually a matter of controversy within the bioethics community whether lack of comprehension on the part of a potential research subject invalidates that person’s informed consent. At the time, I had considered including that dimension of the debate around consent in my post, but ultimately decided not to, in the service of keeping the post brief and focused on the central point of not using consent as a transitive verb.

But as I was reflecting on this exchange recently, I went back and re-read the Kennedy Institute of Ethics Journal article Alan and his colleague Frank Miller wrote in 2011, in which they argued for a model of consent (which they called the “Fair Transaction” model) that does not make comprehension a requirement for valid consent. It’s a brilliant paper—though in the end, I’m not sure I agree with their view (more on that later)—and when reading it, I was reminded just how significant are Alan’s contributions to research ethics scholarship. So I thought I’d use this post to both pay tribute to Alan, whom I miss very much, and shed some light on this controversy, by taking a brief look at Alan and Frank’s conception of informed consent.

According to the traditional model of informed consent (often called the autonomous authorization (AA) model), substantial comprehension on the part of a subject is a requirement for valid informed consent. But that model, the most comprehensive account of which can be found in Ruth Faden and Tom Beauchamp’s seminal book, A History and Theory of Informed Consent (Oxford University Press, 1986), runs into a real problem, namely, the Therapeutic Misconception (TM). TM is the phenomenon whereby clinical research subjects fail to understand the difference between research and ordinary treatment (including, for example, that research follows a fixed protocol which precludes making personalized decisions about care), and therefore mistakenly attribute therapeutic intent to research procedures (Lidz C. and Appelbaum, P. “The Therapeutic Misconception: problems and solutions.” Medical Care, 2002). There is evidence that a substantial percentage of clinical research subjects manifest TM (see Appelbaum, P. and Lidz, C. “The Therapeutic Misconception,” Oxford Textbook of Clinical Research Ethics, Oxford University Press, 2008).

Since TM constitutes a lack of substantial understanding, on the AA model, it would seem to follow that if a subject consents to research participation while under the TM, his or her consent is invalid and the research unethical. In their paper, Miller and Wertheimer point out that most people who subscribe to the traditional view of consent nevertheless reject that conclusion in practice—that is, they don’t acknowledge that TM invalidates informed consent or that a considerable portion of current clinical research is unethical. According to Miller and Wertheimer, this inconsistency between what the model entails and what people who subscribe to the model are in practice willing to conclude suggests a flaw in the AA model of consent. So they suggest an alternative.

According to Miller and Wertheimer, requiring substantial comprehension for valid consent in all cases can actually be a failure of respect for persons. To show this, they ask us to consider two cases: first, a case where subjects are randomized in a trial comparing two standard treatments for depression that are expected to offer similar risks and benefits, and where there has been clear disclosure by investigators about the nature of the research, but some of the subjects fail to appreciate that they will be randomized to one of the two interventions, believing instead that the doctor will select the intervention that is best for them. They argue, “Despite the subjects’ defective comprehension, it seems disrespectful not to recognize the validity of their less than autonomous consent, given their choice to participate after receiving adequate information about the trial and given the personally favorable risk-benefit ratio of trial participation” (207). In other words, Miller and Wertheimer suggest that though these subjects’ consent may not be fully autonomous (because it is given without full comprehension), it is nevertheless freely given, and to discount such freely given consent by saying they nevertheless cannot participate in the trial seems disrespectful. Furthermore, they argue, it seems unfair not to let these subjects participate, in light of the prospect of benefit and lack of predictable harm from participation.

If, on the other hand, we are talking about a placebo-controlled trial of an experimental anti-depressant in the same population, then things look very different. In this second case, Miller and Wertheimer argue, the experimental intervention involves much greater uncertainty about risks and benefits, and randomization to placebo means that some subjects will get something that departs dramatically from standard treatment for depression. (I leave aside, as they do, the fact that some would argue that conducting a placebo-controlled trials in such a case is unethical). Manifesting a TM in this case, Miller and Wertheimer argue, does invalidate consent, because subjects would be failing to appreciate the significant possible disadvantage to them of not receiving active treatment by being randomized to placebo. That is, here the failure to understand the difference between research and treatment constitutes a failure to understand the much less favorable risk-benefit profile of the research, and, in particular, that there is a “known potential for disadvantage” if randomized to placebo (210).

Miller and Wertheimer thus suggest that by placing comprehension above all else, the traditional model of consent is inappropriately insensitive to other considerations that are relevant to respecting persons and their well-being, such as advancing their interests and values, and respecting their preferences—including, for instance, preferences not to be excluded from research that has a personally favorable risk-benefit ratio. The model is thus unfair to subjects. Miller and Wertheimer argue that determining what level of understanding is required for informed consent to be valid should be sensitive to the risk-benefit profile of the research in question. For low-risk research, there is nothing ethically wrong in accepting as valid a subject’s less-than-fully-autonomous consent, though there should always be good faith efforts to communicate information about the research in language the potential subject can understand, and other regulatory safeguards and research protections mechanisms, such as regular ethics review of risks and benefits, must, of course be in place.

Interestingly, Miller and Wertheimer also suggest that the traditional model of consent is unfair to investigators. “The lengths to which investigators should be expected to go in assessing the quality of informed consent should be reasonable in view of the risk-benefit profiles of different studies” (210). While they agree that, in general, investigators should assess the capacity of subjects to consent and enroll subjects only when they are “reasonably confident that they have adequate comprehension,” they think that insisting on rigorous testing of comprehension in low-risk studies is unnecessarily costly and unreasonable, and thus unfair to researchers.

And so, Miller and Wertheimer propose instead a Fair Transaction model of consent, which does not require substantial comprehension in all cases of valid research consent, as the AA model does, but is instead, sensitive to context. What fairness requires, with respect to comprehension, will vary depending on the risk-benefit profiles of the research in question. They write, “It is fair to both subjects and to investigators to require more stringent efforts to promote and to test comprehension when the negative consequences to subjects from trial participation are potentially more significant as compared with standard medical care,” but unreasonable to require “exacting scrutiny of consent to low-risk, life-saving treatment.” And with respect to the TM, specifically, they argue that there need be only minimal concern about correcting it in trials that compare similar treatments in conditions that are like standard practice (i.e., pragmatic trials), and more concern in trials that pose potentially important disadvantages to subjects (212).

Thus, according to Miller and Wertheimer, and contrary to much standard thinking, “Autonomy is not the decisive consideration in the validity of consent” (212). Rather, consent is valid “when subjects are treated fairly in making decisions about research participation consistent with their preferences and values” (217).

So what to make of Miller and Wertheimer’s critique of the traditional view of informed consent, and of their alternative? Though I find their arguments thought-provoking, I wonder whether their account misses some of the point of seeking informed consent for participation in research by focusing so much on the relevance of the risk-benefit profile of the research in question. That is, I’m not convinced that the level of risk subjects are about to undertake in entering a research study should be the arbiter of how much concern we have about whether they understand the difference between research and clinical care. Rather, respect for research subjects would seem to require that we always be concerned that people who are about to enroll in research understand what it means to participate in research—an enterprise whose goal is the creation of generalizable knowledge rather than achieving a personalized benefit, and whose procedures are therefore governed by a standard protocol, rather than personalized decisions about care. That is not to say that the informed consent process need look exactly the same in high and low risk cases. But what seems objectionable to me is the idea that if the risks are low enough, we need not be too worried whether people understand that they are research subjects, with all that that entails.

What do you think?

Modernizing Biomedical Innovation: Understanding the 21st Century Cures Act

2015-08-28T13:00:00.000-04:00

by Avery Avrakotos, education and policy consultant

On July 10, 2015, the US House of Representatives passed H.R. 6, the 21st Century Cures Act, with a vote of 344-77. The passage of the bill, which many have hailed as a noteworthy example of bipartisan collaboration, is the result of more than a year of congressional hearings, roundtable discussions, whitepapers, and political debate. First introduced in April 2014 by Fred Upton (R-MI), chairman of the US House of Representatives’ Energy and Commerce Committee, and Representative Diana DeGette (D-CO), the 21st Century Cures initiative seeks to “accelerate the pace of cures in America.”

The legislative phase of the 21st Century Cures initiative began in January 2015, with the release of the first discussion draft of the bill. This version proposed major changes to the drug and device development process and touched on issues related to human subjects protections, the sharing of clinical trial data, expanded access, adaptive clinical trial designs, orphan drugs, and much more. The reaction to the discussion draft was varied, with supporters hailing the collaborative and transparent nature of the bill’s development, and critics voicing concerns over provisions that they believed would negatively affect patient safety.

Over the next several months, additional discussion drafts were released and the 21st Century Cures Act was further refined, with later versions representing “a less aggressive streamlining of the drug approval process.” Nonetheless, the version of the 21st Century Cures Act that was passed by the House on July 10 proposes significant changes and has prompted debate among scientists, academics, industry representatives, patient advocacy groups, and regulators.

One element of the 21st Century Cures Act that has been met with a mixed reception are provisions that would broaden the evidence base that can be used to demonstrate the safety and efficacy of drugs and devices. Some have praised the changes for their ability to expedite the drug and device approval process, while others have expressed concern that the proposed changes will lower safety standards. In an opinion piece for The New England Journal of Medicine, Jerry Avorn, MD, and Aaron S. Kesselheim, MD, JD, MPH, raised concerns that the bill would take the United States back in time in terms of drug and device approval. They write, “Embedded in the language of the 21st Century Cures Act are some good ideas that could streamline the development and evaluation of new drugs and devices; its call for increased NIH funding may prove to be its most useful component. But political forces have also introduced other provisions that could lead to the approval of drugs and devices that are less safe or effective than existing criteria would permit.”

Tucked within the lengthy 21st Century Cures Act are a number of provisions that apply directly to the clinical trials process and human subjects protections. Early versions of the draft legislation called on the Secretary of the Department of Health and Human Services (DHHS) to make modifications to the existing regulations for the protection of human subjects so as “to ensure that human subject research that is subject to the Federal Food, Drug, and Cosmetic Act or to section 351 of this Act, and is therefore subject to parts 50, 56, 312, and 812 of title 21, Code of Federal Regulations (or any successor regulations), is not subject to subpart A of part 46 of title 45, Code of Federal Regulations (or any successor regulations).” However, in the version that was ultimately approved by the House, that language, which raised concerns among some in the research protections community, was removed.

The legislation now focuses more broadly on directing the Secretary of DHHS to make modifications to existing regulations governing the protection of human subjects in order to: harmonize FDA and DHHS requirements to the extent possible; modernize the provisions for multi-site and collaborative research projects; “reduce regulatory duplication and unnecessary delays;” and “incorporate local considerations, community values, and mechanisms to protect vulnerable populations.” The legislation also calls on the Secretary of DHHS to ensure that federally funded research can use joint or shared review and to provide further guidance on such arrangements. The use of central IRBs for the review of multi-site research is further supported later in the bill by a provision that requires Section 520 of the Federal, Food, Drug, and Cosmetic Act be amended to remove the term “local.” This change will allow for centralized review of FDA-regulated studies involving a device.

Another noteworthy provision would amend the Federal Food, Drug, and Cosmetic Act in order to allow for waivers of informed consent for drug and device research in situations where “the proposed clinical testing poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of the human subject.” This change would eliminate one of the significant differences between the FDA and DHHS regulations governing the protection of human subjects.

The 21st Century Cures Act also proposes a number of changes that would allow for easier access to health data for use in research. Specifically, the 21st Century Cures Act calls for amendments to the HIPAA Privacy Rule “to allow: (1) use of protected information for research purposes to be treated as use for health care operations, (2) remote access to information by researchers, and (3) individuals to authorize future use of their information for research.” In addition to the specific provisions outlined above, the bill also addresses the need to include patient perspectives in the drug development process, the promotion of pediatric research, the inclusion of under-represented communities in clinical trials, and the issue of reducing administrative burden for researchers.

With the passage of the 21st Century Cures Act by the House, attention has turned to the Senate, which is working on a parallel bill under the leadership of Lamar Alexander (R-TN), chairman of the Committee on Health, Education, Labor, and Pensions (HELP); and Patty Murray (D-WA), ranking minority member of HELP. Over the past several months, HELP has held a number of congressional hearings and is gathering information as they work to develop their own legislation aimed at fostering biomedical innovation. Most recently, Senator Alexander informed a National Academies panel charged with “develop[ing] a new framework for Federal regulation of research universities in the 21st century” that he welcomes their input and encourages the group to provide preliminary recommendations by the end of the summer, so that their work can be incorporated into the Senate’s efforts.

Earlier this year, Upton and DeGette, who moved the 21st Century Cures Act quickly through the House, shared that they hope to have a final bill signed into law by year’s end. Ultimately, however, the feasibility of that goal is dependent on the Senate, which appears to be moving at a slower pace than the House did.

Portions of this post were adapted from an article titled 21st Century Cures Looks to Modernize Clinical Trials which appeared in the May 2015 edition of the PRIM&R Member Newsletter. The PRIM&R Member Newsletter is distributed once a month to PRIM&R members. To learn more about the PRIM&R Member Newsletter, as well as other member benefits, please visit our website.

#TBT - An August to Remember: Celebrating the Animal Welfare Act

2015-08-27T13:00:00.000-04:00

By Angela Craig, DVM, lab animal veterinarian and institutional animal care and use committee (IACUC) member at the University of Minnesota

If you were to reflect on important events that occurred in 1966, a legal decision handed down that year had such impact as to influence the conduct of our society every day thereafter. History buffs may think I’m referring to the Supreme Court decision in the case of Miranda v. Arizona which protected the rights of the accused, and introduced the Miranda warning. While this was undeniably monumental and provided necessary protections within the criminal justice system, it was not the only important safeguard measure enacted that year. For animals, the critically significant Public Law 89-544 was signed into existence on August 24, 1966. It is more familiar to us as the Animal Welfare Act (AWA).

This original AWA responded to societal concerns about the treatment of animals, specifically defining how dogs, cats, and certain other animals would be procured, transported, and used for research, among other things. To this day, the AWA is the only federal law describing the requirements for how animals are to be treated in the United States of America; its enforcement falls to the United States Department of Agriculture. Given its critical importance in providing direction and protection for animals, it is no surprise that the AWA has changed over time to remain current with societal standards and to address new concerns as they arise.

The AWA has been amended seven times since 1966, with each change providing greater clarity of expectations and expansion of coverage. In 1985, the Improved Standards for Laboratory Animals Act amendment (also called the Food Security Act) provided additional direction on standards for sanitation, housing, and ventilation for lab animals. Exercise requirements for dogs and the promotion of psychological well-being in nonhuman primates were other key changes. The Institutional Animal Care and Use Committee (IACUC) was introduced and described, and so many things considered standard practices of IACUCs today—such as the minimization of pain and distress, and the consideration of alternatives to painful procedures—were written into law in this amendment.

The AWA has been criticized by some who focus on its limitations. For instance, it does not cover birds, rats of the genus Rattus, and mice of the genus Mus—animals common to research. However, many other policies and guidance documents provide standards and expectations to supplement those found in the AWA and cover additional species. These include the Guide for the Care and Use of Laboratory Animals, the Public Health Service Policy on Humane Care and Use of Laboratory Animals, the Guide for the Care and Use of Agricultural Animals in Research and Teaching, and the U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training.

Another criticism is that the AWA “only” describes the minimum expected standards for facilities, husbandry, transport, and veterinary care. One can argue, convincingly, that laws are not the sole motivation that drives animal care and use professionals to make appropriate decisions about animal care and well-being. The AWA ensures action will be taken against those who do not meet minimum standards. Yet, many individuals and institutions exceed the Act’s expectations each day in their conduct and care. They strive to surpass the idea of ‘minimally acceptable’ and exemplify what is infinitely possible with continued refinement and dedication to best practices in every aspect of their work with animals. Their choices have nothing to do with legality and everything to do with an enduring commitment to animal welfare.

When we look back years from now, we’ll know the outcomes of current discussions related to the Animal Welfare Act. Rather than exercise our right to remain silent, the AWA reminds us of our duty to be vocal about how we can best provide high quality care to our animals while furthering improvements in human and animal health. The two are not mutually exclusive. New standards will be based on the changing values of society, and as knowledgeable members of that group, we must listen closely and contribute to the conversation to keep the Animal Welfare Act robust and applicable for decades to come.

PRIM&R’s Comments in Response to Framework for NIH-wide Strategic Plan

2015-08-26T11:20:00.001-04:00

by Avery Avrakotos, Education and Policy Consultant
On July 22, the National Institutes of Health (NIH) announced it was seeking comment on a framework for a five-year, NIH-wide Strategic Plan. The plan, which will ultimately be submitted to Congress and is being generated with input from senior leadership and staff across NIH, is intended to “outline a set of unifying principles to guide NIH in pursuit of its mission” and “highlight major trans-NIH themes” in order to help advance the biomedical research enterprise.

In the framework, NIH identifies three areas of opportunity that apply across biomedicine: (1) the promotion of fundamental science, (2) the improvement of health promotion and disease prevention, and (3) the advancement of treatment and cures. In addition to the crosscutting areas of research, NIH identifies two unifying principles: (1) set NIH priorities, and (2) enhance stewardship. Notably absent from the areas of opportunity and unifying principles identified is an explicit discussion of NIH’s role in promoting the ethical conduct of research.

Recently, PRIM&R’s Public Policy Committee, which is composed of experts from a range of disciplines and institutional settings, responded to NIH’s request with a brief letter. In this response, PRIM&R acknowledges the role that NIH has played in promoting human subjects protections, the ethical conduct of science, and scientific integrity, and asks the Institutes to build on that history and ensure that the centrality of ethics in the research enterprise is reflected in its forthcoming strategic plan.

Specifically, PRIM&R encourages NIH to add the following as a unifying principle in its strategic plan:

Integrate Ethics—NIH integrates ethics, including principles for the ethical conduct of science, robust human and animal subject protections, and scientific integrity, by ensuring that ethics is an integral component of scientific design, the training of scientists, grant and contract review, the sharing, dissemination, and assimilation of research results, and public education.

PRIM&R goes on to note that the success of NIH’s crosscutting objectives “rests on a scientific enterprise that is and appears to be based on ethical principles, including transparency and independence from financial and other outside interests” and that “explicit inclusion of ethics as a unifying principle of the framework will serve as a strong affirmation to the community of scientists that attending to research ethics is not a wasteful ‘burden’ but a means to better and more sustainable research.”

Take a moment to read PRIM&R’s complete response to NIH and to share your thoughts about PRIM&R’s comments or the framework for the NIH-wide Strategic Plan in the comments below.

Research Ethics Roundup: Exploring Research Misconduct, Alternatives to Animal Models, and More

2015-08-21T14:53:00.000-04:00

New techniques and technologies are changing the way we think about research. This week’s Research Ethics Roundup explores some of those developments, including the growing use of randomized trials to evaluate social programs and continued efforts to create alternatives to animal models.

A Scientific Look at Bad Science: In this piece for The Atlantic, Bourree Lam reviews recent literature in an effort to answer the question: “are retractions increasing because errors and other misdeeds are becoming more common, or because research is now scrutinized more closely?”

Can We Eliminate Animals from Medical Research?: Teal Burrell reports on efforts to develop alternatives to animal models, including the work of Donald Ingber, MD, PhD, who developed a lung-on-a-chip, in this piece for NOVA Next.

Can Randomized Trials Eliminate Global Poverty? : Economists are increasingly turning to randomized trials in order to generate empirical data on the effectiveness of social programs. In this article for Nature, Jeff Tollefson explores this trend, as well as its history and potential future growth.

How to Know Whether to Believe a Health Study: In this piece for The New York Times, Austin Frakt explains some common elements of clinical trial design in an effort to increase understanding and help the public become “savvy consumer[s] of research.”

Registered Clinical Trials Make Positive Findings Vanish: A new study published in PLoS One suggests that the number of studies reporting positive trial results has declined significantly since 2000, when requirements for the registration of clinical trials were enacted. Chris Woolston provides insight into the study, as well as the public reaction, in this article for Nature.

On the Way to Better Informed Consent for Clinical Research

2015-08-11T10:32:00.000-04:00

By Lika Nusbaum , RN, MN, Nursing PhD Candidate at Northeastern University, faculty member at the Department of Nursing, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel

To fulfill ethical requirements, each year, millions of people (Krall, 2009) engage in an informed consent discussion before joining clinical trials, ‎weighing both possible risks and benefits of the trial participation when making their choice to take part in the proposed study.

However, studies suggest many research participants do not understand these risks and benefits (Guarino et al., 2006; Bergenmar et al., 2008; Jefford et al., 2011; Koh, 2012; Montalvo & Larson, 2014) even ‎after they have agreed to join a research study.

A poor understanding of risks may lead to future regret concerning joining the trial, and may cause participants to leave the trial before it ends. This may negatively affect all of the study findings (Stryker et al., 2006; Meneguin & Cesar, 2012). Worst of all, this poor communication of risk information may result in physical or psychological harm to research participants (Shalala, 2000; Buchanan, 2013).

To solve this problem, we need to better understand what happens during the informed consent process. Nurses, as a part of a research team, play an increasingly active role in obtaining informed consent from potential participants (Banner & Zimmer, 2012; Tomlin et al., 2014; Cresswell & Gilmour, 2014), while providing detailed explanations of the study protocols and finding answers to participants’ questions.

Like others, I am concerned about these issues, so I am studying the perceptions and experience of research nurses regarding the communication of risks and benefits. Nurses’ voices are markedly under-represented in research literature discussing communication of risk information to the research participant. My study aims to address this gap while also developing a better understanding of how to improve the informed consent process. I am looking for nurses’ opinions and experiences to address some shortcomings in the informed consent process.

If you currently are, or have ever been, a research nurse on a clinical trial research team and have ever participated in obtaining informed consent, I invite you to complete my survey of Nurses’ Opinions Regarding the Informed Consent Process in Research. Your anonymous responses will contribute to a greater understanding of the process, which can lead to recommendations for needed improvements. You can take the survey by clicking on the link below.

https://bouve.co1.qualtrics.com/SE/?SID=SV_1LKRuMCCBz7Fzjn

Please forward this link to research nurses you know, even if you are not a nurse.

I plan to share the findings on this blog and look forward to a rich discussion of ways to improve the informed consent process.

If you have questions or comments, please contact me at Nusbaum.l@husky.neu.edu.

Research Ethics Roundup: The Ethics of Charging Patients for Research, Ruling on Personhood Status for Chimps, and More

2015-08-07T12:18:00.000-04:00

From considering whether it is appropriate to ask patients to pay for research to the responsibility to share research data, this week’s Research Ethics Roundup explores some of the important ethical questions that emerge in the conduct of research.

Chimps Aren’t People, New York State Supreme Court Judge Rules: Last week, the New York State Supreme Court ruled that “two research chimpanzees at a state university on Long Island shouldn’t be considered legal persons and given the rights bestowed by so-called personhood.” Corrine Ramsey reports on the ruling in this article from The Wall Street Journal.

How Ebola-Vaccine Success Could Reshape Clinical-Trial Policy: In this piece for Nature, Declan Butler, Ewen Callaway, and Erika Check Hayden consider the recent success of a clinical trial of an Ebola vaccine and its implications for “how future clinical trials are conducted in outbreaks.”

Pace of Research Should Not Barrel Ahead of Ethical Safeguards: Alexander M. Capron, Elisa A. Hurley, and David H. Strauss respond to a recent opinion piece in The Boston Globe that argued that bioethicists need to “get out of the way” of science. Capron et al. contend that “science unfettered by ethics is bad science.”

Scientists Are Hoarding Data And It’s Ruining Medical Research: In this piece for Buzzfeed, Ben Goldacre reports on scientists’ efforts to reproduce findings from clinical trials. He argues that researchers have a responsibility to make raw data available so others can reanalyze the work and verify the findings.

Should We Charge Patients for Medical Research?: Ezekiel J. Emanuel and Steven Joffe consider whether it is ethical to ask patients to pay for research in this opinion piece for The New York Times. They argue that “charging [patients to pay for research] would be a mistake.”

The Crucial Role Research Plays: An Interview with Jackie Blundon

2015-08-06T09:00:00.000-04:00

By Nora Murphy, membership assistant

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 Jackie Blundon, MS, CIP, director of the Human Research Protection Program at Wheaton Franciscan Healthcare.

Nora Murphy (NM): When and why did you join the field?
Jackie Blundon (JB): Like so many who work in human subjects protections, I didn’t set out looking for a career in this field. After completing graduate school in 2008, I knew that I didn’t want to continue in basic science research and was looking for something different than, but related to, my years of training. I was happy to find a place in the quality improvement unit in the human research protection program at the university where I attended graduate school. I’ve continued in this field because I enjoy the role I play in supporting ethical and compliant research, and the researchers who conduct it.

NM: What is one tool you use every day that you could not do your job without?
JB: The internet. I often wonder how people did anything before the internet, and I can’t imagine doing this job without it. From resources like the PRIM&R website, Knowledge Center, and IRB Forum, to networking and easily searching for regulation and guidance, to operational support like electronic IRB systems, email communication, webinars, and teleconferencing, the internet and all the tools it makes available are invaluable.

NM: What is one thing you wish the general public knew about human subjects research?
JB: I wish the general public was more aware of human subjects research, including the importance of participation and the crucial role research plays in improving society’s understanding and healthcare advancement.

NM: What is something you know now that you wish someone had told you when you first entered this field?
JB: It is not “black and white”, and it will never be. In general, I find “it depends” to be a very unsatisfying answer, but as you gain experience in this field you learn that it almost always depends. Even though there are written regulations, laws, policies, and guidance, each project is different and it often comes down to judgement, knowledge, and expertise.

NM: What changes in the research field most concern you? What changes are you encouraged by?
JB: We are all aware the current federal regulations are rather don’t always apply to all research, especially new types of research that may not have even existed when the regulations were written (online/social media, medical device apps, genetic research, etc.). I am excited and encouraged by the desire to update the regulations and guidance to better address today’s issues, but I am also concerned these changes may not be any better than the current rules that we’ve all come to learn to work with. PRIM&R’s Public Policy Committee provides a great service by developing policy positions and other initiatives to voice the concerns of the PRIM&R community.

NM: Have there been any PRIM&R events or talks that you have attended that have made a significant impact on your approach to your work? If so, what were they and how did they influence you?
JB: I have found at least some value in pretty much any PRIM&R event that I’ve attended. I think the annual Advancing Ethical Research (AER) Conference can have a great impact based on the size and scope of the event—there is literally something for everybody. I was lucky enough to be able to attend the AER Conference very early in my career and it had a huge impact on my view and understanding of the field in general, as well as my own role and development plan.

NM: How has membership in PRIM&R’s community of research ethics professionals helped you to advance in your career or do your job better?
JB: In addition to the AER Conference, PRIM&R also offers a lot of online materials, which I find incredibly helpful and use frequently to stay up to date on current issues, hear other professionals’ view points, and connect with peers. In addition, the Certified IRB Professional (CIP^®) credential not only demonstrates your knowledge and expertise, but is an important step in career development, as it is often preferred or required by employers.

Thank you for being a member of PRIM&R, Jackie, and for shedding light on some of your experiences in the field!

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

In Memoriam: Warren K. Ashe

2015-07-31T14:40:00.000-04:00

Warren K. Ashe, PhD, retired associate dean for research at Howard University and former PRIM&R Board member, passed away on July 26, 2015. He was 85.

Dr. Ashe had a self-described love affair with Howard University from childhood, when he dreamed of being involved in the medical school. After receiving his bachelor’s degree in psychology from Howard, Dr. Ashe enlisted in the US Marines Corps. He remarked that the day he enlisted was both the best—and the worst—day of his life. “[The Marines] have a motto that I still remember. They say, ‘the difficult we do immediately; the impossible takes a little time.’…I live my life on that principle.”

After an honorable discharge in 1953, Dr. Ashe was hired at the National Institutes of Health (NIH). He worked at NIH for 20 years, and was the first African-American to become a senior scientific advisor at the National Institute for Dental Research. In 1961, after spending time studying the herpes simplex virus, he published his first paper in the journal, Archives of Oral Biology. In 1962, he earned a master’s degree in microbiology from Howard.

In 1971, Dr. Ashe received a call from the dean of Howard University College of Medicine, asking him to join the administration. Dr. Ashe began his work at Howard later that year, starting as an assistant dean and instructor of microbiology. In 1976, Dr. Ashe enrolled as a PhD student in the department of microbiology, working during the day and taking classes at night. He completed his longed-for doctoral degree in 1984.

When Dr. Ashe first arrived at Howard, there was no formal process for reviewing research. He formed the Human Research Review Committee, charged with reviewing all human research in the College of Medicine, which eventually transformed into the first institutional review board (IRB) at the University. He served as executive secretary for the IRB from 1971 until 2006.

While involved with the IRB, Dr. Ashe began attending PRIM&R conferences, and was invited by William Freeman, a PRIM&R Board member, to speak at a conference sponsored by the Applied Research Ethics National Association (PRIM&R’s former membership division) on a panel titled Can Tuskegee Happen Again? Held in 1998, this conference marked the beginning of Dr. Ashe’s involvement with PRIM&R; he was elected to PRIM&R’s Board of Directors that year, serving until 2010.

During his time on the board, Dr. Ashe and Dr. Freeman created the organization’s Institutional Capacity Building Scholarship Program, which was established to help individuals from under-represented minority institutions take advantage of participating in PRIM&R’s annual conferences. The program continues today, and has been instrumental in bringing professionals from historically Black colleges and universities, tribal colleges, and Hispanic-serving institutions to PRIM&R events for more than a decade.

Dr. Ashe also worked with Charles McCarthy, another PRIM&R Board member, to develop the Pillars of PRIM&R Program to recognize sustained contributions from members of the PRIM&R board to PRIM&R and to provide support for early career professionals.

Dr. Freeman noted Dr. Ashe’s passing by sharing the following: “I learned much from Warren. It was my pleasure to work closely with him on several PRIM&R Board issues, including the creation of our scholarship program. When I last met him in DC, he gave me a tour of the area in and near Chinatown, including the building that was first a synagogue, then [his beloved] Turner Memorial AME Church and now is the historic I Street Synagogue. To Warren’s family, I say, May his memory be a blessing. His memory is a blessing for me.”

In 2013, Dr. Ashe sat down with Gigi McMillan for an interview for PRIM&R's People and Perspectives initiative. During his interview, Dr. Ashe discusses his life, from early childhood in the segregated South to becoming the first African-American senior scientific advisor at the NIH.

He goes on to describe his time at Howard, his quest to earn a PhD, and his involvement with PRIM&R’s Board of Directors.

Though Dr. Ashe experienced some health challenges toward the end of his life, he maintained his positive outlook. “I pray constantly to…let me live my life to the best I can…Let me come to the end of my journey, and I can say truthfully that I have not wounded any souls…I have lived by what I believe is right, not what other people think should be right. And I try to be true to that.”

Dr. Ashe was an important friend, colleague, and mentor to so many, touching many lives with his wisdom and sincerity. “Because I’ve had so many experiences, I want to share them with everybody I possibly can. [There are] some people who may think ‘well that’s just an old Black guy just talking.’ But believe me it’s not that. I want to leave a legacy behind me so people know that Warren Kelly Ashe has been here.”

As PRIM&R’s Managing Director, Kimberly Hensle Lowrance, noted: “I am very lucky to have known Warren. He was such a special man—so committed to research, to doing better, to supporting one another. He always provided great advice to our staff and was a warm, lovely human being. I will miss him.”

The PRIM&R Board and staff extend their deepest sympathies to Warren’s beloved family.

Memorial contributions and donations may be made to The Lee B. Ashe/Enta M. Ashe Endowment Fund at the Howard University College of Medicine.

Capacity, Consent, and Progress: Recommendations from the Bioethics Commission

2015-07-27T09:02:00.000-04:00

By Nicolle K. Strand, JD, M.Bioethics, research analyst at the Presidential Commission for the Study of Bioethical Issues

Earlier this year, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) released the second part of its report on neuroscience and ethics—Gray Matters: Topics at the Intersection of Neuroscience, Ethics, and Society (Gray Matters, Vol. 2). The report examines in depth several controversial topics that bring ethical issues to the fore, including cognitive enhancement, neuroscience and the law, and the ethical conduct of research with participants with impaired capacity for informed consent.

The challenge of impaired consent capacity has been a perennial issue in research ethics for decades yet it is nonetheless well-placed in a report about contemporary neuroscience. Neuroscientists commonly study the very diseases that can cause impairments in decision-making capacity, making informed consent difficult or impossible. These include head trauma, stroke, dementia, schizophrenia, and major depression, among others. Neuroscience research can promote progress towards understanding and alleviating these conditions, but that progress requires the participation of persons affected. Informed consent is a central tenet of research ethics and, in its absence—when working with participants whose capacity is impaired—researchers and IRBs need clear guidelines for whether and how to proceed ethically.

It is vital to find ways whenever possible to ethically and responsibly include individuals with impaired consent capacity in research, but researchers must also vigilantly protect participants from exploitation and abuse. In addition, researchers must guard against and mitigate stigma and harmful assumptions about individuals based on diagnoses or impaired consent capacity.

With all of this in mind, Gray Matters, Vol. 2 explains the long and complex history of national bodies crafting guidance about impaired consent capacity, describes the current regulatory framework to protect participants, and elucidates additional protections that can be employed when consent capacity is impaired or in question. These additional protections include using improved assessment techniques, respecting assent and dissent, engaging independent consent monitors, limiting acceptable levels of risk, requiring legally authorized representatives, honoring research advance directives, and ensuring meaningful stakeholder engagement. The Bioethics Commission made four recommendations in this area, emphasizing responsible inclusion, and calling for clearer requirements for identifying legally authorized representatives to provide permission on behalf of participants when consent capacity is impaired.

As a part of its continued efforts to distribute its findings and recommendations to relevant stakeholders, the Bioethics Commission has developed educational materials to accompany its reports. Included among the Gray Matters educational material is a primer for researchers on neuroscience and consent capacity. Researchers can use the primer to aid ethical decision making and ensure that they have considered and implemented appropriate safeguards. All of the Bioethics Commission’s materials are free and available at http://bioethics.gov/education.

Research Ethics Roundup: Female Mice in Research, IRB Member Conflicts of Interest, and More

2015-07-24T09:42:00.000-04:00

From a new report that indicates that the use of regulated animals in biomedical research is declining to an editorial arguing for the use of female mice in research, animal research takes center stage in this week’s Research Ethics Roundup.

Conflicts of Interest on Institutional Review Boards Remain Problematic: A recent study in JAMA Internal Medicine concluded that while there has been significant progress with respect to reporting and managing institutional review board (IRB) member conflict of interests, there is still more work to be done. Ed Silverman reports on the findings in this article from The Wall Street Journal’s Pharmalot.

Genome Researchers Raise Alarm Over Big Data: In this piece for Nature, Erika Check Hayden reports on the growing concern among biologists and computer scientists that the challenge of managing genomic data will exceed the capability of current computing resources.

The FDA’s Medical Device Problem: In this opinion piece for The New York Times, Rita F. Redberg and Sanket S. Dhruva argue that the 21st Century Cures Act will “severely weaken, not strengthen, the FDA’s already ineffective regulatory scheme for medical devices. The device industry may stand to benefit from this legislation, but the health of the public does not.”

Use of Regulated Animals in US Biomedical Research Falls to Lowest Levels on Record: In this article from Science, David Grimm reports that new statistics posted by the United States Department of Agriculture reveal that the “number of federally regulated animals used in U.S. biomedical research dropped last year to its lowest level since data collection began in 1972.”

Why Science Needs Female Mice: This editorial from The New York Times reflects on a recent study published in Nature Neuroscience, which “suggests that research done on male animals may not hold up for women.” The authors of the editorial argue that new grant requirements from the NIH, which require justification for only using one sex in research, are a step in the right direction.

Opportunities for Advancement: Promoting Employee Engagement in Animal Care and Use Programs

2015-07-22T09:18:00.000-04:00

By Angela Craig, DVM, lab animal veterinarian and institutional animal care and use committee (IACUC) member at the University of Minnesota

Each of us has a unique path that brought us to our career in laboratory animal care and use. I started my career in laboratory animal medicine twenty years ago as a member of the husbandry staff. I enjoyed the close connection I made with the animals under my care, and I understood that they depended on me for their basic needs. I further realized how the scientific discoveries unfolding were dependent on physically and psychologically healthy animals. When you feel deeply invested in the work you do, it is natural to think about the ways you can improve your knowledge, skills, and experience for the benefit of the animals and the research program. You think about how the work you enjoy might develop into a lifelong career. For me, the connection I felt to the animals in my care led me to become a laboratory animal veterinarian.

Opportunity for advancement is frequently cited as a key factor affecting employee job satisfaction. Advancement may include the development of new skills, greater responsibility, and/or promotion. Within an animal care and use program, there are many options for growth, but staff members are not always aware of how to get on the right track. They also may not realize the various directions they can go with their interests. In addition to careers oriented toward husbandry and veterinary care, there are also the paths of laboratory animal resource management, and animal program administration and compliance.

Managers and supervisors are in a position to learn about the goals of their staff and mentor each on to achieve his or her personal best within the field. One way to do this is to direct people to training and certification which will lead to new opportunities for advancement. As a lab animal veterinarian I frequently direct staff to technician certification through the American Association of Laboratory Animal Science (AALAS), but this is just one of many sources for career-advancing education. For staff members who are interested in management, pursuing the Certified Manager of Animal Resources (CMAR) certification is another route.

When ethics, welfare, and compliance are at the top of a staff member’s list of interests, PRIM&R offers two unique opportunities for education and growth. They are a Certificate in the Foundations of Animal Care and Use and Certified Professional IACUC Administrator (CPIA®) credential. Each of these programs promotes the acquisition of skills and expertise necessary for a career supporting ethical animal care and use and compliance, both of which require knowledgeable and dedicated individuals.

Lifelong learning in each of the roles described is further supported by PRIM&R’s yearly IACUC Conference, webinars, short courses, and mentoring from others in the field. Similarly, AALAS has a National Meeting and offers continuing education.

Every day in our institutions, we have the opportunity to encourage the growth of our staff members and give them guidance which can lead to advancement and greater job satisfaction. The more invested they are in their careers and engaged in lifelong learning, the better it is for the animals we serve. With educational offerings from AALAS and PRIM&R, we do not have to invent the path or the opportunities, merely introduce staff to what is possible and support their journey.

From the Director: Shedding Light on Compassion Fatigue

2015-07-20T15:32:00.002-04:00

By Elisa A. Hurley, PhD, executive director

PRIM&R is unique in the research ethics world, serving as we do both the human subjects research and animal care and use communities. And from this unique position, we often see bridges and links between work with animals and work with humans, whether it’s thinking about the translational impact research with animals has on understanding and treating human disease; identifying and addressing similarities in research oversight processes between human research protection and animal care and use programs; or recognizing parallels between the ethical concepts called into play in each domain – for example, risk/benefit analysis— and gleaning generalizable lessons from such commonalities.

I’ve recently been thinking about another bridge between humans and animals in the research world: compassion fatigue among the people who work with, care for, and oversee the welfare of laboratory animals. As a phenomenon, compassion fatigue is not limited to animal care and use—indeed, the topic is widely discussed in other caring professions (see for example, Compassion Fatigue: A Nurse’s Primer, this article from the Journal of Hospice and Palliative Nursing, or this Emergency Nurses’ Association Topic Brief)—but it is a predictable outcome of working with research animals.

For the purposes of this discussion, I define compassion fatigue as the unintended emotional distress, fatigue, or apathy that develops from caring for, investing in the wellbeing of, and bonding with, animals whose health or lives may be sacrificed for the good of discovery through research. Given the documented power of the human/animal bond, compassion fatigue can affect the well-being of highly skilled animal care and use professionals, and, ultimately, the care of the animals themselves.

While not all animal care and use professionals develop bonds with the animals for which they care, research in this area suggests that the majority of laboratory animal technicians “experience some form of attachment to a laboratory animal at least once in his or her career.” (Arluke, A. 1994. The Ethical Socialization of Animal Researchers. Lab Anim. 23(6):30-35; cited in Cost of Caring.) Indeed, the very practices designed to enhance research animal welfare can serve to strengthen these bonds. According to the American Association of Laboratory Animal Science’s (AALAS) publication, Cost of Caring:

Practices of gentle handling, compassion and patience serve to build the bond between humans and animals. The development of the human/animal bond can improve animal welfare by minimizing stress [on the animal], enhancing [the animal’s] sense of safety and security, and fostering trust [by the animal with the human handler]. The same can be said for what those practices do for the human handler. It is well documented that close contact with animals can create feelings of satisfaction and affection, lower blood pressure, and provide an overall sense of well-being. For an animal care professional, “…feelings of satisfaction can arise from knowing that not only basic husbandry needs are met, but that animal welfare is enhanced by connecting through compassion, affection, and respect.

This topic caught my interest because it seems to get relatively little attention. In fact, as pointed out in a recent AALAS webinar on the topic (Compassion Fatigue and Compassion Satisfaction in the Workplace: Is the Cost of Caring Affecting Me?), the phenomenon has only very recently been recognized as relevant in the laboratory animal field. There are few if any support services for those who work with research animals and suffer from compassion fatigue, and very little exists in the way of print or online resources. Moreover, animal care and use professionals who find themselves struggling with compassion fatigue may be ashamed of their feelings, and fear discussing them with either peers, who might ridicule them, or family members and others outside the lab, who might express disgust about the specific work or disapproval of research with animals all together.

In fact, this last point may be one reason why the topic doesn’t get more coverage in the research community. Given the sensitive and sometimes very polarized climate around animal research, we likely worry that even acknowledging compassion fatigue exists in our ranks might give fodder to animal rights groups, calling into question the commitment to the research, or the belief in its value, on the part of those who work with animals and feel this way, and becoming a talking point, or worse, a politically inflated and misconstrued headline.

So what can and should the animal care and use community do? First and foremost, we should acknowledge the very real emotional impact of caring for research animals. Indeed, there are a number of important reasons why we should talk about compassion fatigue more often, and more publicly. First, doing so will send a clear message to animal care and use staff that their feelings—whether of anxiety, stress, guilt, fear, sadness, denial, or apathy (all of which can be manifestations of compassion fatigue)—are natural, expected, and valid, and are, in fact, appropriate responses to emotionally difficult work.

Second, acknowledging compassion fatigue may help to build bridges with those who remain unconvinced of the value of well-conducted animal research: talking openly about the toll caring for animals takes on those who work in the lab or oversee lab animal research humanizes these front-line individuals, and demonstrates that it’s possible to think that research with animals is incredibly important and valuable, yet still react with empathy, guilt, or grief to the experiences and loss of the animals in the lab.

Third, talking about the issue within labs and more broadly within institutions might also serve to stop compassion fatigue from becoming an animal welfare issue in its own right. This last point alone should prompt institutional animal care and use committees (IACUCs) to give this topic space in their meetings. As AALAS’ Cost of Caring notes,

To safeguard against feelings of loss, individuals may engage in anticipatory grief practices in preparation for loss… Once the loss occurs, individuals may choose to ignore feelings of anxiety, grief, or bereavement rather than acknowledge and accept these emotions. [This] building of emotional walls, ignoring feelings, and disengaging from the animals can lead to personal emotional vulnerability, a potentially ineffective emotional safeguard, and a loss for the animals in developing feelings of trust, safety, and security.

There are, as a result, practical concerns for the institution in not addressing the impact of compassion fatigue on staff, including high rates of attrition and absenteeism, poor performance, low morale, and an uncaring or callous attitude toward animals that can lead to noncompliance around animal care and use.

A second step, beyond recognizing the issue, is to provide support, both culturally and operationally, within the organization. For instance:

Cultural	Operational
Create an open atmosphere for discussion that encourages staff to acknowledge feelings; consider partnerships with counseling providers if your institution permits	Institute a safe open-door policy, and processes/spaces for employees to reflect and remember
Consider institutional adoption program for animals suited to transition to a home or sanctuary environment (per institutional policies)	Rotate staff to distribute job responsibilities and share difficult tasks, for instance have long-term care givers not participate in euthanasia, or excuse those who do not feel able to participate
Encourage individuals to build an outside support network of family and friends	Offer educational opportunities that address humane animal care and use, animal welfare and ethics
Discuss why the research is important and potential benefits of the results

List derived from AALAS, Cost of Caring

It seems clear that well-constructed, successful animal research programs will only benefit from acknowledging and helping to ameliorate the existence of compassion fatigue among all of those who have a role in promoting the welfare of laboratory animals, whether directly, in the lab, or indirectly, by overseeing research procedures as part of an IACUC. Addressing compassion fatigue and its effects is an emerging challenge for our community, and one where great gains can be made by just starting a conversation. So tell me, does your IACUC or institution deal with the issue of compassion fatigue? How? Do you talk about it with colleagues? Do you provide any support mechanisms? What could PRIM&R do to facilitate the conversation and help IACUCs and institutions manage compassion fatigue among staff?

Sources for additional resources:

Applying Principles to Process: the Belmont Report and the work of the IRB

2015-07-15T12:02:00.000-04:00

The Belmont Report serves as the ethical basis upon which regulations on the use of human subjects in research are based. These principles do not technically govern the research process, and yet are essential to ensure that research is done ethically. At the 2014 Advancing Ethical Research Conference, Gigi McMillan interviewed Ilene Wilets, PhD, CIP, executive director of the institutional review board (IRB) at the New York State Psychiatric Institute, for People and Perspectives. During her interview, Dr. Wilets explained, “you have to have the ethical underpinnings woven into the fabric of human subjects protections.”

In order to get a better understanding of how the Belmont Report is being applied to functioning IRBs, Ms. McMillan asked Dr. Wilets, “How do you see the principles of the Belmont Report being applied in the actual IRB process?”

Respect for Persons: The Belmont Report states, “Respect for persons requires that subjects, to the degree that they are capable, be given the opportunity to choose what shall or shall not happen to them. This opportunity is provided when adequate standards for informed consent are satisfied.” In thinking about her own IRB office, Dr. Wilets spoke of developing a process that leads to valid, informed consent. Further, she also emphasized that we should not compare informed consent as it exists in research to other times when someone may consent to doing something – having Italian food for dinner, or going to a movie, for instance.

Beneficence: In terms of beneficence, the Belmont Report offers, “Two general rules have been formulated as complementary expressions of beneficent actions: (1) do not harm and (2) maximize possible benefits and minimize possible harms.” When considering risk/benefit, Dr. Wilets explained that, in her experience, IRBs are really becoming “brilliant at…looking at best ways to minimize the risk and correctly stating the possible benefit.” That being said, there are many different ways to think about risks, including cultural differences. One thing Dr. Wilets would like to see researchers consider in the future is that “not everyone thinks about risk [in the same way]…we need to find ways to really broaden how we discuss, conceptualize research risk.”

Justice: When considering justice, the Belmont Report asks “Who ought to receive the benefits of research and bear its burdens?” Dr. Wilets explained that she is most interested in distributive justice, where the “risks, benefits, and burdens of research make their way to all communities.” The advent of social media and other technologies has expanded access to research for some, but not everyone. There are individuals who aren’t connected—“You hear that a quarter of the world is on Facebook but [that leaves] three-quarters of the world not on Facebook”—and we should not forget them.

Hear more from Dr. Wilets, including how an IRB administrator facilitates interaction between all stakeholders in the review process, on the People and Perspectives website. Or, share your own thoughts about how the Belmont Report is being applied to processes used in your IRB in the comments below or by sharing your story on the People and Perspectives website.

Research Ethics Roundup: China’s Role in Research, NIH’s Single IRB Policy, and More

2015-07-10T09:17:00.000-04:00

This week’s Research Ethics Roundup reflects on the past by exploring revelations that the US government conducted race-based experiments on American troops and considers emerging issues such as China’s growing presence in biomedical research and the move toward single IRB review.

A Scientific Ethical Divide Between China and West: In this article for The New York Times, Didi Kirsten Tatlow explores some ethical concerns that have come to the fore amidst China’s efforts to “become a leader biomedical research.”

Please, Corporations, Experiment on Us: In this piece for The New York Times, Michelle N. Meyer and Christopher F. Chabris explore whether it can “ever be ethical for companies or governments to experiment on their employees, customers or citizens without their consent.”

Secret World War II Chemical Experiments Tested Troops by Race: Caitlin Dickerson reports on a “once-secret government program — formally declassified in 1993 — to test mustard gas and other chemical agents on American troops.” In this piece for NPR, Dickerson shares that an NPR investigation into the program revealed that subjects were grouped by race.

In the OSP Kitchen – Single IRB for Multisite Research Policy: In this blog post from the National Institutes of Health’s Office of Science Policy, Carrie D. Wolinetz, the associate director for science policy, provides a summary of the comments the NIH received in response to the agency’s December 2014 draft “Policy on the Use of a Single Institutional Review Board for Multi-site Research.”

US Vaccine Researcher Sentenced to Prison for Fraud: Last week, Dong Pyou Han, “a former biomedical scientist at Iowa State University in Ames, was sentenced to 57 months for fabricating and falsifying data in HIV vaccine trials.” This article from Nature explores Han’s case, including Federal prosecutors’ decision to press charges against him.

The Power of Mentoring

2015-07-09T10:06:00.000-04:00

By Megan Frame, membership manager

Every year, PRIM&R’s Mentoring Program connects hundreds of members to one another, in order to share knowledge, grow people professionally, and help solve short- and longer-term challenges. PRIM&R routinely checks in on these mentoring pairs to see how their conversations are progressing, and to assure the match is a good one. Quite often, their feedback reminds us of the importance of this program, and our members’ willingness to support one another.

Today, we are pleased to offer a snapshot into one mentoring relationship between Paul Reitemeier, PhD, corporate director of bioethics at Beaumont Health in Royal Oak, MI, and Ann Morrison, PhD, assistant professor of teacher education and education and outreach liaison for the human subjects protections program at Metropolitan State University in Denver, CO.

Ann Morrison (AM): Paul Reitemeier, referred to me through the PRIM&R’s Mentoring Program, was one of the key contributors to our flourishing human research protection program (HRPP).

In June 2012, I assumed responsibility to rebuild the non-operational institutional review board (IRB) at my university, which has 24,000 students and 1,500 faculty. As an assistant professor in teacher education, my only prior IRB experience was as a researcher and one year serving as a reviewer on the IRB (during which time I read just one protocol and attended our only meeting). The sum total of my knowledge of the ethics, regulations, and precedent for human research protections had come from weeks of late nights reading material on the Office for Human Research Protections and other websites.

After taking over I came to find that we lacked standard operating procedures, accurate or complete records of protocols, and documentation of most determinations. In addition, human research studies had been reviewed incorrectly, had expired while research continued, or had never been properly approved. Many researchers had simply stopped bothering to gain IRB approval for their studies. Our administration, although supportive and enthusiastic to learn, had limited understanding of our institutional obligations. Worst of all, our box was checked so that all of our studies were subject to federal oversight, not only those funded by federal agencies.

Attending the 2012 AER Conference was a baptism into the world of human research protections. The HRPP community was welcoming, supportive, and helpful. One of the bright spots was meeting Megan Frame, PRIM&R’s membership manager. She listened carefully while I told her about my situation, and understood my circumstances and the type of support I needed. I filled out some information and requested a mentor. At that point I would have been thrilled for any help I could get.

Just a couple of weeks after the conference, Megan had a mentor for me. Paul Reitemeier turned out to be much more than “any help” – he became one of the key factors in my ability to build the foundation of a now-thriving HRPP.

Paul Reitemeier (PR): Two years ago, Ann reached out to PRIM&R asking for a mentor and my name was suggested as someone who might be a good fit. I did not even know about the Mentoring Program, but quickly agreed when it was explained to me.

Ann and I began with a phone meeting and then connected for 90 minutes every three weeks for a year, over which time she took her institution from the dark ages (in terms of IRB operations competency) to a font of institutional knowledge, careful review, and IRB best practices in two years.

AM: Each time we spoke, Paul allowed me time to ask questions, regardless how inane. While we often laughed together at the situations I encountered (“We don’t need to get approval from the university IRB because we have a department IRB.”), he never laughed at me or my situation. Paul was considerate of my unique circumstances, and in his feedback and advice he always took the nuances of my situation into account.

In addition to answering my questions, Paul allowed me time to voice my misgivings and consistent challenges (“I need service so I will be on the IRB, but do I really have to review protocols or come to meetings?”). He listened to my frustration and, on more than one occasion, my tears.

Two-and-a-half years later we have two amazing, full-time office staff, SOPs, a qualified panel, complete and accurate records, and an educated and supportive administration, among other things.

PR: It was all due to Ann’s energy, initiative, leadership, dedication, and ability to build the right relationships in the right order. My role was to listen, encourage, make a few suggestions here and there, and to cheer her successes along the way—she did all the work.

AM: I met Paul face-to-face for the first time at the 2014 AER Conference. He was unassuming and gracious amid my gushing thanks.

PR: I knew the next best thing for her would be to get to another PRIM&R meeting, which was beyond her reach the first year. Last year, she managed to get enough support to bring four other staffers with her to the PRIM&R Conference, as well as speak on the schedule! Ann Morrison is a real success story that should be told widely and often. She is a fireball of a presenter, and now that she has become more involved with PRIM&R, I know she will be happy to come whenever she is called.

AM: While he would never take credit for his contribution, I hope Paul knows the positive impact he had on both me and my institution.

Paul and Ann, thank you for sharing your story with the PRIM&R community. You are powerful examples of the value to be found in our PRIM&R community, and the strength of the connections members and others make within it.

PRIM&R members, interested in becoming involved? Learn more about the Mentoring Program, and consider joining as a mentor, mentee, or both. We look forward to working with you!

Questions? Email membership@primr.org.

Data Sharing in Clinical Trials: Webinar Follow-Up

2015-07-08T09:34:00.000-04:00

By Samia Rizk, MD, professor of clinical pathology at Cairo University

Open data refers to “data that can be freely used, shared, and built-on by anyone, anywhere.” Data which is considered “open” is further required to be legally acceptable, technically readable, and available to others. The many potential benefits attributed to data sharing are combined with its many challenges: assuring privacy and security, the autonomy of participants as it relates to their ability to give valid consent, population and cultural issues, measures for appropriate governance, commercialization, and sustainability of databases.

With no binding requirement, it is a scientist’s decision whether or not to share data. Since transparency, openness, and reproducibility are considered part of the scientific method in research, data sharing aligns with those tenets.

In response to the need for a universal framework as to how, when, and what types of data should be shared, the Institute of Medicine’s Committee on Strategies for Responsible Sharing of Clinical Trial Data, recently reported guiding principles and a practical framework to implement data sharing across the research enterprise. To advance understanding of this issue, PRIM&R held a webinar titled, Maximizing Benefits to Research with Human Subjects Through Data Sharing, during which speakers discussed the Committee’s recommendations as they apply to those who review research with human subjects, and addressed data sharing in a research environment and the culture of data sharing at academic institutions.

Many initiatives for data sharing have been driven by funders and research sponsors in order to maximize the usefulness of data gathered. GlaxoSmithKline made a noteworthy announcement in October, 2012, when it stated that it plans to openly share its trial data. In response to mounting pressure from transparency advocates, the large pharmaceutical companies in Europe and the United States adopted a common initiative of sharing data with qualified researchers. They released a joint set of principles that stipulates any released data is subject to terms of protection for patient privacy and confidential commercial information. Such a step by pharmaceutical companies represents a reasonable alternative to proposals put forth by the European Medicines Agency, who requested the release of all data relevant to newly approved drugs, which could undermine the competitiveness of the pharmaceutical industry.

Certain research contexts may require special considerations. Genome-wide association studies are one area in which data sharing is of utmost importance. However, these studies also pose unique concerns related to the big data produced, and the related sensitive and cultural issues. The Global Alliance for Genomics & Health promotes international cooperation and interoperability of data with the aim of harmonizing ethical and regulatory approaches, and promoting autonomy. However, in the context of research involving developing countries special challenges are faced. As an example, the Malaria Genomic Epidemiology Network, a partnership of malaria researchers in over 20 countries, has developed policies and procedures for data release with a key principle of retaining ownership by the contributing investigators through the use of an independent data-access committee and a legally binding data-access agreement.

Implementation of international guidelines for data sharing in developing countries may also face many roadblocks, especially notable is the absence of clear national laws and regulations for data protection and use.

Data sharing and openness is clearly the future of research, yet more discussion and infrastructure are needed to ensure strong adherence to ethical principles is maintained and the protection of human subjects is preserved.

If you were unable to attend PRIM&R’s recent data sharing webinar and are interested in purchasing the archive, you may do so here.

If the Field Fits, Work in it: An Interview with Edith Paal

2015-07-02T09:34:00.000-04:00

By Nora Murphy, membership assistant

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 Edith Paal, MSJ, MPH, CHRC, CIP, IRB program manager at the University of Arkansas for Medical Sciences.

Nora Murphy (NM): When and why did you join the field?
Edith Paal (EP): I joined the field in 2003 after working as a journalist and scientific writer. I worked for nine years as an auditor, then as an auditing manager in the University of Arkansas for Medical Sciences Research Compliance Office, focusing on human subject protections, before joining our institutional review board staff in 2012 as a program manager. I was looking for an area that would allow me to apply my interests in science, ethics and regulatory matters, and writing/editing/communication, and this field has been a great fit in that regard.

NM: What is one tool you use every day that you could not do your job without?
EP: My willingness to admit that I don’t know all the answers, and to go find the answer, or at least an answer that we can support from a regulatory and ethical standpoint (because there are often multiple possible answers).

NM: What’s one specific challenge that you have faced during your career, and how did you overcome it?
EP: Too many of our investigators don’t know about the research-related services and resources available to them on campus. We are still working on overcoming this challenge by being as accessible as possible to the research community through educational offerings, blogs, and encouraging people to get in touch and stop by whenever they have a question. Being responsive to questions and concerns has also helped.

NM: What is one thing you wish the general public knew about human subjects and animal research?
EP: The stories that make the news, describing injuries to subjects or maltreatment of animals due to major ethical lapses, are the outliers. Most people don’t hear about the research that is being done ethically, where no human subjects are injured, and animal welfare and enrichment are high priorities because so many people work hard every day to ensure ethical and regulatory requirements are being met.

NM: What is something you know now that you wish someone had told you when you first entered this field?
EP: It’s really worth it to take the time to deliver bad news in a way that emphasizes that, while we may have a problem, here’s how we can fix it.

NM: What motivates you to maintain your commitment to advancing ethical research?
EP: I am motivated by, and grateful for, the opportunities provided by my work at an academic medical center. I greatly enjoy the variety of research proposals that cross my desk, and the variety of investigators I get to work with—everyone from students doing projects because they are required to do so, to seasoned investigators who are experts in their fields and for whom research has been a cornerstone of their careers.

NM: How has membership in PRIM&R’s community of research ethics professionals helped you to advance in your career or do your job better?
EP: Attending the annual Advancing Ethical Research (AER) Conference whenever possible has been very helpful to me. I’ve found it beneficial to learn that other institutions and human research professionals struggle with the same issues that we do, and hearing how they’ve addressed them has helped me find solutions applicable to our workplace.

Thank you for being a member of PRIM&R, Edith! We’re glad to hear that your experiences at the AER Conference have helped you find solutions applicable to your institution, and we hope to see you in Boston later this year.

Are you joining us in Boston in November? Learn more about the SBER and AER Conferences.

If you’re not part of the PRIM&R member community, learn more about becoming a PRIM&R member, and the benefits that PRIM&R membership provides.

Risk of Groupthink

2015-06-30T10:04:00.000-04:00

Collaborative discussions are not unique to the research ethics community. One can assume that every day, all over the world, there are many groups sitting in rooms trying to come to consensus on issues.

Given our near-universal constraint of time in a day, and the range of knowledge in any given room, these discussions can—often inadvertently—lean towards “groupthink,” where the attempt is made to minimize conflict, and in doing so reach a consensus without considering all viewpoints. Think of it as one of those “everyone agree?…[brief pause]…good, moving on...” situations.

When this happens, some in the group may feel uncomfortable dissenting, and a decision is made without considering all opinions. In this excerpt from People and Perspectives, Christy Rentmeester, PhD, associate professor at the Center for Health Policy and Ethics at Creighton University School of Medicine, discussed the risks that arise with groupthink:

“The risk of groupthink is that dissent is silenced. [If the person who disagrees] is not free to speak up or tell why they think differently, or they are never asked why they think differently, your deliberative process is broken.”

Dr. Rentmeester points out that groupthink is particularly dangerous for IRBs. As she puts it, the “quality of your deliberative process is directly related to how inclusive it is.” There’s always a risk that the process can be intimidating, particularly for those who may not feel they have the power to speak up.

“If you have questions about what you’ve read…you have to have space and you have to have courage to be able to ask those questions. And asking those questions means you are exposing your own ignorance…If you have that question, there very well might be other members of the committee who have that question.”

Watch the full interview with Dr. Rentmeester on People and Perspectives.

Do you have any good methods for ensuring your IRB stays away from, or is aware of groupthink? Have you felt uncomfortable speaking up during a meeting, but you found a method to do so? Share your thoughts in the comments below.

Promoting Animal Welfare through Ethical Service: Servant Leadership and the IACUC

2015-06-26T08:54:00.000-04:00

By Angela Craig, DVM, lab animal veterinarian and institutional animal care and use committee (IACUC) member at the University of Minnesota

Have you ever had this experience? You learn something new, such as an interesting concept or novel word, and suddenly that concept or word comes up repeatedly in a variety of situations over the next few weeks or months. Whether it is a coincidence or just your mind recognizing something that is now familiar, it is an interesting phenomenon.

I’ve recently had this experience with the concept of ‘servant leadership,’ which I was introduced to while participating in a mentorship program for veterinary students. Since then, I feel like I have repeatedly been made aware of how servant leadership can positively impact individuals and organizations.

Servant leadership is not a new philosophy, but Robert K. Greenleaf is credited with describing the modern tenets in an essay he wrote in 1970 called The Servant as Leader. While not every servant leadership concept aligns perfectly with the way an IACUC should function, the basis could be used to promote a healthy and functional committee. At its core, servant leadership is about serving others before oneself, promoting the growth and development of others, sharing power, and creating a better society. According to Larry C. Spears, servant leaders listen, have empathy, are good stewards, build community, and commit to the growth of people. Kent M. Keith would add that they practice self-reflection. These concepts lend themselves easily to the community of individuals that come together to form an IACUC.

IACUCs must have specific members to be appropriately constituted. Without each member’s contribution, the group would lack the richness of experience, knowledge, and perspective necessary to promote scientific growth while ensuring animal well-being. For this reason, it is easy to see how the leaders and facilitators of these committees, the IACUC chairs, could employ servant leadership to make the committee truly strong and engaged. They can make the decision to enhance growth by ensuring thorough training and development of each member, and by encouraging active participation in discussion and committee activities. They can use their voices, not to dictate, but to encourage others to lend their individual voices to every discussion. In turn, these members, who can easily identify their key role within the committee, are equally confident in leading others to promote the culture necessary for a high quality animal care and use program.

An important way for IACUC members to practice servant leadership is to provide guidance to investigators. Thoughtful protocol review and constructive feedback allow members to listen to the needs of investigators and suggest practical refinements. During lab visits members can help research staff to achieve high-quality results by promoting best practices in animal use and sharing helpful tips for remaining in compliance. In-depth mentorship may be necessary for new labs or those struggling with complex issues. Continuing education opportunities provided by the IACUC can help investigators keep their teams updated about expectations for responsible research conduct. In each of these ways, the member is promoting the growth and development of others within the organization. They empower them to take action to improve the program at every level.

By virtue of its role, the IACUC inherently leads others within the animal care and use program. The decisions made by the committee impact the actions and conduct of the local scientific community. If the leadership style of the committee emphasizes service, integrity, and stewardship, it inspires others to lead in the same way. Ultimately, by adhering to servant leadership principles, and promoting them in others, an IACUC can assure a direct positive impact for the animals within their organization.

#TBT: Looking Back at PRIM&R’s 2011 SBER Conference

2015-06-25T10:39:00.000-04:00

It’s been four years since PRIM&R’s last Social, Behavioral, and Educational Research (SBER) Conference and, this November, we will host the 2015 SBER Conference in Boston, MA. As we get ready for this year’s event, let’s look back at topics discussed in 2011 to see how they have transformed and evolved over the years.

Issues around data sharing and privacy have been widely discussed in our community, but they’re not new; even back at the 2011 SBER Conference, these issues were important themes:

In his keynote address, Alex (Sandy) Pentland, PhD, Toshiba professor of media arts and sciences at Massachusetts Institute of Technology, discussed personal data and the movement into a data-driven world. He concluded that current privacy regulations need to be adjusted to deal with this data and its place in the research process. Now, in 2015, this discussion continues and concerns remain about data and privacy, especially since regulations have not yet caught up with this changing landscape.

Members: watch the full video on PRIM&R’s Knowledge Center. Not a member? Join today.

In a panel titled, “Technology, Research, and Implications for Privacy/Confidentiality,” Latanya Sweeney, PhD, professor of government and technology in residence at Carnegie Mellon University, provided context around the concept of de-identification of genetic data. Dr. Sweeney noted that, in 2011, we were still trying to get a handle on the rules surrounding de-identification of genetic material.

Members: watch full video on PRIM&R’s Knowledge Center. Not a member? Join today.

Conversations around these issues have continued, but four years later, the field still grapples with the changing nature of identification, de-identification, and re-identification of data; privacy and confidentiality, and how they are defined in today’s research landscape; how institutional review boards (IRBs) think about these definitions as they apply to their work; and how emerging methods and techniques contribute to these changing definitions. During this year’s SBER Conference, expert facilitators will talk about these subjects during the following sessions:

Plenary Session: Emerging Areas in SBER – During this session, speakers will discuss privacy as it relates to research with social media, mhealth, and the evolving definition of privacy in the research landscape.

C6: Panel Follow-Up: What Do We Need to Do With This? Reviewing SBER Studies that Involve Emerging Methods and Technologies – This session is a follow up to the Emerging Areas plenary session.

Changing Concepts of Anonymity, Confidentiality, and Privacy in SBER (A2, Basic and A4, Advanced) – During these sessions, faculty will discuss the changing definitions of these concepts and will share examples of de- and re-identification of data in SBER.

And for those SBER attendees staying on to continue their SBER-related learning, several related sessions are planned during the 2015 Advancing Ethical Research Conference as well:

Panel III: Moving Targets: The Challenges of Responsible Mobile Health (mHealth) Research will include discussion about privacy as it relates to mHealth and the data being gathered from those technologies

A22: Ethical Issues in Research with Big Data - similar to the above panel, except this session will focus on big data and issues of public trust, privacy, identifiability of individuals or groups, and protection of public interest.

B24: Data Streams, Behavioral Research, and Public Health – similar to the above sessions, but as it relates to SBER and public health.

Panel IV: Picked Out of a Crowd: Privacy and Re-Identification Research – this panel will cover the reverse issue: protocols are designed to explore the limits of existing privacy and confidentiality protections; in particular, this panel will cover research attempting to re-identify supposedly de-identified data sets.

C16: When it Happens to You: Identifying and Managing Privacy Breaches in Research – this session will inform attendees how to manage breaches in privacy.

Data sharing and privacy are just two of the topics that will be discussed at the 2015 SBER Conference on November 12, 2015 in Boston. Registration is now open! View the conference schedule here .

2015 IACUC Conference: Say Anything, We’re Listening

2015-06-24T16:58:00.000-04:00

By Maeve Luthin, professional development manager

PRIM&R’s 2015 Institutional Animal Care and Use Committee (IACUC) Conference brought over 600 individuals from around the world together, in Boston, MA and online through the Virtual Meeting. Approximately 61% of these attendees provided feedback about the conference by completing evaluations.

Better Off Read: We saw a spike in the number of respondents who rated the educational materials and handouts for this program as either excellent or very good. This appears to be the result of a combination of two factors: a record number of faculty members shared their slide decks and session materials in advance of the program, and PRIM&R disseminated these resources through a new tool: the interactive schedule, which allowed attendees to download this information directly from the online conference schedule.

Agents of Yield: Respondents enthusiastically received the three keynote speakers, all of whom have led groundbreaking research: Darin S. Carroll, who spoke about his research in emerging zoonoses, including research on monkey pox; David K. Meyerholtz, who spoke about using novel animal models to further his research on cystic fibrosis; and Frans B. M. de Waal, who spoke about primate social intelligence. In the future, however, respondents indicated that they would like to see at least one general session address issues related to IACUC administration or research ethics. They also would like to see those who deliver talks involving translational medicine explain the intersection of their work with those of IACUCs.

Lions and Tigers and Bears, Oh My! Respondents appreciated the inclusion of sessions on field studies, even if they do not encounter these protocols on a day-to-day basis. “Wildlife protocols don't often come up, but this highlighted how important it is to have them. Hearing about wildlife crises was scary but the experience was also motivating,” one evaluation respondent noted.

Please Use as Directed: Respondents requested that program titles and descriptors be more indicative of the content that will be presented during the sessions, and include such information as the specific learning level (e.g., beginner, intermediate, advanced), and what regulations will be discussed.

Thank you to everyone who took time to share their thoughts about the conference! This feedback—the rest of the conference evaluation results—will be passed onto the 2016 IACUC Conference Planning Committee. That meeting will be held March 30-April 2 in Bellevue, WA. Remember to share your 2016 program ideas by submitting a poster abstract or through the call for session proposals by October 2, 2015. Learn more here.

If you attended the 2015 IACUC Conference, you can view the conference proceedings, using the access key you received prior to the meeting. If you have questions, please contact us.