Poster Spotlight: Disclosure of Fees and Honoraria in Consent Forms

by Avery Avrakotos, education and policy coordinator

The poster presentations for the 2012 Advancing Ethical Research (AER) Conference will soon be announced. To help tide you over while you wait to explore the latest innovations in human subjects protections at the 2012 AER Conference, I sat down with Mike Linke who participated in the poster presentations at the 2011 AER Conference.

In 2011, Mike and his colleagues conducted phone surveys with research participants in order to gauge perceptions of disclosures about fees and honoraria paid to investigators on consent forms and whether or not these disclosures influenced participation decisions. The results of the study suggested that research participants were concerned about financial relationships in research, but that other factors had greater influence on their likelihood to participate.

Avery Avrakotos (AA): It’s been a year since you presented this abstract at the 2011 AER Conference.  How has your research since evolved?
Mike Linke (ML): Upon further analysis of the data, it became clear that disclosure language was not the only piece of information in the informed consent documents that participants had problems understanding. It was also evident that what participants recall from the consent process does not always reflect the real content of the informed consent document itself. We are now planning to conduct debriefing interviews with actual participants in clinical trials to develop a better understanding of the informed consent process and how it relates to information provided in the informed consent document.

AA: What challenges have you faced in implementing your research? 
ML: The institutional review board (IRB) has always concentrated on keeping consent forms as uncomplicated as possible. We have increased our vigilance to ensure participants are able to understand the information being provided. The IRB has discussed implementing a mandatory post-consent comprehension evaluation procedure for all studies; however, we have not implemented this for several reasons. The main argument against implementing a comprehension tool is that this type of evaluation may result in investigators “teaching to the test.” This could take away from the overall consent process and not really improve participants’ understanding. The IRB is continuing to discuss methods to improve the consent process and hopes to use information gained from interviews with participants to develop methods that will lead to development of improved consent documents and processes.

AA: What is one principle that has guided you in your research?
ML: This research was undertaken to develop what information participants in clinical trials understand and retain from informed consent documents. Therefore, in this research, we focused on the principle of respect for persons. This principle dictates that, participants must be given the information they need to make a truly informed consent to participate in a research study.

Thank you for sharing, Mike! Readers, we hope that you will be able to join us at the 2012 AER Conference to explore the efforts of this year’s poster presenters. 

Insider trading based on clinical trials: One of many unethical behaviours in clinical research

by Johan PE Karlberg, MD, PhD, BSc, Founder and Editor of Clinical Trial Magnifier; Author and Editor of Reviewing Clinical Trials: A Guide for the Ethic Committee; and Author and Editor of Study Site SOP Standardization – The 4S Project

During the past thirty-five years I have been active in clinical research; between 1998 and 2011, I acted as the director for the Clinical Trials Centre at The University of Hong Kong. During those twelve years we conducted 640 industry-sponsored clinical trials. I have seen many good clinical studies, but also a number of poorly run, unethical studies.

Unethical and fraudulent behaviour have become more and more common among academics. For instance, a recent article in Nature reported a 1,330% increase in the number of retracted publications in scientific journals, even though the total number of papers published has risen by only 44% over the past decade.

A recent study in the British Medical Journal included the responses of 2,800 clinicians and academics. The study showed that 13% had witnessed colleagues intentionally altering or fabricating research data and 6% were aware of possible research fraud at their institution that hadn't been properly examined. If those figures are accurate then we are facing scientific fraud on a large scale. The saga goes on and on.

Fraud and manipulation of research data can also be linked to other unethical behaviour. I just came across a report about a medical professor at a university in Germany. He has been a world-leading clinical researcher in anesthesiology  He is currently under criminal investigation for possible research forgery. According to the report, 89 of 102 studies published by the professor contained research that lacked proper approval from an ethics committee.

Another area of fraudulent behaviour is insider trading. Last November, US regulators were suspicious when Gilead Sciences, Inc. announced it was buying Pharmasset, Inc. for $11 billion. The stocks volume and per share premiums were unusually large, prompting US regulators to investigate the transaction. In another example, from August 2012, Robert Ramnarine, a Bristol-Myers Squibb executive, was arrested and charged with making $311,361 in illegal profit by buying stock options in three companies targeted for acquisition.

Concerns about insider trading also exist in academia. There are growing concerns about the interaction between academic researchers and the life-sciences industry, and the extent to which confidential research data are being traded improperly. For instance, a French doctor in Paris was an investigator for a trial of a hepatitis C drug. He also acted as a member of the steering committee for the trial. The doctor was accepting gifts and cash in exchange for insider information that he gave to an American hedge fund manager. The doctor recently pleaded guilty and was sentenced in the US to a total of 24 days in prison. The US hedge fund manager was sentenced to five years in prison. This example demonstrates that inappropriate exchange of early results from clinical trials has reached international proportions, further challenging efforts to detect it. It also shows that society views such crimes more and more seriously, as evidenced by the sentence of the fund manager.

Inspired by these cases, I have written a detective novel (published under the name Marjus Swan) addressing unethical and fraudulent behaviours in clinical research.

Assassin in Svanstrand is a detective story about the unethical conduct of clinical trials and insider trading based on the trial results. The story takes place in Svanstrand, a small Swedish fishing village and summer holiday paradise for people escaping from the city. A series of murders occur during a heavy Christmas snowstorm that paralyses infrastructures in Svanstrand, Österlen, and Skåne. Assassin in Svanstrand is available as an ebook at Amazon.com, and a second novel on this same topic is underway.

My objective is to expose this very challenging and disturbing development to a larger public, so that we can begin to work towards addressing and combating these issues. I welcome you to share your own experiences and what you have done to address unethical behaviours in the conduct of research by leaving a comment or emailing me at CTMagnifier@gmail.com.

Document, document, document: An interview with Melissa Epstein

By Joanna Cardinal, Assistant Director for Membership and IT Operations

Today, in the second of our posts on PRIM&R’s Diversity Advisory group, we’d like to introduce you to Melissa Epstein, PhD, CIP. Read previous posts in this series here.

Melissa Epstein has been a PRIM&R member for five years. She received her Bachelors Degree from the University of Pennsylvania, has a PhD in linguistics from UCLA, and conducted her doctoral dissertation on vocal cord vibration patterns in English. She had further training as a postdoctoral fellow at the University of Maryland Dental School where she studied three-dimensional modeling of tongue motion during speech. After her postdoc, Melissa pursued a career in research administration and human subjects protection. In 2009, she obtained a certificate in bioethics from the Montefiore-Einstein Center for Bioethics. She is currently pursuing a Masters in bioethics from the Center, and works for the recently combined Montefiore and Einstein institutional review boards (IRBs).

Joanna Cardinal (JC): When and why did you join the field?
Melissa Epstein (ME): I joined the field in November 2005. I had wanted to pursue a career in research administration or science policy after my time in academia. My father, a professor at Ohio State, introduced me to the director of the university’s IRB and the compliance director at the university’s medical center. The two of them encouraged me to look at jobs in human subjects protections, and have been incredible mentors and resources ever since.

JC: What skills are particularly helpful in a job like yours?
ME: Being able to see things from both the research and the IRB side. Having been an investigator, I understand how frustrating the IRB process can be.  Also, having very good organizational skills has been important.

JC: Tell us about one or more articles, books, or documents that have influenced your professional life. Or, tell us about one or more recent articles, books, or documents that you feel are particularly relevant to the field.
ME: I have been strongly influenced by David Rothman’s Strangers at the Bedside. It tells the story of 20th century medicine and clinical research, and is an eye-opening explanation of the modern doctor-patient relationship. On a more entertaining note, this summer I read Alexander McCall Smith’s Isabel Dalhousie series. Isabel, the title character, is a philospher and informal detective, and loves pondering philosophical and moral conundrums. It’s been a charming review of basic philosophy!

JC: How has membership in PRIM&R’s community of research ethics professionals helped you to advance in your career?  
ME: My PRIM&R mentor has been a tremendous resource in navigating both the regulations and my career.

JC: Why is the issue of diversity important to you?
ME: It is important both from a scientific perspective (our research results should be representative of and applicable to the population) and from an ethical perspective (the principle of justice requires that the entire population bear the burden and receive the benefits of research).

JC: Why did you agree to serve on PRIM&R’s Diversity Advisory Group?
ME: I strongly believe in giving back to my professional community. It’s a pleasure to serve.

JC:  What would you suggest to readers who are looking to strengthen the diversity of their institution, organization, or company?
ME: This is a very good question. I’m hoping we will come up with some good answers at our Grand Finale Session at the 2012 Advancing Ethical Research (AER) Conference.

JC: What advice have you found most helpful in your career?
ME: Document, document, document. And you can never thank people enough for helping you.

JC: What is something you know now that you wish someone had told you when you first entered this field? 
ME: How many paper cuts I would get when reviewing a file! And when you get beyond the paperwork, how much I would enjoy thinking deeply about the ethical issues in our field.

Interested in hearing more from Melissa? Join her and Diversity Advisory Group Chair Eric Mah on December 6 at the 2012 AER Conference for Grand Finale 7 -The Uncomfortable Conversation: Talking about Diversity.

Your thoughts on this important topic are welcome. To share your perspective on diversity with the DAG, please leave a comment or email membership@primr.org. 

Would we even have Belmont without the PHS Syphilis Study at Tuskegee?

by Elizabeth Cooper, program assistant 

October 2012 marks the 40th anniversary of the end of the 40-year-long Public Health Service (PHS) Syphilis Study at Tuskegee. Partly because of this significant milestone, the study and its legacy for the research ethics field have been on our minds here, at the PRIM&R office, and were the topics of discussion during a recent staff meeting. To stimulate our discussion, the staff read excerpts from Tuskegee’s Truths: Rethinking the Tuskegee Syphilis Study, Susan Reverby’s excellent, comprehensive collection of primary and secondary documents, which when viewed together present a range of perspectives on this infamous study.

As many readers may know, the “Tuskegee Study of Untreated Syphilis in the Negro Male” was initiated in 1932 and ran until 1972, when a whistleblower notified the press of the unethical nature of the experiments prompting an investigation and closure of the study. We noted in our staff conversation that the disregard for what we now consider basic rights of research subjects exhibited in this study was almost certainly not unique in that era. However, the public condemnation of this study marked a turning point in the evolution of research ethics attitudes and policy.

Indeed, the ethical problems of the study are so flagrant and numerous that, as we reflected on them—with the perspective afforded by 40 years—it was easy to understand how the recognition of these atrocities contributed to the development of the Belmont principles and their application in law.

During our conversation, we discussed some of the most blatant ethical problems of the study including the racist subject selection process, deceptive recruitment practices, lack of informed consent, withholding of treatment, and lack of continuing review of the study. These failures are all the more shocking in light of the fact that  the medical research community was privy to the study details throughout its 40-year duration.

Clearly, the implications of this study have been far-reaching, and our conversation led us to further probe the historical significance of the study and the reaction to it. We questioned how an atrocity such as this could have gone unexamined and unstopped for so long on the heels of the Nazi crimes involving human experimentation and  subsequent codification of the principles of ethical research in the Nuremberg Code. How could the research community tolerate such practices?

The Belmont Report was written, in part, in reaction to the PHS Syphilis study, and became the foundation for legislation governing protection of human subjects in research.  Reflecting on the protectionist pendulum swing that occurred in the aftermath of the syphilis study and in the writing of Belmont, we could not help but notice that research ethics has been and seems to continue to be born out of scandal. Therefore, how can we know when we have done “enough” to ensure that atrocities such as these do not happen again? We wondered, would we even have Belmont without the PHS Syphilis Study? Or, if not that tragedy, would some other unethical study have gained equal infamy at a later point in time to have spurred the development of human subjects protections?

As we prepare to reflect on the end of the study at our 2012 Advancing Ethical Research Conference this December in San Diego, we are aware that much progress has been made but that there is work yet to be done to protect the rights and welfare of research subjects.

Time Capsule Tuesday: “Local IRBs are simply out of their league.”

In October 1989, PRIM&R hosted a conference titled Whither IRBs in the 1990s? New Directions and New Decisions. During the conference, Professor George Annas, JD, MPH, reflected on the limits of institutional review boards (IRBs) when speaking on a panel about uses of fetal tissue and genetic research. He observed:

I think that IRBs have to recognize their institutional limits. In dealing with artificial hearts, xerographs, genetic engineering research, embryo research, multiple organ transplants, first-of-their-kind transplants, and fetal tissue transplants, local IRBs are simply out of their league. In dealing with such issues, they have reached the limits of their institutional competence. They should understand that they may be able to play basketball, as I can, with my son, but they certainly cannot play in the same league as Larry Bird; to pretend that they can is simply something that is going to lead not only to disillusionment, but to conclusions that simply will not hold. As an IRB member, you may think of yourself as Daniel in the lion’s den; you may think that, no matter what you do, people are not going to like you. It seems to me that the challenge for the nineties is to try to determine what to do when you reach your institutional limits. 

Do you agree with the assessment made by Annas? Has the charge he set forth been met? How do we define institutional limits in human subjects protections, and where do we go when those limits are met?

Research Ethics Roundup: Fast-tracking obesity treatments, stem cell research, and more!

Autumn may be here, but the leaves are not the only things turning heads this week. Peruse the latest installment of the Research Ethics Roundup for some colorful articles, including a fresh perspective on the purported rise of fraud in research, an essay on the role of institutional review boards (IRBs) in social science, and much more.

Stem cell opponents appeal to U.S. Supreme Court: This week, two scientists seeking to block Federal funding for human embryonic stem cell research filed a petition to the U.S. Supreme Court to appeal the August ruling by a Federal appeals court against their claim. The decision in this case may have a significant impact on the funding available for future research involving stem cells.

FDA considers faster approval process for obesity drugs: According to Bloomberg, the Food and Drug Administration (FDA) has announced that it is will consider allowing the use of an accelerated clinical trial and approval process for certain drugs and treatments “deemed to offer societal benefit despite their risks.” Details are still unclear, though it is expected that the approval pathway might be used for antibiotics and weight-loss treatments.

Ethics, interdisciplinarity, and the institutional review board: This fascinating post on Southern Fried Science examines the role of the IRB, not just in medical research, but within the context of social science as a whole. Through the use of two hypothetical case studies, the author illuminates how the current IRB system can be both a burden and a benefit to non-medical scholars.

Scientific fraud: a sign of the times?: Has dishonesty become endemic in the world of research?  The author of this piece argues that recent press coverage of scientific misconduct may have exaggerated the pervasiveness of fraud in science. The article suggests that violations of integrity occur very rarely, and should not serve as the barometer for the state of science as a whole.

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

Update from PRIM&R’s Public Policy Committee

by Amy Davis, JD, MPH, Senior Director for Programs and Publications

PRIM&R recently sent comments to Congressman Edward Markey, (D-MA), senior member of the House Energy and Commerce Committee, on a bill called the Trial and Experimental Studies Transparency (TEST) Act of 2012. The goal of the bill is to increase transparency of clinical trials by expanding reporting and registration requirements for ClinicalTrials.gov, an online clinical trial registry data bank.

 

In his press release about the bill, Rep. Markey argues that current registry and reporting requirements contain loopholes that deny the public full access to clinical trial information. Rep. Markey states that “Unreported results and missing registrations leave participants, doctors and researchers vulnerable.”

 

Under the new bill, all foreign clinical studies must meet the same registration and reporting requirements as domestic trials if they are conducted in support of a Food and Drug Administration product application. This is a powerful enhancement to the clinical trials registry given the increasing amount of research being conducted overseas.

 

In its letter to Rep. Markey, PRIM&R expresses support for increasing transparency of clinical trials. We agree that greater transparency will strengthen the public’s trust in the research enterprise. However, PRIM&R cautions that preliminary steps be taken to analyze the efficacy of the current registry systembefore attempting to expand its requirements. PRIM&R argues that if the current structure is not serving the public as intended then “expanding the registration and reporting requirements will do little to further transparency and knowledge.”

 

As always, we welcome your thoughts. Let us know what you think of the TEST Act and PRIM&R’s letter to Congressman Markey.

A feminist perspective on community engagement in research

by Kaye Edwards, Associate Professor of Independent College Programs at Haverford College

On September 27, I attended the PRIM&R webinar titled Community Engagement in International Research: Considerations for Ethics Review with Jim Lavery, MSc, PhD, and Katherine King, PhD. As a new member of PRIM&R and a former institutional review board (IRB) member at my institution, Haverford College, I found the webinar to be relevant and thought-provoking.

In their role of protecting human subjects in research, institutional review boards (IRBs) tend to focus on informed consent of individual participants, but Lavery and King encouraged us to consider not just individuals who directly participate in a study, but the broader community that may be affected by the research or interventions. Lavery and King draw on the report by the Presidential Commission for the Study of Bioethical Issues, Research Across Borders: Proceedings of the International Research Panel of the Presidential Commission for the Study of Bioethical Issues, which calls for researchers to “demonstrate respect for human subjects and their communities in all phases of clinical trial design and implementation. Recognizing other cultural standards and practices through community engagement is one concrete means of showing respect.”

In their webinar, I heard a call to move from our current framework of securing individual consent to the larger and inherently political process of seeking consensus, in order to respect the voices of different, relevant interest holders within a community. In their nuanced and multi-layered presentation, Lavery and King espoused a new perspective on community engagement and offered guidelines for demonstrating respect through the formation of ongoing relationships to help reduce the risks, balance the benefits, and enhance the legitimacy of the research program. They also argued that community engagement in global health research “is about seeking and facilitating aggregate agreement from the collection of layers of authority within the ‘relevant community.’”

While I support their overall framework, I see much work yet to be done. As a faculty member who teaches courses in global health justice and in gender and sexuality studies, and as a biomedical researcher who is embarking on a new collaboration to prevent cervical cancer in Central America, I am concerned about the on-the-ground realities of negotiating the different layers of authority. While respect for communities is essential for researchers working across borders, what happens if women's voices and/or health are not respected or valued within a given community? How do we respond when women don’t have the political space to voice their concerns or to help shape the community’s consensus about projects that may improve their health?

I hope that feminist ethicists, anthropologists, and others will share their insights and experiences as to how researchers can respectfully engage with communities, while not compromising women’s basic human right to health. Please join in the discussion.

Community engagement picks up where the usual guidelines and regulations leave off

by Alexandra Shlimovich, Online Learning and Certification Coordinator

On September 27, 2012, PRIM&R hosted a webinar titled Community Engagement in International Research: Considerations for Ethics Review. Following the webinar, I had a chance to connect with the presenters, Jim Lavery, MSc, PhD, and Katherine King, PhD, to discuss some of the questions they were unable to cover during the time allotted for the webinar.

Alexandra Shlimovich (AS): How is the framework for community engagement (CE) you presented different from the framework for research with individual participants?
Jim Lavery (JL): There are many ways to answer this question, and I'll try to highlight a few of the differences we see and some challenges associated with focusing on communities in general. It’s important to remember that we try to start from an "interests-based" perspective. In individual-focused regulations and guidelines, the interests of the participants are paramount. One simple way to think about the CE framework is that it picks up where the usual guidelines and regulations leave off. Rather than limiting the focus to participants or the occasional third party, we work on the assumption that there are people and organizations whose legitimate interests may be affected by the research. Therefore, one way to think about the CE framework is that it is an individual-focused framework, but it applies equally to anyone with a legitimate interest in the conduct and outcomes of the research.   

Katherine King (KK): Whether it makes sense to talk about collective interests (interests that belong to the group proper) above and beyond the collected interests of individuals is a philosophical dilemma. Individual interests and/or individual harms can never be meaningfully collected. We are inclined to believe that there are some interests that people share in ways that go beyond each individual, but this would require a far lengthier discussion than space allows for today.  Moreover, this subtle distinction will not alter the importance of community engagement. As in either case, the core proposition of community engagement remains the same: -research affects the interests of people and organizations beyond the traditional research participant, and these further people and organizations should be given a voice in the research program.

AS: What is the power balance between communities and researchers through CE (especially with regard to knowledge)?
JL: The issue of power often comes up when we discuss CE, and in some respects, CE is all about power. One way of thinking about power is that the interests of investigators, or sponsors, or funders, or host institutions, tend to be prioritized over the interests of the poor people who are often the end targets for new treatments or technologies. Just because certain interests tend to be given priority over others doesn't mean they aren't legitimate, so an ideal approach would facilitate a fair and reasonable balancing of all interests. This is what we'd like to see in a CE framework eventually, but there are lots of details to be worked out before that is likely.

AS:  Have you had any experience with establishing a community ombuds or bridge leader to address the changing relationships during the trial?
JL: We have not personally had the experience of establishing these kinds of roles, but we have seen different forms of representation used s, in various contexts. The whole question of "representation" is itself an extremely complex.  We have also been doing some  other work related to "brokering" engagements between and among various interest-holders. I think we need more case examples of how these roles work.

AS: What is the relevance of ownership in CE from the perspectives of both communities and researchers? How does CE transform power relations between investigators and the communities?
JL: The term "ownership" is often used in discussions about CE. We have seen many examples of community members (i.e., those participating in trials, or those living and working in the immediate vicinity of a trial or study, or participating in other direct ways) explaining to us how their sense of "ownership" of a project, or their stakes in the project, has been enhanced because of CE. For example, in a study with sex workers in Kenya, the women talked about the profound impact on them when the investigators provided them with a dedicated meeting space. This very concrete gesture made the women feel that they were much more a part of the study than they had ever felt previously. The downside of relying too heavily on the term "ownership," is that it is usually meant more figuratively than literally. This takes us back to the power issue. In our interests-based model, ownership (i.e., having the final control over key aspects of a study and the necessary resources at your disposal to effect the necessary decisions and actions) may ultimately matter less than whether your legitimate interests in the conduct and outcomes of the research are acknowledged and addressed fairly. 

AS: When should an IRB require the development of a CE plan?
JL: An IRB should develop a CE plan when the IRB suspects there may be people or organizations with legitimate interests in the research and whose interests could be affected by the research, but who have not been accounted for in any way in the research plan. Our CE framework provides a decent starting place. It was designed to be short and digestible and provides 12 "points to consider" rather than a long document that is difficult to navigate.

If you’re interested in learning more about community engagement and did not have a chance to participate in last week’s webinar, the archive is available for purchase. PRIM&R members can also access additional readings related to this topic on our Knowledge Center.

Raise awareness to unfair treatment or situations: An interview with Eric Mah

by Joanna Cardinal, Assistant Director for Membership and IT Operations

In 2006, PRIM&R’s Board of Directors adopted a number of core values to codify the culture and priorities of our organization. One of these core values is diversity, or the priority of working “hard to value and promote the diversity of people, ideas, and opinions.” To ensure success supporting this value, in 2011, the Diversity Advisory Group (DAG) was developed. The DAG’s initial goal is to examine the issue of diversity as it pertains to PRIM&R’s membership. Specifically, the DAG will make recommendations to the staff and Board of Directors regarding strategies and/or activities designed to ensure that we are maximizing our outreach to diverse populations (including diversity of gender, age, ethnicity, race, geography, professional position, and institutional affiliation) and that PRIM&R is generally fostering an environment where different communities, professions, and ideas can flourish. In a series of posts here on Ampersand, we’ll introduce you to the members of the DAG and explain the group’s work.

Today, in our first post about the DAG, we’d like to introduce you to Eric Mah, MHS, CIP®, who serves as a chair of PRIM&R’s DAG.

Eric Mah has been a PRIM&R member for four years. He received his undergraduate degree in philosophy at the University of California, Los Angeles (UCLA), obtained his master’s at the Johns Hopkins School of Public Health, and is a full-time doctoral student in education at the University of California, Davis. At the same time, he is currently the senior director of the research compliance program in the Office of Ethics and Compliance at the University of California, San Francisco, and has held leadership positions in human research protection programs at the University of California, Davis and UCLA. Eric regularly presents to audiences at national conferences as well as government advisory and legislative committees on issues dealing with human subjects protections, conflicts of interest, and research ethics.

Joanna Cardinal (JC): When and why did you join the field?
Eric Mah (EM): In college and graduate school I was drawn to philosophy, ethics, and public health. I started working in behavioral research in 1995, but I found that applied research—while unquestionably important—did not excite me like I could see it excited my co-workers. Looking for something different, I transitioned to the institutional review board (IRB) in 2007. Having had experience submitting IRB applications, and with a background in medical ethics, I hoped I could impact the IRB process in a positive way.

JC: What skills are particularly helpful in a job like yours?
EM: Problem solving and communicating effectively are important, as is budgeting and forecasting. Usually there is a limited amount of information available to base a decision on and you try your best to (1) collect all of the data you can on an issue, (2) weigh the quality of the data, and (3) make the best decision based on the first two.

JC: Tell us about one or more articles, books, or documents that have influenced your professional life.
EM: The ubiquitous What Color Is Your Parachute? (Bolles) because all of us have asked at least once in our lives, “Am I doing the right thing in my work/career?” Understanding Power (Chomsky), regardless of whether you agree with his political leanings, he talks simply and clearly about power in ways that play out in communities and governments; A Theory of Justice (Rawls) is a must-read for anyone serious about normative ethics and how to weigh right versus wrong in everyday situations, and Zen at Work (Kaye) because hectic work can just sometimes spin you out of control and you need a way to keep it together.

JC: Have there been any PRIM&R events or talks that you have attended that have significantly impacted your approach to your work?
EM: Anytime I attend a conference, if I learn one new thing that actually leads to an improvement to a practice or procedure at work, I consider it a good conference. PRIM&R tends to give more of those opportunities consistently than any other organization in this field. I credit this to PRIM&R for bringing new voices and diverse perspectives to the table.

JC: How has membership in PRIM&R’s community of research ethics professionals helped you to advance in your career?
EM: I have been tremendously fortunate in my career and PRIM&R allows open dialogue to challenge norms through questioning fellow members, speakers, and participants. Much of what IRB and institutional animal care and use committee (IACUC) folks do is rooted in prima facie straightforward regulation, but there is an art and skill to the work as well because we interact with people, not simply their protocols and applications. PRIM&R is a place to explore new ideas, identify others who take similar (or different) approaches in philosophy and professional sensibility, and to build on those relationships.

JC: Why is the issue of diversity important to you?
EM: Diversity is critical to the success of any organization, and I do not limit “diversity” to ethnic or racial diversity, but that is commonly part of any diversity discussion. We need diversity in age, experience, geography, able-ism, sexual orientation, gender identity, political affiliation…you name it. Without diversity and a community that represents a variety of opinion or ideas, organizations stagnate. Our field is no different from others in that we need innovators, people who challenge the norms, but also people who question change. Consequently, a full set of ideas and opinions are then available for broad consumption and discussion. Last but not least, it is imperative to have a supportive, nonjudgmental, and intellectually safe place to engage in this conversation. PRIM&R has tremendous potential in this regard.

JC: Why did you agree to serve on PRIM&R’s Diversity Advisory Group?
EM: I took it as an honor to contribute back to PRIM&R. I appreciate the openness from PRIM&R’s executive director Joan Rachlin, the PRIM&R staff, and the Board of Directors to the Diversity Advisory Group’s ideas. When you are part of an organization, care about its success, and are called upon to help support it, you simply must.

JC: What would you suggest to readers who are looking to strengthen the diversity of their institution, organization, or company?
EM: It starts small. Often times it can seem overwhelming. How can I change this big place when I’m just one person? You change your community by being the change you seek, to paraphrase Gandhi. Beyond treating those around you with honesty and respect, you must raise awareness to unfair treatment or situations and micro-aggressions, and give voice to those who may not have the influence, power, or confidence to defend or stand up for themselves.

JC: What advice have you found most helpful in your career?
EM: Give credit where credit is due. When I hear a great idea, I tend to blurt out: “I think it’s a great idea!” And I mean it. I probably wish I had thought of it first. Good ideas are meant to be shared and I’m likely to share the great idea with others and tell them who came up with the great idea. In competitive times or perhaps out of inexperience or insecurity, not enough people share other people’s great ideas and give credit where credit is due. It builds trust, respect, and just makes work more fun for everyone.

JC: What is something you know now that you wish someone had told you when you first entered this field?
EM: We make our own happiness. A mentor and friend, Warren Littlefield, who was president of NBC Television in the 1990s shared with me years ago, “Sometimes you need to know what you don’t like to do before you know what you do like to do.” In our field, there are many different kinds of work requiring many different kinds of skills that there is a match for everyone. Perhaps you prefer teaching or giving presentations, there’s an education position. Perhaps you like structure and order, there is auditing and post-approval monitoring positions. Like numbers? Budgeting, billing, or analytics. There are no bounds. The positions that use your strongest skills tend to be the most enjoyable.

Interested in hearing more from Eric? Join him and fellow Diversity Advisory Group member Melissa Epstein on December 6 at the 2012 AER Conference or Grand Finale 7 - The Uncomfortable Conversation: Talking about Diversity.

Your thoughts on this important topic are welcome. To share your perspective on diversity with the DAG, please leave a comment or email membership@primr.org.

Research Ethics Roundup: Scientific misconduct, reporting science, and more!

Is it October already? Time to break out those scarves and mittens! As you’re digging through the attic this weekend, be sure to take a break to catch up on some recent headlines. From investigations into scientific integrity, to using crowdsourcing for drug development, you won’t want to miss the articles featured in this week’s Research Ethics Roundup. 

Reporting science: Journalistic deficit disorder: A recent study has found that, of articles written in English-language newspapers during the 1990s relating to attention-deficit hyperactivity disorder (ADHD), the vast majority focused on only a handful of studies. Further studies examining the validity of these papers were rarely published, despite the fact that 80% were later proven to be “wrong or questionable.” These findings suggest that news sources may be contributing to a distorted perception of progress in scientific research.

New cures sought from old drugs: After Ionafarnib failed to effectively fight head and neck cancer—the disease it was originally designed to treat—researchers have found it to be successful at treating progeria, an unrelated illness. This success has inspired drug manufacturers to utilize crowdsourcing to search for alternative uses of failed drug compounds.

Seeking cures, patients enlist mice stand-ins: A new technique is allowing doctors to test the efficacy of several different drugs or doses simultaneously on a specific patient’s disease or immune system. The process involves transplanting the individual’s disease or immune system into several different mice, and then using the animals to test treatments before attempting them on the human subject.

Misconduct widespread in retracted science papers, study finds: A new study has found that in 2011—a year that saw an unprecedented rise in the number of retracted scientific papers—roughly three quarters of the retractions analyzed could be attributed to misconduct. According to one of the researchers, “the rising rate of retractions reflects perverse incentives that drive scientists to make sloppy mistakes or even knowingly publish false data.”