Tuesday, August 19, 2014
Conducting empirical research on research ethics can be daunting. It requires thinking beyond the ethics of a treatment, procedure, or new technology to considerations involving the scientific validity, social value, and potential ethical challenges of the research process itself. Nonetheless, ongoing evidence-based research is crucial for the advancement and improvement of the responsible conduct of research.
The Fordham University Center for Ethics Education, in partnership with the Fordham HIV and Drug Abuse Prevention Research Ethics Training Institute, has addressed the need for resources in this area through the creation of the Research Ethics Scales and Measures website. The site was developed with the intention of encouraging empirical research on research ethics by providing researchers with existing scales and measures—quantitative tools such as questionnaires and surveys—they can utilize or adapt in their own research.
This continuously updated evidence-based research ethics resource includes an extensive index of scales and measures for investigators who wish to study all aspects of research ethics, including consent capacities of vulnerable populations, participant perspectives on research risks and benefits, attitudes toward and challenges facing IRB protocol evaluations, and the effectiveness and challenges of community engaged research.
The site also contains an extensive bibliography of methodological approaches to conducting empirical research on research ethics. Users may search for measures by content area keywords (e.g., monetary compensation, or motivation to participate) or by method (e.g., evaluations, interviews, questionnaires or vignettes).
As the only comprehensive source of its kind, Research Ethics Scales and Measures website has received national attention. The site was mentioned in the Center for Disease Control and Prevention’s Minority Health newsletter, and has been listed as a resource on the American Anthropological Association’s website and the National Academy of Engineering’s Evaluation Tools website.
IRB members and investigators are encouraged to submit their own research ethics scales and measures for consideration, or submit any measures that are not included on the site. Please send submissions to Elizabeth Yuko.
In addition to the Research Ethics Scales and Measures website, the Fordham University HIV and Drug Abuse Research Ethics Training Institute also makes available several other research ethics resources. More than 500 empirical and theoretical articles and chapters are included in the continuously updated HIV and drug abuse prevention bibliography, and are categorized by topic.
The resources website also contains pages with downloadable lectures given by faculty of the HIV and Drug Abuse Prevention Research Ethics Training Institute, information on research ethics regulations and guidelines, and relevant government and organization resources.
IRB members and investigators are also encouraged to submit commentary to the Center’s Ethics and Society blog, which provides the most up-to-date ethics news, opinion pieces, funding and job opportunities, event listings, calls for papers or conferences, and other relevant announcements.
Celia B. Fisher, PhD, is the Marie Ward Doty University Chair, professor of psychology, and director of the Fordham University Center for Ethics Education and the Fordham HIV and Drug Abuse Prevention Research Ethics Training Institute. She has served on the National Academies' Revisions to the Common Rule for the Protection of Human Subjects in Research in the Behavioral and Social Sciences Committee, the Secretary’s Advisory Committee on Human Research Protections, chaired the Environmental Protection Agency’s Human Studies Review Board, and received the 2010 Health Improvement Institute's Lifetime Achievement Award for Excellence in Human Research Protection.
Elizabeth Yuko, PhD, is a bioethicist at the Fordham University Center for Ethics Education and the program administrator for the Fordham HIV and Drug Abuse Prevention Research Ethics Training Institute. She is the senior editor of Ethics and Society.
Tuesday, August 5, 2014
Recently, PRIM&R received a letter from Allyson J. Bennett, PhD, chair of the Committee on Animal Research and Ethics at the American Psychological Association (APA), and Sangeeta Panicker, PhD, director of research ethics at the APA, in response to a post on Ampersand. The post, “40 Years of Research Ethics: Environmental Enrichment,” was intended to highlight the development of environmental enrichment practices in animal research, and referenced a 2005 article published in the Institute for Laboratory Animal Research Journal.
PRIM&R is committed to transparency and respectful dialogue and, to that end, we would like to use this opportunity to share with you the letter from Drs. Bennett and Panicker:
“We are writing to express our strong disapproval of the messages endorsed in a recent PRIM&R blog post titled “40 Years of Research Ethics: Environmental Enrichment”. Contrary to well established facts, the post implicitly maligned a distinguished member of the psychological science community (involved in the ‘Silver Spring Monkey case’), and lauded the less than honorable tactics of the individual associated with a group, People for the Ethical Treatment of Animals (PETA), that is publicly opposed to research with nonhuman animals. Furthermore, based on scant, if any, credible evidence, the blog post credited PETA for almost singlehandedly achieving changes to the Animal Welfare Act (AWA) that led to environmental enrichment requirements for research animals.
We are disappointed that PRIM&R has used this forum to contribute to and perpetuate substantial misrepresentation of the history of laboratory animal welfare regulations in the US, and the role of various entities in effecting regulatory change. An accurate account is imperative given the continuing efforts by entities opposed to research with nonhuman animals to unfairly portray scientists and the research community as callous and uninterested in the humane care and treatment of nonhuman animals in research. Such a portrayal is not only false but also disregards the central and essential role that scientists have and continue to play in producing the knowledge, understanding, evidence, and actions that improve laboratory animal welfare. Ironically, it was pioneering research by behavioral scientists that provided the evidence in support of environmental enrichment for captive animals, including nonhuman animals in research.
Research by psychologists such as Donald Hebb and Mark Rosenzweig demonstrated the tremendous effects of enriched environments on laboratory rodents. While the bulk of the research by Harry Harlow was on learning, his work on attachment and social stimulation changed views of nonhuman animal behavior and cognition in radical ways and drove improvements in captive animal care in both laboratories and zoological parks. It is also worth acknowledging that laboratory studies of nonhuman primates and other nonhuman animals were essential to changes in our understanding of and appreciation for the complexity of nonhuman primate cognition and behavior. A great deal of this work, which would not have been possible in field settings, has contributed novel insights that, in turn, have shaped changes in our views about and treatment of the animals in laboratories and zoos as well as the wild.
Finally, circling back to the events described in the PRIM&R blog post, we note that not only was the researcher in question exonerated on all but one count of AWA violation by USDA, as well as the US judicial system, but three highly respected scientific organizations—the American Association for the Advancement of Science, the Society for Neuroscience, and the American Psychological Association—independently investigated the so-called ‘animal abuse’ and found his conduct to be beyond reproach. Furthermore, in light of the baseless accusations against the researcher, we believe it is incumbent upon PRIM&R, the premier organization in the continuing education of institutional animal care and use committees, to acknowledge the impact of this ethically and scientifically sound research with nonhuman primates on the rehabilitation of individuals recovering from strokes and spinal cord injuries.
Nonhuman animal research is a topic that is complex and that merits civil dialogue informed by fact and serious consideration. Although this can be difficult to achieve in a lay forum with short, accessible articles, it is possible. Furthermore, we believe that it is the responsibility of organizations like PRIM&R that seek to provide an honest forum for serious, fact-informed respectful dialogue, to set the record straight and accurately convey the regulatory history of research with nonhuman animals.”
Upon reviewing the post in the context Drs. Bennett and Panicker put forth, it is clear that misinterpretation of our intent is possible. Our post was too brief to fully and adequately capture the complex history of this issue or the contributions of the many people who have shaped regulatory change in this area. For 40 years, we have prided ourselves on being a neutral party, a convener of all sides of the issues surrounding animal care and use in research, and at no time did we intend to promote any one organization or group of people over another. We regret and apologize for the incomplete retelling of events surrounding the development of environmental enrichment practices and the unintentional misinterpretation of those events that the post might therefore have promulgated.
We look forward to exploring this issue in greater detail in the coming weeks and, with the help of experts in this field, plan to share a follow-up post that explores in more detail the central and essential role scientists have and continue to play in improving animal welfare and supporting environmental enrichment.
Friday, August 1, 2014
Research Ethics Roundup: The rise of big data in health care, support for psychiatric research, and more
As summer swings into full gear, be sure to take a break from the heat to delve into the research ethics news making headlines this month.
The Era of Big Data and its Implication for Big Pharma: The integration of technology into health care has resulted in an abundance of data about our health. In this piece for the Health Affairs Blog, Marc Berger et al. discuss how “big data” can be used by researchers to predict patient outcomes, as well as the implications for the pharmaceutical industry.
Misjudgments Will Drive Social Trials Underground: Michelle Meyer, on behalf of 27 ethicists, urges readers to reconsider Facebook’s recent mood experiment. She argues that social experiments, such as the one conducted by Facebook, can generate meaningful conclusions about human interaction and warns that these valuable experiments may be discontinued if public reaction remains so negative.
Living With Cancer: The New Medicine: Decades have passed since the last drug for ovarian cancer was approved by the Food and Drug Administration. Recently, however, several new drugs progressed to phase III trials. In this piece for The New York Times, Susan Gubar writes about her experience participating in a phase III trial aimed at treating ovarian cancer.
Spark for a Stagnant Search: Ted Stanley’s son was diagnosed with bipolar disorder in 1988. Stanley watched effective treatment transform his son’s life, and, as a result, Stanley has now committed to support psychiatric research through a $650 million donation to the Broad Institute. It is hoped that the donation will help spur basic research into an area that has stagnated in recent years.
Tuesday, July 29, 2014
In early June, I was invited to attend a multiday convention, The Asilomar Convention for Learning Research in Higher Education, co-hosted by Stanford University and the Massachusetts Institute of Technology to share my IRB expertise. The event, which was largely supported by the National Science Foundation, tackled the issue of massive open online courses (MOOCs), educational research, and, by extension, human subjects research and IRB review. Knowing next to nothing about MOOCs, what I learned was fascinating.
There is now software that can track an online learner’s every move throughout the learning process, and researchers are hungry to analyze the "big data" that is generated by the more than 50,000 course enrollees from around the world, with the goal of improving learning. Educational researchers are getting data from commercial companies that host MOOCs, such as Cousera and edX, or from their own in-house courses that utilize similar platforms. Typically, at the beginning of a course, enrollees accept (i.e., click on) a basic user agreement, but they may not realize that included in that agreement is language that allows for the use of their data in a research field referred to as learning analytics. This lack of awareness is somewhat akin to the recent Facebook study controversy.
MOOCs, and the abundance of data that results from these courses, are likely to have a significant impact on research in the learning sciences. Those of us involved with the IRB can either be a hinder or facilitate research in this new domain. IRB professionals and institutions need to consider what is "normal" educational practice per 45 CFR 46.101 (b)(1). Where do data domains such as log files and text data fit? What are distance/online learners' expectations of how their data will be used? Is this research exempt? What about when a learning experience is modified based on real-time analysis of learning data? Does this intervention require the learning experience (and research study) to undergo expedited level review? How should the educational databanks that result from MOOCs be managed? And, how do institutions view those participating in MOOCs? Are they seen the same as students who attend on-campus courses? And, if so, what are the implications of that decision with respect to the protections afforded under the Family Educational Rights and Privacy Act? Do the same rules apply to on-campus courses that utilize MOOCs to generate data that can be analyzed (e.g., key strokes, use of resources, sequence of learning activities, etc.) to improve learning?
In much the same way that attendees at the Asilomar Convention did, those of us in human subjects research compliance need to start thinking about the aforementioned questions and many more. Institutions’ IRBs will need to be proactive and promote collegial science as this field moves forward, while still finding ways to respect privacy and the voluntary participation of learners. To begin this discussion at your institution, I encourage you to review the two-page principles document that was developed by the attendees at the Asilomar Convention. Several of the agreed upon principles are informed by The Belmont Report. In closing, stay tuned! It’s going to be an interesting ride in the realm of educational research, learning analytics, and technology whether at a distance or in your local higher education classrooms.
Tuesday, July 22, 2014
During my previous job at a tertiary hospital in India, a pediatrician from the institution approached the IRB office with a grant proposal. He wished to conduct a study with children under 12 years of age. While he had reviewed information online about the necessary documentation and regulatory requirements, he still sought the help of the IRB office since it was his first time serving as a principal investigator (PI).
Upon reviewing his documents, the IRB administrative staff found that the assent form was missing. The PI was not aware that an assent form was required for participants under 18 years of age. The staff also noticed that the translated, local language version of the study was not easy for a layperson to understand. The IRB staff recommended that the translation be improved with the help of a translator appointed by the research department. The IRB staff also asked the PI to submit the necessary documents to the IRB office by a specific deadline.
Unfortunately, the PI was not able to submit the documents by the deadline, which resulted in his protocol being excluded from the agenda for the next IRB meeting. This upset the PI—he felt he had checked all the documents and he was hoping to have a grant approved for his research. The IRB manager assured him that they would work with him to come up with a solution. The IRB manager called the grant approval office and asked them to hold on to this particular protocol as it was with the IRB office, and would certainly get reviewed during their next meeting. The grant approval office was helpful and the matter was resolved amicably.
For my IRB, this experience highlighted the necessity of conducting regular trainings and creating awareness among researchers and IRB members about the importance of protocol documents and on-time submissions. If PIs lack knowledge about IRB procedures, they may show a lack of respect for the process, which may cause conflict.
A webinar hosted by PRIM&R, titled Working through Conflict: Helping IRB Staff Communicate Effectively with Investigators, that I recently attended helped to reinforce the importance of education and communication in the research process. The presentation reminded me that investigators need to keep in mind that IRBs are charged with facilitating safe, ethical, high quality research within the scope of existing regulations, while IRBs should do their best to treat researchers as customers and demonstrate that the IRB is on the client’s side by maintaining open, honest, and transparent communication. Consider the words of science writer Atif Kukaswadia: “If we want to bring people together, we have to avoid using language that drives us apart. If we want to promote science, we have to discourage hate. And if we want to educate others, we first have to start by understanding others.” Ultimately, a collaborative approach among IRBs, IRB staff, and investigators helps everyone work toward the common goal of protecting research participants and moving science forward.