Tuesday, July 29, 2014

Getting ahead of the wave: MOOC’s and human subjects research

by Rebecca D. Armstrong, DVM, PhD, director of research subject protection, at the University of California, Berkeley and a member of PRIM&R’s Education Committee

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

Working Together to Advance Science and Protect Participants

by Veena Joshi, PhD, Independent Consultant, India

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.

Monday, July 14, 2014

Research Ethics Roundup: Facebook’s unethical experiment, FDA's support for marijuana clinical trials, and more

Perhaps you’ve already read – on your Facebook News Feed, no doubt – about Facebook’s recent mood experiment. Not to worry—this post has no hidden motive. We’re just pleased to be able to share recent headlines from around the research ethics world with you.

Everything We Know about Facebook’s Secret Mood Manipulation Experiment: Following the publication of a paper in the Proceedings of the National Academy of Sciences, an experiment conducted among Facebook users has come to light. The experiment, which Facebook administered over the course of one week in 2012, sought to examine whether users were more likely to post positive or negative content after being presented with extremely positive or negative content in their News Feed. Facebook claims that the experiment was allowable under the site’s terms and conditions, while others argue that the study was not consistent with ethical or regulatory standards.

FDA Supports Marijuana Clinical Trials: The Food and Drug Administration (FDA) recently announced its support for research into medical marijuana use. Though the FDA has not approved marijuana for medical use, it has publicly announced its support for clinical trials that seek to understand its impact on medical conditions, and is currently working with several states to ensure that these trials are conducted legally.

Glaxo Dumps Firm for Preying on College Grads for Clinical Trials:  British pharmaceutical company GlaxoSmithKline came under fire recently for promoting clinical trials to college graduates as a way to alleviate financial debt. Glaxo has fired the external marketing firm that is responsible for posting the trials on a website that specializes in career advice for college graduates.

HIV Trial Attacked: Following new recommendations from the World Health Organization, some are urging the National Institute of Allergy and Infectious Diseases to stop the Promoting Maternal-Infant Survival Everywhere (PROMISE) study, which compares the efficacy of three different delivery methods for antiretroviral therapy to pregnant women. Those opposed to the continuation of the study argue that older regimens should not be continued when newer therapies are known to be more effective.

Monday, July 7, 2014

A chance meeting at the 2013 AER Conference

by Julie Fine, BS, Legal Specialist, Worldwide Research and Development, Pfizer Inc, La Jolla, California

In the many months that have passed since the 2013 Advancing Ethical Research Conference, I’ve been reflecting on the keynote speeches, the sessions I attended, and the incredible retirement luncheon celebrating Joan Rachlin’s outstanding leadership of PRIM&R. Recently, my Pfizer colleagues and I had an opportunity to share highlights from our experiences with members of our legal organization, giving them the benefit of some of what we learned. We talked about data sharing, “best medical care” vs. “research,” and academic-industry partnerships.* It was a good opportunity for us to bring research ethics conversations to the fore and share some of the insights we gained from attendance at the conference.

But it was a chance meeting on the final day of the conference that has really stuck with me. On the Saturday morning of the conference, I went to grab coffee and breakfast with a friend of mine. We picked a quiet table where only one other person was sitting. The woman at the table was Inge Auerbacher, who was at the conference to present her documentary film, Finding Dr. Schatz: The Discovery of Streptomycin and a Life It Saved. The three of us chatted, and I quickly became enthralled by Inge’s curiosity and intelligence.

Later that day, I attended Inge’s presentation of her documentary, and I discovered that the charming, articulate woman that I had shared breakfast with had survived the Holocaust and overcome tuberculosis to become a respected scientist and author. Her frankness, courage, determination, and enormous sense of humor were inspirational. Her unabashed self-promotion of her books and plea for support for her film just added to her charm and wit.  Nobel Prize Winner, Elie Wiesel, once called Inge “an illumination,” and I couldn’t agree more—indeed, she shines.

Finding Dr. Schatz is a well-crafted film based on the eponymous book by Inge Auerbacher and Albert Schatz. The documentary chronicles a budding friendship between Inge, who overcame tuberculosis with the help of streptomycin, and Albert, a scientist whose involvement in the discovery of streptomycin went unrecognized for many years. A thoughtful ode to her friend and healer, Inge’s documentary examines the contradictions that often arise between scientific pursuits, medical discoveries, and commercialization. After the screening, I felt grateful for the serendipity that brought three strangers to the breakfast table that morning. I encourage everyone to take a moment to learn about Inge’s extraordinary life.

*If you were unable to join us for the 2013 AER Conference, you can still discover a wealth of resources from the conference by purchasing access to our Conference Proceedings. Session handouts and select video presentations are available on the topics Julie mentioned, as well as much more.

Wednesday, June 25, 2014

Learn to be a professional: An interview with Brenda Ruotolo

by Megan Frame, membership coordinator 

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 their professional experiences, how membership helps connect them to a larger community, and what goes on behind-the-scenes in their lives!

Today we’d like to introduce you to Brenda Ruotolo, who recently began a new position as executive director of the Human Research Protection Office at Columbia University in New York, NY. 

Megan Frame (MF): When and why did you join the field of human subjects protections?
Brenda Ruotolo (BR): As the first of our six children started to reach their teens and endless semesters of college tuition suddenly loomed very large, my husband and I decided that we needed more stability than a personally owned small business could provide and sought outside employment. To test the unknown waters of a 9-to-5 routine, I signed up with a temporary staffing agency and was immediately placed in the institutional review board (IRB) office at Robert Wood Johnson Medical School. They were preparing for a Food and Drug Administration (FDA) inspection and were looking for extra help. I was subsequently hired as a regular employee, and remained there for four and a half years, assisting the IRB director and managing the institutional animal care and use committee. I spent the next three years at Rutgers University as the sponsored projects administrator, overseeing the IRB. While at Rutgers, I had to very quickly expand my thinking about the application of the regulations to social science and behavioral research. Early in 2003, Columbia University offered me a role as manager of a new IRB they were starting, and I was promoted to associate director of the IRB office in 2004. Throughout this process, my knowledge of the regulations and their application to an increasingly broad range of research has expanded, and I am grateful for each of the opportunities that have brought me to my current position.

MF: You were appointed as executive director of the Human Research Protection Office at Columbia. Within this new role, what are your key goals and responsibilities?
BR: My primary goal is always to maximize the protection that our researchers provide to everyone who is a participant in or subject of research. To accomplish that goal, it is my responsibility to ensure that the staff of our office are knowledgeable and invested in their work of providing support to researchers, the members of our six IRBs, and everyone else who is involved in human research protections at Columbia. We need to stay abreast of changes in regulations, official guidance, and interpretations and trends, and work as efficiently as possible to ensure that we are doing all that we can to protect research volunteers and private information about subjects. We are continually evaluating our metrics, then revamping our processes, policies, or office structure as warranted. Knowing and involving our researchers in our efforts, because we are collaborators in the research enterprise, has also facilitated a strong program. Immediately, my main objective is to fill vacant and new positions in our office, so that we can operate with maximum efficiency. Then I will consider how we may most effectively address the challenges that new technology, such as personalized medicine, and emerging trends, particularly central IRB arrangements, present for our IRBs and office.

MF: What skills are particularly helpful in a job like yours?  
BR: Multi-tasking (raising six kids while managing a business has helped), being organized, knowing how to handle stress, networking, hiring the right people, and delegating.

MF: Tell us about one article, book, or document that you would recommend to individuals interested in learning more about the field.
BR: My primary go-to documents are the federal regulations at 45 CFR 46 and 21 CFR 50, 56, 312, 600, and 812.  Despite being in the field for 19 years, I access these documents fairly frequently, and consult other supporting documents as necessary to help with interpretation or application.

MF: What is your proudest achievement?
BR: My children. As for my career, the fact that I was able to enter a totally new field midstream, immerse myself in learning what it was all about, and become successful at it. The fact that my efforts may contribute significantly to the safety of others is a tremendous plus.

MF: What advice would you give to young professionals who are interested in pursuing a career in human subjects protections?
BR: You can learn regulations, laws, and policies. First, however, you need to learn how to be a professional: Observe successful people, no matter what their career, to see how they manage their time, handle crises, make sound decisions, and interact with others, particularly those who are subordinate to them. Then learn about research and ethics–-volunteer, work as a research assistant or coordinator for a while, participate in or attend ethics committee meetings, presentations, or classes in ethics or disciplines in which human research is crucial. With good professional skills, knowledge about research, and a lot of energy, a career in human subjects protection will be a success.

Thank you for being part of our membership community and sharing your story, Brenda. Congratulations on your new role at Columbia University. We look forward to continuing to work with you! 

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