Wednesday, May 27, 2015

Giving Back to the Human Community: An Interview with Carole Ehleben

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. During May, Member Appreciation Month at PRIM&R, we are featuring a new member interview every week! Please read on to learn more about Carole Ehleben, EdD, senior partner at Consultants for Evaluation and Applied Research (CEAR).

Nora Murphy (NM): When and why did you join the field?
Carole Ehleben (CE): By way of background, I'm the senior partner and owner of Consultants for Evaluation and Applied Research (CEAR), a private consulting company. It's through CEAR that I've been a part of the IRB world. I've helped establish several new IRBs and worked with existing ones to review standards of function and compliance. Among other roles, I've served as IRB administrator for both a public and a private hospital system since the 90s. I entered the field at a time when it was developing and expanding, and initially became involved because of my background in project development and clinical research—there weren't actual job descriptions for IRB staff then.

NM: What's one specific challenge that you have faced during your career, and how did you overcome it? 
CE: The most difficult part of establishing an IRB when I started was getting buy-in from the physician investigators. Up until that point, with the exception of large academic institutions, clinical research was largely unregulated in community hospitals and private practices. We achieved buy-in by involving the investigators in every part of the process— helping them develop their proposals and consent forms, having them present and participate in discussions at meetings, and providing training. We demonstrated that conducting ethical research not only protected subjects but the investigators as well, and could even improve the research being conducted.

NM: What is one thing you wish the general public knew about human subjects research?
CE: I wish the public understood that ethically and scientifically sound, well-conducted studies are the best way of establishing and advancing medical knowledge, which is in everyone's best interest. Persons volunteering to be subjects are critical to this process and are giving back to the human community.

NM: What is something you know now that you wish someone had told you when you first entered this field?
CE: The best IRB members are volunteers—not conscripts.

The most engaged and involved volunteers are there because they understand the value of the role the IRB plays in the research enterprise and want to be a part of it. These willing participants bring a level of energy and commitment to their service that cannot be administratively mandated.

NM: What changes in the research field most concern you? 
CE: The trend towards centralized IRB review concerns me. There are several valid arguments for why such a process should be in place—consistency, elimination of redundancy, guaranteed expertise—but speed of review in the absence of demonstrated concern for subject safeguards is not one of them. Since the potential for harm is greatly expanded with a centralized process, the need for transparency and oversight becomes even more critical.

NM: What motivates you to maintain your commitment to advancing ethical research?
CE: It remains a field where I can make a difference in a very real and immediate way to all those volunteers who are helping advance clinical science.

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? 
CE: When I started, very few people knew much about what IRBs did and how they worked. PRIM&R was a community of people who became teachers, colleagues, resources, advocates, and friends; people working towards a common goal of improving research protections—not always agreeing, but providing a forum for ideas and practices to be discussed and tested. It was very exciting and motivating to be part of that. It still is.

Thank you for being part of the membership community, Carole! We are glad to hear that the PRIM&R community has been a benefit to you over the years.

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

Friday, May 22, 2015

Research Ethics Roundup: Addressing Questions Raised by Compassionate Use, Ebola Drug Trials, and More

In this week's Research Ethics Roundup, we explore how new approaches are being used to address longstanding questions, such as those raised by expanded access or compassionate use, and chart a course for the future of biomedical innovation.

Company Creates Bioethics Panel on Trial Drugs: In an effort to address concerns related to compassionate use requests, Johnson and Johnson announced last week that they have appointed bioethicist Arthur L. Caplan, PhD, to "to create a panel that will make decisions about patients' requests for potentially lifesaving medicine."

House Seeks Momentum on Medical Cures: On May 14, the most recent draft of the 21st Century Cures bill, which seeks to "accelerate the pace of cures in America," was unanimously approved by the US House of Representatives' Energy and Commerce Committee's Health Subcommittee. This article from The Hill outlines the next steps for the legislation, as well as the Senate's progress on a similar bill.

Disputes Emerge on African Ebola Drug Trials: The 2014 West African Ebola outbreak is waning. However, questions about how best to develop Ebola vaccines and therapeutics remain. This article from the Wall Street Journal considers the debate surrounding the use of randomized controlled trials to study experimental Ebola vaccines and therapeutics.

Drugmaker and University Ally to Seek Cure for AIDS: Last week, the University of North Carolina at Chapel Hill and GlaxoSmithKline announced they are partnering in an effort to find a cure for HIV and AIDS. The partnership is part of a growing trend "in which pharmaceutical companies are working directly with university researchers."

Llamas as Lab Rats: Llamas are one of a number of animals that produce heavy-chain antibodies. In this article for The Scientist, Jenny Rood explores the scientific significant of these antibodies in llamas, as well as how their use is helping to advance HIV vaccine research.

Tuesday, May 19, 2015

Webinar Follow-Up: Practical and Effective Approaches to Educate IRB Members

By Alexandra Shlimovich, webinar and publications specialist

Recently, PRIM&R hosted a webinar titled Practical and Effective Approaches To Educate IRB Members, which was presented by Mina P. Busch, MS, CCRP, CIP, and Scott Lipkin, DPM, CIP.

Educating institutional review board (IRB) members can be a challenging task. How do you balance finding effective ways to deliver relevant and valuable information with limited time and resources? What are the best methodologies to evaluate the impact of your educational plan? For those responsible for, or involved in educating IRB members, this webinar helped explore these questions and develop a successful IRB member education program.

At the conclusion of the webinar, Ms. Busch and Dr. Lipkin shared additional insight in response to questions from webinar attendees, and we're pleased to share that with the readers of Ampersand.

1. What recommendations—in addition to those you presented during the webinar—can you share about training IRB chairs and vice chairs?

Scott Lipkin (SL): In addition to what was discussed during the webinar, networking with peers and colleagues at other institutions is an excellent way for IRB chairs and vice chairs to garner educational insight. Attendance at PRIM&R's annual Advancing Ethical Research (AER) Conference and participating in the IRB Chair Affinity group can also be effective. As co-chair of the Workshop Didactic Planning Committee for this year's AER conference, I am proud to announce that, for the first time, the conference will feature a full track dedicated to IRB chairs.

Mina Busch (MB): I would also recommend a webinar that PRIM&R held in 2012, titled A Roadmap to Success for New IRB Chairs. It's available to PRIM&R members free of charge in the Knowledge Center, and available for purchase to nonmembers.

2. Two issues our academic institution struggles with are motivating IRB members, and ensuring comprehension and retention of information. Are there any strategies that you've found effective?

SL: Serving on the IRB is not for everyone, so I'd ask yourself if those who are struggling to maintain engagement are a good fit for the committee. That said, some ideas for incentives to motivate IRB members during the meeting might include providing CME credits (which requires partnering with your education department and a considerable amount of time) and offering food during your IRB meetings.

MB: Involving IRB members in the selection and/or delivery of the topics increases their commitment. We typically poll our members about topics they'd like to hear about and find that giving them a vote often enhances their commitment to attend. We've also had some sessions taught by IRB members (alone or in tandem with another speaker) and again, we see higher attendance at these events.

3. How do you respond to training evaluation data? 

MB: We read all training evaluation data and make revisions to our programs based on the feedback we receive. Sometimes if the feedback is inconsistent, we discuss it in an IRB meeting or poll to find the key data.

4. Can you comment on the challenge of educating alternate members that do not attend the meetings? When you send materials to IRB members, how do you know that they have read the materials?

SL: This is a very good question and an issue that we all face. Distributing meeting minutes, educational materials, etc. to all IRB members (alternates included) is very important. You, of course, never really know if any IRB member is reading and reviewing required materials, and that goes back to my point in the earlier question. Perhaps a member who is not able to be engaged with the material isn't the right fit for the committee.

A very effective way to educate alternate members is by keeping them engaged and interested. This can be done through assigning them reviews and assuring that they occasionally attend meetings.

PRIM&R would like to thank Ms. Busch and Dr. Lipkin for sharing their expertise. Do you have an idea for a webinar? Consider contributing to our third annual Call for Webinar Proposals.

If you were unable to attend this webinar and are interested in purchasing the archive, you may do so here.

Monday, May 18, 2015

Maintaining Protections for Research Participants in a Rapidly Changing Environment: An Interview with Katherine Lerner

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. During May, Member Appreciation Month at PRIM&R, we feature a new member interview every week! 

Please read on to learn more about Katherine Lerner, JD, CIP, associate director of the Social and Behavioral Sciences IRB at the University of Chicago, and planning committee member for PRIM&R's 2015 Social, Behavioral, and Educational Research Conference.

Nora Murphy (NM): When and why did you join the field?
Katherine Lerner (KL): IRB work is my third career. Prior to entering the IRB world, I was a budget and policy analyst with state and local governments, and I then went to law school and was a lawyer with the federal government for over five years. When my kids were very young and I was home pretty much full-time, I became a community member on the IRB at Children's Memorial Hospital (now Lurie Children's Hospital) in Chicago and spent over three years in that role. I then served as a vice chair of that IRB for a couple of years, at which point, looking to take on more full-time type of work, I became IRB manager for the National Opinion Research Center (NORC). Working as the IRB manager for NORC was a great introduction to social science IRB work—and it's a one-person IRB office, which was also a big change. I learned a huge amount quickly about social science IRB review and managing all aspects of an IRB office. In January 2014, I became associate director of the Social and Behavioral Sciences IRB at University of Chicago.

NM: What is one tool you use every day without which you could not do your job?
It is an especially exciting time to be involved in social science IRB work. Social science research is being transformed by the ease of access to data on large numbers of people via the internet/social media, as well as by the use of mobile devices and other technologies. It makes our work endlessly interesting and challenging. Being able to discuss these challenges with colleagues is enormously helpful. I turn to the IRB Forum frequently when we have questions that we want to run by colleagues. When I was a one-person IRB office, the IRB Forum was an essential way for me to be able to reach out to colleagues and bounce things off of them, and it continues to be a tremendous source of information and advice to which I often turn. Additionally, sage advice from Elizabeth Buchanan, endowed chair in ethics and director of the Center for Applied Ethics at the University of Wisconsin-Stout, regarding review of research using internet/social media is incredibly helpful as well. I have attended Advancing Ethical Research Conference (AER) sessions taught by Elizabeth and also make sure to sign up for any webinars that she does on research using internet/social media.

NM: What motivates you to maintain your commitment to advancing ethical research?
KL: Social science IRBs are on the front lines of dealing with challenges related to the ease of accessing information about individuals without their knowledge and the ability to re-identify individuals from supposedly anonymous datasets. It's important work maintaining protections for research participants in this rapidly changing environment, and I take pride and pleasure in this work day in and day out.

NM: What PRIM&R events or talks have made a significant impact on your approach to your work? 
KL: Although many PRIM&R events stand out in my memory, I was very affected by the keynote speech that Elyn Saks gave at the 2012 AER Conference. It was a tremendously moving speech about the struggles of living with mental illness and the assumptions that others make about people with mental illness, and the power of her words and experience have stuck with me ever since.

Thank you for being part of the membership community, Katherine! Our community wouldn't be as strong without the support of members like you. 

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

Friday, May 15, 2015

The Culture of Research Ethics: An Interview with Rachel Zand

By Marley Thrasher, director of education and professional development

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 PRIM&R 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 Rachel Zand, PhD, the newest member of PRIM&R's Education Committee, who is the director of the office of research ethics at the University of Toronto.

Marley Thrasher (MT): When and why did you join the field?
Rachel Zand (RZ): I fell into the field of research ethics in 2002. I had ended a post-doctoral fellowship early after having my first child and realized that academia was not the path for me. Recognizing that my experience in conducting human research would be an asset, I applied for the health sciences ethics review officer at the University of Toronto. I got the job and I have enjoyed working in the field ever since.

MT: What's one specific challenge that you have faced during your career, and how did you overcome it?
RZ: In 2009, due to the economic difficulties of the previous fall, my office lost two positions: one coordinator, and one research ethics board (REB) manager. The workload didn't decrease by any means, so it was a particular challenge figuring out how to handle the deficit. I had to restructure the office in terms of responsibilities and take on a dual role for a period of time of both director and REB manager. While it wasn't an ideal situation, it helped me to focus on the most important aspects of both roles and taught me perseverance.

MT: What is one thing you wish the general public knew about human subjects research?
RZ: I don't think the general public is even aware of the existence of institutional review boards (IRBs)/REBs and the process that research studies undergo between being developed and starting recruitment. I think the fundamental understanding of research ethics and ethics review is essential in winning and maintaining public trust. Without that trust, the research enterprise falters, delaying the necessary work to learn, understand, and improve our physical, mental, and emotional health.

MT: What is an example of a lesson you had to learn the hard way?
RZ: The hardest part, when I first entered the field, was to recognize the various constituencies that are involved in the human research protection program (HRPP) system (researchers, REB members, departmental chairs, deans, students, research staff, administrators), how best to work with each constituency separately, and, more importantly, interweave their roles. Creating a culture of research ethics requires that all stakeholders within the institution recognize the importance of this common goal and work together to make the system function. Developing and executing the strategies to do this was something I learned the hard way.

MT: What changes in the research field most concern you? What changes are you encouraged by?
RZ: The "democratization" of research both concerns and encourages me. Society now plays a big role in generating data (whether they know it or not), influencing what researchers study, funding research, and even conducting research themselves (crowdsourcing, citizen research). While in many ways these new changes have positive impact on facilitating research, I am concerned that evidenced-based theories requiring fundamental research may lose out to what society sees as being trendy or interesting.

MT: What motivates you to maintain your commitment to advancing ethical research?
RZ: I can see how the culture of research ethics has taken root and flourished both at the University of Toronto and globally. Research ethics, integrity, and responsible conduct were barely topics of discussion a decade ago. I feel that I am a part of a greater process that has brought these terms into everyday conversations among researchers and administrators, and believe that we are making a difference in ensuring that human subjects research is done ethically and with integrity.

MT: What interested you about serving on PRIM&R's Education Committee?
RZ: I believe that providing education in ways that are informative, comprehensive, interesting, and inspiring is essential to maintaining the professionalism of all roles within the HRPP. I also feel that because I am Canadian, and have provided education as part of system that is principle- and guidelines-based (not rule- or regulation-based), my perspective could provide some additional insights to the Education Committee.

MT: 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? 
RZ: One of the best PRIM&R talks I have ever heard (and I have experienced many) was a keynote by Atul Gawande at the 2013 AER Conference on the importance of healthcare systems and how a system that works well can literally save lives. This brought home to me the importance of the HRPP system functioning well, with all parts understanding their jobs and communicating efficiently. Reviewing the system frequently is essential to identifying gaps and unnecessary redundancies, and requires that the system be nimble enough to correct these quickly.

MT: How has membership in PRIM&R's community of research ethics professionals helped you to advance in your career or do your job better?
RZ: Being at the largest university in Canada, it is difficult to find many Canadian peers that have similar issues and concerns that we do, from a volume and workload perspective. PRIM&R has enabled me to network with other larger institutions that have challenges similar to ours. Through my participation on the 2014 Advancing Ethical Research Conference Poster Abstract Subcommittee, I have also been able to see what programmatic activities other institutions have engaged in. Many of these are novel and practical and have inspired me to improve the HRPP at my institution.

MT: What other programs or research initiatives are you involved with outside of your work with University of Toronto?
RZ: I have been a member of the Canadian Association of Research Ethics Boards (CAREB) for 12 years, and a director of its board since 2007. I have been involved in professional development, public affairs, conference planning and have served as treasurer, vice-president, and president. I am now starting a two-year term as past-president, while I continue to chair the steering committee on research ethics professional certification.

MT: What challenges do you see ahead for human subjects research? 
RZ: I think that Big Data has started and will continue to challenge us in our understanding of some of the most important principles of research ethics, including autonomy, privacy and confidentiality, free and informed consent, and justice. As ways of collecting, analyzing, re-analyzing, linking, retaining, storing, de-identifying, and re-identifying data change, IRBs/REBs will have significant challenges in terms of how these principles are evaluated and applied. I am optimistic that we will be able to solve such challenges and recognize that we will need to bring in expertise that research ethics has not typically involved before – computer scientists, engineers, and librarians.

Thank you for joining the Education Committee, Rachel, we look forward to working with you! 

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