Saturday, November 22, 2014

Meet the PRIM&R Blog Squad for the 2014 AER Conference: Jim Gearhart

by Jim Gearhart, BA, Member of the Board of Directors for Quorum Review IRB

PRIM&R is pleased to introduce Jim Gearhart, BA, a member of the PRIM&R Blog Squad at the 2014 Advancing Ethical Research (AER) Conference. The PRIM&R Blog Squad is composed of PRIM&R members who will blog here, on Ampersand, about the conference to give our readers an inside peek of what's happening December 4-7 in Baltimore, MD. 

I first attended PRIM&R’s annual human subjects conference in 2005, a few months after I had started working at Quorum Review IRB. I was new to working at an IRB, and I often had problems explaining to others what, exactly, the job was all about. I could not always fit the ethical review of research involving human participants into a one or two-word summation of a career. I soon discovered I wasn’t the only one encountering this issue—a colleague’s friend urged her to stop trying; the business was just too esoteric to explain.

This dilemma made it inspiring to walk into the opening session in 2005. I looked around the crowded auditorium and realized that everyone—all 2000 of the attendees—understood what I did all day. They—we—were all involved with fostering ethical review with the same set of regulations, and we all shared similar professional rewards and frustrations.

And like that 2005 gathering, this year’s conference has a rich list of relevant topics. I’m looking forward most to discussions about our challenges in the face of rapidly changing technologies. How do we manage privacy and consent in a world where devices and computers track our actions, our decisions, and possibly our health information? The intersection of health data and ethics is just one of the many topics that I am looking forward to hearing more about.

I may have implied earlier that clinical research and IRBs were completely foreign to me in 2005.That is not entirely true. In many ways, I have been around research my entire life. My mother worked as a study coordinator and medical technologist, and she often worked from home. I may have been in middle school before I realized it was not typical to have a microscope and manual cell counter in the family room, a centrifuge in the laundry room, or conversations about informed consent around the dinner table.

A few years after those dinner talks about clinical research, I joined the US Department of State as a foreign service officer, and my parents launched an adventure of their own by co-founding Quorum Review. After gaining more experience in clinical research, as well as my Certified IRB Professional (CIP®) certification, I now contribute to Quorum as a member of the organization’s board of directors and frequent blogger.

Now, in 2014, I am honored to have an opportunity to continue those conversations that started around the dinner table by blogging for PRIM&R at the 2014 AER Conference. See you in Baltimore!

Check back and use this link to read more of Jim’s posts throughout the conference.

Friday, November 21, 2014

Find the Things No One Else Wants to Do, Do Them, and Do Them Well: An Interview with Jamie Gothro

by Maeve Luthin, JD, Professional Development Manager

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. Over the course of the next few months we will be shining a spotlight on members of the Certified IRB Professional (CIP®) and Certified Professional IACUC Administrator (CPIA®) Councils. Please read on to learn more about their professional experiences and what goes on behind-the-scenes in their lives!

Today we’d like to introduce you to Jamie Gothro, animal welfare officer and IACUC administrator at the VA San Diego Healthcare System. 

Maeve Luthin (ML): When and why did you join the field? 
Jamie Gothro (JG): I morphed into the world of IACUC as a natural extension of some of my veterinary technology and animal resource duties. I started out being responsible for setting up a training program for animal research personnel, and that led to looking at the qualifications of protocol participants. From there, I started getting more interested and involved in IACUC processes. I especially like the opportunity to see the research studies in their early stages during protocol review, and I enjoy post-approval monitoring, too. I get a chance to see the work in action!

ML: What prompted your interest in joining the CPIA Council, and why did you agree to serve?
JG: The CPIA Council focuses on improving the quality of the administrative staff of the IACUC. There are programs that help promote and advance most of the other careers in the laboratory animal field, but the world of regulations is complex and requires a lot of time and dedication by IACUC staff to keep their institutions on the right side of the laws. The Council serves to promote recognition and validation of those roles and helps us develop a body of collective knowledge (and wisdom) to be better at what we do. I agreed to serve on the Council because I was excited to be a part of what I view to be an important contribution to the world of laboratory animal care and welfare.

ML: How did you learn about the CPIA® credential? 
JG: I first heard about the CPIA credential when it was introduced at a PRIM&R meeting as a future enhancement for the field. When the certification was offered, I knew it was for me, and I was part of the first group of people who sat for the exam.

ML: How did you become involved with PRIM&R? 
JG: My first exposure to PRIM&R was the first time an event was offered in San Diego, and I really liked its focused approach to the role and function of IACUCs. I attended meetings over the years as budgets and time permitted, and I guess I became somewhat of a regular. I don't know when I was first asked to serve as a co-moderator at a session, but I’ve been fortunate enough to be invited back to many conferences. It's a great way to interact with colleagues across the field from all types of industry, academia, and government agencies. We have a lot we can learn from each other.

ML: What skills are particularly helpful in a job like yours? 
JG: Organization! I am organized to a fault, which really helps keep track of all of the moving pieces that are involved in protocol review. There are so many stops in the flow of information along the approval path (be it electronic- or paper-based)—scientists, review boards, granting agencies, safety, and many others. To keep from losing something or having something take too long at one stop requires a system or person that can keep track of what is where and where it needs to go next. That can be overwhelming if you aren't organized.

ML: What advice have you found most helpful in your career? 
JG: Find the things no one else wants to do, do them, and do them well.

ML: Is there anyone, living or dead, who has inspired you in your career and/or in life?
JG: Marky Pitts. She has been a friend and mentor for many years. She helped pioneer the field of IACUC administration as it is today and did it without a lot of resources.

ML: What is one thing you wish “the man/woman on the street” knew about your work? 
JG: I would like the person on the street to know that the people who do what I do care about those who benefit from the amazing work done by the scientists, and we care about the animals who serve the science. I hope one day my job, as it relates to the use of animals, becomes obsolete. Then we can take all we have learned from IACUC processes and apply them to something else.

Thank you for being part of the membership community and sharing your story, Jamie. We hope to see you at next year’s 2015 IACUC Conference, to be held March 17-20 in Boston, MA.

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

Wednesday, November 19, 2014

Meet the PRIM&R Blog Squad for the 2014 AER Conference: Anita Pascoe

by Anita Pascoe, MS, CIP, Project Coordinator at Intermountain Healthcare

PRIM&R is pleased to introduce Anita Pascoe, MS, CIP, a member of the PRIM&R Blog Squad for the 2014 Advancing Ethical Research (AER) Conference. The PRIM&R Blog Squad is composed of PRIM&R members who will blog here, on Ampersand, about the conference to give our readers an inside peek of what's happening December 4-7 in Baltimore, MD. 

Hello! My name is Anita Pascoe, and I am a card-carrying IRB professional, a full-time graduate student, an enthusiastic writer, and a very excited soon-to-be third time attendee at PRIM&R’s annual Advancing Ethical Research Conference (aptly titled Reflecting on the Past, Shaping the Future), which will be held in Baltimore, MD next month. I was thrilled to receive the email stating that I had been accepted as a PRIM&R Blog Squad member and I cannot wait to blog about my impressions of the conference and the ideas and information I gain from the sessions and connections with other conference attendees.

Reflecting on my past, my first introduction to research ethics came during the mid-80s when I was a nursing student in my native Norway. I became fascinated by an ongoing and heated national debate regarding active and passive euthanasia. Zoom forward a couple of decades, following a move to the United States, I enrolled in an undergraduate medical ethics course at the University of Utah. The rest is history. I have been hooked ever since.

I was introduced to the quirky world of IRB regulations, processes, and procedures roughly four years ago, when I joined the IRB staff at Intermountain Healthcare. During my first week at the office, I was quite stunned to see the giant piles of paper applications we couriered to our committee members for review every month. Since then, we have thankfully transitioned to the modern era and traded our largely paper-based process for a more efficient and fully electronic review system. Along the way, I have gained a great deal of insight into the whys and wherefores of IRB work and its inherent challenges, complexities, and opportunities.

I am passionate about ethics in general and human subjects research protections in particular. As a project coordinator for the IRB, I spend most of my work hours processing and appraising clinical research applications. In my other life, as a doctoral student in the Department of Sociology at the University of Utah, I have a vested academic interest in social studies and related research pursuits. I left last year’s AER Conference in Boston full of new ideas for my personal research and inspiration for how we could improve processes and procedures at my organization back home in Utah. This year, I am particularly looking forward to attending sessions related to the design of effective quality improvement/quality assurance programs. I am also hoping to learn more about how we can foster continued engagement from our IRB members and staff.

I hope you can tell that I am eagerly anticipating this year’s conference and cannot wait to meet my fellow PRIM&R Blog Squad members, as well as the conference speakers, poster presenters, and attendees. The inspiration and motivation I gain at the conference will surely fuel me through months of post-conference mental gymnastics. Good morning, Baltimore!

Check back and use this link to read more of Anita’s posts throughout the conference.

Friday, November 14, 2014

“Innovative Care:” Human Subjects Research That Isn’t?

by James E. Lewis, PhD, an independent consultant and formerly a columnist for the Association of American Medical Colleges blog, Wing of Zock

A little known, but intentional, loophole in the federal regulations allows activities involving human subjects to be labeled “innovative care.” In spite of all that has been done since World War II to protect human subjects in clinical research, this ambiguity offers a mechanism through which unscrupulous individuals can avoid the ethical and regulatory obligations for the protection of human research subjects and the norms of professional and scholarly behavior. Recent cases demonstrating this dilemma can be found on the internet, but my purpose here is not to review any specific case but rather to bring broader attention to the generic question: “when is what appears to be human subjects research not research?” and the fundamental question: “how is it possible for such activities to occur without oversight?”

Let’s start by considering a hypothetical worst case scenario: A clinician, eager to investigate a self-generated hypothesis, decides to ignore everything anyone has ever said about protecting human subjects and undertake and fund an activity at his/her own discretion. The "innovative treatment" the physician is planning to implement is brought to the attention of the hospital and they determine, at the appropriate administrative level, that, based on the very limited information they’ve been provided, the activity does not meet the definition of human subjects research and does not require IRB approval. However, the hypothetical research subjects die. FDA is going to investigate. The Centers for Medicare and Medicaid Services is going to investigate because the subjects were Medicare eligible for inpatient coverage. This is the skeleton of a case study in which everything that could go wrong, does go wrong.

Cases such as the one described above bring several questions to the fore, including when does innovative and non-standard patient care become research and, thus, subject to the usually required and rigorous process of human subjects research review and approval? In thirty years of fairly close involvement with human research subjects protection in academic and community medical centers across the country, I have wondered from time to time about whether certain advances in surgical or other procedural techniques and instrumentation have been properly brought to the attention of the relevant IRB. And I have found myself left with the nagging question of whether there is a giant loophole in existing human subjects research regulations that allows researchers to avoid the policies and processes related to the protection of human research subjects through the use of phrases like “procedural experimentation” and “innovative care.”

Since I work nationally with institutions on IRB policy, requirements, and operations, the question of whether there is a category of exploratory activity involving human subjects that can be construed as innovative and non-standard, but not research and, therefore, legitimately be exempt from the IRB process is relevant to the quality and value of my advice. So I sent an email to the Office for Human Research Protections (OHRP) a few months ago asking for clarification on situations in which innovative and non-standard patient care is not research that requires IRB approval under the federal regulations. After about a month, I received the following response (emphasis added):
Please note that many ‘innovative treatments’ are part of research studies. However, if the activity involving the innovation does not meet the regulatory definition of research then those activities are not research under 45 CFR Part 46. However, they may be subject to regulation by the FDA or the state in which they are conducted.
OHRP also provided the regulatory definition of research at 45 CFR 46.102(d):
…a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
Unfortunately, that definition may generate more questions than it answers. What constitutes a systematic investigation? Does the use of the phrase in the regulatory definition of research encourage individuals seeking to avoid interaction with an IRB to engage in sloppy science? And what exactly constitutes generalizable knowledge? My colleagues, who are very active every day in IRB operations at the institutional level across the nation, point out that some individuals, who are bent on avoiding interaction with IRBs, will also cite the “contribute to generalizable knowledge” criterion to prove that there is no need for IRB involvement. With ambiguous terms such as “systematic investigation” and “generalizable knowledge,” the distinction between innovative and non-standard patient care and research becomes even less clear and paves the way for potential abuse.

The tenuous line between innovative care and research is one that can be seen in many key research ethics doctrines, including The Belmont Report, which served as the basis for much of 45 CFR 46. The Belmont Report seems to give much of medicine a free pass by waltzing around clinical experimentation and relying on review by "medical practice committees," which may or may not exist let alone have any way of knowing when a clinician "departs in a significant way from standard or accepted practice." The case I laid out at the beginning of this post offers a salient example of this. We can see what can happen when institutional oversight mechanisms for activities at the edge of research fail or don’t exist at all. How do institutions make decisions and communicate about what is and what is not human subjects research? And should it really be those institutions making those determinations? Perhaps, it is time for the leadership in this field to take a deep look at “clinical experimentation” qua “innovative treatment” and develop some new policies and regulations.

Tuesday, November 11, 2014

Supporting Your IRB: It’s Not Just About the Board

by Rebecca S. Ohnemus, MAA, CRA, Research Officer at University of the Incarnate Word

As IRB administrators, we find ourselves on the frontlines. Whether you’re a director, administrative support person, or anywhere in between, an incredible amount of time is consumed facilitating the transfer of information between the IRB and your institution’s research community.

If all a person knew about our work was the brief bit from the regulatory description, “sufficient staff to support the IRB’s review and recordkeeping duties,” they would marvel at the volume contained between those words.

In a recent PRIM&R webinar, IRB Administration: Providing Stellar Support to your IRB, Maria Arnold, CIP, and Megan Kasimatis Singleton, JD, MBE, CIP, focused heavily not only on the direct support mechanisms that IRB administrators provide (e.g., record keeping, standard operating procedures, and regulatory compliance), but also on the intersections between providing IRB support and providing support for the research community more generally.

Drawn from Maria and Megan’s advice, here are a few ideas for strengthening the support you provide to the research community:
  1. Don’t play hide and seek. If members of the research community at your institution can’t find the necessary forms, policies, and deadlines for submission quickly and easily, there can be little expectation they’ll use them as intended. If your community knows where to go to find these resources and to seek assistance, they’ll be more likely to use them. Similarly, it is important to design your web pages or portals to be clearly laid out, accessible, and easily navigated. For larger institutions, Megan suggested creating “help desks” for specific assistance. Granted, there will always be a few ornery folks who (despite your best efforts) will get lost, but when the community has the necessary resources to do a good job, there will be those who take full advantage—and their submissions will reflect your efforts.

  2. Make the help truly helpful. During the course of our careers, we’ve inevitably run into an instance where something created to be helpful just wasn’t: checklists longer than the entire 45 CFR, forms you need a magnifying glass to read, and process maps that you need a map to decode. Sometimes the best-intentioned form or checklist isn’t helpful at all. If you, your board, or your research community depend on a resource that convolutes and clouds the process, your work will be slow, ineffective, and frustrating. Maria and Megan recommend reviewing policies and standard operating procedures on a regular, planned basis to make sure everything is up to date, meets your needs, and supports the IRB process effectively. Getting user feedback on pieces also helps clarify when a tool isn’t working.

  3. Build a team of experts. Whether you’re a one-person support crew or a member of a much larger team of IRB administrators, mentoring your teammates and successors plays an integral role in maintaining high-quality support. Maria and Megan suggest making training a collaborative effort—pairing new employees with seasoned professionals, and approaching training step-by-step so as to ensure mastery of important processes. Both agree that maintaining a dynamic knowledge base through ongoing education (e.g., conferences, quick trainings during staff meetings, reading reports from the Office for Human Research Protections, etc.) is essential. PRIM&R’s Mentoring Program works on a similar model, so if you're a one-person office, or don’t have a seasoned veteran in-house to call on, consider seeking assistance through the Mentoring Program. 
Ultimately, resources for the research community can help IRB administrators strengthen the support provided to the IRB by helping to ensure that everyone involved in research with human subjects at your institution is on the same page. Are there practices other than the ones listed above that you use at your institution to support the research community? I encourage you to share them in the comments.

Missed this webinar? You can purchase IRB Administration: Providing Stellar Support to your IRB   for on-demand viewing and share it with your research community.