Tuesday, November 25, 2014

Meet the PRIM&R Blog Squad for the 2014 AER Conference: Krystal Bradford

by Krystal Bradford, CIP, Research Compliance Specialist at Cincinnati Children’s Hospital Medical Center

PRIM&R is pleased to introduce Krystal Bradford, 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, and welcome to my corner of Ampersand! I work with the IRB and have since I started at Cincinnati Children’s Hospital Medical Center in 2005. When I share with people what I do, one question that frequently comes up is:  “How did you get into the research field?”

My story starts in 1998 with the birth of my son. He was born at 25 weeks gestational age, 15 weeks too soon! At the time of his birth, clinicians informed me that research showed he was just old enough to fight for, words have been burned into my brain ever since. I knew then that I had to find a way to give back to the research community. Soon after, I embarked on a path that led me to my current role as research compliance specialist at Cincinnati Children’s Hospital Medical Center.

Looking back, I am humbled by the experience and knowledge I have been able to gain over the years. I have had wonderful teachers in my career path, have been able to attend conferences to broaden my knowledge, and have even had the opportunity to earn my Certified IRB Professional (CIP®) credential, an achievement that outranks, in my view, the attainment of my college degree.

This year’s AER Conference will be my third PRIM&R conference, and as I am preparing to head to Baltimore, I have a bit of a confession to make: I am a gadget junkie. Therefore, as an experienced attendee and self-declared gadget junkie, I wanted to use this opportunity to share some things that I would have loved to known about when I attended my first AER Conference:
  • If you are going to bring an electronic device such as a tablet or iPad, invest in a portable charger that can fit in your handbag or pocket. Attending conferences always seems to drain my battery faster. A small investment in a portable charger can make all the difference.  Relatedly, if you have been on the fence about a Bluetooth keyboard for your device, now would be a great time to purchase. Taking notes is always easier with a keyboard at your fingertips.

  • Before you arrive in Baltimore, make sure you know your device and how to silence it quickly before the sessions begin. Nothing is more embarrassing then Siri telling you she “didn’t get that” in the middle of a session.

  • I encourage you to download PRIM&R’s new conference app, which includes the full schedule for the conference, as well as slides, handouts, and poster abstracts. You can take notes on every session within the app, even directly on slides when they are available, and email them to yourself after the conference. The schedule in the app also allows you to “favorite” those sessions you don’t want to miss, so you can easily see where you should be going and when.

  • In addition to PRIM&R’s conference app, I would also encourage you to make sure that you have a good .pdf reader app (such as GoodReader, pdfForms, or Notability) on your tablet or iPad, preferably one that allows you to make notations. Why you may ask? This will allow you to easily open and view PDF resources on your mobile device.

  • In addition to a .pdf reader, I would recommend downloading a good notebook app (such as OneNote, MagicalPad, or Moleskin) for your tablet or iPad. These apps are pretty robust and can help keep your thoughts and notes organized. For instance, meet someone and have an engaging conversation? You might consider having one notebook dedicated exclusively to contacts and connections.

  • Download a good document scanning app (such as DocScanner, DocScan HD, or TinyScan) on your tablet or iPad. This will allow you to quickly and easily scan business cards that you receive onsite.

  • Make sure to link all of the apps that you are using onsite to an online backup service (such as Dropbox, Google Drive, or OneDrive). This will allow you to retrieve the information you collect easily on another machine, as opposed to only the device you used onsite. 
Finally, as you prepare to travel, I also recommend downloading the app TripIt. You can send your itinerary information to this app and it will all be saved in one location. This is a great app for traveling, as it provides an overview of your itinerary, maps from the airport to your hotel, check in/out times for hotels, and more. It is a must for business travel!

I look forward to meeting and connecting with you at the conference. If you use any of my tips, please feel free to tell me what you thought. I’d love to hear your feedback!

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

Monday, November 24, 2014

Meet the PRIM&R Blog Squad for the 2014 AER Conference: Mike Kraten

by Michael (Mike) Kraten, PhD, CPA, IRB Chair at Providence College

PRIM&R is pleased to introduce Mike Kraten, PhD, CPA, 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. 

When I was first asked to consider accepting an appointment as chair of the institutional review board (IRB) of Providence College, I blinked. Then I blinked again.

Me? Really?

Me?

After all, I'm an accounting professor in a liberal arts college. I teach debits and credits in a Catholic and Dominican institution with a mission "in pursuit of the truth, growth in virtue, and service of God and neighbor." I was hardly a "typical" faculty member.

So why was I asked? I think I became a potential choice because of my experience in risk management, my research in behavioral accounting, and my interest in applied ethics, which were also the very traits that compelled me to join Providence College's School of Business in the first place. The institution focuses on values-based leadership, and it relies on the accounting principles of transparency, objectivity, and oversight to protect the interests of its students and other constituents.

It just so happens that those principles also serve as the foundation for human subjects protections, and thus I was invited to become the IRB chair three months ago. Taking the leap, I accepted the invitation.

So how is it going?

Well, it's been one challenge after another, after another.

First, came the need to immerse myself in policies and procedures. Although I had served as an IRB member for two years, and I was familiar with the requirements of the responsible conduct of research activities, it took some time to for me to familiarize myself with the details of my new administrative duties.

Then came the transition from a paper-based system to online technologies. Should we restrict our public online presence to web pages and PDF files, or should we embrace blogging platforms as well? Should we mandate online filings of research applications, or should we continue to accept paper documents?

And what about the structure of our application review activities? As a reflection of our communal philosophy, all members of our IRB had always been personally apprised of every application. Whether exempt or expedited or full in nature, each study was summarized—and when appropriate, fully vetted—at meetings of the full board. The recent growth of the college, however, resulted in an increase in the volume of research applications. Could we possibly continue to process all applications in this manner? And if not, how could we streamline our operations while strengthening our oversight functions? All while maintaining our communal traditions?

Working with my fellow board members, we’ve been able to address all of these challenges. But of course, we're only three months into our academic year. There are, indeed, many challenges yet to come.

Did we actually make all of the right choices? We may never know for sure, but I'm delighted to have an opportunity to learn from the experiences of others at the 2014 AER Conference. After all, the best way to identify best practices is to share knowledge and experiences with colleagues, and what better place to do that than at a PRIM&R event?

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

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.