Meet the PRIM&R Blog Squad at the 2013 AER Conference: Stephanie Pyle

by Stephanie Pyle, MFA, Manager of Community and Communications, Schulman Associates IRB

PRIM&R is pleased to introduce another member of the Blog Squad for the 2013 Advancing Ethical Research (AER) Conference. The 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 November 7-9 in Boston. 

I have a confession: when I started in clinical research, I knew basically nothing about the industry. I was a total n00b. Research ethics was similarly foreign. Before I began working at Schulman Associates IRB, I’d been a college composition instructor and creative writing student. So when I first started at Schulman, I'll admit there were times I worried that I’d gotten in over my head. However, as I talked with my colleagues at the IRB and learned more about the work they were doing each day, I became intrigued by the many issues and nuances associated with research ethics. Fascinated, I wanted to find out all I could about this multifaceted, incredibly important aspect of clinical research.

It’s been five years since I made the leap from poems to protocols and from rhymes to regs (sorry, I couldn’t resist!), and I’m still eager to learn all I can about research ethics. Clinical research is an ever evolving field, and in research ethics every single situation is unique. As manager of community and communications at Schulman, I really value the role that thoughtful discussion and collaboration can play in examining these unique situations and ensuring that the rights and welfare of human research participants are protected. Those discussions and collaborations are what I’m looking forward to the most at PRIM&R’s 2013 Advancing Ethical Research (AER) Conference.

I’m also excited to be attending this year’s meeting as a member of the PRIM&R Blog Squad. As a past exhibitor at the conference, 2013 marks my third year in attendance. It’s the first year, however, that I’ll be able to explore the aspects of the conference occurring outside of the exhibit hall. I’m eager to take advantage of everything the conference has to offer, and I look forward to sharing with you the intriguing ideas that arise from the discussions and presentations.

So many talented research ethics professionals will be gathered in Boston to examine old challenges and share new views on ethical issues. There’s something amazing about this coming together–the personal interactions, the brilliant conversations–that can only happen when so many great minds convene in one place. Through these conversations we’ll discover new approaches and unexpected solutions to persistent problems.

I think this year’s AER Conference will be a wonderfully revitalizing event. We can sometimes get bogged down by the daily challenges and details of our individual jobs, and this conference is a great way to re-energize ourselves. I hope the stimulating conversations we have in Boston will send us home reinvigorated and ready to accomplish our goals of protecting human subjects and advancing clinical research innovation.

Personally, I can’t wait for the AER Conference. See you in Boston!

Stay updated on the 2013 AER Conference by following PRIM&R on Twitter. Conference updates will use the hashtag #AER13. 

Meet the PRIM&R Blog Squad at the 2013 AER Conference: László Szabó

by László M. Szabó, Esq., Director of the Office of Research Regulatory Affairs at Rutgers, The State University of New Jersey 

PRIM&R is pleased to introduce the PRIM&R Blog Squad for the 2013 Advancing Ethical Research Conference. The PRIM&R Blog Squad is composed of PRIM&R members who are devoted to blogging live from our conferences.

Earlier this year I joined Rutgers, The State University of New Jersey, as director of the newly created Office of Research Regulatory Affairs. On July 1, Rutgers integrated most of what was the University of Medicine and Dentistry of New Jersey. In doing so, it inherited two medical schools, a dental school and several centers of clinical and biomedical research. Although most recently I was a litigator with the New Jersey Attorney General’s Office, some time ago I was the IRB administrator for Rutgers. In that role, I had an interest in human subjects research taking place abroad, and PRIM&R was a source of expert presentations on that topic. It was through those presentations that I became aware of PRIM&R.

Rutgers has expanded from a primarily social-behavioral, engineering, and agricultural research institution to include a robust and diverse portfolio of biomedical and clinical research (and, thankfully, they’ve inherited an expert staff who will continue to oversee such research). The presentations at the 2013 AER Conference will provide me with an excellent opportunity to deepen my understanding of biomedical and clinical research.

An added benefit of such conferences, of course, is the opportunity to meet other professionals that oversee diverse research portfolios at their institutions. Learning how other institutions effectively handle compliance not only works to deepen one’s own understanding of common or best practices in the field, but also helps to demonstrate how much variety there is in the way that institutions deal with compliance matters. When I was the IRB administrator at Rutgers, I met many other administrators at PRIM&R’s conferences and was often pleasantly surprised by the different ways compliance was handled–each achieving full compliance with the regulations. My conversations at the conference lead to my recognition that the regulations (the drafters, really) intentionally gave each institution wide berth to implement their regulatory obligation to protect human subjects. I am sure that I will engage in many similar conversations at the upcoming 2013 AER Conference, much as I did many years ago when I last attended PRIM&R’s annual conference.

I look forward to picking up, from many years ago, conversations along this theme, and meeting new colleagues from other major research universities.

Research Ethics Roundup: Fallout from the US federal government shutdown, new allegations of unethical research, and more

By Maeve Luthin, JD, Professional Development Manager

Last week, the US federal government shutdown was suspended, and a temporary spending measure that guarantees operations funding through January 15 was signed into law. As government employees return to work, the effect of the shutdown is the subject of much discussion in the news. Discover the potential impact of the shutdown for biomedical research and more in this week’s Research Ethics Roundup.

Shutdown’s Science Fallout Could Last for Years: The impact of the federal government shutdown will continue indefinitely for scientists and those involved in the research enterprise system: for example, government agencies have been unable to effectively monitor flu and salmonella outbreaks; thousands of grant applications have been left unprocessed; data from real-time natural sciences research have been compromised; and clinical trials have been unable to enroll new subjects. Federal agency administrators expect delays in the processing of federal grant applications to continue in the weeks following the reopening of the government.

Medical Experiments Conducted on Bowery Alcoholics in 1950s: Two new papers have been published about an NIH-financed study of prostate cancer screening conducted on homeless alcoholics living in lower Manhattan in the 1950s and 1960s. The papers criticize the investigator for not properly informing subjects about the potential serious complications that could result from the surgical biopsies, and that treatment, for those diagnosed with prostate cancer, had not been proven to prolong life. The study team was also faulted for not using a control group.

Animal Research: A Balancing Act: Nature, in a recent editorial, warned that public policy decisions made over the past year, including NIH’s decision to decommission most of its chimpanzees, and the Italian parliament’s decision to ban xenotransplantation and the breeding of dogs, cats, and nonhuman primates for research purposes, may drastically change the future of biomedical research. Although there are some alternative in vitro and in vivo research models for certain procedures, new tools will be needed to investigate certain aspects of diseases and cell culture systems that cannot currently be replicated.

Tax Dollars Save Lives – And Cuts, Shutdown Risk Them: In an opinion piece, University of Michigan Health System chief executive officer and executive vice president for medical affairs Ora Pescovitz examines the long term impact of federal research funding cuts, the sequestration, and shutdown. The US government’s $3.8 billion investment in the Human Genome Project led to a $141 return for every dollar spent, as well as significant advances in the sciences. By not making similar investments now, there will be a decrease in the development and production of new drugs, treatments, and therapies, leading to a projected $200 billion loss, as well as an increase in future Medicare and Medicaid spending.

Catch other Research Ethics Roundup posts here.

Be vigilant and steadfast: An interview with Elyse Summers

by Avery Avrakotos, Education and Policy Manager

On Monday, October 14, Elyse I. Summers, JD, assumed the role of president and CEO of the Association for the Accreditation of Human Research Protections Programs, Inc. (AAHRPP). Ms. Summers has been a devoted member of the human subjects protections field for nearly 15 years, having served most recently as the director of the Division of Education and Development in the Office for Human Research Protections (OHRP). Ms. Summers has also contributed her talents to PRIM&R over the years as a dedicated member of our conference faculty and co-chair in 2012 and 2013 of the Workshop/Didactic Sub-Committee at the annual Advancing Ethical Research Conference. In the midst of her first week at AAHRPP, Elyse sat down with us to reflect on her new role and her commitment to the field of human subjects protections.

Avery Avrakotos (AA): When and why did you join the field of human subjects protections?
Elyse Summers (ES): My first professional job at the Association of American Universities, which represents leading research universities in the US and Canada, was my first exposure to the research enterprise broadly. During that experience and subsequent positions at the Food and Drug Administration (FDA) and a boutique FDA law firm, I ran into issues related to human subjects protections that I found fascinating. The goal of respecting and supporting the volunteers who make the research enterprise possible was very appealing to me on both an ethical and personal level. At the FDA, I also had the opportunity to participate in a group involved with rewriting the regulations at 45 CFR 46 Subpart B, which relate to the participation of pregnant women, human fetuses, and neonates in human subjects research. The whole topic of women’s participation in research, including the issue of respecting women’s autonomy and their ability to make decisions about research participation, was very appealing to me as well.

AA: What motivated you to become involved with AAHRPP?  
ES: That is a very timely question. While I really enjoyed my work at OHRP, I was starting to see some of the limitations with respect to what a person can achieve from within the government sector. I was ready to explore other avenues for bringing to bear some of my skills in the support of human subjects protections. More broadly, since as I speak today we are in the midst of the federal government shutdown, I am seeing and valuing even more the importance of organizations such as AAHRPP and PRIM&R working in parallel with—but independently from—the government to ensure that people are properly educated and committed to robust human research protection programs.

AA: What are your key goals as president and CEO of AAHRPP?
ES: I think of this as an opportunity to begin “AAHRPP 2.0” and to help bring AAHRPP well into the 21st century by expanding the body of organizations that understand that AAHRPP accreditation is an accessible but rigorous process that can bring value to all stakeholders in research. Another major goal is to really reconnect AAHRPP with its founding members—including, of course, PRIM&R, plus, the Association of American Medical Colleges, the Association of Public and Land-Grant Universities, the Consortium of Social Science Associations, the Federation of American Societies for Experimental Biology, the National Health Council, and the Association of American Universities. I think our strength as a non-profit, educational organization, and ultimately our strength in helping to protect human subjects, comes in part from close ties and collaborations with other organizations that worry about the same issues and take them very seriously.

AA: Can you tell me about an article, book, or document that has influenced your professional life?
ES: The Belmont Report has been very influential to my professional life. Fairly or unfairly, I think people tend to think of issuances from the federal government as documents that end up on a bookshelf collecting dust. However, The Belmont Report in its eloquence and relative brevity has stood the test of time in its articulation of the three principles of respect, beneficence, and justice. While The Belmont Report stands as an important foundational text, it also remains a very dynamic and living document. For instance, the notion of justice used to be thought of strictly in terms of protection from the costs and risks associated with research. Since the mid-80s and the emergence of the HIV/AIDS pandemic, members of advocacy groups have shifted their perspectives and have recognized that research might also be a source of hope and benefit. Thus, the notion of justice as embodied in The Belmont Report has been expanded to include weighing both the burdens and possible benefits of being a research subject when determining who should be recruited to participate.

AA: What motivates you to maintain your commitment to advancing ethical research?
ES: The issues that we grapple with everyday are interesting and compelling. I feel very fortunate to work in a field that has as its centerpiece such a laudable and noble goal, which is to protect the rights and welfare of people who volunteer their time and energy to, in turn, make the world better for others.

AA: What do you consider to be the most challenging ethical issues facing human research protections professionals today?
ES: With regard to human research protection professionals, one challenge that I think we all face is doing more with less. I think that as professionals in the field we can feel pressured to move things along or cut corners. However, I believe it is essential for us to remain steadfast and vigilant so as to not compromise our own convictions about what is right, as well as our understanding of what is right  in terms of our organizational roles and in terms of the ethical and regulatory principles that govern human subjects research.

AA: What advice do you have for young professionals interested in pursuing a career in research, research ethics, or a related field?
ES: I would advise people interested in the field to try to get a sense of the landscape and find a way in through a field or profession that is comfortable to them. One of the things that I love about our community is that it has attracted so many people with rich and diverse backgrounds. I am a lawyer by training—I always wanted to be a lawyer—and I am happy I became a lawyer because I think that type of study—in addition to the rigor and the analytical thinking necessary for it—was something that was comfortable and natural for me. I have been happy to be able to bring these skills to bear in my role as an educator, working in compliance, and now in this position as president and CEO of AAHRPP. There are so many different courses of study—whether it be ethics qua ethics, public health, medicine, law, social work, nursing, to name just a few—that can bring a person to human subjects research, and as a field, we are blessed to have organizations such as PRIM&R, with certification programs such as the Certified IRB Professional (CIP®) where, regardless of a person's particular educational background or degree, they can learn and become a professional in human subjects protections.

Thank you for taking the time to speak with us, Ms. Summers. We look forward to working with you in your new capacity as president and CEO of AAHRPP!

If you are interested in learning more about Ms. Summers and her vision for the future at AAHRPP, we encourage you to read a recent interview with her from the AAHRPP Advance or follow her on Twitter @eiceoaahrpp.

Tools for Success for Institutions with Small Research Programs

by Alexandra Shlimovich, Webinar and Publications Specialist

On Wednesday, September 18, PRIM&R hosted a webinar titled Doing More with Less: Best IRB Practices for Institutions with Small Research Programs. Scott Lipkin, DPM, CIP, chief of the Network Office of Research and Innovation at the Lehigh Valley Health Network, and Lori Roesch, CIM, CIP, manager or the research subject protection program at Aurora Health Care, Inc, participated as speakers, with Elisa A. Hurley, PhD, education director at PRIM&R, as moderator.

Following the webinar, we connected with the presenters, and they kindly answered a few more questions that came in from webinar participants, exclusively for Ampersand.

Alexandra Shlimovich (AS): Where should you start when developing a set of policies and procedures?
Scott Lipkin (SL): This is a difficult question to answer in general terms. Institutional review boards (IRBs) are required to have policies and procedures to review and approve human subjects research. Writing effective and compliant IRB policies requires a working
knowledge of applicable regulations and of the status of your terms of assurance under your institution’s Federalwide Assurance (FWA). Once you have this information, you then need to understand the policy approval and formatting requirements of your institution. Finally, you need to inventory existing policies and determine which policies are in order, which are missing, and which require revision. After these questions are addressed, you can begin the process of actual policy writing. I suggest that you keep copies of all applicable regulations by your side during the writing process. Many policies from reputable institutions are available online, and I would recommend looking them over as part of the process.

Lori Roesch (LR): Here are some helpful resources for doing a gap analysis:

• Food and Drug Administration (FDA) Self-Evaluation Checklist for IRBs  
• Office for Human Research Protections (OHRP) Quality Assurance Self-Assessment Tool  
• Association for the Accreditation of Human Research Protection Programs (AAHRPP) Evaluation Instrument for Accreditation   

Don’t hesitate to use AAHRPP’s evaluation instrument even if you are not planning to seek accreditation. Domain II outlines in a systematic way what IRBs must have in place, and provides regulatory references to support each requirement. You could also consider contracting with a consulting company or asking your legal counsel for assistance. It might be a higher cost upfront, but can be done very quickly. A word of caution – do not implement unless you have an in-depth working knowledge of what you are implementing.

AS: How do you earn the professional respect of your investigators/physicians who think that they are doing your hospital a favor by doing research there and that you are there to serve them?
SL: I recommend focusing on providing professional, accurate, and timely customer service to all investigators that utilize your services. Respect will be earned by maintaining professionalism at all times.

LR: Also, make sure you know why you are doing or requiring something. If you aren’t able to back something up, it casts doubt in the minds of investigators and/or physicians. View yourself as a key component of your IRB leadership team. You shouldn’t be alone. Having a strong and knowledgeable IRB chair and institutional official that support and echo your efforts will help greatly; it’s essential to be on the same page.

AS: How do you get your institution to realize that your attendance at professional conferences and pursuit of Certified IRB Professional (CIP®) certification is worth their investment?
SL: This largely depends on the culture and financial disposition of your organization. Assuming that your organization values quality and is financially solvent, I think the question is why wouldn’t they realize that attending conferences and obtaining CIP certification is a valuable investment? CIP certification affirms quality in you as an individual and in your organization as well.

LR: You might also want to consider investing in yourself if such opportunities are not available through your organization. CIP certification is $335 for PRIM&R members (and $435 for nonmembers), and is valid for three years before you need to recertify. Continuing to educate your leaders about human subject protections and sharing what can happen if you don’t (check out recent FDA warning letter) can do wonders!

AS: What follow up readings or resources would you suggest people take a look at?
LR: Here are some “must read” resources for IRB administrators:

• IRB Management and Function, Second Edition
• From the FDA’s website:
• IRB Information Sheets
• International Conference on Harmonisation E6 Good Clinical Practice
• Adverse Event Reporting 
• In Vitro Diagnostic Testing of Anonymous Samples – Waiver of Informed Consent
• Device Frequently Asked Questions
• Significant and Nonsignificant Risk Device Guidance
• HIPAA and Stand Alone Consent
• From OHRP’s website: 
• Recent Compliance Oversight Determinations
• Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events
• Human Research Questions and Answers
• Policy Guidance by Topic
• Quality Assurance/Quality Improvement: A Guided Self-Assessment for Human Research Protection Programs
• AAHRPP Standards
• Office for the Protection of Research Subjects Flexibility Coalition information 

If you’re interested in learning more about best IRB practices for institutions with small research programs and did not have a chance to participate in last week’s webinar, the archive is available for purchase. PRIM&R members can also access additional readings related to this topic on our Knowledge Center.

Research Ethics Roundup: Government shutdown's impact on research, new revelations on Milgram experiments, and more

by Maeve Luthin, JD, Professional Development Manager

It’s been a challenging several days in the research world with uncertainty looming in the wake of the shutdown of the federal government last week. We offer our support to colleagues directly affected by this development and to those who are feeling its far-reaching impact. In this week’s Research Ethics Roundup, we provide information about the shutdown’s effects as well as a look back at two seminal events that helped shape the field.

Federal Government Shutdown: On Tuesday, October 1, following disagreement between Republicans and Democrats on a budget for the fiscal year, the United States federal government shut down. The impact on science and biomedical research is wide ranging: many ongoing studies have been put on hold, and agencies charged with both research and its oversight are largely closed. Below are links to contingency plans and announcements from some of the federal agencies and offices affected by the shutdown:

• Department of Agriculture Animal and Plant Health Inspection Service 
• Department of Defense
• Department of Energy
• Department of Health and Human Services
• National Institutes of Health Extramural Grantees
• National Science Foundation
• Office for Human Research Protections
• Office for Laboratory Animal Welfare
• Presidential Commission for the Study of Bioethical Issues

The Death and Afterlife of Thalidomide: In this Retro Report video from The New York Times, journalist Michael Winerip chronicles the story of thalidomide, a drug first marketed in Europe in the 1950s as a safe sleeping pill that was effective for treating morning sickness. After garnering widespread success, it was discovered that the medication caused severe birth defects. Thalidomide prompted a new era of regulatory reform by the FDA.

Looks Good on Paper: In China, research grants and promotions are awarded based on the number of articles a researcher publishes, rather than on the quality of the original research. This incentive structure fosters  a culture of misconduct, which has become a $150 million industry in itself. Investigations have unveiled fabricated research results, counterfeit scientific journals, and ghostwritten articles.

Stanley Milgram and the Uncertainty of Evil: As the fiftieth anniversary of the first published paper on Stanley Milgram’s infamous experiments approaches, new examinations of his work are giving insight into his methodology. Scholars, including Gina Perry, author of a recently published book on Milgram, have uncovered documentation that  raises questions about whether subjects believed they were actually hurting anyone. Perry also reports that researchers working with Milgram did not strictly adhere to the protocols documented by Milgram. Some commentators believe that these revelations do not change the value of Milgram’s research, while others believe that this new information dilutes his findings.