Friday, September 26, 2014

Diplomacy is a must: An interview with Steven O’Geary

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 Steven “Steve” O’Geary, assistant vice president for research compliance at Oklahoma State University-Stillwater in Stillwater, OK. 

Megan Frame (MF): When and why did you join the field?
Steve O’Geary (SO): I joined the field in January 2002 when my alma mater, the University of Oklahoma (OU), began restructuring its research compliance programs. I left a tenure-track faculty position to return to OU to serve as the director of the Office of Human Research Participant Protection. That was the beginning of an amazing career that led me to the University of California-Berkeley and now Oklahoma State University. Although I miss the challenges of engaging students in active learning, I have never regretted my decision to directly support the mission of IRBs. After 14 years, I remain earnest and diligent in my efforts to safeguard the rights and welfare of human subjects.

MF: What skills are particularly helpful in a job like yours?
SO: Diplomacy is a must. A person needs to possess solid interpersonal skills, especially the ability to communicate effectively with people from diverse backgrounds. You need a robust understanding of all pertinent regulations, and you also need to be patient, detail oriented, organized, and even-tempered. Enthusiasm, passion, and a sense of humor help, too.

MF: Tell us about one or more articles, books, or documents that have influenced your professional life. 
SO: Along with books like Bad Blood: The Tuskegee Syphilis Experiment and Acres of Skin: Human Experiments at Holmesburg Prison, which many of us read when joining the field, there are several books that have influenced me:
Some may seem far afield at least at first glance, but each one helped me to better appreciate the principles of the Belmont Report.

MF: Have any of the PRIM&R talks you’ve attended had a significant impact on your approach to your work? 
SO: Former Office for Human Research Protections (OHRP) director Greg Koski, MD, PhD, spoke at PRIM&R’s 2005 Human Research Protection Program Conference, one of the first PRIM&R conferences I attended. This was shortly after he had stepped down as director and returned to a faculty position at Harvard Medical School. During his presentation, he spoke about the challenges of being the first director of the newly created OHRP. He spoke very eloquently about the moral obligations that accompany research involving humans and about why IRBs matter. He also discussed the sad circumstances surrounding the death of Jesse Gelsinger, the first subject publicly identified as having died as a result of his participation in a gene therapy trial. Dr. Koski struck a chord with me. He helped me realize, even more so than I had previously, the significance of the professional decisions I make every day. I was left with the realization that I was a part of something far greater than myself.

MF: What advice have you found most helpful in your career?
SO: To surround myself with people who drive me forward rather than those who would hold me back. I’ve done this at Oklahoma State, where I have the privilege of working with outstanding professionals who truly function as a team. The sense of community that exists on our campus is stronger than I’ve experienced. Collectively, my colleagues and I have created an office where talented people want to work.

Thank you for being part of the membership community and sharing your story, Steven. We hope to see you at the 2014 AER Conference, where Dr. Koski will be joining us once again as a member of our conference faculty

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

Wednesday, September 24, 2014

Poster Spotlight: Ethical Challenges and Solutions Involved in Reviewing a Protocol with Sex Offenders as Participants

by Meryn Robinson, Educational Program Intern

When reviewing a study that sought to investigate how sex offenders used networked technologies and communications for human trafficking, Hila Berger, MPH, CIP, and her colleagues on the IRB at Montclair State University faced a unique challenge: balancing protections for the study’s subjects—sex offenders—against protections for potential victims. The potential for subjects to incriminate themselves and potential legal obligations related to information disclosed during the research further complicated the protocol review. To overcome these challenges, the IRB and legal counsel worked together to implement additional protections for the group.

At the 2013 Advancing Ethical Research (AER) Conference, as a poster presenter and panelist, Hila discussed her experience and the systems put in place to manage such a challenging protocol at her institution. Recently, I connected with Hila to see how her work has progressed since last year’s conference.

Meryn Robinson (MR): It’s been nine months since you presented your poster at PRIM&R’s 2013 AER Conference. How has your research changed or evolved in the past nine months?
Hila Berger (HB): The work presented at the conference revolved around identifying and developing solutions for research involving sex offenders. The research in question is still ongoing, and the IRB and compliance team continue to informally assess whether the solutions we chose have been implemented successfully. Discussions with the principal investigator (PI) during additional submissions and at the time of continuing review have brought to light any concerns. Initially, during the review process, the PI had concerns about whether certain limitations would impact recruitment. However, according to the PI, while the project has struggled with recruitment, it is not as a result of the additional protections set forth by the IRB.

MR: What challenges have you faced in implementing these solutions?
HB: As a predominantly social-behavioral research-based institution, some assume that we do not have to regularly deal with greater than minimal risk research. This is far from the truth, but the nature of our greater than minimal risk studies do look different than those found in biomedical institutions. For example, since this initial protocol we have actually had another researcher request to conduct a study that would study involve assessing the effect of sexual offender legislation on registered sex offenders. Fortunately, the IRB was able to use some of the same protections put into place with the previous study. One of the most important lessons we’ve learned is that while a Certificate of Confidentiality may be appealing, as it offers additional protections for greater than minimal risk behavioral research, it may not always be attainable. Weighing the risk of subpoena against the benefits of the research may be something that can only be done with input from counsel, law enforcement, and other experts.

MR: What is one principle that guided you in your research?
HB: When reviewing this type of research, the key ethical principle that guides us is beneficence, as described in the Belmont Report. The moral dilemma of protecting sexual offenders did not escape the IRB’s discussions, but the group worked diligently to separate personal biases from the need to protect the subject population, in this case sex offenders, and to focus on the potential benefits that could emerge from such research.    

MR: What is one thing that you learned or took away from your experience?
HB: When it comes to human subject protections, there are always going to be unique research designs or populations that require the IRB to think critically and create a new recipe for protecting participants. There is no cookie-cutter solution that can be applied to every research study. Bringing in experts and taking the time necessary to fully understand the risks associated with a particular protocol will ultimately better serve the research and the participants.

Thank you for connecting with us and providing an update on your work, Hila. We hope that you are planning to join us for the 2014 AER Conference, which will take place December 5-7 in Baltimore, MD. This year’s program will feature more than 100 posters highlighting best practices and research related to human subjects protections, including nine exemplary posters, which will be presented during a special panel series.

Thursday, September 18, 2014

Petrie-Flom Center Launches New Book on Human Subjects Research Regulation

by Holly Fernandez Lynch, JD, MBioethics, Executive Director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics

The current framework for the regulation of human subjects research emerged largely in reaction to the horrors of Nazi human experimentation, revealed at the Nuremburg trials, and the US Public Health Service Syphilis Study at Tuskegee, conducted by US government researchers from 1932 to 1972. This framework, combining elements of paternalism with efforts to preserve individual autonomy, has remained fundamentally unchanged for decades. Yet, it has significant flaws—including its potential to burden important research, lag behind developments in how research is conducted, overprotect some subjects and inadequately protect others, and generate inconsistent results.

A new book from the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, titled Human Subjects Research Regulation: Perspectives on the Future, documents some of the issues that persist with the current system of research regulation. Invigorated by the US government’s first steps toward change in over twenty years, Human Subjects Research Regulation, which was co-edited by myself and the Center's faculty director I. Glenn Cohen, JD, brings together the leading thinkers in the fields of ethics, law, medicine, and public policy to discuss how to make the system better. The result is a collection of novel ideas—some incremental, some radical—for the future of research oversight and human subject protections.

The edited volume stems from the Petrie-Flom Center’s 2012 annual conference, which brought together leading experts in a conversation about whether and how the current system of human subjects research regulation in the US ought to change to fit evolving trends, fill substantial gaps, and respond to identified shortcomings. After reviewing the history of US research regulations and the 2011 Advance Notice of Proposed Rulemaking for revision to the “Common Rule”—in a chapter by PRIM&R’s own Elisa A. Hurley, PhD, and Amy Davis, JD, MPH—the contributors consider such topics as risk–based regulation; research involving vulnerable populations (including military personnel, children, and prisoners); the relationships among subjects, investigators, sponsors, and IRBs; privacy, especially regarding biospecimens and tissue banking; and the possibility of fundamental paradigm shifts.  

The book is currently available from MIT Press and Amazon, and its introduction can be downloaded for free here. We will be hosting a book discussion at Harvard Law School on October 22 (in Wasserstein Hall Room 2009 from 12-1:30pm), and in Baltimore on December 5 at PRIM&R’s 2014 Advancing Ethical Research Conference.

We hope to see you there!

Tuesday, September 16, 2014

PRIM&R’s Response to the FDA’s Draft Guidance on Informed Consent

by Avery Avrakotos, Education and Policy Manager

PRIM&R has long been committed to the protection of the rights and welfare of human subjects, and strongly believes that informed consent is an essential mechanism for providing potential subjects with the information they need to make considered, autonomous decisions about research participation.

In July, the US Food and Drug Administration (FDA) announced it was seeking comment on a draft guidance document titled "Informed Consent Information Sheet: Guidance for IRBs, Clinical Investigators, and Sponsors." The draft is a substantial revision to the FDA’s prior guidance on this topic, which was issued by the agency in September 1998. Yesterday, PRIM&R’s Public Policy Committee, which is composed of experts from a wide range of disciplines and institutional settings, responded to the agency’s request with a set of comments on the draft guidance.

In its response, PRIM&R commends the FDA for encouraging investigators to think of informed consent as not simply a form, but rather a dynamic process that can be adapted to reflect the unique needs of potential subjects, as well as local context. PRIM&R also thanks the FDA for its efforts to harmonize regulatory requirements and guidance for human subjects research put forward by the Department of Health and Human Services, the Office for Human Research Protections, and the FDA. PRIM&R’s comments also applaud the addition of expanded sections on informed consent with respect to vulnerable populations and the agency’s consideration of the use of new technologies for obtaining informed consent.

PRIM&R comments also identify several areas where further guidance could benefit IRBs, investigators, sponsors, and, ultimately, subjects:

The Consent Form Versus the Consent Process
In a recent blog post, PRIM&R’s executive director, Elisa A. Hurley, PhD, discussed how the language we use to talk about informed consent can have an effect on our general attitudes toward consent. Along those same lines, in its comments, PRIM&R urges the FDA to replace the term “consent interview” with the term “consent discussion,” which more accurately reflects the desired tenor—an exchange of information between two parties—of such interactions. PRIM&R also recommends that the FDA carefully consider how it explains the purpose of the consent form, as what is said in the guidance document is likely to have far-reaching effects on the content of consent forms. As a final point, PRIM&R asks the agency to provide greater clarity regarding the form and function of the consent discussion, as well as its relationship to the consent form.

Presentation of Risks
In the draft guidance, the FDA acknowledges that reducing length may increase the readability of consent forms. PRIM&R commends the agency for this recognition, but cautions that the call for disclosure of any reasonably foreseeable risks associated with the medically recognized standard care and appropriate alternatives seems likely to perpetuate the problem of overly long and complicated forms. PRIM&R believes the consent form, as well as the consent discussion, should focus on presenting potential subjects with the information that is most likely to be significant to their decisions to participate in research. In its comments, PRIM&R also recommends a framework— making a distinction between “risks” and “side effects” associated with a clinical investigation—that investigators, IRBs, and sponsors can utilize when determining which risks should be considered “reasonably foreseeable,” and thus, most likely, germane to a potential subject’s decision to participate.

Responsibilities of Investigators
One of the strengths of the draft guidance is the addition of clear information on the respective responsibilities of IRBs, investigators, and sponsors for informed consent, as all of these parties have an essential role to play in the informed consent process. In its comments, PRIM&R offers several additional recommendations with respect to the responsibilities of investigators. PRIM&R asks the FDA to consider requiring investigators and/or research staff to attest that they have discussed the risks, benefits, and alternatives and provided the potential subject with an opportunity to ask questions, and that, in their judgment, the potential subject understands the information that has been presented and has voluntarily chosen to participate in the clinical investigation. PRIM&R also asks the FDA to encourage investigators to consider the order in which information is presented in the consent discussion and to utilize alternative approaches to information disclosure that will enhance the discussion, such as videos or online resources.

Understandable Language
From the outset, the FDA recognizes in the draft guidance that the health literacy and numeracy (quantitative literacy) of many US adults are at a basic level. In its response, PRIM&R commends the FDA for recognition of this fact, and makes several additional recommendations intended to ensure that language used throughout the consent process is understandable to potential subjects. As a starting point, PRIM&R asks the FDA to recommend that scientific and medical terms only be used when necessary and, whenever possible, as parentheticals to ordinary language descriptors. Given the limited quantitative literacy of many US adults, PRIM&R also asks the FDA to provide clearer guidance on the presentation of quantitative information to potential subjects, for instance, the most effective way to present the likelihood of potential risks and benefits. As a final point, PRIM&R asks the FDA to ensure that all sample language provided in the draft guidance is consonant with its recommendations regarding the use of understandable language.

Enrollment of Non-English-Speaking Subjects
The principle of justice requires that no specific population either be unfairly excluded from the potential benefits of research or unduly subjected to its burdens. When barriers to enrolling individuals from a specific population, such as non-English speakers, are high, concerns related to the principle of justice arise. In its comments to the FDA, PRIM&R raises concerns about certain requirements for the unexpected enrollment of non-English-speaking subjects—including the post-hoc provision of a translated long form to subjects who have already participated in a consent discussion and enrolled in the research—which PRIM&R believes may carry significant financial and administrative burdens, without evidence that such requirements will enhance subject protections. PRIM&R asks the FDA to reconsider these requirements with the principle of justice in mind.

I encourage you to take a moment to read PRIM&R’s complete response to the FDA, and to share your thoughts about PRIM&R’s comments or the FDA’s draft guidance below.

Thursday, September 11, 2014

Finding Empowerment at the 2013 AER Conference

by Betty Kalama, Senior Community Facilitator at the Kenya Medical Research Institute Wellcome Trust Research Programme

As a community facilitator within the Kenya Medical Research Institute (KEMRI)-Wellcome Trust Research Programme, my primary responsibility is supporting community engagement. From workshops for community members to staff training sessions on research ethics and communication skills, I work frequently with researchers and community members to strengthen the relationship between the programme and the community. In addition, I participate as a member of the Consent and Communication Committee, which aims to support ethical research by advising on locally appropriate strategies for communicating with participants and the wider community about research.

Given my professional responsibilities, I was very pleased to be able to attend PRIM&R’s 2013 Advancing Ethical Research (AER) Conference through the organization’s Global Research Scholarship Program. The conference provided me with an opportunity to learn in greater detail about the convergence of ethics with medicine and research. Furthermore, I was able to expand my understanding of the diverse ethical challenges that can arise in the review of research. The experience solidified for me the idea that, while the principles of research ethics may be global, careful attention needs to be paid to the research setting to ensure the appropriate application of those principles. By sharing experiences with other scholars and conference attendees, I discovered how complex ethical principles can be applied in a variety of settings. The conference also provided me with new strategies to tackle the challenging issues inherent in human subjects research.

Upon returning home, I shared the knowledge I gained with other staff in my organization. Through my participation, my colleagues were able to learn about new things, including the use of placebos in clinical trials and recent changes to the Declaration of Helsinki. This knowledge empowered my team to address ethical issues in protocol review, trainings, workshops, outreach efforts, and regular interactions with both the staff and the community. Thanks in part to the knowledge I gained at the conference, I was also able to advance: I was nominated to serve as secretary of the Consent and Communication Committee.

I am grateful to PRIM&R for the opportunity to attend the conference. I am also thankful to the KEMRI-Wellcome Trust Research Programme for encouraging me to attend.

Registration for the 2014 AER Conference, which will be held December 5-7 in Baltimore, MD, is now open. Please visit our website for more information.