Saturday, December 20, 2014

Avoiding Mediocrity Through Ethics Education


by Anne Meade, MS, PMP, Senior Manager for Website and Social Media

For its December Question of the Month, our People & Perspectives program wants to know what you think will be the greatest challenge the research ethics field will face in the next 20 years.

Need inspiration? How about considering your own moral identity, and how you apply that identity to your work?

For more on this topic, watch this People & Perspectives interview, in which John Gluck, PhD, professor emeritus of psychology and senior advisor to the president on animal research ethics at the University of New Mexico, talks about ethics education.

Dr. Gluck believes that ethics education is not comprehensive enough. While there are ways to learn about the laws and regulations, focusing on compliance doesn’t always allow you to take a step back and examine your own moral identity. Dr. Gluck argues that ethics education needs to go beyond compliance, and there doesn’t currently seem to be a lot of room for this type of open education. “Absent that,” he says, “I think we’re going to be pretty mediocre.”

Watch the full video.

What do you think will be the greatest challenge faced by the field of research ethics in the next 20 years? Respond to the Question of the Month on the People & Perspectives website, or share a comment below.

Friday, December 19, 2014

The Fundamental Things Apply, As Time Goes By

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

PRIM&R is pleased to share a post from 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 happened December 4-7 in Baltimore, MD.

On December 7, the last day of the conference, Susan E. Lederer, PhD, the Robert Turell Professor of the History of Medicine and Bioethics at the University of Wisconsin School of Medicine and Public Health, delivered an excellent keynote presentation titled “Beyond the Bombshell: The Legacy of Henry K. Beecher's Call for Reform in Clinical Research Ethics.” Lederer put current human subjects research issues into historical perspective with stories about renowned physician and researcher Henry K. Beecher, a professor of anesthesiology who was involved with human subjects research at Massachusetts General Hospital in the 1960s. Beecher wrote a controversial 1966 article,‘‘Ethics and Clinical Research,’’ in which he issued a scathing critique of contemporary human subjects research practices. The article caused a significant stir in the scientific community at the time of its publication. The paper has since been recognized as one of the most influential papers related to human subjects research in the United States. Its publication also set the stage for the development of our current regulatory framework, which is to a large degree focused around the principle of informed consent.

Informed consent refers to process by which research participants are informed of, and given the opportunity to ask questions about, potential risks, harms, benefits, and burdens of a study, so as to enable them to make an informed decision about whether or not to participate. Interestingly, as Lederer mentioned, Beecher did not agree that informed consent, as it is currently conceptualized, should be the basis for human research protections. He questioned the feasibility of ever obtaining ‘‘consent in any fully informed sense.” Rather, he argued, that the best protection for research participants was gained through investigators’ careful attention to ethical principles during the design research and conduct of a study.

Beecher’s misgivings about the feasibility of obtaining fully informed consent are becoming particularly relevant in today’s rapidly changing society. As I mentioned in a previous post, the widespread use of mobile and digital technologies is changing our social environment. Data research is becoming more prevalent and current consent practices may no longer adequately protect consumers.

“Consider how ideas and thoughts change when you really take a look at what is going on,” commented Anthony S. Fauci, MD, during his keynote address on December 4. The issues Henry Beecher was wrestling with in the 1960s and the current research protections issues we are considering today might seem radically different on the surface, but the underlying ethical question is the same: should our goal be fully informed research participants, fully ethical researchers, or both?

An Accountant's Ideal Session

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

PRIM&R is pleased to share a post from Mike Kraten, 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 happened December 4-7 in Baltimore, MD.

When I arrived at the 2014 AER Conference, I couldn't help but wonder whether I'd find sessions that address all of my professional identities. I suspected that it might not be easy to do so; after all, I'm not a medical professional, and I don't engage in clinical research.

Rather, I'm a Certified Public Accountant who teaches in the School of Business at a liberal arts college. I'm an administrator as well, the newly appointed chair of an IRB that is striving to embrace the latest efficient technologies.

So would I be able to find intellectual content that is relevant to all of my interests? To my surprise and delight, that was an easy task! In retrospect, the process began even before I arrived in Baltimore, when I joined the technologically savvy PRIM&R Blog Squad.

Then, on Thursday, I attended a pre-conference program titled IRB Chairs Boot Camp: Tools for Successful IRB Leadership. On Friday, I found some information to enrich one of my teaching cases. And yesterday, I enjoyed a session that addressed my research interests in communication technologies.

I wrote about these experiences in my previous postings, but when I arrived at the convention center on the final morning, I wondered whether I would find anything that was relevant to my professional activities as a Certified Public Accountant. Of all of the elements of my professional identity, that was the one that had not yet been addressed.

And guess what? That morning, I found the perfect workshop! It was an accountant's ideal session: “Institutional IRB Performance: Benchmarking and Optimization.” I found the session content was extremely informative.

Jeffrey Cooper, MD,MMM, and Stuart Horowitz, PhD, MBA, of the WIRB-Copernicus Group, joined Daniel Nelson, MSc, of the US Environmental Protection Agency, to present a performance report that was released just two days prior to the session. Fortunately, most of their findings were reassuringly familiar. They found, for instance, that IRBs often require more than one month to process expedited and full review applications.

Other benchmarking metrics, however, surprised me, and will directly impact my perception of my own IRB's efficiency. For instance, I had no idea that most IRBs routinely process exempt review applications in less than two weeks. And I was unaware that the ratio of "minimal risk" to "more than minimal risk" applications at most institutions is very heavily weighted towards the "minimal risk" categorization.

The "bottom line," though, is that during my four days in Baltimore, I managed to find intellectual content that appealed to each and every aspect of my professional identity. Without a doubt, that was the single most impressive (and rewarding) discovery of the conference for me.

HIV/AIDS Research: We've Learned A Lot, We've Come a Long Way, but There is Plenty More To Do

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

PRIM&R is pleased to share a post by Rebecca Ohnemus, MAA, CRA, 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 happened December 4-7 in Baltimore, MD.

Following closely on the heels of World AIDS Day, “Issues Related to the HIV/AIDS Epidemic and the Populations Affected,” a panel at the 2014 AER Conference, was timely, relevant, and emotionally powerful. The panel featured policymakers and advocates alongside members of the research community, some of whom have worked for more than 30 years to develop treatments for HIV/AIDS.

This multi-disciplinary panel reflected an important component of HIV/AIDS research: collaborations between subject communities, advocates, and researchers. However, despite the collaborations that have bolstered HIV/AIDS research, all panelists agreed that there is still a long way to go.

The panelists suggested that the communities should be encouraged to play a larger role in order to help address underlying social and cultural structures issues. Panelist Darrell P. Wheeler, PhD, MPH, urged the research community to take up a “mantle of humanity” as we look at the circumstances of these lives, “there is a reality we don’t like to talk about which places people in these situations.”

Questions from the audience turned the conversation toward two challenges for IRBs:

Should IRBs consider subjects with HIV/AIDS to be a vulnerable population?
Though not specifically listed in the regulations as a vulnerable population, there is, as the panelists noted, room for interpretation. When considering whether or not someone would be more vulnerable to coercion or undue influence, or whether or not an individual is likely to be placed at a greater risk of social damage, Nancy E. Kass, ScD, suggested taking a look at the study as a whole.

“Consider study design, the subject population, the risks involved,” suggested Kass. IRBs must analyze and look at these elements both separately and as part of the whole. Ask the question: are people with HIV/AIDS more vulnerable? Sometimes they won’t be any more vulnerable than any other subject; other times they will be profoundly more vulnerable.

Do IRBs have a role to play in engaging vulnerable populations? 
“This is serious déjà vu for me,” said Anthony S. Fauci, MD. He noted that while clinical trials had historically developed by scientists, in the early days of the epidemic, it made sense to include activists and community members when designing HIV/AIDS interventions. “Fast forward 20 years, and we wouldn’t dream of designing [an intervention] without involving communities,” commented Fauci.

“IRBs always have the opportunity to seek external expertise from the community or from experts,” said Kass. She suggests that IRBs and researchers build connections to relevant communities and utilize them as needed.

Wheeler commented: “We must look at the intersections between our disease research and the injustices of our world. If I’m not looking at the actual impact of a study on the population involved, I am not doing my job as an IRB member.”

Tuesday, December 16, 2014

2014 Membership Services Survey Results

by Megan Frame, Membership Coordinator

This fall, we asked PRIM&R members to share their feedback through our annual Membership Services Survey. This is our staff’s opportunity to learn more about our community and what members need from PRIM&R as they navigate their roles in the research ethics and oversight fields. More than 500 individuals responded to our call—the most in the survey’s history—and the responses generated pages of helpful information. Read on for some of the highlights:

Membership Research Ethics Digest Self-Study Program Knowledge Center Workload Salary Surveys Member Directory Knowledge Center Program Archives Discounts Newsletter Mission Newsletter PRIM&R Homepage Email Membership

Most Valuable Member Benefits: This year, the top-ranked member benefits included complimentary access to conference and webinar archivesdiscounts on registration fees for educational programming, and the PRIM&R Member Newsletter, which is distributed to members via email each month. As many of you may have noticed, the PRIM&R Member Newsletter underwent a visual transformation this past May during Member Appreciation Month, and 97% of respondents said they like the new design and layout of this resource. The December edition of the PRIM&R Member Newsletter will arrive in inboxes this Thursday, December 18

Thoughts on New Benefits: The survey also gave us an opportunity to hear members’ thoughts on benefits recently added to the roster. The Research Ethics Digest Self-Study Program, which debuted in August of this year, allows members to earn continuing education credit for reading Research Ethics Digest and completing a quiz about three selected articles on human subjects protections. Sixty-eight percent of respondents who were unaware of or hadn’t tried the program said they were likely to use it in the future. For those interested in getting started, the self-study quiz from December’s edition of Research Ethics Digest, sent on Friday, December 12, is open until Thursday, March 12. By passing this quiz with a score of 80% or higher, PRIM&R members can earn 1.5 continuing education credits.

The Membership Onboarding Experience: We asked specific questions to members of one year or less to get feedback on the membership onboarding experience. Seventy-eight percent of new member respondents found our welcome emails to be helpful, and sixty-nine percent of this same group said they would be interested in receiving a mailed welcome packet that details our member benefits. As a result of this feedback, we will be sending hard copy member welcome packets to new members on a monthly basis starting in 2015. We hope these materials make it easier for you to take advantage of resources and connect with other members of the PRIM&R community. Want more information about member benefits as an active member? Let us know and we’ll gladly send you the packet too!

New Continuing Education Opportunities: In terms of continuing education, members requested additional workshops and conferences on topics related to social, behavioral, and educational research (SBER). We recognize this is in high demand and are excited to share that on November 12, 2015, PRIM&R is hosting the 2015 SBER Conference, a one-day meeting held before our annual Advancing Ethical Research Conference, in Boston, MA. Save the date, as more information on the program will be forthcoming. 

As a reminder, the PRIM&R membership team can always be reached by writing to membership@primr.org. Don’t hesitate to contact us if you have a question about one of your member benefits or how to access members-only material on our website.

In the last weeks of PRIM&R’s 40th anniversary year, we are preparing even greater plans for how to serve and support PRIM&R members in 2015. Thank you for your commitment to PRIM&R and to helping us to continually strengthen our offerings.