Friday, January 30, 2009

Comments on OHRP Draft Guidance

OHRP recently invited public comment on a draft guidance document entitled, "Guidance on Important Considerations for When Participation of Human Subjects in Research is Discontinued.'' This draft guidance is intended to explain how to interpret the terms “participation” and “discontinuation of participation” in research. The guidance would also clarify that investigators may continue to analyze already collected individually identifiable private information about a subject even when the subject's participation has been discontinued, and that research may continue to involve human subjects even when the participation of all subjects has been completed or discontinued.

PRIM&R's Public Policy Committee developed comments that request further clarification about the ongoing responsibilities of the investigator and IRB toward subjects whose participation in a study has terminated. The comments recommend inclusion of additional guidance on the duty to report new findings to research subjects whose participation in a study has been discontinued. In addition, PRIM&R recommends that the guidance advise researchers to include information on future risks that may exist beyond participation in research. Please review PRIM&R's comments and let us know your thoughts by leaving a comment below.

Wednesday, January 28, 2009

Witnessing History

PRIM&R is excited to welcome a new addition to our team—Joanna Cardinal, our membership manager.

Before coming to PRIM&R earlier this month, I spent five years living in Washington, DC, and I was lucky enough to return for the presidential inauguration last week.


What struck me most wasn’t the historic moment, nor was it the large crowds. It was the sense of community that everyone shared. I’m part of the so-called “apathetic generation.” However, I’ve found myself wondering if perhaps being apathetic has less to do with age and more to do with access to inspiration.


Never before had I found myself engaging with so many strangers in such a short time. In restaurants, on the National Mall, in grocery stores, on the Metro, on sidewalks, at events and in airports I talked to hundreds of exuberant people about President Obama and our nation’s future. A lot of people spoke about wanting to be in DC to share in the celebration with the expected crowd of millions. I did hear a few stories of problematic travel to and at the event, but even the people who were unable to reach the Capitol have formed a community nearly 6,000 strong ... a Facebook group titled “Survivors of the Purple Tunnel of Doom.”


While people certainly came to celebrate, everyone seemed to grasp that President Obama is but one man and cannot change this nation’s course alone. We all took to heart to hear Obama’s words when he was inaugurated,


What is required of us now is a new era of responsibility -- a recognition, on the part of every American, that we have duties to ourselves, our nation and the world; duties that we do not grudgingly accept but rather seize gladly, firm in the knowledge that there is nothing so satisfying to the spirit, so defining of our character, than giving our all to a difficult task.


Here’s to a new year, a new president and a new sense of community. I hope to see everyone again in four years!


If you were there, we’d love to hear about your experience. Even if you weren’t, please share your thoughts or comments below.

Monday, January 26, 2009

Take a walk down Monday Memories lane!

Posted by Catherine Rogers, marketing coordinator


With our 35th anniversary upon us, the PRIM&R staff has been doing a lot of digging through our archives, and my, how far we've come! To remind you (and ourselves) of PRIM&R's journey, we will periodically post interesting photos in a feature called Monday Memories. Do you know what's going on in this image? Are you one of the enthusiastic chorus, or maybe you took the photo yourself? If you have any ideas about who's who, or what's what, please leave a comment and let us know!







Thursday, January 22, 2009

Learning and connecting in an economic downturn

Posted by Kimberly Hensle Lowrance, Deputy Director

The current economic downturn is widely seen as the most serious in decades, and each day's news reminds us that volatility and uncertainty have become our new reality. For all the challenges this situation presents, we are fortunate to be part of a community filled with strong personal and professional connections, an unwavering commitment to looking out for the best interests of research subjects, and a dedication to striving for the best in all that we do. For 35 years, PRIM&R has been proud to be the home of this community and to play an important role in the research protections field.

We must recognize that PRIM&R and the research community at large are not invulnerable to the seismic financial shocks rippling through the world today. Therefore, we will need to act in ways that reflect that reality to assure that we can continue to advance our mission.

The economic downturn puts pressure on the revenues that fuel our—and your—annual budgets. In fact, some of you have already expressed concerns about the year ahead and the limits your institutions have placed on professional development activities that are so critical to ensuring that you remain current on the latest ethical issues, regulations, and compliance matters.

We understand these challenges. Therefore, in planning for 2009, we offer three cost-effective ways—with special pricing available to our members—for you to continue learning and connecting:

  1. Webinars – PRIM&R will offer at least six webinars that focus on hot topics facing today’s IRB and IACUC professionals. Special group registration rates are available.
  2. Regional Programs – We are taking our programs—including IRB 101sm, Essentials of IACUC Administration, IBC Basics, and more—to Texas, California, and Massachusetts. We’ve chosen these locations to reach as many people as possible, thereby increasing your access to education, while decreasing your travel costs.
  3. Annual Conferences – Our animal care and use and human subjects meetings offer unprecedented professional connections and important educational opportunities. We want to help as many of you to attend as possible, and therefore, we will not be raising our registration rates from 2008. Additionally, for the 2009 Advancing Ethical Research Conference, special pre-registration is available to those who would like to pay for their registration rates before registration officially opens in August.

Additionally, as we continue to offer you high-quality programs, we will work to bring greater financial discipline to our activities. We are developing new approaches for generating savings and revenue, building on the best practices many others in the non-profit world employ. We welcome your suggestions as well, so please feel free to e-mail me with your comments. Today, perhaps as never before, we need to work collectively to develop approaches and efficiencies that will allow our field—and PRIM&R—to thrive in the years to come. Together, we must continue to advance the priorities that define us.

Thank you for your continued support of PRIM&R and of our shared work.

Wednesday, January 21, 2009

PRIM&R's Newest Member

We are happy to announce that Jen Levine-Fried, PRIM&R's membership specialist, and her husband Matt welcomed little Ava to their family on January 13, 2009 at 8:06 AM. She weighed 8 lbs. 2 oz and was 21" long. The entire family is doing well and resting at home (including big brother Jonah).

Welcome little Ava!


Tuesday, January 20, 2009

Inauguration Day

Posted by Joan Rachlin, executive director

On a day when the earth is moving beneath the feet of the millions who have assembled on the Mall in Washington, DC, I'm overflowing with emotion as I think of the many sung and unsung heroes who have stood up to injustice. Dr. Martin Luther King, Jr. is near the top of the list, but so are Rosa Parks, the Little Rock 9, James Meredith, Medgar Evers, and many others.

Facing History and Ourselves, an international organization I greatly admire, refers to them as "upstanders," characterized by their willingness to speak out and make an impact on others. The stories of upstanders remind us that it only takes one person, or a small group of people, to bring significant change. Do you know someone who qualifies as an upstander?

I've seen some in action, but unfortunately, I’ve seen more "downsitters." My mother was raised in Selma, Alabama, and my life therefore intersected with that of the civil rights movement from a very young age. Those years were among the most important in my life and put me on a path that led to my work with PRIM&R and research protections.

Having a hard time seeing the connection? It's not immediately obvious, and it's more than one degree (but less than six) of separation, but I think that IRBs and IACUCs have the capacity to be upstanders. They are charged with speaking out when they think a proposed research project is not either ethically or scientifically defensible. Justice is one of the Belmont principles, as is respect, both of which are also core principles in the ongoing quest for civil rights.

As William Faulkner once wrote, “The past isn’t dead and buried. In fact, it isn’t even past.” All of us know about the history of racial injustice in this country and we must never stop studying and retelling that history. In fact, if you haven't yet listened to President Obama's powerful speech on the topic, please take the time to do so and you won't be disappointed.


Deep disparities still exist in the treatment of African Americans and other minority groups as well. These inequalities extend to health care and research, and there are often speakers at PRIM&R who talk about racial disparities and the subtle effects of bias, especially regarding quality health care. I'm hopeful that the new administration will immediately begin to ameliorate these and other inequities even before there is widespread systemic change.

So on this momentous day, we celebrate President Barack Obama, new beginnings, the pursuit of justice, and the healing power of hope. We also celebrate the triumph of community. As President Obama has shown us, we can transcend our divided past, if we get to know, really know, one another.

One of the watershed novels in the civil rights pantheon is To Kill A Mockingbird by Harper Lee. One line that has stuck with me from childhood was Scout’s comment that “Atticus was right. One time he said you really never know a man until you stand in his shoes and walk around in them. Just standing on the Radley porch was enough.” Atticus was an upstander, and Scout became one, too. They had empathy for those around them, they practiced respecting others irrespective of race, class, or disability, and they pursued justice despite the personal risks (and in Atticus’ case, professional risks as well) involved.

Today and every day, we at PRIM&R celebrate the work that you do, and I encourage all of you to be "upstanders" in that work. "Out of many, we are one," President Obama so frequently reminds us, as so much more unites than divides us.

Friday, January 16, 2009

New Issue of PRIM&R’s Research Ethics Digest – Available Today

Posted by Shaquanna Philip, program assistant

PRIM&R’s Research Ethics Digest (RED) explores noteworthy news events, studies, journal articles, and policy reports relevant to the world of human and animal research ethics. The latest issue of RED is now available to members
.

Select articles are highlighted below:

Animal Research and News

“The Animal Care Annual Report of Activities—Fiscal Year 2007.” U.S. Department of Agriculture. October 2008.

IRB Critiques and Commentaries

Van Howe, R. S and Svoboda, J. S. “Neonatal Pain Relief and the Helsinki Declaration.” Journal of Law, Medicine & Ethics. December 2008.

Informed Consent & Research with Vulnerable Populations
Hull S, Sharp R, Botkin J, Brown M, Hughes M, Sugarman J, Schwinn D, Sankar P, Bolcic-Jankovic h D, Clarridge B, Wilfond B. "Patients' Views on Identifiability of Samples and Informed Consent for Genetic Research." AJOB. October 2008.

Ethical Considerations

Evans M.A, Combs L.M. “When Dealing with Human Subjects: Balancing Ethical and Practical Matters in the Field.” TechTrends. November – December 2008.

International Considerations
Clarke DL and Egan A. “Ethics Review Boards in South Africa and the Need for Patient Advocacy.” South African Journal of Bioethics and Law.” December 2008.

In the News

Rubin R. “Placebo effect: New survey gives life to ethical debate.” USA Today. December 2008.

Access to RED Is one of many PRIM&R member benefits.
If you have questions about becoming a PRIM&R member, please
contact us.

Wednesday, January 14, 2009

PRIM&R's 35th Anniversary, Part I

Posted by Joan Rachlin, executive director

This being PRIM&R's 35th anniversary, I wanted to take a short stroll down memory lane and kick-off a year-long celebration of our past, present, and future. A warm wash of memories come to visit as I think back over the past three and a half decades. What began as a small band of concerned researchers and research administrators has grown into a 3,305 member strong, internationally respected organization that has provided educational programs and services to over 25,000 individuals, that has influenced institutional, local, and federal research policies, and that has certified nearly 1,200 research professionals via our credentialing process.

As with most success stories, luck, hard work, but mostly, committed individuals are all part of ours. And boy, have we been blessed with committed individuals! In fact, I suspect that almost everyone reading this blog is a member, or has participated in our educational programs, or has earned their CIP® or CPIA credential. PRIM&R's progress is therefore thanks to each of you, for like the would-be wizard behind the velvet green curtain in the land of Oz, there is no one making magic here at 126 Brookline Avenue. Instead, our organizational growth is a function of the fact that our members, attendees, and other supporters care deeply about ethical research and about the subjects, be they humans or animals, which make that research possible, and they make that commitment concrete through their involvement with PRIM&R.

There was also some luck involved in the organization's birth and "youth," in that PRIM&R was "born" the same year that the National Research Act
was passed. In this "timing is everything" world, that coincidence afforded us a rare opportunity to participate in the process surrounding the development of both IRBs and, later, IACUCs. This new regulatory structure required a cadre of individuals with keen minds, ethical clarity, and unshakeable professional commitments to make the words in the Code of Federal Regulations apply to the "real world."

Those who came to our conferences in the early years (and you know who you are!) were searching for answers to the new, multiple, and complex problems that accompanied the new regulations. They became amateur "wrestlers," as they grappled with the need to balance regulations, guidances, and institutional policies with the needs of research subjects, investigators, and sponsors. In a field that could just as easily have been characterized by a sense of "we-hate-all-this-red-tape-and-so-we-will-get-the-job-done-with-a-minimum-amount-of-effort." Not this bunch! They were highly principled and equally determined, and although they found precious few answers, they did find a community of new colleagues and friends who doubled as advisers and networkers. An organization was born, and a profession began to grow up around it.

Among those of our founders and other early leaders, I still rely on and cherish the advice of Joe Byrne, Sandy Chodosh, Leonard Glantz, Paula Knudson, and Bob Levine.

In future blogs, I will write more about our founders, founding, and about some milestones in PRIM&R's history. For now, let me simply say "Happy Birthday to US," as it is truly all of you who have been the yeast which has made us rise. THANK YOU!

Tuesday, January 13, 2009

FDA Selects GCP Over DOH for Research Conducted Outside U.S.

Posted by Amy Davis, program director

Last year the U.S. Food and Drug Administration (FDA) ended the need for clinical trials conducted outside of the U.S. to comply with the Declaration of Helsinki (DOH)
. Now, such research must be conducted in accordance with Good Clinical Practices (GCP) of the International Conference on Harmonization.

Critics of this change describe it as a "major victory of corporate interests" since it arguably weakens the ethical standards for international clinical trials, making it easier to conduct research outside the US than inside. An additional criticism is that the change creates new inconsistencies among international policies related to human subjects research and puts further out of reach the universal goal for a harmonious, global system of regulation of biomedical research. Many countries rely on the Declaration of Helsinki as a basis for their research policies. Allowing US companies to conduct research in those countries, that is not compliant with this document, creates inconsistent ethical standards for the research conducted there.

Critics of the revised FDA regulations also highlight several differences between the DOH and the GCP. They say the GCP principles allow placebo-controlled clinical trials, while the DOH requires new drugs to be tested against “the best current prophylactic, diagnostic, and therapeutic method.” They also point out that the GCP does not address conflicts of interest, the need to publish results, or the tested drug’s post-trial availability to research subjects.

However, the FDA justifies the change because the GCP principles provide more specific guidance on how to design research trials, monitor safety, and report adverse events, all of which ultimately offer greater protections for human subjects.


Most of us who work in the field of human subjects research are aware of the importance of the DOH as a foundational policy for the ethical conduct of biomedical research. Inspired in part by the horror of the Nazi experiments revealed during the Nuremberg Trials, the DOH was developed and adopted by the World Health Association in 1964. The document has been revised (most recently in November 2008) six times since its first adoption to keep up with technological advances and scientific discovery, but remains the most widely used set of ethical principles that guide the protection of human subjects in biomedical and social research. The DOH is cited in research policies adopted throughout the world, and many scholarly journals prohibit the publication of papers based on research that was not conducted in compliance with the DOH.

So we wonder:

Do you think the revised FDA regulations allow U.S. sponsors to conduct research more easily outside the U.S. than inside?

If so, does this lead to the unjust treatment of research subjects?

Are the GCP standards sufficient and appropriate for the protection of human subjects in research?

How important is the harmonization of ethical principles in the conduct of international research?

Let us know your thoughts either on this blog or through our discussion forums (members only).

Other blogs that discuss this topic:

Thursday, January 8, 2009

Board of Directors Election Results

Posted by Catherine Rogers, marketing coordinator

Recently, PRIM&R’s Board of Directors held an election for both leadership and membership. While the faces on the board will remain the same, two members will transition into new roles: As of January 1, Walter Straus became treasurer, and Judy Norsigian became secretary. These positions were previously held by Harry Rozmiarek and Cornelius Baker, respectively.

Among the re-elected officers for 2009 are Leonard Glantz
, who will maintain his position as board chair, and Robert Levine, who will continue to serve as the vice chair. Six other board members were also re-elected for additional three-year terms, including Warren K. Ashe, Susan Fish, Cynthia Gomez, Charles McCarthy, Leonard Glantz, and Robert Levine.

The PRIM&R staff would like to extend its gratitude to all of the board members for their tireless dedication. We’re looking forward to an outstanding ’09, and wish the same for each board member in his or her professional and personal endeavors.

On a special note, we would like to thank Harry and Cornelius for their service as board officers. PRIM&R was fortunate to benefit from their leadership, and is even more fortunate to continue depending on both for their insight for years to come.

Tuesday, January 6, 2009

Engage in the Exchange of Ideas and Strategies for IACUCs

Posted by Shaquanna Philip, program assistant

2009 IACUC Conference – Call for Poster Abstracts!
Deadline for Submission – January 30

We’re only a few days into 2009 and we’re already looking forward to spring, when the institutional animal care and use committee (IACUC) community comes together on March 28–31 at the Town and Country Resort in San Diego, CA.

Each New Year brings with it the possibility of new beginnings and new successes. Please be a part of bringing such newness to fruition by sharing your best practices and other innovations via poster abstracts with the PRIM&R audience. The annual poster presentation at the IACUC conferences promotes interdisciplinary sharing and collaboration, and facilitates the exchange of ideas, information, and practical strategies for, and/or solutions to, the many challenges faced by IACUC professionals.

If accepted, abstract authors will be invited to present their poster abstracts at the meeting. In addition, a small subset may be nominated to give a 15-20 minute oral presentation as part of a breakout session during the conference. This community is one with enormous talents and resources, and we look forward to hearing your ideas for improving animal care and use programs.

More information is available on our website. Be sure to review all of the other guidelines before submitting an abstract.