PRIM&R Staff Wishes for 2009

With the end of 2008 quickly approaching, we asked PRIM&R staff to provide their wishes for 2009. Feel free to comment and add your own!

Mariellen Diemand, conference and program manager:

1. In 2009, I hope that the Obama administration can make sense of the financial crisis and that things begin to look upward! (I have a house to sell! JK!).
2. In 2009, I hope that nations around the world can begin to settle their differences and work cooperatively toward peace (can’t we all just get along?!).
3. In 2009, I hope that we, as a nation, can focus on the issues plaguing our citizens, e.g., healthcare, homelessness, hunger, etc.
4. In 2009, I hope that we have another great Boston sports year! Can you believe the Bruins are first in the division and that the Celtics finally won a championship?!
5. In 2009, I hope that PRIM&R can continue growing as an organization, both in our membership and at our conferences.
6. In 2009, I hope that my colleagues and I experience happiness, joy, health, and success in all our ventures.

Emily Hayden, program coordinator: The continuous wish that the Sox win the World Series!

Kimberly Hensle Lowrance, deputy director: For 2009, I wish that everyone—our families and friends and all those in the PRIM&R community—are blessed with good health.

Jen Levine-Fried, membership manager: I hope that my daughter does not decide to make her entrance into the world in the middle of a snowstorm. Or rush-hour traffic. Or both.

On a PRIM&R note, I hope that we can equal or top the tremendous growth we saw in 2008. (Our membership grew from 2,900 to more than 3,400!)

Maeve Luthin, project coordinator: Peace and goodwill throughout the world.

Anne Meade, web and distance education coordinator: I hope we can take 2009 as an opportunity to continue to learn and grow, personally and professionally, through our relationships (both face-to-face and electronic!) with each other.

Joan Rachlin, executive director: I wish that there will be peace where there is none, good health – and good healthcare – for all, and for an economic recovery so strong that everyone seeking a good job will find one. I’m also hoping for safety for our new President, for his family, and for all those in harm’s way.

Karen Reiser, conference coordinator, hopes for…

P rosperity in these difficult economic times
R enewed strength to meet the challenges of the days to come
I nspiration to be the best that we can be
M eaningful contributions to our own small worlds and society at large
&
R espect for all mankind and the world in which we live

Catherine Rogers, marketing coordinator: I wish to stumble upon a supply of Polaroid 600 film so that 2009 isn't the last year I can enjoy taking instant pictures. And no, digital doesn't count.

Ashley Schofield, administrative assistant: For the New Year, I hope to become a stronger member of the PRIM&R team. And I resolve to have a smaller footprint on the planet but a bigger hand in my community.

Happy New Year to all from the entire PRIM&R staff!

NIH Notice about ClinicalTrials.gov

On November 16, 2007, and December 21, 2007, the National Institutes of Health issued the following notices (respectively):

• NOT-OD-08-014: Guidance on New Law (Public Law 110-85) Enacted to Expand the Scope of ClinicalTrials.gov: Registration
• NOT-OD-08-023: Clinical Trials Registration in ClinicalTrials.gov (Public Law 110-85): Competing Applications and Non-Competing Progress Reports)

On December 11, 2008, the NIH released information clarifying the criteria under “When Must I Register My Trial?” in both notices, as follows:

When Must I Register My Trial?

1. Trials initiated after 9/27/2007 must be registered in full not later than 21 days after the first patient is enrolled, or by 12/26/2007, whichever is later.
2. Trials that were initiated on or before 9/27/2007 and “ongoing” as of 12/26/2007 and do involve a “serious or life threatening disease or condition” must be registered in full by 12/26/2007.
3. Trials that were “ongoing” as of 9/27/2007 and do not involve a “serious or life threatening disease or condition” must be registered in full by 9/27/2008.
4. Trials that were “ongoing” as of 9/27/2007, do involve a “serious or life threatening disease or condition,” and are completed (meaning, not “ongoing”) by 12/26/2007 are not subject to these requirements, though they may be subject to pre-existing registration requirements. (“Ongoing” in this context means a trial had one or more patients enrolled, but had not examined the final subject or provided the final subject an intervention for the purposes of final collection of data for the primary outcome.)

If you have questions about the clarification of these criteria, please contact the Office of Extramural Programs, Office of Extramural Research, at the National Institutes of Health by e-mail.

Season’s Greetings from PRIM&R

Looking back on 2008, and looking forward to 2009 and beyond, we have much to celebrate...

• Ethics & Excellence
• Protections & Possibilities
• Research & Responsibility
• Community & Connections

We also have many people to thank, starting with YOU, our blog readers, our members, our non-members, our friends in the federal government, and everyone in our community who works tirelessly to advance ethical research. Thank you for your support, as we could not have reached our thirty-fifth year without you.

From the PRIM&R family to yours, we wish you a New Year filled with health, joy, safety, peace, meaning, and abundant blessings.

It's everywhere! The Recession's Impact on Research

Posted by Joan Rachlin, Executive Director

It's the official "one week and counting" homestretch before Christmas, and the media outlets are full of speculation as to how the recession will affect the season’s traditional buying frenzy.

Beyond the consumer spending angle, these sad and scary stories about the economy got me thinking about how the economic downturn will affect research. While much is unknown, it's clear that the financial quicksand will have a profound impact on research.

I’m no expert, but it seems likely that patients—some of whom might also be prospective research subjects—have the most to lose. Job losses, rising prices, shrinking bank accounts, and/or housing travails, can translate to mounting medical bills, thus adding to their “dis-ease” (AKA, “stress”). It’s also conceivable that financial constraints could force the patient to consider enrolling in a study for reasons that contradict the Belmont Report’s principles of autonomy and justice.

Those research subjects currently enrolled in clinical trials could also be affected if the funding is reduced or even terminated. Subjects who might be benefitting from a therapy or test article might have a harder time continuing to obtain that drug or device. Those who were not responding to the drug, etc. will likely have to wait longer for a new trial given the widespread funding cutbacks

Voluntary health organizations, which power scientific advancement and the wider economy, have also taken a hit. Their walks and other fundraisers are suffering because donations and grants have declined. Research that was on the drawing board when the recession hit—e.g., diabetes, heart disease, stroke, and other chronic illnesses—could confront delays of indeterminate length if the funding declines or disappears.

Flat-lined NIH funding has dramatically affected research institutions, including hospitals, and universities. I read recently that the Clinical Translational Science Awards will see a reduction of almost 5%. These awards were the NIH’s way of stimulating the interface among medical research institutions and their decrease is thus very unfortunate.

When the federal budget is strained, state budgets are strangled, and state research institutions, hospitals, and universities will all be squeezed by the downturn.

Pharma, biotech, and device manufacturers are not exempt from this equal-opportunity “destroyer” either. In the past, as federal funds dried up, industry stepped in to fill the void. Today, though, the headlines are shouting about major cuts at Merck, Pfizer, and others, so it seems unlikely there will be much “rescuing” of research from those quarters.

Among those caught in the economic vise are researchers and research staff. Less available money means less research.

No surprise, then, that IRBs, IACUCs, IBCs, ESCROs, and other ethics committees and oversight mechanisms will be affected. Their continued vigilance is more needed than ever given the above-listed possibilities and pressures, and I therefore hope that they continue upholding their charge to protect subjects, identify and manage conflicts, and advance ethical, responsible, high quality science despite economic pressures and inadequate numbers of staff.

Everyone is affected, but we react to this new reality in different ways. Some of us are stressed, afraid, in denial, or “all of the above.” Then there are those fortunate optimists among us who are simply biding their time until things get better. Things will, hopefully, get a whole lot better once families and friends come together during these fast-approaching winter holidays.

If you have a moment during this busy time of year, please let us hear your stories as to how the economy is affecting your professional life and any strategies you might want to share for minimizing the negative impact on any stakeholders. Thanks and happy healthy holidays to all!

2009 International Compilation of Human Subject Protections

The 2009 edition of the International Compilation of Human Subject Protections recently has been released and is now available online. The document can be seen at: http://www.hhs.gov/ohrp/international/HSPCompilation.pdf.

This resource includes about 1,100 laws, regulations, and guidelines on human subject protections from 92 different countries. This year’s Compilation includes numerous additions and updates to the 2008 Edition, and features the laws, regulations, and/or guidelines from seven new countries: Burma, Egypt, the Gambia, San Marino, South Korea, the Sudan, and Vietnam.

The listings are organized into categories by rows (general, drugs, privacy/data protection, human biological materials, genetic, and embryos/stem cells/cloning) and columns (key organizations, legislation, regulations, and guidelines). Many of the listings include web addresses, allowing the reader to link directly to the laws, regulations, or guidelines of interest.

Prepared by the Office for Human Research Protections of the U.S. Department of Health and Human Services, the Compilation is designed for use by IRBs, researchers, sponsors, and others involved in human subjects research around the world. Using this Compilation, these groups can familiarize themselves with the laws, regulations, and guidelines where the research will be conducted, to assure those standards are followed appropriately.

PRIM&R’s Top 10 Office Tips for Staying Green

Posted by Maeve Luthin, Project Coordinator

We have found that the most effective way to stay green as an office is to monitor how we consume the small things in life—like our daily cups of coffee—and how we cut back on waste—like accidently printing out the wrong e-mail three times. So, PRIM&R is jumping onto the end-of-the-year listology bandwagon, and we’re happy to share with you our favorite ways to reduce our carbon footprint!

1. No page goes unturned at 126 Brookline Avenue, as we are very careful about using both sides of every piece of paper before it goes into a blue recycling bin.
2. When the bins are full and the cardboard is stacked sky high, we give a cheer when Save that Stuff comes to save our paper goods from Dumpster damnation.
3. We also make sure our print and toner cartridges meet a similar fate by participating in the Ink Drop program.
4. We purchase our office supplies in bulk, and that we order mailers and envelopes that are made out of 100% recycled paper and at least 10% post-consumer waste.
5. We avoid using dishes and cutlery made out of paper, Styrofoam, or plastic by keeping our kitchen area stocked with mugs, dishes, forks, knives, and spoons.
6. Since our office building does not have a recycling program, all recyclable plastics are sorted and then sent home with Joan Rachlin, our executive director, to be included with her household’s weekly recycling pickup.
7. We keep a stack of handy cloth reusable shopping bags around the office to avoid using plastic bags when running mid-day errands.
8. We reuse! PRIM&R staff members reduce consumption by sharing books and DVDs with one another.
9. A few times a year, we clean our closets and donate gently worn clothing to Material Aid, sponsored by the Society of Friends. We also clean out our office supplies and donate anything we don’t need to local schools and other charities.
10. Most staff members do not drive to the office; instead, they take the T (Boston’s public transportation system), walk, or ride their bikes to work. Disclaimer: Some of us do this just for the excuse to walk around Fenway Park next door to try and see some players before game time!

Have any other tips for being green that you’d like to share? Leave a comment below!

Where do you work?

Posted by Catherine Rogers, Marketing Coordinator

It was a taxicab ride like any other: Within a few blocks, the driver and I had exchanged typical pleasantries about how I was doing, how he was doing, the weather, and the Red Sox. That was the first time the conversation came to a halt.

“I don’t know much about baseball, but I work right behind Fenway Park,” I said, trying to salvage a shred of dignity after admitting I’m not a sports fan.

“Oh yeah?” he asked. “Where do you work?”

Halfway through reciting PRIM&R’s full name, I saw the driver’s eyes glance into the rearview mirror. By the time I had said, “…and Research,” he was staring into the mirror.

“Okaaaaaaay,” he said, audibly digesting my response. “And what does Public Research, er, Medicine and… What does your organization do?”

At that moment, I could have sworn that the screeching brakes I heard were real. The driver was looking into the mirror for so long. How could he possibly have been watching the road? He cleared his throat, and asked, “Well?”

Snapping back to reality and recalling our mission statement, I told him that PRIM&R is dedicated to advancing ethical research. For a moment I was relieved to have conjured that phrase, exactly as I had read it in our Style Guide the day before, but the driver wasn’t in it for the small talk. He politely asked what I was talking about.

So I told him, and began with what I was working on that week: Publicizing a variety of events across the country where researchers, ethicists, lawyers, representatives from the federal government, and others can come to learn about maintaining ethical standards in the conduct of research. The research might involve humans or animals, whether it’s for drug trials, genes, social issues, or embryonic stem cells.

The driver nodded attentively, and asked a few questions as I told him more about PRIM&R’s membership base and online endeavors. By the time I was finished explaining, we were moments away from my destination, which made for a quick wrap-up, thank you, and goodbye.

I exited the cab a little dazed, but proud to have summarized an organization whose broad scope seems difficult to capture in just a few words, especially to a person outside the world of research. It hasn’t happened since, but I know that when it does, I’ll be less daunted at the prospect of boiling down, to layman terms, what it means to advance ethical research.

But what about you? Whether your work involves institutional review boards, human research protection programs, institutional animal care and use committees, embryonic stem cell research oversight committees, or institutional biosafety committees, how do you go about explaining what you do to the (lucky) person who happens to ask?

While the intricacies of the research enterprise might be hazy to many and unknown to most, everyone shares a common bond: Advances in research affect you, me, your neighbors, your in-laws, and generations yet to come. This might be the best starting point, as a shared experience is the best way to make connections, especially across the broad scope of advancing ethical research.

"Real Time" Relationships

Posted by Joan Rachlin, Executive Director

I spent almost eight hours last week in an airless room on the banks of the Potomac with the Planning Committee charged with developing the program for our March 30-31, 2009 Animal Care and Use Conference. This was the first time that a PRIM&R program has been planned "in person," as opposed to by phone and/or e-mail, and the experiment was a huge success! Those who eventually attend the March meeting will have to be the judge of whether or not they like the Planning Committee’s handiwork, but I can tell you that, at least from a process point of view, it was wonderful sitting around a table with 10 incredibly smart, dedicated, warm, funny, and hard-working individuals and watching them create "something from nothing."

This got me thinking about what has been lost and what has been gained since telecommunications overtook so much of our work lives. Yes, it's true that e-mail, listservs, conference calls, and faxes are all very efficient -- magical, really -- ways to communicate, but what is lost when you don't sit with someone, look into their eyes, listen to their words as you look, and then have the kind of exchange that builds relationships as well as, in this case, conference agendas?

You're probably thinking right about now that I'm hopelessly old-fashioned, nostalgic, and/or "Luddite-like," and you would be at least partially correct. I am all that, but I am also a shameless believer in learning from others, building relationships with others, being inspired by others, and, in general, in the wisdom of groups. While it's no doubt possible to harness that wisdom via the internet and/or phone lines, nothing compares to getting a group of folks with diverse interests, skills, and experiences around a table and then respectfully listening to that multiplicity of voices.

A lot can happen in the more free-wheeling, open, trusting, atmosphere of a "live" gathering, and so the vets, IACUC administrators, "feds," and HSUS, AAALAC, International and AALAS colleagues at one point found themselves talking about the search for common ground among those who support the use of animals in research and teaching, and those who do not. Common ground finding is nigh unto impossible when done from afar, because reducing or eliminating the gulfs that divide opposing factions requires "face time," or that other, less visually acceptable, cliché, "skin in the game."

But when two groups—even two previously warring groups—sit together and slowly, slowly build trust, anything is possible. One of my favorite examples is the work of the Public Conversations Project whose inspiring work includes getting Israelis and Palestinians, loggers and environmentalists, and anti- and pro-choice activists (among others) to sit down together.

As with our President Elect's pledge to engage in greater diplomacy, some work simply cannot be done remotely. Even that which can, though, is so much more rewarding, productive, and worthwhile when done in community, and so I felt very, very grateful to sit in a room with Andrew, Beth, Betty, Chris, Cindy, Harry, Marky, Mariellen, MJ, Nelson, Nicole, and Taylor while developing the March program. How else would I have had the chance to share stories about caring for aging parents, share the agonies and ecstasies of raising our children, get advice on what to feed my dog, hear about a blissful studio apartment on the beach in Maui where one member of our group goes for annual R&R, learn about another's plans to head for North Carolina when he retires, and still another's waterfront Shangri-La in Maine.

Sure you can plan a program, help an investigator, mentor a colleague, or catch up with an old friend on the phone and via e-mail, but I, for one, want to work harder to make time for those I care about—real time! It's hard to build relationships "electronically," although I'm sure that the internet dating world is full of stories to the contrary. And, as relationships are waaaaaaaaaaaay up there on the "what makes life worth living" scale, they are well worth the investment of time—despite the fact that time seems to be the most limited commodity in today's society. In fact, Friday's Boston Globe says that we can feel happy "just because" those around us are happy. Wow! Who knew!?!?

I, therefore, want to work toward "real-time" relationships whenever possible. Speaking of which, remember that "airless room" to which I referred in this posting's opening paragraph? Well, thanks to those gathered around that table, I got so much of the most wonderful kind of oxygen imaginable, and an infusion of happiness and gratitude as well. All that will last me a good, long time, and so sit down with someone and breathe in that wonderful air of connection.

Finally, putting faces to all those names

Posted by Jen Levine-Fried, Membership Manager

PRIM&R’s members are the heart and soul of the organization. There’s nothing I enjoy more than connecting the names and voices from e-mail and the phone with the faces of all the wonderful members I met recently at the 2008 Advancing Ethical Research Conference. This year’s conference was particularly exciting because so many attendees took advantage of our Join and Save registration package and opted into membership when they registered. Nearly three-quarters of our attendees this year were members, which is a remarkable increase over previous years.

But I am not the only one who benefits from this expanded membership attendance at the annual conference! This year member attendees had numerous opportunities to connect—in person—with other members:

• At the Membership Orientation and Continental Breakfast, PRIM&R Board member and Membership Committee Chair David Borasky welcomed new members and offered an overview of membership benefits.
• Both member and non-member attendees made new connections at the Common Ground Luncheon. Colorful balloons represented different areas of the country (and the world!) so attendees could forge new relationships with others from their region.
• Many participants in the Mentoring Program and the Ambassador Program finally had a chance to meet their “matches” in person.

Perhaps my favorite story of two members making a connection at the conference comes from our Speed Mentoring event. One of our Speed Mentors, Denyse Pettersson, had been contacted by another PRIM&R member several months ago regarding a comment she had posted to the IRB Forum, and the two talked by phone and e-mail during the months leading up to the conference. They made plans to finally meet in person in Orlando, but had trouble finding the time to get together. By the time Speed Mentoring rolled around on Tuesday evening, it seemed as though they would just have to miss one another. Amazingly, however, their meeting was in the stars: The second mentee who was assigned to meet with Denyse was the very same member she had been trying to connect with! They each were thrilled to make their “virtual connection” a reality, especially through such a serendipitous encounter.

Do you have any great stories of making connections at PRIM&R events? Did you make a lifelong friend, or reconnect with someone from your past? If you have suggestions for additional opportunities for networking and connecting through PRIM&R, we’d love to hear about them! Post a comment here, or contact me directly.

PRIM&R’s Green Initiatives – GreenPrint

Posted by Anne Meade, Web and Distance Education Coordinator

PRIM&R is constantly aiming to help our planet be healthy and safe. Not only have we focused on “greening our meetings” but we’ve also carried over our environmental practices to our office—and homes (Check out a great resource to get started with recycling strategies.). We wanted to use Ampersand to share some ideas for greening your office or home.

About a year ago here in our office in Boston, we installed software called GreenPrint on all of the computers. GreenPrint eliminates wasteful pages in any printout, analyzing each page of every document sent to the printer and looking for typical waste characteristics (like that last page with just a URL, banner ad, logo, or legal jargon). GreenPrint also allows you to select pages to be removed (did you really need to print that entire e-mail chain?). It may not sound like much, but since installing GreenPrint, my computer alone has saved 104 sheets of paper. Assuming each piece of paper costs $0.10, that’s $10.40 saved for PRIM&R!

The best part? The GreenPrint World version is free! Plus, you can always upgrade to a premium version if you are interested in some of the more advanced features.

So, download GreenPrint today, and start saving time, money, and trees, reducing greenhouse gasses, and decreasing waste. That’s a lot of good out of one little printer program.

Please share your ideas for ways you or your office is “green,” and we’ll include them in a future blog post!

Members Report on the 2008 Conference

Before the 2008 Advancing Ethical Research Conference, we asked two PRIM&R members to report back about their conference experience. Thanks to both Madeline Peyton and Sarah Marie Huban of Emory University for telling us about their time in Orlando.

2008 Advancing Ethical Research Conference – WOW!
By Madeline Peyton

This year’s conference officially began for me just before 7:00 AM on Monday, November 17, as I found my way to the registration area to collect my conference materials and name badge. I then allowed myself to be herded to breakfast, where, amid a crowd of hundreds, several of my co-workers and I discussed our expectations and hopes for the conference.

The morning’s keynote address was preceded by a surprising selection of Latin and jazz music, so despite the early hour, I found myself quite happily tapping my feet. Watching the hall fill up with representatives from 29 countries, I instinctively knew the conference would prove to be an impressive event with a growing reputation destined to draw even more interest and participation.
The high level of energy continued through conference co-chair George Gasparis’ welcoming remarks and introductions of a few human subject protections’ superstars. I joined the applause for the remarkable ingenuity and effectiveness of the keynote speaker on the second day, Dr. Stephen Thomas, Philip Hallen Professor of Community Health and Social Justice at the University of Pittsburgh, and his team’s outstanding work in inner-city barbershops.

For me, Dr. Thomas’ example stood out as a way to heal old wounds and gain the confidence of those who are skeptical of researchers. What a wonderful way to build the bridge connecting medical professionals with the communities they serve. Can we continue to reduce misunderstanding and distrust? Yes, we can!

I believe the conference left us all with a feeling of carpe diem―nay, carpe omnium (seize it all)!

Signed,

Proud to be a member of the PRIM&R team

________________________________________

Shared Knowledge Energizes Attendees
By Sarah Marie Huban

I just arrived home from my first-ever Advancing Ethical Research Conference. Even though I’m exhausted, I came back to work feeling re-energized. I can describe my experience in one word—impressive. If you gave me a second word, I’d say massive.

If you haven’t ever attended a PRIM&R conference, you don’t know what it’s like to be in a room of 2,600 people who know all about the alphabet soup of human subjects protections: IRB, CIP®, DSMB, OHRP, SACHRP…

If you haven’t ever attended a PRIM&R conference , you probably don’t realize what a huge support group you have. Nearly everyone you meet deals with the same types of problems. It is so refreshing to not have to explain what exactly it is that an IRB professional does and what makes your job worthwhile. What a great way to develop a network of people from whom you can ask questions, get input, or just vent.

If you haven’t ever attended a PRIM&R conference, you can’t imagine how many valuable sessions, impressive speakers, and different topics are available. The worst part is choosing among the sessions; they are all so appealing.

If you haven’t ever attended a PRIM&R conference, you can’t possibly understand how hard the PRIM&R staff worked to put on such a well-organized and valuable conference.

And, if you haven’t ever attended a PRIM&R conference, you should come to Nashville in ’09!

World AIDS Day

Posted by Kimberly Hensle Lowrance, Deputy Director

During his keynote address at PRIM&R’s recent annual conference, Carl Elliott, MD, PhD, Professor, Center for Bioethics at the University of Minnesota, remarked that the rapid growth of the research field has produced a cautionary tale for human subjects professionals. He noted that “three-quarters of clinical trials are now administered in the private sector,” which has increasingly removed the academic institutional review board and human research protection program from research activities. It has also, at times, resulted in situations where the motivation to “do good” has been replaced by the motivation for profit.

This issue is sobering for us all, and especially relevant today as we mark yet another World AIDS Day. With more than 33 million people worldwide living with HIV/AIDS, the need for better treatments, and hopefully, one day, a vaccine, are reasons why the work of the research enterprise is so vital. The shared efforts of the PRIM&R community—of those committed to advancing research, protecting subjects, and making our world healthier and better—brings us closer to realizing these goals.

Dr. Elliott’s talk also pointed a spotlight on the “business” of “guinea pigging,” where “semi-professional” research subjects make a living by enrolling in clinical trials. These people are, in effect, workers, but without the rights and protections, he explained, of those working in other industries throughout the United States. They are, as a result, vulnerable and without the needed oversight of a system designed to look out for them throughout the research process, from recruitment to follow-up. Additionally, many of them, as Dr. Elliott illuminated, would not have the means to access the drugs or treatments that are being tested on them, a violation, he explained, of the Declaration of Helsinki.

Research subjects—no matter what their motivation for enrolling in a study—need advocates, just like the 7,000 people who become infected with HIV each day. They need an effective oversight system, that, should they decide to participate in a study that might further our understanding of epidemics like HIV/AIDS, assures they will be protected and their rights respected.

PRIM&R observes this twentieth World AIDS Day in hope and in thoughtful consideration of all whose lives have been ever changed by the HIV/AIDS epidemic.