PRIM&R Dashes for a Difference

In an effort to give back to the community (and have fun doing it), four PRIM&R staff members raced around town (and beyond) last Saturday in a mad dash for some do-gooding. The Dash for a Difference benefitted Boston Cares, an organization that leads team-oriented volunteer opportunities throughout Greater Boston. While the PRIM&Rettes (that's Emily Butler, Anne Meade, Ashley Schofield, and Catherine Rogers) didn't win the race, we all had an excellent time deciphering the scavenger hunt clues and trekking from one destination to the next. We started off searching for 10 Harvard Street, and took the Green Line to Brookline Village.


Unfortunately, that idea was shot when we realized there is no 10 Harvard Street in Brookline (though there was an 8 and a 14...). After another mini-adventure in Chinatown (there's a Harvard Street there, too), we landed at Dudley Station, where we waited for the #23 bus...

...which took us to Four Corners, Dorchester! There, we built a birdhouse, which will be donated to the Audubon Society.

After that, it was on to making Mother's Day cards for mothers at The Women’s Lunch Place and hopeFound. With Saturday's wind, some cards almost escaped our grasp, but luckily we had plenty of help from the Boston Cares coordinator to help chase them down.

We then went to the Franklin Park Zoo (hands-down, our favorite part!) and saw tigers, gorillas, tapirs, girraffes, snakes, lemurs, and (yep!) camels!

There were a lot of children there that day, so when we found a moment to pose as a rooster (Emily), snake (Ashley), goat (Anne), and hawk (Catherine), it wasn't possible to get a photo without an excited kid in the foreground.

Once we returned from the zoo, many of the other teams were awaiting our arrival. Still, we managed to cross the finish line, and even break through an actual ribbon! We may not have won the Dash, but we were proud to partake in an event that values community and collaboration. Can't wait to do it again next year!

Watch & discuss: PRIM&R’s video

Posted by Catherine Rogers, marketing coordinator

My elbow grease may be running on “E”, but at least my apartment is clean. This past weekend, I assembled the No Holds Barred Cleaning Brigade (my roommates) to tackle a year’s worth of clutter and dust-bunnies in a full-on cleaning assault. As we organized, wiped, recycled, and tossed, one thing was clear: Spring cleaning is akin to opening a time capsule of the past year.

The receipts, clippings, photos, and souvenirs were reminders of our history in that house, even though we’ve only been there a year. And this got me thinking about PRIM&R. Not about the dust-bunnies that could accumulate over 35 years (gross!), but about the memories that are contained in the organization’s own receipts, clippings, photos, souvenirs, and, of course, the people.

Perhaps it was these sense of preservation and reflection that drove PRIM&R to make a video about the organization’s past, present, and future. In a way, the video has become our very own twenty-first century time capsule, in that it imprints upon history the faces that made the organization grow to its current size and scope.

We’re proud to have made this video, and hope you will enjoy it as well, so please, check it out on YouTube and leave a comment to let us know what you think!

Coast IRB and undercover operation update

(Originally posted by the Northwest Association for Biomedical Research)

On Tuesday, April 14, officials at the Food and Drug Administration issued a warning letter to Coast IRB in response to their recent approval of a fake device study submitted by the Government Accountability Office. As a result Coast IRB has voluntarily agreed to review no new studies or enroll new subjects into ongoing protocols, both under 21 CFR Part 56.

• FDA warning letter: http://www.fda.gov/foi/warning_letters/s7157c.pdf
• FDA press release: http://www.fda.gov/bbs/topics/NEWS/2009/NEW01996.html

According to a Wall Street Journal article published on April 15, suspension of Coast IRB’s review functions represents the largest shutdown of an IRB to date by the FDA, impacting 300 trials and more than 3,000 researchers. Many other news agencies have picked up the story.

• New York Times
• Seattle Times
• The Oregonian
• Idaho Statesman

Sixth time’s a charm, DeGette hopes

With the Government Accountability Office’s recent sting operation on an independent IRB, today’s headlines suggest that the system for protecting humans who volunteer in research studies is unsound. As the research world witnessed the revelation that an independent IRB approved a fictitious and risky medical device, human subjects and their advocates glimpsed some of the serious shortcomings in regulations governing human research. (Read The Government Accountability Office’s response to the IRB sting and subsequent hearing.(PDF))

It’s no wonder Rep. Diana DeGette, D-CO, is trying, for a sixth time, to reintroduce legislation that would protect human subjects in research by broadening the scope of federal regulations. (Read a press release from Diana DeGette’s office.)

The proposed bill, Protection for Participants in Research Act (H.R. 1715), would amend the Public Health Service Act in several ways. According to DeGette, the bill would reform IRB oversight by:

• Expanding federal regulations to apply to all research that is in or affects interstate commerce;
• Strengthening the educational requirements for IRB members;
• Requiring further harmonization of FDA regulations and the Common Rule;
• Bolstering protections against conflicts of interest by investigators and IRB members; and
• Strengthening data and safety monitoring requirements for human subjects research.

The bill broadens the applicability of the Common Rule to all human subjects research regardless of funding source. Currently, the Common Rule is applicable only to research that receives federal funding. Additional highlights of the bill include guidelines that would improve accountability for IRB oversight of multi-center trials, provisions to guide the development of effective data safety and monitoring plans, and requirements to offer IRB member orientation and ongoing education to ensure competence in overseeing research.

H.R. 1715 seeks to modernize the Public Health Service Act’s ability to protect human subjects in the current practice of human subjects research. We invite you to share your opinions on this proposed legislation by writing a comment below.

Got Research Subjects Bill of Rights?

Posted by Joan Rachlin, executive director

While walking through the Beth Israel Deaconess Medical Center (BIDMC) hospital lobby, I caught sight of one of the documents in those ever-present racks of information. Their Research Subjects Bill of Rights was the object of my interest and so I took a look. The relevant section of the document requires that…

Participants have the right to be told:

• the purpose of the study
• what will happen and how those procedures differ from standard practice
• about possible risks and/or side effects
• of any benefits that could result
• about other possible choices and their advantages/disadvantages
• what treatment is offered if complications occur
• they can refuse to participate (and change their mind once the study has begun)
• they are free from pressure when deciding whether to participate on the study

Participants also have a right to receive a copy of the signed and dated informed consent form.

In addition, participants should be aware of what will be expected of them, what they might expect to learn from the study, and if they will receive compensation.

I then began to wonder what other local hospitals had to say on the subject, and found that Massachusetts General Hospital (MGH) requires that research subjects have the right…

• To be treated in a caring and polite way.
• To be told what the study is trying to find out.
• To be informed what will happen, and whether any of the procedures, drugs, or devices are different from what would be used in standard medical care.
• To be told about possible side effects or discomforts that may occur during the study.
• To be told whether to expect any benefit from being in the study and, if so, what the benefit might be.
• To be told of other treatment options, and how they might be better or worse than being in the study.
• To be told what sort of treatment is available if any medical problems arise.
• To be allowed to ask any questions about the study both before agreeing to be involved and during the course of the study.
• To be free from pressure when deciding to participate in the study.
• To be told about new information learned during the study that might affect the subject’s safety or willingness to continue to take part in the study.
• To refuse to be in the study, or to withdraw after the study has started. This decision will not affect the care the subject receives at the hospital.
• To receive a copy of the signed consent form.

WOW! I’m impressed by and proud of both these Boston hospitals for developing such clear and accessible statements of subjects’ rights. Speaking of the Boston ties to such manifestos, I’d like to give a shout out to George Annas of the Boston University School of Public Health for having written the original Patients Bill of Rights, from which many, if not most, of these other corollaries have been developed.

BIDMC also has a version for patients, and this version includes, at item number 7,

You have the right to a full explanation of any research study in which you may be asked to participate. You also have the right to refuse to participate in research. Your refusal will not affect your access to care and BIDMC. BIDMC respects the rights of all individuals who choose to participate (or not participate) in research at BIDMC.

So, as they say on Saturday Night Live, “discuss.” All kidding aside, I’d love to hear from the rest of you about some questions I’ve been wondering about since reading these two statements:

1. What do you think of the content of the BIDMC’s Research Subject Bill of Rights? If you like it, what would you change? If you don’t like it, why not?
2. What do you think of the content of the MGH’s Research Subject Bill of Rights? Ditto re: the above follow-up questions.
3. Does your institution have a Subjects’ Bill of Rights? If not, do you think it should?
4. What are the essential elements that should be included in any such Subjects’ Bill of Rights?
5. How does an institution go about not only preparing and posting these statements of rights, but how do they ensure their implementation and adherence?

I’d love to get some chatter going about whether these kinds of documents make a difference, as I’m thinking they can and do, but I’m not in the trenches, so thanks for reading and responding!

(Photo credit: American Consitution Society of Law and Policy Blog)

Let us help you become one of tomorrow’s thought-leaders, today!

Don’t miss the Call for Applications for the 2009 Pillars of PRIM&R Award!

In honor of two of PRIM&R’s revered Board members, Dr. Louis Lasagna and Dr. Herman Wigodsky, the Pillars of PRIMR Memorial Fund was founded to recognize promising professionals who, although fairly new to the field, are studying, teaching, and/or writing about research ethics. The PRIM&R community works hard to advance research ethics, and believes that the recognition and support of tomorrow’s thought-leaders today is assurance that our mission will be fulfilled for years to come.

Last fall, PRIM&R awarded the first Pillars of PRIM&R Award to Dr. Dyaeldin Elsayed of Khartoum, Sudan. Over the past few months, Dr. Elsayed has been working continuously to develop the curriculum for the first ever ethics training program at Al Zaiem Al Azhari University. As the program develops, we look forward to keeping you updated about Dr. Elsayed efforts via this blog.

In the meantime…PRIM&R is interested in learning about your research projects and/or initiatives geared towards advancing ethical research and invites you to submit an application in consideration for a 2009 Pillars of PRIM&R Award!

The award consists of:

• a stipend of at least $1,000 for the expressed and designated purpose described in the application;


• registration, travel, and accommodation expenses for the 2009 Advancing Ethical Research Conference;


• recognition at the aforementioned conference; and


• a one-year PRIM&R membership.

Qualified applicants are research ethics professionals in the early stages of their careers. Award criteria include consideration of the applicant’s academic and professional accomplishments, relevance of past activities (particularly those consonant with the mission of PRIM&R), the designated research project/initiative for which the stipend will be used, and the “fit” between the purpose of the Pillars of PRIM&R Memorial Fund, and the applicant.

The deadline for submission of applications is June 30, 2009. Those interested in applying are encouraged to visit the PRIM&R website for more information, eligibility requirements, and a downloadable application form.

It is our hope that, through this initiative, the unique spirit and principles of those designated as Pillars will inspire the next generation of leaders in the field.

Those with questions about this award are encouraged to contact Shaquanna Philip, program assistant, via e-mail or call 617-423-4112, ext. 22.

Guest Blogger: Dr. Jonathan Moreno

The comments and opinions in this post reflect the opinion of Dr. Moreno, Professor of Biomedical Ethics at the University of Pennsylvania, and do not necessarily represent the opinion of PRIM&R or its Board of Directors.

The Washington Post report of March 30, 2009 that nothing of value was learned from one of the several detainees who was water boarded at the Guantanamo prison facility could fuel the efforts of Senator Patrick Leahy to undertake a systematic investigation of detention and interrogation practices. In an interesting historic irony, if Senator Leahy's judiciary committee does move this initiative forward its final report is likely to appear in 2010, exactly 25 years after Senator Frank Church's committee report was issued, which disclosed intelligence community abuses starting in the 1950s and extending through the Watergate scandal. Among the operations discussed were experiments with hallucinogens like LSD as they might be used in interrogations of, say, a kidnapped American nuclear scientist by an enemy and how to defend against such practices.

It is clear that innocent people, both in the U.S. and abroad, were caught in these un-consented and often clumsy experiments, and that there were deaths in at least two cases. Yet a number of respected historians and journalists argue that the subsequent reforms within the American intelligence community led to a catastrophic over-reaction that gravely impaired the ability of the CIA and other agencies to conduct clandestine operations. Some, like former Vice President Cheney, believe that the 9/11 attacks were partly the upshot of a hamstrung covert system. Journalists like Thomas Ricks and Jane Mayer have brilliantly documented the complexities of this experience.

I have theorized that innovative interrogation practices were applied in Guantanamo that were not limited to harsh tactics that have historically been considered forms of torture. Certainly the use of humiliation and sleep deprivation as techniques to elicit information are not new in the history of prisoner interrogation. The provocative question is whether other systematic programs were covertly initiated in the past few years by, for example, federally employed psychologists that could be considered research to create generalizable knowledge. Both the American Psychiatric Association, after much consternation and debate, and the American Psychological Association have created strictly limited parameters for psychiatrists' and psychologists' role in interrogation. But experimental activities by federal agencies could be brought within the ambit of the Common Rule, introducing an intriguing new dimension to the story of Guantanamo and the war on terrorism.

If Senator Leahy's inquiry does go forward, it will be interesting to observe whether psychological experiments are addressed (some perhaps involving drugs or artificially induced neural hormones like oxytocin), and how the ultimate reaction in the intelligence community resembles that of 25 years ago.

OHRP Guidance on the Genetic Information Nondiscrimination Act

Implications for Investigators and Institutional Review Boards

OHRP has posted on its website a finalized guidance document entitled, "Guidance on the Genetic Information Nondiscrimination Act:
Implications for Investigators and Institutional Review Boards." The guidance document provides OHRP’s first formal guidance on this topic.

The document, which is available on the OHRP website at http://www.hhs.gov/ohrp/humansubjects/guidance/gina.html and http://www.hhs.gov/ohrp/humansubjects/guidance/gina.pdf, is intended primarily for investigators who conduct, and institutional review boards (IRBs) that review, non-exempt human subjects research involving genetic testing or collection of genetic information. The guidance document provides background on protections provided by the Genetic Information Nondiscrimination Act of 2008 (GINA) and discusses some of the implications of GINA for investigators who conduct, and IRBs that review, genetic research, particularly with respect to the criteria for IRB approval of research and the requirements for obtaining informed consent under the Department of Health and Human Services regulations for the protection of human subjects (45 CFR part 46). The Federal Register notice announcing the availability of this new guidance document can be found at:
http://edocket.access.gpo.gov/2009/E9-7782.htm; or http://edocket.access.gpo.gov/2009/pdf/E9-7782.pdf.

OHRP welcomes comments on this new guidance documents. Please send any comments to OHRP by e-mail at ohrp@hhs.gov, with citation of the specific document related to the comments in the subject line.

Monday Memories - EthicsBowl 2002

Did you compete in PRIM&R's EthicsBowl in 2002? Maybe you're one of the players at the table, or perhaps the eye behind the lens of this photo! If so, we'd love to hear about it, so post a comment and tell us what you remember!

In March’s Newsletter…

The most recent issue of the PRIM&R Newsletter (members only) was distributed on Friday, March 27.

In addition to our regular features, such as Recent Headlines, Government and Legal News, and Public Policy, this issue included…

• Information about the Call for Applications for the 2009 Pillars of PRIM&R Award;
• An overview of the US House Energy and Commerce Committee hearing titled “Institutional Review Boards that Oversee Experimental Human Testing for Profit,” which was held on Thursday, March 26, 2009;
• A featured talk from PRIM&R Through the Years, a 532-page compilation of presentations delivered by internationally esteemed experts in the field of research ethics at PRIM&R's past annual meetings. This month’s feature is Alexander Capron’s speech, “IRBs: The Good News and the Bad News,” which he gave in March 1981 at PRIM&R’s The New Federal Regulations: What They Do and Do Not Regulate meeting;
• Our Website Feature of the Month, which highlighted how to update your profile to ensure you receive the correct information from us; and
• A recap of the February 10 webinar, Tools and Tips to Ensure Your IACUC’s Success.

Can’t find the Newsletter in your inbox? Check out the Newsletter Archives.

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