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New
Rule on Research Misconduct Proposed
The Office
of Research Integrity (ORI) published a notice of proposed rulemaking
(NPRM) on April 16, 2004. The proposed rule would rewrite the policies
and procedures under which ORI oversees investigations of alleged
misconduct in research. It includes a revised definition of what
constitutes research misconduct, expanded jurisdiction for ORI, and
new procedures to govern how disputed findings of misconduct are
adjudicated. The proposed rule may be found online at http://ori.hhs.gov/multimedia/acrobat/42CFRParts50and93.pdf and is open for
comment by affected communities until June 15.
The current framework for the Public Health Service (PHS) policy on
research misconduct was adopted in 1989. Various modifications have
been made since then, but according to ORI, the proposed rule
represents “substantial revisions” to “implement legislative and
policy changes that have occurred since the [1989] regulation was
issued.” The proposed rule includes changes in definition and
terminology based upon the common definition of research misconduct
that was issued by the Office of Science and Technology Policy in
December 2000. This definition uses the narrower term “research
misconduct” rather than the broader term “scientific misconduct” that
was used in the 1989 PHS rule. The proposed rule would define research
misconduct and the elements that comprise it as follows:
Research misconduct means fabrication, falsification, or plagiarism in
proposing, performing or reviewing research, or in reporting research
results.
(a) Fabrication is making up data or results and recording or
reporting them.
(b) Falsification is manipulating research materials, equipment, or
processes, or changing or omitting data or results such that the
research is not accurately represented in the research record.
(c) Plagiarism is the appropriation of another person’s ideas,
processes, results, or words without giving appropriate credit.
(d) Research misconduct does not include honest error or differences
of opinion.
The definition further states that findings of research misconduct
require that:
(a) There be a significant departure from accepted practices of the
relevant research community; and
(b) The misconduct be committed intentionally, knowingly, or
recklessly; and
(c) The allegation be proven by a preponderance of the evidence.
This wording includes some changes that narrow the scope of ORI’s
authority and others that widen it. The proposed definition narrows
the definition of research misconduct because it focuses solely on
fabrication, falsification, or plagiarism and eliminates the phrase
“other practices” that was intended to serve as a catch-all to permit
ORI wider-ranging authority. Howard Garrison of FASEB’s Office of
Public Affairs told The Scientist that the old wording was “vague and
confusing and could lead to mistaken allegations of what is fair and
not fair.”
On the other hand, the proposed rule widens ORI’s authority to include
misconduct associated the reporting of research findings and in
scientific peer review. It would also extend ORI’s authority to
include intramural research and to research conducted under contracts
as well as grants.
Many in the scientific community welcomed the revised definition of
research misconduct and the inclusion of intramural research and
contracts. However, there may be problems with some of the proposed
changes to procedures for adjudicating disputed allegations of
misconduct.
According to ORI’s explanation of the proposed rule, “Once the
institution or HHS makes a prima facie showing of research misconduct,
the respondent has the burden of proving any affirmative defenses
raised.” This would mean that if misconduct were alleged and research
records were missing, the accused scientist would have to prove that
no misconduct had taken place. Similarly, if erroneous data or
conclusions were reported, the burden of proof would be on the
scientist to prove that the cause was honest error.
The proposed rule would also eliminate the current practice of
convening a three-judge panel of HHS Departmental Appeals Board that
typically includes a scientist who can help the two administrative law
judges sort through technical issues requiring scientific expertise.
The proposed rule would instead have research misconduct cases heard
before a single administrative law judge.
Members of Congress To President: Ease Stem Cell Rules
On April 28, 205 Members of Congress urged President Bush to modify
his stem cell research policy to permit federal funding of additional
cell lines. Representatives Mark Castle (R-DE), Diana DeGette (D-CO),
Randy “Duke” Cunningham” (R-CA), and Calvin Dooley (D-CA) were
co-authors of the letter that was signed by 36 Republicans and 169
Democrats.
“As you know, embryonic stem cells have the potential to be used to
treat and better understand deadly and disabling diseases that affect
more than 100 million Americans, such as cancer, heart disease,
diabetes, Parkinson’s, Alzheimer’s, multiple sclerosis, spinal cord
injury, and many others,” the letter said. “We would very much like to
work with you to modify the current embryonic stem cell policy so that
it provides this area of research the greatest opportunity to lead to
the treatments and cures we are hoping for.”
Under the policy President Bush put into place on August 9, 2001,
federal funds can only be used for research on stem cell lines created
prior to that date. The signers pointed out that the administration
originally claimed that 78 embryonic stem cell lines would be
available to researchers, but in reality this number is closer to 19.
Furthermore, these lines are all contaminated by mouse cells—making
their usefulness uncertain. The letter also contends that the
currently policy is making it difficult to recruit US scientists to
undertake this research.
The scientific community applauded this effort. “This strong showing
of bipartisan support is a gratifying and clear indication that
Congress realizes how important these research tools are to medical
progress,” said Jordan Cohen, President of the Association of American
Medical Colleges (AAMC) in a press statement. “Stem cell research is
one of the most remarkable advances in the history of science. These
cells offer real hope of life-affirming treatments for diabetes,
damaged heart tissue, arthritis, Parkinson’s Alzheimer’s, ALS and
spinal cord injuries to name but a few examples…”
Opponents of embryonic stem cell research object to the fact that in
order to harvest stem cells, an early embryo must be destroyed. They
assert that adult stem cells, which can be harmlessly obtained from
adults, are just as promising as embryonic stem cells. “Instead of
throwing more federal dollars into embryonic stem cell research, the
administration should expand its support for adult stem cell
research—research that is producing real results with real patients,”
said the Washington based group Do No Harm. Representative David
Weldon (R-FL) agreed. “If this controversial research has all the
promise that its supporters claim, let the private sector fund it,
because taxpayers shouldn’t have to pay for what many think is
unethical.”
The Bush administration has showed no sign of moving to permit
research with additional cell lines. In a brief statement on the
letter, White House spokesman Trent Duffy said, the president
“continues to believe” the policy is adequate.
NIH Panel Issues Conflict of Interest Report
Top NIH officials responsible for program funding decisions or grants
management should be prohibited from engaging in consulting activities
with pharmaceutical or biotech companies or paid academic consulting
according to a blue ribbon panel convened to make recommendations to
avoid conflict of interest at the NIH. The report, which was delivered
to NIH Director Elias Zerhouni on May 6, suggested further that NIH
employees who are allowed to engage in consulting for industry should
not be compensated through stock options or other forms of equity.
Such payments “in essence make the NIH employee an owner of the
company, in addition to coupling reward with outcomes, with
consequences that could cause conflict of commitment as well as
interest,” the panel noted.
Zerhouni appointed the Blue Ribbon Panel on Conflict of Interest
Policies in response to news reports last fall suggesting that some
senior employees of NIH had engaged in lucrative consulting
arrangements with companies that could have influenced their work as
government employees. Congressional hearings were also held to examine
the conflict of interest allegations. The report of the Blue Ribbon
Panel is available on the NIH web site page at http://www.nih.gov/about/ethics_COI_panelreport.htm.
Zerhouni asked the Blue Ribbon Panel to review current law and NIH
procedures regarding conflicts of interest and to recommend
improvements. The panel, co-chaired by National Academy of Sciences
President Bruce Alberts and Lockheed-Martin Executive Committee Chair
Norman Augustine, made a total of 18 recommendations. In its report,
the panel said that it found “an extremely complex set of rules
governing conflicts of interest at the NIH.” These rules “are widely
misunderstood by some of the very people to whom they are intended to
apply, thereby creating uncertainty as to allowable behavior and
adversely affecting morale,” the panel noted further.
The guiding principle behind the panel’s recommendations was that “NIH
employees must avoid conflicts of interest incompatible with the
proper exercise of their authority and the proper performance of their
duties.” Therefore, “Employees in a position to influence the
financial interests of an outside entity such as a current or possible
future recipient of an NIH grant or contract should neither receive
financial benefits from that organization nor have significant
financial interests in it.”
The panel advised NIH to require more employees to file financial
disclosure forms or to disclose financial interests in some other
fashion so that the agency will better be able to manage conflicts of
interest. It recommended that all requests for approval of outside
activities be updated on an annual basis and that supervisors should
be held accountable for the evaluation and approval of outside
activity requests. It suggested providing NIH supervisors with
enhanced training on how to evaluate potential conflicts and
recommended that NIH publish an annual agency-wide statistical report
on the number and types of outside activities approved for its
employees to assist in more effective tracking of approved outside
activities.
In an effort to keep NIH competitive with the private sector, the
panel also suggested increasing the pay for senior employees. Given
the current highly competitive market, the panel expressed concern
that “the present ceiling is limiting the agency’s ability to recruit
and retain the nation’s best scientists.”
The panel found that under current rules, NIH scientists were too
often prevented from talking about their work at scientific meetings
and some believed that they were not allowed to receive professional
awards, which has left some NIH scientists feeling removed from the
scientific community. To remedy this situation, the panel recommended
that NIH intramural scientists be allowed to engage in compensated
speaking, teaching, and writing for professional societies and for
academic and research institutions as an outside activity. This
approval was contingent on all ethics reviews and approval
requirements being met.
Zerhouni praised the report as “very thoughtful and very thorough” and
said he would weigh the recommendations carefully with an eye toward
implementing them “the sooner the better.”
APS Submits Testimony on NSF, VA and NASA Funding
On May 5, 2004, the American Physiological Society (APS) submitted
testimony calling on Congressional Appropriators to increase funding
for the National Science Foundation (NSF), the VA Medical and
Prosthetics Research Program (VA), and NASA’s Office of Biological and
Physical Research (OBPR). The testimony can be found online at:
http://www.the-aps.org/pa/action/news/fy05NSF-test.htm.
With a war raging in Iraq and fiscal conservatives in Congress
fighting to hold the line on federal spending, many groups are
competing for a smaller portion of the funding pie in fiscal year
2005. In its testimony, the APS highlighted how increased funding for
NSF, VA and OBPR can contribute to the overall health and safety of
our country. “We are living in challenging times and our national
priorities must reflect these challenges,” APS President D. Neil
Granger wrote. “A strong commitment to science can help keep our
nation safe and strong and help us meet future challenges.”
For FY 2005, the APS made the following recommendations:
National Science Foundation:
The APS joins with the Federation of American Societies for
Experimental Biology (FASEB) and the Coalition for National Science
Funding (CNSF) in calling for a renewed commitment to the NSF and
respectfully asks Congress to increase the FY 2005 funding level for
this agency by 15% over the FY 2004 enacted level.
VA Medical and Prosthetics
Research Program:
The APS supports FASEB and the Friends of VA Medical Care and Health
Research (FOVA) recommendation that Congress appropriate $460 million
for VA research in FY 2005. This represents a $54.4 million or 13%
increase over current year funding.
NASA’s Office of Biological
and Physical Research:
For FY 2005 APS recommends that competitive peer-reviewed research and
training be supported through increased funding to OBPR. To enhance
the overall strength of NASA’s research program, APS calls on Congress
to appropriate the President’s requested level of $1.049 billion. This
is a 6.4% increase over FY 2004 levels.
“Pet Safety” Bill
Unneeded;
Legislation Would Hamper
Research
Senator Daniel Akaka has again introduced legislation to block the use
of non-purpose-bred dogs and cats in research, teaching, and testing.
Akaka sponsored similar legislation in 1996, 1999, and 2001. The most
recent bill is S. 2346, which Akaka calls the “Pet Safety and
Protection Act of 2004.” He introduced it on April 26, 2004 with no
co-sponsors.
According to Akaka, S. 2346 is intended to “stop unethical animal
dealers from selling stolen pets and strays to research facilities.”
The Hawaii Democrat said in a statement that the legislation is needed
because the USDA “routinely fails to provide pets and pet owners
reliable protection against the actions of disreputable animal
dealers, also known as ‘random source’ dealers.”
S. 2346 would prohibit USDA licensed Class B animal dealers from
selling dogs and cats to research facilities and would require pounds
and shelters to register with the USDA in order to provide unclaimed
strays for research. (The Animal Welfare Act already requires pounds
and shelters to hold strays for a minimum period to give owners time
to locate lost pets.)
The provisions of S. 2346 would interfere with research on certain
genetic diseases, physiological conditions, and problems associated
with aging because it would make it more difficult for researchers to
obtain appropriate animal subjects. Some research can be done with any
animal, while research on some conditions requires animals with
specific traits. Animal breeders can readily provide animals that are
chronologically young, purebred, or come from small breeds. However,
breeders cannot readily supply larger or older animals or those with
specific physiological defects, genetic traits, or other diseases. S.
2346 would interfere with research on diseases or conditions that
depend upon access to such animals.
Akaka claims that Class B dealers acquire “tens of thousands of dogs
and cats,” and that “many” of these animals are “family pets” obtained
from middle-men who “resort to theft and deception as they collect
animals and sell them to Class B dealers.” It is unlikely however that
any such complaints have emanated from Akaka’s constituents since
according to the USDA’s most recent Animal Welfare Act annual report,
only one cat and no dogs were used in research, teaching, or testing
in the state of Hawaii in 2002.
Unfortunately, S. 2346 is predicated on many factual errors. Reading
Akaka’s statement, one might believe that there is a massive problem
in this country of stolen pets ending up in research facilities. It is
true that claims along these lines have been a rallying cry among
animal activists since the 1960s. However, Congress, the USDA, and the
research community have worked together since then to make significant
changes that should reassure the American public about the safety of
family pets.
Furthermore, even as provisions to assure pet safety have been
implemented, the numbers of dogs and cats used in research has
steadily declined. In 1973 when the USDA first collecting statistics,
approximately 195,000 dogs and 66,000 cats were used in research,
teaching, and testing. In 1993, that number had declined to 106,000
dogs and nearly 34,000 cats. By 2002, the numbers had declined further
to some 68,000 dogs and 24,000 cats. These totals represent all dogs
and cats, including those supplied by animal breeders, pounds and
shelters, and random source animal dealers. The number of animals
needed for research should also be compared with what is
conservatively estimated as several million unwanted dogs and cats
that are put to death in pounds each year.
Many research institutions are located where there are state laws,
local ordinances, or internal policies to prohibit pounds and shelters
from providing animals for research. Class B dealers provide a
necessary service by supplying them with animals that breeders cannot
produce. S. 2346 would not only prohibit Class B dealers from
supplying these animals, it would also require pounds and shelters to
register with the USDA in order to do so. Going through a registration
process in order to perform a public service may be one hurdle too
many for hard-pressed pounds and shelters, and some may decide that it
is not worth their effort.
The Laboratory Animal Welfare Act was originally passed in 1966 to
protect family pets from unscrupulous animal dealers. Congress has
since approved a number of new pet protection provisions as part of
what is now known as the Animal Welfare Act. Over the past decade, the
USDA has significantly stepped up its enforcement efforts, putting a
number of non-compliant animal dealers out of business. This includes
frequent inspections of problem dealers and audits of their records to
trace dogs and cats back to the individuals listed on identification
records as the original owner. The success rate of such trace back
audits is now around 96%. These enforcement efforts should be
continued, but no new legislation is needed to assure the safety of
family pets.
“Making Science News” Symposium Summaries
The “Making Science News” symposium was offered for the second
consecutive year at EB 2004. Chaired by APS Communications Committee
chair, Andrea Gwosdow, the goal of this symposium was to familiarize
scientists with how the media works. APS invited three journalists to
discuss the definition of “newsworthy,” the differences in print,
radio and television news, and useful tips for getting scientific
research reported by the media. A summary of the session follows.
Complete handouts and media samples can be found at http://www.the-aps.org/press/conference/eb04/sciencenews.htm.
Bethany Halford, is an associate editor at Chemical and Engineering
News. Dubbed “the news magazine of the chemical world,” CEN is
published weekly by the American Chemical Society. A chemist by trade,
Halford became a journalist after being an AAAS Mass Media Science and
Engineering Fellow. Before joining CEN, Halford worked for the St.
Louis Post-Dispatch and Prism magazine.
“What Makes Print News?”
For print, newsworthy means subject matter that readers will find
interesting, informative and/or entertaining. Halford looks for
stories that are new and of broad interest. Print news will often
times have more space for pictures and more overall space than radio
and television, so they have the opportunity to tease out stories
without regard to time. They like to receive graphics.
Knowing what makes news for individual media outlets is the first step
to getting research reported. Many times, newsworthy topics for print
publications can be found “in the name.” For example, the St. Louis
Post-Dispatch looks for stories of interest to St. Louisans, while
CEN
looks for stories of interest to chemists. Speaking to a publications
readership in a media pitch is also key to getting news covered. The
audience for CEN differs from a general news audience because they are
assumed to be scientists or others well-versed in chemistry.
Therefore, research pitched to CEN should be closely related to
chemistry and should supply a sufficient amount of technical detail.
If pitching a trade publication, one should be sure the research is in
line with the subject matter of that publication. For example,
biomedical research pitches should be made to biomedical trade
newspapers.
Some of the best ways to get Halford’s attention are to contact her
before the research paper is released, send information that is
related to her “beat” (subject matter that she typically writes
about), and give her a concise rundown of what the research is and why
it is exciting.
She also shared her list of tips for scientists in communicating with
the press, including:
If you’re working with someone to develop a release about your
research, ask to see the final version to make sure it’s accurate.
Always research the reporter who’s interviewing you
Accept that once the press release is distributed, you lose control
over the type and amount of coverage that it will get.
Henry Fishman, reports on the health and medical beat for AP
Broadcast. Additionally, he is a medical reporter for WMAL, a
Washington, DC news and talk radio station, and hosts a medical
television series for PBS. Fishman is also a practicing allergist.
“What Makes Radio News?”
Even though dealing with the media can be daunting at first, Fishman
asserted that it is a worthwhile undertaking for scientists. The
information that trickles down from the media to regular people
influences the public to support funding for science. Radio is a
unique and fitting vehicle for conveying research. It has the
advantage of a captive audience, since most people listen in their
cars. In a distraction-free environment, listeners are more likely to
comprehend and appreciate science news.
Radio likes topics that affect health, heart and wallet. Pitch them
“news you can use”—stories that have immediate value and would make
good conversation at the water cooler. All of Fishman’s news stories
are between 60-90 seconds and each one must be short and tight. Often
times, he has to distill extremely complex concepts into cute, simple
clips that are easy to digest in a short time period. He cannot
include every detail, so scientists must clearly and concisely explain
the most important points of their research to him.
Fishman, too, stressed the importance of understanding media
audiences. One should always attempt to answer the question “why does
this matter to my listeners?” when pitching a reporter. The Associated
Press, with its diverse audience, prefers news with universal
implications that appeal to all ages. Conversely, WMAL’s has a very
specific target audience between the ages of 35-55, affluent,
Caucasian. They prefer stories that pertain to those listeners. A
strong pitch will speak directly to a station’s audience.
He suggested that scientists work with their institutional PR
departments to present research in a media-ready format. Fishman also
encouraged scientists to acquaint themselves with local reporters and
share their research with them. By doing these two things, scientists
can greatly increase the chances of getting their research covered.
Kathy Fowler is the medical and health reporter for WJLA-TV, the
Washington, DC ABC affiliate. She has been nominated for two Emmys and
has been honored with an Edward R. Murrow award for her reports about
the worldwide organ trade from desperately poor donors in the
Philippines. Fowler also does newsbreaks for the Discovery Health
Channel.
“What Makes Television News?”
With television, one must always keep the visual element in mind.
Television reporters are more likely to cover research that converts
well to film. Controversial topics are more powerful when told with a
human patient attached, so one of the first story elements she looks
for is a patient. She likes her stories to have the “personal hook.”
With typical television news story averaging about 90 seconds, time is
also definitely a concern.
Though she does want the facts, she also wants scientists to play up
some of the more exciting details of the research (neat ways they did
the testing, the implications it could have toward curing/lessening
the effects of a disease). In order to make a good television news
story, there should be a certain level of excitement. She also
encouraged interviewees not to worry about providing the perfect
“sound byte.” A good sound byte is like an exclamation point on your
story, but a clear and complete explanation of the research is what
truly makes the story.
Fowler’s favorite interviews are those where the scientist has a
patient who is concerned about their health, a new method or therapy
that will potentially help that patient and a procedure that can be
performed from start to finish on the air. Though having all these
components is usually beneficial, they are not an automatic formula
for a good news story. If the test is too graphic or if the patient is
drugged or incoherent, a significant amount of reworking may be
required to get it broadcast-ready.
The best way to send your research to a television reporter is to
email a one-pager on the research, do a follow-up call (be sure not to
call within an hour of airtime). An attention-grabbing headline is
also effective in garnering media interest. Since she gets hundreds of
press releases a day, it is important to clearly state a relationship
to other hot topics in the news. She encourages “outside of the box”
thinking when pitching story ideas.
Media Workshop
The second part of the symposium was a workshop led by APS publicist
Donna Krupa. She began with a summary of what the panelists
highlighted as the fundamentals of media and what makes news. Krupa
discussed who at news stations should receive press releases, the news
cycle and the typical shelf life of a news story.
Krupa also outlined eight factors that denote newsworthiness:
Impact–something that happens to a lot of people; Topicality–useful
information people can begin to use right now or tomorrow);
Timeliness–either it just happened or is about to take place;
Proximity–all things being equal, something that occurs down the
street is bigger news than something that takes place 1,000 miles
away; Sensation–extreme emotions of shock, joy, pain, etc.;
Prominence–big names attract big ratings; Conflict– one party makes a
claim, the other party denies; and Novelty–if a dog bites a man, it’s
not news–BUT–if a man bites a dog, that’s definitely news.
She especially stressed the importance of communicating research in
context with familiar topics and recently reported stories in
jargon-free language. Krupa demonstrated how she got media attention
for newsworthy abstracts by rewording them into plain English.
Finally, she walked participants through the progression of two
highlighted research abstracts that were developed to press releases
and were subsequently covered in Newsweek and on CNN. |
