[SSRI-Research] AHRP speaks out against proposed NIH Misconduct Rules-Nature_New Scientist

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[sSRI-Research] AHRP speaks out against proposed NIH Misconduct

Rules-Nature_New Scientist

 

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting openness and full disclosure

http://www.ahrp.org

 

 

FYI

 

On April 19 NIH posted a request for comment about proposed rule

change about research ethics in the Federal Register.

NIH proposes to change the rules regarding whistleblowers " who

historically have brought to light the majority of misconduct cases. "

 

The New Scientist reports that " Representatives of professional

research societies and US medical schools generally support the

proposed changes. " This is not surprising, since they represent the

institutions that have been found in violation of ethical research

standards.

 

An example of these societies' defense of a member institution that

had been found to have conducted unethical research, is an Amicus

Curiae brief filed by such professional associations on behalf of the

Kennedy Krieger Institute (a subsidiary of Johns Hopkins University).

 

Following the landmark decision by Maryland's highest court which

issued a strong condemnation of Johns Hopkins research practices and

the university's institutional research review boards that approved

an experiment in which underprivileged babies were exposed to lead

poison in partially abated homes. The experiment was a government

funded study documenting the effects of partial lead abatement on

these children's blood. The experiment was widely criticized by the

public, but defended by the academic research community.

 

The Maryland Court of Appeals decision (Higgins v KKI) is at:

http://www.courts.state.md.us/opinions/coa/2001/128a00.pdf

 

Amicus Briefs requesting the Court to reconsider were submitted by:

The Association of American Medical Colleges, the Association of

American Universities, Johns Hopkins University, the University of

Maryland, and Medical System Corp.

 

The Alliance for Human Research Protection was the only organization

to file an Amicus brief in support of the Court decision--and we

prevailed. See: http://www.ahrp.org/children/AmicusKKI.html

 

The New Scientist and Nature (below) cite AHRP's position deploring

these efforts to reduce the effectiveness of whistleblowers who are

the best guides to evidence of institutional research violations.

Contact: Vera Hassner Sharav

Tel: 212-595-8974

e-mail: veracare

 

 

 

April 26, 2004

 

NIH misconduct rules reviewed

Professional societies support revisions to rules on whistleblowers

and research misconduct | By Ted Agres

The US Department of Health and Human Services, which includes the

National Institutes of Health (NIH), has proposed changes to rules

governing misconduct in federally sponsored research and the status

of whistleblowers who allege scientific wrongdoing.

 

The proposed rules, which update and standardize the definition of

misconduct and the process for investigating and adjudicating

complaints, would also expand the scope of plagiarism to cover

individuals conducting peer review for funding or journal publication

as well as scientists performing research.

 

Representatives of professional research societies and US medical

schools generally support the proposed changes, which replace

regulations originally approved in 1989 and have been amended several

times since. Among the changes are government-wide policies and

procedures on research misconduct issued by the White House Office of

Science and Technology Policy in 2000. The department is seeking

public comment through June 15, 2004.

 

The new rules are designed to " help ensure public confidence in the

integrity of scientific data and the Public Health Service–supported

research process, " according to Chris B. Pascal, director of the

department's Office of Research Integrity. " We're pleased to see

these, " said Howard Garrison, public affairs director for the

Federation of American Societies for Experimental Biology. " We have

to take a closer look at the provisions, but many of the changes are

consistent with positions we have taken over the past several years, "

he told The Scientist.

 

Under the new rules, the scope of misconduct would be expanded to

include research conducted under contract as well as that supported

by grants. While continuing to define misconduct as " fabrication,

falsification, or plagiarism, " the reach would be expanded to include

scientists engaged in peer review for funding or publication in a

scientific journal. " Since plagiarism in reviews has been known to

occur, extending the reach of misconduct regulations seems perfectly

appropriate, " said David Korn, senior vice president of Biomedical

and Health Sciences Research at the Association of American Medical

Colleges (AAMC).

 

The proposed rules also redefine several key terms: " scientific

misconduct " is changed to " research misconduct, " while " other

practices, " a catchall phrase intended to be inclusive, would be

dropped. " It was vague and confusing, " Garrison said, " and could lead

to mistaken allegations of what is fair and not fair. " To be

misconduct, the new rules would require fabrication, falsification,

or plagiarism to be a " significant departure " from accepted

practices, as opposed to the current standard of " serious deviation. "

 

Once an allegation is made, the new rules would separate the inquiry

and investigation phases from the adjudication and appeal phases.

This " would level the playing field by providing the accused

researchers with much needed notice of the required process to be

used and protections offered in addressing the allegations, " the

notice states.

 

Whistleblowers, who historically have brought to light the majority

of misconduct cases, would no longer be considered a " party " to the

probe and guaranteed a role in the investigation. Instead, they would

be " complainants " who do not participate beyond being a witness. " The

institution may, but would no longer be required, to give the

complainant an opportunity to comment on the inquiry and

investigation reports, " the notice states. Institutions would still

be obliged to pursue an allegation of misconduct and to protect the

whistleblower from retaliation as long as the complaint was made

in " good faith. "

 

Not everyone is pleased with the proposed change in whistleblower

status. " This is an effort to protect the institutions from serious

investigations and accountability, " said Vera Hassner Sharav,

president of the Alliance for Human Research Protection. " They are

trying to eliminate the whistleblower's inclusion in the process. By

doing that, they are insuring they will not obtain the relevant

information, " she said. " If they don't know what to ask for, they are

not going to get it. "

 

But the AAMC's Korn said the whistleblower was like a witnesses in a

criminal trial. " They present their knowledge and their facts, " he

said. " They don't actually participate [in conducting] the trial. "

 

 

 

Links for this article

Department of Health and Human Services, " Public health service

policies on research misconduct; proposed rule, " 42 CFR Parts 50 and

93, Federal Register, 69:20777-20803, April 16, 2004.

 

 

 

Regulations.gov

http://comments.regulations.gov/EXTERNAL/index.cfm?action==comme

nt & docketId=-08647

 

http://www.regulations.gov/fredpdfs/04-08647.pdf

 

L. DeFrancesco, " Researcher seeks whistleblower protection, " The

Scientist, November 1, 2002.

http://www.biomedcentral.com/news/20021101/04/

 

 

 

©2004, The Scientist Inc. in association with BioMed Central

 

 

 

http://www.nature.com/cgi-taf/DynaPage.taf?

file==/nature/journal/v428/n6985/full/428786a_fs.html

 

 

 

Nature

 

428, 786 (22 April 2004); doi:10.1038/428786a

 

Health department lays down the law on scientific misconduct

 

MEREDITH WADMAN

 

[WASHINGTON] The US health department has issued comprehensive rules

for handling scientific misconduct cases. And instead of kicking up a

stink, most research organizations say that they find the regulations

to their liking.

 

On 19 April, the Department of Health and Human Services issued a 27-

page notice in the Federal Register, which publishes rules for US

federal organizations. The department has narrowed its current

definition of research misconduct and set out procedures for

universities and government officials investigating allegations of

scientific wrong-doing by federally funded researchers.

 

The regulations are probably the final chapter in a decade-long

debate over what exactly constitutes scientific misconduct. And the

department, which oversees most US biomedical research, has

restricted the definition to " fabrication, falsification and

plagiarism " — the offences that most researchers agree are egregious.

The department has ditched the inclusion, in its current rules, of

the ominous phrase " or other practices " , which scientists criticized

as vague and overly broad.

 

Last week's notice expands the definition of misconduct to say that

it can occur during the review of grant proposals and journal

articles. It also limits the role of whistle-blowers in

investigations, stating that complainants may not participate except

as witnesses.

 

" What they have created is a consistent, clean definition, " says

David Korn, senior vice-president for biomedical and health sciences

research at the Association of American Medical Colleges. " Everybody

understands what it means. "

 

Not everyone shares Korn's cheerful perspective. " They are now saying

a whistle-blower is merely someone who reports, and then stands

aside, " complains Vera Sharav, president of the Alliance for Human

Research Protection, a New York-based patient advocacy group. " That

is outrageous. Who else knows how to guide the investigation to

evidence of the violations? "

 

Among other things, the revised policy requires complaints of

misconduct to be filed within six years of the alleged event. The

notice is open to public comment until 15 June, after which a final

version will be published.

 

 

 

 

 

 

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