Forces International's Complaint to the Office of Research Integrity
| Signatory Organizations | Signatory Individuals | How to become a Signatory | Excerpts from Rules and Regulations |
Update October 29, 2008
On October 25, 2007, Forces International sent a letter to the Office of Research Integrity (ORI) charging that the 2006 Surgeon General's Report, The Health Consequences of Involuntary Exposure to Tobacco Smoke: A Report of the Surgeon General, violated rules of scientific conduct.
The report is not a study but a meta-analysis of other studies on Environmental Tobacco Smoke (ETS), known prior to the 1993 report from the Environmental Protection Agency as Secondhand Smoke (SHS).
The introductory letter prefaced the body of the complaint.
The complaint was also sent to the Inspector General. The documents were shipped/mailed on October 25, 2007, via Express Mail.
As seen in the excerpts from the rules and regulations on the left, the ORI investigates research funded by the Public Health Service. From the Surgeon General's website,
"The Office of the Surgeon General, under the direction of the Surgeon General, oversees the operations of the 6,000-member Commissioned Corps of the U.S. Public Health Service and provides support for the Surgeon General in the accomplishment of his other duties. The Office is part of the Office of Public Health and Science in the Office of the Secretary, U.S. Department of Health and Human Services."
Therefore, the investigation of scientific misconduct in the 2006 Surgeon General's Report falls under the funding jurisdiction of the ORI.
Forces International received a reply from the ORI office, dated November 19, 2007. A letter was sent in response from ServingFreedom on behalf of Forces International on May 15, 2008, and delivered on May 21.
A follow-up to the ORI May 21 response has been sent on September 9th, 2008. The follow-up is the first of a series of critiques that demonstrate the flawed methodology use to obtain political results out of insignificant and defective studies. Given its qualifications, the office of the SG should have been keenly aware that, under no circumstance, has there been any Scientific Metholology applied to passive smoke in the first place. Furthermore, he should not have made the claim that the “dangers” of ETS are based on "scientific evidence" when addressing the media and the public. Both were lead to believe that the SG's "opinion on the studies" is "science", in favour of special interest groups.
To read the ORI response to the above, click here. Our reply can be seen by clicking here.
Further Information on the original Complaint
Appendix A: The model "questionnaire" of the World Health Organization as an example of data gathering for the quantification of vague memories of exposure of decades earlier. This questionnaire has been used to gather data for the Multicenter case-control study of exposure to environmental tobacco smoke and lung cancer in Europe, Boffetta P, Aguado A, Ahrens W, Benhamou E, Benhamou S, Darby SC, et al., J Natl Cancer Inst., 1998;90(19):1440-50. This questionnaire is a model for all studies on passive smoking, regardless of their results. All studies follow the same methodology. This study, that overall shows no risk from passive smoking exposure, is the largest institutional study on passive smoking ever. The measuring of unverifiable memories is not science.
The signatories of this complaint can be either organizations or private
citizens.
To become a signatory, you can either email our President, Maryetta Ables, at
maryetta.ables@forces.org or call 001-304-765-5394 between 9:00 AM and 9:00 PM,
EST. The information necessary to become a signatory is as follows:
- Each individual name, i.e.: husband and wife, etc)
- Complete postal address
- Phone number
- Email address
How will this be used? As you can see from the existing list, you can either
have your name OR initials used, your city, state and country OR state and
country - these are your choices, the intent is to protect your privacy. This is
also the "only information" that will be submitted to the Office of Research
Integrity when the Signatory List is periodically submitted.
Why do we ask for your complete postal address, phone number and email - in case
we have to "prove" our signatories are "real". This information will not be used
for any other purpose.
The information concerning organizations will be published.
SIGNATORY ORGANIZATIONS TO THIS COMPLAINT
|
Palo
Petroleum, Inc. 5944 Luther
Lane, Suite 900, Dallas, Texas 75225
USA |
Consultant-Emergency Services Peer Review/Mediation 401 Rocky Hill Road, Brownwood, Texas 76801, USA Phone: 001 325-784-6697 Contact person: John Dale Dunn MD JD E-mail address: jddmdjd@web-access.net |
|
Netzwerk Rauchen - Forces Germany
Bornheimer Str. 104 53119 Bonn, Germany |
Freedom to Choose
5 Church Street Portsoy Banff, Scotland AB45 2RN |
|
The Heartland Institute 19 South LaSalle Street #903 Chicago, IL 60603
Phone: 001 312 377-4000 |
FORCES Italiana
Casella Postale 2501 - 16146 Genova, Italy |
|
Reason Foundation
Contact Person: Dr. Adrian Moore, Vice President |
Bluegrass Institute for Public Policy Solutions PO Box 51147, Bowling Green, KY 42102 |
|
Grassroot Institute of Hawaii 1314 S. King Street Suite 1163, Honolulu, HI 96814 Contact person: Richard O. Rowland, President |
C.A.G.E. (Citizens Against Government Encroachment) 3445 Drummond, #307, Montreal, QC, Canada H3G 1X9 |
SIGNATORY INDIVIDUALS TO THIS COMPLAINT
| Iro Cyr, Blainville, Qc, Canada A. J. Davis, Bath, United Kingdom Pamela L. Parker, Grove City, OH, United States Dayton Ables, Sutton, W.V., United States William Brown, Ohio, United States Dean Rogers, Ohio, United States Philip John Williams, Norwich, United Kingdom Michael J. McFadden, PA, United States Capri Lione, WI, United States R.N.L., WA, United States Marc S. Moisa, SC, United States M. and G. S., West Palm Beach, FL, United States David W. Kuneman, St. Louis , MO, United States Thomas F. Windsor, Mansfield, Ohio, United States Virgil Kleinhelter, Fairdale, KY, United States Robert Klouser, PA, United States Brian Kaiser, Perham, MN, United States Frank Tobia, Nebo, WV, United States Mike Bolton, Ohio, United States Sharon Hasselbeck, Ohio, United States Karyn Kimberling, Virginia, United States |
Caroline Freeman, Leicester, United Kingdom A.J.G., United Kingdom January Oaten, Taunton, United Kingdom Deanna Spencer, Grove City, Ohio, United States Keith A. Parker, Grove City, Ohio, United States David Atherton, London, United Kingdom Rebecca Rogers, Ohio, United States Mandy Vincent, Godmanchester, United Kingdom Patricia Glass, Alabama, United States M.K.F., FL, United States Donna St. Felix, Ohio, United States Scott Edward Bryant, Georgia, United States Tony Collins, Cornwall, United Kingdom Sandra L. Beckner, Milford, Ohio, United States Lou Ella Thorbjornsson, Dayton, OH, United States Barbara Klouser, PA, United States C.M.M., Marion, Ohio, United States Diana Stinnett, Nebo, WV, United States Rebecca Bolton, Ohio, United States N.B.M., Virginia, United States John Gray, Wales, UK Patricia Dwayer, New Jersey, United States |
EXCERPTS FROM RULES AND REGULATIONS
To be found in:
Part III
Department of Health and Human Services
42 CFR Parts 50 and 93
Public Health Service Policies on Research Misconduct; Final Rule
§ 93.103 Research misconduct.
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.
§ 93.104 Requirements for findings of research misconduct. A finding of research misconduct made under this part requires 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.
§ 93.201 Allegation.
Allegation means a disclosure of possible research misconduct through any means of communication. The disclosure may be by written or oral statement or other communication to an institutional or HHS official.
§ 93.202 Charge letter. Charge letter means the written notice, as well as any amendments to the notice, that are sent to the respondent stating the findings of research misconduct and any HHS administrative actions. If the charge letter includes a debarment or suspension action, it may be issued jointly by the ORI and the debarring official makes an allegation of research misconduct.
§ 93.210 Good faith.
Good faith as applied to a complainant or witness, means having a belief in the truth of one’s allegation or
testimony that a reasonable person in the complainant’s or witness’s position could have based on the information
known to the complainant or witness at the time. An allegation or cooperation with a research misconduct proceeding is not in good faith if made with knowing or reckless disregard for information that would negate the
allegation or testimony. Good faith as applied to a committee member means cooperating with the research misconduct proceeding by carrying out the duties assigned impartially for the purpose of helping an institution meet
its responsibilities under this part. A committee member does not act in good faith if his/her acts or omissions on the
committee are dishonest or influenced by personal, professional, or financial conflicts of interest with those involved
in the research misconduct proceeding.
§ 93.402 ORI allegation assessments.
(a) When ORI receives an allegation of research misconduct directly or becomes aware of an allegation or apparent instance of research misconduct, it may conduct an initial assessment or refer the matter to the relevant institution for an assessment, inquiry, or other appropriate actions.
(b) If ORI conducts an assessment, it considers whether the allegation of research misconduct appears to fall within the definition of research misconduct, appears to involve PHS supported biomedical or behavior research, research training or activities related to that research or research training, as provided in § 93.102, and whether it is sufficiently specific so that potential evidence may be identified and sufficiently substantive to warrant an inquiry. ORI may review all readily accessible, relevant information related to the allegation.
(c) If ORI decides that an inquiry is warranted, it forwards the matter to the appropriate institution or HHS component.
(d) If ORI decides that an inquiry is not warranted it will close the case and forward the allegation in accordance
with paragraph(e) of this section.
(e) ORI may forward allegations that do not fall within the jurisdiction of this part to the appropriate HHS component, Federal or State agency, institution, or other appropriate entity.
§ 93.403 ORI review of research misconduct proceedings.
ORI may conduct reviews of research misconduct proceedings. In conducting its review, ORI may
(a) Determine whether there is HHS jurisdiction under this part;
(b) Consider any reports, institutional findings, research records, and evidence;
(c) Determine if the institution conducted the proceedings in a timely and fair manner in accordance with this part with sufficient thoroughness, objectivity, and competence to support the conclusions;
(d) Obtain additional information or materials from the institution, the respondent, complainants, or other persons or sources;
(e) Conduct additional analyses and develop evidence;
(f) Decide whether research misconduct occurred, and if so who committed it;
(g) Make appropriate research misconduct findings and propose HHS administrative actions; and
(h) Take any other actions necessary to complete HHS’ review.
§ 93.404 Findings of research misconduct and proposed administrative actions.
After completing its review, ORI either closes the case without a finding of research misconduct or
(a) Makes findings of research misconduct and proposes and obtains HHS approval of administrative actions
based on the record of the research misconduct proceedings and any other information obtained by ORI during its
review; or
(b) Recommends that HHS seek to settle the case.
§ 93.406 Final HHS actions.
Unless the respondent contests the charge letter within the 30-day period prescribed in § 93.501, the ORI finding of research misconduct is the final HHS action on the research misconduct issues and the HHS administrative actions become final and will be implemented, except that the debarring official’s decision is the final HHS action on any debarment or suspension actions.
§ 93.407 HHS administrative actions.
(a) In response to a research misconduct proceeding, HHS may impose HHS administrative actions that include but are not limited to:
- Clarification, correction, or retraction of the research record.
- Letters of reprimand.
- Imposition of special certification or assurance requirements to ensure compliance with applicable regulations or terms of PHS grants, contracts, or cooperative agreements.
- Suspension or termination of a PHS grant, contract, or cooperative agreement.
- Restriction on specific activities or expenditures under an active PHS grant, contract, or cooperative agreement.
- Special review of all requests for PHS funding.
- Imposition of supervision requirements on a PHS grant, contract, or cooperative agreement.
- Certification of attribution or authenticity in all requests for support and reports to the PHS.
- No participation in any advisory capacity to the PHS.
- Adverse personnel action if the respondent is a Federal employee, in compliance with relevant Federal personnel policies and laws.
- Suspension or debarment under 45 CFR Part 76, 48 CFR Subparts 9.4 and 309.4, or both.
(b) In connection with findings of research misconduct, HHS also may seek to recover PHS funds spent in support of the activities that involved research misconduct. (c) Any authorized HHS component may impose, administer, or enforce HHS administrative actions separately or in coordination with other HHS components, including, but not limited to ORI, the Office of Inspector General, the PHS funding component, and the debarring official.
