Monday, April 21, 2008

The Contract (Procter and Gamble)

In 2002 I signed a research agreement with Procter and Gamble Pharmaceuticals [1]. Research was to be carried out at the University of Sheffield by two named investigators (Dr Aubrey Blumsohn, Professor Richard Eastell).

It is accepted that a University would be guilty of negligence in permitting investigators to sign a contract prohibiting or hindering release of information involving a drug [2,3]. Industry cannot buy the right to desired findings or the right to suppress undesired findings. The agreement signed[1] was however in accordance with good practice, and should have protected integrity:
  • The agreement did not seek to impose restrictive limitations on the rights and obligation of investigators with regard to data [1 section 4.3]. It specified that the university clinical investigators would interpret and report upon the data.
  • The agreement did not seek to impose restrictive conditions on honest unfettered publication [1 section 4.3]. The contract stated that sponsor should be given courtesy of sight of any proposed publication, but specified that investigators were under no obligation to incorporate any comment from the sponsor.
  • The agreement imported the obligations placed on academics by the University itself, the policies of the University, and obligations imposed by professional rules of conduct [1 section 1.2]. It stated - "The institution through its policies and practices" should cause the investigators to observe "all responsibilities" as "employees of the University of Sheffield". The University of Sheffield in turn has clear guidance pertaining to research integrity and professional obligations (See Sheffield University Research Integrity Guidelines).
  1. Research Agreement between P&G Pharmaceuticals, Dr A Blumsohn and Professor R Eastell. The University of Sheffield (2002-06-02).
  2. Steinbrook, Robert (2005-05-26). "Gag clauses in clinical-trial agreements". The New England journal of medicine 352 (21): 2160-2. PMID 15917381.
  3. Mello, Michelle M; Brian R Clarridge, David M Studdert (2005-05-26). "Academic medical centers' standards for clinical-trial agreements with industry". The New England journal of medicine 352 (21): 2202-10. PMID 15917385.

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