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Government Affairs Home > Research > Clinical Research

Comment Letter on "Standards for the Protection of Research Misconduct Whistleblowers"

December 18, 2000

Chris Pascal, J.D.
Director
Office of Research Integrity
5515 Security Lane, Suite 700
Rockville, Maryland 20852

Dear Mr. Pascal:

On behalf of the nation's 125 accredited medical schools, over 400 teaching hospitals, and 91 academic and scientific societies, the Association of American Medical Colleges (AAMC) is pleased to comment on the proposed "Standards for the Protection of Research Misconduct Whistleblowers," as announced in the November 28 Federal Register [65 FR 70830]. Through its various guidelines, most notably the 1992 document Beyond the "Framework": Institutional Considerations in Managing Allegations of Misconduct in Research, the AAMC has repeatedly underscored the importance of creating an environment in which cases of misconduct can be reported and investigated without retribution upon the witness. This is a responsibility incumbent upon institutional leadership as a steward not only of federal funds, but also of research programs whose integrity is the cornerstone of academic scholarship and essential to the public's future well-being.

Overall, the Association finds that this notice places appropriate responsibility on institutions for creating processes that permit responsible reporting of wrongdoing in research. It offers reasonable flexibility relative to the various institutional mechanisms that may be used, while outlining procedural standards that ensure fairness for all parties. The ORI is to be commended for this thoughtful approach. That said, we do offer the following suggestions to enhance specific aspects of the notice:

  • The term "whistleblower" - Although the term "whistleblower" has become a term of art that is readily understood and was used in the statute mandating this rule, its use in administrative and legal proceedings, as well as in formal notices of this sort, should be discouraged. It has an unnecessarily colorful and at times pejorative connotation that can undermine the status of those who report misconduct responsibly. In addition, the term "whistleblower" is generally applied only to the originator of an allegation and not to those who may corroborate facts or otherwise assist with an inquiry or investigation, and is thus too narrow in scope. As noted in our Beyond the Framework document, more suitable descriptors of those who report or provide information on suspected misconduct are "complainants" or "witnesses." These terms are more neutral and better define the role of such individuals in the investigative process.

  • Standards of proof - In the discussion of standards of proof (§ 94.420(e)(1) and (2)), a decisionmaker reviewing a retaliation allegation can order an institutional remedy if a preponderance of the evidence supports that the "good faith whistleblowing was a contributing factor in the alleged adverse action." This section goes on to say that such an order should not be made if the institution proves by clear and convincing evidence that it would have taken the action at issue even in the absence of the whistleblower's allegation. The use of two different standards for the same determination creates a confusing and procedurally uncertain process. The goal from the outset should be to make a single determination whether retaliation occurred by application of the same burden of proof to both parties, be it "preponderance of the evidence" or "clear and convincing proof," as institutional processes dictate. If, during an evaluation of the facts, the institution or its member can prove that the actions in question were taken for reasons unrelated to the complainant's allegation (e.g., a dismissal on the basis of poor performance or unprofessional conduct), then a finding of "no retaliation" should be made. If a causal link is established, then the decisionmaker should make a finding of retaliation and order remedies as appropriate.

  • Second-person voice - Subpart B on "Whistleblower Retaliation Complaints" is written in the second person, which is distracting and creates ambiguous references (since "you" refers to the reader, regardless of that person's status as a whistleblower). A more customary format for a regulation would be to specify all requirements in the third person. Once the rule is finalized, ORI could prepare some interpretative "Q&A" in the second person as a means of addressing complainants specifically.

  • Responsible whistleblowing - Although the rule is focused on protecting complainants from retaliation, it would be useful to add language concerning the responsibilities of those who bring forth allegations of wrongdoing. Accusations of misconduct can have life-long repercussions for the accused, even when an investigation comes to a finding of "no misconduct." The mere history of such an accusation can irreparably taint an investigator's reputation, so complainants must be extremely judicious in making such claims, and do so only when they are reasonably certain of the facts. The ORI "Whistleblowers Bill of Rights," for example, states that "Whistleblowers have a responsibility to participate honorably in [misconduct] procedures by respecting the serious consequences for those they accuse of misconduct, and by using the same standards to correct their own errors that they apply to others." Similar language could be added to this rule, particularly to subpart B.

In summary, the AAMC agrees with the general outlines of the proposed rule and in particular agrees with the intent to provide flexibility within the parameters of specific rules of "fairness." That said, some of the language used in the rule could be improved to enhance clarity and accord complainants and witnesses a proper degree of respect. The Association appreciates this opportunity to comment and invites you to contact us directly if we can be of further service.

Sincerely,

Jordan J. Cohen, M.D.

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