Handling Misconduct - Whistleblowers
ORI Guidelines for Institutions and Whistleblowers: Responding to Possible Retaliation Against Whistleblowers in Extramural Research
(November 20, 1995)
I. INTRODUCTION
The Office of Research Integrity (ORI),
Department of Health and Human Services (DHHS), strongly believes
in the importance of protecting whistleblowers who make good faith
allegations of scientific misconduct to ORI or appropriate institutional
authorities. In particular, ORI is committed to protecting good
faith whistleblowers from retaliation by covered institutions and
their members.
By regulation, each extramural entity
that applies for a biomedical or behavioral research, research-training,
or research-related grant or cooperative agreement under the Public
Health Service (PHS) Act must establish policies and procedures
that provide for "undertaking diligent efforts to protect the
positions and reputations of those persons who, in good faith, make
allegations." 42 C.F.R. Part 50.103(d)(13).
Although the regulation does not provide
specific direction on how to protect whistleblowers, ORI has determined
that adherence to the policies and procedures set forth in these
Guidelines is one method of satisfying the requirements of the regulation.
ORI will recognize an institution's substantial conformity with
these Guidelines as meeting the whistleblower protection requirement
of 42 C.F.R. Part 50.103(d)(13). Specifically, each institution
which substantially adheres to Sections IV and V of these Guidelines
in responding to whistleblower retaliation complaints will be considered
in compliance with the regulatory whistleblower protection requirement
for resolution of retaliation complaints. However, institutions
are free to disregard these Guidelines and adopt other procedures
that conform to the regulatory requirement.
If an institution elects to adopt these
Guidelines, it must abide by each provision that uses the operative
word "shall." On the other hand, provisions which employ
the words "should" or "may" are merely practical
suggestions. An institution will not be out of conformity with the
Guidelines if it fails to carry out these recommendations. Rather,
an institution may substitute for these suggested provisions alternative
procedures that are consistent with the mandatory provisions of
these Guidelines and the regulatory whistleblower protection provisions.
In addition to the requirements of
42 C.F.R. Part 50.103(d)(13), ORI encourages covered institutions
to adopt policies and procedures that conform to PHS Act Part 493(e),
a whistleblower protection statute enacted by Part 163 of the National
Institutes of Health Revitalization Act of 1993, although Part 493
has not been implemented by regulation at the time of issuance of
these Guidelines. Besides protecting good faith allegations of scientific
misconduct, PHS Act Part 493(e) mandates the protection of whistleblowers
for (1) good faith allegations of an inadequate institutional response
to scientific misconduct allegations and (2) good faith cooperation
with investigations of such allegations. The statute covers allegations
of misconduct which involve research or research related grants,
contracts or cooperative agreements under the PHS Act.
ORI also encourages institutions to
adopt principles consistent with the Whistleblower
Bill of Rights (Appendix A) recommended by the Commission
on Research Integrity and to foster institutional commitment to
those principles. The specific principles of the Whistleblower Bill
of Rights are as follows:
(1) whistleblowers are free to disclose
lawfully whatever information supports a reasonable belief of research
misconduct as it is defined by PHS policy,
(2) institutions have a duty not to
tolerate or engage in retaliation against good-faith whistleblowers,
(3) institutions have a duty to provide
fair and objective procedures for examining and resolving complaints,
disputes and allegations of research misconduct,
(4) institutions have a duty to follow
procedures that are not tainted by partiality arising from personal
or institutional conflict of interest or other sources of bias,
(5) institutions have a duty to elicit
and evaluate fully and objectively information about concerns raised
by whistleblower,
(6) institutions have a duty to handle
cases involving alleged research misconduct as expeditiously as
possible without compromising responsible resolutions, and
(7) at the conclusion of proceedings,
institutions have a responsibility to credit promptly, in public
or private as appropriate, those whose allegations are substantiated.
These Guidelines are consistent with
the rights and responsibilities enumerated in the Whistleblower
Bill of Rights.
While compliance with these Guidelines
will satisfy the existing regulatory requirements at 42 C.F.R. Part
50.103 (d)(13), this publication does not bind the Department in
any way as to the substantive provisions of the forthcoming new
regulation implementing the whistleblower protection statute, PHS
Act Part 493(e).
II. PURPOSE
The purpose of these Guidelines is
to set forth ORI's suggested approach for handling whistleblower
retaliation cases which arise at covered institutions. Substantial
adherence to the Guidelines in each whistleblower case affords a "safe harbor" in which conforming institutions will be
deemed in compliance with Part 50.103(d)(13) of the scientific misconduct
regulation. For those institutions which adopt alternative procedures
to comply with the regulation, ORI may review those cases which
do not abide by these Guidelines to determine whether an institution
has taken diligent efforts to protect the positions and reputations
of good faith whistleblowers.
These Guidelines also provide information
to whistleblowers on an appropriate method of submitting retaliation
complaints and subsequent procedures for resolving the complaints.
ORI encourages whistleblowers to refer institutions to these Guidelines
when making specific complaints of retaliation.
These Guidelines apply to all instances
of possible retaliation against whistleblowers whose allegation
of scientific misconduct is covered by 42 C.F.R. Part 50, Subpart
A.
III. DEFINITIONS
"Adverse action" means any action taken by a covered institution or its members which
negatively affects the terms or conditions of the whistleblower's
status at the institution, including but not limited to his or her
employment, academic matriculation, awarding of degree, or institutional
relationship established by grant, contract or cooperative agreement.
"Allegation" means
any disclosure, whether by written or oral statement, or any other
communication, to an institutional, a Department of Justice (DOJ),
or a DHHS official who receives the allegation while acting in their
official capacity, that a covered institution or member thereof
has engaged in scientific misconduct. Allegations made to any of
the above officials may be in conjunction with communications to
Congress (1).
"Arbitration" means
the process described in this Part through which an unresolved dispute
regarding whistleblower retaliation is submitted to an arbitrator
for a final and binding decision.
"Arbitrator" means
one or more impartial persons selected according to the rules of
a designated arbitration association who shall hear and decide whistleblower
retaliation complaints under this Part.
"Covered institution" means any entity, whether individual or corporate, which applies
for or receives funds under a research, research-training, or research-related
grant or cooperative agreement under the PHS Act.
"Deciding official" means the official designated by the administrative head of a covered
institution to make a final institutional determination as to whether
retaliation occurred.
"Good faith allegation" means an allegation of scientific misconduct made with a belief
in the truth of the allegation which a reasonable person in the
whistleblower's position could hold based upon the facts. An allegation
is not in good faith if made with reckless disregard for or willful
ignorance of facts that would disprove the allegation.
"Institutional member, or
member" means a person who is employed by, affiliated with
under a contract or agreement, or under the control of a covered
institution. Institutional members include but are not limited to
administrative, teaching and support staff, researchers, clinicians,
technicians, fellows, students, and contractors and their employees.
"Office of Research Integrity
(ORI)" means the office to which the Secretary has delegated
responsibility for addressing scientific misconduct issues related
to PHS activities, including the protection of good faith whistleblowers.
"Responsible official" means the official designated by and reporting to the administrative
head of a covered institution to establish and implement the institution's
whistleblower policies.
"Retaliation" means
any adverse action or credible threat of an adverse action taken
by a covered institution, or member thereof, in response to a whistleblower's
good faith allegation of scientific misconduct. It does not include
an institution's decision to investigate a good faith allegation
of scientific misconduct.
"Scientific misconduct" means fabrication, falsification, plagiarism, or other practices
that seriously deviate from those that are commonly accepted within
the scientific community for proposing, conducting, or reporting
research. It does not include honest error or honest differences
in interpretations or judgments of data.
"Whistleblower" means
an individual who makes an allegation or demonstrates an intent
to make an allegation (or what is perceived to be an allegation)
while a member of the institution at which the alleged scientific
misconduct occurred.
IV. PROCESSING WHISTLEBLOWER RETALIATION
COMPLAINTS
A. Responsible Official
1. Covered institutions shall designate
a "responsible official" to establish and implement the
institution's whistleblower policies according to 42 C.F.R. Part
50.103(d)(13) and these Guidelines. The responsible official also
serves as a liaison between the institution and ORI for transmitting
such information as ORI may require.
2. The responsible official shall be
free of any real or apparent conflicts of interest in any particular
case.
3. If involvement of the responsible
official in a particular case creates a real or apparent conflict
of interest with the institution's obligation to protect good faith
whistleblowers, and the conflict cannot be satisfactorily resolved
for that case, the administrative head of the institution shall
appoint a substitute responsible official who has no conflict of
interest.
B. Notice of Institutional Policy
The institution shall provide to all
its members notice of its whistleblower policies and these Guidelines
with Appendices. The notice shall include the requirement set forth
below regarding a whistleblower's deadline for filing a retaliation
complaint. The institution's policies and these Guidelines shall
be either disseminated or be publicized and made readily available
to all institutional members.
C. Filing Complaints
1. A whistleblower who wishes to receive
the procedural protections described by these Guidelines shall file
his or her retaliation complaint with the responsible official at
the appropriate institution within 180 days (2) from the date the whistleblower became aware or should have become
aware of the alleged adverse action. Covered institutions shall
review and resolve all whistleblower retaliation complaints and
should do so within 180 days after receipt of the complaint. If
the whistleblower fails to receive an institutional response to
the complaint in accordance with these Guidelines within ten (10)
working days (3), the
whistleblower may file the retaliation complaint directly with ORI
at the following address:
Office of Research Integrity
Division of Investigative Oversight
1101 Wootton Parkway, Suite 750
Rockville, MD 20852
Telephone: (240) 443-8800
Fax: (301) 594-0043
ORI will forward such
complaints to the institution's responsible official for appropriate
action.
2. In addition to prospective complaints,
institutions may apply these Guidelines to complaints of retaliation
made prior to the effective date of the institution's adoption of
these Guidelines.
3. The retaliation complaint must include
a description of the whistleblower's scientific misconduct allegation
and the asserted adverse action, or threat thereof, against the
whistleblower, by the institution or its members in response to
the allegation. If the retaliation complaint is incomplete, the
responsible official shall describe to the whistleblower what additional
information is needed in order to meet the minimum requirements
of a complaint under this Part.
D. Responding to Complaints
1. Upon receipt of a whistleblower
retaliation complaint, the responsible official shall notify the
whistleblower of receipt within ten (10) working days (4) after receipt. The notice shall also inform the whistleblower of
which process under Section V of the Guidelines the institution
proposes to follow in resolving the retaliation complaint and the
necessary actions by the whistleblower required under that process.
The notice shall also notify the whistleblower of his or her choice
of responses listed below.
2. The whistleblower may raise any
concerns about the proposed process with the responsible official
and the institution may modify the process in response to the whistleblower's
concerns.
3. The whistleblower has five working
days from the date of receipt of the initial notification in Part
1 above to:
a. accept the proposed process, although
the whistleblower may also submit documentation for the official
record about any concerns he or she may have about the proposed
process; or
b. not accept the proposed process.
If the whistleblower rejects the proposed process, he or she may
pursue other remedies as provided by law.
4. If the whistleblower does not accept
the proposed process, the institution may, but is not required to,
propose the alternative option under Section V of the Guidelines.
5. The institution shall notify ORI
of any whistleblower retaliation complaint it receives within ten
(10) working days (5) after receipt of the complaint.
E. Interim Protections
1. At any time before the merits of
a whistleblower retaliation complaint have been fully resolved,
the whistleblower may submit a written request to the responsible
official to take interim actions to protect the whistleblower against
an existing adverse action or credible threat of an adverse action
by the institution or member.
2. Based on the available evidence,
the responsible official shall make a determination of whether to
provide interim protections and shall advise the whistleblower of
his or her decision in writing. Documentation underlying the decision
whether to provide interim protections shall become part of the
record of the complaint. When the whistleblower retaliation complaint
is fully resolved, any temporary measure taken to protect the whistleblower
shall be discontinued or replaced with permanent remedies.
V. RESOLUTION OF COMPLAINTS
1. For each whistleblower retaliation
complaint received, a covered institution shall adhere to one of
the two alternative processes for resolving the whistleblower retaliation
complaint, or settle the complaint, as described below.
2. Whichever process is elected shall
be implemented in a timely fashion. The process should be completed
within 180 days of the date the complaint is filed, unless the whistleblower
agrees to an extension of time. The institution shall promptly report
the final outcome of either process or any settlement to ORI.
3. If the whistleblower declines the
institution's proposed process according to these Guidelines, he
or she may pursue any other legal rights available to the whistleblower
for resolution of the retaliation complaint. However, ORI will deem
the institution to have met its obligation under 42 C.F.R. Part
50.103(d)(13) and will not pursue the whistleblower complaint further.
Option A: Institutional Investigation
1. If the institution elects Option
A, the institution shall conduct an investigation of the whistleblower
retaliation complaint according to these Guidelines and implement
appropriate administrative remedies consistent with the investigation's
finding and institutional decision thereon.
2. An investigation of whistleblower
retaliation shall be timely, objective, thorough, and competent.
The investigation should be conducted by a panel of at least three
(3) individuals appointed by the responsible official. The members
of the investigation panel, who may be from outside the institution,
shall have no personal or professional relationship or other conflict
of interest with the whistleblower or the alleged individual retaliator(s),
and shall be qualified to conduct a thorough and competent investigation.
3. The investigation shall include
the collection and examination of all relevant evidence, including
interviews with the whistleblower, the alleged retaliator(s), and
any other individual who can provide relevant and material information
regarding the claimed retaliation.
4. The institution shall fully cooperate
with the investigation and use all available administrative means
to secure testimony, documents, and other materials relevant to
the investigation.
5. The confidentiality of all participants
in the investigation shall be maintained to the maximum extent possible
throughout the investigation.
6. The Panel members shall evaluate
and respond objectively to any concerns raised by the whistleblower
about the process, including concerns regarding the selection of
the deciding official, responsible official and specific panel members,
which are raised prior to resolution of the complaint.
7. The conclusions of the investigation
shall be documented in a written report and made available to the
whistleblower. The report shall include findings of fact, a list
of witnesses interviewed, an analysis of the evidence, and a detailed
description of the investigative process.
8. The deciding official shall make
a final institutional determination as to whether retaliation occurred.
This decision shall be based on the report, the record of the investigation,
and a preponderance of evidence standard.
9. If there is a determination that
retaliation has occurred, the deciding official shall determine
what remedies are appropriate to satisfy the institution's regulatory
obligation to protect whistleblowers. The deciding official shall,
in consultation with the whistleblower, take measures to protect
or restore the whistleblower's position and reputation, including
making any public or private statements, as appropriate. In addition,
the deciding official may provide protection against further retaliation
by monitoring or disciplining the retaliator.
10. The institution shall promptly
notify ORI of its conclusions and remedies, if any, and forward
the underlying investigation report to ORI.
11. The ORI will review the institutional
report to determine whether the institution has substantially followed
the process described herein. If the institution has substantially
conformed to the process, ORI will not review the merits of the
institutional determination under Paragraphs 8 and 9.
12. Institutional compliance with Option
A does not bar the whistleblower from seeking redress against the
institution's decision under Paragraph 8 and 9, under State law,
institutional procedure, policy or agreement, or as otherwise provided
by law.
Option B: Arbitration
1. If the institution elects Option
B, the institution shall offer the whistleblower the opportunity
to submit the retaliation dispute to binding arbitration. The parties
shall sign a written agreement that the retaliation dispute will
be decided by final and binding arbitration, identifying the person
who shall conduct the arbitration.
2. The arbitration agreement shall
specify that the institution and the whistleblower abrogate all
other rights under Federal, State and local law, and other institutional
policies or employment agreements pertinent to the resolution of
the whistleblower retaliation complaint, other than enforcement
of the arbitration award. However, the parties may enter into any
legally enforceable settlement agreement before a final arbitration
award is made. A sample arbitration agreement is attached at Appendix
B.
3. Any retaliation complaint submitted
to arbitration shall be arbitrated according to the rules and procedures
of the presiding arbitrator and designated arbitration association.
4. An arbitration under these Guidelines
shall be conducted by an arbitrator who has no personal or professional
relationship or conflict of interest with the whistleblower, the
institution, the alleged retaliator(s), or any person who is the
subject of the underlying scientific misconduct allegation. The
institution and the whistleblower shall agree on the choice of arbitrator.
The arbitration should be facilitated by the American Arbitration
Association or any other recognized non-profit arbitration association.
5. The institution and the whistleblower
shall share equally the administrative costs of the arbitration.
Each party is responsible for the cost of presenting its own case.
6. The arbitration agreement shall
specify that the arbitrator shall require the institution to compensate
the whistleblower for part or all of his or her arbitration costs,
including attorney fees, if the arbitrator finds that the institution,
or its members, retaliated against the whistleblower.
7. The arbitration agreement shall
also specify that the arbitrator shall require the whistleblower
to compensate the institution for part or all of any filing fees
and arbitrator's costs if the arbitrator finds that the whistleblower's
allegation of scientific misconduct was not made in good faith.
If an institution seeks compensation on this basis, it shall make
a preliminary motion to dismiss the retaliation complaint prior
to commencement of a hearing. The arbitrator shall, if possible,
make a threshold decision on the question of good faith based on
written submissions prior to commencement of a hearing on the merits
of the retaliation dispute. The institution has the burden of proving
by a preponderance of the evidence that the allegation of scientific
misconduct was not made in good faith.
8. The arbitration agreement shall
specify a preponderance of the evidence standard in determining
whether retaliation occurred or any other standard mutually agreed
to by the parties.
9. The arbitration agreement shall
state that the arbitrator's award is final and binding on all parties,
and enforceable as provided by law.
10. If the arbitrator finds that the
institution, or its members, retaliated against the whistleblower,
the arbitrator may order any relief necessary to make the whistleblower
whole for the direct or indirect consequences of retaliation, including
protection against further retaliation through imposing a system
to monitor or discipline the retaliator. The institution shall abide
by the arbitrator's final award and shall implement any additional
administrative actions it determines is necessary to correct the
retaliation.
11. The institution shall promptly
forward a copy of the final arbitration award to ORI.
C. Settlement
In lieu of the two options described
above, an institution and whistleblower may, at any time after the
retaliation complaint is made, enter into any binding settlement
agreement which finally resolves the retaliation complaint. If both
parties agree, the responsible official shall facilitate negotiation
of such settlements. If such an agreement is reached, the institution
and the whistleblower shall sign a statement indicating that the
retaliation complaint has been resolved. The institution shall within
30 days send a copy of the signed statement to ORI. ORI does not
require a copy of the actual terms of the settlement. The settlement
may not restrict the whistleblower from cooperating with any investigation
of an allegation covered by 42 C.F.R. Part 50, Subpart A. ORI shall
consider a settlement meeting these requirements as fulfilling the
institution's regulatory obligation under 42 C.F.R. Part 50.103(d)(13).
VI. INSTITUTIONAL COMPLIANCE
At any time ORI may review a covered
institution's compliance with 42 C.F.R. Part 50.103(d)(13) and these
Guidelines to the extent that the institution relies on these Guidelines
for regulatory compliance. Covered institutions and their members
shall cooperate with any such review and provide ORI access to all
relevant records. If a covered institution's procedures and implementation
thereof substantially conforms to Sections IV and V above, it shall
be deemed to have met its whistleblower protection obligation under
42 C.F.R. Part 50.103(d)(13).
Footnotes:
(1)
Communications to Congress must be made in a way that affords "affected
individual(s) confidential treatment to the maximum extent possible"
consistent with 42 C.F.R. 50.103 (d)(3).
(2) The institution may establish
a longer period of time.
(3)The institution may establish
a shorter period of time.
(4)The institution may establish
a shorter period of time consistent with footnote 2.
(5)The institution may establish
a shorter period of time.
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