Source: https://www.federalregister.gov/documents/2000/11/28/00-29988/public-health-service-standards-for-the-protection-of-research-misconduct-whistleblowers
Timestamp: 2018-08-16 19:06:14
Document Index: 149372249

Matched Legal Cases: ['ART 94', 'art 94', '§\u2009493', '§\u2009493', '§\u2009493', '§\u2009493', '§\u2009493', 'art 94', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994', '§\u200994']

Federal Register :: Public Health Service Standards for the Protection of Research Misconduct Whistleblowers
A Proposed Rule by the Health and Human Services Department on 11/28/2000
Submit comments on or before January 29, 2001.
70830-70841 (12 pages)
Subchapter I—Policies Relating to Research Misconduct
PART 94—PUBLIC HEALTH SERVICE STANDARDS FOR THE PROTECTION OF RESEARCH MISCONDUCT WHISTLEBLOWERS
Subpart B—Whistleblower Retaliation Complaints
Subpart C—Responsibilities of Covered Institutions
Subpart E—Responsibilities of the Office of Research Integrity
Subpart D—Administrative Proceedings
https://www.federalregister.gov/d/00-29988 https://www.federalregister.gov/d/00-29988
The Department proposes to add a new Subchapter I, Part 94, to Title 42 of the Code of Federal Regulations to implement section 493(e) of the Public Health Service Act. Under this proposed regulation, covered institutions must follow certain requirements for preventing or otherwise responding to occurrences of retaliation against whistleblowers. The purpose of this part is to protect persons who make a good faith allegation that a covered institution or one of its members engaged in or failed to respond adequately to an allegation of research misconduct and persons who cooperate in good faith with an investigation of research misconduct.
Address all comments concerning this proposed rule to Chris B. Pascal, J.D., Acting Director, Office of Research Integrity, 5515 Security Lane, Suite 700, Rockville, MD, 20852.
You may submit comments and data by sending electronic mail (E-mail) to whistlereg@osophs.dhhs.gov.
Legal Information: Gail L. Gibbons, 301-443-3466 (This is not a toll-free number).
Technical Information: Barbara Bullman, 301-443-5300 (This is not a toll-free number).
Section 493(e) of the PHS Act requires the Secretary to establish regulatory standards for preventing and responding to occurrences of retaliation taken against whistleblowers by entities which have a research misconduct assurance under § 493 and by those entities' officials and agents. These entities and their officials and agents are prohibited from retaliating against an employee with respect to the terms and conditions of employment when the employee has in good faith (1) made an allegation that the entity or its officials or agents, has engaged in, or failed to respond adequately to an allegation of, research misconduct, or (2) cooperated with an investigation of such an allegation.
The Commission on Research Integrity (established by section 162 of the NIH Revitalization Act of 1993) recommended that the standards stated in its document, “Responsible Whistleblowing: A Whistleblower's Bill of Rights” (Commission Report, Department, 1995), be adopted by regulation. Two of the seven principles in the Whistleblower's Bill of Rights relate directly to the prevention of and response to whistleblower retaliation. These two are: protection from retaliation (“Institutions have a duty not to tolerate or engage in retaliation against good faith whistleblowers.”), and fundamentally fair procedures (“In cases of alleged retaliation * * * whistleblowers should have an opportunity to defend themselves in a proceeding where they can present witnesses and confront those they charge with retaliation against them. * * *”). The substance of those two provisions has been incorporated in this proposed regulation. You may obtain the full text of the Commission's proposed Whistleblower's Bill of Rights upon request at the Office of Research Integrity address above, or on the ORI web page at http://ori.dhhs.gov/​whistle.htm.
If the dispute is not resolved by the end of the negotiation period, the institution must make an administrative proceeding available to the whistleblower to address the retaliation complaint. The proceeding offered by the institution must meet all of the standards in the proposed regulation. A whistleblower may agree to have a retaliation complaint resolved through this proceeding or may elect to pursue any other available remedy provided by law.
Although certain settlement mechanisms such as mediation may be used during the negotiation period, they might not qualify as an acceptable administrative proceeding after the negotiation period has terminated because they do not meet the regulation's requirements. For example, mediation does not constitute an acceptable administrative proceeding because it does not use an “objective Start Printed Page 70831decisionmaker” who will make a final determination on whether retaliation occurred, as required by the regulation.
The proposed regulation gives institutions wide latitude in the types of administrative proceedings they may choose to offer. However, the proceeding must meet certain minimum standards such as allowing the whistleblower an opportunity to be represented by counsel and having a qualified, objective decisionmaker. Although the terms “qualified” and “objective” are not defined in the proposed regulation, the decisionmaker should have significant training, experience, or expertise in adjudicating disputes. Moreover, the decisionmaker must not have any real or apparent conflict of interest in hearing or deciding the case.
One type of administrative proceeding that institutions may make available is binding arbitration. Arbitration is specifically encouraged in the Conference Report recommendations accompanying the NIH Revitalization Act. The Conferees suggested that the regulation should, “where the whistleblower consents, allow for the possible adjudication of disputes through an arbitration proceeding conducted under the auspices of the American Arbitration Association.” H.R. Conf. Rep. No. 100, 103d Cong., 1st Sess. 19, 107 (1993).
Another type of administrative proceeding that may be used for resolving retaliation disputes is an institutional fact-finding procedure similar to an option allowed under the ORI “Guidelines for Institutions and Whistleblowers: Responding to Possible Retaliation Against Whistleblowers in Extramural Research” (November 20, 1995) (Whistleblower Guidelines) which will be superseded when this part is issued as a final rule. You may obtain a copy of these interim Whistleblower Guidelines by contacting ORI at the above address, or on the ORI web page at http://ori.dhhs.gov/​whistle.htm. Unlike the administrative proceedings in the interim Whistleblower Guidelines, an institutional fact-finding procedure under the proposed regulation must satisfy the minimum standards specifically in this part.
Regardless of the type of administrative proceeding used, the decisionmaker's final decision must be based on the standards of proof set forth in the regulation. The decisionmaker must order an institutional remedy if the whistleblower proves by a preponderance of the evidence that the act of good faith whistleblowing was a contributing factor in the alleged adverse action taken by the institution or one of its members against the whistleblower. However, even if the whistleblower meets this burden, the decisionmaker may not order an institutional remedy if the institution then proves by clear and convincing evidence that it would have taken the action at issue even in the absence of the whistleblower's allegation or cooperation with an investigation. The legislative history of the PHS Act § 493(e) shows that the Conferees encouraged adoption of this specific standard. Also, the proposed regulatory standard is the same as that used in the Federal Whistleblower Protection Act of 1989, 5 U.S.C. 1201, et seq.
If the decisionmaker determines that the institution or one of its members has retaliated against the whistleblower, the proposed regulation allows the decisionmaker to authorize appropriate remedies. For example, the decisionmaker could order reinstatement, back pay, rehabilitation of reputation, or compensation to the whistleblower for expenses, including attorneys' fees, incurred in the administrative proceeding.
Section 493(e)(2) of the PHS Act requires the Director of ORI to monitor covered institutions' implementation of the proposed regulatory standards. Moreover, § 493(e)(3) requires ORI to establish remedies for noncompliance with this whistleblower retaliation regulation. Therefore, the proposed regulation authorizes ORI to review any covered institution's compliance with the regulation and to impose appropriate administrative actions for retaliation or other regulatory noncompliance. Administrative actions against noncompliant institutions may include, but are not limited to, termination or recovery of PHS funds.
Several of the definitions require brief explanations. The proposed regulation adopts the term “research misconduct” instead of “misconduct in science” as currently used in PHS' scientific misconduct regulation at 42 CFR 50.102 (1989). Section 493(a)(3)(A) of the PHS Act instructs the Secretary to establish a definition for the new term “research misconduct.” As discussed earlier, the OSTP has published a proposed government-wide Federal policy for research misconduct for adoption and implementation by agencies that conduct and support research. This policy includes a new proposed definition of research misconduct. 64 Start Printed Page 70832FR 55722, Oct.14, 1999. When the OSTP policy is adopted in final form, the Department will implement the policy, including the new definition of “research misconduct,” through rulemaking. In the meantime, the term “research misconduct” in this proposed regulation will be defined in the same manner as “misconduct in science,” as used in the existing PHS misconduct regulation.
The proposed regulation uses the term “whistleblower” despite negative connotations that might be associated with it. The common understanding of the term's meaning strongly supports its continued usage, in keeping with the authorizing statute, PHS Act § 493(e), and consistent with other statutes such as the Whistleblower Protection Act of 1989, 5 U.S.C. 1201, et seq. The Department strongly disavows any negative inference that might be drawn from the term “whistleblower.”
The proposed regulation does not confine the use of the term “whistleblower” to those who raise an initial allegation of research misconduct. Rather, it defines a whistleblower as any institutional member, including a non-employee, who makes an allegation that a covered institution or one of its members has engaged in, or failed to respond adequately to an allegation of, research misconduct, or who cooperates with an investigation of the allegation. Although the PHS Act § 493(e) specifically protects an “employee” with respect to the terms and conditions of employment, the Department is proposing that the regulation cover all institutional members, i.e., all persons who are employed by, affiliated with under a contract or agreement, or under the control of, a covered institution, including students, fellows, and contractors.
The Department may extend its jurisdiction to protect non-employee whistleblowers based upon its general rulemaking authority as well as its authority to establish the terms and conditions of PHS support. Potential whistleblowers include more than just employees of the covered institution. Students and research fellows at an academic institution, for example, may be in a position to allege research misconduct or cooperate with a misconduct investigation. The proposed regulation's more inclusive definition of whistleblower is consistent with the Department's interpretation of the current scientific misconduct regulation which is not limited to employees of the institution but requires protecting “those persons who, in good faith, make allegations,” 42 CFR 50.103(d)(13).
Consistent with the proposed definition of whistleblower, the proposed regulation's definition of “retaliation” focuses on adverse actions that negatively affect the terms or conditions of the whistleblower's status at the institution, including employment, academic matriculation, and institutional relationship under a grant, contract, or cooperative agreement.
An “adverse action” by an institution or one of its members may also include the threat of an adverse action if the threat in and of itself negatively affects the conditions of the whistleblower's institutional status. Whether a threat constitutes an “adverse action” under the proposed rule must be determined on a case-by-case basis. However, the Department believes that only objectively credible and imminent threats that substantially and negatively inhibit the whistleblower's normal institutional activities would constitute adverse actions.
The proposed regulation applies only to whistleblower retaliation complaints that are made within 180 days of the alleged adverse action, or its discovery. This time limitation for filing retaliation complaints is consistent with other statutory and regulatory programs that establish a date certain after which complaints may not be filed, and encourages whistleblowers to come forward with a complaint promptly. This improves the opportunity for a rapid resolution of the dispute. See, e.g., 29 U.S.C. 1855(b) (Migrant and Seasonal Agricultural Worker Protection; Discrimination prohibited); 10 CFR 50.7(b) (Nuclear Regulatory Commission; Employee Protection). The 180-day limitation period is also consistent with ORI's interim Whistleblower Guidelines, § IV.C.1.
In addition to cases of whistleblower retaliation that occur after this regulation's promulgation, the Department also proposes that the regulation cover pending cases of retaliation, if the retaliation complaint and the underlying whistleblower activity took place within one year before the effective date of the regulation. The Department has required covered institutions to protect whistleblowers since at least 1989 pursuant to 42 CFR 50.103(d)(13). The proposed regulation merely prescribes new procedural, as opposed to substantive, requirements for implementing an already established duty. Thus, extending the applicability of the proposed regulation to previously filed, pending whistleblower complaints does not violate the principle of impermissible retroactivity. See Landgraf v. USI Film Products, 511 U.S. 244 (1994); U.S. v. Riddick, 104 F.3d 1239 (10th Cir. 1997).
A. Review under Executive Order 12866, sections 202 and 205 of the Unfunded Mandate Reform Act of 1995 (Pub. L. No. 104-4), and the Regulatory Flexibility Act (5 U.S.C. 603-605).
The Department has examined the potential impact of this proposed rule as directed by Executive Order 12866, sections 202 and 205 of the Unfunded Mandates Reform Act of 1995 (Pub. L. No. 104-4), and the Regulatory Flexibility Act (5 U.S.C. 603-605).
The Regulatory Flexibility Act requires agencies to prepare a regulatory flexibility analysis describing the impact of the proposed rule on small entities, but also permits agency heads to certify that a proposed rule will not, if promulgated, have a significant economic impact on a substantial number of small entities. The primary effect of this rule would be to require covered institutions to implement policies and procedures for preventing and responding to whistleblower retaliation in research misconduct cases. Start Printed Page 70833Currently, ORI receives about 125 allegations of research misconduct a year from the 3700 entities which file assurances with ORI. Of these, only five of the allegations were received from the approximately 1000 entities which are considered small. Therefore, the Secretary certifies that this proposed rule would not have a significant impact on a substantial number of small entities as defined by the Regulatory Flexibility Act.
Description: This proposed rule implements section 493(e) of the PHS Act (added by section 163 of the NIH Revitalization Act of 1993, Pub. L. No. 103-43). Section 493(e)(1) requires the Secretary to establish standards for preventing and responding to occurrences of whistleblower retaliation by entities, their officials or agents, against an employee in the terms and conditions of employment in response to the employee having made a good faith allegation or cooperated with an investigation of such an allegation. In addition, sections 493(e) (2) and (3) of the PHS Act require that remedies be established for regulatory noncompliance by entities, their officials or agents, and that procedures be established for monitoring implementation of the standards established by the entities.
Description of Respondents: The “respondents” for the collection of information described in this regulation are (1) institutions that apply for or receive grants, contracts, or cooperative agreements under the PHS Act for any project or program that involves the conduct of biomedical or behavioral research, and (2) whistleblowers who seek protection from or restitution for retaliation in accordance with the regulation.
Number of Respondents—20.
Annual Average Burden per Response—8 hours
Total Annual Burden—160 hours
Number of Respondents—244.
Number of Responses per Respondent—1
Annual Average Burden per Response—8 hours.
Total Annual Burden—1848 hours.
Number of Respondents—3700.
Annual Average Burden per Response—40 hours.
Total Annual Burden—148,000 hours.
We estimate that it will take between 10-80 hours to establish these Start Printed Page 70834procedures with an average of 40 hours per covered institution. This burden estimate applies only to the first year when all the covered institutions will be required to establish procedures. In subsequent years, the burden will only be for new recipients or applicants of PHS funding or to update a covered entity's procedures.
After receipt of a retaliation complaint, a covered institution is required by this part to provide the whistleblower with a copy of this regulation, 42 CFR Part 94, and the institution's policies and procedures for responding to retaliation complaints. The institution must also provide the whistleblower with written notification of (1) the date the complaint was received by the institution, (2) the date the negotiation period will expire, and (3) the institution's determination regarding the issue of jurisdiction as discussed in § 94.215(b). The institution is also required to process the complaint in accordance with this part.
Annual Average Burden per response—2 hours
Total Burden—40 hours.
Annual Average Burden per response—2 hours.
Total Annual Burden_2 hours.
Total Annual Burden—40 hours.
Annual Average Burden Per Response—1 hour.
The Department will submit a copy of this proposed rule to OMB for its review and approval of this information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to the agency official designated for this purpose whose name appears in this preamble, and to the Office of Information and Regulatory Affairs, OMB, New Executive Office Bldg., 725 17th Street, N.W., Rm 10235, Washington, D.C. 20503, Attn: Allison Eydt. Submit written comments by January 29, 2001.
What provisions of confidentiality apply to this part?
When must you file your retaliation complaint?
Where do you file a retaliation complaint?
Must your retaliation complaint be in writing?
What information must you provide in your retaliation complaint?
May you revise your retaliation complaint?
May you ask the covered institution to take actions to protect you?
May you negotiate or settle your retaliation complaint?
Subpart C—Responsibilities of Covered Institutions Responsibilities and Procedures
What institutions are covered by this part?
What responsibilities does a covered institution have?
Are subawardees and subcontractors of a covered institution included in this part?
Must a covered institution establish procedures for whistleblowers?
What procedures must a covered institution establish?
Who must a covered institution inform of these procedures?
What is an assurance of compliance?
Who designates the responsible official, and what are the responsible official's duties?
How does a covered institution process whistleblower complaints?
Must a covered institution provide temporary protections to whistleblowers?
What temporary protections may a covered institution offer?
How long do temporary protections last?
How may a covered institution negotiate and settle a retaliation complaint?
How long may a covered institution conduct negotiations on a retaliation complaint?
What must a covered institution do if it questions jurisdiction during negotiations?
What happens if negotiations do not resolve a retaliation complaint? Start Printed Page 70835
What information must a covered institution report to ORI regarding retaliation complaints?
Must a covered institution cooperate with ORI compliance reviews?
What happens if a covered institution retaliates or fails to comply with this part?
Subpart D—Administrative Procedures Election of Remedies
May a whistleblower elect remedies other than an administrative proceeding?
What actions may a covered institution take if a whistleblower elects a remedy other than an administrative proceeding?
Must a covered institution offer a whistleblower an administrative proceeding?
What types of administrative proceedings may a covered institution offer?
What elements must a covered institution include in its administrative proceeding?
What information must a covered institution provide to a whistleblower?
What happens if a whistleblower fails to timely file supporting documentation for the administrative proceeding?
May a covered institution or whistleblower challenge the decisionmaker's qualifications?
May the decisionmaker be replaced?
What remedies may a decisionmaker impose?
May a covered institution or whistleblower appeal an adverse decision or remedy?
Subpart E—Responsibilities of the Office of Research Integrity General Provisions
What are ORI's responsibilities?
What does ORI do when it receives a whistleblower retaliation complaint?
When does ORI do an institutional compliance review?
What factors does ORI consider in a compliance review?
What administrative actions may ORI take pursuant to a compliance review?
May a covered institution appeal administrative actions imposed by ORI or the Department?
Institutional member or member
Office of Research Integrity or ORI
PHS funds or PHS funding
§ 94.100
(a) This part describes the standards used by the Office of Research Integrity (ORI) and covered institutions for preventing and responding to retaliation against whistleblowers who in good faith—
(a) Portions of this part may apply to you if you are a—
If you are a—
then the portions that may apply to you are—
(1) Covered institution or subawardee or subcontractor of a covered institution Subparts A, C, D, E, and F.
(2) Decisionmaker Subparts A, D, and F and §§ 94.420 and 94.435-94.450.
(3) Institutional member Subparts A, C, and F and §§ 94.410 and 94.445.
(4) ORI Subparts A, E, and F.
(5) Responsible official Subparts A, C, and F and §§ 94.205, 94.210, 94.225, 94.430, 94.505, and 94.520.
(6) Whistleblower Subparts A, B, D, and F, and §§ 94.360-94.375, and 94.505.
§ 94.200
(c) However, if your retaliation complaint was pending on the effective date of this part, ORI will consider your complaint to have been timely filed if—
(2) Your allegation or cooperation with an investigation of the allegation also occurred within that year; and Start Printed Page 70836
(3) You refile your pending complaint, using the procedures in this subpart for filing complaints, within 120 calendar days of the date on which the covered institution provides the § 94.325 written information to its members about its whistleblower policies and procedures.
§ 94.205
§ 94.210
§ 94.215
§ 94.220
Yes, if your whistleblower retaliation complaint does not contain all the information required by § 94.215, you may revise it to supply that information at any time before the complaint is fully resolved, dismissed, or otherwise closed under this part.
§ 94.225
May you ask the covered institution to take temporary actions to protect you?
Yes, you may ask the responsible official to take temporary actions under §§ 94.345 through 94.355 to protect you against an existing or threatened adverse action by the covered institution or one of its members at any time before your whistleblower retaliation complaint is fully resolved, dismissed, or otherwise closed under this part.
§ 94.230
Yes, you may negotiate or settle your whistleblower retaliation complaint with the covered institution by using the procedures described in §§ 94.360 through 94.375.
§ 94.300
§ 94.305
(b) A covered institution and its members must—
§ 94.310
§ 94.315
§ 94.320
A covered institution must establish written procedures for whistleblowers that—
§ 94.325
§ 94.330
(b) The institution must assure that it—
(2) Will comply with and enforce these procedures; and Start Printed Page 70837
§ 94.335
(a) Each covered institution must—
(3) Authorize the responsible official to oversee each whistleblower retaliation case that arises at the institution, to oversee the negotiation and settlement process described in §§ 94.360 through 94.375, including implementing and enforcing appropriate institutional remedies as part of any agreement with the whistleblower, and to serve as a liaison between the covered institution and ORI.
§ 94.340
(b) Within 20 calendar days of receiving a whistleblower retaliation complaint, the institution must provide the whistleblower with copies of this part, the institution's policies and procedures implementing this part, including its administrative procedures under § 94.415, and a written notification, which includes—
(1) The dates the institution received the retaliation complaint and on which it believes the 30 day negotiation period of § 94.365(a) expires; and
(2) The institution's determination of whether the retaliation complaint satisfies the jurisdictional elements required by § 94.215 and, if the jurisdictional elements are not satisfied, the specific basis for that determination.
§ 94.345
(a) Consistent with § 94.350, a covered institution must provide reasonable and necessary temporary protections to whistleblowers before the final resolution of a retaliation complaint under this part if, based on the evidence, the responsible official reasonably determines that protection is warranted.
§ 94.350
A covered institution must authorize the responsible official to provide any reasonable and necessary temporary protection(s), including but not limited to—
§ 94.355
When a covered institution and a whistleblower have fully resolved the retaliation complaint, any temporary protection(s) taken to protect the whistleblower may be discontinued or replaced with permanent remedies.
§ 94.360
(c) Consistent with § 94.335(a)(3), a covered institution must authorize its responsible official to implement any remedies as part of any agreement with a whistleblower.
§ 94.365
(c) If an institution and a whistleblower fully resolve the complaint during the negotiation period, ORI considers the complaint closed for purposes of this part. The head of the institution, or designee, and the whistleblower must sign an agreement that the complaint has been resolved, and the institution must notify ORI of the agreement within 30 calendar days of its execution, as required by § 94.380(d)(5).
§ 94.370
If a covered institution provided the § 94.340(b)(2) notice to a whistleblower that the retaliation complaint does not contain the jurisdictional information required by § 94.215, the whistleblower has not adequately revised the complaint, and the institution and the whistleblower continue to dispute whether the complaint falls within the jurisdiction of this part, the institution may, at its discretion, either—
(a) Continue settlement discussions during the 30 to 90 day negotiation period allowed under § 94.365 and move to dismiss the complaint for lack of jurisdiction during any administrative proceeding under subpart D of this part; or
§ 94.375
What happens if negotiations do not resolve a retaliation complaint?
(a) If a covered institution and a whistleblower have not fully resolved the retaliation complaint by the end of the 30 to 90 day negotiation period, or if they mutually agree to end negotiations without a settlement, the Start Printed Page 70838institution must immediately offer the whistleblower an administrative proceeding under subpart D of this part.
§ 94.380
(a) Complaint filed. A copy of the whistleblower retaliation complaint, the date the institution received it, and the expected expiration date of the negotiation period under § 94.365.
(c) Proceeding held or offered. A description of the administrative proceeding used or made available to resolve the complaint under subpart D of this part, including an explanation of how the institution met the procedural standards of § 94.420.
(d) Final disposition of complaint. A copy or description of the final disposition of the retaliation complaint including, where applicable—
(5) Any mutual settlement agreement of the complaint including a statement to that effect signed by the head of the institution or designee and the whistleblower. The terms of the settlement agreement need not be disclosed, but the agreement must comply with § 94.360.
§ 94.385
Yes, a covered institution and its members must cooperate with any ORI compliance review conducted under § 94.510, including requests for information, on-site visits, inspection of relevant records, and interview of institutional members.
§ 94.390
A covered institution that engages in whistleblower retaliation or otherwise fails to comply with any provision of this part may be subject to any of the PHS administrative actions provided under § 94.520.
§ 94.400
§ 94.405
§ 94.410
§ 94.415
A covered institution may resolve a whistleblower retaliation complaint by any of the following types of administrative proceedings, if the proceeding satisfies all of the elements of § 94.420:
§ 94.420
(b) The opportunity for the whistleblower and the institution to be represented by counsel. The institution may, but is not required by this part to, provide counsel for the whistleblower.
(1) Subject to paragraph (e)(2) of this section, the decisionmaker must order a binding institutional remedy according to § 94.445 if the whistleblower proves by a preponderance of the evidence that the whistleblower's research misconduct allegation or cooperation with an investigation of the allegation was a contributing factor in an adverse Start Printed Page 70839action taken by the institution or one of its members.
§ 94.425
§ 94.430
(b) However, the whistleblower's failure to timely file will not be grounds for dismissal of the retaliation complaint if either—
§ 94.435
(c) If either party challenges the decisionmaker's qualifications or objectivity, the challenge must be made part of the record, and may be subject to any ORI compliance review under § 94.510.
§ 94.440
The covered institution may replace the decisionmaker for good cause before final resolution of the retaliation complaint. Good cause includes—
(b) The decisionmaker is determined to have a conflict of interest under § 94.435;
(c) The parties mutually agree to a replacement; or
(d) The administrative proceedings' procedures otherwise allow replacement.
§ 94.445
(b) The institution must implement in a timely manner the remedy(s) ordered by the decisionmaker unless the order is revoked or otherwise modified by an appeal under § 94.450.
§ 94.450
§ 94.500
(a) ORI is responsible for monitoring covered institutions to determine whether they have established administrative procedures and are following them in accordance with this part and the institution's certification of compliance under § 94.330.
(b) ORI may take the remedial administrative actions, specified in § 94.520, against covered institutions that retaliate against good faith whistleblowers or that otherwise do not comply with the standards and procedures of this part.
§ 94.505
Consistent with § 94.205, if a whistleblower brings a retaliation complaint directly to ORI, ORI reviews the complaint to determine if, on its face, it meets the requirements of this part. If so, ORI will instruct the whistleblower to send the complaint to the covered institution's responsible official or notify the responsible official directly.
§ 94.510
(a) ORI may review a covered institution's compliance with the provisions of this part at any time. ORI's decision to begin a compliance review may be based on the institution's written whistleblower procedures, its certification of compliance, its submissions to ORI regarding whistleblower retaliation complaints, or Start Printed Page 70840any other information ORI considers relevant to the institution's compliance with this part.
§ 94.515
§ 94.520
§ 94.525
A covered institution may appeal any administrative actions imposed by ORI or the Department under § 94.520 only if an appeal is specifically allowed by an existing Departmental regulation. The institution must appeal under the terms of the applicable regulation.
§ 94.600
§ 94.605
§ 94.610
§ 94.615
§ 94.620
§ 94.625
§ 94.630
§ 94.635
Institutional member or member.
§ 94.640
Investigation, solely for the purpose of this part, means—
§ 94.645
§ 94.650
Public Health Service or PHS means the unit within the Department of Health and Human Services that includes the Office of Public Health and Science and the following Operating Divisions: Agency for Healthcare Research and Quality, Agency for Toxic Substances and Disease Registry, Start Printed Page 70841Centers for Disease Control and Prevention, Food and Drug Administration, Health Resources and Services Administration, Indian Health Service, National Institutes of Health, the Substance Abuse and Mental Health Services Administration, and the offices of the Regional Health Administrator.
§ 94.655
PHS funds or PHS funding.
§ 94.660
Research 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.
§ 94.665
§ 94.670
Retaliation for the purpose of this part means an adverse action taken against a whistleblower by a covered institution or one of its members in response to—
(b) A good faith cooperation with an investigation of an allegation in paragraph (a) of this section.
§ 94.675
§ 94.680
Whistleblower means an institutional member who in good faith—
[FR Doc. 00-29988 Filed 11-27-00; 8:45 am]