The following are suggested modifications to the Code of Federal Regulations of the USA (42 CFR part 93), which deals with the handling of research misconduct. These recommendations were made on October 31, 2022, in response to a Request for Information (RFI) by the federal Department of Health and Human Services’ Office of the Secretary.
(Recommended changes to relevant text of the code are presented within brackets, or by strikethroughs of existing text. Associated comments follow suggested changes. Font emphasis was added to parts of the regulatory text.)
I. Recommended modifications to 42 C.F.R. § 93.100 (General Policy) part (b):
“(b) The U.S. Department of Health and Human Services (HHS) and institutions that apply for or receive Public Health Service (PHS) support for biomedical or behavioral research, biomedical or behavioral research training, or activities related to that research or research training share responsibility for the integrity of the research process. HHS has ultimate oversight [RECOMMENDED ADDITION: “RESPONSIBILITY and] authority for PHS supported research, and for taking other actions as appropriate or necessary, including the [RECOMMENDED REPLACEMENT: “DUTY and REQUIREMENT] right to assess allegations and perform inquiries or investigations at any time.”
“Institutions and institutional members have an affirmative duty to protect PHS funds from misuse by ensuring the integrity of all PHS supported work, and primary responsibility for responding to and reporting allegations of research misconduct, as provided in this part.” [RECOMMENDED ADDITION: “HHS has a MANDATORY DUTY and REQUIREMENT to establish and maintain FULL AUDIT FUNCTIONS AND CONTROLS over all aspects of the research misconduct process. In performing its audit functions, HHS is required to meet FULL INDEPENDENCE and other FEDERAL AUDIT STANDARDS, as applied specifically to EVIDENTIARY and PROCEDURAL AUDIT of the research misconduct process.”
Comments: HHS takes ultimate responsibility for oversight. However, doing so effectively will require making many more of ORI’s functions mandatory, rather than discretionary, and most importantly, instituting independent audit procedures of research misconduct program.
II. Recommended modifications to 42 C.F.R. 93.105 (Time limitations) parts (a) and (b)(1):
(a) Six-year limitation. This part applies only to research misconduct occurring within six years of the date HHS or an institution receives an allegation of research misconduct.
[RECOMMENDATION TO STRIKE the limitation in 93.105(a).
Comment: The time limitation can produce clashes with grant funding clawback provisions, and it can also produce an incentive to obfuscate, delay, and otherwise promote acceptance of misconduct. Requirements to retain laboratory and administrative records in primary and/or archival forms should be adjusted as necessary to permit subsequent reviews.
(b) Exceptions to the six-year limitation. Paragraph (a) of this section does not apply in the following instances:
(1) Subsequent use exception. The respondent continues or renews any incident of alleged research misconduct that occurred before the six-year limitation through the citation, republication or other use for the potential benefit of the respondent of the research record that is alleged to have been fabricated, falsified, or plagiarized. [RECOMMENDED ADDITION: “CONTINUING GRANT RENEWALS based in any part on allegedly falsified or fabricated evidence shall be considered within the scope of this exception.”
Comment: At least one federal court has interpreted grant renewals as not falling under such continuing fraud prohibitions. Therefore, making such coverage explicit could be helpful, in particular in allowing ORI and NIH to effectuate grant fund clawback provisions, and avoiding other statute of limitation problems in court.
III. Section 93.307 (Institutional inquiry) part (a)(3), (b), and (c)
(a) Criteria warranting an inquiry. An inquiry is warranted if the allegation–
(1) Falls within the definition of research misconduct under this part;
(2) Is within §93.102; and
(3) Is sufficiently credible and specific so that potential evidence of research misconduct may be identified.
Comment: Auditability of the inquiry initiation process would encompass the handling of allegations. But what is “sufficient” about credibility, and how “specific” must evidence be? This is an example of why federally compliant evidentiary audit standards should be instituted within these regulations. (See also Sci Eng Ethics. 2016 Aug;22(4):1027-1049.) It is strongly recommended that this RFI be presented to the federal CIGIE for comment, along with other U.S. and international audit societies, such as the Institute of Internal Auditors.
(b) Notice to respondent and custody of research records. At the time of or before beginning an inquiry, an institution must make a good faith effort to notify in writing the presumed respondent, if any. If the inquiry subsequently identifies additional respondents, the institution must notify them. To the extent it has not already done so at [RECOMMENDED STRIKES and REPLACMENTS: “[At] the allegation stage, the institution must, on or before the date on which the respondent is notified or the inquiry begins, whichever is earlier, promptly take all reasonable and practical steps to obtain custody of all the research records and evidence needed to conduct the research misconduct proceeding, inventory the records and evidence, and sequester them in a secure manner, except that where the research records or evidence encompass scientific instruments shared by a number of users, custody may be limited to copies of the data or evidence on such instruments, so long as those copies are substantially equivalent to the evidentiary value of the instruments.
Comment: Recommendation is made to strike out language permitting any intuitional discretion, e.g. by their own interpretations of “reasonable and practical”, to not take timely custody of all relevant records at the earliest moment. Ensuring the acquisition of all relevant evidence would promote more effective assessment and auditability of allegations. If comprehensive acquisition and archiving of research records really cannot be accomplished, the institution can document why not, and such claims can themselves be audited.
(c) Review of evidence. The purpose of an inquiry is to conduct an initial review of the evidence to determine whether to conduct an investigation. Therefore, an inquiry does not require a full [EXPERT] review of all the evidence related to the allegation, [RECOMMENDED ADDITION: “which would be a function of an investigating committee.”]
Comment: The use of the term “full” is not clear, unless by “full review” the authors were trying to say that a full EXPERT review was not necessary. That would presumably be the purpose of an investigatory panel.
IV. Section 93.308 (Notice of the results of the inquiry) (b)
(b) Notice to complainants. [RECOMMENDED STRIKEOUTS, REPLACEMENTS, and ADDITIONS: “The institution may [MUST] notify the complainant who made the allegation whether the inquiry found that an investigation is warranted. The institution [MUST] may provide [ALL] relevant portions of the report to the complainant for comment.” [ADDITION: “The complainant’s comments at the conclusion of the inquiry process must be included with all other auditable materials and records.”]
[Comment: Protect the integrity of the process by keeping the complainant fully informed and involved. Otherwise, a disincentive to report could be exacerbated.
V. Section 93.402 (ORI allegation assessments) parts (a) and (b)
(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.
[RECOMMENDED CHANGE: “When ORI receives an allegation of research misconduct directly, it MUST conduct an initial assessment. It may refer the matter to the relevant institution for further assessment, inquiry, or other appropriate actions, and/or directly investigate the matter further through use of an expert external panel.”]
(b) If [WHEN] 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[MUST] review all readily accessible, relevant information related to the allegation.
Comments: Amending this section to make ORI’s performance more mandatory could provide a means of comparing the interest of informants in contacting ORI directly, rather than working solely within their institutions. The latter is known to be a very highly risky prospect to the informant. By contrast, ORI might be less conflicted than the affected institution in honoring confidentiality and anti-retaliation requirements needed to protect the confidential informant/complainant. (Anonymous reporting options could also be specified in these regulations). The addition of an expert panel option to assist ORI could potentially allow auditors to compare such outcomes with those produced by using a fully institutional route.
VI. Additional recommendations
There are many other points which could be revised or written with greater stringency in these regulations. For instance:
> Section 93.316 (Completing the research misconduct process) part (a)
“(a) ORI [REQUIRES] expects institutions to carry inquiries and investigations through to completion”
> Section 93.300 (General responsibilities for compliance) part (b)
“Institutions under this part must –
(b) Respond to each allegation of research misconduct for which the institution is responsible under this part in a thorough, competent, objective and fair manner, including precautions to ensure that individuals responsible for carrying out any part of the research misconduct proceeding do not have unresolved personal, professional or financial conflicts of interest with the complainant, respondent or witnesses;
Comment: The specification of part 93.300 (b) are too vague and undefined to provide for any required actions. Definitive requirements should be specified and the standards for such referenced. Similar concerns exist for the phrase “all reasonable and practical steps” in parts (d) and (f) of this section.
> Section 93.319 (Institutional standards) part (a)
(a) Institutions may have internal standards of conduct [RECOMMENDED REPLACEMENT AND STRIKE:“different from [MORE STRINGENT THAN] the HHS standards for research misconduct under this part.Therefore, an institution may find conduct to be actionable under its standards even if the action does not meet this part’s definition of research misconduct.”
Comment: Consider a scenario whereby the institution’s standards are more lax than those within federal regulations. This possibility should be ruled out explicitly.
> A section specifically addressing audit functions should be added to these regulations.
For example, new language could be added along the lines of “HHS will also fully comply with regular PERFORMANCE AUDITS of its own functions under this Section, including by providing full and direct access to all records which auditors may deem relevant at any institution over which HHS has oversight authority, as well as access to its own staff, records, and any other materials independent auditors may seek.” Also potentially of value: “All audit records and reports shall be made PUBLIC in a fully detailed but anonymized form.”
In conclusion, in furtherance of the above recommendations, HHS is urged to bring in expert audit organizations, in particular the federal CIGIE, to comprehensively address improvements to 42 C.F.R. Part 93, including with reference to the suggestions made above.
If further recommendations along the lines of the preceding are desired, the author, (Robert P. Bauchwitz M.D., Ph.D., C.F.E.) can be reached at rpb@amerares.com. For example, conflict of interest provisions could also be added to these regulations such as by instituting external assessment of allegations. (Sci Eng Ethics. 2016 Aug;22(4):1027-1049.)