Public Health Service Policies on Research Misconduct, 28370-28400 [05-9643]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 70, Number 94 (Tuesday, May 17, 2005)]
[Rules and Regulations]
[Pages 28370-28400]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-9643]



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Part III





Department of Health and Human Services





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42 CFR Parts 50 and 93



Public Health Service Policies on Research Misconduct; Final Rule

Federal Register / Vol. 70, No. 94 / Tuesday, May 17, 2005 / Rules 
and Regulations

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Parts 50 and 93

RIN 0940-AA04


Public Health Service Policies on Research Misconduct

AGENCY: U.S. Department of Health and Human Services (HHS).

ACTION: Final rule.

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SUMMARY: This final rule removes 42 CFR part 50, subpart A, 
``Responsibilities of Awardee and Applicant Institutions for Dealing 
With and Reporting Possible Misconduct in Science,'' and replaces it 
with a new, more comprehensive part 93, ``Public Health Service 
Policies on Research Misconduct.'' The proposed part 93 was published 
for public comment on April 16, 2004. The final rule reflects both 
substantive and non-substantive amendments in response to public 
comments and to correct errors and improve clarity, but the general 
approach of the NPRM is retained. The purpose of the final rule is to 
implement legislative and policy changes applicable to research 
misconduct that occurred over the last several years, including the 
common Federal policies and procedures on research misconduct issued by 
the Office of Science and Technology Policy on December 6, 2000.

DATES: This final rule will become effective June 16, 2005.

ADDRESSES: Address any comments or questions regarding this final rule 
to: Chris B. Pascal, J.D., Director, Office of Research Integrity, 1101 
Wootton Parkway, Suite 750, Rockville, MD 20852. Some commonly asked 
questions and answers to them will be posted on the Office of Research 
Integrity Web site prior to the effective date of the regulation. The 
URL for the ORI Web site is: https://ori.hhs.gov.
    You may submit comments and questions on this final rule by sending 
electronic mail (e-mail) to research@osophs.dhhs.gov. Submit electronic 
comments as either a WordPerfect file, version 9.1 or higher, or a 
Microsoft Word 97 or 2000 file format. You may also submit comments or 
questions as an ASCII file avoiding the use of special characters and 
any form of encryption.

FOR FURTHER INFORMATION CONTACT: Brenda Harrington, (301) 443-3400. 
(This is not a toll-free number).

SUPPLEMENTARY INFORMATION: 

I. Public Comments--General

    The Notice of Proposed Rulemaking (NPRM) proposing to remove 42 CFR 
part 50, subpart A and replace it with a new part 93 was published in 
the Federal Register on April 16, 2004 (69 FR 20778). Comments were 
requested on or before June 15, 2004. In addition to this invitation 
for public comment on any aspect of the proposed rulemaking, the NPRM 
requested comment on specific aspects of the proposed rule including: 
(A) Whether there should be any limitation on the ability of 
institutions to conduct a research misconduct proceeding through a 
consortium or other entity qualified by practice and experience to 
conduct research misconduct proceedings (Sec.  93.306); (B) the use of 
Administrative Law Judges (ALJs) to conduct HHS research misconduct 
hearings rather than a panel of three decisionmakers (Sec.  93.502); 
(C) treating the decision of the ALJ as a recommended decision to the 
Assistant Secretary for Health (ASH) as opposed to the current practice 
in which the decision of the panel on the merits of the HHS findings of 
misconduct and administrative actions, other than debarment, 
constitutes final agency action (Sec. Sec.  93.500(d) and 93.523(c)); 
(D) authorizing the ALJ to appoint a scientific expert (that 
appointment is required if requested by either party) to advise the ALJ 
on scientific issues, but not provide testimony for the record (Sec.  
93.502(b)); (E) consistent with current practice, permitting HHS to 
amend its findings of research misconduct up to 30 days before the 
scheduled hearing (Sec.  93.514); (F) extending the period for 
retaining records of the research misconduct proceeding, including 
inquiries, from 3 to 7 years (Sec.  93.317); (G) imposing a 120-day 
deadline for the completion of any institutional appeal from a finding 
of research misconduct (Sec.  93.314); and (H) whether the HHS 
estimates on the potential burden of information collection 
requirements are accurate and whether those requirements are necessary 
for the proper performance of HHS functions.
    Twenty-eight documents commenting on the NPRM were submitted to HHS 
by mail or e-mail. Most of the documents addressed multiple sections of 
the proposed rule. A number of the commentators made general positive 
comments such as that: the proposed rule is well drafted, provides 
valuable guidance for researchers and institutions and is much improved 
over the current regulation; the detail and transparency of the 
procedures will result in a better focus on the merits of a case rather 
than procedural complications; the proposal recognizes the importance 
of primary reliance on the institutions to respond to allegations of 
research misconduct; and the clarification and harmonization of 
definitions, standards, and procedures are appreciated.
    Most of the commentators endorsed the changes in the definition of 
research misconduct and the incorporation of the three elements 
necessary for a finding of research misconduct in conformity with the 
Federal Policy on Research Misconduct issued by the Office of Science 
and Technology Policy (OSTP). Some expressed support for the PHS 
practice of excluding coverage of authorship disputes in the absence of 
a clear allegation of plagiarism. There were expressions of support for 
the coverage of PHS intramural programs and PHS contractors, the 
coverage of the plagiarism of a PHS supported research record, even if 
the respondent does not receive such support, the clarification of the 
role of the complainant, the adoption of a six-year limitation on the 
pursuit of misconduct allegations, separation of adjudication and 
appeal from the inquiry and investigation stages, setting a time limit 
on the investigation by the institution, and the inclusion of ALJs in 
the hearing process. These and other supportive comments may be 
discussed in the consideration of specific changes to the proposed rule 
that follows.
    There were also general, negative comments on the proposed rule, 
some of which were in direct opposition to positive comments. Some 
commentators feel that the proposal is overly detailed and thus 
contrary to the OSTP goal of a more uniform Federal-wide approach. 
Another criticizes the continuation in the proposed rule of a trend 
toward legalization of scientific disputes by immediately casting 
parties into adversarial roles. Other commentators object to the change 
from a hearing conducted by a three-member panel to one conducted by an 
ALJ, stating that there has not been any showing of a need to change 
the current practice. One commentator felt that HHS should be 
responsible for investigating allegations of misconduct at institutions 
that have repeatedly failed to properly investigate research 
misconduct. These and other critical comments may be discussed in the 
consideration of specific changes that follow.
    Some letters of comment repeated comments that had been made in 
response to the OSTP proposal for a government-wide Federal policy on 
research misconduct. Because OSTP considered those comments prior to

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issuing its final policy and this final rule is consistent with the 
aspects of the OSTP policy addressed in the comments, those comments 
will not be further discussed here.
    Comments on specific sections of the regulation are addressed below 
under headings based on the general issue raised by the comments. If 
that issue encompasses more than one section of the regulation, all 
those sections will be discussed under that heading.

II. Changes Made in Response to Comments

A. Applicability, Secs. 93.100(b) and 93.102(b)

    A number of commentators concluded that the applicability section, 
93.102, and the descriptions of applicability in other sections 
unreasonably extend HHS jurisdiction beyond PHS supported biomedical or 
behavioral research and research training. One commentator recommended 
that descriptions of applicability be uniform throughout the 
regulation. There were specific objections to: (1) The statement in 
Sec. 93.100(b) that covered institutions must comply with the 
regulation with respect to allegations of misconduct ``occurring at or 
involving research or research training projects or staff of the 
institution''; (2) the coverage, in Sec. 93.102(a) and other sections 
describing applicability, of ``activities related to that research or 
research training;'' and (3) the extension of coverage in Sec. 
93.102(a) to allegations of misconduct involving any research record 
generated from covered research, research training, or activities 
related to that research or training, regardless of whether the user or 
reviewer receives PHS support or whether an application resulted in any 
PHS support.
    Several clarifying changes have been made in response to these 
comments, but these changes do not change the intended substance of the 
provisions in the NPRM. The current regulation, 42 CFR 50.101, covers 
each entity that applies for a ``research, research-training or 
research-related grant or cooperative agreement'' under the PHS Act. 
Such an entity must establish policies and procedures for investigating 
and reporting instances of alleged misconduct involving ``research or 
research training or related research activities that are supported 
with funds available under the PHS Act.'' Thus, applicability to 
research-related activities is not new. The NPRM was not intended to 
change the applicability to those activities as it is expressed in the 
current regulation and has been applied in practice under that 
regulation.
    This rulemaking establishes the necessary HHS jurisdiction to 
implement the new term ``reviewing research'' in the OSTP definition of 
research misconduct. In ORI's experience, plagiarism can occur during 
the review process when a manuscript is submitted for publication. In 
the great majority of cases where an allegation arises that a PHS 
supported research record was plagiarized, we expect that the reviewers 
will be current recipients of PHS research funds because the reviewers 
are selected based on their subject matter expertise and the research 
in question is PHS funded biomedical and behavioral research. In cases 
where the respondent is PHS supported or affiliated with a PHS 
supported institution, we would expect the misconduct allegation to be 
pursued by the PHS supported institution. In those cases where the 
reviewer who is alleged to have committed plagiarism is solely funded 
by another Federal agency, ORI would refer the allegation to that 
agency. In addition, jurisdiction does not attach to allegations of 
plagiarism where there is no PHS support for the research record in 
question. Thus, we have removed the phrase ``regardless of whether the 
user or reviewer currently receives PHS support'' from Sec. 93.102.
    To eliminate redundancy and clarify the general policy and 
applicability provisions, Secs. 93.100 and 93.102, we have: (1) Moved 
the statement of applicability to institutions from Sec. 93.100(b) to 
Sec. 93.102(b) and rewritten it to be more concise; and (2) moved 
paragraph (c) of Sec. 93.100 to paragraph (a) of that section and 
combined the proposed paragraphs (a) and (d) into a new paragraph (b).
    The provision setting forth the types of allegations to which the 
regulation applies has been moved from Sec. 93.102(a) to paragraph (b) 
of that section and has been amended to clarify that the regulation 
applies to allegations of research misconduct involving: (i) 
Applications or proposals for PHS support for biomedical or behavioral 
extramural or intramural research, research training, or activities 
related to that research or research training, such as the operation of 
tissue or data banks or the dissemination of research information; (ii) 
PHS supported biomedical or behavioral extramural or intramural 
research; (iii) PHS supported biomedical or behavioral extramural or 
intramural research training programs; (iv) PHS supported extramural or 
intramural activities that are related to biomedical or behavioral 
research or research training, such as the operation of tissue and data 
banks or the dissemination of research information; and (v) plagiarism 
of research records produced in the course of PHS supported research, 
research training, or PHS supported activities related to that research 
or research training. The examples of activities that are related to 
research or research training are intended to be illustrative, not 
exhaustive. They are intended to convey the concept that under its 
research and research training authorities, PHS funds many activities 
that are closely related to research and research training, but might 
not be considered to be within the common understanding of what 
constitutes research or research training. Consistent with the intent 
of, and practice under the current regulation, allegations of research 
misconduct involving those funded activities, or applications for the 
funding of those activities, are covered.
    In each section that refers to the applicability of the regulation 
we have referenced the applicability section or repeated the 
applicability of the regulation to PHS supported research, research 
training, and activities related to that research or research training.

B. Subsequent Use Exception to Six Year Limitation on Misconduct 
Allegations, Sec. 93.105(b)(1)

    In response to a comment requesting clarification, we have amended 
paragraph (b)(1) of Sec. 93.105. The amendment clarifies that even 
though HHS or an institution does not receive an allegation of research 
misconduct within six years of when the misconduct is alleged to have 
occurred, the regulation would apply if, within six years of when the 
allegation is received, the respondent has cited, republished, or 
otherwise used for his or her potential benefit the research record 
that is the subject of the allegation of misconduct.

C. Rebuttable Presumption of Misconduct in the Absence of Records, 
Secs. 93.106(a)(1) and 93.516(b)

    Commentators raised several concerns about proposed Sec. 
93.106(a)(1) and Sec. 93.516(b) under which the absence of, or 
respondent's failure to provide research records adequately documenting 
the questioned research establishes a presumption of research 
misconduct that can be rebutted by credible evidence corroborating the 
research or providing a reasonable explanation for the absence of, or 
respondent's failure to provide the research records. The concerns 
included: (1) Retroactive application of the provision where there was 
no previous requirement for the retention

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of the records; (2) holding the respondent responsible for the 
retention of records over which he/she may have no control; and (3) 
there is no guidance on what would be a ``reasonable explanation'' for 
the absence of records.
    In response to these comments, we have eliminated the rebuttable 
presumption of research misconduct. Sections 93.106 and 93.516 have 
been changed to state that the destruction, absence of, or respondent's 
failure to provide records adequately documenting the questioned 
research is evidence of research misconduct where the institution or 
HHS establishes by a preponderance of the evidence that the respondent 
intentionally, knowingly, or recklessly had research records and 
destroyed them, had the opportunity to maintain the records but failed 
to do so, or maintained the records, but failed to produce them in a 
timely manner, and that respondent's conduct constitutes a significant 
departure from accepted practices of the relevant research community. 
This is in keeping with the definition of falsification to include 
omitting data or results such that the research is not accurately 
represented in the research record (Sec. 93.103(b)) and with the 
requirements for a finding of research misconduct in Sec. 93.104. This 
answers the concerns about retroactive application and that the 
respondent may not have had control over the records by holding the 
respondent to the accepted practices of his/her research community. The 
weight to be accorded the evidence of research misconduct under these 
circumstances must be determined by the trier of fact in each case.

D. Respondent's Burden To Prove Honest Error or Difference of Opinion, 
Secs. 93.106(a)(2) and 93.516(b)

    As proposed, Sec. 93.106(a)(2) provided that once the institution 
or HHS makes a prima facie showing of research misconduct the 
respondent has the burden of proving any affirmative defenses raised, 
including honest error or difference of opinion. There were a number of 
objections to that section on the grounds that shifting the burden of 
proving honest error or difference of opinion to the respondent 
effectively shifts the burden of the institution and HHS to prove each 
element of research misconduct or, at the least, creates confusion. 
Some of the commentators opined that the institution and the HHS have 
the burden of proving the absence of honest error or difference of 
opinion.
    As stated in the preamble of the Federal Register notice 
promulgating the final OSTP Research Misconduct Policy (65 FR 76260, 
Dec. 6, 2000), the exclusion of honest error or difference of opinion 
from the definition of research misconduct does not create a separate 
element of proof; institutions and agencies are not required to 
disprove possible honest error or difference of opinion. Given that 
guidance, this final rule retains honest error or difference of opinion 
as an affirmative defense that the respondent has the burden of proving 
by a preponderance of the evidence.
    However, we recognize that there is an overlap between the 
responsibility of respondents to prove this affirmative defense and the 
burden of institutions and HHS to prove that research misconduct was 
committed intentionally, knowingly, or recklessly. Accordingly, 
consistent with the opinion of the United States Supreme Court in 
Martin v. Ohio, 480 U.S. 228, 107 S. Ct. 1098 (1987), we have amended 
Sec. 93.106 to require consideration of admissible, credible evidence 
respondent submits to prove honest error or difference of opinion in 
determining whether the institution and HHS have carried their burden 
of proving by a preponderance of the evidence that the alleged research 
misconduct was committed intentionally, knowingly, or recklessly. This 
consideration would be required, regardless of whether respondent 
carries his/her burden of proving honest error or difference of opinion 
by a preponderance of the evidence.
    In light of this change, we have removed the reference to the 
institution or HHS making a prima facie showing of research misconduct 
as unnecessary and confusing. Because this is the only use of prima 
facie in the regulation, we have removed the definition of that term.

E. Coordination With Other Agencies, Sec. 93.109

    Some commentators pointed out that Sec. 93.109(a), as proposed, is 
not consistent with the statement in the OSTP Policy that a lead agency 
should be designated when more than one agency has jurisdiction. We 
have amended paragraph (a) to state that if more than one agency of the 
Federal government has jurisdiction, HHS will cooperate with the other 
agencies in designating a lead agency. We have added a sentence 
clarifying that where HHS is not the lead agency, it may, in 
consultation with the lead agency, take action to protect the health 
and safety of the public, promote the integrity of the PHS supported 
research and research process, or to conserve public funds.

F. Definition of Research Record, Sec. 93.224

    One commentator recommended that the research record include the 
comments of the complainant and respondent on the inquiry and 
investigation reports. We agree that documents and materials provided 
by the respondent as part of his/her comments on the inquiry and 
investigation reports, or at any other stage of the research misconduct 
proceeding do not differ significantly from those provided in response 
to questions regarding the research. Only the latter were included in 
the proposed definition of research record. Accordingly, we have 
amended Sec. 93.224 (formerly Sec. 93.226) so that the definition of 
research record includes documents and materials that embody the facts 
resulting from the research that are provided by the respondent at any 
point in the course of the research misconduct proceeding. The purpose 
of including documents provided by respondent in the research record is 
to hold the respondent responsible for the integrity of those research 
documents regardless of when they were prepared or furnished to the 
institution or HHS.
    Because the complainant is not being held responsible for the 
record of data or results that embodies the facts resulting from the 
research at issue, we are not including comments provided by the 
complainant during the research misconduct proceeding in the definition 
of the term ``research record.'' Those comments may be considered by 
the institution and/or HHS and they may be admitted as evidence in any 
hearing, but they are not part of the research record. If the 
complainant possesses documents that embody the facts resulting from 
the research that is the subject of the research misconduct proceeding, 
those documents are research records and the institution is responsible 
for maintaining and securing those documents in the same manner as 
other research records. Those documents are distinct from analyses of 
research records or results that a complainant may prepare prior to or 
in the course of a research misconduct proceeding to support his or her 
allegation of misconduct. Any such documents may be considered evidence 
pertinent to the allegation, but they are not part of the research 
record.

G. Reporting Inquiries to ORI, Sec. 93.300(a)

    Several commentators interpreted the general language in proposed 
Sec. 93.300(a), requiring institutions to have policies and procedures 
for ``reporting

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inquiries and investigations of alleged research misconduct in 
compliance with this part,'' to require the reporting of all inquiries 
to ORI, contrary to the requirement in Sec. 93.309 for reporting only 
those inquiries resulting in a finding that an investigation is 
warranted. We have amended Sec. 93.300(a) to clarify that the 
institution's policies and procedures must comply with the requirements 
of the regulation for addressing allegations of research misconduct. 
This includes the requirements of Sec. 93.309.
    It was also recommended that this section be amended to require 
that the institution's written policies and procedures be provided to 
the complainant and other interested parties on request. We have added 
a requirement that the policies and procedures be provided to members 
of the public upon request to Sec. 93.302(a)(1) because it addresses 
the availability of the institution's policies and procedures to HHS 
and ORI upon request.

H. Precautions To Protect Against Conflicts of Interest, Secs. 
93.300(b) and 93.304(b)

    In response to a general comment that the regulation should ensure 
that those conducting inquiries and investigations do not have 
conflicts of interest, we have amended Secs. 93.300(b) and 93.304(b) to 
require institutions to include precautions against conflicts of 
interest on the part of those involved in the inquiry or investigation. 
This expands upon the requirement in Sec. 93.310(f) that institutions 
take reasonable steps to ensure an impartial investigation, ``including 
participation of persons with appropriate scientific expertise who do 
not have unresolved personal, professional, or financial conflicts of 
interest with those involved with the inquiry or investigation.''

I. Reporting of Aggregated Information by Institutions, Sec. 93.302(c)

    Several commentators recommended deletion of proposed Sec. 
93.302(c) because its broad language would encompass research 
misconduct proceedings that are outside the jurisdiction of HHS. We 
agree with the intent of these comments and have amended this provision 
to refer to aggregated information on the institution's research 
misconduct proceedings covered by this part.

J. Responsibility for Securing Research Records and Evidence, Secs. 
93.305, 93.307(b) and 93.310(d)

    Several commentators recommended that Sec. 93.305 be amended to 
ensure that any securing of scientific instruments not interfere with 
ongoing research. Scientific instruments are included in the definition 
of ``research record'' in Sec. 93.224 to the extent they are, or 
contain physical or electronic records of data or results that embody 
the facts resulting from scientific inquiry. In response to these 
comments we have added language to paragraphs (a) and (c) of Sec. 
93.305, paragraph (b) of Sec. 93.307, and paragraph (d) of Sec. 93.310 
permitting institutions to secure copies of data or other research 
records on shared scientific instruments, so long as those copies are 
substantially equivalent in evidentiary value to the instruments 
themselves. It is expected that institutions will exercise discretion 
in determining whether copies of the data are substantially equivalent 
in evidentiary value to the instruments themselves, consulting with ORI 
as the institution determines necessary. The evidentiary value of 
scientific instruments will vary from case to case. In some cases their 
value may be dependent upon the manner in which they record data, 
rather than the data they contain. In those cases, it may be reasonable 
for the institution to permit continued use of the instrument, so long 
as it remains available for inspection by those conducting the inquiry 
and investigation.

K. Using a Consortium or Other Entity To Conduct Research Misconduct 
Proceedings, Sec. 93.306

    One commentator recommended that there should be greater detail 
regarding the kinds of practice and experience that would qualify an 
outside entity to conduct research misconduct proceedings, how possible 
conflicts of interest would be handled, and whose responsibility it 
would be to determine whether the outside entity is qualified.
    The proposed Sec. 93.306 contains a catchall phrase providing that 
an institution may use a consortium or other entity to conduct research 
misconduct proceedings, if the institution prefers not to conduct its 
own proceeding. In light of the incorporation of this broad discretion 
in the proposed section, we have simplified Sec. 93.306 to provide that 
an institution may use the services of a consortium or person that the 
institution reasonably determines to be qualified by practice and 
experience to conduct research misconduct proceedings. Thus, the 
institution may decide to use an outside consortium or person for any 
reason and it determines whether that outside consortium or person is 
qualified. We have substituted the defined term ``person'' for the term 
``entity.'' Any outside person conducting a research misconduct 
proceeding would be subject to the requirements for precautions against 
conflicts of interest in Secs. 93.300(b) and 93.304(b).

L. Standards for Investigation, Sec. 93.310(g) and (h)

    A number of commentators felt that the provisions of proposed Sec. 
93.310(g) and (h) establish a performance standard that cannot be met 
through the use of the terms ``any'' and ``all.'' We have amended 
paragraphs (g) and (h) to require, respectively, interviews of each 
person who has been reasonably identified as having information 
regarding relevant aspects of the investigation, and the pursuit of all 
significant issues and leads discovered that are determined relevant to 
the investigation. The institutions are responsible for making the 
relevancy determinations that are included in these paragraphs.

M. Opportunity To Comment on the Investigation Report and Review the 
Supporting Evidence, Sec. 93.312(a) and (b)

    One commentator proposed language clarifying the period for the 
respondent to comment on the investigation report. Another commentator 
felt that the institution should be required to give the respondent an 
opportunity to review all research records and evidence upon which the 
investigation report is based. We believe that clarification of the 30-
day period for comment by the respondent and for comment by the 
complainant, at the discretion of the institution, is needed. We have 
amended paragraphs (a) and (b) of Sec. 93.312 accordingly. In addition, 
we have amended paragraph (b) to make it clear that institutions have 
the discretion to provide the complete investigation report to the 
complainant for comment or relevant portions of it.
    The OSTP Guidelines for Fair and Timely Procedures, Section IV of 
the Uniform Federal Policy, provide that one of the safeguards for 
subjects of allegations is reasonable access to the data and other 
evidence supporting the allegations and the opportunity to respond to 
the allegations, the supporting evidence and the proposed findings of 
research misconduct, if any. Consistent with that guidance, we have 
amended Sec. 93.312(a) to require institutions to give the respondent, 
concurrently with the draft investigation report, a copy of, or 
supervised access to, the evidence on which the report is based.

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N. Institutional Appeals, Sec. 93.314(a)

    One commentator requested language clarifying that the 120-day 
period for completing institutional appeals applies only to appeals 
from the finding of misconduct, not appeals from personnel actions. We 
have implemented this comment through the addition of appropriate 
language to Sec. 93.314(a).

O. Completing the Research Misconduct Process, Sec. 93.316

    Several commentators objected to this provision because they 
interpreted it as requiring that ORI be notified when an inquiry ends 
in a finding of no misconduct. These commentators recommended that the 
regulation address the question of whether settlements based on an 
admission of misconduct are reportable. In response to these comments 
we have amended Sec. 93.316(a) to require that institutions notify ORI 
if they plan to close a case at the inquiry, investigation, or appeal 
stage on the basis that the respondent has admitted research 
misconduct, a settlement with the respondent has been reached, or for 
any other reason, except a determination at the inquiry stage that an 
investigation is not warranted, or a finding of no misconduct at the 
investigation stage, which must be reported to ORI under Sec. 93.315. 
We have also changed Sec. 93.316(b) to provide for ORI consultation 
with the institution on its basis for closing a case, rather than 
simply reviewing the institution's decision, and expanded the actions 
ORI may take to include approving or conditionally approving closure of 
the case and taking compliance action.

P. Retention and Custody of Records of the Research Misconduct 
Proceeding, Sec. 93.317

    There were several objections that the seven-year retention period: 
(1) Creates storage problems; (2) should not apply to scientific 
instruments; and (3) is contrary to the 3-year retention period for 
records relating to grants in OMB Circular A-110. One commentator 
recommended that the term ``records of research misconduct 
proceedings'' be defined to include a relevancy standard.
    In order to clarify what must be retained, we have added a new 
paragraph (a) to Sec. 93.317 defining records of research misconduct 
proceedings by referring to the sections of the regulation that 
describe what records institutions must prepare in the course of 
research misconduct proceedings. The definition includes a relevancy 
standard and requires that an institution document any determination 
that records are irrelevant. We have added two exceptions to the 
requirement for retention of the records for a period of 7 years that 
is now in paragraph (b) of Sec. 93.317. The institution is not 
responsible for maintaining the records if they have been transferred 
to HHS in accordance with paragraph (c), formerly (b), or ORI has 
advised the institution in writing that it no longer needs to retain 
the records.
    As stated in the preamble of the NPRM (69 FR at 20784) the 7-year 
retention period is based on concerns that the 3-year period for 
retaining inquiry records in the current regulation, 42 CFR 
50.103(d)(6) is too short to permit HHS or the Department of Justice to 
investigate potential civil or criminal fraud cases. While the 7-year 
retention period is potentially burdensome, that burden will fall on a 
limited number of institutions, 53 according to the Paperwork Reduction 
Act burden estimate in the preamble to the NPR, and the burden is 
mitigated by exceptions for transfer of custody to HHS and for a 
written notification from ORI that the records do not have to be 
retained by the institution. Upon the effective date of this final 
rule, the 7-year retention period for records of research misconduct 
proceedings will supercede the more general requirements for the 
retention of records relating to grants. We note that the 7-year 
retention period is consistent with the provision in the HHS general 
grants administration regulation, 45 CFR 74.53(b)(1) providing that if 
any review, claim, financial management review, or audit is started 
during the 3-year retention period, the pertinent records must be 
retained until all such matters have been resolved and final action 
taken.

Q. ORI Allegation Assessments, Sec. 93.402

    Several commentators recommended requiring that ORI notify the 
institution of any allegation received by ORI, regardless of how ORI 
disposes of the allegation. Consistent with this recommendation, we 
have amended paragraph (d) of Sec. 93.402 to provide that if ORI 
decides that an inquiry is not warranted, it will close the case and 
may forward the allegation in accordance with paragraph (e) which 
provides that allegations not covered by the regulation may be 
forwarded to the appropriate HHS component, Federal or State agency, 
institution or other appropriate entity. In deciding whether to forward 
a specific allegation to the institution, ORI will consider potential 
confidentiality issues for the complainant and others. We are open to 
further dialogue with the research community on this issue.

R. Standard for the Assistant Secretary for Health's Review of the 
ALJ's Decision, Secs. 93.500(d) and 93.523

    One commentator recommended that there be criteria for the 
Assistant Secretary for Health (ASH) to review the ALJ's decision, 
similar to the ``arbitrary and capricious, or clearly erroneous'' 
standard for the HHS debarring official to review the ALJ's decision 
(paragraph (e) of Sec. 93.500).
    In response to this comment, we have added to Sec. 93.523(b) a 
standard of review for the ASH's review of the decision of the ALJ. The 
standard of review for the ASH is the same ``arbitrary and capricious 
or clearly erroneous'' standard that applies to the debarring 
official's review where debarment or suspension is a recommended HHS 
administrative action. In addition, we have amended Secs. 93.500 and 
93.523 to establish a procedure for the ASH review, clarify the 
relationship between the ASH review and the debarring official's 
decision on recommended debarment or suspension actions, and identify 
what constitutes the final HHS action. The Assistant Secretary for 
Health notifies the parties of an intention to review the ALJ's 
recommended decision within 30 days after service of the recommended 
decision. Upon review, the ASH may modify or reject the decision in 
whole or in part after determining it, or the part modified or 
rejected, to be arbitrary and capricious or clearly erroneous. If the 
ASH does not notify the parties of an intent to review the recommended 
decision within the 30-day period, that decision becomes final and 
constitutes the final HHS action, unless debarment or suspension is an 
administrative action recommended in the decision. If debarment or 
suspension is a recommended HHS action either in a decision of the ALJ 
that the ASH does not review, or in the decision of the ASH after 
review, the decision constitutes proposed findings of fact to the HHS 
debarring official.
    As noted in the discussion of changes not based on comments, we 
have amended several sections to ensure that the Assistant Secretary 
for Health cannot be responsible both for making findings of research 
misconduct and for reviewing the ALJ's recommended decision on those 
findings, if respondent contests the findings by requesting a hearing. 
ORI will be responsible for making those findings, consistent with its 
responsibilities as the reviewer of institutional findings of

[[Page 28375]]

research misconduct and as a party to any hearing on those findings. 
This maintains the separation between investigation and adjudication, 
because any inquiry or investigation would be conducted by the 
institution, or if conducted by HHS, it would not be conducted by ORI 
(Sec. 93.400(a)(4)).

S. Extension for Good Cause To Supplement the Hearing Request, Sec. 
93.501(d)

    One commentator recommended that the 30-day limit for supplementing 
the hearing request be measured from notification of the appointment of 
the ALJ, rather than from receipt of the charge letter. The commentator 
notes that the ALJ may not be appointed within 30 days after receipt of 
the charge letter and recommends an amendment providing that the ALJ 
may grant an additional period of no more than 60 days from the 
respondent's receipt of notification of the appointment of the ALJ. 
This comment makes a good point, but 60 days from notice of the 
appointment of the ALJ is too long a period, given that there may be an 
additional 30 days for appointment of the ALJ after the request for a 
hearing is filed. Thus, we have amended paragraph (d) to provide that 
after receiving notification of the appointment of the ALJ, the 
respondent has 10 days to file with the ALJ a proposal for 
supplementation of the hearing request that includes a showing of good 
cause for supplementation. Note that this 10-day period is consistent 
with the period for responding to a motion in Sec. 93.510(c) and that 
in accordance with Sec. 93.509(d), the ALJ may modify the 10-day period 
for good cause shown.

T. Role of Scientific Expert Appointed by ALJ, Sec. 93.502

    It was recommended that advice of the scientific expert appointed 
to advise the ALJ be part of the record and available to both parties. 
It was further recommended that the scientific expert be available for 
questioning by the parties. Another commentator recommended specific 
guidance in the regulation to assist ALJs in retaining appropriate 
scientific expertise. Another commentator felt that the appointment of 
an expert to assist the ALJ should be mandatory in every case, while 
others felt such an appointment should be mandatory in those cases 
involving complex scientific, medical or technical issues. For the 
reasons explained below under the heading, ``Significant Comments Not 
Resulting in Changes,'' we are not requiring the appointment of an 
expert to assist the ALJ in every case.
    The proposed Sec. 93.502 provides some guidance on the selection of 
scientific and technical experts by requiring that they have 
appropriate expertise to assist the ALJ in evaluating scientific or 
technical issues related to the HHS findings of research misconduct. 
Furthermore, experts may not have real or apparent conflicts of 
interest, or as added in this final rule, bias or prejudice that might 
reasonably impair their objectivity in the proceeding.
    In paragraph (b)(1) of Sec. 93.502 of this final rule we are 
providing further guidance on the selection of an expert to advise the 
ALJ. Upon a motion by the ALJ or one of the parties to appoint an 
expert to advise the ALJ, the ALJ must permit the parties to submit 
nominations. If such a motion is made by a party, the ALJ must appoint 
an expert, either: (1) The expert, if any, who is agreeable to both 
parties and found to be qualified by the ALJ; or, (2) if the parties 
cannot agree upon an expert, the expert chosen by the ALJ.
    These provisions will ensure the selection of well-qualified 
experts, minimize disputes, speed the appointment process by providing 
precise procedural rules, and enhance fairness by providing for greater 
involvement of the parties in the process.
    Consistent with the greater involvement of the parties in the 
selection of the expert and with the comment recommending a more 
formalized process for the expert to provide advice, we are adding Sec. 
93.502((b)(2) to clarify the role of the expert appointed by the ALJ. 
The ALJ may seek advice from the appointed expert at any time during 
the discovery or hearing phase of the proceeding. Advice must be 
provided in the form of a written report, containing the expert's 
background and qualifications, which is served upon the parties. The 
report and the expert's qualifications and advice may be challenged by 
the parties in the form of a motion or through testimony of the 
parties' own experts, unless the ALJ determines such testimony to be 
inadmissible in accordance with Sec. 93.519, or that such testimony 
would unduly delay the proceeding. In this manner, the report and any 
comment on it would be part of the record. These procedures will 
greatly enhance the detail and quality of the expert advice available 
for consideration by the ALJ and provide greater transparency and 
confidence to the scientific community on the expertise provided to the 
ALJ.

II. Changes Not Based on Comments

A. Grandfather Exception to Six Year Limitation on Receipt of 
Misconduct Allegations, Sec. 93.105(b)(3)

    We have changed the condition for the grandfather exception from 
``had the allegation of research misconduct under review or 
investigation on the effective date of this regulation'' to ``had 
received the allegation of research misconduct before the effective 
date of this part.'' This makes the condition for the grandfather 
exception consistent with the event that tolls the running of the six-
year limitation: the receipt of the misconduct allegation by the 
institution or HHS.

B. Confidentiality, 93.108

    Consistent with longstanding practice and with Sec. 93.403, we have 
added a provision to clarify that ORI is within the category of those 
who need to know the identity of the respondent and complainant and 
that an institution may not invoke confidentiality to withhold that 
information from ORI as it conducts its review under Sec. 93.403.

C. Definition of Deciding Official, Sec. 93.207, and Authority of ORI, 
Sec. 93.400.

    To ensure that the Assistant Secretary for Health is not 
responsible for both making findings of research misconduct and for 
reviewing the recommended decision of the ALJ on those findings if 
respondent contests the findings by requesting a hearing, Sec. 93.400 
has been amended to give ORI the authority to make findings of research 
misconduct. That section and Sec. 93.404 have also been amended to 
clarify that ORI proposes administrative actions to HHS (defined as the 
Secretary or his delegate) and upon HHS approval, proceeds to implement 
those proposed actions in accordance with the procedures in the 
regulation. Accordingly, the definition of, and references to the term 
``deciding official'' have been deleted. Giving ORI the responsibility 
for making findings of research misconduct is consistent with its 
responsibilities for reviewing institutional findings of research 
misconduct and for defending those findings if the respondent 
challenges them. This change will maintain the separation between 
investigation and adjudication, because ORI will not conduct any 
inquiry or investigation on behalf of HHS.
    These changes have necessitated changing references to HHS and ORI 
and other clarifying changes in Secs. 93.403-406, 93.411, 93.500-501, 
93.503, and 93.516-517. As provided in Sec.

[[Page 28376]]

93.406, the ORI finding of research misconduct is the final HHS action 
only if the respondent does not contest the charge letter within the 
prescribed period. The administrative actions, proposed by ORI and 
approved by HHS, become final in the same manner, except that the 
debarring official's decision is the final HHS action on any debarment 
or suspension action.

C. Definition of Good Faith, Sec. 93.210

    Under Secs. 93.227 and 93.300(d), committee members are protected 
against retaliation for good faith cooperation with a research 
misconduct proceeding. As proposed, Sec. 93.211 (now Sec. 93.210) 
defined ``good faith'' for complainants and witnesses, but not for 
committee members. We have added such a definition, stating that a 
committee member acts in good faith if he/she cooperates with the 
research misconduct proceeding by carrying out the duties assigned 
impartially for the purpose of helping an institution meet its 
responsibilities under this regulation. A committee member does not act 
in good faith if his/her acts or omissions on the committee are 
dishonest or influenced by personal, professional, or financial 
conflicts of interest with those involved in the research misconduct 
proceeding.

D. Definition of Institutional Member, Sec. 93.214

    We have added more examples of institutional members.

E. Institutional Policies and Procedures--Reporting the Opening of an 
Investigation, Sec. 93.304(d)

    We have simplified the date for institutions to report the opening 
of investigations to ORI. This report must be made on or before the 
date on which the investigation begins. Institutions are encouraged to 
report the opening of an investigation to ORI as promptly as possible 
after the decision to open an investigation is made.

F. Taking Custody of and Securing Records at the Beginning of an 
Inquiry, Sec. 93.307(b)

    We have added a requirement that on or before the date on which the 
respondent is notified of the inquiry, or the inquiry begins, whichever 
is earlier, the institution must, to the extent it has not already done 
so, 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. This is consistent with the 
identical requirements that become applicable when the institution 
notifies the respondent of the allegation and when the respondent is 
notified of an investigation. (Secs. 93.305(a) and 93.310(d)). These 
requirements are necessary because of the potential for the destruction 
or alteration of the research records. To minimize that potential, an 
institution should take custody of the records whenever it has reason 
to believe that the records may be subject to alteration or destruction 
because of an allegation or potential allegation of research 
misconduct. This may protect the respondent, as well as the 
institution.

G. Interaction With Other Offices, Sec. 93.401

    To accurately reflect ORI's authority and practices, we have 
expanded this section to authorize ORI to provide expertise and 
assistance to the Department of Justice, the HHS Inspector General, PHS 
and other Federal offices, and State or local offices involved in 
investigating or otherwise pursuing research misconduct allegations or 
related matters.

H. Procedures for Debarment or Suspension Actions Based on Misconduct 
Findings, Secs. 93.405, 93.500-501, 93.503 and 93.523.

    We have amended these sections to clarify the relationship between 
the regulations governing debarment and suspension and the procedures 
in subpart E for contesting ORI findings of research misconduct and 
proposed HHS administrative actions. Section 93.500(d) (comparable to 
Sec. 93.500(c) of the NPRM) explains that the procedures under subpart 
E provide the notification, opportunity to contest and fact finding 
required under the HHS regulation governing debarment and suspension. 
Consistent with that regulation, the debarring official provides 
notification of the proposed debarment or suspension as part of the 
charge letter (Sec. 93.405(a)) and makes the final decision on 
debarment and suspension actions whether that decision is based upon 
respondent's failure to contest the charge letter (Secs. 93.406, 
93.501(a) and 93.503(c)), the decision of the ALJ, or the decision of 
the ALJ as modified by the Assistant Secretary for Health (Secs. 
93.500(c) and 93.523(b) and (c)).

I. HHS Administrative Action--Recovery of Funds, Sec. 93.407(b)

    We have clarified what funds HHS may seek to recover in connection 
with a finding of research misconduct by amending Sec. 93.407(b) to 
refer to the potential recovery of PHS funds spent in support of 
activities that involved research misconduct.

J. Appointment of the ALJ--Description of Functions, Sec. 93.502(a)

    We have amended Sec. 93.502(a) to describe the functions of the ALJ 
more completely.

K. Limits on the Authority of the ALJ, Sec. 93.506(a) and (c)

    We have added references in Secs. 93.506(a) and (c) stating that 
the ALJ does not have the authority to find invalid or refuse to follow 
Federal statutes or regulations, Secretarial delegations of authority, 
or HHS policies. This is consistent with a similar provision in the 
regulation upon which the research misconduct hearing process is based, 
42 CFR part 1005, which governs the hearing process for OIG exclusion 
of health care providers.

L. Actions for Violating an Order or Disruptive Conduct, Sec. 
93.515(b)(6)

    We have changed ``taking a negative inference from the absence of 
research records, documents, or other information'' to ``drawing the 
inference that spoliated evidence was unfavorable to the party 
responsible for its spoliation.'' This change is intended to clarify 
the nature of the negative inference that may be reached by the ALJ and 
distinguish the spoliation of evidence during or in anticipation of the 
hearing, from the absence or destruction of records that may be 
evidence of research misconduct. In this context, spoliation has 
essentially the same meaning as is accepted by Federal courts, i.e., 
the destruction or significant alteration of evidence during or in 
anticipation of the hearing.

M. Corrections and Minor Changes

    In addition to the significant changes not based on comments 
described above, we have made changes to: (1) Correct errors, such as 
references to PHS rather than HHS, or to a hearing officer, rather than 
the ALJ; (2) use uniform language in describing the same condition or 
event in different sections of the regulation; (3) adding citations to 
other sections, where appropriate, to make cross-references more 
concise and

[[Page 28377]]

technically correct; and (4) use plain, and more precise language.

III. Significant Comments Not Resulting in Changes

A. Definition of Research Misconduct, Sec. 93.103

    Although most commentators supported the new definition of research 
misconduct, there were a number of comments recommending changes, 
including that: (1) The definition should be based on deception; (2) 
the definition of falsification is inadequate because it does not cover 
the nonexperimental manipulation of human or animal subjects with the 
goal of influencing research results, or bias in the coding of 
qualitative data; (3) the definition of plagiarism should expressly 
exclude authorship and credit disputes; and (4) the definition of 
misconduct should be expanded to include negligent and intentional 
mistreatment of animals.
    As explained in the preamble of the NPRM, the proposed definition 
of research misconduct, which is included in this final rule without 
change, includes OSTP's description of ``fabrication, falsification, 
and plagiarism.'' That description is clear and sufficiently concrete 
to provide the basis for reasonable determinations of whether research 
misconduct has occurred and whether the misconduct was intentional, 
knowing, or reckless. Given the careful consideration that has been 
given to this definition and the value of a uniform government-wide 
definition, we are adopting the definition as it was proposed. We note 
that the nonexperimental manipulation of human or animal subjects to 
influence the research results would appear to be a manipulation of 
research materials or processes within the intendment of the definition 
of falsification.

B. Confidentiality, Secs. 93.108, 93.300(e) and 93.304(a)

    Several commentators recommended including witnesses and committee 
members and strengthening the confidentiality protections to provide 
the same protections as the OSTP Policy. Other commentators recommended 
that: (1) The rule give examples of what disclosures are limited and 
state when an institution is free to announce the results of an 
investigation to scientific journals; (2) the identity of the 
complainant and his/her statement be disclosed to the respondent; and 
(3) that the sanctions for a violation of confidentiality be specified.
    We have not changed Sec. 93.108 or the other provisions requiring 
institutions to provide confidentiality to respondents, complainants, 
and research subjects who are identifiable from research records or 
evidence. We believe these provisions provide the same protections as 
the OSTP policy. Institutions have considerable discretion in 
implementing the confidentiality protections and are free to extend 
them to witnesses and committee members. However, consistent with the 
limitation of the OSTP confidentiality provision to complainants and 
respondents, we are not requiring that they do so.

C. Definition of Allegation--Inclusion of Oral Allegations, Sec. 93.201

    Several commentators objected to the inclusion of oral allegations 
in the definition of the term ``allegation.'' Although, the current PHS 
regulation at 42 CFR part 50, subpart A, does not define the term 
allegation, it has been longstanding ORI practice to accept oral 
allegations, including oral, anonymous allegations. Experience has 
shown that oral allegations may contain relatively complete 
information, but if they do not, they are often followed by more 
complete allegations, or lead to more complete information.
    The definition of allegation must be considered in the context of 
the criteria warranting an inquiry. Under Sec. 93.307(a), an inquiry is 
warranted if the allegation: (1) Falls within the definition of 
research misconduct; (2) involves PHS supported biomedical or 
behavioral research, research training, or activities related to that 
research or research training; and (3) is sufficiently credible and 
specific so that potential evidence of research misconduct may be 
identified. Information sufficient to make these determinations can be 
transmitted orally. If such information is not transmitted orally or by 
other means, the institution cannot initiate an inquiry based upon the 
oral allegation. Under Sec. 93.300(b), an institution is obligated to 
respond to each allegation of research misconduct involving PHS 
supported biomedical or behavioral research, research training or 
activities related to that research or research training. The response 
must consist of assessing the allegation to determine if the criteria 
for initiating an inquiry are met and should consist of reasonable 
efforts to obtain further information about the allegation. We do not 
believe these are unreasonable burdens in response to oral allegations, 
particularly since oral allegations can, and have conveyed information 
leading to findings of research misconduct that have protected the 
integrity of PHS supported research. We also note that the Offices of 
the Inspector General at various Federal agencies routinely accept oral 
and anonymous allegations in their pursuit of fraud, waste, and abuse.

D. Definition of Research Record, Sec. 93.226

    We did not make any changes in this section in response to comments 
that the inclusion of oral presentations will inhibit open scientific 
discourse and objections to the interpretation of ``data and results'' 
to include computers and scientific equipment. The definition of 
``research record'' is consistent with the definition of that term in 
the OSTP Policy. Oral presentations are a widely accepted method of 
conveying scientific information and research results. There is no 
logical reason why scientists should be permitted to falsify, 
fabricate, and plagiarize PHS supported biomedical and behavioral 
research, research training and activities related to that research and 
research training in oral presentations. The interpretation of the OSTP 
definition to include computers and scientific instruments is 
reasonable and consistent with the wording of the definition. 
Laboratory records, ``both physical and electronic,'' are covered in 
the OSTP definition. Computers and scientific instruments contain 
electronic records. As explained above, we have made changes to clarify 
that if those electronic records can be extracted from the computer or 
instrument without change and recorded for later use, the computer or 
instrument need not be retained as the repository of the record.

E. Definition of Retaliation, Sec. 93.226; Protection From Retaliation 
Secs. 93.300(d) and 93.304(l)

    One commentator recommended that the definition be amended to 
include retaliation against the respondent for his/her efforts to 
defend against the charges of research misconduct. The proposed 
definition would not include action resulting from research misconduct 
proceedings or personnel actions. It was also recommended that Secs. 
93.300(d) and 93.304(l) be amended to require institutions to protect 
respondents from retaliation by referring to ``all participants.''
    The purpose of the retaliation provision is to encourage 
researchers to come forward with good faith allegations of research 
misconduct and to encourage good faith cooperation with a research 
misconduct proceeding. In ORI's experience, there has been no showing 
of a need to protect

[[Page 28378]]

respondents from retaliation in order to ensure they will take steps to 
defend against an allegation of misconduct. In contrast, experience has 
shown a need to restore the reputations of respondents where there is a 
finding of no misconduct and Sec. 93.304(k) requires institutions to do 
that. If a need to protect respondents from retaliation is shown, 
institutions have broad discretion under the rule to address that 
situation on a case-by-case basis or adopt a policy to remedy the 
problem.

F. Responsibility of Institutions To Foster Responsible Conduct of 
Research, Sec. 93.300(c)

    Several commentators objected to the requirement that institutions 
foster a research environment that promotes the responsible conduct of 
research, arguing that it is beyond the scope of a regulation on 
research misconduct. One letter, signed by four separate organizations, 
stated: ``Though responsible conduct of research is clearly an 
imperative that our institutions embrace, the nature of the general 
research environment and the promotion of the responsible conduct of 
research are not tied only to research misconduct as ORI staff have 
asserted in many venues, and, as a consequence, should not be linked in 
this particular policy.''
    These commentators are reading too much into this provision. This 
is not a requirement for institutions to establish a new program for 
the responsible conduct of research. Rather, this provision 
appropriately updates the language of the current regulation requiring 
institutions to foster a research environment that discourages 
misconduct in all research and deals forthrightly with possible 
misconduct associated with research for which PHS funds have been 
provided or requested (42 CFR 50.105). The new provision recognizes the 
continuing importance of the responsible conduct of research to 
competent research that is free of any research misconduct. As stated 
by the Institute of Medicine (IOM) in its 2002 report, Integrity in 
Scientific Research: Creating an Environment That Promotes Responsible 
Conduct, ``instruction in the responsible conduct of research need not 
be driven by federal mandates, for it derives from a premise 
fundamental to doing science: the responsible conduct of research is 
not distinct from research; on the contrary, competency in research 
encompasses the responsible conduct of that research and the capacity 
for ethical decisionmaking.'' (Report at p. 9). In the context of this 
regulation, the directive in Sec. 93.300(c) to foster a research 
environment that promotes the responsible conduct of research means an 
environment that promotes competent, ethical research that is free of 
misconduct. This is directly related to the purposes of the regulation 
to establish the responsibilities of institutions in responding to 
research misconduct issues and to promote the integrity of PHS 
supported research and the research process (Sec. 93.101).

G. Responsibility for Maintenance of Research Records and Evidence, 
Sec. 93.305

    One commentator recommended that this section be amended to require 
the prompt return to the respondent of records that, upon inventory, 
are found not to be relevant to the misconduct proceeding. Paragraph 
(a) of Sec. 93.305 requires the institution to obtain custody of all 
records and evidence needed to conduct the research misconduct 
proceeding. That requirement would not extend to records that are 
reasonably determined by the institution not to be needed to conduct 
the proceeding. We believe the imposition of an affirmative duty to 
return records that are determined to be irrelevant could adversely 
affect inquiries and investigations, because experience has shown that 
research misconduct proceedings are better served by broadly securing 
all records thought to be relevant. The respondent is protected by 
paragraph (b) of Sec. 93.305 under which he/she may obtain copies of 
the records or reasonable, supervised access.

H. Institutional Inquiry--Consideration of Honest Error or Difference 
of Opinion, Sec. 93.307

    Several commentators recommended amending this section to impose an 
affirmative burden on institutions to assess whether honest error or 
difference of opinion exempts the allegation from consideration as 
research misconduct.
    As noted earlier in this supplementary information, we have 
concluded that honest error or difference of opinion is an affirmative 
defense based on the statement in the preamble of the OSTP final rule 
that institutions and agencies are not required to disprove possible 
honest error or difference of opinion in order to make a finding of 
research misconduct. However, because of the overlap between this 
affirmative defense and the responsibility of institutions and HHS to 
prove that the alleged research misconduct was committed intentionally, 
knowingly, or recklessly, evidence of honest error or difference of 
opinion is to be considered in determining whether the institutions and 
HHS have met their burden of proving that element, a prerequisite to a 
finding of research misconduct.
    Under Sec. 93.307(c), the purpose of an inquiry is to conduct an 
initial review of the evidence to determine if an investigation is 
warranted. An investigation is warranted under Sec. 93.307(d) if: (1) 
There is a reasonable basis for concluding that the allegation involves 
PHS supported research, research training, or activities related to 
that research or research training and falls within the definition of 
research misconduct, and (2) preliminary information-gathering and 
fact-findin