Government Documents: Responsible Conduct of Research

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.

This section of the Code of Federal Regulations, entitled "Research Institutions Conducting USDA-Funded Extramural Research; Research Misconducts" includes the direction: "Research institutions that conduct extramural research funded by USDA must foster an atmosphere conducive to research integrity."

Changes in the 2019 edition of the Proposal and Award Policies and Procedures Guide include: "Chapter IX.B, Responsible Conduct of Research (RCR), has been supplemented with language encouraging the training of faculty in the responsible and ethical conduct of research" and "Chapter IX.B, Responsible Conduct of Research (RCR), has been supplemented with new coverage to state NSF’s responsibility regarding allegations of research misconduct."

The Office of Research Integrity (ORI) announces the opportunity for non-federal public and private sector entities to co-sponsor ORI conferences or workshops (ORI Workshops). Potential co-sponsors must have a demonstrated interest and experience in the responsible conduct of research (RCR) or the handling of research misconduct allegations. Potential co-sponsors must be willing to participate substantively in the co-sponsored activity.

Portions regarding Responsible Conduct in Research remain unchanged from 2017

The language of this section of the United States Code codifies that of P.L. 110-69 Section 7009 (below)

In 2007, Congress passed the America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science Act (America COMPETES Act),1 which among other things directed NSF to introduce a requirement for awardees to provide adequate training for undergraduate students, graduate students, and postdoctoral researchers about the Responsible Conduct of Research (RCR). In 2013, 3 years after NSF’s implementation of the Act, we contacted 53 institutions to learn how they had implemented their own RCR training in response to NSF’s requirement. We requested and reviewed institutions’ RCR plans and asked a variety of questions of institutional officials and RCR trainees about the institutional plans, such as who gets trained, the format of the training, and the training’s content.

The Office of Research Integrity (ORI) announces the award of a single-source, grant in response to an unsolicited proposal from Washington University, St. Louis, Missouri. The proposal submitted was not solicited either formally or informally by any federal government official. ORI performed an objective review of the unsolicited proposal from Washington University to expand and evaluate the Professionalism and Integrity in Research Program (PI Program), the only remediation program for researchers who violate expectations for the responsible conduct of research. Based on an external and internal review of the proposal, ORI determined that it has merit.

The previously two-volume set was combined with the chapters renumbered appropriately, but portions regarding Responsible Conduct in Research remain unchanged from 2016

This Notice revises NOT-OD-10-019 (see below) to indicate the currently active websites for resources on the responsible conduct of research.

Finalized the joint interim final rule announced in 79 FR 75992 (see below) with no relevant changes

Portions regarding Responsible Conduct in Research remain unchanged from 2015

Portions regarding Responsible Conduct in Research remain unchanged from 2014

This Federal Register joint interim final rule announcement indicates the creation of a new Code of Federal Regulations section, 2 CFR 422, entitled "Research Institutions Conducting USDA-Funded Extramural Research; Research Misconducts" (see above)

Portions regarding Responsible Conduct in Research remain unchanged from 2013

Portions regarding Responsible Conduct in Research remain unchanged from 2011 (There was no 2012 edition)

The purpose of this Notice is to update NIH policy on instruction in the responsible conduct of research, convey some of the consensus best practices that have evolved in the research training community over the past two decades, and to provide access to additional information that may be useful to institutions and individuals in meeting their obligations under NIH policy.

Portions regarding Responsible Conduct in Research remain unchanged from 2010

Changes from the 2009 edition include: Grant Proposal Guide Chapter II.C.1.e, Proposal Certifications, has an entirely new proposal certification added regarding responsible conduct of research. When submitting a proposal to NSF, the Authorized Organizational Representative is required to complete a certification that the institution has a plan to provide appropriate training and oversight in the responsible and ethical conduct of research to undergraduates, graduate students, and postdoctoral researchers who will be supported by NSF to conduct research. While training plans are not required to be included in proposals submitted to NSF, institutions are advised that they are subject to review upon request. Award and Administration Guide Chapter IV.B, Responsible Conduct of Research, is another new section that provides NSF’s implementation of Section 7009 of the America COMPETES Act regarding responsible conduct of research (RCR). Institutions must have a plan in place to provide appropriate training and oversight in the responsible and ethical conduct of research to undergraduates, graduate students, and postdoctoral researchers who will be supported by NSF to conduct research. Institutions must designate one or more persons to oversee compliance with the RCR training requirement and must verify that appropriate training was provided.

This Federal Register announcement indicates that the National Science Foundation (NSF) has implemented "Section 7009 of the America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science (COMPETES) Act (42 U.S.C. 1862o-1). This section of the Act requires that “each institution that applies for financial assistance from the Foundation for science and engineering research or education describe in its grant proposal a plan to provide appropriate training and oversight in the responsible and ethical conduct of research to undergraduate students, graduate students, and postdoctoral researchers participating in the proposed research project.”

The National Science Foundation (NSF) solicited public comment on the agency's proposed implementation of Section 7009 of the America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science (COMPETES) Act (42 U.S.C. 1862o-1). (See 74 FR 42126, above)

Section 7009 of the America COMPETES Act, entitled "Responsible Conduct of Research", directs the Director of NSF to ensure that "each institution that applies for financial assistance from the Foundation for science and engineering research or education describe in its grant proposal a plan to provide appropriate training and oversight in the responsible and ethical conduct of research to undergraduate students, graduate students, and postdoctoral researchers participating in the proposed research project."

The conferees recognize that what constitutes "appropriate training" may not be the same for undergraduate students as for graduate students or postdocs. The conferees prefer to give NSF maximum flexibility in determining the full range of activities that would constitute appropriate training; however, the conferees do expect NSF to promptly develop and provide written guidelines and/or templates for universities to follow so that compliance can be verified by all parties. The conferees intend for NSF, when developing guidelines, to consider the financial impact that these measures will have on institutions and seek to minimize such impacts accordingly.

As part of its efforts to promote integrity in PHS-funded research, ORI is authorized to undertake activities and to support programs that enhance education in the responsible conduct of research (RCR). The ORI Introduction to the Responsible Conduct of Research is being issued to further this important mission.

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 Department proposes substantial revisions to the existing regulation at 42 CFR part 50, subpart A, “Responsibilities of Awardee and Applicant Institutions for Dealing With and Reporting Possible Misconduct in Science,” 54 FR 32446 (Aug. 8, 1989) (final rule). We propose to delete this regulation, which implemented section 493 of the PHS Act, and add a new part 93, subparts A, B, C, D, and E. The purpose of this proposed rule is to implement legislative and policy changes that have occurred since the regulation was issued, including the common Federal policies and procedures on research misconduct issued by the Office of Science and Technology Policy. We have developed the proposed changes based on over 12 years of experience with the existing final rule.

As part of its efforts to promote integrity in PHS-funded research, ORI is authorized to undertake activities and to support programs that enhance education in the responsible conduct of research (RCR). The ORI Introduction to the Responsible Conduct of Research is being issued to further this important mission.

On December 7, 2000, the Office of Research Integrity (ORI), in collaboration with each of the Public Health Service (PHS) Operating Divisions, announced in the Federal Register the issuance of a Final Policy on Instruction in the Responsible Conduct of Research. 65 FR 76647. A Draft PHS Policy on Instruction in the Responsible Conduct of Research was announced in the Federal Register on July 21, 2000, and made available for public comment until September 21, 2000. In response to the public comment, ORI and the PHS agencies made substantial revisions to the draft policy before its issuance in final form. Consistent with the President's January 20, 2001, Regulatory Review Plan, on behalf of PHS, ORI hereby suspends implementation of the “PHS Policy on Instruction in the Responsible Conduct of Research” to permit additional review both of the substance of the policy and the process for adoption. Pending completion of that review, institutions that might otherwise be subject to the RCR policy are under no obligation to implement the policy unless further public notice is issued in the Federal Register. Any future PHS action taken to implement the RCR policy would provide extended implementation time frames that take into consideration this suspension.

Memorandum for the Heads and Acting Heads of Executive Departments and Agencies: Subject: Regulatory Review Plan

In response to public comment, ORI and the PHS agencies have made substantial revisions to the draft policy and hereby announce the final “PHS Policy on Instruction in the Responsible Conduct of Research.”

Research misconduct is defined as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.

Shortly thereafter suspended at behest of incoming Bush administration per their Regulatory Review Plan. Still suspended

The Office of Research Integrity (ORI) in collaboration with the Agency Research Integrity Liaison Officers for each of the PHS Operating Divisions, announced on July 21, 2000, (65 Fed. Reg. 45381) the availability for public comment of a new Draft PHS Policy for Instruction in the Responsible Conduct of Research for extramural institutions receiving PHS funds for research or research training. This comment period is being extended until September 21, 2000.

The Office of Research Integrity (ORI) in collaboration with the Agency Research Integrity Liaison Officers for each of the PHS Operating Divisions, is announcing the availability for public comment of a new draft PHS Policy for Instruction in the Responsible Conduct of Research for extramural institutions receiving PHS funds for research or research training.

On behalf of the Commission on Research Integrity, I am pleased to transmit our final report and recommendations: Integrity and Misconduct in Research. The Commission's mandate was established in Section 162 of Public Law 103-43, the NIH Revitalization Act of 1993, in reaction to continuing misconduct in research and retaliation against whistleblowers in spite of federal regulations existing since 1989 and more than a dozen congressional hearings. According to the Commission charter, we were asked to consider: a new definition of research misconduct; an assurance process for institutional compliance with HHS regulation; mechanisms by which to respond to and oversee related administrative functions and investigations; and development of a regulation to protect whistleblowers.

An in depth description of characteristics of acceptable Responsible Conduct of Research plans, and explicit requirement for one.

The Office of Research Integrity (ORI) is publishing the revised Guidelines for Hearings Before the Research Integrity Adjudications Panel of the Departmental Appeals Board (DAB). Publication is intended to provide notice to the scientific community and the general public of the procedures followed by the DAB, based on their experience and applicable legal principles, on conducting hearings on ORI findings of scientific misconduct. These hearings are provided upon the request of the accused scientist and are made available for scientists who receive or apply for Public Health Service (PHS) support under grants, contracts, or cooperative agreements or who conduct research in PHS laboratories. The availability of hearings was first announced by ORI in November 1992. See 57 FR 53125, Nov. 6, 1992. These Guidelines were revised by the DAB on May 5, 1994, and will apply to any request for a hearing that occurs after the date of publication.

Sec. 161 of the National Institutes of Health Revitalization Act of 1993 establishes the Office of Research Integrity as an independent entity in the Department of Health and Human Services. Requires grant, contract, or cooperative agreement applicants to have a process to review and report allegations of research misconduct. Establishes the Commission on Research Integrity.

The PHS published in the Federal Register its proposed Policies and Procedures for Dealing With Possible Scientific Misconduct in Extramural Research for public comment on June 13, 1991. 56 FR 27384. Based on those comments and input received from the PHS Advisory Committee on Scientific Integrity, PHS has decided to offer an administrative hearing to each person where the ORI has made a finding of scientific misconduct involving research, research training, or research related activities which involve PHS funds or applications for PHS funds.

Announces the abolition of the Office of Scientific Integrity in the Office of the Director, NIH. Creates the Office of Research Integrity, with a Division of Policy and a Division of Research Integrity Assurance. Abolishes the Office of Scientific Integrity Review

Pursuant to Public Law 92-463, notice is hereby given of the meeting of the Advisory Committee on Scientific Integrity, Public Health Service, on Saturday, March 7, and Sunday, March 8,1992, at the National Institutes of Health, Bethesda, Maryland. The purpose of the meeting will be to continue discussion of the June 13,1991 Federal Register Notice (56 FR 27384-94) of the PHS Policies and Procedures for Dealing With Possible Scientific Misconduct in Extramural Research and of means by which the PHS could respond to concerns voiced by the scientific community.

Pursuant to Public Law 92-463, notice is hereby given of the meeting of the Advisory Committee on Scientific Integrity, Public Health Service, on Sunday, November 17,1991 at the Hyatt Regency Cambridge in Cambridge, Massachusetts. The purpose of the meeting will be to discuss the June 13,1991 Federal Register Notice (56 FR 27384-94) Policies and Procedures for Dealing With Possible Scientific Misconduct in Extramural Research and the public’s responses, as well as develop recommendations on the policies and procedures.

The Public Health Service (PHS) is extending for 30 days the public comment period on its policies and procedures for dealing with possible scientific misconduct in extramural research. The extension is in response to several written requests for an extension of time due to the complexity of the Notice of Policies and Procedures in 56 FR 27384 (June 13,1991).

Policies and Procedures for Dealing with Possible Scientific Misconduct in Extramural Research. The Public Health Service (PHS) is announcing and seeking public comment on its policies and procedures for dealing with possible scientific misconduct in extramural research. These policies and procedures focus on the responsibilities of Federal officials and the relationships among Federal agencies that deal with possible misconduct in science.

The NIH published its first Notice of policy concerning instruction in responsible conduct of research in the NIH Guide (Volume 18; Number 45. December 22, 1989). This Notice required that institutional training grant applications include a description of activities related to instruction about responsible conduct of research.

To implement section 493 of the Public Health Service (PHS) Act (and also section 501(f) of the PHS Act as amended by section 2058(a)(2)(C) of the Anti-Drug Abuse Act of 1988), this Final Rule adds a new Subpart A to 42 CFR part 50. The new Subpart A sets forth the responsibilities of PHS awardee and applicant institutions for dealing with and reporting alleged or suspected misconduct in science involving research, research training, applications for support of research or research training, or related activities for which PHS funds have been provided or requested.

Established the Office of Scientific Integrity in NIH and the Office of Scientific Integrity Review in the Office of the Assistant Secretary of Health, both in the Public Health Service

Entitled "Misconduct in Scientific Research", this inspection was conducted to determine the extent to which the National Institutes of Health and its grantee institutions have developed and implemented policies and procedures to prevent, detect, and handle scientific misconduct, as required by the Health Research Extension Act of 1985

The forward to the ORI's Introduction to the Responsible Conduct of Research cites this report as the first explicit recognition of the importance of RCR education

To implement section 493 of the Public Health Service (PHS) Act, it is proposed to add a new Subpart A to 42 CFR Part 50. The new Subpart A sets forth the responsibilities of PHS awardee and applicant institutions for dealing with and reporting possible misconduct in science involving research, research training, or related activities for which PHS funds have been provided or requested.

The Public Health Service (PHS) seeks comments from the public on developing regulations to protect against scientific misconduct. The PHS is particularly interested in receiving comments on issues presented below from individual researchers, scientific societies and associations, independent science advisory bodies, members of Congress, other Federal agencies that support or conduct research and institutions that receive PHS funds to conduct or support biomedical or behavioral research.

Policies and Procedures for Dealing with Possible Misconduct in Science

Section 2 of the Health Research Extension Act of 1985 revised Sec. 493 of the Public Health Services Act to require of NIH grantees "an administrative process to review reports of scientific fraud in connection with biomedical and behavioral research" and to report "any investigation of alleged scientific fraud which appears substantial"

The purpose of this two-day workshop was to examine the response of research institutions and federal agencies to reports of fraud or misconduct in federally supported biomedical research and to develop suggestions for improving such responses in the future.

Hearing before Subcommittee on Investigations and Oversight of the House Committee on Science and Technology

Title III of this Act established the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research