Title II of The Comprehensive Drug Abuse Prevention and The Public Health Service Act
42 U.S.C. § 289b, 42 U.S.C. § 299c-3, and 42 U.S.C. § 300v
- Regulations on Scientific Misconduct 42 CFR Part 93
- Protection of Human Subjects 34 CFR Part 97, 45 CFR Part 46
- Uniform administrative requirements for awards and subawards 45 CFR Part 74
- Responsible prospective contractors 45 C.F.R. Part 94
- See also Federal Whistleblower Protection Act 5 USC 1201
The Office of Research Integrity (ORI) oversees and directs Public Health Service (PHS) research integrity activities on behalf of the Secretary of Health and Human Services with the exception of the regulatory research integrity activities of the Food and Drug Administration. Extensive resources are available on the ORI web page.
Proposed New Rule on Conflict of Interest, 75 Fed. Reg. 28687, May 21, 2010
This rule proposes to amend the 1995 rules to update the conflict of interest regulations in instances where PHS funding is sought. The proposed rule would lower the threshold for investigator reporting of potential financial conflicts of interest from $10,000 to $5,000. Institutions would be required to review investigator reports of financial interests to determine whether a financial interest is related to the research for which investigators are receiving federal funding. If a conflict of interest is identified, institutions would be required to develop formal plans to manage the conflict of interest and to monitor researchers’ compliance with such plans. Institutions would also be required to report identified conflicts of interest and associated management plans to HHS, and to post information on identified financial conflicts of interest on a publicly accessible website. See the Ropes and Gray May 24, 2010 article summarizing the proposed changes in the rule.
Conflict of Interest Policy
Institutions receiving research money from the Public Health Service (PHS) must maintain and enforce a written conflict of interest policy and take steps to prevent scientific misconduct. An awardee institution must have a policy for investigating and acting on suspected or alleged misconduct. In certain situations the PHS must be immediately notified of the apparent misconduct. The conflict of interest policy must identify, evaluate and resolve conflicts of interest, and if they cannot be resolved, report them to the PHS.
Financial disclosures must be updated annually. Records of financial disclosures must be kept for three years after the expiration of an award or grant (42 C.F.R. §§ 6.04 and 6.05). The regulations on conflict of interest define and set standards for the management of financial interest that will, or may reasonably be expected to, bias a clinical research project, the evaluation of the safety or effectiveness of a drug, or a medical treatment or device. The PHS rule in this area applies to subgrants, the National Science Foundation (NSF) policy does not.
Institutional Review Board
All research involving human subjects requires the establishment of an Institutional Review Board (IRB).
An institution is eligible for PHS funding when it has an assurance on file with ORI stating that is has developed and will comply with an administrative process for responding to allegations of research misconduct in PHS-supported research that complies with the PHS regulation cited above. An institution establishes an assurance when an official signs the face-page (SF 424 (R&R) or PHS 398) of the grant application form or when the institution files a separate assurance form. Once established, institutions maintain their assurance by filing the Annual Report on Possible Research Misconduct (between January 1 and March 1 each year), submitting their policy for responding to allegations of research misconduct for review when requested by ORI, revising their policy when requested by ORI to bring the policy into compliance with the PHS regulation, and complying with the PHS regulation. See http://ori.hhs.gov/assurance/ for more.
NACUANOTE Oct. 30, 2009 on Human Stem Cell Research: 2009 NIH Guidelines
By Alexander Dreier and Robert Kenney, Hogan and Hartson
Final NIH Guidelines on Stem Cell Research: 74 Fed. Reg. 32170 (July 7, 2009)
Effective July 7, 2009. These guidelines apply to NIH funded stem cell research.
Advance Notice of Proposed Rulemaking, 74 Fed. Reg. 21610, May 8, 2009
Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding Is Sought and Responsible Prospective Contractors; Request for Comments; Comments due by July 7, 2009. Recognition of the growing complexity of biomedical research, the increased interaction between Government and the private sector in meeting common public health goals, and recent public scrutiny have raised the question of whether a more rigorous approach to Investigator disclosure, management of conflicts, and Federal oversight is required. The possibilty of more comprehensive guidelines based upon five listed principles is being explored. See the AAU and AAMC June 10, 2009 letter to NIH on the Advance Notice of Proposed Rulemaking.
NIH Grants Policy Statement
The NIH page on the Policy Statement addresses conflict of interest as it relates to grant supported activities. Except as provided below, NIH does not require a grantee to establish separate standards of conduct if it maintains such standards for its non-grant-supported activities, as long as those standards are consistent with State and local laws and cover, at a minimum, expected conduct in regard to financial interests, gifts, gratuities and favors, nepotism, and such other areas as political participation and bribery. At a minimum, a school's policies must do the following:
- Address the conditions under which outside activities, relationships, or financial interests are proper or improper
- Provide for advance notification of outside activities, relationships, or financial interests to a responsible institutional official
- Include a process for notification and review by the responsible official of potential or actual violations of the standards
- Specify the nature of penalties that the grantee may impose. These penalties would be in addition to any penalties that may be imposed by NIH or a cognizant Federal agency for infractions that also violate the terms or conditions of award
HHS Inspector General Report on Conflicts of Intersest in Extramural Research (January 2008)
This report issued by the Office of the Inspector General of the Dept. of Health and Human Services covers NIH (National Institute of Health) oversight of grantee institutions. The report found that NIH could not provide an accurate count of the financial conflict of interest reports it received from grantees during years 2004-06; NIH was not aware of the types of financial conflicts of interest that exist within grantee institutions because details are not required to be reported; and also that many institutes relied upon good faith of the grantee institutions. The report recommended that NIH take a more active oversight role.
Recission of the Regulation Entitled Ensuring That Department of Health and Human Services Funds Do Not Support Coercive or Discriminatory Policies or Practices in Violation of Federal Law, Proposed Rule on Conscience Clause 74 Fed. Reg. 10207 March 10, 2009
The proposed rule would rescind the Department's Provider Conscience Regulation issued on December 19, 2008 at 73 Fed. Reg. 78071 and made effective January 20, 2009. The Provider Conscience regulation was designed to implement the provisions of several "provider conscience" statutes enacted by Congress over the past three decades: The Church Amendments (42 U.S.C. § 300a-7), Public Health Service (PHS) Act §245 (42 U.S.C. § 238n), and the Weldon Amendment (Consolidated Appropriations Act, 2008, Pub. L. No. 110-161, § 508(d), 121 Stat. 1844, 2209). Comments on the proposed recission are due by April 9, 2009. Note that the underlying laws are not affected. This proposed rule, if adopted would only repeal the requirement for an additional certification which would include a reference to the nondiscrimination provisions contained in the Church Amendments, PHS Act Sec. 245, and the Weldon Amendment in certifications currently required of most existing and potential recipients of Department funds.
Draft OIG Compliance Program Guidance for Recipients of PHS Research Awards, 70 Fed. Reg. 71312, Nov. 28, 2005
This draft guidance focuses on statutes, regulations, and other program requirements that affect the allowability of costs and whether awardees should be subjected to a disallowance action, or an investigation for civil or criminal fraud. Through this draft compliance document, the Office of Inspector General of HHS also sets forth its general views on the value and fundamental principles of compliance programs for colleges and universities and other recipients of PHS awards (including NIH funds) for biomedical and behavioral research. Eight basic elements of a compliance program are set forth:
- Implementing written policies and procedures
- Designating a compliance officer and compliance committee
- Conducting effective training and education
- Developing effective lines of communication
- Conducting internal monitoring and auditing
- Enforcing standards through well-publicized disciplinary guidelines
- Responding promptly to detected problems and undertaking corrective action
- Defining roles and responsibilities and assigning oversight responsibility
OIG has identified three major potential areas of risk for NIH research award recipients:
Time and effort reporting; properly allocating charges to award projects and reporting of financial support from other sources.
Note that this draft guidance is not mandatory, but rather addresses voluntary compliance programs. This guidance will assist schools in evaluating and refining existing compliance programs. A helpful bibliography of resources is also contained in this document. One resource that is available online for free is the Council on Governmental Relations, Managing Externally Funded Research Programs: A Guide to Effective Management Practices (June 2005). See also Grants Compliance and Oversight on the NIH Office of Extramural Research Page.
Policies on Research Misconduct; Final Rule, 70 Fed. Reg. 28369 (May 17, 2005)
These are the final rules published by HHS on how universities investigate research misconduct. The new regulations (42 CFR part 93) replace 42 CFR part 50, subpart A. The rule is effective June 16, 2005, and covers research and training funded by the PHS, which includes the NIH and the FDA. The rule applies to each institution that applies for, or receives, PHS support for biomedical or behavioral research. It also extends HHS jurisdiction to researchers and research reviewers accused of plagiarism.
Part 93 does away with the previous use of a rebuttable presumption of guilt when an accused researcher fails to produce documents in defense of an allegation of misconduct. In contrast, the new regulations require the institution to prove guilt by a preponderance of the evidence, making a showing that the accused researcher intentionally, knowingly, or recklessly committed the misconduct and that the misconduct was not the result of an honest mistake. The new regulations also clarify many terms used in the old part 50, subpart A. For example, a research record now includes scientific instruments capable of retaining a physical or electronic record of data or results. Additionally, part 93 clarifies the actual format of a misconduct proceeding including the appointing of expert witnesses and the appeals process.
Complying with the NIH Public Access Policy-Copyright Considerations and Options:
SPARC/Science Commons/ARL white Paper by Michael W. Carroll; Feb. 2008: The paper notes as follows on two new mandates effective April 7, 2008 for schools:
First, the grantee must ensure proper manuscript submission. ***Second, the grantee also has a distinct obligation to grant NIH copyright permission to make the manuscript publicly accessible through PMC not later than 12 months after the date of publication. This obligation is connected to manuscript submission because the author, or the person submitting the manuscript on the author’s behalf, must have the necessary rights under copyright at the time of submission to give NIH the copyright permission it requires.
The white paper analyzes the second requirement and suggests options for compliance.
Revised Policy On Enhancing Public Access to Archived Publications Resulting from NIH-Funded Research:
Released Jan. 11, 2008, effective April 7, 2008 Now mandatory:
The Director of the National Institutes of Health shall require that all investigators funded by the NIH submit or have submitted for them to the National Library of Medicine’s PubMed Central an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication: Provided, That the NIH shall implement the public access policy in a manner consistent with copyright law.
NIH Open Access Mandate: A Careful Look at Two Options by Georgia Harper:
Contains sample text for compliance
PHS Policy on Responsible Conduct of Research
On December 1, 2000, the Office of Research Integrity (ORI) of the Department of Health and Human Services issued the PHS Policy on Instruction in the Responsible Conduct of Research (RCR). In February 2001 the RCR Policy was suspended by DHSS in response to a congressional inquiry requesting review of the substance of the policy and the process followed in its adoption. Congress questioned whether the requirements of the Policy should have been processed as a proposed regulation rather than as a Policy. DHHS issued a response providing what it believed was existing statutory support for its issuance of the Policy. Nevertheless, ORI strongly encourages institutions to develop and implement education plans for RCR. Per an ORI attorney the RCR Policy is likely to be reissued in a new form, not yet determined (e.g. as a regulation, voluntary document, or grant condition). It is unclear whether the content of the new Policy will be identical to that of the original Policy. One way to follow this subject is to sign up for the listserv administered through the NIH server and managed by ORI. Members may use the listserve to exchange ideas and strategies for developing RCR educational programs and materials, share information about existing educational resources, and discuss general issues concerning the responsible conduct of research.
Under the currently suspended policy, each institution that applies for or receives PHS funds for research or research training must assure that:
- The institution has a program of instruction in compliance with the policy and a written description documenting the program, including how the institution plans to document completion of RCR instruction by its research staff. ORI may ask for this description of the RCR program at any time.
- The institution will make the program description available to research staff at the institution and to others who work on PHS supported research.
- The institution will carry out its program of instruction.
- Implementation of the institution’s program of instruction for existing staff would have to have been completed by October 1, 2003.
Form PHS 398, the grant application, and Form 6349, the Annual Report on Possible Research Misconduct, will be the vehicles by which this assurance is provided to the ORI.
Under the proposed regulation regulation, all research staff at the institution must have received a course of instruction, and all new research staff beginning work after October 1, 2003, must have received instruction on RCR prior to working on a research project. It is up to the institution to determine which research staff fall under the policy. A definition of "research staff" is provided in the policy. The policy pertains to all research, including animal, human, and basic research, or research training, conducted with grant, contract or cooperative agreement support from any agency or office of the PHS.
The program of instruction may be provided by a self-study guide, a lecture, a formal course, a workshop or seminar, making a presentation, working through a CD-ROM or Internet program, leading or participating in a discussion of case studies, or participating in any other educational activity consistent with the policy.
Nine core instructional areas are specified for training, and it is up to the institution to determine which core areas are applicable to which staff. The nine core areas are:
- data acquisition, management, sharing and ownership
- mentor/trainee responsibilities
- publication practices and responsible authorship
- peer review
- collaborative science
- human subjects
- research involving animals
- research misconduct
- conflict of interest and commitment
Once the PHS Policy on Instruction in the Responsible Conduct of Research is fully implemented, it will supersede the October 1, 2000 NIH policy on protection of human subjects for purpose of this core requirement. A future announcement will clarify timing on this. See Bioethics Resources on the Web.
Federal Policy on Research Misconduct
On December 6, 2000, the Office of Science and Technology Policy issued the final version of the Federal Policy on Research Misconduct. The policy applies to research supported by the federal government and performed at research institutions, as well as to research conducted by federal agencies. Under the final policy, research misconduct is defined as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.
The policy is limited to addressing misconduct related to the conduct and reporting of research, as distinct from misconduct that occurs in the research setting but does not affect the integrity of the research record. Thus, falsification of data would be covered by this policy, but misallocation of funds would not. The standard of proof will be a preponderance of the evidence. In most cases, federal agencies will rely on the researcher’s home institution to make the initial response to allegations of research misconduct. Research institutions will notify the funding agency (or agencies) of an allegation of research misconduct if: (1) the allegation involves federally-funded research (or an application for federal funding); (2) it meets the federal definition of research misconduct given above; and (3) the institution's inquiry into the allegation determines there is sufficient evidence to proceed to an investigation. When an investigation is complete, the research institution will forward to the agency a copy of the evidentiary record, the investigative report, recommendations made to the institution's adjudicating official, and the subject's written response to the recommendations (if any). When a research institution completes the adjudication phase, it will forward the adjudicating official's decision and notify the agency of any corrective actions taken or planned.
Immediate notification of the funding agency is required under the following circumstances:
- public health or safety is at risk
- agency resources or interests are threatened
- research activities should be suspended
- possible violations of the law
- federal action required to protect the interests of those involved in the investigation
- the research institution believes the inquiry or investigation may be made public prematurely (and the agency needs to take steps to safeguard evidence, etc.)
- the research community or the public should be informed
The federal agency will make the final decision about whether to make an agency finding of research misconduct.
NIH Policy for Required Education for the Protection of Human Research Participants
DHHS's basic policy for the protection of HRP is codified at 45 CFR § 46.101, et. seq.
See June 5, 2000 NIH Notice on Required Education for the Protection of Human Research Participants, follwed up by a September 5, 2001 notice clarifying that the signature of the the official representing the institution need not by accompanied by the PI's signature when documenting completion of the education by key personnel.