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Research Integrity & Bioethics

Health Hippo: Research Integrity & Bioethics

Health Hippo: Research Integrity & Bioethics

US CODE || CFR || CASES || REPORTS || CONGRESSIONAL RECORD || BILLS || FEDERAL REGISTER


Into whatever houses I enter, I will go for the benefit of the sick, and will abstain from every voluntary act of mischief and corruption.

Anything of a serious or compelling nature that reflects poorly on the business integrity, honesty or responsibility of a person may result in federal government debarment, including: convictions, civil judgments, fraud, violation of antitrust laws, financial crimes, tax evasion, false claims, obstruction of justice, violation of the terms of a public agreement, doing business with an ineligible person, failure to pay a substantial debt, violation of a voluntary exclusion agreement and violation of the Drug-Free Workplace Act.

U.S.
Code

Code of Federal Regulations

  • 42 CFR PART 50 POLICIES OF GENERAL APPLICABILITY.
  • 42 CFR Part 93 PUBLIC HEALTH SERVICE POLICIES ON RESEARCH MISCONDUCT
  • 45 CFR PART 689 RESEARCH MISCONDUCT
  • 45 CFR PART 46 PROTECTION OF HUMAN SUBJECTS
  • SUBPART B FETUSES, PREGNANT WOMEN, FERTILIZATION
    • Sec. 46.201 Applicability.
    • Sec. 46.202 Definitions.
    • Sec. 46.203 Duties of IRBs in connection with research involving pregnant women, fetuses, and neonates.
    • Sec. 46.204 Research involving pregnant women or fetuses.
    • Sec. 46.205 Research involving neonates.
    • Sec. 46.206 Research involving, after delivery, the placenta, the dead fetus or fetal material.
    • Sec. 46.207 Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of pregnant women, fetuses, or neonates.
  • SUBPART C PRISONERS
  • SUBPART D CHILDREN
    • Sec. 46.401 To what do these regulations
      apply?
    • Sec. 46.402 Definitions.
    • Sec. 46.403 IRB duties.
    • Sec. 46.404 Research not involving greater than
      minimal risk
    • Sec. 46.405 Research involving
      greater than minimal risk but presenting the prospect of direct benefit to the individual subjects.
    • Sec. 46.406 Research involving greater than minimal
      risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge
      about the subject’s disorder or condition.
    • Sec. 46.407 Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.
    • Sec. 46.408 Requirements for permission by parents or
      guardians and for assent by children
    • Sec. 46.409 Wards.
  • 2 CFR PART 180 OMB GUIDELINES TO AGENCIES ON GOVERNMENTWIDE DEBARMENT AND SUSPENSION
    • Sec. 180.5 What does this part do?
    • Sec. 180.10 How is this part organized?
    • Sec. 180.15 To whom does the guidance apply?
    • Sec. 180.20 What must a Federal agency do to implement these guidelines?
    • Sec. 180.25 What must a Federal agency address in its implementation of the guidance?
    • Sec. 180.30 Where does a Federal agency implement these guidelines?
    • Sec. 180.35 By when must a Federal agency implement these guidelines?
    • Sec. 180.40 How are these guidelines maintained?
    • Sec. 180.45 Do these guidelines cover persons who are disqualified, as well as those who are excluded from nonprocurement transactions?
    • SUBPART A General (180.100 – 180.155)
    • SUBPART B Covered Transactions (180.200 – 180.225)
    • SUBPART C Responsibilities of Participants Regarding Transactions Doing Business With Other Persons (180.300 – 180.365)
    • SUBPART D Responsibilities of Federal Agency Officials Regarding Transactions (180.400 – 180.450)
    • SUBPART E Excluded Parties List System (180.500 – 180.530)
    • SUBPART F General Principles Relating to Suspension and Debarment Actions (180.600 – 180.645)
      • Sec. 180.600 How do suspension and debarment actions start?
      • Sec. 180.605 How does suspension differ from debarment?
      • Sec. 180.610 What procedures does a Federal agency use in suspension and debarment actions?
      • Sec. 180.615 How does a Federal agency notify a person of a suspension or debarment action?
      • Sec. 180.620 Do Federal agencies coordinate suspension and debarment actions?
      • Sec. 180.625 What is the scope of a suspension or debarment?
      • Sec. 180.630 May a Federal agency impute the conduct of one person to another?
      • Sec. 180.635 May a Federal agency settle a debarment or suspension action?
      • Sec. 180.640 May a settlement include a voluntary exclusion?
      • Sec. 180.645 Do other Federal agencies know if an agency agrees to a voluntary exclusion?
    • SUBPART G Suspension (180.700 – 180.760)
      • Sec. 180.700 When may the suspending official issue a suspension?
      • Sec. 180.705 What does the suspending official consider in issuing a suspension?
      • Sec. 180.710 When does a suspension take effect?
      • Sec. 180.715 What notice does the suspending official give me if I am suspended?
      • Sec. 180.720 How may I contest a suspension?
      • Sec. 180.725 How much time do I have to contest a suspension?
      • Sec. 180.730 What information must I provide to the suspending official if I contest the suspension?
      • Sec. 180.735 Under what conditions do I get an additional opportunity to challenge the facts on which the suspension is based?
      • Sec. 180.740 Are suspension proceedings formal?
      • Sec. 180.745 How is fact-finding conducted?
      • Sec. 180.750 What does the suspending official consider in deciding whether to continue or terminate my suspension?
      • Sec. 180.755 When will I know whether the suspension is continued or terminated?
      • Sec. 180.760 How long may my suspension last?
    • SUBPART H Debarment (180.800 – 180.885)
      • Sec. 180.800 What are the causes for debarment?
      • Sec. 180.805 What notice does the debarring official give me if I am proposed for debarment?
      • Sec. 180.810 When does a debarment take effect?
      • Sec. 180.815 How may I contest a proposed debarment?
      • Sec. 180.820 How much time do I have to contest a proposed debarment?
      • Sec. 180.825 What information must I provide to the debarring official if I contest the proposed debarment?
      • Sec. 180.830 Under what conditions do I get an additional opportunity to challenge the facts on which the proposed debarment is based?
      • Sec. 180.835 Are debarment proceedings formal?
      • Sec. 180.840 How is fact-finding conducted?
      • Sec. 180.845 What does the debarring official consider in deciding whether to debar me?
      • Sec. 180.850 What is the standard of proof in a debarment action?
      • Sec. 180.855 Who has the burden of proof in a debarment action?
      • Sec. 180.860 What factors may influence the debarring official’s decision?
      • Sec. 180.865 How long may my debarment last?
      • Sec. 180.870 When do I know if the debarring official debars me?
      • Sec. 180.875 May I ask the debarring official to reconsider a decision to debar me?
      • Sec. 180.880 What factors may influence the debarring official during reconsideration?
      • Sec. 180.885 May the debarring official extend a debarment?
    • SUBPART I Definitions (180.900 – 180.1020)

Cases

  • Office of Research Integrity: Misconduct Case Summaries From the agency responsible for handling allegations of misconduct and promoting integrity in PHS supported research. Includes cases of those who have currently imposed administrative actions – does not include the names of individuals whose administrative action periods have expired.
    • ORI Newsletters Includes articles, educational aids and case summaries from 1993 to the present.
  • Office for Human Research Protections (OHRP) Recent compliance oversight determinations.
  • John Hartman, D.O. (DAB 2014)(CMS lawfully revoked Petitioner’s Medicare enrollment because of his guilty plea to felony assault and because of Petitioner’s failure to report the guilty plea and judgment of guilt to CMS within 30 days of those events)
  • Salgo v. Leland Stanford 154 Cal. App. 2d 560 (1957)(physician has such discretion consistent with the full disclosure of facts necessary to an informed consent – first “informed consent” case)

Reports

  • The Lab: Avoiding Research Misconduct You become the lead character in an interactive movie and make decisions about integrity in research that can have long-term consequences. The simulation addresses Responsible Conduct of Research topics such as avoiding research misconduct, mentorship responsibilities, handling of data, responsible authorship, and questionable research practices.
  • FDA: Inspections, Compliance, Enforcement, and Criminal Investigations Manual of compliance policy guides.
  • FDA: Application Integrity Policy The AIP describes the Agency’s approach regarding the review of applications that may be affected by wrongful acts that raise significant questions regarding data reliability.
  • CMS System for Sharing Information About Terminated Providers Needs Improvement (OIG 2014) As of June 1, 2013, MCSIS contained records on terminated providers submitted by CMS and 33 State Medicaid agencies and did not contain records from the remaining State Medicaid agencies. Contrary to CMS guidance, about one-third of the 6,439 records in MCSIS did not relate to providers terminated “for cause.” Over half of MCSIS records did not contain NPIs, a critical data element for accurately identifying providers.
  • Special Advisory Bulletin: Effect of Exclusion from Participation in Federal Health Care Programs (OIG 2013) This updated Special Advisory Bulletin describes the scope and effect of the legal prohibition on payment by Federal health care programs for items or services furnished (1) by an excluded person or (2) at the medical direction or on the prescription of an excluded person.
  • Excluded Individuals Employed by Providers Enrolled in Medicaid Managed Care Entities (OIG 2012) This memorandum report provides information about Office o f Inspector General (OIG)-excluded individuals who were employed by service providers participating in 12 Medicaid managed care entities’ (MCE) provider networks in 2011. In addition, it provides information on the safeguards in place to prevent excluded individuals from being employed by providers in those networks.
  • Excluded Providers in Medicaid Managed Care Plans (OIG 2012) We recognize that the number of excluded providers that we identified is small. CMS cited the small number of providers identified as its reason for not concurring with the recommendation made in the draft report. We updated the final report, recommending that CMS periodically remind States of their obligation to ensure that no excluded providers receive Medicaid payments.
  • Biospecimen Research: Meeting Basic Human Subjects Protection Requirements and Communicating Informational Risks (OIG 2013) A biobank is a repository of biospecimens—and, in some cases, associated personally identifiable information (PII) and personal health information—to be used for research purposes. This research must comply with Federal regulations governing human subjects research.
  • Suspension And Debarment: Characteristics of Active Agency Programs and Governmentwide Oversight Efforts (GAO 2013) Spending on contracted goods and services was more than $517 billion in 2012. To protect the government’s interests, federal agencies are required to award contracts only to responsible sources. One way to protect the government’s interest is through the use of suspensions and debarments, which are actions taken to exclude firms or individuals from receiving contracts or assistance based on various types of misconduct. A suspension is a temporary disqualification from government contracting, while a debarment is an exclusion for a specified period.
  • Conflict-of-Interest Waivers Granted to HHS Employees in 2009 (OIG 2011) Waivers permit employees who have conflicts of interest to act in an official Government capacity on matters in which they would otherwise be prohibited from participating. In 2009, HHS granted 342 waivers; 334 waivers were granted to SGEs on committees.
  • Institutional Conflicts of Interest at NIH Grantees (OIG 2011) Grantee institutions consist of universities, medical schools, and other research institutions (e.g., private or nonprofit research organizations) receiving research grants from NIH. An institutional conflict may arise when an institution’s own financial interests (e.g., royalties, equity, stockholdings, and gifts) or those of its senior officials pose a risk of undue influence on decisions involving the institution’s research.
  • Suspension And Debarment: Some Agency Programs Need Greater Attention, and Governmentwide Oversight Could Be Improved (GAO 2011) The four agencies GAO reviewed with the most suspensions and debarments based on acquisition regulations shared certain characteristics that were not present at agencies with relatively few or no such cases. These agencies had staff dedicated to the suspension and debarment program, detailed implementing guidance, and practices that encourage an active referral process. The six agencies without such characteristics had virtually no suspensions or debarments, regardless of the dollar level of their contract obligations. For example, the Department of Health and Human Services, the civilian agency among those GAO reviewed with the highest amount of contract obligations, had no suspensions and debarments based on acquisition regulations.
  • Guidance for Implementing Permissive Exclusion Authority Under Section 1128(b)(15) of the Social Security Act (OIG 2010) Sets forth nonbinding factors the Office of Inspector General will consider in deciding whether to impose permissive exclusion.
  • Human Subjects Research: HHS Takes Steps to Strengthen Protections, But Concerns Remain (GAO 2001) Overall, HHS’ actions appear promising, but GAO has some concerns about the pace and scope of HHS’ efforts to ensure the safety and protection of participants in clinical trials.
  • The Globalization of Clinical Trials: A Growing Challenge in Protecting Human Subjects (OIG 2001) To document the growth of non-U.S. clinical drug trials contributing data to New Drug Applications for Food and Drug Administration (FDA) approval, and to assess FDA’s capacity to assure human subject protections in these trials.
  • Recruiting Human Subjects: Pressures in Industry-Sponsored Clinical Research (OIG 2000) To evaluate the Department of Health and Human Services’ (HHS) oversight of sponsor and investigator efforts to recruit human subjects for industry-sponsored clinical trials.
  • Recruiting Human Subjects: Sample Guidelines for Practice (OIG 2000) To identify institutional review board and professional medical association human-subject recruitment guidelines that exceed guidelines set forth by the Department of Health and Human Services.
  • FDA Oversight of Clinical Investigators (OIG 2000) To examine the Food and Drug Administration’s (FDA) selection of clinical investigators for inspection and FDA’s discipline of those clinical investigators found in violation of FDA’s regulations.
  • Protecting Human Research Subjects: Status of Recommendations (OIG 2000) In our call for widespread reform, we conveyed a sense of urgency, one that was reinforced by one of our prior inquiries. In that inquiry we discovered disturbing inadequacies in IRB oversight of clinical trials involving investigational medical devices.
  • Managing Allegations Of Scientific Misconduct: A Guidance Document for Editors (ORI 2000) The purpose of this document is to provide guidance to editors and their staff on reporting suspect manuscripts, facilitate the investigation of misconduct allegations, improve the correction of the literature, and promote research integrity.
  • Low-Volume Institutional Review Boards (OIG 1998)
    While conducting the research for these reports, we became aware that there are some unique challenges facing hospital-based IRBs outside of the academic health centers. Because these IRBs tend to oversee considerably fewer research protocols than those at the large research centers, we refer to them as “low-volume” IRBs; in this memorandum, we define low-volume IRBs as those that conduct less than 125 initial reviews annually.

  • Institutional Review Boards: Their Role in Reviewing Approved Research (OIG 1998) Institutional review boards (Irks) play vital roles in protecting human research subjects. They review initial research plans to make certain that the plans provide subjects with adequate opportunity to provide informed consent and do not expose subjects to unreasonable risks.
  • Institutional Review Boards: Promising Approaches (OIG 1998) To identify promising approaches that institutional review boards use to enhance their effectiveness and efficiency in protecting human subjects.
  • Institutional Review Boards: The Emergence of Independent Boards (OIG 1998) This report focuses on independent IRBs, about which little has been published. One of 4 reports we are issuing on IRBs, it draws primarily on the interviews we held with representatives of 11 independent IRBs.
  • Institutional Review Boards: A Time for Reform (OIG 1998) This is a synthesis report. It draws on our broad inquiry of 1-s and on findings we presented in three parallel reports. Its overarching conclusion is that the long-established system for protecting human research subjects has vulnerabilities that threaten its effectiveness.
  • NIH-Funded Research: Therapeutic Human Fetal Tissue Transplantation Projects Meet Federal Requirements (GAO 1997). Pursuant to a legislative requirement, GAO reviewed the fetal tissue transplantation research funded by the National Institutex of Health (NIH) under the NIH Revitalization Act, focusing on: (1) compliance with informed consent and other documentation; and (2) any violations occurring in the acquisition of human fetal tissue for use in transplantation.
  • Internal Controls Are Key to Safeguarding Phase III Trials Against Misconduct (GAO 1996) Pursuant to a congressional request, GAO reviewed the National Institutes of Health’s (NIH) oversight of the clinical trials it sponsors, focusing on NIH internal controls to prevent misuse of federal funds and safeguard the integrity of clinical trial data.
  • NIH Extramural Clinical Research: Internal Controls Are Key to Safeguarding Phase III Trials Against Misconduct (GAO 1996) Pursuant to a congressional request, GAO reviewed the National Institutes of Health’s (NIH) oversight of the clinical trials it sponsors, focusing on NIH internal controls to prevent misuse of federal funds and safeguard the integrity of clinical trial data.
  • Scientific Research: Continued Vigilance Critical to Protecting Human Subjects (GAO 1996) Pursuant to a congressional request, GAO reviewed the federal oversight systems for protecting human subjects in federally sponsored scientific experiments.
  • Health Research Misconduct: HHS’ Handling of Cases Is Appropriate, but Timeliness Remains a Concern (GAO 1995) Pursuant to a congressional request, GAO determined whether the Department of Health and Human Services’ (HHS) Office of Research Integrity (ORI): (1) has the appropriate policies, procedures, and investigative practices for handling misconduct allegations in a timely; and (2) has any staffing issues that may adversely affect ORI responsiveness.
  • Report of the Commission on Research Integrity (ORI 1995) The Commission’s task was to advise the Secretary of Health and Human Services and Congress about ways to improve the Public Health Service (PHS) response to misconduct in biomedical and behavioral research receiving PHS funding. Issues to be addressed included: 1) the definition of research misconduct; 2) the assurance process for research institutions’ compliance with DHHS regulations; 3) the administrative processes of institutions and the PHS for dealing with allegations of misconduct; 4) and the development of a regulation to protect whistleblowers.
  • Human Experimentation: An Overview on Cold War Era Programs (GAO 1994) During World War II and the Cold War, the Defense Department (DOD) and other national security agencies conducted extensive radiological, chemical, and biological research programs.
  • Tax Policy: Pharmaceutical Industry’s Use of the Research Tax Credit (GAO 1994) In 1991, Congress enacted the research and experimentation tax credit to encourage businesses to do research. GAO estimates that the pharmaceutical industry earned $1.24 billion worth of these tax credits between 1981 and 1990.
  • Misconduct in Scientific Research (OIG 1989) The most commonly accepted definition of “scientific misconduct” involves plagiarsm and fabrication, falsification, and misrepresentation of data. Isolated cases of such practices sur­ faced from the mid- 1970’s through the early 1980’s. The NIH, the primary funder of biomedical research, received a growing number of reports of alleged misconduct among its grantees. At that time, research institutions were not prepared to deal with cases of deliberate deception because they lacked procedures for handling such allegations.
  • The Belmont Report (OHRP 1979) A statement of basic ethical principles and guidelines for the protection of human subjects of research from the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
  • U.S. Public Health Service Syphilis Study at Tuskegee In 1932, the Public Health Service, working with the Tuskegee Institute, began a study to record the natural history of syphilis in hopes of justifying treatment programs for blacks. It was called the “Tuskegee Study of Untreated Syphilis in the Negro Male.”
  • The Nuremberg Code Established ethical requirements for biomedical research on human subjects.

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