Health Hippo: Research Integrity & Bioethics

1...2...3...zzz...huh? Why do all these sheep look the same? Perhaps they are clones. At least we won't have to worry about people looking the same in the U.S., now that President Clinton has banned federal funding of projects to clone human beings. But what about the private sector? See AgResearch SheepMap Database Project; National Center for Genome Resources Home Page.

• Genetic Screening Bills (105th Congress)
• 1997 Congressional Record: "Genetic Screening"
• Search "Genetic Screening"
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• Cloning Bills (105th Congress)
• 1997 Congressional Record: "Cloning"
• Search "Cloning"
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• Search "Research Misconduct"
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• 41 CFR PART 50 - RESPONSIBILITY OF PHS AWARDEE AND APPLICANT INSTITUTIONS FOR DEALING WITH AND REPORTING POSSIBLE MISCONDUCT
  • Sec. 50.101 Applicability
  • Sec. 50.102 Definitions
  • Sec. 50.103 Assurance - Responsibilities of PHS awardee
  • Sec. 50.104 Reporting to the OSI
  • Sec. 50.105 Institutional compliance
• 45 CFR PART 46 - PROTECTION OF HUMAN SUBJECTS
  • Sec. 46.101 (BASIC) To what do these regulations apply?
  • Sec. 46.102 Definitions
  • Sec. 46.103 Assurances
  • Sec. 46.107 IRB membership
  • Sec. 46.108 IRB functions and operations
  • Sec. 46.109 IRB review of research
  • Sec. 46.110 Expedited review procedures
  • Sec. 46.111 Criteria for IRB approval of research
  • Sec. 46.112 Review by institution
  • Sec. 46.113 Suspension or termination of IRB approval
  • Sec. 46.114 Cooperative research
  • Sec. 46.115 IRB records
  • Sec. 46.116 General requirements for informed consent
  • Sec. 46.117 Documentation of informed consent
  • Sec. 46.118 Applications and proposals lacking definite plans
  • Sec. 46.119 Research undertaken without the intention of involvinghuman subjects
  • Sec. 46.120 Evaluation and disposition of applications
  • Sec. 46.121 Investigational new drug or device 30-day delay
  • Sec. 46.122 Use of Federal funds
  • Sec. 46.123 Early termination of research funding
  • Sec. 46.124 Conditions
• FETUSES, PREGNANT WOMEN, FERTILIZATION
  • Sec. 46.201 Applicability.
  • Sec. 46.202 Purpose.
  • Sec. 46.203 Definitions.
  • Sec. 46.204 Ethical Advisory Boards.
  • Sec. 46.205 Additional duties of the Institutional Review Boards in connection with activities involving fetuses, pregnant women, or human in vitro fertilization.
  • Sec. 46.206 General limitations.
  • Sec. 46.207 Activities directed toward pregnant women as subjects.
  • Sec. 46.208 Activities directed toward fetuses in utero as subjects.
  • Sec. 46.209 Activities directed toward fetuses ex utero, including nonviable fetuses, as subjects
  • Sec. 46.210 Activities involving the dead fetus, fetal material, or the placenta
  • Sec. 46.211 Modification or waiver of specific requirements.
• PRISONERS
  • Sec. 46.301 Applicability.
  • Sec. 46.302 Purpose.
  • Sec. 46.303 Definitions.
  • Sec. 46.304 Composition of Institutional Review Boards where prisoners are involved.
  • Sec. 46.305 Additional duties of the Institutional Review Boards where prisoners are involved.
  • Sec. 46.306 Permitted research involving prisoners.
• 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.
• 45 CFR PART 76 - GOVERNMENTWIDE DEBARMENT AND SUSPENSION
  • Sec. 76.100 Purpose
  • Sec. 76.105 Definitions
  • Sec. 76.110 Coverage
  • Sec. 76.115 Policy
  • Sec. 76.200 Debarment or suspension
  • Sec. 76.205 Ineligible persons
  • Sec. 76.210 Voluntary exclusion
  • Sec. 76.215 Exception provision
  • Sec. 76.220 Continuation of covered transactions
  • Sec. 76.225 Failure to adhere to restrictions
  • Sec. 76.300 General (Debarment)
  • Sec. 76.305 Causes for debarment
  • Sec. 76.310 Procedures
  • Sec. 76.311 Investigation and referral
  • Sec. 76.312 Notice of proposed debarment
  • Sec. 76.313 Opportunity to contest proposed debarment
  • Sec. 76.314 Debarring official's decision
  • Sec. 76.315 Settlement and voluntary exclusion
  • Sec. 76.320 Period of debarment
  • Sec. 76.325 Scope of debarment
  • Sec. 76.400 General (Suspension)
  • Sec. 76.405 Causes for suspension
  • Sec. 76.410 Procedures
  • Sec. 76.411 Notice of suspension
  • Sec. 76.412 Opportunity to contest suspension
  • Sec. 76.413 Suspending official's decision
  • Sec. 76.415 Period of suspension
  • Sec. 76.420 Scope of suspension
  • Sec. 76.500 GSA responsibilities
  • Sec. 76.505 HHS responsibilities
  • Sec. 76.510 Participants' responsibilities

• Health Research Misconduct: HHS' Handling of Cases Is Appropriate, but Timeliness Remains a Concern (Letter Report, 08/03/95, GAO/HEHS-95-134). 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.
• Scientific Research: Continued Vigilance Critical to Protecting Human Subjects (Letter Report, 03/08/96, GAO/HEHS-96-72). Pursuant to a congressional request, GAO reviewed the federal oversight systems for protecting human subjects in federally sponsored scientific experiments.
• NIH Extramural Clinical Research: Internal Controls Are Key to Safeguarding Phase III Trials Against Misconduct (Letter Report, 07/11/96, GAO/HEHS-96-117). 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-Funded Research: Therapeutic Human Fetal Tissue Transplantation Projects Meet Federal Requirements (Letter Report, 03/10/97, GAO/HEHS-97-61). 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.
• Practice Guidelines: Overview of Agency for Health Care Policy and Research Efforts (Testimony, 07/25/95, GAO/T-HEHS-95-221). In 1989, Congress created the Agency for Health Care Policy and Research--part of the Public Health Service--to serve as the federal government's focal point for effectiveness and outcomes research.
• Human Experimentation: An Overview on Cold War Era Programs (Testimony, 09/28/94, GAO/T-NSIAD-94-266). 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 (Chapter Report, 05/13/94, GAO/GGD-94-139). 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.
• HHS: Promoting Integrity in Research
• HHS: AHCPR, AAHP, and AMA to Develop National Clinical Guideline
• Amyloid - The International Journal of Experimental and Clinical Investigation
• 87-26, PHS Grant Application Form, Assurance on Scientific Fraud (Misconduct) The May 15, 1987 Contracts and Grants Information Letter transmitted copies of the revised Public Health Service Grant Application Form PHS 398, a summary of the major changes, and a summary of recent revisions to the PHS Grants Policy Statement.
• Article on GAP's Scientific Integrity Campaign At a time when the political winds are blowing against government oversight, corporate accountability, and employee rights, a blue ribbon commission on scientific integrity has struck a blow for all three.
• APA: Guidelines for Ethical Conduct in the Care and Use of Animals These guidelines were developed by APA's Committee on Animal Research and Ethics to help researchers who use animal subjects.
• Biomedical Ethics: listserv@VM1.nodak.edu Biomedical Ethics list. Send the following message: subscribe biomed-L Your Name
• Conduct and Misconduct in Science My career in Scientific Fraud began some years ago when...hmmm
• Data Council home page The HHS Data Council meets monthly to coordinate all health and non-health data collection and analysis activities of the Department of Health and Human Services. (Everyone should have their own data council (counsel?)).
• Discover Magazine Discover Television on the Discovery Channel (Discover Magazine (the television version) on the Discovery Channel, a pitch for the channel as a way to learn about TV, or a whole nutter thing)?
• EurekAlert!: The latest Whether you're interested in cancer treatments, gene mapping, global warming, or space probes, you will find the latest advances.
• Federation of American Scientists The Federation of American Scientists is engaged in analysis and advocacy on science, technology and public policy for global security. (OK, er... wait a 'sec... global security?)
• Institute of Electrical and Electronic Engineers (IEEE) Copyright © 1997 Institute of Electrical and Electronics Engineers, Inc.
• False Claims Act Can Hamper Science With 'Bounty Hunter' Suits Fraud and misconduct in scientific research have become a problem attracting national and international attention.
• FASEB Research Integrity, Letter to Sec. Shalala The Ryan Commission's report is so seriously flawed that it is useless as a basis for policy making and should be disavowed by the Department of Health and Human Services.
• HHS: Policy, Research, and Administrative Information The bible, from the organization that makes all this fun possible.
• (NCVHS) home page The National Committee on Vital and Health Statistics serves as the statutory [link to US Code ommitted] public advisory body to the Secretary of Health and Human Services in the area of health data and statistics.
• Professional Ethics Report Published by the American Association for the Advancement of Science Scientific Freedom, Responsibility and Law Program
• Protecting Human Subjects Workshop: Highlights This panel addressed past abuses of human participants in research and the history of bioethics, in addition to discussion of legal and ethical considerations for conducting research.
• Science Ethics Bibliography Compiled by Vince Hamner. The [bracketed] identifier is the Library of Congress recommended call-number. Books and journals in the Newman Library at Virginia Tech are catalogued using this recommendation.
• The James Randi Educational Foundation Homepage Turning your head sideways helps alotnot.
• Walter W. Stewart's Page on Scientific Misconduct Professor Stewart rocks again at a new location.

American Association for the Advancement of Science ~ American Association for Laboratory Animal Science ~ American Board of Genetic Counseling ~ American Board of Medical Genetics ~ American College of Medical Genetics ~ American Society of Human Genetics ~ American Medical Informatics Association ~ American Physiological Society ~ Association for Practical and Professional Ethics ~ Bioethics Bibliography ~ Bioethics Law in New York State ~ Center for Human Genome Studes ~ Digital Resources in Ethics ~ Ethics in Science ~ Genetics Society of America ~ HHS: GrantsNet ~ Health Care Providers: NY State Dept of Health ~ Institute of Medicine ~ Internet Links for Whistleblowers ~ JAMIA, The Journal of the American Medical Informatics Association ~ MacLean Center for Clinical Medical Ethics ~ Medical Ethics: Codes and Policies ~ National Academy of Sciences ~ Office of Research Integrity ~ Professional Ethics Report ~ Science ~ Welcome to HSR - The Health Service Research Journal ~ WUACC: Bioethics Law