External Links

Below are links to external sites that contain information on IRB processes, guidelines, and news. These sites are not affiliated with the University of Indianapolis.

• Advertising for and Recruiting Study Subjects
   
• Belmont Report
  On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into law, there-by creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. One of the charges to the Commission was to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines which should be followed to assure that such research is conducted in accordance with those principles.
   
• Belmont Report Historical Archive
  The Belmont Archive includes the following:
  • Belmont Report Oral History Interviews: transcripts of interviews with members, staff and consultants of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974-78); OHRP will soon add the video versions of these interviews
  • Training Video: a 9-minute educational/training video with highlights from the Oral History interviews
  • Commemorative Program Video: a one-hour edited version of the November 16, 2004 Department of Health and Human Services (HHS) ceremony honoring the members, staff and consultants of the National Commission
  • History of the Belmont Report: a short history of the Belmont Report and the current human subject protection regulations
     
• Categories of Research Federally Classified as Exempt
  Research which may be classified as “exempt” from IRB review is described in 45 CFR 46.101B (Common Rule). The University of Indianapolis IRB will “in most instances” review research in these categories using an “expedited” process. Consistent with Federal Regulations, it is the responsibility of the IRB to make the final determination regarding the review “status” of research protocols.
   
• Categories of Research that may be Reviewed by the IRB through an Expedited Review Procedure
  Research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the following categories, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110.
   
• Definition of Research: Federal Policy for the Protection of Human Subjects
  Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
   
• Family Educational Rights and Privacy Act (FERPA) Regulations
   
• FDA Guidance for Institutional Review Boards and Clinical Investigators: 1998 Update
  These information sheets from the Federal Drug Administration (FDA) provide guidance in the following areas: Charging Participants for Investigational Products; Recruitment of Study Subjects; Payment to Research Subjects; and Screening Tests Prior to Study Enrollment
   
• Guidance for Institutional Review Boards and Clinical Investigators
  The U.S. Food and Drug Administration Guidance Update for IRB Boards and Investigators.
   
• IRB Guidebook Online
  The impetus for developing this Guidebook for Institutional Review Boards (IRBs) was a finding of need by the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. In its 1981 report, Protecting Human Subjects: The Adequacy and Uniformity of Federal Rules and their Implementation, the Commission stated that it “is clear that researchers and IRB members desire help both in understanding the policies and principles that underlie the regulations governing research with human subjects, and in identifying the issues to which one should be sensitive in designing or reviewing research proposals”.
  
  A first edition of the Guidebook was produced in the early 1980s under contract for the President's Commission by Public Responsibility in Medicine and Research (PRIM&R). PRIM&R is a Boston-based, nonprofit organization that sponsors annual conferences on topics related to the protection of human subjects.
  
  The present Guidebook is a revised, updated, and expanded second edition, prepared under contract by Robin Levin Penslar, Research Associate at the Poynter Center for the Study of Ethics and American Institutions, in consultation with the Office for Protection from Research Risks and its numerous advisors. The Poynter Center is an independent ethics center housed at Indiana University.
   
• Office for Human Research Protections
  The Office for Human Research Protections (OHRP) is a division of the US Department of Health and Human Services (DHHS). From the OHRP web site, educational materials, policy statements and contact information is available.
   
  
• Office of Human Subjects Research: Regulations and Ethical Guidelines
  Important foundational documents regarding legal and ethical aspects of human subjects research found on this site include the Belmont Report, Nuremberg Code, World Medical Association Declaration of Helsinki & Guidelines for the Conduct of Research Involving Human Subjects (45 CFR 46)
   
• Prisoners Involved in Research (45 CFR part 46, subpart C)
  • Federal Register Notice for waiver of certain provisions of 45 CFR part 46, subpart C, for HHS-conducted or supported epidemiologic research involving prisoners as subjects
  • OHRP Guidance on the Involvement of Prisoners in Research
     
• Protection of Pupil Rights Amendment (PPRA)
   
• Recent News In Research With Human Subjects
  This site includes links to articles about recent news in research with human subjects. These articles are from newspapers across the country.
   
• Subtitle A—Department of Health and Human Services Part 46--Protection of Human Subjects
  This is the federal document that includes information about IRB functions and operating procedures.