The Juvenile Justice Professional's Guide to
Human Subjects Protection and the IRB Process
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Noncompliance With Human Subjects Regulations
Federalwide Assurance
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IRB Research Review Process
Types of IRB Review
Issues Relevant to the IRB Review Process
Modificationof Amendment of the Research Project
Project Suspension or Termination
Re-certification of Research Project
Non-compliance with Human Subjects Regulations
Assurance and Educational Training
 
Reports of noncompliance with Federal human subject protection regulations may originate from IRB members, investigators, research subjects, agency personnel, or the news media. Alleged noncompliance may result in an OHRP inquiry and investigation known as a compliance oversight evaluation. Except in extreme cases of ethical misconduct, the institution under scrutiny has the opportunity to provide information to the evaluation committee that may contradict or mitigate allegations of noncompliance. A compliance oversight evaluation may result in one or more of the following conclusions:
  1. The protections under the institution’s Assurance of Compliance are in compliance with Department of Health and Human Services (HHS) Regulations.

  2. The protections under the institution’s Assurance of Compliance are in compliance with DHSS Regulations, but the Committee has recommendations for improvement.

  3. Restrictions may be applied to the institution’s Assurance of Compliance. HHS support of the research projects in question is withdrawn until the terms of the restrictions have been fulfilled.

  4. OHRP may withdraw the institution’s Assurance of Compliance. HHS support of the research projects in question is withdrawn until an appropriate Assurance is approved by OHRP.

  5. OHRP may recommend to HHS that the institution or the investigator be temporarily suspended or permanently removed from a specific project or that IRBs be notified of the institution’s or investigator’s noncompliance history prior to the review of new projects.

  6. OHRP may recommend to HHS that the institution or the investigator be declared ineligible to participate in or disbarred from DHSS-supported research.

Acts of noncompliance with Federal human subject protection regulations may originate from the research investigator, the IRB, and the institution.
  • Investigator noncompliance issues commonly include unreported changes in research protocols, inappropriate use or lack of informed consent, and failure to submit IRB protocols in a timely manner. These matters are usually rectified without risk to the research subjects. Occasionally, however, an investigator will mislead the IRB or disregard IRB determinations. All unapproved research must be terminated by the IRB and the institution and reported to OHRP.

  • IRB compliance violations typically include poor monitoring of the proposed informed consent process, failure to ensure that the research design addresses data security, neglecting continuing review obligations, and disregarding IRB protocols such as recordkeeping and quorum requirements. IRBs that demonstrate an inability to meet regulatory requirements can have institutional assurance suspended or withdrawn.

  • Institutions that commit compliance violations most often have failed to implement practices and procedures guaranteed in the institution’s Assurance. These violations commonly include failure to provide the IRB with institutional support and staffing, failure to ensure that investigators meet their obligations to the IRB and that the IRB meets its obligations under the Assurance. Institutional non-compliance with Federal Assurance will result in withdrawal of approval of the Assurance.


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