The Juvenile Justice Professional's Guide to
Human Subjects Protection and the IRB Process
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Issues Relevant to the IRB Review Process
Federalwide Assurance
IRB Membership
IRB Meetings
IRB Voting
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
 
An IRB takes into account a number of factors when reviewing proposed research projects and ongoing research efforts. The number of factors examined depends on the specific nature of the research study or the statistical procedures and analyses under review. Common factors include risks and benefits, subject selection, informed consent, confidentiality and privacy, and vulnerable populations.

The IRB verifies that:
  1. Risks to research subjects are minimized.

  2. Risks to the subjects are reasonable in relation to the potential benefit and the importance of knowledge that may be reasonably expected to be gained from the research.

  3. Only those risks and benefits that may result from the research are considered by the IRB; these risks and benefits are distinguished from any benefit or risk of interventions subjects would receive if not participating in research.

  4. The selection of subjects is equitable when subject selection is integral to the proposed research study.

  5. Informed consent is obtained from each research subject (or from the subject’s legally authorized representative) and appropriately documented. Consent must be solicited in language that is understandable to the subject and in a manner that gives the subject sufficient opportunity to decide whether or not to participate. Consent may not be secured through coercion or undue influence, and no attempts should be made to induce subjects to waive rights in connection with the granting of consent.

  6. The confidentiality and privacy of all subjects are protected.

  7. When appropriate, the Principal Investigator has adequate provisions to monitor and collect data to ensure the safety of all subjects.

  8. Vulnerable populations are provided adequate protection with regard to coercion or undue influence.

  9. The Principal Investigator has documented IRB approval and consent forms from other institutions, if so required.

  10. The Principal Investigator and/or the research team has the essential qualifications and experience to carry out the proposed research relative to the complexity of the research design and methodology, the degree of potential risk to human subjects, and the research team’s past record of IRB approved research.


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