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Procedures used in research

Robert Hood

08/21/2008 05:13 pm

Help for Researchers: Identify procedures used in research, and distinguish from treatments or procedures used in standard practice

Procedures used in research Information
Required Determinations by the IRB In order to conduct a complete review research, the IRB must review procedures in research, and understand the difference between procedures for research and any treatments or procedures that are standard of care. The investigator should explain to the IRB, keeping in mind that IRB membership includes non-scientists, what procedures will be used in the research. The investigator should distinguish procedures performed for research from treatments and procedures performed as part of standard of care when requesting initial review, continuing review or review of a proposed change to a study.
  • Example: An investigator proposes to use an investigational new drug for HIV, along with an optimized background regime of other antivirals. The investigator should clarify the relationship between monitoring that would be done for standard of care, and additional monitoring (such as additional blood draws) used in research, if only to help the IRB understand when this would constitute an improvement over standard monitoring.
  • Example: An investigator intends to conduct research to improve a behavioral health community project (like smoking cessation). Although the program currently includes an evaluation component, the investigator intends to conduct a separate assessment, one that is designed to yield systematic, generalizable knowledge. The investigator should clarify, for example, how the research questionare and the standard evaluation are related, and whether all participants would use both, or whether some communities might be randomized, and whether the additional questions in the assessment would be part of the existing evaluation, or given separately.
  • Example: If an investigator seeks an additional sample from a patient in a sexually transmitted disease clinic, the investigator should explain the procedures used that are standard of care, and any additional proposed research-related procedures or interventions.
  • Example: If a laboratory study intends to compare the current method of analysis using FDA-licensed test kits to an investigational test, the investigator should explain the differences between the FDA-approved test and the investigational test, and clarify how all elements of proposed research procedures relate to existing testing, including collection of samples, testing, analysis, and communication of findings to clinicians or the sponsor.
  • Example: If a program normally conducts surveillance or engages in public health practice required by statute, but wants to add experimental procedures, methods, or questions, then the investigator should clarify how the proposed research differs from standard surveillance or public health practice. For example, the investigator might explain why certain additional questions constitute research, or how a certain method of analysis constitutes research. In explaining how additional questions or other changes would be research, the investigator should explain why they are systematic investigations designed to create generalizable data, and how they differ from practice.
Accreditation Element
  • Element II.2.C: The Research Review Unit receives and reviews the relevant information to evaluate research studies during initial review.
  • Element II.2.D: The Research Review Unit receives and considers relevant information to conduct continuing reviews of research studies and, when appropriate, requests changes.
  • Element II.2.E: The Research Review Unit receives and considers the relevant information to evaluate proposed amendments to research studies.
Regulations  
Guidance
References Evaluation Instrument for Accreditation, Association for Accreditation of Human Research Protection Program

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