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Scientific or Scholarly Rationale or Purpose

Robert Hood

04/16/2008 08:10 am

Researcher Help: Describe the Scientific or Scholarly Rationale or Purpose

General considerations The design, conduct and monitoring of a research activity involving human subjects is the responsibility of the Principal Investigator (PI) who provides a complete written description of the proposed research (a “research protocol”) to a DOH Institutional Review Board (IRB), even if portions of the activity are carried out by others or contracted out.

Biomedical Research

Describe the background, including previous human subject or animal research and references that are relevant to the design and conduct of the study. Where new techniques or procedures are to be used, a description of preliminary or early work should be provided. If an FDA Investigational New Drug (IND) is to be used, animal data on the drug should be included (summarize, and indicate where detailed information may be found in the protocol).

Social Science Research

Describe the background, including previous research (for example, research in similar populations, or previous research that is being extended by this project). If pilot studies or small-scale research have been conducted previously, describe this, and how the current project builds upon that work.

  • If the project involves a behavioral intervention, describe the standard of care, if any. For example, for a research study involving HIV prevention, describe how the activity compares to current HIV prevention methods used by the Department. If there is no accepted standard of care, indicate that.
  • For survey research, describe whether the project utilizes standard instruments, or whether the research includes development of a new instrument.

Registry Research and Data Analysis

Researchers who are requesting use of non-public data from the Office of Vital Statistics, or the Florida Cancer Registry Data System, or the Florida Birth Defects Registry, or other data repositories at the Department of Health are engaged in registry research or data analysis. The regulatory criteria for IRB approval are the same for this kind of research as for other kinds of research, so researchers need to provide similar kinds of information to the IRB so it can assess the research.

  • Describe the background, indicating previous research if any. For example, a proposed analysis of Florida Cancer Registry Data System data to analyze incidence of a particular cancer could include a description of whether similar research has been conducted previously at the national level or in other states.
  • Describe the proposed method of analysis; if the method is particularly unusual or novel, the researcher should describe previous work in the field.
  • The IRBWise application will request a description of specific fields to be used in analysis, and details of the specific data fields should be included in that section of the application.
  • If you are using the registry as a recruitment tool, you should indicate this under recruitment procedures, in that section of the IRBWise application.
Required Determinations by the IRB In order to approve research, the IRB has to make determinations required by regulation. Description of the scientific and scholarly rationale is required because the IRB is required in regulation to determine that "Risks to subjects are minimized: (i) By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes." (45 CFR 46.111(a)(1))
Accreditation Element
  • Element III.2.C: Principal Investigators maintain appropriate oversight of their research protocols and research staff including recruitment, selection of study participants, and study conduct, and they appropriately delegate research responsibilities.
  • Element II.4.A: The Research Review Unit has and follows written policies and procedures for identifying and analyzing potential sources of risk and measures to minimize risk, including physical, psychological, social, legal, or economic risks. The analysis of risk includes a determination that the risks to participants are reasonable in relation to potential benefits to participants and to society.
Regulations 45 CFR 46.111; 21 CFR 56.111
Guidance  
References

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