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Is there adequate scientific or scholarly rationale?

Robert Hood

03/29/2008 05:13 pm

Help for IRB Committee Members: Evaluating whether there is adequate scientific or scholarly rationale

Belmont principle Beneficence
Where to start: initial application Summary Question A
Where to start: continuing review application Summary Question A
Required Determination The requirement that the research study has adequate scientific or scholarly rationale is implicit in required determinations that risks are minimized and that risks are reasonble.
General considerations To conduct an analysis of risks and potential benefits of research, IRB committee members, or reviewers using the expedited procedure, need to evaluate the scientific or scholarly rationale for the research. IRB members need to understand whether there is adequate scientific or scholarly merit in order to determine whether risks are minimized, and whether risks are reasonable.IRB members need to have adequate expertise to understand the science. IRB members should contact staff and request additional expertise whenever they feel there is not adequate scientific expertise to evaluate a study.

Scientific Review

The IRB may consider external scientific or scholarly reviews conducted:

  • as part of a grant-funding process
  • as part of internal review process by a Division, Bureau, or County Health Department, including sign-off from CHD-based residency programs
  • as part of an application for approval of a new drug or device with the Food and Drug Administration
  • as part of a degree-seeking activity, where the activity includes evidence of support from the student's major professor (for example, if the application includes advisor sign-off on a dissertation prospectus)

General Considerations

IRB members should consider the following:

  • Is the hypothesis clear? Is it clearly stated?
  • Is the study design appropriate to prove the hypothesis?
  • Will the research contribute to generalizable knowledge?
  • Is it worth exposing subjects to risk?
  • Are the investigators competent to conduct the study?
Accreditation Element 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(a)(1) and .45 CFR 46.111(a)(2)
Guidance  
OHRP Guidebook IRB Guidebook, Chapter 3 and IRB Guidebook, Chapter 4

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