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Goals of Research

Robert Hood

08/25/2008 03:55 pm

Scientific or Scholarly validity

Information

General Considerations Researchers should describe the goals of their research, including hypotheses and how the design will address the hypothesis. Scientific or scholarly merit review of the researcher's goals provides information the IRB needs to make required regulatory determinations. The scientific review process evaluates the soundness of the research design and the ability of the research to answer the proposed questions.
  • For example, a study might be designed to show that a new HIV drug is non-inferior to other existing drugs in the same class as part of an application to the FDA for approval of the drug. The application and protocol should address how the design will accomplish this goal.
  • Similarly, a study might be designed to create generalizable data using interviews and surveys to characterize social networks and their impacts on sexual disease transmission. The application and protocol should explain how the survey instruments and interviews will be used to measure network effects.
Required Determinations by the IRB The IRB must determine:
  • Risks to participants are minimized by using procedures consistent with sound research design and which do not unnecessarily expose participants to risk.
  • Risks to participants are reasonable in relation to anticipated benefits, if any, to participants, and the importance of the knowledge that may reasonably be expected to result.
To make these determinations, the scientific or scholarly review must address the following:
  • Does the research use procedures consistent with
    sound research design?
  • Is the research design sound enough to yield the
    expected knowledge?
At DOH scientific or scholarly review may take place in a program, Office, Bureau or Division, or as part of a grant award process, or by the IRB. If scientific merit reivew is conducted by someone other than the IRB, then these findings should be documented and included as part of the IRB application as information for the IRB to consider. The IRB may not delegate the scientific or scholarly merit determination to an external body. However, the IRB will consider those findings as part of its deliberations. In the absence of external review of scientific or scholarly merit, the IRB will conduct its own review. In all cases the conduct of the scientific or scholarly review requires the reviewers to have the expertise to understand the goals of the research, and the background, aims, and methods of the research to answer the above questions. If the IRB does not have sufficient expertise, it will seek a consultation.
Accreditation Element Element I.1.B: The Organization has and follows written policies and procedures for reviewing the scientific or scholarly validity of a proposed research study. Such procedures are coordinated with the ethics review process.
Regulations 45 CFR §46.111(a)(1)(i), 45 CFR §46.111(a)(2), 21 CFR §56.111(a)(1)(i), 21 CFR §56.111(a)(2)
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