ELEMENT I.1.F.

ELEMENT I.1.F.: 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.

This Element requires an organization to have a level of scientific or scholarly review sufficient to fulfill two criteria for approval of research used by the IRB or EC:

Risks to participants are minimized by using procedures consistent with sound research design and that 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.

An organization may use various mechanisms to evaluate scientific or scholarly validity of proposed research. The IRB or EC may draw on its own knowledge and disciplinary expertise, or the IRB or EC may draw on the knowledge and disciplinary expertise of others, such as review by a funding agency, an organizational scientific review committee, or department chairs. The organization may also use a combination of these mechanisms. In all cases, the conduct of the scientific or scholarly review requires the reviewers to have the expertise to understand the background, aims, and methods of the research to address the two criteria of approval listed above and to draw on the discipline’s standards for conducting research.

The results of the review should be communicated to the IRB or EC as part of the process for review and approval. The IRB or EC cannot delegate its responsibility to judge whether the criteria for approval are met.

This Element does not require a merit review that compares the value of the research to other research studies or a peer review designed to maximize scientific quality, except when following DoD requirements. Therefore, this Element does not require the level of disciplinary expertise required for review of relative merit or peer review, except when following DoD requirements.

Regulatory and guidance references

DHHS: 45 CFR 46.111(a)(1)(i), 45 CFR 46.111(a)(2)
DoD: Instruction 3216.02 6 paragraphs 3.a.(2), 4.b.(2)
DOJ: 28 CFR 512.11(a)(2)
FDA: 21 CFR 56.111(a)(1)(i), 21 CFR 56.111(a)(2)
ICH-GCP: 2.4, 2.5, 2.13
VA: VHA Directive 1200.01(1) section 9; VHA Directive 1200.01(1) section 12
AAHRPP Tip Sheet: Following the Guideline of the International Conference on Harmonisation – Good Clinical Practice (E6)

Required written materials

Essential requirements:
1. Policies and procedures describe the organization’s evaluation of proposed research for scientific or scholarly validity.
  1. Policies and procedures indicate the individuals or entities that are responsible for scientific review.
  2. Scholarly or scientific review of proposed research addresses the following issues:
    1. Does the research use procedures consistent with sound research design?
    2. Is the research design sound enough to yield the expected knowledge?
  3. If scientific review is conducted by an entity other than the IRB or EC, policies and procedures describe how the review is documented and communicated to the IRB or EC.
When following DoD requirements:
1. When an IRB or EC at a non-DoD institution reviews DoD-supported research, the IRB or EC must consider the scientific merit of the research.
2. The IRB or EC may rely on outside experts to provide an evaluation of the scientific merit.
When following DOJ requirements: (a) Policies and procedures include that for research conducted within the Bureau of Prisons, the project must have an adequate research design and contribute to the advancement of knowledge about corrections.
When following the ICH-GCP (E6) guideline:
1. Policies and procedures include the evaluation of the available nonclinical and clinical information on an investigational product is adequate to support the proposed clinical trial.
2. The scientific review process provides the IRB or EC the information it needs to determine whether the criteria for approval of research are met.
3. The scientific review process evaluates:
  1. The soundness of the research design.
  2. The ability of the research to answer the proposed questions.
When following VA requirements:
1. The R&D Committee is responsible for ensuring the scientific merit of the research proposal.
  1. If the protocol has been peer reviewed by a VA merit review committee, a National Institutes of Health (NIH) study section, or other Federal peer review committee, the R&D Committee or IRB may rely on that peer review if the findings of the peer review committee are submitted with the protocol.

Common types of materials that may be used to meet the element

Reviewer checklist
Written evaluations

Outcomes

Individuals who conduct scientific or scholarly review include members who have relevant expertise and draw upon the standards to conduct research applicable to the scientific or scholarly discipline.
The scientific review process provides the IRB or EC the information it needs to determine whether the criteria for approval of research are met.
The scientific review process evaluates:
- The soundness of the research design
- The ability of the research to answer the proposed question

Proceed To: ELEMENT I.1.G.

Resources: For Accreditation - Evaluation Instrument

Evaluation Instrument for Accreditation

Table of Contents

ELEMENT I.1.F.