ELEMENT II.3.B.

ELEMENT II.3.B.: The IRB or EC has and follows written policies and procedures for reviewing the plans for data and safety monitoring, when applicable, and determines that the data and safety monitoring plan provides adequate protection for participants.

A criterion for approval of research is that when appropriate, the research protocol or plan makes adequate provisions for monitoring the data to ensure the safety of participants. The IRB or EC should evaluate whether research submitted for review satisfies this criterion.

For clinical research involving no more than minimal risk and for most behavioral and social science research (because most involves no more than minimal risk), provisions for data and safety monitoring are not needed to protect participants. IRB or EC members should have criteria for determining when such monitoring is necessary.

IRB or EC members should understand the range of possible options for monitoring and that monitoring might occur at specific points in time, after a specific number of participants have been enrolled, or upon recognition of harm. IRB or EC members should understand that monitoring might be conducted by the researcher, the sponsor (e.g., medical monitor, safety monitoring committee), or by an independent monitoring board.

Regulatory and guidance references

DHHS: 45 CFR 46.111(a)(6)
DoD: Instruction 3216.02 8; SECNAVINST 3900.39D, para. 6c
FDA: 21 CFR 56.111(a)(6)
ICH-GCP: 5.1.6
VA: VHA Directive 1200.05(3), 12
AAHRPP Tip Sheet: Following the Guideline of the International Conference on Harmonisation – Good Clinical Practice (E6)
AAHRPP Tip Sheet: Sufficient Information to Determine Whether the Criteria for Approval are Met

Required written materials

Essential requirements:
1. Policies and procedures describe when the IRB or EC considers provisions for monitoring data to ensure the safety of participants to be appropriate.
  1. When the IRB or EC considers provisions for monitoring data to ensure the safety of participants to be appropriate, policies and procedures have applications include descriptions of such provisions.
  2. In order to approve research in which the IRB or EC considers provisions for monitoring data to ensure the safety of participants to be appropriate, policies and procedures have the IRB or EC determine that the research plan makes adequate provisions. The IRB might consider provisions such as:
    1. What safety information will be collected, including serious adverse events.
    2. How the safety information will be collected (e.g., with case report forms, at study visits, by telephone calls with participants).
    3. The frequency of data collection, including when safety data collection starts.
    4. The frequency or periodicity of review of cumulative safety data.
    5. The plan might include establishing a data monitoring committee and a plan for reporting data monitoring committee findings to the IRB and the sponsor.
    6. For studies that do not have or are not required to have a data monitoring committee and are blinded, have multiple sites, enter vulnerable populations, or employ high-risk interventions, the IRB or EC needs to carefully review the data and safety monitoring plan and determine whether a data monitoring committee is needed.
    7. If not using a data monitoring committee, and if applicable, statistical tests for analyzing the safety data to determine whether harm is occurring.
    8. Provisions for the oversight of safety data (e.g., by a data monitoring committee).
    9. Conditions that trigger an immediate suspension of the research, if applicable.

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

Application form
Reviewer checklist

Outcomes

IRB or EC members articulate when provisions for data and safety monitoring are required.
IRB or EC members determine that research protocols or plans include adequate provisions for monitoring the data to provide for the safety of participants.

Proceed To: ELEMENT II.3.C.

Resources: For Accreditation - Evaluation Instrument

Evaluation Instrument for Accreditation

Table of Contents

ELEMENT II.3.B.