IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed: Guidance for IRBs, Clinical Investigators, and Sponsors

Description

This guidance is intended to clarify IRBs' responsibilities for reviewing the qualifications of investigators, determining the adequacy of research sites, and determining whether an investigational new drug application (IND) or investigational device exemption (IDE) is needed. Although these activities are viewed primarily as sponsor responsibilities, FDA encourages all parties—IRBs, clinical investigators, and sponsors—to work together in order to protect the rights and welfare of study subjects.

Key Topics

Terms and concepts identified from this document

Scope & Applicability

Product Classes

2

Significant Risk Medical Device

medical devices addressed by this guidance are generally considered significant risk

Nonsignificant Risk Medical Device

Significant Risk and Nonsignificant Risk Medical Device Studies

Stakeholders

7

Institutional Review Board

Governs top dose in clinical studies

Clinical Investigator

Veterinarian responsible for selecting anesthetic regimens and conducting field studies

Sponsor

Entity responsible for submitting applications under section 524B

Sponsor-Investigator

A licensed physician who submits an expanded access IND and administers the drug.; Physician acting as a sponsor for an individual patient IND; An individual who both initiates and conducts a clinical investigation.; Role that may authorize expanded access protocols

IRB

Institutional Review Board providing study approvals

Clinical Investigators

Individuals responsible for monitoring and reporting protocol deviations

Regulatory Context

Regulatory Activities

5

IND

Investigational New Drug submissions

IDE

Investigational Device Exemption submissions; Submission Documentation for Investigational Device Exemptions; Investigational Device Exemption submission recommendations

IRB Inspection

FDA field investigators review records during inspections

Investigational New Drug Application

IND for treatment use; Regulatory submission required for clinical trials and expanded access.

Investigational Device Exemption

A medical device submission type (IDE).

Document Types

4

Compliance Program Guidance Manual 7348.809

Instructions to field investigators for IRB inspections

Warning Letter

Notification to a manufacturer regarding significant violations of FDA regulations.; Agency's principal means of achieving prompt voluntary compliance.

Curriculum Vitae

Curriculum Vitae of investigator

written procedures

Required documentation for supplier approval and verification.

Attributes

2

Significant Risk

Risk classification for medical device clinical investigations.; A classification for medical device studies.; A risk determination for a clinical study.

Nonsignificant Risk

Risk classification for medical device clinical investigations.; A risk determination for a clinical study.

Technical Details

Processes

1

Informed Consent

Process of obtaining participant agreement

Clinical Concepts

1

Human Subjects

Participants in research whose rights and safety must be protected

ICH References (1)

ICH E6

Referenced for safety data collection and adverse event reporting plans.

Related CFR Sections (6)

21CFR56.114§ 56.114 Cooperative research.
In complying with these regulations, institutions involved in multi-institutional studies may use joint review, reliance upon the review of another qualified IRB, or similar arrangements aimed at avoidance of duplication of effort.Read full regulation →
21CFR56.107§ 56.107 IRB membership.
(a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members,Read full regulation →
21CFR56.111§ 56.111 Criteria for IRB approval of research.
(a) In order to approve research covered by these regulations the IRB shall determine that all of the following requirements are satisfied:Read full regulation →
21CFR312.53§ 312.53 Selecting investigators and monitors.
(a) Selecting investigators. A sponsor shall select only investigators qualified by training and experience as appropriate experts to investigate the drug.Read full regulation →
21CFR812.43§ 812.43 Selecting investigators and monitors.
(a) Selecting investigators. A sponsor shall select investigators qualified by training and experience to investigate the device.Read full regulation →
21CFR56.109§ 56.109 IRB review of research.
(a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by these regulations.Read full regulation →

Enforcement Impact

Deficiencies cited in Warning Letters referencing the same regulations

Failure to select qualified investigators and monitors

1

Failure to obtain signed investigator agreements

1

Failure to obtain financial disclosure information

1

Failure to prepare, maintain, and follow written procedures governing the functions and operations of the IRB

1

Failure to prepare and maintain adequate documentation of IRB activities, including minutes of IRB meetings

1

Failure to review proposed research at convened meetings with a majority of members present

1

Failure to prepare and maintain adequate documentation of IRB activities, including a list of IRB members

1

Failure to ensure informed consent documents contained the required clinical trial registry statement

1

Failed to ensure that the investigation was conducted according to the investigational plan

1

Failure to ensure proper monitoring and IRB review

1