The scope of the IRB written procedures (e.g., who the written procedures apply to, what happens if the written procedures are not followed, who is responsible for preparation and maintenance, including who writes, revises, and approves the written procedures, and how often written procedures are reviewed and updated).IV. The IRB’s written procedures should be reviewed on a regular basis and updated as necessary to ensure they reflect the IRB’s current processes. Manufacturing Practices : Good HAQ .
For example, if an IRB reviews studies involving children as subjects, the IRB should have written procedures that describe how the IRB ensures the review of such research is in accordance with the regulatory requirements for the additional protections for children (45 CFR Part 46 Subpart D, or 21 CFR Part 50 Subpart D). Instructions: Always download the forms from the IRB website to ensure you are using the most current versions.
Laboratory Practices : Good GMP . Humanitarian Device Exemption (must be in place to use a HUD) HUD . NOTE: IRB written procedures do not need to follow the order of the items presented in the Checklist and may be integrated to avoid redundancy.14. If you want to discuss an alternative approach, contact the appropriate OHRP or FDA staff responsible for implementing this guidance. The institution’s process for determining which HHS-conducted or -supported research studies qualify as exempt from the HHS regulations.48.
Include the approval letter (if applicable) with your submission. IRB written procedures should be sufficiently detailed so that IRB members and administrative staff understand how to carry out their duties consistently and effectively in ways that ensure that the rights and welfare of subjects are protected, and that the IRB operates in compliance with the regulations.
Include the proposed instruments (if applicable) with your submission.Examples: All greater than minimal risk research; Clinical trials; Any research use of radiation; Any research use of anesthesia; Any research use of invasive proceduresForm EE - Institutional Biosafety CommitteeThis is not an IRB template. Good Clinical Practices : GLP . Reviewing the qualifications of the investigator(s) and study staff, and the adequacy of the site where the research will be conducted.The IRB Written Procedures Checklist is designed to prompt a thorough evaluation of procedures essential for ensuring the protection of human research subjects.
ADDITIONAL CONSIDERATIONS AND SUGGESTIONS FOR POLICIES/PROCEDURES:54. We recognize that procedures may vary among institutions and IRBs due to differences in the type of research studies reviewed by the IRB, institutional policy or administrative practices, number of IRBs at the institution, affiliation with an institution, and local and state laws and regulations. Handling subject complaints, problems, concerns and questions about rights as a research subject.19.
IRB Functions and Operations37. PIs and researchers can now submit IRB applications involving human subjects and/or human biological materials and/or human data online using the system. This guidance is intended for institutional review boards (IRBs) and institutions responsible for review and oversight of human subject research under the HHS or FDA regulations, or both.1. Ensuring Prompt Reporting to the IRB, Appropriate Institutional Officials, Any Department or Agency Head, OHRP and FDA of Any Unanticipated Problems Involving Risks to Human Subjects or Others, Any Instance of Serious or Continuing Noncompliance with the Applicable HHS and/or FDA Regulations, or the Requirements or Determinations of the IRB, and Any Suspension or Termination of IRB Approval [45 CFR 46.103(b)(5)(i) and (ii), 21 CFR 56.108(b)(1)(2) and (3)]50. Human Research Forms - Full Board Review. Ensuring Prompt Reporting to the IRB of Proposed Changes in a Research Activity, and Ensuring that Changes in Approved Research, During the Period for Which IRB Approval Has Already Been Given, May Not be Initiated Without IRB Review and Approval Except Where Necessary to Eliminate Apparent Immediate Hazards to the Human Subjects [45 CFR 46.103(b)(4)(iii), 21 CFR 56.108(a)(3) and (4)]To sign up for updates, please click the Sign Up button below.2.