HRPP policies & procedures manual

402: Amendments/study updates

1. Purpose

The purpose of this policy is to describe exempt, expedited, and full-board amendment processing and determinations.

2. Policy

Minor changes that do not increase the risk to research subjects may receive review at expedited or administrative levels. An amendment may require full IRB review if the amendment is significant and impacts the risks and benefits to subjects in the research.

3. Specific policies

3.1 Amendments/project updates

Investigators or sponsors must submit requests for changes to the IRB in writing.  Each update/amendment will include:

  • Description of the changes
  • Reason for the change
  • Whether or not changes are needed to the informed consent document
  • The impact the changes will have on the study and/or the subjects: risk/benefit rationale
  • All appropriate documents:
    • Revised informed consent (changes underlined or tracked)
    • Sponsor correspondence concerning the amendment
    • Amended protocol (if appropriate)

3.2 Full-board amendment review

Minor administrative changes (adding personnel, updating phone numbers, minor editorial changes to consent documents, cover letters, advertising, etc.) may be reviewed and approved by the chair and/ or the IRB coordinator.

Amendments to approved applications that may affect the risk to subjects may be forwarded to the full IRB for review. Reviewers will receive the request for amendment and any modified items such as consent forms, applications, investigator brochures, study instruments, recruitment tools, background materials, etc.

Changes in the risks or benefits to subjects may require amendments to the consent form and re-consenting of subjects.

The IRB approval of an amendment does not extend the approval period. For example, if the new or continuing review is approved on January 1, 2015, it will have an expiration date of December 31, 2015.  If an amendment is approved during this time, the approval still lasts only until December 31, 2015.

If possible, reviewers of the initial IRB submission will be assigned as the reviewers. All other members will receive all the materials.

3.3 Expedited amendment review

If the project amendment/update is a minor change involving no more than minimal risk to the subject, it will be reviewed by the expedited review process and will be reported to the IRB on the next month’s agenda.  See 401 Expedited Review.

3.4 Exempt amendment review

The investigator must inform the IRB of any changes to the scope or design prior to implementation to ensure that the study continues to meet the exempt criteria.

3.5 Investigator notification

All approvals for requested revisions will be reported to the investigator via e-mail.

4. Applicable regulations and guidelines

21 CFR 812.64

21 CFR 56.108, 56.109, 56.113

45 CFR 46.103, 46.109, 46.115

FDA Information Sheets, 2019

5. Forms

Amendment request

6. Procedures employed to implement this policy & assignment of responsibility

IRB coordinator Prepare all information received from investigator and prepare reviewer packet.

Determine whether amendment can be reviewed via expedited review and which are to be placed on the agenda for the next meeting.

Assign to primary and secondary reviewers.

Process amendments and project updates.
Reviewers Review amendment or change in the research at a convened IRB meeting.
IRB coordinatorComplete processing of amendment/project update.