Continuing review of study Protocols

8.1 Purpose:

The purpose of the continuing review is to:

  • Monitor the progress of the research study which was previously approved by the IRB,
  • To ensure the continued protection of the rights and welfare of the research participants.

Continuing review of the study may not be conducted through an expedited review procedure unless:

  • The study was eligible for, and initially reviewed by an expedited review procedure, or
  • The study has undergone changes such that the remaining activities are eligible for expedited review.

8.2 Scope:

The SOP relates to conducting continuing reviews of the study previously approved by the IRB at intervals appropriate to the degree of risks to human participants but at least once a year. The IRB chooses to decide the frequency of reviewing a study depending on the following factors:

  • Degree of risks to the human participants
  • Nature of the study
  • Vulnerability of the study participants, and
  • The duration of the study.

8.3 Responsibility:

  • It is the duty of the Chairperson of the IRB, to set a date for continuing review of the various study previously approved by the IRB and also to remind the IRB and the Principal Investigator(s).
  • All studies approved by the IRB will be reviewed annually. The IRB chairperson will choose a date for the continuing review if any of the projects need to be reviewed more than once annually. This decision is usually taken during the course of the IRB meeting where the project was finally approved.
  • The IRB is responsible for making a continuing review of the various studies to ensure the smooth progress of the study. It is also responsible for the occurrence of any unexpected events or problems and the rate of accrual of participants.
  • The IRB is to examine the following to ensure that the information reviewed is accurate and reliable:
  • The original study protocol
  • Informed consent documents
  • Assent documents
  • The IRB retains the same options for decision-making on continuing the review package as for an initial review.
  • The IRB will decide to either:
  • Give the Approval to continue the study, or
  • Approve with recommendations, or
  • Give disapproval of the study.
  • All the Principal Investigators along with the submission of the annual project progress, will also apply for approval of the extension of the project.
  • The IRB secretariat will distribute the protocol progress report to the other IRB members prior to the meeting.
  • The IRB secretariat will follow the set guidelines for preparing the meeting agendas and place the submitted annual project reports to the IRB.
  • If required, the chairperson of the IRB shall call for an additional day to review the study.