The purpose of this section to explain the category of expedited review, its procedures and responsibilities.
5.2 Categorization of protocol
- The IRB secretariat shall initially screen the submitted research protocol for its completeness and if the type of risk involved in the research is not more than minimal risk (see table 2 for the types of risk) than the research proposal can be categorized under two types, viz; Expedited review or Initial review.
- An investigator/researcher cannot decide that his/her proposal fall under expedited review.
5.3 Expedited review
An expedited review may be conducted only if the protocols involve-
- Revised proposal previously approved through full review by the IRB or continuing review of approved proposals where there is no additional risk or activity is limited to data analysis or health record
- Retrospective chart reviews and Anonymous survey
- Analysis of discarded pathological specimens / stored paraffin blocks without personal identifi
- Proposals involving previously banked materials and/or tissues as per policies of respective authorities like – tumor tissue repository, following scientific approval by
- Research involving clinical materials (data, documents, records, or specimens) that have been collected for non-research (clinical)
- Research on educational practices such as instructional strategies or effectiveness of or the comparison among instructional techniques, curricula, or classroom management metho
- When research on use of educational tests, survey or interview procedures, or observation of public behavior can identify the human participant directly or through identifiers, and the disclosure of information outside research could subject the participant to the risk of civil or criminal or financial liability or psychosocial
- When interviews involve direct approach or access to private papers
- Other documents which would be considered for expedited review are as follows but may not restrict to:
- Minor deviations from originally approved research during the period of approval (usually of one-year duration)
- Change in the name, address of sp
- Change in contact details of PI and Co-PI.
- Change in PI or hand over of trials or projects
- Inclusion or deletion of name/s of co-investigator/s.
- Request for change in PI, Co-I, change in any member involved in the researc
- Minor amendments in the protocol, case report form (CRF)
- Minor corrections in
- Other administrative changes in the investigative brochure(IB), informed consent form, etc
5.4 Responsibility and detailed instruction
5.4.1 It is the responsibility of the member secretary to identify which research protocols or documents can or should be reviewed through expedited review.
5.4.2 Detailed instruction to the IRB secretariat:
5.4.2a Receiving the submitted protocol.
- Receive the submitted protocols by the investigator and verify as per check list.
- Acknowledge the submitted protocol.
- Hand over the received document to the member secretary.
5.4.2b Expedited review process
- The subcommittee comprising of member secretary will review the documents which qualify for expedited review.
- The chairman is informed who will nominate one or two IRB members to review the proposal. The chairman and the nominated IRB members can request for a full review.
- Review may be made either by circulation of comments, telephone discussion, or meeting.
- The minutes of the expedited review meeting should be ratified in the next regular IRB full board meeting.
- If consensus cannot be reached, the chairperson will revert the proposal back to the IRB for a full board review.
5.4.2c Communication between the IRB and the investigator
- The decision of the expedited review will be communicated to the PI immediately after minutes of the IRB is finalized.
- If the proposal is disapproved or requires resubmission after certain modifications, this will be informed to the PI in writing. The reasons for disapproval of the protocol will be specified in the letter sent to the PI.