BMY Health Pakistan IRB
Stages of IRB
IRB is a continuous process with a fee involved at each step. For most projects that required delegated/ exempt review, minimum of two reviews are done, an initial review and a concluding review. The fee of both stages is included in the fee taken at time of initial review. For projects of longer duration/ risk involved additional fee payable later at each stage.
Initial Review
The first review done by IRB, for approval of data collection, for all projects having minimal risk.
Review time: 1-3 Weeks
Ongoing & Continuing Review
Ongoing Review: Review for any change in project design/ methods after its approval. Where changes are necessary to alleviate immediate/ serious negative impact on human participants, they can be implemented prior to IRB review.
Continuing Review: IRB reviews done at periodic intervals (such as annually, or more frequent in risky projects) after approval, to ensure compliance with ethics. For projects requiring continuing review, researchers must submit periodic updates as scheduled by the IRB.
Concluding Review (Audit)
- Data protection practices
- Protocol adherence
- Record-keeping
- Reporting of adverse events
- Publication Ethics
IRB Submission Requirements at different stages
Required Components
- Completed IRB application form
- Full study protocol
- Participant-facing documents (consent forms, information sheets, scripts)
- Data collection tools (surveys, interview guides, observation checklists)
- Recruitment materials
- Data management and privacy plan
- Conflict of interest declaration
- Funding or sponsorship information (if applicable)
Researcher Responsibilities
- Ensure consistency across all submitted documents
- Use clear, non-technical language in participant materials
- Justify all methodological and procedural choices
- Declare all potential risks honestly
Continuing Review Reports Must Include
- Recruitment status
- Deviations from approved protocol
- Adverse events or unanticipated issues
- Data security incidents (if any)
- Updated risk assessment
All changes to an approved protocol must receive prior IRB approval, except when necessary to eliminate immediate hazards.
Amendments Include
- Changes in objectives or design
- Modifications to instruments or procedures
- Changes in population or recruitment
- Changes in consent process
- Addition of new study sites
Unapproved changes may constitute non-compliance.
Reporting Adverse Events and Deviations
Researchers must report:
- Serious adverse events
- Unanticipated problems
- Protocol deviations
- Breaches of confidentiality
Reports must be submitted as soon as reasonably possible.
Researcher Obligations
- Submit summary report (manuscript)
- Data Audit
- Any adverse events
- Data retention and disposal plan
- Dissemination plans & author credits
For initial review response:
If minor revisions are suggested after the scientific review is complete, begin revisions as suggested or add your justification comments under the reviewer comments. Justify scientifically and ethically when a suggestion is not adopted. Address each comment individually. Indicate where changes were made (page and section numbers). Comments can be added in the same google doc where reviewers comment.
If the project requires major revisions, the ethics and operational teams cannot proceed until amendments to the scientific section are received. Applicants must respond to queries within the specified timeframe.
Response to comments can be: Revision, Justification, or Assurance as relevant.