September 30, 2023

Institutional Review Board IRB / Independent Ethics committee IEC

Institutional Review Board IRB / Independent Ethics committee IEC

Unit IV Clinical trials, BP804 ET: Pharmaceutical Regulatory Science Notes

The ICH defines an institutional review board (IRB) as a group formally designated to protect the rights, safety and well-being of humans involved in a clinical trial by reviewing aspects of the trial and approving its start-up.

IRBs can also be called independent ethics committees (IECs).

An IRB/IEC reviews the appropriateness of the clinical trial protocol as well as the risk and benefits to study participants. It ensures that clinical trial participants are exposed to minimal risks in relation to any benefits that might result from the research.

An IRB/IEC: Reviews all study-related materials before and during the trial. Must operate in accordance with national and/or local regulations, as well as with ICH good clinical practices (GCPs) guidelines.

Composition of an Institutional Review Board (IRB)/ Independent Ethics Committee (IEC):

An IRB/IEC should have a reasonable number of members who have collectively assumed sufficient expertise and experience to review and evaluate the scientific, medical and ethical aspects of a research proposal.

It is recommended that the IRB/IEC should include:

(a) At least five members.

(b) At least one member whose primary area of interest is in a non- scientific area.

(c) At least one member who is independent of the institution/trial site.


The IRB/IEC should establish a document in writing and follow its procedures, which should include:

  • Determine composition and source of authority under which it is established.
  • Schedule, notify members and conduct meetings.
  • Conduct initial and continuing review.
  • Determine frequency of continuing review.
  • Provide expedited review mechanism for minor changes.
  • Specify that no subject may be enrolled and no deviation prior to approval.
  • Specify that investigator promptly report protocol changes or deviations, increased risks to subjects, ADRs (serious and unexpected), new information related to subject safety.
  • Promptly notify in writing the investigator/ institution about its decisions, reasons for its decisions and procedures for appeal.


Maintain all relevant records at least three years after completion of the trial.

  • Written procedures.
  • Membership files.
  • Submitted documents (protocol related files).
  • Minutes of meetings.

The IRB/IEC may be asked by investigators, sponsors or regulatory authorities to provide its written procedures and membership lists.

Final Year B Pharm Notes, Syllabus, Books, PDF Subjectwise/Topicwise

Final Year B Pharm Sem VIIBP701T Instrumental Methods of Analysis Theory
BP702T Industrial Pharmacy TheoryBP703T Pharmacy Practice Theory
BP704T Novel Drug Delivery System TheoryBP705 P Instrumental Methods of Analysis Practical
Final Year B Pharm Sem VIIBP801T Biostatistics and Research Methodology Theory
BP802T Social and Preventive Pharmacy TheoryBP803ET Pharmaceutical Marketing Theory
BP804ET Pharmaceutical Regulatory Science TheoryBP805ET Pharmacovigilance Theory
BP806ET Quality Control and Standardization of Herbals TheoryBP807ET Computer-Aided Drug Design Theory
BP808ET Cell and Molecular Biology TheoryBP809ET Cosmetic Science Theory
BP810ET Experimental Pharmacology TheoryBP811ET Advanced Instrumentation Techniques Theory
BP812ET Dietary supplements and NutraceuticalsPharmaceutical Product Development

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