Research Integrity

Institutional Review Board (IRB) Standard Operating Procedures (SOPs)

The Office for Human Research Protections (OHRP), Health and Human Services (HHS) has compiled a summary of the relevant regulatory requirements and guidance issued routinely over the past several years. OHRP has not developed a model written IRB procedures document for institutions to adapt because procedures appropriately can vary significantly among institutions as the result of differences in institution size, the type of research activities, institutional administrative practices, number of IRBs, and local and state laws and regulations. For each required element, the written IRB procedures should provide sufficient step-by-step operational details so that an independent observer can understand how an IRB operates and conducts its major functions.

Pursuant to guidance from OHRP, HHS regulations at 45 CFR 46.103(b)(4) and (5) require that institutions have written IRB procedures for each of the following areas:

  1. the procedures which the IRB will follow for conducting its initial review of research;
  2. the procedures which the IRB will follow for conducting its continuing review of research;
  3. the procedures which the IRB will follow for reporting its findings and actions to investigators and the institution;
  4. the procedures which the IRB will follow for determining which projects require review more often than annually;
  5. the procedures which the IRB will follow for determining which projects need verification from sources other than the investigators that no material changes have occurred since previous IRB review;
  6. the procedures which the IRB will follow for ensuring prompt reporting to the IRB of proposed changes in a research activity, and for ensuring that such changes in approved research, during the period for which IRB approval has already been given, may not be initiated without IRB review and approval except when necessary to eliminate apparent immediate hazards to the subject; and
  7. the procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, any Department or Agency head, and OHRP of:
    1. any unanticipated problems involving risks to subjects or others;
    2. any serious or continuing noncompliance with 45 CFR Part 46 or the requirements or determinations of the IRB; and
    3. any suspension or termination of IRB approval.

This document contains a variety of SOPs covering these requirements as well as others pertinent to the Ball State University IRB.

Questions regarding these SOPs may be made of the Director of Research Integrity at 765-285-5070. For more information on IRB and human subject regulatory requirements, please visit the Office for Human Research Protections at http://www.hhs.gov/ohrp/.