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IRB Main > IRB Forms > Amendment Guidance


When Should You Submit an Application to Amend Your Study?

Investigators with approved projects must submit an Amendment Application when any study design, informed consent procedures, or the investigator team within an IRB approved research protocol is revised. There is only one exception to this rule, specifically where the change is necessary to eliminate apparent immediate hazards to the subjects. In such cases, the investigator must submit a report to the IRB explaining the protocol deviation.

Amendments involving minor changes that pose no more than minimal risk to subjects will be reviewed on an expedited basis. Amendments involving changes that pose more than minimal risk will be reviewed by the full Committee, at the next available IRB meeting. In general, amendments to protocols considered to be more than minimal risk, are reviewed by the full committee. Similarly, amendments to protocols considered to involve no more than minimal risk, are reviewed via an expedited review process.

Changes may not be implemented until the Principal Investigator receives  final written IRB approval for the change

Some examples of situations that require that an amendment application be submitted for IRB review:

  • Changes in the content of a previously-approved personal interview, telephone interview, or self-administered questionnaire – new or substantially rewritten questions (you do not need to report typos and minor wording changes)
  • Review of the final interview or questionnaire for a previously approved study
  • Addition of new consent or assent forms
  • Changes to any of the consent forms or scripts
  • Changes to the aspect of the informed consent process, including oral consent
  • Changes in the population studied, e.g. including minors as well as adults
  • Changes in study recruitment procedures, e.g. changing from telephone to email recruitment
  • For focus groups, major changes in recruitment procedures or aims
  • Changes in the mode of administration of a study, e.g. from mail or telephone to web or Internet access
  • Change in the amount of compensation or method of providing compensation
  • Changes in the leadership of a research project, e.g. change in the principal investigator, adding a co-investigator, changing faculty adviser.
  • Addition of personnel who will interact with human participants or have responsibility for research data
  • Data set enhancements, such as merging community, company, or neighborhood level data into survey records
  • Any changes in research design
  • Addition of study locations