AMENDMENTS TO APPROVED RESEARCH
Investigators are responsible for ongoing requirements in the conduct of approved research. This includes obtaining prior approval from the IRB before implementing any changes to previously approved research. The only exceptions to this requirement are:
- a change that is necessary to eliminate an immediate hazard to one or more of the participant;
- the change that is limited to updating contact information on approved flyers or letters; or,
- correcting typographical errors that do not alter the original meaning of the text.
Amendments or changes to the protocol are sometimes referred to as “modifications."
Examples
Examples of common amendments include:
- changes to study personnel
- the addition or alteration of research activities
- the addition or alteration of recruitment materials
- the addition or alteration of data collection forms
- an increase or decrease in proposed human research subject enrollment supported by a statistical justification
- revising the inclusion or exclusion criteria
- alterations in the dosage or route of administration of an administered drug
- changing the type, volume or frequency of biological sample collections
- changing the length or number of study visits
- alterations in human research subject compensation
- the addition or deletion of study sites
- the addition of serious unexpected adverse events or other significant risks
Amendments to Exempt Research
Changes in research procedures, participant characteristics, the content or scope of information to be collected, privacy or confidentiality measures, etc., must be submitted for approval by the IRB. Significant changes that increase the risk or new activities that do not meet the boundaries of the exemption categories that the IRB found were applicable may result in loss of Exempt status. Accordingly, IRB review of modifications focuses on verifying that the project continues to be eligible for Exempt status.
Submission and Review
Amendments are submitted through the Kuali Research electronic submission system. The link to instructions are provided below under RESOURCES. The type of IRB review (i.e. Expedited or Full Board) a proposed modification will undergo is dependent upon whether the proposed changes potentially alter the risk/benefit ratio of the study. The IRB Chairperson or his/her designee has final responsibility for this designation. Investigators planning to implement changes to an approved study should allow approximately a month (Full Board) or one week (Expedited) for review and approval. IRB approval of amendment typically does not alter the original approval date or expiration date of the protocol. However, if the modification request substantially alters the risk-to-benefit ratio of study participation, it may also alter the expiration date previously assigned to the protocol.
