Modifications

Many changes related to IRB approved research must be reviewed and approved by the IRB before the changes may be implemented. This includes, but is not limited to, changes in study staff, recruitment, procedures, and funding.

• Exempt - All Modifications for studies involving PHI and/or substantive modification must be reviewed by IRB office
• Expedited - All Modifications must be reviewed by IRB
• Full Board - All Modifications must be reviewed by IRB

Modifications for Exempt Studies

If the exempt research involves protected health information (PHI), the PI is required to submit a modification to his/her application via the electronic submission system prior to any study staff changes and/or study data collection changes (e.g., collection of additional data points, increase in number of subject records or biospecimens to be involved).  The IRB staff will review the modification and send a written letter approving the change via administrative review, if appropriate.

If the exempt research does not involve PHI, modifications are not required.  However, the PI must consult with an IRB staff member prior to making any substantive changes to the initial research plan that received the exemption to determine whether the modified research plan remains exempt.

Substantive changes include, but are not limited to:

• Changes to study personnel (to review credentialing)
• Changes that involve protected health information (PHI)
• Changes that increase the risk to participants or change the risk: benefit ratio of the study
• Changes that affect a participant’s willingness to participate in the study
• Changes to the study sponsor
• Changes to study procedures that are not covered by the Exemption Category determined for this study.

Full Board Modifications

Certain types of minor revisions to approved greater than minimal risk studies (i.e. research requiring review at a convened meeting) may be reviewed via expedited procedures (i.e. one IRB member). A minor change is a proposed change to research that does not significantly affect the risk and benefits of the study and does not substantially change the specific aims or design of the study.

Modifications that may be reviewed using the expedited procedure may include:

• The addition or removal of qualified investigators
• Adding or revising recruitment materials
• An increase or decrease in proposed human research subjects' enrollment;
• Narrowing the range of the inclusion criteria;
• Broadening the range of the exclusion criteria;
• Alterations in the dosage form (e.g., tablet to capsule or oral liquid) of an administered drug, provided the dose and route of administration remains constant;
• Decreasing the number or volume of biological samples collections, provided that such a change does not affect the collection of information related to safety evaluations;
• A decrease in the length of hospitalization or number of study visits, provided that such a decrease does not affect the collection of information related to safety evaluations;
• Alternations in human research participant payment or alteration of the payment schedule with proper justification;
• Changes to improve the clarity of statements or to correct typographical errors, provided that such a change does not alter the content or intent of the statement;
• Adding a survey/measure involving minimal risk (e.g., quality of life survey);
• Removing a study procedure, provided that such a change does not affect the collection of information relation to safety evaluations or change the risk: benefit ratio of the study;
• The addition or deletion of study sites.

However, a revision that may either adversely affect the willingness of current participants to remain in the study or that may change the risk-to-benefit ratio for subjects must be reviewed at a convened IRB meeting. Following are examples of full board study modifications that must be reviewed at a convened meeting.
 

Modifications that must be reviewed at a convened IRB meeting may include:

• Substantial alteration to the research design or methodology;
• Broadening the range of inclusion criteria;
• Narrowing the range of exclusion criteria;
• Alterations in the dosage or route of administration of an administered drug;
• Extending substantially the duration of exposure to the test material or invention;
• The deletion of laboratory tests, monitoring procedures, or study visits directed at the collection of information for safety evaluations;
• The addition of serious unexpected adverse events or other significant risks to the study informed consent form/process;
• Personnel or site changes that affect the qualifications of the research team or facilities available to support the safe conduct of research;
• The addition of a qualified investigator with a disclosable conflict of interest

Requirements for Submission

Investigators must complete a Modification Form in Cayuse Human Ethics and submit the following documentation as applicable:  

• Revised local research protocol
• Revised or new consent/parental permission/assent documents
• Other relevant documents, revised or new, such as recruitment material, data collection or assessment tools, etc.
• Any other documentation that would be provided to subjects when such information might relate to their willingness to continue to participate in the study

How do I submit a Modification in Cayuse Human Ethics?

For step-by-step instructions for creating and submitting a Modification submission refer to the Cayuse Investigators Guide (PDF)