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Protocol Amendment

When and How to Amend an IRB Approved Human Research Study

Per federal regulations, once a human research study has received IRB approval, any subsequent changes to the study must be reviewed and approved by the IRB prior to implementation except when necessary to avoid an immediate, apparent hazard to a subject. (See Reporting of Unanticipated Problems.Amendments to IRB approved protocols are faciliated via Kuali Research (KR) Protocols.

Amendment to Exempt Research

Research activities in which the only involvement of human subjects will be in one or more of the categories specified under 45 CFR 46.104 (d) are exempt from the requirements of the basic Health and Human Services Policy for the Protection of Human Research Subjects (Subpart A). Because of this, and in an effort to streamline, the UCI HRP has implemented several efficiencies related to exempt research.

Examples of minor changes to exempt research: Do NOT submit an amendment to the UCI IRB when:
1.    Making editorial or administrative revisions to consent documents or other study documents
2.    Adding non-sensitive questions to a survey or interview or revising current questions
3.    Adding a new recruitment material that follows IRB guidelines
4.    Increasing or decreasing the number of participants - unless adding a new population as noted below**
5.    Making study team/personnel changes - except a change in Lead Researcher (LR)

Examples of significant changes to exempt research: DO submit an amendment to the UCI IRB when:

1.   When adding a new population as follows:
       a.    A targeted recruitment of children
       b.    A targeted recruitment of adults (age 18 or older) who may not be legally/mentally/cognitively competent to consent
       c.    A targeted recruitment of prisoners
       d.    A targeted recruitment of American Indian/Alaska Native tribes
       e.    A targeted recruitment of undocumented people
2.    Adding non-UCI personnel engaged in research: a) intervening or interacting with the participants and/or b) having access to participant identifiable private information for research purposes.  
3.    Adding the use of the UCI Social Science Human Subject Lab (SONA).
4.    Adding an international research site
5.    Adding questions about sensitive aspects of the participants’ behavior such as illegal conduct, drug use, sexual behavior or use of alcohol – to a survey or interview
6.    For a change in study LR
7.    To disclosure a new financial interest
8.    When adding Department of Justice (DOJ) funding
9.    For any change that makes the study no longer eligible for Certification of Exemption (study will require expedited or full committee review)

Non Exempt Research Amendment

Types of Amendments

Amendments are categorized into minor and significant changes.

Examples:

Minor change - A proposed change in research related activities that does not significantly affect an assessment of the risks and benefits of the study and does not substantially change the specific aims or design of the study.

Examples of minor changes to a research study include but are not limited to, the following:

  • The addition of research activities that would be considered independent from the main research protocol;
  • 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;
  • The addition or deletion of qualified investigators;
  • The addition of study sites (which may require a Federal Wide Assurance (FWA) and appropriate IRB approval) or the deletion of study sites; or
  • Minor changes specifically requested by the Conflict of Interest Oversight Committee (COIOC); Institutional Biosafety Committee (IBC); the Scientific Review Committee (SRC); or other University Committees with jurisdiction over the research.

Significant change - A proposed change in research related activities that significantly affects an assessment of the risks and benefits of the study or substantially changes the specific aims or design of the study.

Examples of significant changes to a study may include, but are not limited to, the following:

  • 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 Informed Consent Disclosure; or
  • Changes, which, in the opinion of the IRB chairperson or his/her designee, do not meet the criteria or intent of a minor modification;
  • The addition of a qualified investigator with a disclosable conflict of interest.

Level of Review for Amendment

An amendment to an approved human research study will generally be reviewed at the same level of review in which the study was first reviewed, however, it is the level of risk posed to the subject that helps determine the review process (via subcommittee or full committee).

  • Minor changes may undergo subcommittee review
  • Significant changes require review by the full committee.

There are submission deadlines for full committee review of amendment requests.

Prospective Deviation

Amendments can also occur as prospective deviations to the protocol.

A Prospective Deviation is an anticipated and / or intentional and known deviation to the protocol for no more than 3 subjects before they occur.

Examples of prospective deviations to a research study include but are not limited to, the following:

  • Inclusion/exclusion criteria deviation

  • Allowing subject to remain in study despite reaching an endpoint or progression of disease

  • Dosing variance

To request approval of a proposed prospective deviation, complete and submit a Prospective Deviation Request in Kuali Research (KR) Protocols.

Do not use this form for routine, non-significant reporting of issues such as out-of-window or rescheduled visits. 

Notification of IRB Approval

Approval of amendment requests are documented in an approval letter to the Lead Researcher, and copied to the Faculty Sponsor (if applicable).

Amendments approvals will be uploaded in Kuali Research (KR) Protocols.

Reminder: Approved amendments do not extend the approval period of the protocol.

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