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Changes in Research

August 2010

1. Why must changes in research be reviewed?
2. What is required prior to JHM IRB review?
3. How will the changes in research request be reviewed if the research qualified for expedited review in the past?
4. How will the change(s) in research request be reviewed if the research required convened review in the past?
5. What action may the IRB take on a change in research request?

1. Why must changes in research be reviewed?

Federal regulations require that changes to IRB approved research may not occur without prior IRB review and approval, unless a change is required to eliminate an apparent immediate hazard to subjects.  If the change was made to eliminate an apparent immediate hazard to subjects, it should be submitted to the JHM IRB promptly for review. “Prompt” reporting at Johns Hopkins Medicine means as soon as possible, but not later than ten (10) working days. 

Approval notices sent to the PI by the JHM IRB state the requirement for JHM IRB review and approval of any changes to approved research prior to the activation of those changes.   

2. What is required prior to JHM IRB protocol review?

To initiate the review of a change in research request, the PI must submit a “Changes in Research Application” for paper studies or a Further Study Action for Changes in Research in eIRB.  If the request involves a change to the protocol, application, and/or Consent Form, the revised documents or pages must be submitted with the changes highlighted.  All new documents which are part of the request must be submitted as well.  

3. How will the change(s) in research request be reviewed if the research qualified for expedited review in the past?

If the research met the criteria for expedited review during the initial or last continuing review, and the proposed change does not affect that status, the JHM IRB review will be conducted using an expedited review procedure.  If the proposed change does not qualify for an expedited review procedure, the proposed change will be reviewed at a convened meeting of the JHM IRB and the status of the study will be changed from expedited review to convened review.

4.How will the change(s) in research request be reviewed if the research required convened review in the past?

(a)  If the research required convened review at the initial or last continuing review, but the proposed change is minor, the JHM IRB review may be conducted using an expedited review procedure. 

(b)  If the research required convened review at the initial or last continuing review and the change is not minor, the review of the request must be conducted during a convened meeting of the JHM IRB.

Major modifications - Convened review:

Minor modifications - Expedited Review Criteria:

  • Increasing the physical and/or psychological risk/discomfort to the participant
  • Major change in the design or goal of the study
  • Making multiple changes in the protocol, instruments, and/or consent
  • Adding a new consent form
  • Expanding the eligibility criteria
  • Increasing the number of participants at risk
  • Adding questions asking for sensitive information e.g. depression or sexuality
  • Adding an element that may breach the confidentiality of the participant (example: adding focus groups)
  • Numerous modifications throughout the year where there may be confusion or a question as to the full scope of the study
  • Whenever a study is closed for safety reasons e.g. FDA, DSMB, and/or PI initiated the closure will be referred to the full Board for review
  • Gene Therapy Trial - unless minor administrative changes or the IRB Chair determines that the risk/discomfort is reduced to the participant.
  • Reduction of risk/discomfort to the participant
  • Adding or removing an institution
  • Changes to recruitment and advertising
  • Changes in the PI
  • Adding a questionnaire or instrument similar to the one already approved e.g. uses many of the same questions
  • Removing question from a questionnaire or instrument
  • Minor editorial modifications to the protocol, questionnaire, and/or consent that do not alter the meaning or procedure (spelling change, grammar, etc)
  • Consent form modifications that add or remove information from the consent form so that it is consistent with an already approved IRB requirement.
  • Defining a phrase more clearly in lay language
  • Updating a consent form to use IRB approved boiler plate language

NOTE:The above examples are presented as general guidelines only. Specific amendment classifications are made on a case-by-case basis.

5. What action may the IRB take on a change in research request?

The JHM IRB may act on a change in research request in one of three ways:

  1. The request may be approved;
  2. The request may be tabled pending submission of revisions; or
  3. The request may be disapproved

(Note: a request may not be disapproved in an expedited review procedure. If the reviewer determines that the request should be disapproved, the request will be scheduled for review at a convened meeting.)

Written notification of actions taken after review of the request is provided to the PI. Provided with the approval notice is the final approved version of respective consent form(s) if applicable.  For electronic studies, the consent form(s) will be uploaded in eIRB.  The research and consent forms are approved only for the period specified by the IRB.  Generally, approval of a change(s) in research will not change the date that the research will expire.  If a consent form is revised in association with the change(s) in research, it is valid only until the original approval date for the research expires.  In cases where the request is disapproved, the IRB will provide its rationale for the action taken. 


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