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Amendments

 

If, after the initial approval of a research project, the Investigator wishes to amend or modify the study in any way (such as: changes to the study population, research personnel roster, recruitment, consent, inclusion/exclusion criteria, medications, devices or study procedures) the requested change(s) must be submitted on an Amendment Request form or a revised Personnel Roster form with a cover letter to the CHS outlining the changes and the reasons for the them.

The most frequent example of non-compliance reviewed by the CHS is the implementation of study changes without prior CHS approval. Any changes, no matter how minor (minor changes include: a change that does not alter the risk:benefit analysis of the study, affect the safety of participants, include the addition of study procedures, interactions or interventions, alter in any way the scientific integrity of the study, or include a procedure or vulnerable population for which expedited review is not permissible), must be submitted to and approved by the CHS, documented by a ROA, prior to implementation of the change(s).

The federal regulations specifically require the CHS to review proposed changes in research activity and to ensure that such changes are not initiated without CHS review and approval, except when necessary to eliminate apparent immediate hazards to the participant [45 CFR § 46.103(b)(4)(iii) and 21 CFR § 56.108(a)(4). In some circumstances, the CHS may request verification from others (such as a Department Chair, the study or site Coordinator, or the CHS QA Coordinator) that requested changes by the CHS have occurred, or that no material changes have occurred without appropriate and prior CHS review and approval.

Significant changes to the study, such as changes to the study population and study procedures, must be incorporated into the CHS Initial Application (and protocol, when appropriate), as all current study activities must be documented in one place. In addition, if changes are sought to the consent form, or if the change to the study will affect the risk:benefit analysis for participants or should otherwise be communicated to potential participants, then two consent documents (one with highlighted changes and one unmarked copy incorporating the proposed change) must be submitted to the CHS for review and approval. Incomplete submissions (lacking requisite forms, signatures, or documentation) will not be placed on the CHS monthly agenda or sent for expedited review.

 

Updated: 21-Oct-2009