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Amendment Request Cover Letter

Procedures for the Use of the Amendment Request Cover Letter

The Amendment Request Cover Letter form was created to formalize the means for providing the IRB/HRPP with sufficient information for an appropriate review of a request for change/modification (amendment request). Without sufficient information, the request is considered incomplete, which is likely to delay review and possible approval. By appropriately completing the form, and submitting the form and associated documentation, sufficient information can be provided for IRB/HRPP review allowing for a more timely review determination and possible ultimate approval of the request.

The form can be found here.

FAQs regarding the use of the Amendment Request Cover Letter form:

1. Why does the IRB/HRPP request the rationale for the requested changes? (Item 1 of the Request Form)

The IRB/HRPP must ensure the changes requested are appropriate for the study as done at this site. Without information regarding the rationale for the changes/modifications, the IRB would be unable to make such a determination.

2. Why does the IRB/HRPP request specific information about what the change/modification includes? (Item 2 of the Request Form)

In order to provide an appropriate review of the change/modification, the IRB/HRPP must know what is included in the request. This information should be determined by the PI. The PI should make this determination to ensure only changes/modifications directly relevant to this study as done at this site are highlighted for review.

3. Why require information about changes made to the Research Plan and consent/permission/assent documents and why they are being made? (Items 3 and 4 of the Request Form)

The IRB/HRPP must be able to confirm that changes/modifications made because of the amendment are appropriately reflected in the study documents including the Research Plan and/or consent/permission/assent documents.

4. Why ask about reconsent/reassenting of subjects? (Item 5 of the Request Form)

This information helps the IRB/HRPP determine the effect, if any, the changes/modifications may have on subjects already enrolled in the study. Additionally, should subjects be enrolled, the PI's determination whether the changes/modifications would affect the subject's willingness to continue to participate in the study is considered. If the PI does determine it may affect the subject's willingness, the subject/parent should be "reconsented/reassented" to continue to allow the subject/parent to provide an informed consent/assent and procedures for reconsenting/reassenting should be described.

5. Why ask to provide specific information about what documents that are being submitted? (Item 6 of the Request Form)

By providing this information, the PI indicates specifically the documents that should be considered for review in association with the changes/modifications being requested.

6. Why provide an evaluation regarding any changes in the risk to subjects, risk management procedures, and/or risk/benefit ratio associated with the changes/modifications? (Item 7 of the Request Form)

Per current federal regulations (45 CFR 46.111l and 21 CFR 56.111 ) and UCSD IRB/HRPP SOPPs (section 3.21 ), the IRB must ensure the study continues to satisfy the criteria for approval for research involving human subjects. These criteria include an evaluation of risks to subjects associated with the study and whether those risks are minimized. Further, providing an evaluation regarding changes to risks/risk management procedures helps in determining whether the request can be reviewed using expedited process or requires review by a convened IRB.

The regulations, policies, and procedures also include that the IRB must ensure the study continues to satisfy the criterion that the benefits derived from performing the research outweigh any risks associated with the study. If the risks outweigh the benefits, it would be unethical to continue to approve such a study.

7. Why ask if the changes/modifications affect the study in any other way? (Item 8 of the Request Form)

The approval criteria also include that the selection of subjects must be equitable and the protection of subject privacy and confidentiality of information collected must be appropriate. If the amendment would affect these additional criteria, a description of such an affect must be provided for review.

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