(AS - Approved As Submitted) (AA - Approved Pending Minor Revisions) (AH -Action Held, Serious Concerns) (Obtain Expert Consultant Opinion) (Not Approved) I believe this study qualifies under Expedited category number: Definitions: No changes required to protocol or informed consent documents AS Approved As Submitted – – Specific revisions to protocol or informed consent documents are being provided AA Approved Pending Revisions – – to the PI for simple concurrence AH Action Held, Serious Concerns Substantive revisions or clarifications are needed to the protocol or informed consent – – documents that are directly relevant to the IPRB’s determination that: Risks to subjects are minimized Risks to subjects are reasonable in relation to anticipated benefits Selection of subjects is equitable Informed consent is sought in accordance with, and to the extent required by law Informed consent is documented, in accordance with, and to the extent required by law When appropriate, the research plan makes adequate provision for monitoring data When appropriate, there are adequate provisions to protect subject privacy Additional safeguards are in to protect vulnerable populations or those subject to coercion Obtain Expert Consultant Opinion The protocol is referred to an expert for an additional review – Not Approved Study is not approved –
(AS - Approved As Submitted) (AA - Approved Pending Minor Revisions) (AH -Action Held, Serious Concerns) (Obtain Expert Consultant Opinion) (Not Approved) I believe this study qualifies under Expedited category number: Definitions: AS – Approved As Submitted – No changes required to protocol or informed consent documents AA – Approved Pending Revisions – Specific revisions to protocol or informed consent documents are being provided to the PI for simple concurrence AH – Action Held, Serious Concerns – Substantive revisions or clarifications are needed to the protocol or informed consent documents that are directly relevant to the IPRB’s determination that: Risks to subjects are minimized Risks to subjects are reasonable in relation to anticipated benefits Selection of subjects is equitable Informed consent is sought in accordance with, and to the extent required by law Informed consent is documented, in accordance with, and to the extent required by law When appropriate, the research plan makes adequate provision for monitoring data When appropriate, there are adequate provisions to protect subject privacy Additional safeguards are in to protect vulnerable populations or those subject to coercion Obtain Expert Consultant Opinion – The protocol is referred to an expert for an additional review Not Approved – Study is not approved
IPRB%20Committee%20Form.docx