News & Information
Updates for the Sterling IRB Website
01/26/10
See Chapter 4-D of the Investigator Handbook for details of Sterling IRB’s new program to audit investigative sites meeting select risk and/or enrollment criteria at random.
01/26/10
Please make note of changes in Sterling IRB’s policy pertaining to the review of studies that may involve cognitively impaired persons:
- See Chapter 9-D of the Investigator Handbook, noting Sterling IRB’s policy pertaining to obtaining assent (when possible) from persons unable to provide legally effective informed consent, including documentation of their assent to participate, and the added details regarding the continued verification of capacity to consent throughout the study.
- New Study Submission Application updated: revised question 22 (re ICD(s) submitted with protocol).
- Submission Application for the Investigator/Site updated: added questions 33 (re plan for determining capacity to consent/assent) and 38 (re process for continued verification of a subject’s capacity to consent).
- Registry Study Submission Application for the Investigator/Site updated: added questions 21 (re process for continued verification of a subject’s capacity to consent) and 28 (re plan fordetermining capacity to consent/assent).
01/26/10
Sterling IRB requires Principal Investigators (PI) to promptly report all events that may constitute unanticipated problems involving risk to subjects or others and new or updated safety information relating to the study or study product.
Unanticipated Problems Involving Risk to Subjects or Others are considered, in general, to include any incident, experience, or outcome that meets the following criteria:
- Unexpected: (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied;
- Related or possibly related: to participation in the research (possibly related means that there is a reasonable possibility that the incident, experience, or outcome may have been caused by the study product or procedures involved in the research); and
- Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.
The following events/safety information should be reported to Sterling IRB within 10 business days.
- Serious Adverse Events
- Significant Protocol Deviations
- Prospective Protocol Exceptions
- Other Unanticipated Problems
- External SAE reports (e.g., IND Safety Reports)
- Complaints from research subjects (minor subject complaints that are adequately resolved by the research staff do not need to be reported)
- Reports, publications, or interim results or findings
- DMC or DSMB reports and recommendations
- Regulatory Agency Public Health Advisory
- New or updated study product information
- Revised Investigator Brochure
- Revised label / Package Insert
- Revised Device Manual
- Sponsor or regulatory agency recall / withdrawal / clinical hold
- Adverse sponsor or regulatory agency audit or enforcement action
Please see Chapter 7 – Reportable Events and Chapter 10 – Research Conflicts and Non-compliance in the Sterling IRB Investigator Handbook for additional information regarding reporting guidelines.
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