Purpose Describes the policies and procedures that researchers follow for identifying and reporting Reportable New Information (RNI).
BeginningThe researcher identifies possible RNI.
EndThe researcherreceives a final determination letter.
1POLICY
1.1Federal regulations and University of Washington (UW) policy require UW researchers to promptly notify the Human Subjects Division (HSD) of the following information and events, for any human subjects research in which the UW is engaged and is the IRB of record.
1.1.1Qualifying medical problem in research covered by the UW Human Subjects Assistance Program (HSAP)
1.1.2Breach (or risk of breach)or loss of subject confidentiality or privacy
1.1.3Inappropriate access or useof Protected Health Information (PHI)
1.1.4Incidental incarceration of a subject in a study that the IRB has not approved for the inclusion of prisonersand where study activities or data collection will continue while the subject is incarcerated
1.1.4.1For Department of Defense funded EFIC (Exception From Informed Consent) studies only: All incidental incarceration of a research subject must be reportedto HSD even if study activities and data collection will not occur during the incarceration
1.1.5Premature suspension or termination of some or all of the research by the sponsor, researcher, or institution
1.1.6Unanticipated problem
1.1.7Unanticipated adverse device effect
1.1.8Serious non-compliance
1.1.9Continuing non-compliance
1.1.10Emergency deviation from IRB-approved procedures made without prior IRB review to eliminate an apparent immediate hazard to a subject or others
1.1.11Continuation of research procedures after IRB approval has lapsed, because the procedures are of direct benefit to individual subjects or withholding the research intervention (if any) may increase risks to subjects
1.1.12Audit, inspection, compliance-related inquiry, or safety-related inquiry from a federal agency
1.1.12.1Includes initial notification of an upcoming audit or inspection
1.1.12.1.1Initial notification may be made by phone or email
1.1.13Information that indicates a new or increased risk or safety issue (or a decrease in study benefits) such as:
1.1.13.1A publication in the literaturethat indicates an increase in the frequency or magnitude of a previously known risk, or uncovers a new risk.
1.1.13.2An investigator brochure, package insert, or device labelingthat is revised to indicate an increase in the frequency or magnitude of a previously known risk, or to describe a new risk.
1.1.13.3Modification of FDA-approved labeling, or withdrawal, restriction, or modification of a marketed approval of a drug, device, or biologic used in a research protocol.
1.1.14Any Data and Safety Monitoring Board (DSMB) or other study monitoring reports
1.1.15Complaint from a subject or other person about the study which cannot be resolved by the research team
1.2HSD relies upon the expertise of the researcher to make an initial assessment of the information/event, to determine whether it meets the reporting requirements described above, and to determine the relationship of the information/event to the research.
1.3Reporting time frame.
1.3.1Qualifying medical problems, breaches, loss of confidentiality or privacy, or inappropriate access or use of PHI must be reported within 24 hours of when the researcher becomes aware of the problem.
1.3.2Incidental incarceration of a subject (as defined above) must be reported within 3 business days of when the researcher becomes aware of the event.
1.3.3All other RNI must be reported within 10 business days of when the researcher becomes aware of the information or event.
2RESPONSIBILITIES
2.1Researchers are responsible for:
2.1.1Understanding and following the above reporting requirements.
2.1.2Providing and implementing any IRB-approved corrective or preventive action plan (CAP) within the specified time frame.
2.1.3Notifying other UW offices or other institutions where required (e.g. UW Medicine Patient Safety Net, study Sponsor, FDA, etc.).
2.2HSD staff members are responsible for:
2.2.1Providing consultation to researchers on reporting requirements.
2.2.2Determining whether the RNI represents an unanticipated problem, unanticipated adverse device effect, and/or serious or continuing noncompliance.
2.2.3Notifyingthe IRBs, other UW offices, regulatory agencies, sponsor(s), or other institutions as outlined in theZIPLINESOP: HSD Management of RNI(where applicable).
2.2.4Providing a written determination to the researcher.
2.3IRB members are responsible for:
2.3.1Reviewing the reported new information, requiring modifications (where necessary), and approving any proposed corrective or preventive action plan or changes in research.
3PROCEDURE
3.1Submit RNI. Follow the INSTRUCTIONS: Submit RNI (Researcher Version) in Zipline, making sure to include the:
3.1.1ZIPLINE SUPPLEMENT: Report of New Informationform if the RNI involves noncompliance or a problem or event related to a subject
3.1.2DSMB or other monitoring report (if applicable)
3.1.3Audit or compliance report (if applicable)
3.1.4Any relevant supporting documentation
3.2Requests for clarification. Follow the INSTRUCTIONS: Respond to Clarification or Modification Requestsin Zipline if you receive an email request from the system to provide additional information or make changes to your RNI submission.
3.3Requests for additional action.Follow the INSTRUCTIONS: Respond to Action Requiredin Zipline if you receive an email request from the system to take additional actions requested by the IRB.
3.4Withdrawing or discarding RNI. Follow the INSTRUCTIONS: Withdraw or Discard Submission in Zipline if:
3.4.1You need to withdraw the submission to make edits before HSD review has begun.
3.4.2You wish to discard the submission prior to HSD review because the submission does not require review (i.e. does not meet RNI reporting requirements)
4MATERIALS
4.1INSTRUCTIONS: Respond to Action Required
4.2INSTRUCTIONS: Respond to Clarification or Modification
4.3INSTRUCTIONS: Submit RNI (Researcher Version)
4.4INSTRUCTIONS: Withdraw or Discard Submission
4.5ZIPLINESOP: HSD Management of RNI
4.6ZIPLINE SUPPLEMENT: Report of New Information
5REFERENCES
None
02/05/2018 / ZIPLINE SOP:RNI Reporting by Researchers / #2071Version 2.0 / Page 1 of 3