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Reportable New Information (RNI)

During the course of a research study, Unanticipated Problems Involving Risk to Subjects or Others (UPIRSOs) and Non-compliance may occur and need to be reported to the IRB. The guidance contained here is intended to help ensure that the reporting and review of these events occur in a timely, meaningful way so that research participants can be protected from avoidable harms.

What Must Be Reported To The IRB?

The following events are reported as a Reportable New Information and/or a Modification submission in eIRB+.

Information that does not fit into one of the categories below does not need to be submitted to the IRB.

  • Risk: Information that indicates a new or increased risk, or a safety issue. This includes a chance that something bad could happen.  For example:
    • New information (e.g., an interim analysis, safety monitoring report, publication in the literature, sponsor report, or investigator finding) indicates an increase in the frequency or magnitude of a previously known risk or uncovers a new risk.
    • An investigator brochure, package insert, or device labeling is revised to indicate an increase in the frequency or magnitude of a previously known risk, or to describe a new risk.
    • Withdrawal, restriction, or modification of a marketed approval of a drug, device, or biologic used in a research protocol.
    • Protocol violation that harmed subjects or others or that indicates subjects or others might be at increased risk of harm.
    • Complaint of a subject that indicates subjects or others might be at increased risk of harm or at risk of a new harm.
    • Any changes significantly affecting the conduct of the research.
  • Harm/Death: Any harm (including death) experienced by an NU subject or other individual(s) that, in the opinion of the investigator, is unexpected and at least probably related to the research procedures. Harms can include psychological, economic, legal, and other non-physical harms.
    • A participant at the Northwestern site has experienced a severe and unexpected reaction to the study drug. The PI thinks this is possibly related to the study drug.
    • An investigator finds out that the study involves a currently approved drug that may cause renal failure according to newly published literature. An interim analysis or safety monitoring report that indicates that frequency or magnitude of harms or benefits may be different than those initially presented to the IRB.
    • Change in FDA labeling or withdrawal from marketing of a drug, device, or biologic used in a research protocol.
    • An investigator realizes participants have accidentally been given study drug at a higher dose than was approved by the IRB. While no side effects were reported, the increase in dosage placed the subjects at potential risk of harm.
    • Four weeks into the study of a new asthma drug, a participant informs the research staff that she is pregnant although the pregnancy test done at screening was negative. Pregnancy is an exclusion factor in the study.
  • (Reportable) Non-compliance: Serious and/or continuing non-compliance with the federal regulations governing human research or with the requirements or determinations of the IRB that causes harm, increases the risk of harm, adversely affects the rights or welfare of participants or undermines the scientific integrity of the data, or an allegation of such non-compliance. Incidents of non-compliance on the part of research participants which do not involve risk need not be reported to the IRB (i.e., failure to turn in medication diary).

    Examples of Reportable Non-compliance include, but are not limited to, the following:

    • Human subjects research conducted without IRB approval.
    • Research personnel do not obtain written consent or assent for a study when the IRB has determined that consent or assent is required for a study that involves the collection of discarded tissue. While no harm occurred, failure to obtain consent/assent is a violation of the research participant’s rights.
    • Enrollment of participants before IRB approval has occurred and/or after IRB approval has lapsed.
    • Continued treatment of participants after IRB approval has lapsed without first obtaining permission from the IRB.
    • PI enrolls a participant that does not meet all of the inclusion/exclusion criteria. The criteria that were not met puts the participant at risk of harm.
    • Enrollment of children, prisoners, pregnant women and fetuses, without prior IRB approval.
    • Use of an unapproved consent form.
    • Use of unauthorized study personnel to conduct study procedures, obtain informed consent, or have access to identifiable participant information.
    • A required lab test is not done whose omission, in the opinion of the PI, poses risk of harm to participants.
    • Assessment for any inclusion/exclusion criterion was not done prior to beginning if study procedures. The criteria that were not evaluated prior to study procedures puts the participant at risk of harm.
    • A procedure, treatment, or visit specified in the protocol is conducted outside of the required time frame and has clinical consequence; poses risk of harm to subject or others; and/or is thought to be impactful to the scientific integrity of the study.
  • Audit: Audit, inspection, or inquiry by a federal agency and any resulting reports (e.g., FDA Form 483)
  • Reports: Only certain written reports of study monitors must be reported. Prompt reporting (within 5 days) is required for monitoring reports for which the industry sponsor determines the findings could affect the safety of participants or influence the conduct of the study.
  • Researcher Error: Failure to follow the protocol due to the action or inaction of the investigator or research staff.
  • Confidentiality: Breach of confidentiality.
  • Unreviewed Change: A participant at a non-Northwestern site has experienced a severe and unexpected reaction to the study drug. The sponsor thinks this may be related to the study drug and instructs sites to promptly lower the drug dosage to eliminate an immediate hazard to participants. In this case, the PI should immediately implement the dosage change prior to IRB approval and then submit an RNI to notify the IRB.
  • Incarceration: Incarceration of a subject in a study not approved by the IRB to involve prisoners.
  • Complaint: Complaint of a subject that cannot be resolved by the research team.
  • Suspension: Premature suspension or termination of the research by the sponsor, investigator, or institution.
  • Unanticipated Adverse Device Effect: Any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.
  • Investigational Pharmacy Error: An error involving the investigational pharmacy that puts participants’ rights and/or welfare at risk or undermines the scientific integrity of the data.  Please also notify the Investigational Pharmacy at INVdrugser@nm.org to get additional information for your RNI (e.g., Corrective Action Plan).
  • Short Form: If using a translated short form from the IRB website and the English language consent document as the written summary, the short form consent process may take place prior to IRB review. An RNI should be submitted to the IRB within 10 days, to report the use of the short form consent process. The RNI should contain the documents and confirmations previously described above. Additional guidance on short forms can be found here.

IRB Determinations and Definitions

Below are Board determinations with examples and are not categories to select in your RNI form:

  • Non-compliance: Failure to follow the federal regulations governing human research, requirements and/or determinations of the IRB.

    Noncompliance may result from actions or omissions by study personnel, and can range from relatively minor or technical deviations to serious deviations that threaten subjects’ rights or welfare.

    Examples of non-compliance which may not be reportable to the IRB may include, but are not limited to the following: Inadvertent use of an IRB approved non-watermarked ICF; an out of window study visit that did not cause any harm or increase the risk of harm or adversely affect the participants rights and welfare or negatively affect the integrity of the study data; or other administrative errors. Please note all occurrences of non-compliance should be documented within the study records. 

  • Serious Non-compliance: Non-compliance with the federal regulations governing human research or with the requirements or determinations of the IRB that causes harm, increases the risk of harm, adversely affects the rights or welfare of participants and/or undermines the scientific integrity of the data.

    Examples of serious non-compliance may include, but are not limited to the following:  use of an incorrect version of an ICF that omitted a potential risk of participation; safety laboratory assessments not being conducted prior to administering the next cycle of drug; conducting study procedures prior to obtaining informed consent; numerous instances of not adhering to the protocol, such that the participants data is no longer usable.

    The Board may consider mitigating factors, such as corrective action, that play a role in the determination of whether the event increased risk, decreased potential benefits, or negatively affected the integrity of the study data but if despite these factors, the panel may determine the event’s occurrence meets the definition of serious noncompliance, and then the event will be categorized as such.

  • Continuing Non-compliance: A pattern of non-compliance through failure to adhere to the regulations or institutional requirements that protect the rights and welfare of participants and others and suggests a likelihood that non-compliance will continue without intervention, or involves frequent instances of minor non-compliance.

    Continuing non-compliance may also include failure to respond to a request from the IRB to resolve an episode of non-compliance or a pattern of minor non-compliance.

    Examples of continuing non-compliance, may include but are not limited to the following: non-safety related laboratory assessments were not completed on day 15 for cycles 1-12; the quality of life assessments were not administered for participants #6-15; despite a corrective action plan the study team continues not to distribute the drug diary.

    *Note that multiple instances of non-compliance that are deemed not serious individually may constitute serious and/or continuing non-compliance when considered collectively

  • UPIRSO:  Any information, including any incident, experience, or outcome that meets ALL of the following conditions:
    1. is unexpected (in terms of nature, severity, or frequency) given the procedures described in the research protocol documents (e.g., the IRB-approved research protocol and informed consent document) and the characteristics of the human subject population being studied;
    2. is related or possibly related to participation in the research (“possibly related” means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research); and
    3. suggests that the research places human subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized, even if no harm has actually occurred.
  • Suspension of IRB Approval: An action of the IRB, IRB Executive Director, Institutional Official/Organizational Official, or designee of the Institutional Official/Organizational Official to temporarily or permanently withdraw IRB approval of some or all research procedures short of a Termination of IRB Approval. Suspended studies remain open and are subject to continuing review.
  • Termination of IRB Approval: An action of the IRB, IRB Executive Director, Institutional Official/Organizational Official, or designee of the Institutional Official/Organizational Official to permanently withdraw IRB approval of all research procedures. Terminated studies are permanently closed and no longer require continuing review.
  • Additional information needed:  When additional information is needed before the board can make a determination of UPIRSO or Non-compliance or Suspension/termination of IRB approval or None of the above.
  • None of the above: When an event does not fit the criteria for UPIRSO, Non-compliance (including Serious or Continuing), Suspension/termination of IRB approval, Allegation of non-compliance with no basis in fact, the IRB acknowledges the event as none of the above.

Death of a Research Participant

Northwestern University investigators are required to report deaths of NU* participants to the IRB office if the death was:

  • not anticipated and
  • possibly related to participation in the study.

The investigator should contact the IRB Office as soon as possible via phone or email.

Depending on the circumstances, the IRB may need to take immediate action to minimize further harm to participants such as halting the enrollment of additional participants or suspending approval of the research.

Formal notification to the IRB of the event is still required and accomplished through a New Information Report submission under the applicable study in eIRB.

NU participant includes participants enrolled at NU’s affiliate sites (RIC, NMH, NMG) or sites for which NU has agreed to serve as the IRB of Record through a signed IRB Authorization Agreement (IAA).

Reporting Requirements and Timeframes

Death of an NU/NU Affiliate* Participant that is:

  • Unanticipated
  • Related
  • Reporting Timeframe: Within 24 hours of knowledge or notification

Reportable New Information

  • Information pertaining to an NU/NU affiliate* that fits into any of the categories listed on the Reportable New Information page.
  • Reporting Timeframe: Within 5 business days of knowledge or notification
 *NU subject includes subjects enrolled at NU’s affiliate sites (NMH, NMG, NLF, SRALab) or sites for which NU has agreed to serve as the IRB of Record through a signed IRB Authorization Agreement (IAA).
 
Note:  Information that does not fit into one of the categories listed on the Reportable New Information Page does not need to be reported to the IRB.

Preparing the RNI in eIRB+

Before You Begin

Review the guidance for New Information Reporting.  Submissions that do not fit within these guidelines will be returned to the submission preparer without review.

Provide details of the event you are submitting to the IRB, the actions taken to resolve the incident, and how this type of incident will be prevented in the future. If applicable to the event, the description must address the following:

  • What happened and when?
  • What factors and/or who contributed to why it happened?
  • What was done to immediately address the issue?
  • What is the plan going forward for preventing this from happening again?

Steps To Complete The Submission

  1. Log-in to eIRB+ using your NU NetID and password.
  2. Determine if the new information is applicable to a specific study or several studies.
    1. If the new information is related to a particular study:
      1. Click My Studies and filter by PI or Study Number.
      2. Choose the applicable study from the resulting list.
      3. Click Report New Information.   (Located in the left column of the page under My Current Activities.)
    2. If the new information is related to several studies:
      1. Click Report New Information (Located in the upper left corner of your Inbox.)
  3. A blank application will open. You must complete all questions.
  4. Select the appropriate category(ies) and provide other relevant information.
  5. You will be asked:
    1. Does this information indicate a new or increased risk, or a safety issue?
    2. Does the study need revision?
    3. Does the consent document need revision? If revisions are required, describe them in the space provided and submit a study modification for review.
  6. Click Finish when you have completed the application. Please Note: This activity does not submit the form to the IRB Office.
  7. The PI or PI Proxy must click Submit for the submission to reach the IRB.

Following Your RNI Submission

The basic process for Reportable New Information in the eIRB+ system includes the following states:

  • RNI Review – The designated IRB member/convened IRB panel is currently reviewing the Reportable New Information submission.
  • Clarification Requested (RNI Review) – The IRB panel member/convened IRB panel has reviewed the submission and has requested changes or clarifications.
  • RNI Review Completed – The designated IRB member/convened IRB panel has acknowledged the RNI submission.  No additional changes are required.
  • Closed – The RNI submission may also be closed by an IRB Coordinator or a designated reviewer if not deemed to be necessary.

Post Submission Process

  1. New Information Report is submitted in eIRB+.
  2. The IRB review process begins:

Pre-Review:

The New Information Report will undergo a pre-review by IRB staff to ensure that the submission is complete and in keeping with the IRB’s requirements.  The investigator may be asked to provide additional information.  Once the submission is determined to be complete, it will be routed for IRB review.

IRB Review:

Expedited Review:

The submission is sent to an IRB member for review. The submission will receive one of the following determinations:

  • Non-compliance that is neither serious nor continuing,
  • None of the above.

An acknowledgment letter that may or may not request additional actions will be issued through eIRB+. If additional action is specified, a modification or an additional New Information Report must be submitted.

Full Board Review

The submission will be assigned to a Board meeting for review. The submission will be presented at a convened IRB meeting by a primary reviewer. The submission will receive at least one of the following determinations by the IRB:

  • Unanticipated problem involving risks to subjects or others,
  • Suspension or termination of IRB approval,
  • Serious non-compliance,
  • Continuing non-compliance,
  • Non-compliance that is neither serious nor continuing,
  • Additional information needed before determination,
  • None of the above

If the IRB determines the reported event constituted a UPIRSO, or serious and/or continuing non-compliance and the study is funded by HHS or subject to FDA regulations, these agencies will be notified by the IRB of this finding.

An acknowledgment letter that may or may not request additional actions will be issued through eIRB+. If additional action is specified, a modification or an additional New Information Report must be submitted.