Reportable New Information FAQs

Who specifically is responsible for submitting Reportable New Information (RNI)?

The Primary Investigator assumes ultimate responsibility for ensuring that RNIs are reported to the IRB within the required time frames.

What kind of events are required to be reported to the IRB?

  • Unanticipated Problems involving risk to human subjects or others
     
  • Adverse Events
     
    • Internal Adverse Events that are (i) Unexpected, (ii) Related or Possibly Related to the Research Intervention, and (iii) serious or otherwise suggests that the research places the subject or others at a greater risk of harm (including physical, psychological, economic or social harm) than was previously known or recognized.
       
    • External Adverse Events that are (i) Unexpected; (ii) Related to the Research Intervention and (iii) Serious or otherwise suggests that the research places subjects or others at greater risk than was previously recognized.
       
  • Non-compliance/protocol deviations that:
     
    • Adversely affect the rights and welfare of human subjects OR compromise the integrity of the research data

What is the definition of an Unanticipated Problem (UAP)?

Unanticipated Problem Involving Risks to Human Subjects or Others: Any accident, experience, or outcome that meets all of the following criteria: 1) unexpected in terms of nature, severity, or frequency; 2) related, or possibly related, to a subject’s participation in the research; 3) places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.

What is the definition of an adverse event?

An unfavorable medical occurrence, which may include abnormal signs (for example, abnormal physical exam or laboratory finding), symptoms, or disease, temporally associated with, but not necessarily considered related to, the subject’s participation in the research study. Not all adverse events meet IRB reporting guidelines.

What is a serious adverse event or suspected adverse reaction?

  • The FDA defines an adverse event or suspected adverse reaction as “serious” if, in the view of either the investigator or sponsor, it results in any of the following outcomes: Death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/ birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of drug dependency or drug abuse.

What are the differences between an internal and external adverse event?

  • External adverse events are adverse events that occur at a site external to the authority of the University IRB and is reported to the University or UPMC investigator.
     
  • Internal adverse events are adverse events that occur at a site that falls directly under the authority of the University IRB.  

What is the definition of Non-compliance/protocol deviations?

Non-compliance/protocol deviations are defined as any failure on the part of the investigator or any member of the study team to follow the terms of University of Pittsburgh IRB approved protocol or to abide by applicable laws or regulations, or University of Pittsburgh IRB policies.

What is the difference between a “reportable event (OSIRIS)” and “Reportable New Information (PittPRO)”?

In the most basic terms, reportable events and Reportable New Information (RNI) are the same thing – the terminology is just different. More specifically, when investigators submit a reportable event in the OSIRIS system, they must select whether the reportable event is either a) Non-compliance/protocol deviation, b) an Unanticipated problem involving risk to human subjects or others, or c) an adverse event. Additionally, each reportable event must be attached to a specific protocol.The PittPRO system attempts to simplify reporting to the IRB by only having one reporting category, “Reportable New Information”. This reduces the burden on the investigator to make the determination of what is the correct type of submission, and also allows for an investigator to submit a single submission to be attached to multiple protocols (for example, if the FDA issued a new black box warning for a medication that is being used in multiple research protocols by an investigator, he or she could submit one new reportable new information submission and link this report to all of his/her protocols that are using that medication).

Within what timeframe does the PI need to submit reportable new information?

  • Internal Adverse Events which are unexpected, fatal or life-threatening, and related or possibly Related to the Research Intervention must be reported to the IRB within 24 hours of learning of the event. (Note: It is recognized that the information available during this 24-hour period may not be sufficient to permit accurate completion of the required adverse event reporting forms. However, the IRB should, at a minimum, be notified of the fatal or life-threatening internal adverse event during this time frame, with subsequent follow-up submission of a more detailed written report.) All other internal Adverse Events will be reported to the IRB within 10 working days of the investigator learning of the event.
     
  • External Adverse Events which are Unexpected, Serious AND suggest that the research places subjects or others at greater risk than was previously recognized and Related to the Research Intervention will be reported to the IRB within 30 working days of their receipt by the University/UPMC investigator. (Note: only sponsor-generated safety reports that meet the Adverse Event reporting of the IRB should be submitted to the IRB.)
     
  • Unanticipated Problems Involving Risks to Human Subjects or Others and incidents of reportable non-compliance (see below) must be submitted within 10 working days of the investigator becoming aware of the event.

When does the PI need to report non-compliance/protocol deviations to the IRB and when can it be filed in a log?

The IRB is changing the requirement for Primary Investigators to report all non-compliance/protocol deviations directly to the IRB. PI’s will now be able to keep track of minor non-compliance/protocol deviations in a tracking log. This reduces the administrative burden on Primary Investigators, their staff, and the IRB staff.

The mission of the IRB is the protection of the rights and welfare of human subjects participating in medical research. When evaluating any occurrence of a non-compliance/protocol deviation, the first question to ask is “Did this event adversely affect the rights and welfare of human subjects OR significantly compromise the integrity of the research data?”

Making this determination can be challenging at first for someone who does not regularly evaluate research protocols for compliance. An investigator should err on the side of reporting to the IRB or call the adverse events coordinator for insight if he or she is unsure if something should be reported.

Evaluating the event in the context of patient safety often provides the best direction. First ask “what are the specific risks and/or research activities that this subject consented to, and were these risks elevated in any way by the non-compliance/protocol deviation”? If that answer is “no”, the second question to ask is “Did this non-compliance (or series of non-compliant activities) create a situation where the integrity of the research data could be affected?” If both questions can be answered negatively, it is likely that the non-compliance can be kept in the log and not reported directly to the IRB.

For a detailed explanation of what constitutes risk to human subjects, please refer to Chapter 17 of the IRB Policies and Procedures.

What are some examples of non-compliance that would need to be reported to the IRB?

Examples of non-compliance that must be reported to the IRB include (but are not limited to):

  • Failure on the part of the investigator or any member of the study team to follow the terms of University of Pittsburgh IRB approved protocol or to abide by applicable laws or regulations, or University of Pittsburgh IRB policies that:
     
    • adversely affect that rights and welfare of human subjects, or
       
    • significantly compromises the quality of the research data  
       
  • Performing non-exempt human subject research without obtaining prospective University IRB approval;
     
  • Implementing protocol modifications without obtaining prospective IRB approval;
     
  • Initiating research activities prior to obtaining consent  
     
  • Altering from the informed consent process as described in the IRB approved protocol  
     
  • Having research activities performed by individuals who are not sufficiently trained or credentialed to perform the task.   
     
  • Obtaining consent using an outdated consent form, when the new consent form contained new information that may have caused the subject to change their mind about participating;
     
  • Conducting research during a lapse in IRB approval;
     
  • Not adhering to inclusion/exclusion criteria;
     
  • Enrolling more subjects than were approved in the protocol of a greater than minimal risk study;
     
  • Performing research at an unapproved site
     
  • Failure on the part of IRB staff involved in research review or oversight to abide by applicable laws or regulations, or University of Pittsburgh IRB policies.

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).

What is the difference between an adverse events log and a non-compliance log?

An Adverse Event Log is meant to be a record of all adverse medical events that occur to subjects during the course of the study, including both significant and non-significant adverse events. A Non-Compliance log is meant to be a record of all protocol deviations and instances of protocol non-compliance that occur during the course of a study.

When are non-compliance and/or adverse events logs mandatory and when are they recommended (not mandatory)?

  • Adverse Events Log: It is mandatory for Sponsor-investigators to maintain a log of adverse events. While not mandatory for clinical investigators, maintenance of an adverse event log is a best practice for all clinical investigators.
     
  • Non-Compliance Log: it is a mandatory requirement for non-compliance logs to be maintained for:
     
    • Greater than minimal risk studies
       
    • Studies that meet the federal definition of a “clinical trial”
       
    • Studies for which reporting is required by the funding agency

Failure to maintain a log as required may be determined by the IRB to represent serious or continuing noncompliance. Non-Compliance logs are not required to be submitted at annual review but must be available upon request.

Non-Compliance Logs are recommended but non-mandatory for all other studies

How do reporting responsibilities of the PI change if the University of Pittsburgh is not the IRB of record?

Responsibilities for reporting are case-by-case and are dictated through either the IRB Authorization Agreement or additional study specific research plans executed for the project.  For assistance with this, email irb.reliance@pitt.edu.

What are the reporting requirements for research subject non-compliance and deviations, I.e. events that are not the fault of the investigator or study team?

  • Generally, when non-compliance/protocol deviations occur that are the responsibility of the research subject (examples include but are not limited to missed appointments causing out-of-window research procedures, investigational agent/medication non-compliance, inclusion of subject who meets exclusion criteria due to subject error), it should be documented in a non-compliance log but not reported to the IRB.
    • What if risk to human subjects is involved?

All instances of non-compliance/protocol deviations that increase risk to human subjects, including non-compliance/deviations that are not the responsibility of the research staff, should be reported to the IRB as an Unanticipated Problem (UAP; OSIRIS) or RNI; PittPRO).

How do I submit an RNI in PittPRO?

Please refer to the IRB Researchers's Quick Reference Guide available in PittPRO Help Center that provides detailed instructions for submission of an RNI (Create and submit Reportable New Information).

How do I submit reportable events in OSIRIS?

  • Open the study where you need to submit a report
     
  • Under “My Activities,” click on New Reportable Event
     
  • Complete the branching questions
     
  • Once completed, the PI must hit the “submit” button

What does the IRB do with the report event or RNI once we submit it?

Reportable new information is reviewed by the IRB. If there is the possibility that the RNI represents an unanticipated problem with risk to human subjects or others, or possibly serious or continuing non-compliance, the RNI will be reviewed by an IRB committee.

What are the possible actions the IRB can take when reviewing an adverse event or RNI?

A detailed description of IRB Committee procedures is available in Chapter 17, Responsibilities of the IRB, of the IRB Policies and Procedures.

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