Reportable New Information

Reportable New Information (RNI)

Table of Contents

• What is Reportable New Information (RNI)?
• Why Reporting RNI Matters
• What Kinds of Events/Information Should Be Reported to BYU IRB
• What is an Adverse Event (AE)
• Typical Situations that Count as RNI or Require Reporting
• When and How to Report
• Principal Investigator Responsibilities
• What Happens After You Report (What the IRB Does)
• Simple "RNI Decision Checklist" - Should I Report?

What is Reportable New Information (RNI)?

Any new information, event, or issue that arises during a research study (i.e., an accident, experience, new information or outcome) that may:

• Place human subjects or others at a greater risk of harm, 
• Adversely affect the safety, rights or welfare of human subjects, 
• Compromise the quality or integrity of the research data, 
• Significantly adversely affect the Human Research Protection Program (HRPP), or 
• Represent a pattern of on-going non-compliance.   

Reportable New Information must be promptly reported to the Human Research Protection Program, BYU.HRPP@byu.edu.

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Why Reporting RNI Matters

• Protects the welfare, privacy, and rights of research subjects. 
• Enables the IRB to assess whether changes to the study protocol or consent process are necessary. 
• Helps to maintain institutional compliance with federal and University regulations and policies. 
• Ensures trust in the research process and ethical conduct. 

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What Kinds of Events / Information Should Be Reported to BYU IRB

Events that may meet the below definitions of an Unanticipated Problem Involving Risk to Human Subjects or Others, Serious Non-Compliance, and/or Continuing Non-Compliance must be promptly reported to the University IRB.

• Unanticipated Problems (UAP) Involving Risk to Human Subjects or Others defined as any accident, experience, new information or outcome that meets all of the following criteria: 

  • Unexpected in terms of nature, severity, or frequency; AND 
  • Related, or possibly related, to a subject’s participation in the research; AND 
  • Places human subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized. 
• Serious Non-compliance:   Non-compliance that significantly adversely affects the safety, rights or welfare of human research subjects or others, significantly compromises the quality or integrity of the research data (i.e., negatively impacts the ability to draw conclusions from the study data), or significantly negatively affects the integrity of HRPP.   
• Continuing Non-compliance: Non-compliance that has been previously reported or a pattern of ongoing Non-compliance that  significantly adversely affects the safety, rights or welfare of human research subjects or others, significantly compromises the quality or integrity of the research data (i.e., negatively impacts the ability to draw conclusions from the study data), or significantly negatively affects the integrity of the HRPP. 

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What is an Adverse Event (AE)

OHRP defines an adverse event (AE) as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research.

Adverse events encompass both physical and psychological harms.  They occur most commonly in the context of biomedical research, although on occasion, they can occur in the context of social and behavioral research. BYU does engage in research that are both biomedical and psychological.

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 
• For Devices, required intervention to prevent permanent impairment or damage 

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.

Unanticipated Problem Involving Risk to Human Subjects or Others (UAP)

While an UAP is often an Adverse Event, it includes other negative events in addition to Adverse Events.  An UAP may involve breach of confidentiality, published literature that may impact the conduct of the study, unresolved subject complaint, etc.  

An adverse event may be an UAP if it meets ALL of the definitions below depending on where the event occurred:

Adverse Events that are:

1. unexpected,  
2. related or possibly related to the research intervention, and  
3. 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. 

Most Adverse Events will not meet the definition of an Unanticipated Problem Involving Risk to Subjects or Others.  Expected Adverse Events or Adverse Events which are determined by the Investigator to be unrelated to the research intervention do not need to be submitted to the IRB as Reportable New Information but should be documented in an adverse event log. 

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Typical situations that count as RNI or require reporting:

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When and How to Report

• The Principal Investigator must determine whether or not a problem is caused by or related to the study. The regulations at 45 CFR 46.108 (a)(4)(i) and 21 CFR 56.108 (b)(1) allow the PI to make the initial reporting determination. 
• The PI is also responsible for meeting all reporting obligations (i.e., notifying the study sponsor, lead site, etc.). 
• For serious or unexpected events (e.g., physical/psychological harm): report immediately, with a written report from the PI — within 24 hours for serious adverse events.  
• For other events/problems (e.g., breaches of confidentiality, noncompliance, protocol deviations, complaints): report promptly — often within one week of first awareness.  
• Submit an Incident Report in OneAegis. 
• If needed, the IRB may request additional information, corrective actions, re-consent, modification of protocol or consent materials, or even suspend the study.  

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Principal Investigator Responsibilities

• Monitor your study constantly for any new issues, feedback, or unexpected events. 
• Ensure all research team members (staff, students, assistants) understand and follow data security, confidentiality, and protocol procedures. (BYU strongly encourages data-security planning — e.g., coded identifiers, secure file storage, encrypted data, etc.) 
• Report any RNI to the IRB as soon as possible, using the correct forms and procedures. 
• Document all actions taken: what happened, when you learned of it, what you did, how subjects (if any) were affected, and any corrective measures. 
• Cooperate fully if the IRB investigates, and implement any required modifications, re-consent, or follow-up. 

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What Happens After You Report (What the IRB Does)

Once you submit an RNI report:

• HRPP Associate Director, in consultation with the IRB Chair, Vice Chair, and a subcommittee of IRB members will triage the event: decide whether it is “non-reportable,” “minor,” “possible non-compliance,” or a serious problem.  
• The IRB may review it via an expedited pathway or refer to full-board review if serious risk or noncompliance.  
• Possible IRB actions: 
• Accept the report and continue the study with no changes 
• Require modifications to the research protocol or consent materials 
• Ask for re-consent of participants 
• Mandate additional data-security or monitoring procedures 
• Suspend or terminate the study if risk is unacceptable or compliance problems are serious  
• The IRB may require you to inform research subjects of new risks or changes, depending on the nature of the RNI.  

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Simple "RNI Decision Checklist" - Should I Report?

Use this as a quick self-check. If you answer “yes” to any of these, you should report to BYU IRB:

• Did something happen that was not expected when the study was approved? 
• Could participants’ privacy, confidentiality, or data security be compromised? 
• Did you or someone on the team deviate from the approved protocol (consent, procedures, recruitment)? 
• Did a participant complain or express concerns about harm, coercion, or privacy? 
• Is there new information (research findings, external regulation, etc.) that might change the risk/benefit balance? 
• Has there been a change in funding, investigator conflict of interest, or sponsorship? 
• Are you stopping, pausing, or significantly changing the study for reasons related to risk or compliance? 

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