Reportable New Information includes any unexpected developments or incidents that may affect:

• The safety, rights, or welfare of participants
• The integrity of the research data
• The compliance of the study with IRB-approved procedures or regulations

Examples of RNI include:

• Unanticipated problems involving risks to participants or others
• Serious or continuing noncompliance with the protocol or regulations
• New information that may affect participants’ willingness to continue in the study
• Significant protocol deviations or violations
• Any suspension or termination of research by a sponsor, investigator, or institution

Information items that fall into one or more of the following categories must be reported to the IRB within five business days of becoming aware of said item. Information that does not fall under any of the categories does not require reporting to the IRB.

Why Reporting Matters

Reporting RNI:

• Helps protect current and future research participants
• Ensures your study remains in compliance with federal regulations and institutional policies
• Enables the IRB to provide appropriate oversight and take action if needed

The requirement to report applies to all approved human subjects research, regardless of funding source or risk level.

When and How to Report

• RNI must be reported promptly, typically within 5 business days of becoming aware of the issue.
• Use Huron IRB to submit a Reportable New Information Form.

What to Include in Your Report

According to the HRPP Toolkit guidance, your RNI submission should contain:

• A clear description of the event or information
• Identification of the cause, when it can be determined
• An assessment of risk to participants
• Any corrective or preventive actions already taken or planned

Sample RNI Form: HRP-214

In some cases, Reportable New Information (RNI) may reveal the need to change the research protocol, consent documents, recruitment materials, or study procedures to protect participants or address new risks.

Common Scenarios

• New risks or side effects identified during the study
• A need to update the consent form with new information
• Changes in study procedures to reduce risk or improve participant safety
• Implementation of corrective actions following noncompliance
• Revisions to recruitment or data collection methods in response to a problem

What To Do

If your RNI results in a change to the research, you must submit:

1. A Reportable New Information (RNI) report, and
2. A Modification request to reflect the necessary changes

These two submissions may be reviewed together by the IRB, but both are required to maintain compliance.

Research participants, their family members or anyone else may have complaints, concerns or questions about a Brown research study. Such complaints should be reported to the HRPP. All complaints or concerns reported to the HRPP are reviewed and, if necessary, further investigated.

submitting complaints and concerns

An adverse event is any untoward or unfavorable occurrence (physical or psychological) in a human participant, including any abnormal sign, symptom or disease, temporally associated with the participant’s time in a research study, whether or not considered related to their participation. These events can occur in the context of biomedical or social/behavioral research. This term is construed broadly.

Continuing Noncompliance

Continuing noncompliance is any demonstrated pattern of noncompliance that may indicate:

• an insufficient understanding or misapplication of federal, state or local regulations that govern human subjects research, or institutional policies and procedures that apply to human subjects research;
• a compromise of the study quality or scientific integrity such that important conclusions can no longer be reached; or
• frequent instances of noncompliance suggesting a likelihood that noncompliance will continue without intervention.

Minimal Risk

Nonincarcerated Populations

Minimal risk to nonincarcerated populations means that the probability (likelihood) and magnitude (consequences) of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Incarcerated Populations

Minimal risk to incarcerated populations means the probability (likelihood) and magnitude (consequences) of physical or psychological harm anticipated in the research is what is normally encountered in the daily lives, or in the routine medical, dental or psychological examination of healthy persons.

Noncompliance

Noncompliance includes, but is not limited to, any incident involving: 

• a failure to comply with federal, state or local regulation that governs human subjects research;
• a violation of institutional policies or procedures applicable to human subjects research;
• any unapproved deviation from stipulations imposed by the institution as a condition of HRPP/IRB approval; and
• any unapproved deviation from an HRPP/IRB-approved protocol, unless such deviation is necessary to preserve the life or health of a participant and the HRPP team and IRB, as appropriate, are notified as soon as possible after the deviation occurs.

Related or Possibly Related to Participation

An adverse event may be related or possibly related if there is a reasonable possibility that the incident, experience or outcome may have been caused by the research activities.

Serious Adverse Event (SAE)

An SAE is any adverse event that:

• results in death;
• is life-threatening (places the subject at immediate risk of death from the event as it occurred);
• results in inpatient hospitalization or prolongation of existing hospitalization;
• results in persistent or significant disability/incapacity;
• results in congenital anomaly/birth defect; or
• based upon appropriate medical judgment, may jeopardize the subject’s health and may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.

Serious Noncompliance

Serious noncompliance is any incident of noncompliance that involves a willful disregard or knowing violation of the federal, state or local regulations that governs human subjects research, or the institutional policies and procedures that apply to human subjects research, which may have included or led to a significant harm, or a risk of significant harm, to the rights, welfare or safety of participants; or significant compromise of the quality or scientific integrity of a human subjects research study.

Suggests Research Places Participants or Others at a Greater Risk of Harm than Previously Known

An adverse event may suggest the research places participants or others at a greater risk of harm than previously known or recognized based on the information available at the time of IRB approval or new information revealed while the study is underway. The risk of harm includes but is not limited to physical, psychological, economic or social harm.

Suspension

Suspension is an action taken by the convened IRB, the IRB chair, a federal agency, a sponsor or a sponsor-investigator to temporarily stop some or all approved research activities in order to protect participants pending completion of an investigation. Suspended studies remain open until the convened IRB or applicable federal agency determines to lift the suspension or terminate the study or some activities of the study.

Termination

Termination is an action taken by the convened IRB, the IRB chair, a federal agency, a sponsor or a sponsor-investigator to permanently stop all research activities in an approved research study.

Unanticipated Adverse Device Effects

Unanticipated adverse device effects are any serious adverse effects on health or safety, 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 FDA Investigational Device Exemption application; or any other unanticipated serious problem associated with a device that relates to the rights, safety or welfare of subjects.

Unanticipated Problem Involving Risks to Participants or Others

An unanticipated problem is any incident, experience or outcome in the course of human subjects research that:

• is unexpected (in terms of nature, severity or frequency);
• is related or possibly related to participation in research; and
• suggests that the research places participants or others at greater risk of harm (including physical, psychological, economic or social harm) than was previously known or recognized.

Unexpected

An adverse event may be unexpected (in terms of nature, severity or frequency) given the research procedures described in the IRB-approved study documents and the characteristics of the enrolled participant population.

Unexpected Adverse Event (AE)

Any AE occurring in one or more participants in a research study, the nature, severity or frequency of which:

• is not considered consistent with either the known or foreseeable risk of AEs associated with the procedures involved in the research that are described in the protocol-related documents, investigator brochure, informed consent document, or other relevant sources of information regarding the research, such as product or device labeling and package inserts; or
• is not considered consistent with the expected natural progression of any underlying disease, disorder, or condition of the participant(s) experiencing the AE and the participant’s predisposing risk factor profile for the AE.